0A4F4F9BD490A749D5437F821CF06DF1
GCC Book
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator crime:
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p.(None): The most relevant fairness concepts in global research ethics are fairness in exchange and corrective
p.(None): fairness. In global collaborations, at least two parties are involved in a range of transactions. Typical fairness
p.(None): issues between partners from high-income countries (HICs) and those from low- and middle-income countries (LMICs) are:
p.(None): • Is the research relevant to local research needs?
p.(None): • Will benefit sharing take place?
p.(None): • Are authors from LMICs involved in publications?
p.(None):
p.(None): 5 Local communities and research participants should be included throughout the research process, wherever possible,
p.(None): from planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly represented.
p.(None): This approach represents Good Participatory Practice.
p.(None): 6 Local researchers should be included, wherever possible, throughout the research process, includ- ing in study
p.(None): design, study implementation, data ownership, intellectual property and authorship of publications.
p.(None):
p.(None): The Four Values
p.(None): 21
p.(None):
p.(None): Fairness in
p.(None): exchange
p.(None): • establishes the equity of transactions between at least two parties.
p.(None):
p.(None): Distributive fairness
p.(None): • deals with the division of existing, scarce resources among qualifying recipients.
p.(None):
p.(None): Corrective fairness
p.(None): • rights a wrong that one has brought upon another, often through a court.
p.(None):
p.(None): Retributive fairness
p.(None): Fig. 3.2 Types of fairness
p.(None): • establishes which punishment is appropriate for any given crime.
p.(None):
p.(None): These are questions about fairness in exchange. For instance, LMIC research participants contribute to the progress of
p.(None): science, but this is only fair if the research is relevant to their own community or if other benefits are received
p.(None): where this is not possible. For instance, to carry the burden of a clinical study is only worthwhile for a community if
p.(None): the disease under investigation occurs locally and the end product will become available locally.
p.(None): Corrective fairness, which presupposes the availability of legal instruments and access to mechanisms to right a wrong
p.(None): (e.g. a complaints procedure, a court, an eth- ics committee) is also important in global research collaborations. For
p.(None): instance, if no host country research ethics structure exists, corrective fairness is limited to the research ethics
p.(None): structure in the HIC, which may not have the capacity to make cul- turally sensitive decisions.
p.(None): The broader question of what HICs owe LMICs falls under distributive fairness. One can illustrate the difference
p.(None): between fairness in exchange and distributive fair- ness using the example of post-study access to successfully tested
p.(None): drugs. In the first case (fairness in exchange) one could argue that research participants have contrib- uted to the
...
Searching for indicator illegal:
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p.(None): article 7:
p.(None): Medical research is subject to ethical standards that promote and ensure respect for all human subjects
p.(None): and protect their health and rights. (emphasis added)
p.(None): Its ubiquitous use does not, however, mean that “respect” is a clear term. In everyday life, it is used in
p.(None): the sense of deep admiration. For instance, somebody could say, “I respect the achievements of Nelson Mandela”.
p.(None): However, that is not what is meant by respect in research ethics. The statement from the Declaration of Helsinki does
p.(None): not mean that research participants must be admired. To be respected in research ethics is almost the opposite. It
p.(None): means that one must accept a decision or a way of approaching a matter, even if one disagrees strongly. A case in point
p.(None): would be respecting the decision of a competent adult Jehovah’s Witness to refuse a blood transfusion for reasons of
p.(None): religious belief, even if this means certain death.
p.(None): Respect is therefore a difficult value, as there will be cases where one cannot accept another’s decision. For
p.(None): instance, if a researcher learns about female genital mutilation being used as a “cure” for diarrhoea in female babies
p.(None): (Luc and Altare 2018), respecting this approach to health care is likely to be the wrong decision – particularly as the
p.(None): practice is probably illegal. But the fact that respect may be dif- ficult to operationalize in global research
p.(None): collaborations does not mean that it is a value one can dispense with.
p.(None): There are many possible ways of showing respect that do not create conflicts of conscience. For instance, illiterate
p.(None): San community members should not be enrolled in research studies unless San leaders have been contacted first, in
p.(None): accordance with com- munity systems. And researchers from HICs should not insist that LMIC ethics com- mittees accept
p.(None): the format of the researchers’ preferred ethics approval submission; instead the HIC researchers should submit the
p.(None): study for approval in the format required by the LMIC committee. This shows respect in international collaborative
p.(None): research.
p.(None): While it may be difficult to imagine a situation where an HIC researcher is accused of being too fair, too
p.(None): honest or too caring, it is possible to be accused of being “too respectful” – for instance, if one tolerates major
p.(None): violations of human rights. It is indeed sometimes difficult to strike a balance between dogmatically
p.(None): imposing one’s own approach and carelessly accepting human rights violations, but that is the balance researchers
p.(None): should strive for.
p.(None):
p.(None):
p.(None): Care
p.(None):
p.(None): Sometimes one word describes different concepts. This is the case with “care”. The statement, “I care for my
p.(None): grandfather,” can mean two diametrically opposed things. First, it could mean that the person is very attached to her
p.(None): grandfather even though she hardly ever sees him. Second, it could mean that she is the person who injects
p.(None):
...
p.(None):
p.(None): Our Findings
p.(None): 43
p.(None):
p.(None): shows the primary risks related to corrective fairness for persons, institutions, com- munities, countries, animals and
p.(None): the environment.
p.(None): Individuals who are harmed by their participation in research may have no means of seeking retribution or compensation
p.(None): if they cannot afford legal representation and there is no form of legal aid. For communities, a lack of awareness and
p.(None): expertise, or too much trust in the HIC researchers, may lead to the loss of intellectual property rights (IPRs) to
p.(None): local knowledge and resources. At a national and international level, researchers from HICs who choose to ignore or
p.(None): flout the research ethics and legal requirements in the host LMIC can be difficult to police. This is especially
p.(None): problem- atic in localities where there is a lack of resources and/or infrastructure to ensure ethical compliance
p.(None): through the entire research process and where the home institu- tions in HICs do not ensure that their employees comply
p.(None): with requirements.
p.(None):
p.(None):
p.(None): Respect
p.(None):
p.(None): Respect requires an acceptance of customs and cultures that may be different from one’s own, and a commitment not to
p.(None): behave in a way that causes offence. One may need to abide by decisions or ways of approaching matters with which one
p.(None): dis- agrees. This can be problematic, especially if local customs are illegal or perceived as dangerous.6 However,
p.(None): respect is important in LMIC-HIC collaborations, and there are many possible ways of showing respect that do not
p.(None): create conflicts of con- science. For instance, HIC researchers should not insist that LMIC ethics commit- tees accept
p.(None): the ethics approval submission in the HIC’s preferred format, but should rather conform with the format preferred by
p.(None): the LMIC committee. Table 5.3 shows the primary risks related to respect for persons, institutions, communities,
p.(None): countries, animals and the environment.
p.(None): Local LMIC customs, traditions, and religious and spiritual beliefs may be very different from those of the HIC
p.(None): researcher. For example, from an African cultural point of view, human body parts are sacred, whether they are obtained
p.(None): from living or deceased persons. Hence, the removal of blood or other body parts for research may have a profound
p.(None): impact that needs to be acknowledged and addressed in a man- ner that is sensitive to the wishes of the local
p.(None): community. A liberal interpretation of autonomy, i.e. individual autonomy, prevails in HICs but may not be
p.(None): easily transferred to LMIC settings where “community” or “group autonomy” is also highly valued. Furthermore,
p.(None): in some settings it might be deemed rude for a research participant to say “no” or to ask questions about the research.
p.(None): In other situations, people may be too afraid or unconfident to do so. Either way, the power imbalance between
p.(None): researcher and research participant can impact upon the consent process.
p.(None):
p.(None): 6 For instance, if a researcher learns that female genital mutilation is being used as a “cure” for diarrhoea in female
p.(None): babies, respecting this approach to health care is likely to be the wrong deci- sion, particularly as the practice is
p.(None): likely illegal. At the very least such a decision would leave the researcher with a serious conflict of conscience (Luc
p.(None): and Altare 2018).
p.(None):
p.(None): 44 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): Table 5.3 Primary risks for respect
p.(None): Level of risk Nature of risk
p.(None): Personal • Unequal power relations
p.(None): • Tendency to defer to authorities
p.(None): • Individual spiritual and religious priorities incompatible with or ignored by HIC partners
p.(None): • Researchers and/or ethics committees deciding “what is best”
p.(None):
p.(None): Researcher/ institutional
p.(None): • Research protocol and papers imported from HIC partners and not tailored to local needs
p.(None): • Ethical approval sought only from HIC partner
p.(None): Community • Diverse interpretations of important values
p.(None): • Local requirements for effective community engagement ignored
p.(None): • Diverse ethical priorities for matters such as:
p.(None): - gender equality
p.(None): - sexual relations
p.(None): • Particular spiritual and religious priorities incompatible with or ignored by Northern partners
p.(None): • Localized social effects from research team presence
p.(None): • Local customs that may violate laws of the country and/or human rights Country • Research protocols and
p.(None): practices which fail to take account of national
p.(None): traditions and legislation
...
p.(None): programme devel- opment and partnerships. PHDA’s programmes are implemented by a collaborative group of scientists and
p.(None): public health professionals from the University of Manitoba (Canada), the University of Nairobi and the government of
p.(None): Kenya. Its work focuses mainly on HIV prevention, treatment and care, research, capacity-building and
p.(None): training.
p.(None): The Sex Workers Outreach Programme (SWOP) is a PHDA initiative that under- takes active community engagement and
p.(None): provides clinical and preventative services to 33,000 sex workers residing in Nairobi. These sex workers would
p.(None): otherwise find access to medical services in public health facilities extremely limited due to stigma and
p.(None): discrimination. Those enrolled in the sex workers cohort for HIV prevention services are free to volunteer for
p.(None): available research studies after providing informed consent. Most studies are on the epidemiology of sexually
p.(None): transmitted diseases, and on host genetic factors that influence infectivity and disease progression.
p.(None): Given that sex work is illegal in Kenya, we cannot assign input to specific, named individuals here. Suffice to say
p.(None): that the personal contributions of courageous and admirable sex workers, both female and male, provided the TRUST team
p.(None): not only with practical advice that took shape in specific articles of the GCC, but also with inspiration. Table 6.4
p.(None): presents two examples of issues raised by the Nairobi sex workers (Chatfield et al. 2016a) that were implemented in the
p.(None): GCC.
p.(None):
p.(None): 64 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.4 Input from sex workers and GCC connection
p.(None): Issues raised by sex workers Relevant GCC Article
p.(None):
p.(None): “We need feedback to the community from the research in simple and non-scientific language. Some results have been
p.(None): shared with us in the past, but I did not know what they meant. Do not give us results in scientific language. It puts
p.(None): us at risk if we do not understand the results. … Come back with the results and tell us how we can make our lives
p.(None): better.”
p.(None): “We know that the samples that are collected from us are sometimes sent to other countries. What happens to them? In my
p.(None): culture – if my blood is taken, it must come back to me and I bury it. … [L]ocal and cultural values should be taken
p.(None): into account.”
...
p.(None): research. He asked: “Who consents on behalf of animals?”
p.(None): There are currently no globally agreed ethical standards for research involving animal experimentation, and regulation
p.(None): varies from country to country. In the EU, animal experiments are governed by Directive 2010/63/EU, known as the Animal
p.(None): Experiments Directive, which stipulates measures that must be taken to replace, reduce and refine (the “Three
p.(None): Rs”12) the use of animals in scientific research. Among other requirements, it lays down minimum standards for housing
p.(None): and care and regu-
p.(None):
p.(None):
p.(None):
p.(None): 12 The “Three Rs” are the underpinning requirements of most policies and regulations in animal research:
p.(None): → Replacement: Methods that avoid or replace the use of animals.
p.(None): → Reduction: Methods that minimize the number of animals used per experiment.
p.(None): → Refinement: Methods that minimize suffering and improve welfare.
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 65
p.(None):
p.(None): lates the use of animals through systematic project evaluation that requires the assessment of pain,
p.(None): suffering, distress and lasting harm caused to the animals.
p.(None): Some researchers knowingly exploit variations in standards and opt to conduct animal studies in LMICs because it
p.(None): is cheaper and/or because regulation is less strict than in HICs (Morton and Chatfield 2018). For example,
p.(None): researchers might conduct experiments on non-human primates in an LMIC setting that would be illegal in
p.(None): their HIC home country.
p.(None): For research collaborations between groups in different countries, partners may find that they are confronted with
p.(None): different ethical standards for animal experimen- tation. In such cases ethical standards should comply with the
p.(None): highest ethical stan- dards rather than be adjusted to the lowest common denominator. Hence the GCC states that
p.(None): standards for animal research in international collaborative research must comply with those that are more
p.(None): demanding and protective of animal welfare (article 17).
p.(None):
p.(None):
p.(None):
p.(None): External Engagement with Research Ethics Committees
p.(None):
p.(None): The main engagement meetings with research ethics reviewers and chairs of research ethics committees took
p.(None): place in India (2016) and Kenya (2017).
p.(None): The Forum for Ethics Review Committees in India is led by Dr Vasantha Muthuswamy, who was responsible
p.(None): for issuing the Indian Council of Medical Research’s Ethical Guidelines for Biomedical Research on Human Subjects
p.(None): in 2000 and the revised version, Ethical Guidelines for Biomedical Research on Human Participants, in 2006,
p.(None): and also contributed to the most recently launched version in 2017. At her invitation, 30 leading bioethicists from
p.(None): India came together with guests from Europe in a two-day workshop in Mumbai in 2016. This workshop, which was attended
...
p.(None): exacerbated.
p.(None): The relationship between the person who brings the complaint and the bureau- cracies to which they must direct
p.(None): their complaint can be a factor (Cowan and Halliday 2003). This relationship can either encourage or
p.(None): discourage a potential complainant’s trust in complaints mechanisms. The power imbalance between par- ties in such
p.(None): relationships can be substantial. For example, when working with impoverished communities, HIC researchers
p.(None): should be aware that participation in a clinical study may provide a participant’s only access to health care or other
p.(None): much- needed benefits. Fear of retribution is often cited as a barrier to making a complaint, particularly in
p.(None): circumstances where the complainant has an ongoing relationship with the complainee (HPC 2009). In situations where
p.(None): there is a power imbalance, people may not have the confidence to complain; they may be reluctant to seem ungrateful,
p.(None): not wish to be seen as a complainer, or fear loss. Research has shown that some people even reconstruct negative
p.(None): experiences in a positive light in order to maintain relationships (Edwards et al. 2004).
p.(None): In addition to the above, participatory engagement activities in the TRUST proj- ect (Chapter 6) have revealed the
p.(None): following factors that could also act as barriers to research participants making complaints about research activities
p.(None): in LMICs:
p.(None): • Fear of damage or stigmatization from loss of confidentiality or anonymity. In Kenya, for example, where sex work
p.(None): is illegal, sex workers may be reluctant to make any formal complaints.
p.(None): • Cultural norms that preclude complaining. In some cultures, it is not acceptable to make complaints, especially
p.(None): to or about visitors and/or those in authority. Complaining may be perceived as disrespectful, ungrateful or
p.(None): inappropriate.
p.(None): • Illiteracy of research participants and communication (language) difficulties, leading to a lack of
p.(None): understanding of reasonable rights relating to informed con- sent and to reasonable expectations of the research.
p.(None):
p.(None): Developing an Accessible Complaints Procedure 101
p.(None):
p.(None): • Inability to access the means by which to file a complaint: for example, if only an email address is provided as a
p.(None): contact and one has no access to computers or internet connections.
p.(None):
p.(None):
p.(None): The Scope of a Complaints Procedure
p.(None):
p.(None): A comprehensive complaints procedure can have a broad scope; it can be used to complain about any activities that are
p.(None): associated with a research study. These may include, for example:
p.(None): • any perceived deviation from the information provided
p.(None): • any deviation from agreed processes
p.(None): • treatment by members of the research team that is considered inappropriate
...
p.(None): Exploitation, 2, 3, 14, 24, 37–49, 54, 58, 60,
p.(None): 62, 63, 65, 66, 74, 82, 83, 105
p.(None): Exploitative, 19, 38, 40, 41
p.(None):
p.(None):
p.(None): F
p.(None): Fairness, 2, 5–7, 13–24, 27–31, 33, 40–43, 68,
p.(None): 70, 74, 77–78, 82, 84, 90, 93, 95–98,
p.(None): 102, 110–112, 117
p.(None): Index
p.(None):
p.(None): Fair research contract (FRC), 90, 103, 104
p.(None): Farmers, 101
p.(None): Feedback, 6, 8, 20, 41, 48, 61, 63, 64, 83,
p.(None): 96, 105
p.(None): Four values framework, 13–24, 30, 102 Free and prior informed consent, 7, 66 Funders, 53–58, 60, 61, 70, 79, 116
p.(None):
p.(None):
p.(None): G
p.(None): Gender, 44, 49, 61, 100
p.(None): Genetic research, 54, 74, 92
p.(None): Genetics, 2, 7, 13, 60, 62, 63, 74, 75,
p.(None): 81, 82
p.(None): Global Code of Conduct for Research in Resource-Poor Settings, 2, 5, 14, 27,
p.(None): 37, 51, 80, 89, 109, 115–117
p.(None): Good Participatory Practice, 6, 20, 63
p.(None):
p.(None):
p.(None): H
p.(None): Harm, 1, 17, 19, 28, 34, 35, 38, 43, 45–47, 54,
p.(None): 65, 73, 75, 84, 95, 98
p.(None): Health and safety, 9, 10
p.(None): HealthyXvolunteers, 63
p.(None): Helicopter research, 23, 41
p.(None): High-income countries (HICs), 2, 9, 20–23,
p.(None): 38–44, 47, 48, 56, 65, 70, 99–101, 104
p.(None): Honesty, 2, 5, 6, 10–11, 13–24, 27–31, 33, 40,
p.(None): 46–48, 68, 70, 74, 82, 83, 90, 93,
p.(None): 95–98, 102, 110–112
p.(None): Horizon 2020, 23, 52, 53
p.(None): Human participants, 65, 117
p.(None): Human rights, 22, 42, 44, 55, 75
p.(None):
p.(None):
p.(None): I
p.(None): Ideals, 3, 16, 17, 24, 32
p.(None): Illegal, 22, 43, 63, 65, 100
p.(None): Illiterate populations, 22, 47
p.(None): Incrimination, 9, 11, 68
p.(None): India, 39, 44, 56, 61, 65, 110, 111, 115, 116
p.(None): Indigenous peoples, 49, 55, 63, 73, 75,
p.(None): 80, 112
p.(None): Industry, 39, 54–58, 61, 69, 70, 117
p.(None): Inequalities, vii
p.(None): Information sheets, 24, 47, 98, 103
p.(None): Informed consent, 2, 7, 8, 24, 44–47, 63, 66,
p.(None): 74, 82, 84, 100, 105
p.(None): Integrity, 5, 23, 24, 46–48, 53, 67, 70, 74,
p.(None): 78–79, 82, 85, 86, 94, 112, 117
p.(None): Intellectual property, 6, 20, 43, 60, 66,
p.(None): 80, 104
p.(None):
p.(None): Index
p.(None): 121
p.(None):
p.(None):
p.(None): K
p.(None): Kenya, 2, 39, 40, 42, 61, 63, 65, 100, 110,
p.(None): 115, 116
p.(None): !Khomani, 74, 77, 78, 81, 86
p.(None): Khwe, 74, 77, 78, 81
p.(None): Knowledge holders, 7, 55, 66
p.(None):
p.(None):
p.(None): L
p.(None): Lawyers, 79, 80, 104
p.(None): Legal framework, 45, 55
p.(None): Legal support, 74, 79, 80, 85, 105
p.(None): Local communities, 6, 7, 9, 20, 27, 40,
p.(None): 42–45, 52, 61, 63, 64, 69, 90, 92,
p.(None): 94–98, 105
p.(None): Local relevance, 6, 17, 60–62, 68, 102, 105
p.(None): Local researchers, 6, 7, 10, 20, 27, 40, 48, 60,
p.(None): 64, 66, 94, 96, 101
p.(None): Low- and middle-income countries (LMICs), 2, 20–22, 37–44, 46–48, 55, 56, 58, 61,
p.(None): 62, 65, 66, 69, 70, 99–105
p.(None):
p.(None):
p.(None): M
p.(None): Majengo, 63
p.(None): Medical research, 22, 23, 41, 45, 57, 65, 66,
p.(None): 104, 111, 116, 117
p.(None): Metaethical relativism, 30–32
p.(None): Misconduct, 8, 47, 105
p.(None):
p.(None):
p.(None): N
p.(None): Non-compliance, 1
...
Political / Indigenous
Searching for indicator indigenous:
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xvii
p.(None):
p.(None): Abbreviations
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ACF Action contre la Faim
p.(None): CBD UN Convention on Biological Diversity COHRED Council on Health Research for Development EC
p.(None): European Commission (EC)
p.(None): EDCTP European and Developing Countries Clinical Trials Partnership EFPIA European Federation of
p.(None): Pharmaceutical Industries and Associations FERCI Forum for Ethics Review Committees in India
p.(None): GCC Global Code of Conduct for Research in Resource-Poor Settings GVA Global Values Alliance
p.(None): HIC high-income country
p.(None): Inserm Institut national de la santé et de la recherche médicale IPR intellectual property
p.(None): rights
p.(None): LMICs low- and middle-income countries NGO nongovernmental organization
p.(None): PHDA Partners for Health and Development in Africa REC research ethics committee
p.(None): SASC South African San Council SASI South African San Institute
p.(None): SWOP Sex Workers Outreach Programme
p.(None): UNESCO United Nations Educational, Scientific and Cultural Organization WIMSA Working Group of Indigenous
p.(None): Minorities in Southern Africa
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xix
p.(None):
p.(None): Chapter 1
p.(None): Ethics Dumping and the Need for a Global Code of Conduct
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The UN’s 2030 Agenda for Sustainable Development calls for more research and innovation to end
p.(None): poverty, leaving no one behind – and yet the export of unethical practices from high-income to lower-income settings is
p.(None): still a major concern. Such ethics dumping occurs in all academic disciplines. When research is regarded, on the one
p.(None): hand, as a dirty word among vulnerable populations who face ethics dumping, and, on the other, as a solution to many of
p.(None): humanity’s problems, how can the resulting gulf be bridged? This book describes one initiative to counter ethics
p.(None): dumping: the development and promotion of the Global Code of Conduct for Research in Resource-Poor Settings.
p.(None):
p.(None): Keywords Ethics dumping · Global research ethics · Exploitation · Vulnerability · Research governance
p.(None):
p.(None):
p.(None): Research has become a global enterprise. Individual researchers around the world are encouraged to be as mobile as
p.(None): possible (Sugimoto et al. 2017). At the same time, the activities of mobile researchers have made research “one of the
p.(None): dirtiest words in the indigenous world’s vocabulary” (Tuhiwai Smith 1999: 1). The indigenous com- munities in which
p.(None): Tuhiwai Smith, a Māori professor, grew up saw research as some- thing that “told us things already known, suggested
p.(None): things that would not work, and made careers for people who already had jobs” (Tuhiwai Smith 1999: 3).
p.(None): There is a gulf between those advocating more researcher mobility because “sci- ence is the engine of prosperity”
p.(None): (Rodrigues et al. 2016) and those who argue that research can represent harmful “visits by inquisitive and
p.(None): acquisitive strangers” (Tuhiwai Smith 1999: 3). When concerns about ethics dumping1 are added, this gulf becomes
p.(None): almost unbridgeable.
p.(None):
p.(None):
p.(None): 1 The term was introduced by the Science with and for Society Unit of the European Commission: “Due to the progressive
p.(None): globalisation of research activities, the risk is higher that research with sensitive ethical issues is conducted by
p.(None): European organisations outside the EU in a way that would not be accepted in Europe from an ethical point of view. This
p.(None): exportation of these non-compliant research practices is called ethics dumping” (European Commission nda).
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 1
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_1
p.(None):
p.(None): 2 1 Ethics Dumping and the Need for a Global Code of Conduct
p.(None):
p.(None): There are two main reasons for ethics dumping – that is, the export of unethical research practices from a high-income
p.(None): to a resource-poor setting. The first is inten- tional exploitation, where research participants and/or resources in
p.(None): low- and middle- income countries (LMICs) are exploited on purpose because the research would be prohibited in the
p.(None): high-income country (HIC). The second is exploitation based on insufficient knowledge or ethics awareness on the part
p.(None): of the mobile researcher. In both cases a lack of adequate oversight mechanisms in the host LMIC is likely to
p.(None): exacerbate the problem (Schroeder et al. 2018).
p.(None): Examples of ethics dumping in the 21st century include:
p.(None): • In clinical research, misinterpreting the standard of care, leading to the avoidable deaths of research
p.(None): participants (Srinivasan et al. 2018).
p.(None): • Research among indigenous populations that led to the publication of “private, pejorative, discriminatory and
p.(None): inappropriate” conclusions and a refusal to engage with indigenous leaders on the informed consent process
p.(None): (Chennells and Steenkamp 2018).
p.(None): • The export of valuable blood samples from a rural area in China to a US genetic bank, leading to a large amount of
p.(None): research funding for the US team (Zhao and Zhang 2018).
p.(None): • The use of wild-caught non-human primates in research by a UK researcher who undertook his experiments in Kenya,
p.(None): thus “bypassing British law” (Chatfield and Morton 2018).
p.(None): • An attempt to seek retrospective ethics approval for a highly sensitive social sci- ence study undertaken among
p.(None): vulnerable populations following a local Ebola crisis (Tegli 2018).
p.(None): How can one reconcile recent cases of ethics dumping with our generation’s highly ambitious call for more
p.(None): research and innovation? The United Nations 2030 Agenda for Sustainable Development aims “to end all forms of poverty…
p.(None): while ensuring that no one is left behind” (UN ndb). To achieve these aims, the UN encourages “fostering
p.(None): innovation” (Goal 9 of Agenda 2030), as “without innovation
p.(None): …, development will not happen” (UN nda).
p.(None): This book describes one initiative to counter ethics dumping: the development and promotion of the Global Code of
...
p.(None): provides guidance across all disciplines. It is based on a new ethical framework that is predicated on the values of
p.(None): fairness, respect, care and honesty; values that are imperative for avoiding ethics dumping. The GCC opposes all double
p.(None): standards in research and supports long-term equitable research relationships between partners in lower-income
p.(None): and higher-income set- tings. This book introduces the GCC in the following manner:
p.(None): • Chapter 2 reproduces the GCC as launched in the European Parliament in June 2018 and adopted as a mandatory
p.(None): reference document by the European Commission (ndb).
p.(None):
p.(None): References
p.(None): 3
p.(None):
p.(None): • Chapter 3 explains why values rather than standards, principles, virtues or ideals provide the best guidance in the
p.(None): fight against ethics dumping.
p.(None): • Chapter 4 answers a philosophical question: how can the GCC can be defended against claims of moral relativism?
p.(None): • Chapter 5 details 88 risks for ethics dumping, the analytical foundation of the GCC.
p.(None): • Chapter 6 describes how the GCC was built, from extensive stakeholder engage- ments to its final translation into
p.(None): Russian, French, Spanish, German, Portuguese, Mandarin, Japanese and Hindi.
p.(None): • Chapter 7 recounts the history of the San Code of Research Ethics, sister code of the GCC and the first ethics code
p.(None): launched by an indigenous group on the African continent.
p.(None): • Acknowledging that an ethics code is not enough on its own to counter ethics dumping, Chapter 8 offers advice on
p.(None): community engagement, workable com- plaints procedures and negotiating fair contracts.
p.(None): • Chapter 9 presents a brief conclusion.
p.(None): • The names of the 56 authors of the GCC are set out in the Appendix.
p.(None): Can an ethics code overcome ethics dumping and bridge the gulf between those for whom international collaborative
p.(None): research is exploitation by strangers, and those who believe it is essential to end all poverty? That is the hope of
p.(None): the authors of the GCC.
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Chatfield K, Morton D (2018) The use of non-human primates in research. In: Schroeder D, Cook J, Hirsch F, Fenet S,
p.(None): Muthuswamy V (eds) Ethics dumping: case studies from North-South research collaborations, Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 81–90
p.(None): Chennells R, Steenkamp A. (2018) International genomics research involving the San people. In: Schroeder D, Cook J,
p.(None): Hirsch F, Fenet S, Muthuswamy V (eds) Ethics dumping: case stud- ies from North-South research collaborations,
p.(None): Springer Briefs in Research and Innovation Governance, Berlin, p 15–22
...
p.(None): participants/docs/h2020-funding-guide/cross-cutting-issues/ethics_en.htm
p.(None): Rodrigues ML, Nimrichter L, Cordero RJB (2016) The benefits of scientific mobility and interna- tional collaboration.
p.(None): FEMS Microbiology Letters 363(21):fnw247. https://academic.oup.com/ femsle/article-lookup/doi/10.1093/femsle/fnw247
p.(None): Schroeder D, Cook J, Hirsch F, Fenet S, Muthuswamy V (eds) (2018) Ethics dumping: case stud- ies from North-South
p.(None): research collaborations. Springer Briefs in Research and Innovation Governance, Berlin
p.(None): Srinivasan S, Johari V, Jesani A (2018) Cervical cancer screening in India. In: Schroeder D, Cook J, Hirsch F, Fenet S,
p.(None): Muthuswamy V (eds) Ethics dumping: case studies from North-South research collaborations. Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 33–47
p.(None):
p.(None): 4 1 Ethics Dumping and the Need for a Global Code of Conduct
p.(None):
p.(None): Sugimoto CR, Robinson-Garcia N, Murray DS, Yegros-Yegros A, Costas R and Larivière V (2017) Scientists have most impact
p.(None): when they’re free to move. Nature 550(7674):29–31
p.(None): Tegli J (2018) Seeking retrospective approval for a study in resource-constrained Liberia. In: Schroeder D,
p.(None): Cook J, Hirsch F, Fenet S, Muthuswamy V (eds) Ethics dumping: case stud- ies from North-South research
p.(None): collaborations. Springer Briefs in Research and Innovation Governance, Berlin, p 115-119
p.(None): Tuhiwai Smith, Linda (1999) Decolonizing methodologies: research and indigenous Peoples. Zed Books, London and New York
p.(None): UN (ndb) The sustainable development agenda. Sustainable Development Goals. https://www.
p.(None): un.org/sustainabledevelopment/development-agenda/
p.(None): UN (nda) Goal 9. Sustainable Development Goals. https://www.un.org/sustainabledevelopment/
p.(None): infrastructure-industrialization/
p.(None): Zhao Y, Zhang W (2018) An international collaborative genetic research project conducted in China. In:
p.(None): Schroeder D, Cook J, Hirsch F, Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North-South research
p.(None): collaborations. Springer Briefs in Research and Innovation Governance, Berlin, p 71–80
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
...
p.(None): Researchers cannot solve this problem, but they can show heightened awareness of it and try their best to promote local
p.(None): improvements, for example by equitably involving local research- ers, by focusing their research on local research
p.(None): needs and by obtaining input from local populations.
p.(None):
p.(None):
p.(None): Extreme Differentials in Power
p.(None):
p.(None): The relationship between wealth and power, and the differentials in power between those who are wealthy and those who
p.(None): live in poverty, is a topic that has filled books, halls and television programmes. However, other factors also
p.(None): play a part in
p.(None):
p.(None):
p.(None): 8 Many academic journals that publish results from animal experimentation stipulate requirements that the studies have
p.(None): been conducted in a manner that is consistent with high ethical standards such as EU Directive 2010/63 (EU 2010).
p.(None):
p.(None): References
p.(None): 49
p.(None):
p.(None): maintaining power differentials. To give one striking example, the United Nations Security Council has 15 members. Of
p.(None): these, ten are elected by the General Assembly for periods of two years while five (China, France, Russia, the United
p.(None): Kingdom and the United States) have been permanent members with “veto power” since 1946. More than 60 United
p.(None): Nations member states have never been members of the Security Council and hence have never even had voting
p.(None): rights, let alone veto power.
p.(None):
p.(None):
p.(None): Past History of Colonialism
p.(None):
p.(None): Does the history of colonialism still bear upon research today? We believe it does, as can be seen from the experience
p.(None): of indigenous peoples in research. Linda Tuhiwai Smith has powerfully shown that indigenous peoples often
p.(None): consider research a “dirty word”. She describes how “imperialism frames the indigenous experience” and how
p.(None): “indigenous peoples had to challenge, understand and have a shared lan- guage for talking about ... colonialism” (Smith
p.(None): 2012).
p.(None): We close this chapter with a comment from the TRUST gender adviser, Prof.
p.(None): Fatima Alvarez-Castillo (2016):
p.(None): A culture’s worldview, expressed in language, contains norms and values about power and relations of power. For
p.(None): example, the word “expert” imbues persons with authority and assigns higher credibility to their claims than
p.(None): those of non-experts. The public is expected to defer to their opinions on matters of their expertise. It was not until
p.(None): about the 1960s when the usual understanding of expertise was challenged by feminists, who argued that
p.(None): unschooled women have more expertise about their own situation than the experts. This ushered in a new research
p.(None): philosophy that valorizes poor women’s stories and their own versions of their realities.
p.(None):
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Alvarez-Castillo F (2016) Gender sensitivity: writing and language. In: Chatfield K, Schroeder D, Kimani J (eds)
p.(None): Nairobi plenary meeting report, TRUST Project. http://trust-project.eu/wp-
p.(None): content/uploads/2016/11/Meeting-Report-TRUST-Nairobi-Final.pdf
...
p.(None): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32010L0063
p.(None): Hill CM, Webber AD (2010) Perceptions of nonhuman primates in human–wildlife conflict sce- narios. American Journal of
p.(None): Primatology 72(10):919−924
p.(None): Hughes J (2010) European textbook on ethics in research. European Commission, Brussels
p.(None):
p.(None): 50 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): Luc G, Altare C. (2018) Social science research in a humanitarian emergency context. In: Schroeder D, Cook J, Hirsch F,
p.(None): Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North- South research collaborations, Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 9-14
p.(None): Macklin R (2003) Vulnerability and protection. Bioethics 17(5–6):472–486
p.(None): Pogge T (2006) Justice. In: Borchert DM (ed) Encyclopedia of philosophy, 2nd edn, vol 4.
p.(None): Macmillan Reference, Detroit, pp 862–870
p.(None): Russell WMS, Burch RL, Hume CW (1959) The principles of humane experimental technique.
p.(None): Methuen & Co, London
p.(None): Schwartz J (1995) What’s wrong with exploitation? Nous 29:158–164
p.(None): Stone CD (2010) Should trees have standing? Law, morality, and the environment, 3rd edn. Oxford University Press,
p.(None): Oxford
p.(None): Smith, LT (2012) Decolonizing methodologies: research and indigenous peoples. Zed Books, London
p.(None): Universities UK (2015) The concordat to support research integrity. Universities UK, London Wood A (1995) Exploitation.
p.(None): Social Philosophy and Policy 12:150–151
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 6
p.(None): How the Global Code of Conduct Was Built
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract How can an ethics code achieve impact? The answer is twofold. First, through adoption by influential research
...
p.(None):
p.(None): Table 6.1 Main research stakeholders involved as TRUST budget holders
p.(None): Stakeholder
p.(None): type TRUST partner
p.(None):
p.(None): Research policymakers
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research funders
p.(None): The United Nations Educational, Scientific and Cultural Organization (UNESCO) promotes policy frameworks for research
p.(None): through drafting internationally focused guidelines on scientific co-operation.
p.(None): The “Institut national de la santé et de la recherche médicale”® (Inserm) holds responsibility for the strategic,
p.(None): scientific and operational coordination of French biomedical research.
p.(None): The European and Developing Countries Clinical Trials Partnership (EDCTP) funds research for the prevention and
p.(None): treatment of poverty-related infectious diseases in sub-Saharan Africa.
p.(None): The Swiss-based Global Values Alliance (GVA) is a foundation that focuses on engagement with pharmaceutical industry
p.(None): partners as its main role in the TRUST project
p.(None): Researchers The Centre for Professional Ethics at the University of Central Lancashire is one of the oldest
p.(None): research-only ethics centres in Europe, with specialist expertise in global justice issues.
p.(None): The Bio-Economy Research Chair at the University of Cape Town and her team focus on engagement with communities,
p.(None): indigenous knowledge holders and policymakers to ensure environmentally sustainable poverty reduction. The Law School
p.(None): of the University of the Witwatersrand, Johannesburg, contributed specialist human rights and legal frameworks
p.(None): expertise.
p.(None):
p.(None): Research participants
p.(None):
p.(None):
p.(None): Research advocates (support organizations)
p.(None): Many of the individuals involved in drafting the GCC have previously been research participants. Of particular
p.(None): importance in this process were the indigenous peoples and sex worker representatives who were involved through SASI
p.(None): and PHDA (see “Research communities” below).
p.(None): The Council on Health Research for Development (COHRED) helps promote the health and development of populations in low-
p.(None): and middle- income countries.
p.(None): Action Contre La Faim (ACF) is recognized as one of the leading organizations in the fight against hunger worldwide.
p.(None): ACF undertakes its own research on highly vulnerable populations.
p.(None):
p.(None): 56 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.1 (continued)
p.(None): Stakeholder
p.(None): type TRUST partner
p.(None):
p.(None): Research communities
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research ethics reviewers
p.(None): The South African San Institute (SASI) is dedicated to serving the San communities of southern Africa through legal,
p.(None): advocacy, socio- anthropological and related services.
p.(None): Partners for Health and Development in Africa (PHDA) supports female and male sex workers in the low socio-economic
p.(None): strata who reside in the informal settlements of Nairobi.
p.(None): The Forum for Ethics Review Committees in India (FERCI) promotes the effective implementation of the ethical review of
p.(None): biomedical research studies in India.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): • Advisory board
p.(None): • Engagement panel
...
p.(None): reached through project conferences and consulta- tion meetings.
p.(None):
p.(None):
p.(None): External Engagement with Research Policymakers
p.(None):
p.(None): National research foundations, research councils and government ministries guide the strategic direction of research.
p.(None): Representatives from all of these groups attended the TRUST plenary in Cape Town in 2017, in particular senior
p.(None): representatives from the following national bodies:
p.(None): • The South African Department of Science and Technology
p.(None): • The South African Department of Environmental Affairs
p.(None): • The South African National Research Foundation
p.(None): • The Zimbabwean Agricultural Research Council
p.(None): To give an example of input, articles 17 and 48 of the GCC are directly linked to input from research
p.(None): policymakers. Dr Isaiah Mharapara from the Zimbabwean Agricultural Research Council argued that agricultural
p.(None): research in Africa had largely been based on foreign principles, meaning that the continent’s own crops, fruits,
p.(None): insects, fish and animals had been ignored. Through the historical introduc- tion of Western agricultural systems
p.(None): and cash crops such as tobacco, as well as genetically engineered crops, Africa had failed to develop
p.(None): agricultural solutions adapted to local conditions. According to Dr Mharapara, a lack of financial resources meant
p.(None): that African nations had been, and still were, vulnerable to exploitation by foreign researchers. This had resulted in
p.(None): damage to ecological systems, the loss of soils, fertility, biodiversity and natural resilience, and the
p.(None): erosion of indigenous knowledge. He advocated inclusive, consultative, robust and agreed processes to establish
p.(None): equitable research partnerships (Van Niekerk et al. 2017).
p.(None):
p.(None):
p.(None): External Engagement with Research Funders
p.(None):
p.(None): Estimates for research and development expenditure in the European Union in 2016 indicate that 56.6% of all such
p.(None): expenditure comes from the business sector, 30.9% from the government sector and the remainder mostly from charitable
p.(None): foundations (Eurostat 2018). TRUST’s main consultation workshop for research funders was held in London in 2017
p.(None): and involved all three sectors: public funders, private
p.(None):
p.(None): 7 Local relevance of research … should be determined in collaboration with local partners.
p.(None): 8 Local researchers should be included, wherever possible, throughout the research process, includ- ing in study
p.(None): design, study implementation, data ownership, intellectual property and authorship of publications.
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 61
p.(None): Table 6.3 Good practice input from funders and industry with GCC output
p.(None): Good practice Relevant GCC article
p.(None):
p.(None): Ensuring double ethics review Community
p.(None): engagement
p.(None): Clear roles and responsibilities
p.(None): Article 10: Local ethics review should be sought wherever possible.
p.(None):
p.(None): Article 2: Local communities and research participants should be included throughout the research process.
...
p.(None): between the relevant partners rather than imposed prescriptively by code drafters. Hence, our educational materials
p.(None): future-proof the GCC, as they can be updated in real time for use by early career (or any other) researchers, and,
p.(None): unlike the GCC itself, they are not mandatory.
p.(None):
p.(None):
p.(None): 10 Personal communication from Dr Vasantha Muthuswamy, a TRUST project team member, after a GCC presentation in Taiwan.
p.(None): 11 http://www.globalcodeofconduct.org/
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 63
p.(None):
p.(None): Engagement with Research Participants and Research Communities
p.(None):
p.(None): The inclusion of the perspectives of research participants and research communities who are vulnerable to exploitation,
p.(None): and therefore to ethics dumping, was essential to our bottom-up approach. It is also the ethical approach, as
p.(None): stipulated in article 2 of the GCC:
p.(None): Local communities and research participants should be included throughout the research process, wherever possible, from
p.(None): planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly
p.(None): represented. This approach represents Good Participatory Practice.
p.(None): Two NGO partners in the TRUST project were tasked specifically with ensuring that the voices of vulnerable populations
p.(None): were heard and acted upon. First, the South African San Institute (SASI) made the inclusion of indigenous peoples from
p.(None): South Africa possible. While San leaders and representatives were involved in all the work of the TRUST project,
p.(None): including the drafting of the GCC, the full impact of their contribution is best understood through the account in
p.(None): Chapter 7 of this book of the development of the San Code of Research Ethics. Second, Partners for Health and
p.(None): Development in Africa (PHDA) made the inclusion of sex workers from the Majengo area of Nairobi possible. At this point
p.(None): we will focus on their involvement in order to illustrate the bottom-up approach of the GCC drafting process.
p.(None): PHDA is a nonprofit organization that undertakes work in the fields of health and development in Kenya. Its mission is
p.(None): to increase access to health for disadvantaged communities in Africa by strengthening health systems, research,
p.(None): programme devel- opment and partnerships. PHDA’s programmes are implemented by a collaborative group of scientists and
p.(None): public health professionals from the University of Manitoba (Canada), the University of Nairobi and the government of
p.(None): Kenya. Its work focuses mainly on HIV prevention, treatment and care, research, capacity-building and
p.(None): training.
p.(None): The Sex Workers Outreach Programme (SWOP) is a PHDA initiative that under- takes active community engagement and
...
p.(None): wp-content/uploads/2018/12/TRUST-2nd-Pictorial-Report.pdf
p.(None): Singh M, Makanga M (2017) Funder platform. A report for TRUST. http://trust-project.eu/wp-
p.(None): content/uploads/2017/09/Funder-Platform-Report_20-Sep-2017_funder-approved.pdf
p.(None): Singh M, Schroeder D (2017) Exploitation risks and research ethics guidelines. A report for TRUST.
p.(None): http://trust-project.eu/wp-content/uploads/2016/03/TRUST-Deliverable-Risks- Principles-Final-for-submission.pdf
p.(None): TRUST (2018) Strong speech by Nairobi activist in European Parliament. http://trust-project.eu/
p.(None): strong-speech-by-nairobi-activist-in-european-parliament/
p.(None): United Nations (nda) Goal 3. Sustainable Development Goals. https://www.un.org/
p.(None): sustainabledevelopment/health/
p.(None): United Nations (ndb) Goal 8. Millennium Development Goals. http://www.un.org/millennium- goals/global.shtml
p.(None): Van Niekerk J, Wynberg R (2018) Human food trial of a transgenic fruit. In: Schroeder D, Cook J, Hirsch F, Fenet S,
p.(None): Muthuswamy V (eds) Ethics dumping: case studies from North-South research collaborations. Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 91–98
p.(None): Van Niekerk J, Wynberg R, Chatfield K (2017). Cape Town plenary meeting report. TRUST Project.
p.(None): http://trust-project.eu/wp-content/uploads/2017/08/TRUST-Kalk-Bay-2017-Report- Final.pdf
p.(None): WMA (2013) Declaration of Helsinki. World Medical Association. https://www.wma.net/policies-
p.(None): post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human- subjects/
p.(None): Wynberg R, Schroeder D, Chennells R (2009) Indigenous peoples, consent and benefit sharing: lessons from the San-Hoodia
p.(None): case. Springer, Berlin
p.(None): Youdelis M (2016) “They could take you out for coffee and call it consultation!” The colonial antipolitics of
p.(None): indigenous consultation in Jasper National Park. Environment and Planning A: Economy and Space 48(7):1374–1392
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 7
p.(None): The San Code of Research Ethics
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The San peoples of southern Africa have been the object of much aca- demic research over centuries. In recent
p.(None): years, San leaders have become increas- ingly convinced that most academic research on their communities has been
p.(None): neither requested, nor useful, nor protected in any meaningful way. In many cases dissatis- faction, if not actual
p.(None): harm, has been the result. In 2017, the South African San finally published the San Code of Research Ethics,
p.(None): which requires all researchers intending to engage with San communities to commit to four central values, namely
p.(None): fairness, respect, care and honesty, as well as to comply with a simple process of community approval. The code is the
p.(None): first ethics code developed and launched by an indigenous population in Africa. Key to this achievement were: dedicated
p.(None): San lead- ers of integrity, supportive NGOs, legal assistance and long-term research collabo- rations with key
p.(None): individuals who undertook fund-raising and provided strategic support.
p.(None):
p.(None): Keywords San Peoples · Global ethics · Research ethics · Indigenous peoples · Low-and middle-income countries · Ethics
p.(None): dumping
p.(None):
p.(None):
p.(None): Introduction1
p.(None):
p.(None): The San peoples, widely known as “first” or “indigenous” peoples of southern Africa, have been the object of
p.(None): much academic research over centuries.
p.(None): In recent years San leaders have become increasingly convinced that most aca- demic research on their communities has
p.(None): been neither requested, nor useful, nor protected in any meaningful way. In many cases dissatisfaction, if not actual
p.(None): harm, has been the result. For instance, a genomics study published in 2010, based on the DNA of four San individuals,
p.(None): included conclusions which San community leaders found “private, pejorative, discriminatory and
p.(None): inappropriate” (Chennells and
p.(None):
p.(None):
p.(None):
p.(None): 1 This chapter is based on a longer, illustrated report (Chennells and Schroeder 2019).
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 73
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_7
p.(None):
p.(None): 74 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): Steenkamp 2018). Authors of the paper “refused to provide details about the informed consent process ….
p.(None): [and] defended their denial of the right of the San leadership to further information on the grounds that the research
p.(None): project had been fully approved by ethics committees/institutional review boards” (Chennells and Steenkamp
p.(None): 2018).
p.(None): In March 2017, the South African San launched the San Code of Research Ethics, the first ethics code developed and
p.(None): published by an indigenous community in Africa (Callaway 2017). The code requires all researchers intending to engage
p.(None): with San communities to commit to four central values, namely fairness, respect, care and honesty, as well as to comply
p.(None): with a simple process of community approval.
p.(None): This chapter introduces the San of southern Africa and the main San support institutions involved in producing the San
p.(None): Code of Research Ethics. It goes on to describe key elements in the development and the launch of the code, namely
p.(None): lead- ers of integrity, legal support, supportive research collaborations and the process of drafting. Finally, the
p.(None): code is reproduced in full.
p.(None):
p.(None):
p.(None): The San of Southern Africa
p.(None):
p.(None): The San peoples of Africa are iconic, widely known as the quintessential hunter- gatherers of Africa and said to be the
p.(None): oldest genetic ancestors of modern humans (Knight et al. 2003). Once ranging over the whole of southern Africa, their
p.(None): numbers have now dwindled to approximately 100,000 San living primarily in Botswana, Namibia and South Africa, with
p.(None): small remnant populations in Angola, Zimbabwe and Zambia (Hitchcock et al. 2006). Although they speak at least
p.(None): seven distinct languages2 with numerous subdialects, they nevertheless recognize a common cul- tural identity which
p.(None): is readily identified as a hunter-gatherer heritage, with a shared ancestry also confirmed by genetic research
p.(None): (Soodyall 2006).
p.(None): Prior to 1990, the San peoples lived typically in extended families and small clans in the remote reaches
p.(None): of South Africa, Botswana and Namibia, as well as in smaller scattered populations in Zimbabwe, Zambia and Angola. The
...
p.(None): collective expression of their common inter- ests and concerns (Chennells 2009). Prior to the year 2000, virtually all
p.(None): research was externally conceived, and was perceived by the San as being disruptive and on occasion harmful to the
p.(None): research populations (Chennells and Steenkamp 2018).
p.(None): Internet searches of the words San, Khoisan3 and Bushmen throw up thousands of papers, books and research theses,
p.(None): supporting the assertion that they are among the most researched peoples in the world. Until they formed their own
p.(None): representa- tive organizations, they did not have a unified voice and thus remained powerless to resist unwanted
p.(None): attention from outsiders.
p.(None):
p.(None):
p.(None): Institution Building and Supportive NGOs
p.(None):
p.(None): The most important step towards the San Code of Research Ethics was local institution-building, an
p.(None): initiative that made all further successes possible.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 3 While the term “Khoisan” is frequently used in general discourse as a collective name for two distinct groupings in
p.(None): southern Africa, namely the Khoi, or KhoiKhoi, and the San, this umbrella term is not relevant to a discussion of the
p.(None): San peoples. The Khoi or KhoiKhoi, formerly known in South Africa as Hottentots, are regarded as pastoral, and of more
p.(None): recent origin (Barnard 1992).
p.(None):
p.(None): 76 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): WIMSA: The Catalyst Institution
p.(None):
p.(None): WIMSA (the Working Group of Indigenous Minorities in Southern Africa) has arguably been the most important of
p.(None): a number of San support organizations operat- ing in southern Africa over the past 25 years. Reverend Mario Mahongo,
p.(None): one of the San leaders whose work on the San Code of Research Ethics was crucial, noted of a 1996 workshop: “For the
p.(None): first time we were meeting San leaders from the whole region, and we realised that this new organisation WIMSA could
p.(None): really help our people” (Chennells and Schroeder 2019).
p.(None): Table 7.1 lists the main non-governmental organizations (NGOs) that have pro- vided services to the San in South
p.(None): Africa, Botswana and Namibia.
p.(None): Supported through seed funding from Swedish and Dutch charities, German development worker Axel Thoma and
p.(None): San leaders such as Kipi George and Augustino Victorino promoted the formation of a cross-border, regional
p.(None): organiza- tion to protect the rights of all San peoples in southern Africa. The topics that emerged as
p.(None): clear priorities among San communities were:
p.(None): • Access to land
p.(None): • Benefit sharing for traditional knowledge
p.(None): • Protection of heritage and culture4
p.(None): WIMSA functioned effectively as a regional organization from its inception in 1996 until approximately 2016. The
p.(None): successes of this important San organization in raising awareness and promoting advocacy among the San cannot be
p.(None): overstated.
p.(None):
p.(None): Table 7.1 San support organizations
p.(None): Start year Organization name Organization region 1981
...
p.(None): apartheid government of South Africa and guerrilla fighters in Angola and Namibia. SASI was the partner in the TRUST
p.(None): project which represented the San peoples, and which assisted with the develop- ment of the San Code of Ethics. They
p.(None): hosted all relevant workshops and the launch of the code in Cape Town (see below).
p.(None): The SASC had existed informally since 1996, representing the interests of three South African San communities on the
p.(None): WIMSA board (!Khomani, Khwe, !Xun). It was legally constituted in 2001 so that it could negotiate officially on behalf
p.(None): of the San, and proceeded over the years to become a major success story in San institu- tion building. The SASC
p.(None): negotiated a famous benefit-sharing agreement with South Africa’s Council for Scientific and Industrial Research
p.(None): (CSIR) in relation to the San’s traditional knowledge rights to the Hoodia plant.
p.(None): The global UN Convention on Biological Diversity (CBD) of 1992 was the first instrument to provide for the principle
p.(None): that commercial users of plants with active ingredients based upon traditional knowledge needed to negotiate
p.(None): benefit-sharing agreements with the holders of the traditional knowledge, in order to ensure fair-
p.(None):
p.(None): 78 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): ness. With this development, the San rediscovered the value of their culture and heritage in the form of their
p.(None): traditional knowledge of a wide range of medicinal and other useful indigenous plants. In 2003 the first
p.(None): benefit-sharing agreement was con- cluded with the CSIR.
p.(None): The Hoodia benefit-sharing case achieved seminal status in the CBD world (Wynberg et al. 2009) and can
p.(None): be seen as the first major step taken by the San towards achieving fairness in research. The strong demand
p.(None): for benefit sharing in research is also the reason why fairness is an important, separate value in the San Code of
p.(None): Research Ethics.
p.(None): The importance of the collaboration of SASI (support NGO) and the SASC (rep- resenting San issues directly through
p.(None): San leaders) has been emphasized by the SASC’s director, Leana Snyders:
p.(None): Our relationship with SASI has helped increase our capacity to understand the law, and also to represent our people.
p.(None): With the legal knowledge gained from negotiating benefit sharing agreements resulting from our traditional knowledge,
p.(None): the San have become acknowledged leaders in this field. (Chennells and Schroeder 2019)
p.(None):
p.(None):
p.(None):
p.(None): Leaders of Integrity
p.(None):
p.(None): It is perhaps a truism that collective progress is impossible without leaders of vision and integrity. When the San
p.(None): began their process of institutional development in 1996, they were fortunate to have a group of pioneering
p.(None): leaders who drove and sup- ported the vision to end the isolation of the past and to enter the
p.(None): organizational modern world. The San were blessed during this period with strong leaders, some of whom are still
p.(None): active, who had the wisdom to support change and the ability to engender consensus among sometimes differing opinions
...
p.(None): institution building around their rights?
p.(None): 5. As the San community wishes to assist others in developing their own codes, how can such efforts be funded?
p.(None):
p.(None):
p.(None): Legal Support
p.(None):
p.(None): Many of the important steps undertaken along the path of community empowerment require legal support or intervention.
p.(None): The formulation of constitutions, leases and basic legal documents underpinning salaried appointments, and the drafting
p.(None): of basic agreements with government, funders and other external actors all require the ser- vices of a lawyer to
p.(None): protect the San’s interests.
p.(None): WIMSA and SASI have, from the outset, retained the services of an in-house lawyer. This ensures that they receive basic
p.(None): institutional legal support, as well as strategic legal support, in their various advocacy programmes. Apart
p.(None): from basic institutional legal support, the most visible advocacy successes of the San have all relied upon close
p.(None): collaboration with a legal adviser.
p.(None):
p.(None): 80 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): San policy interventions at the United Nations, land claims and successful San claims for intellectual property
p.(None): rights related to their traditional knowledge (on Hoodia, buchu, Sceletium, rooibos etc), which raised the
p.(None): international profile of the San as indigenous peoples, all required committed legal support. This was made available
p.(None): mostly via SASI.
p.(None): The prohibitive cost of standard commercial lawyers is a well-known deterrent to obtaining legal advice and assistance.
p.(None): In addition, utilizing lawyers who are not familiar with the ethos and needs of the community can lead to expensive
p.(None): mistakes and misunderstandings. Lawyers who are willing to represent the community legally on a pro bono or
p.(None): noncommercial basis can therefore give a vulnerable com- munity a significant advantage.
p.(None): Dr Roger Chennells, SASI’s lawyer, also provided a legal editing service for the San Code of Research Ethics.
p.(None):
p.(None):
p.(None): Supportive Research Collaborations
p.(None):
p.(None): Formulating ethics codes is a time-consuming business that requires funding, in particular to support
p.(None): workshops where San traditional leaders and San community members can discuss their concerns and ways forward. Sceptics
p.(None): may point out that the same individuals always attend such workshops largely out of appreciation for the food provided,
p.(None): and leave without any tangible or lasting benefits.
p.(None): By contrast, there is much anecdotal evidence of San colleagues who reported, after attending workshops, that their
p.(None): thinking, and indeed sometimes their lives, had forever been altered by an insight gained at the workshop. The San
p.(None): development programmes conducted by WIMSA, SASI and the SASC held capacity-building workshops on a range of topics. Of
...
p.(None):
p.(None):
p.(None): Justice and Fairness
p.(None):
p.(None): We require justice and fairness in research.
p.(None): It is important that the San be meaningfully involved in the proposed studies, which includes learning about the
p.(None): benefits that the participants and the community might expect. These might be largely non-monetary but include
p.(None): co-research oppor- tunities, sharing of skills and research capacity, and roles for translators and research
p.(None): assistants, to give some examples.
p.(None): Any possible benefits should be discussed with the San, in order to ensure that these benefits do actually return to
p.(None): the community.
p.(None): As part of justice and fairness the San will try to enforce compliance with any breach of the Code, including through
p.(None): the use of dispute resolution mechanisms.
p.(None): In extreme cases the listing and publication of unethical researchers in a “black book” might be considered.
p.(None): An institution whose researchers fail to comply with the Code can be refused col- laboration in future research. Hence,
p.(None): there will be “consequences” for researchers who fail to comply with the Code.
p.(None): We have encountered lack of justice and fairness in many instances in the past. These include theft of San traditional
p.(None): knowledge by researchers. At the same time, many companies in South Africa and globally are benefitting from our
p.(None): traditional knowledge in sales of indigenous plant varieties without benefit sharing agree- ments, proving
p.(None): the need for further compliance measures to ensure fairness.
p.(None):
p.(None): Conclusion
p.(None): 85
p.(None):
p.(None): Care
p.(None):
p.(None): Research should be aligned to local needs and improve the lives of San. This means that the research process must be
p.(None): carried out with care for all involved, especially the San community.
p.(None): The caring part of research must extend to the families of those involved, as well as to the social and physical
p.(None): environment.
p.(None): Excellence in research is also required, in order for it to be positive and caring for the San. Research that is not up
p.(None): to a high standard might result in bad interac- tions, which will be lacking in care for the community.
p.(None): Caring research needs to accept the San people as they are, and take note of the cultural and social requirements of
p.(None): this Code of Ethics.
p.(None): We have encountered lack of care in many instances in the past. For instance, we were spoken down to, or confused with
p.(None): complicated scientific language, or treated as ignorant. Failing to ensure that something is left behind that improves
p.(None): the lives of the San also represents lack of care.
p.(None):
p.(None):
p.(None): Process
p.(None):
p.(None): Researchers need to follow the processes that are set out in our research protocols carefully, in order for this Code
p.(None): of Ethics to work.
p.(None): The San research protocol that the San Council will manage is an important process that we have decided on,
...
p.(None): slow to take personal offence. Their personal integ- rity shone through, and the trust that they generated in others
p.(None): translated into untold benefits for the San.
p.(None): This approach ensured that the San Council is highly respected in South Africa. In addition, relationships of trust
p.(None): developed with international researchers, generat- ing funding for research and policy projects. One of the many
p.(None): results of the open- ness of San leaders to collaboration with the world is the San Code of Research Ethics, which, it
p.(None): is hoped, will put all future relationships with outsiders onto an equitable basis. As Leana Snyders put it:
p.(None): The San Code of Research Ethics is the voice of a community that have been exploited for so many years. This code
p.(None): manages to bridge the gap between the research community and the San Community through dialogue. By taking ownership of
p.(None): the code, the San Community will ensure that this document will remain relevant for generations to come. (Chennells and
p.(None): Schroeder 2019)
p.(None):
p.(None): References
p.(None): 87
p.(None):
p.(None): References
p.(None):
p.(None): Barnard A (1992) Hunters and herders of southern Africa: a comparative ethnography of the Khoisan peoples.
p.(None): Cambridge University Press, New York and Cambridge
p.(None): CallawayE(2017)SouthAfrica’sSanpeopleissueethicscodetoscientists.Nature543:475–476.https://
p.(None): www.nature.com/news/south-africa-s-san-people-issue-ethics-code-to-scientists-1.21684
p.(None): Chennells R (2009) Vulnerability and indigenous communities: are the San of South Africa a vul- nerable people?
p.(None): Cambridge Quarterly of Healthcare Ethics 8(2):147–154
p.(None): Chennells R, Steenkamp A (2018) International genomics research involving the San people. In: Schroeder D, Cook J,
p.(None): Hirsch F, Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North–South research collaborations. Springer,
p.(None): Berlin, p 15–22
p.(None): Chennells R, Schroeder D (2019) The San Code of Research Ethics: its origins and history, a report for TRUST.
p.(None): http://www.globalcodeofconduct.org/affiliated-codes/
p.(None): Hitchcock RK, Ikeya K, Biesele M, Lee RB (2006) Introduction. In: Hitchcock RK, Ikeya K, Biesele M, Lee
p.(None): RB (eds) Updating the San: image and reality of an African people in the 21st century. Senri Technological Studies 70.
p.(None): National Museum of Ethnology, Osaka, p 4
p.(None): Knight A, Underhill PA, Mortensen HM, Zhivotovsky, LA, Lin AA, Henn BM, Louis D, Ruhlen M, Mountain JL (2003). African
p.(None): Y chromosome and mtDNA divergence provides insight into the history of click languages. Current Biology 13(6):464–473
p.(None): Penn N (2013) The British and the ‘Bushmen’: the massacre of the Cape San, 1795 to 1828. Journal of
p.(None): Genocide Research 15(2):183–200 https://doi.org/10.1080/14623528.2013.793081 TRUST Project Global Research Ethics.
p.(None): (2018a) Andries Steenkamp and Petrus Vaalbooi inter-
p.(None): views – TRUST Project. https://www.youtube.com/watch?v=A4_Mvdwl_Gc
p.(None): TRUST Project Global Research Ethics. (2018b) Reverend Mario Mahongo – TRUST Project.
p.(None): https://www.youtube.com/watch?v=jMhCUNw9eAo
p.(None): Soodyall H (2006) A prehistory of Africa. Jonathan Ball Publishers, Jeppetown, South Africa Ury W (1995) Conflict
p.(None): resolution amongst the Bushmen: lessons in dispute systems design.
p.(None): Harvard Negotiation Journal 11(4): 379–389
p.(None): Wynberg R. Schroeder D, Chennells R (2009) Indigenous peoples, consent and benefit sharing: lessons from the San-Hoodia
p.(None): Case. Berlin, Springer
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 8
p.(None): Good Practice to Counter Ethics Dumping
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract An ethics code is not enough to avoid ethics dumping. Ethics codes can inspire, guide and raise awareness of
p.(None): ethical issues, but they cannot, on their own, guarantee ethical outcomes; this requires a multifaceted approach. For
...
p.(None): assumptions and how these impact upon their relationship to the research, the course of the research and knowledge
p.(None): production.
p.(None):
p.(None): Ethical Engagement with Communities
p.(None): 91
p.(None):
p.(None): Fig. 8.1 The values compass
p.(None): FAIRNESS
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): HONESTY
p.(None):
p.(None):
p.(None):
p.(None): Values compass
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): CARE
p.(None):
p.(None):
p.(None):
p.(None): RESPECT
p.(None):
p.(None):
p.(None): In the following sections we show how the practical application of the values can help guide two important activities
p.(None): in collaborative research: community engage- ment and the development of an accessible complaints procedure.
p.(None):
p.(None):
p.(None): Ethical Engagement with Communities
p.(None):
p.(None): The term “community” is contentious and contextual, and can be difficult to define (Day 2006). For the purposes of this
p.(None): chapter, we use an early definition from the World Health Organization which describes a community as:
p.(None): A specific group of people, often living in a defined geographical area, who share a com- mon culture, values and
p.(None): norms, are arranged in a social structure according to relationships which the community has developed over a period of
p.(None): time. Members of a community gain their personal and social identity by sharing common beliefs, values and norms which
p.(None): have been developed by the community in the past and may be modified in the future (WHO 1998: 5)
p.(None): As we can infer from this definition, there are many different types of communi- ties and also communities within
p.(None): communities. For example, indigenous communi- ties, having a historical continuity with preinvasion and precolonial
p.(None): societies that developed on their territories, may consider themselves distinct from other sectors of the societies
p.(None): that now prevail on those territories, or parts of them. They generally form nondominant sectors of society and can be
p.(None): intent on preserving, developing and transmitting to future generations their ancestral territories and their
p.(None): ethnic identity, as the basis of their continued existence as peoples, in accordance with their own cultural patterns,
p.(None): social institutions and legal systems (Martínez Cobo
p.(None):
p.(None): 92 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): 2014). They often have particular relationships with advocacy groups who work to protect or represent their interests.4
p.(None): The concept of communities within communities also includes groups of people who are vulnerable because of a
p.(None): range of physical (disabilities, for example) or cultural (religion, for example) characteristics. For instance,
p.(None): sex workers, injecting drug users and men who have sex with men are often marginalized within their own broader
...
p.(None): in Research
p.(None): 22(3):123–138
p.(None): Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, Schulman KA (2009) Ethical and
p.(None): scientific implications of the globalization of clinical research. New England Journal of Medicine 360:816–823.
p.(None): https://doi.org/10.1056/NEJMsb0803929
p.(None): Hebert JR, Brandt HM, Armstead CA, Adams SA, Steck SE (2009) Interdisciplinary, translational, and community-based
p.(None): participatory research: finding a common language to improve can- cer research. Cancer Epidemiology, Biomarkers
p.(None): & Prevention 18(4):1213–1217. https://doi. org/10.1158/1055-9965.EPI-08-1166
p.(None): Henwood F, Wyatt S, Hart A, Smith, J (2003) Ignorance is bliss sometimes: constraints on the emergence of the
p.(None): “informed patient” in the changing landscapes of health information. Sociology of Health and Illness
p.(None): 25(6):589–607
p.(None): HPC (2009) Scoping report on existing research on complaints mechanisms. Health
p.(None): Professions Council. https://www.hcpc-uk.org/resources/reports/2009/
p.(None): scoping-report-on-existing-research-on-complaints-mechanisms/
p.(None): Jones L, Wells K (2007) Strategies for academic and clinician engagement in community- participatory
p.(None): partnered research. Journal of the American Medical Association 297(4):407–410 Lawton A (2004) Developing and
p.(None): implementing codes of ethics. Viešoji politika ir administravi-
p.(None): mas 7:94–101
p.(None): Martínez Cobo M (2014) Study on the problem of discrimination against indigenous populations. United Nations Department
p.(None): of Economic and Social Affairs. https://www.un.org/development/
p.(None): desa/indigenouspeoples/publications/2014/09/martinez-cobo-study/
p.(None): NIH (2011) Principles of community engagement. Washington, DC: CTSA Community Engagement Key
p.(None): Function Committee Task Force on the Principles of Community Engagement, National Institutes of Health.
p.(None): https://www.atsdr.cdc.gov/communityengagement/ pdf/PCE_Report_508_FINAL.pdf
p.(None):
p.(None): References
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p.(None): Pleasence P, Buck A, Balmer N, O’Grady A, Genn H, Smith M (2006) Causes of action: civil law and social justice. The
p.(None): Stationery Office, Norwich
p.(None): Sack DA, Brooks V, Behan M, Cravioto A, Kennedy A, IJsselmuiden C, Sewankambo N (2009) Improving international research
p.(None): contracting. WHO Bulletin 87:487–488
p.(None): Webley S, Werner A (2008) Corporate codes of ethics: necessary but not sufficient. Business Ethics: A
p.(None): European Review 17(4):405–415
p.(None): Weijer C, Goldsand G, Emanuel EJ (1999) Protecting communities in research: current guidelines and limits of
p.(None): extrapolation. Nature Genetics 23(3):275
p.(None): WHO (1998) Health promotion glossary. World Health Organization, Geneva. http://www.who.
p.(None): int/healthpromotion/about/HPR%20Glossary%201998.pdf, page 5.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None):
p.(None): 112 9 Towards Equitable Research
p.(None): Partnership
p.(None):
p.(None): TRUST was a game changer.4
p.(None): Ethics dumping is a real threat to the quality of science and the GCC is now a mandatory reference document for EU
p.(None): framework program funding to guard against it. – Dorian Karatzas (Greek), head of Ethics and Research Integrity,
p.(None): European Commission
p.(None): Best science for the most neglected, also means best ethical standards. That’s why the GCC aims high: to protect the
p.(None): most neglected. – Dr François Bompart (French), director of Paediatric HIV/Hepatitis C Programmes at the Drugs
p.(None): for Neglected Diseases initiative (DNDi), former vice president, Access to Medicines at Sanofi, co-author of the GCC
p.(None): We get given consent forms and documents, often in a hurry. We sign because we need the money and then end up with
p.(None): regret. It feels like a form of abuse. They want something from us and they know how to get it. Because of our
p.(None): socio-economic conditions, we will always be vulnerable to those from the North. A code of ethics is needed that
p.(None): protects indigenous people.5 – Andries Steenkamp (1960–2016) (South African), former chair of the South African
p.(None): San Council, co-author of both codes
p.(None): I don’t want researchers to see us as museums who cannot speak for themselves and who don’t expect something in return.
p.(None): As humans, we need support.6 – Reverend Mario Mahongo (1952–2018) (Angolan), co-author of both codes
p.(None): We want to be treated by researchers with fairness, respect, care and honesty. Is that too much to ask?7 – Joyce
p.(None): Adhiambo Odhiambo (Kenyan), health activist and former sex worker, co-author of the GCC
p.(None): Indeed, is that too much to ask?
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Burtscher W (2018) TRUST Global Code of Conduct to be a reference document applied by all research projects applying
p.(None): for H2020 funding. TRUST eNewsletter Issue 5. http://www.global-
p.(None): codeofconduct.org/wp-content/uploads/2018/12/TRUSTNewsletter_2018_Issue5.pdf
p.(None): Economist (2018) Recent events highlight an unpleasant scientific practice: ethics dumping. The Economist, 31
p.(None): January. https://www.economist.com/science-and-technology/2019/02/02/
p.(None): recent-events-highlight-an-unpleasant-scientific-practice-ethics-dumping
p.(None): IIT (nd) The ethics codes collection. Center for the Study of Ethics in the Professions, Illinois Institute of
p.(None): Technology, Chicago. http://ethicscodescollection.org/
p.(None):
p.(None): 4 Opening words during European Commission ethics staff training on the GCC, 3 Dec 2019, Covent Garden
...
p.(None): 102, 110–112, 117
p.(None): Index
p.(None):
p.(None): Fair research contract (FRC), 90, 103, 104
p.(None): Farmers, 101
p.(None): Feedback, 6, 8, 20, 41, 48, 61, 63, 64, 83,
p.(None): 96, 105
p.(None): Four values framework, 13–24, 30, 102 Free and prior informed consent, 7, 66 Funders, 53–58, 60, 61, 70, 79, 116
p.(None):
p.(None):
p.(None): G
p.(None): Gender, 44, 49, 61, 100
p.(None): Genetic research, 54, 74, 92
p.(None): Genetics, 2, 7, 13, 60, 62, 63, 74, 75,
p.(None): 81, 82
p.(None): Global Code of Conduct for Research in Resource-Poor Settings, 2, 5, 14, 27,
p.(None): 37, 51, 80, 89, 109, 115–117
p.(None): Good Participatory Practice, 6, 20, 63
p.(None):
p.(None):
p.(None): H
p.(None): Harm, 1, 17, 19, 28, 34, 35, 38, 43, 45–47, 54,
p.(None): 65, 73, 75, 84, 95, 98
p.(None): Health and safety, 9, 10
p.(None): HealthyXvolunteers, 63
p.(None): Helicopter research, 23, 41
p.(None): High-income countries (HICs), 2, 9, 20–23,
p.(None): 38–44, 47, 48, 56, 65, 70, 99–101, 104
p.(None): Honesty, 2, 5, 6, 10–11, 13–24, 27–31, 33, 40,
p.(None): 46–48, 68, 70, 74, 82, 83, 90, 93,
p.(None): 95–98, 102, 110–112
p.(None): Horizon 2020, 23, 52, 53
p.(None): Human participants, 65, 117
p.(None): Human rights, 22, 42, 44, 55, 75
p.(None):
p.(None):
p.(None): I
p.(None): Ideals, 3, 16, 17, 24, 32
p.(None): Illegal, 22, 43, 63, 65, 100
p.(None): Illiterate populations, 22, 47
p.(None): Incrimination, 9, 11, 68
p.(None): India, 39, 44, 56, 61, 65, 110, 111, 115, 116
p.(None): Indigenous peoples, 49, 55, 63, 73, 75,
p.(None): 80, 112
p.(None): Industry, 39, 54–58, 61, 69, 70, 117
p.(None): Inequalities, vii
p.(None): Information sheets, 24, 47, 98, 103
p.(None): Informed consent, 2, 7, 8, 24, 44–47, 63, 66,
p.(None): 74, 82, 84, 100, 105
p.(None): Integrity, 5, 23, 24, 46–48, 53, 67, 70, 74,
p.(None): 78–79, 82, 85, 86, 94, 112, 117
p.(None): Intellectual property, 6, 20, 43, 60, 66,
p.(None): 80, 104
p.(None):
p.(None): Index
p.(None): 121
p.(None):
p.(None):
p.(None): K
p.(None): Kenya, 2, 39, 40, 42, 61, 63, 65, 100, 110,
p.(None): 115, 116
p.(None): !Khomani, 74, 77, 78, 81, 86
p.(None): Khwe, 74, 77, 78, 81
p.(None): Knowledge holders, 7, 55, 66
p.(None):
p.(None):
p.(None): L
p.(None): Lawyers, 79, 80, 104
p.(None): Legal framework, 45, 55
p.(None): Legal support, 74, 79, 80, 85, 105
p.(None): Local communities, 6, 7, 9, 20, 27, 40,
p.(None): 42–45, 52, 61, 63, 64, 69, 90, 92,
p.(None): 94–98, 105
p.(None): Local relevance, 6, 17, 60–62, 68, 102, 105
p.(None): Local researchers, 6, 7, 10, 20, 27, 40, 48, 60,
p.(None): 64, 66, 94, 96, 101
p.(None): Low- and middle-income countries (LMICs), 2, 20–22, 37–44, 46–48, 55, 56, 58, 61,
p.(None): 62, 65, 66, 69, 70, 99–105
p.(None):
p.(None):
p.(None): M
p.(None): Majengo, 63
p.(None): Medical research, 22, 23, 41, 45, 57, 65, 66,
p.(None): 104, 111, 116, 117
p.(None): Metaethical relativism, 30–32
p.(None): Misconduct, 8, 47, 105
p.(None):
p.(None):
p.(None): N
p.(None): Non-compliance, 1
p.(None): Non-governmental organisations (NGOs), 54, 63, 75–78, 85
p.(None): Non-human primates, 2, 44, 65
p.(None): Normative relativism, 30, 31
p.(None):
p.(None):
p.(None): O
p.(None): Open communication, 24, 94
p.(None):
p.(None):
p.(None): P
p.(None): Peer educators, 40
...
Searching for indicator native:
(return to top)
p.(None):
p.(None): codes, most of which had not been written with LMIC-HIC (high-income country) collaborations in mind.
p.(None):
p.(None):
p.(None): The Nature of Exploitation
p.(None):
p.(None): The potential to be exploited is part of the human condition. Exploiters take advan- tage of others’ vulnerabilities to
p.(None): promote their own interests (Hughes 2010). While there is a morally neutral sense of exploitation (the exploitation of
p.(None): natural talents to create art, for example), the term is generally used to describe a moral failing.
p.(None): Exploitation of people is very often unjust, unfair, harmful or just plain wrong. What is it, then, that
p.(None): distinguishes morally unacceptable exploitation from neutral exploitation?
p.(None): Some argue that exploitation is wrong because it is coercive (Schwartz 1995). If the only way for a woman in an LMIC to
p.(None): access antiretroviral drugs to prevent the transmission of HIV to her unborn baby is to participate in a
p.(None): placebo-controlled clinical trial,2 despite the existence of a proven standard of care,3 then one could say she has
p.(None): been coerced into enrolling (Annas and Grodin 1998). In this sense, exploi- tation occurs where one party takes
p.(None): advantage of another by making them an offer they cannot refuse; they are then coerced to accept simply because there
p.(None): is no alter- native. Others argue that exploitation is wrong because it treats human beings as means rather than ends
p.(None): (Wood 1995). In other words, exploitation instrumentalizes people. Yet others claim that exploitation is wrong
p.(None): because it disadvantages the vulnerable (Macklin 2003).
p.(None): Our investigation was concerned with the risks or vulnerabilities for exploitation, so we adopted Macklin’s definition
p.(None): of exploitation. However, it is important to bear in mind that situations that are conducive to exploitation do not
p.(None): necessarily lead to exploitation. For instance, if a pharmaceutical company is due to test new antiretro- viral drugs
p.(None): to prevent the transmission of HIV to unborn babies, and the company operates in a country where poor mothers have no
p.(None): or very limited access to health care, it does not mean that exploitation will necessarily occur. The company may
p.(None): decide not to exploit vulnerable research participants and offer the accepted stan- dard of care to those in the
p.(None): control arm, rather than a placebo.
p.(None): Exploitation usually requires a moral decision on the part of the potential exploiter, but it can also occur
p.(None): through ignorance. Whether intended or unintended, the effects of exploitation are the same for the exploited. Hence,
p.(None): ignorance is not a legitimate justification for exploitation. Uncovering the primary risks of exploitation
p.(None):
...
Political / criminal
Searching for indicator criminal:
(return to top)
p.(None): structure in the HIC, which may not have the capacity to make cul- turally sensitive decisions.
p.(None): The broader question of what HICs owe LMICs falls under distributive fairness. One can illustrate the difference
p.(None): between fairness in exchange and distributive fair- ness using the example of post-study access to successfully tested
p.(None): drugs. In the first case (fairness in exchange) one could argue that research participants have contrib- uted to the
p.(None): marketing of a particular drug and are therefore owed post-study access to it (should they need the drug to promote
p.(None): their health and wellbeing, and should they not otherwise have access to it). In the second case (distributive
p.(None): fairness) one could provide a range of arguments, for instance being a signatory to the Universal Declaration of Human
p.(None): Rights (UN 1948), to maintain that all human beings who need the drug should have access to it, and not just the
p.(None): research participants. These wider fairness issues cannot be resolved by researchers and are therefore not directly
p.(None): included in the GCC. Likewise, retributive fairness is less relevant as few ethics violations fall under the punitive
p.(None): and criminal law, and if they do, it is indeed crimi- nal law that should be used to deal with a fairness violation.
p.(None):
p.(None): 22 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Respect
p.(None):
p.(None): The term “respect” is used in many ethics frameworks. For instance, the Declaration of Helsinki (WMA 2013) notes in
p.(None): article 7:
p.(None): Medical research is subject to ethical standards that promote and ensure respect for all human subjects
p.(None): and protect their health and rights. (emphasis added)
p.(None): Its ubiquitous use does not, however, mean that “respect” is a clear term. In everyday life, it is used in
p.(None): the sense of deep admiration. For instance, somebody could say, “I respect the achievements of Nelson Mandela”.
p.(None): However, that is not what is meant by respect in research ethics. The statement from the Declaration of Helsinki does
p.(None): not mean that research participants must be admired. To be respected in research ethics is almost the opposite. It
p.(None): means that one must accept a decision or a way of approaching a matter, even if one disagrees strongly. A case in point
p.(None): would be respecting the decision of a competent adult Jehovah’s Witness to refuse a blood transfusion for reasons of
p.(None): religious belief, even if this means certain death.
p.(None): Respect is therefore a difficult value, as there will be cases where one cannot accept another’s decision. For
...
Political / political affiliation
Searching for indicator party:
(return to top)
p.(None):
p.(None): Michelle Singh Africa Office
p.(None): European & Developing Countries Clinical Trials Partnership
p.(None): Cape Town, South Africa
p.(None):
p.(None): Peter Herissone-Kelly
p.(None): School of Humanities and Social Sciences University of Central Lancashire
p.(None): Preston, Lancashire, UK
p.(None): Kate Chatfield
p.(None): Centre for Professional Ethics University of Central Lancashire Preston, Lancashire, UK
p.(None):
p.(None): Roger Chennells
p.(None): Chennells Albertyn Attorneys Stellenbosch, South Africa
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ISSN 2452-0519 ISSN 2452-0527 (electronic)
p.(None): SpringerBriefs in Research and Innovation Governance
p.(None): ISBN 978-3-030-15744-9 ISBN 978-3-030-15745-6 (eBook)
p.(None): https://doi.org/10.1007/978-3-030-15745-6
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019. This book is an open access
p.(None): publication.
p.(None): Open Access This book is licensed under the terms of the Creative Commons Attribution 4.0
p.(None): International License (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing,
p.(None): adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the
p.(None): original author(s) and the source, provide a link to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this book are included in the book’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the book’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None): The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not
p.(None): imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and
p.(None): regulations and therefore free for general use.
p.(None): The publisher, the authors, and the editors are safe to assume that the advice and information in this book are
p.(None): believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give
p.(None): a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may
p.(None): have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional
p.(None): affiliations.
p.(None):
p.(None): This Springer imprint is published by the registered company Springer Nature Switzerland AG. The registered company
p.(None): address is: Gewerbestrasse 11, 6330 Cham, Switzerland
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): To Reverend Mario Mahongo (1952–2018)
p.(None):
p.(None): Foreword
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): In September 2015, after intensive public consultation, the international community went on record with a plan of
...
p.(None): collaborations. Springer Briefs in Research and Innovation Governance, Berlin, p 115-119
p.(None): Tuhiwai Smith, Linda (1999) Decolonizing methodologies: research and indigenous Peoples. Zed Books, London and New York
p.(None): UN (ndb) The sustainable development agenda. Sustainable Development Goals. https://www.
p.(None): un.org/sustainabledevelopment/development-agenda/
p.(None): UN (nda) Goal 9. Sustainable Development Goals. https://www.un.org/sustainabledevelopment/
p.(None): infrastructure-industrialization/
p.(None): Zhao Y, Zhang W (2018) An international collaborative genetic research project conducted in China. In:
p.(None): Schroeder D, Cook J, Hirsch F, Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North-South research
p.(None): collaborations. Springer Briefs in Research and Innovation Governance, Berlin, p 71–80
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 2
p.(None): A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The Global Code of Conduct for Research in Resource-Poor Settings (GCC) is designed to counter
p.(None): ethics dumping, i.e. the practice of moving research from a high-income setting to a lower-income setting to circumvent
p.(None): ethical barriers. The GCC is reprinted here. It was completed in May 2018 and adopted by the European
p.(None): Commission as a mandatory reference document for Horizon 2020 in August 2018. For more information on the GCC,
p.(None): please visit: http://www.global- codeofconduct.org/
p.(None):
p.(None): Keywords Global ethics · Research ethics · International co-operation · Ethics dumping · Low- and middle-income
p.(None): countries
p.(None):
p.(None):
p.(None): Research partnerships between high-income and lower-income settings can be highly advantageous for both
...
p.(None): non-patronising style in the appropriate local languages should be adopted in communication with research participants
p.(None): who may have difficulties comprehending the research process and requirements.
p.(None):
p.(None):
p.(None): Article 22
p.(None):
p.(None): Corruption and bribery of any kind cannot be accepted or supported by researchers from any countries.
p.(None):
p.(None): Honesty
p.(None): 11
p.(None):
p.(None): Article 23
p.(None):
p.(None): Lower local data protection standards or compliance procedures can never be an excuse to tolerate the potential for
p.(None): privacy breaches. Special attention must be paid to research participants who are at risk of stigmatization,
p.(None): discrimination or incrimi- nation through the research participation.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 3
p.(None): The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract Values inspire, motivate and engage people to discharge obligations or duties. This chapter defends the
p.(None): values approach in the context of guarding against ethics dumping, the practice of exporting unethical research from
p.(None): higher-income to lower-income settings. A number of essential questions will be answered: What are values? What is the
p.(None): meaning of the word “value”? Why does it make sense to choose values as an instrument to guide ethical action in
p.(None): preference to other possibilities? And what is meant by fairness, respect, care and honesty? It is concluded that
p.(None): values can provide excellent guidance and aspiration in the fight against ethics dumping, and are therefore a
p.(None): well-chosen structure for the Global Code of Conduct for Research in Resource-Poor Settings.
p.(None):
p.(None): Keywords Values · Virtues · Fairness · Respect · Care · Honesty
p.(None):
p.(None):
p.(None): Introduction
p.(None):
p.(None): Many celebrated documents which advocate for a better world include a preamble that mentions values. For instance,
...
p.(None): core-values-examples/
p.(None): UCLan (nd) The UCLan values. University of Central Lancashire. https://www.uclan.ac.uk/work/ life-at-uclan.php
p.(None): UN (1948) Universal Declaration of Human Rights. http://www.un.org/en/
p.(None): universal-declaration-human-rights/
p.(None): UN (1992) Convention on Biological Diversity. https://www.cbd.int/doc/legal/cbd-en.pdf
p.(None): Wang X, Li F, Sun Q (2018) Confucian ethics, moral foundations, and shareholder value perspec- tives: an exploratory
p.(None): study. Business Ethics: A European Review 27(3):260–271
p.(None): WMA (2013) Declaration of Helsinki. World Medical Association. https://www.wma.net/policies-
p.(None): post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human- subjects/
p.(None): Wolfe PS (1997) The influence of personal values on issues of sexuality and disability. Sexuality and disability
p.(None): 15(2):69–90
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 4
p.(None): Respect and a Global Code of Conduct?
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The Global Code of Conduct for Research in Resource-Poor Settings claims global applicability and
p.(None): promotes respect as one of its four values. Hence, the code anticipates potentially unresolvable differences
p.(None): between cultures, while maintaining it is globally valid. Examining, but discarding, several possibilities to deal
p.(None): with normative relativism, this chapter argues, with Beauchamp and Childress (2013, Principles of Biomedical Ethics,
p.(None): 7th edn. Oxford University Press, New York) that values can be internal to morality itself, allowing their global
p.(None): applicability.
p.(None):
p.(None): Keywords Values · Normative relativism · Global justice · Research ethics · Fairness · Principlism
p.(None):
p.(None):
p.(None): Introduction
p.(None):
p.(None): The Global Code of Conduct for Research in Resource-Poor Settings (GCC) is built around four values: fairness, respect,
p.(None): care and honesty. In this chapter, we tackle the moral relativism claim against values approaches. Some readers may
...
p.(None): Huxtable R (2013) For and against the four principles of biomedical ethics. Clinical Ethics 8(2–3):39–43
p.(None): Kara M A (2007) Applicability of the principle of respect for autonomy: the perspective of Turkey.
p.(None): Journal of Medical Ethics 33(11):627–630
p.(None): Kiak Min MT (2017) Beyond a Western bioethics in Asia and its implication on autonomy. The New Bioethics 23(2):154–164
p.(None): Williams B (1972) Morality: an introduction to ethics. Cambridge University Press, Cambridge Wong D (1991) Relativism.
p.(None): In: Singer P (ed) A companion to ethics. Blackwell, Oxford, p 442–450 Wong D (2009) Natural moralities: a defense of
p.(None): pluralistic relativism. Oxford University Press,
p.(None): New York
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 5
p.(None): Exploitation Risks in Collaborative International Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract Ethics dumping occurs in collaborative international research when peo- ple, communities, animals and/or
p.(None): environments are exploited by researchers. Exploitation is made possible by serious poverty and extreme power
p.(None): differentials between researchers from high-income countries and research stakeholders from low- and middle-income
p.(None): countries (LMICs). To prevent its occurrence, the risks of exploitation have to be tackled. This chapter describes 88
p.(None): risks identified for col- laborative international research, categorized according to four values: fairness,
p.(None): respect, care and honesty. The risks were identified in a broad-based consultative exercise, which included more than
p.(None): 30 members and chairs of ethics committees in LMICs, representatives from vulnerable populations in LMICs, and an open
p.(None): call for case studies of exploitation. The findings of the exercise contributed to the develop- ment of the Global Code
p.(None): of Conduct for Research in Resource-Poor Settings.
p.(None):
...
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_5
p.(None):
p.(None): 38 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): codes, most of which had not been written with LMIC-HIC (high-income country) collaborations in mind.
p.(None):
p.(None):
p.(None): The Nature of Exploitation
p.(None):
p.(None): The potential to be exploited is part of the human condition. Exploiters take advan- tage of others’ vulnerabilities to
p.(None): promote their own interests (Hughes 2010). While there is a morally neutral sense of exploitation (the exploitation of
p.(None): natural talents to create art, for example), the term is generally used to describe a moral failing.
p.(None): Exploitation of people is very often unjust, unfair, harmful or just plain wrong. What is it, then, that
p.(None): distinguishes morally unacceptable exploitation from neutral exploitation?
p.(None): Some argue that exploitation is wrong because it is coercive (Schwartz 1995). If the only way for a woman in an LMIC to
p.(None): access antiretroviral drugs to prevent the transmission of HIV to her unborn baby is to participate in a
p.(None): placebo-controlled clinical trial,2 despite the existence of a proven standard of care,3 then one could say she has
p.(None): been coerced into enrolling (Annas and Grodin 1998). In this sense, exploi- tation occurs where one party takes
p.(None): advantage of another by making them an offer they cannot refuse; they are then coerced to accept simply because there
p.(None): is no alter- native. Others argue that exploitation is wrong because it treats human beings as means rather than ends
p.(None): (Wood 1995). In other words, exploitation instrumentalizes people. Yet others claim that exploitation is wrong
p.(None): because it disadvantages the vulnerable (Macklin 2003).
p.(None): Our investigation was concerned with the risks or vulnerabilities for exploitation, so we adopted Macklin’s definition
p.(None): of exploitation. However, it is important to bear in mind that situations that are conducive to exploitation do not
p.(None): necessarily lead to exploitation. For instance, if a pharmaceutical company is due to test new antiretro- viral drugs
p.(None): to prevent the transmission of HIV to unborn babies, and the company operates in a country where poor mothers have no
p.(None): or very limited access to health care, it does not mean that exploitation will necessarily occur. The company may
p.(None): decide not to exploit vulnerable research participants and offer the accepted stan- dard of care to those in the
p.(None): control arm, rather than a placebo.
...
p.(None): Pogge T (2006) Justice. In: Borchert DM (ed) Encyclopedia of philosophy, 2nd edn, vol 4.
p.(None): Macmillan Reference, Detroit, pp 862–870
p.(None): Russell WMS, Burch RL, Hume CW (1959) The principles of humane experimental technique.
p.(None): Methuen & Co, London
p.(None): Schwartz J (1995) What’s wrong with exploitation? Nous 29:158–164
p.(None): Stone CD (2010) Should trees have standing? Law, morality, and the environment, 3rd edn. Oxford University Press,
p.(None): Oxford
p.(None): Smith, LT (2012) Decolonizing methodologies: research and indigenous peoples. Zed Books, London
p.(None): Universities UK (2015) The concordat to support research integrity. Universities UK, London Wood A (1995) Exploitation.
p.(None): Social Philosophy and Policy 12:150–151
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 6
p.(None): How the Global Code of Conduct Was Built
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract How can an ethics code achieve impact? The answer is twofold. First, through adoption by influential research
p.(None): funders, who then make it mandatory for their award recipients. This is the case with the Global Code of Conduct for
p.(None): Research in Resource-Poor Settings, which was adopted by both the European Commission and the European and Developing
p.(None): Countries Clinical Trials Partnership shortly after its launch in 2018. Second, an ethics code can achieve impact when
p.(None): researchers use it for guidance whether it is compulsory or not. This is most likely to happen with codes that were
p.(None): developed transparently with all research stakeholders involved. This chapter will outline how the GCC was
p.(None): developed, and in particular how exter- nal stakeholders were systematically engaged, how existing codes were carefully
p.(None): analysed and built upon, and who the early adopters were.
p.(None):
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p.(None): Muthuswamy V (eds) Ethics dumping: case studies from North-South research collaborations. Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 91–98
p.(None): Van Niekerk J, Wynberg R, Chatfield K (2017). Cape Town plenary meeting report. TRUST Project.
p.(None): http://trust-project.eu/wp-content/uploads/2017/08/TRUST-Kalk-Bay-2017-Report- Final.pdf
p.(None): WMA (2013) Declaration of Helsinki. World Medical Association. https://www.wma.net/policies-
p.(None): post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human- subjects/
p.(None): Wynberg R, Schroeder D, Chennells R (2009) Indigenous peoples, consent and benefit sharing: lessons from the San-Hoodia
p.(None): case. Springer, Berlin
p.(None): Youdelis M (2016) “They could take you out for coffee and call it consultation!” The colonial antipolitics of
p.(None): indigenous consultation in Jasper National Park. Environment and Planning A: Economy and Space 48(7):1374–1392
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 7
p.(None): The San Code of Research Ethics
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The San peoples of southern Africa have been the object of much aca- demic research over centuries. In recent
p.(None): years, San leaders have become increas- ingly convinced that most academic research on their communities has been
p.(None): neither requested, nor useful, nor protected in any meaningful way. In many cases dissatis- faction, if not actual
p.(None): harm, has been the result. In 2017, the South African San finally published the San Code of Research Ethics,
p.(None): which requires all researchers intending to engage with San communities to commit to four central values, namely
p.(None): fairness, respect, care and honesty, as well as to comply with a simple process of community approval. The code is the
p.(None): first ethics code developed and launched by an indigenous population in Africa. Key to this achievement were: dedicated
p.(None): San lead- ers of integrity, supportive NGOs, legal assistance and long-term research collabo- rations with key
p.(None): individuals who undertook fund-raising and provided strategic support.
p.(None):
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p.(None): Penn N (2013) The British and the ‘Bushmen’: the massacre of the Cape San, 1795 to 1828. Journal of
p.(None): Genocide Research 15(2):183–200 https://doi.org/10.1080/14623528.2013.793081 TRUST Project Global Research Ethics.
p.(None): (2018a) Andries Steenkamp and Petrus Vaalbooi inter-
p.(None): views – TRUST Project. https://www.youtube.com/watch?v=A4_Mvdwl_Gc
p.(None): TRUST Project Global Research Ethics. (2018b) Reverend Mario Mahongo – TRUST Project.
p.(None): https://www.youtube.com/watch?v=jMhCUNw9eAo
p.(None): Soodyall H (2006) A prehistory of Africa. Jonathan Ball Publishers, Jeppetown, South Africa Ury W (1995) Conflict
p.(None): resolution amongst the Bushmen: lessons in dispute systems design.
p.(None): Harvard Negotiation Journal 11(4): 379–389
p.(None): Wynberg R. Schroeder D, Chennells R (2009) Indigenous peoples, consent and benefit sharing: lessons from the San-Hoodia
p.(None): Case. Berlin, Springer
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 8
p.(None): Good Practice to Counter Ethics Dumping
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract An ethics code is not enough to avoid ethics dumping. Ethics codes can inspire, guide and raise awareness of
p.(None): ethical issues, but they cannot, on their own, guarantee ethical outcomes; this requires a multifaceted approach. For
p.(None): research in resource-poor settings, engagement is crucial. Such engagement has been built into the Global Code of
p.(None): Conduct for Research in Resource-Poor Settings as a require- ment, but how can it be put into practice? An
p.(None): approach for ethical community engagement is presented in this chapter, which also includes suggestions
p.(None): for an accessible complaints mechanism. At the institutional level, we tackle the question of concluding fair
p.(None): research contracts when access to legal advice is limited. Throughout, at a broader level, we show how the four
p.(None): values of fairness, respect, care and honesty can be used to help guide decision-making and the practical appli- cation
...
p.(None): Stationery Office, Norwich
p.(None): Sack DA, Brooks V, Behan M, Cravioto A, Kennedy A, IJsselmuiden C, Sewankambo N (2009) Improving international research
p.(None): contracting. WHO Bulletin 87:487–488
p.(None): Webley S, Werner A (2008) Corporate codes of ethics: necessary but not sufficient. Business Ethics: A
p.(None): European Review 17(4):405–415
p.(None): Weijer C, Goldsand G, Emanuel EJ (1999) Protecting communities in research: current guidelines and limits of
p.(None): extrapolation. Nature Genetics 23(3):275
p.(None): WHO (1998) Health promotion glossary. World Health Organization, Geneva. http://www.who.
p.(None): int/healthpromotion/about/HPR%20Glossary%201998.pdf, page 5.
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 9
p.(None): Towards Equitable Research Partnership
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The world’s largest collection of professional ethics codes already holds more than 2,500 codes. What can
p.(None): the Global Code of Conduct for Research in Resource-Poor Settings (GCC) add? This brief chapter gives
p.(None): co-authors and sup- porters of the GCC the opportunity to show why a code with the single-minded aim of eradicating
p.(None): ethics dumping is needed.
p.(None):
p.(None): Keywords Global ethics · Research ethics · International co-operation · Ethics dumping · Low- and middle-income
p.(None): countries
p.(None):
p.(None):
p.(None): The world’s largest collection of professional ethics codes holds more than 2,500 codes (IIT nd). Is another ethics
p.(None): code really needed? The evidence gathered on the 21st-century export of unethical research practices from
...
p.(None): 7 European Parliament, TRUST event, 29 June 2018.
p.(None):
p.(None): References
p.(None): 113
p.(None):
p.(None): Nordling L (2018) Europe’s biggest research fund cracks down on “ethics dumping”. Nature 559:17–18.
p.(None): https://www.nature.com/articles/d41586-018-05616-w
p.(None): Schroeder D, Cook J, Hirsch F, Fenet S, Muthuswamy V (eds) (2018) Ethics dumping: case stud- ies from North-South
p.(None): research collaborations. Springer Briefs in Research and Innovation Governance, Berlin
p.(None): TRUST (2018) Major TRUST event successfully held at European Parliament. TRUST eNewsletter Issue
p.(None): 5. http://www.globalcodeofconduct.org/wp-content/uploads/2018/12/ TRUSTNewsletter_2018_Issue5.pdf
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p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Appendix
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Global Code of Conduct for Research in Resource-Poor Settings (GCC)
p.(None):
p.(None): Authors and Sources of Inspiration
p.(None): Lead Author: Doris Schroeder University of Central Lancashire, UK Authors in alphabetical order:
p.(None): • Joyce Adhiambo Partners for Health and Development, Kenya
p.(None): • Chiara Altare Action contre la Faim, France
p.(None): • Fatima Alvarez-Castillo University of the Philippines, Philippines
p.(None): • Pamela Andanda University of the Witwatersrand, South Africa
p.(None): • François Bompart Drugs for Neglected Diseases Initiative, Switzerland
p.(None): • Francesca I. Cavallaro UNESCO, France
p.(None): • Kate Chatfield University of Central Lancashire, UK
p.(None): • Roger Chennells South African San Institute, South Africa
p.(None): • David Coles University of Central Lancashire, UK
p.(None): • Julie Cook University of Central Lancashire, UK
p.(None): • Julia Dammann South African San Institute, South Africa
p.(None): • Amy Azra Dean (media) University of Central Lancashire, UK
p.(None): • Dafna Feinholz UNESCO, France
p.(None): • Solveig Fenet Institut national de la santé et de la recherche médicale, France
p.(None): • François Hirsch Institut national de la santé et de la recherche médicale, France
...
Searching for indicator political:
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p.(None): decision-making.
p.(None):
p.(None):
p.(None): Article 13
p.(None):
p.(None): A clear procedure for feedback, complaints or allegations of misconduct must be offered that gives genuine and
p.(None): appropriate access to all research participants and local partners to express any concerns they may have with the
p.(None): research process. This procedure must be agreed with local partners at the outset of the research.
p.(None):
p.(None): Care
p.(None): 9
p.(None):
p.(None): Article 14
p.(None):
p.(None): Research that would be severely restricted or prohibited in a high-income setting should not be carried out in a
p.(None): lower-income setting. Exceptions might be permissi- ble in the context of specific local conditions (e.g. diseases not
p.(None): prevalent in high- income countries).
p.(None): If and when such exceptions are dealt with, the internationally acknowledged compliance commandment “comply or
p.(None): explain” must be used, i.e. exceptions agreed upon by the local stakeholders and researchers must be explicitly
p.(None): and trans- parently justified and made easily accessible to interested parties.
p.(None):
p.(None):
p.(None): Article 15
p.(None):
p.(None): Where research involvement could lead to stigmatization (e.g. research on sexually transmitted diseases), incrimination
p.(None): (e.g. sex work), discrimination or indetermi- nate personal risk (e.g. research on political beliefs), special measures
p.(None): to ensure the safety and wellbeing of research participants need to be agreed with local partners.
p.(None):
p.(None):
p.(None): Article 16
p.(None):
p.(None): Ahead of the research it should be determined whether local resources will be depleted to provide staff or
p.(None): other resources for the new project (e.g. nurses or labo- ratory staff). If so, the implications should be discussed in
p.(None): detail with local com- munities, partners and authorities and monitored during the study.
p.(None):
p.(None):
p.(None): Article 17
p.(None):
p.(None): In situations where animal welfare regulations are inadequate or non-existent in the local setting compared with the
p.(None): country of origin of the researcher, animal experi- mentation should always be undertaken in line with the higher
p.(None): standards of protec- tion for animals.
p.(None):
p.(None): 10 2 A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None): Article 18
p.(None):
p.(None): In situations where environmental protection and biorisk-related regulations are inadequate or non-existent in
p.(None): the local setting compared with the country of origin of the researcher, research should always be undertaken in line
p.(None): with the higher stan- dards of environmental protection.
p.(None):
p.(None):
p.(None): Article 19
p.(None):
p.(None): Where research may involve health, safety or security risks for researchers or expose researchers to conflicts of
...
p.(None): piety, loyalty and reciproc- ity (Wang et al. 2018). Virtues are a good way to drive ethical action, in particular
p.(None): global ethical action, but the TRUST team had good reason not to use virtues as the foundation of the GCC.
p.(None): Virtues can be regarded as embodied ethical values because they are manifested in persons. One can learn a lot by
p.(None): observing real people (such as Mother Theresa or Nelson Mandela) and following their example. This makes virtue
p.(None): approaches very useful in leadership and mentoring (Resnik 2012). But not every researcher has access to
p.(None): mentors and learning via example. Besides, early career researchers are said to benefit more from rule-based approaches
p.(None): (Resnik 2012). Hence, while vir- tues were considered as a possibility for the foundation of the GCC, they
p.(None): were excluded because of their strong reliance upon the availability of role models.
p.(None): Principles have a long-standing tradition in practical moral frameworks, espe- cially principlism, the moral
p.(None): framework relating to bioethics developed by Beauchamp and Childress (2013). As argued in Chapter 4, we
p.(None): believe that the four principles of Beauchamp and Childress – autonomy, non-maleficence (do no harm), beneficence and
p.(None): justice – should instead be called values. Principles, as we under- stand them, are more concrete than values.
p.(None): Principles can provide almost immediate and very straightforward answers to ethical questions.
p.(None): A famous principle in political philosophy is Rawls’s difference principle. The principle holds that divergence from an
p.(None): egalitarian distribution of social goods (e.g. income, wealth, power) is only allowed when this non-egalitarian
p.(None): distribution favours the least advantaged in society (Rawls 1999: 65–70). In other words, if a particularly talented
p.(None): wealth creator increases the overall wealth pie so that the least advantaged in society are better off, she can receive
p.(None): a bigger share of the pie than others. Knowing about this principle gives answers to social philosophy questions, which
p.(None): the value of fairness or justice would not. Rawls applied the value of fairness to derive the more concrete difference
p.(None): principle. Principles are therefore too con- crete and too prescriptive to form the foundation of the GCC. They would
p.(None): not leave enough room for local agreements between partners from high- and lower-income settings as envisaged by
p.(None): various GCC articles, such as article 1: “Local relevance of research … should be determined in collaboration with
p.(None): local partners.”
p.(None):
p.(None): 18 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Standards are even more specific than principles and have an even stronger action-guiding function. They
p.(None): prescribe very concrete activities in given settings. To formulate standards for ethical interaction between partners
p.(None): from different settings would certainly be too prescriptive. A standard cannot be diverged from (for exam- ple, a limit
...
p.(None): double ethics review would forbid any research in the San community until an eth- ics committee were established, which
p.(None): might even undermine the San people’s self- determined research governance structures. For this reason, it is clear
p.(None): that standards are too prescriptive to be applied to every setting, and might hinder valuable research.
p.(None): This leaves ethical values, which operate as guides on the route to doing the right thing and are not overly
p.(None): prescriptive. They do not undermine the need to develop bespoke agreements across cultures via discussions
p.(None): between research teams and communities. At the same time, there is another, positive reason to choose values as the
p.(None): foundation for the GCC. Values inspire and motivate people to take action – and that is exactly what is needed to guard
p.(None): against ethics dumping.
p.(None):
p.(None):
p.(None): Values and Their Motivating Power
p.(None):
p.(None): Research stakeholders who are guided by values will hopefully be inspired and motivated by the GCC and not
p.(None): just follow its rules reluctantly or grudgingly. Why is that? Values can serve as motivating factors in promoting or
p.(None): inhibiting human action (Marcum 2008, Locke 1991, Ogletree 2004). The influence of personal val- ues upon behaviour has
p.(None): become a subject of extensive research in the social sci- ences and in psychology, particularly over the past forty
p.(None): years, with just about every area of life being examined through the lens of personal values – for example, con- sumer
p.(None): practices (Pinto et al. 2011), political voting habits (Kaufmann 2016), employee creativity (Sousa and Coelho
p.(None): 2011), healthcare decisions (Huijer and Van Leeuwen 2000), investment decisions (Pasewark and Riley 2010), and
p.(None): sexuality and disability (Wolfe 1997), to name but a few.
p.(None):
p.(None):
p.(None): 4 Local ethics review should be sought wherever possible. It is of vital importance that research projects are approved
p.(None): by a research ethics committee in the host country, wherever this exists, even if ethics approval has already been
p.(None): obtained in the high-income setting.
p.(None):
p.(None): From Values to Action
p.(None): 19
p.(None):
p.(None): Arguably the most prominent theory of the motivational power of human values was developed by social psychologist
p.(None): Shalom Schwartz, back in 1992. Schwartz’s theory of basic values is distinctive because, unlike most other theories, it
p.(None): has been tested via extensive empirical investigation. Studies undertaken since the early 1990s have generated
p.(None): large data sets from 82 countries, including highly diverse geographic, cultural, religious, age and occupational
p.(None): groups (Schwartz 2012). Findings from Schwartz’s global studies indicate that values are inextricably linked to
p.(None): affect. He claims that when values are activated, they become infused with feel- ing (Schwartz 2012). For example,
p.(None): people for whom routine and security are impor- tant values will become disturbed when their employment is threatened
...
p.(None):
p.(None): ALLEA (2017) The European code of conduct for research integrity. All European Academies, Berlin.
p.(None): https://www.allea.org/allea-publishes-revised-edition-european-code-conduct-re- search-integrity/
p.(None): Aristotle (2004) Nicomachean Ethics (trans: Thomson JAK), 2nd edn. Tredennick H (ed). Penguin Classics, London
p.(None): Beauchamp TL, Childress JF (2013) Principles of biomedical ethics, 7th edn. Oxford University Press, New York
p.(None): Clear J (nd) Core values list. https://jamesclear.com/core-values
p.(None): Crabb S (2011) The use of coaching principles to foster employee engagement. The Coaching Psychologist 7(1):27–34
p.(None): Directorate General for Research (2019) Horizon 2020 Programme: guidance – how to complete your ethics self-assessment,
p.(None): version 6.1. European Commission. http://ec.europa.eu/research/
p.(None): participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-self-assess_en.pdf
p.(None): Google (nd) Honesty: synonyms. https://www.google.com/search?q=honesty&ie=&oe= Google (2018) Google search for
p.(None): “Honesty” conducted on 24 November 2018.
p.(None): Huijer M, van Leeuwen E (2000) Personal values and cancer treatment refusal. Journal of Medical Ethics 26(5):358–362
p.(None): ISO (nd) ISO 26000: social responsibility. International Organization for Standardization. https://
p.(None): www.iso.org/iso-26000-social-responsibility.html
p.(None): Kaufmann E (2016) It’s NOT the economy, stupid: Brexit as a story of personal values. British Politics and Policy.
p.(None): London School of Economics and Political Science. http://blogs.lse.ac.uk/
p.(None): politicsandpolicy/personal-values-brexit-vote/
p.(None): Klein LA (2017) A free press is necessary for a strong democracy. ABA Journal. http://www.aba-
p.(None): journal.com/magazine/article/free_press_linda_klein?icn=most_read
p.(None): Locke EA (1991) The motivation sequence, the motivation hub, and the motivation core.
p.(None): Organizational Behavior and Human Decision Processes 50(2):288–299
p.(None): Luc G, Altare C (2018) Social science research in a humanitarian emergency context. In: Schroeder D, Cook J, Hirsch F,
p.(None): Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North- South research collaborations. Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 9–14. https://link.springer.com/book/10.1007%2F978-3-319-64731-9
p.(None): Mansor M, Tayib D (2010). An empirical examination of organisational culture, job stress and job satisfaction within
p.(None): the indirect tax administration in Malaysia. International Journal of Business and Social Science 1(1):81–95
p.(None): Marcum JA (2008). Medical axiology and values. In: An introductory philosophy of medicine: humanizing modern medicine.
p.(None): Philosophy and Medicine 99. Springer Science and Business Media, p 189–205
p.(None): Martins N, Coetzee M (2011) Staff perceptions of organisational values in a large South African manufacturing company:
p.(None): exploring socio-demographic differences. SA Journal of Industrial Psychology 37(1):1–11
...
p.(None): engagement
p.(None): Clear roles and responsibilities
p.(None): Article 10: Local ethics review should be sought wherever possible.
p.(None):
p.(None): Article 2: Local communities and research participants should be included throughout the research process.
p.(None): Article 20: A clear understanding should be reached among collaborators with regard to their roles, responsibilities
p.(None): and conduct throughout the research cycle.
p.(None):
p.(None): funders and charitable funders of research (see Table 6.2). The three main good practice elements9 raised by funders
p.(None): and industry to stop ethics dumping are listed in Table 6.3, with their corresponding GCC articles (Singh and Makanga
p.(None): 2017).
p.(None): As already indicated, engagement with research funders was not restricted to one meeting, but took place over
p.(None): approximately two years via the funder and industry platforms described above. Additionally, the first draft of the GCC
p.(None): was distributed to all members of the platforms nine months after the workshop. Both groups pro- vided further comments
p.(None): on the draft.
p.(None):
p.(None):
p.(None): External Engagement with Researchers
p.(None):
p.(None): The consortium that drafted the GCC represented a wide range of academic disci- plines, namely ethics, medicine,
p.(None): economics, bioethics, law, social psychology, soci- ology, psychology, gender studies, chemistry, social sciences,
p.(None): psychiatry, biology, zoology, veterinary medicine, political science and management. The multidisci- plinary
p.(None): nature of the consortium’s expertise enabled broad engagement with the wider academic community. For example,
p.(None): academic presentations that included the GCC were delivered in Belgium, China, Congo, Cyprus, Germany, India, Kenya,
p.(None): Latvia, the Netherlands, the Philippines, Portugal, Rwanda, South Africa, Sweden, Taiwan, Uganda, Vatican City, the UK
p.(None): and the USA (Dammann and Schroeder 2018). The feedback from researchers was essentially threefold. First, researchers
p.(None): were interested in the potential “grey areas” of ethics dumping. A question in this context, asked on many occasions by
p.(None): different audiences, was: “If a particular research study has no real local relevance to LMICs, and the
p.(None): research money spent by well- intentioned researchers from HICs (who genuinely believe that they are improving the
p.(None): world) is in fact being wasted, does that count as ethics dumping?” A case in
p.(None):
p.(None):
p.(None): 9 A fourth good practice element that was emphasized at the funder and industry workshop was the provision of
p.(None): post-trial access to successfully marketed drugs. This requirement was not included in the GCC for two main reasons.
p.(None): First, the GCC was designed to be applicable to all disciplines, and hence articles with limited applicability were
p.(None): avoided. Second, post-trial access is clearly indicated in existing guidelines, in particular in the Declaration of
...
p.(None): dumping still happens? Inspire them! The four global values of fairness, respect, care and honesty inspire
p.(None): individuals in any context to act ethically. – Professor Pamela Andanda (Kenyan), professor of law at the University of
p.(None): the Witwatersrand, South Africa, co-author of the GCC
p.(None): The inclusion in the GCC of elements relating to agricultural and environmental ethics is long overdue. It is time that
p.(None): fairness, respect, care and honesty were con- sidered more systematically in agriculture. – Associate Professor Rachel
p.(None): Wynberg (South African), South African Bio-economy Research Chair, co-author of the GCC
p.(None): I have had a very close look at the Global Code of Conduct that you have pro- posed, and I really find it
p.(None): impressive (Burtscher 2018). – Wolfgang Burtscher (Austrian), deputy director-general of Research and Innovation
p.(None): for the European Commission
p.(None): Unlike other codes, the GCC has built into it community engagement and mean- ingful involvement of research
p.(None): participants as part of a checklist for designing good studies. – Dr Joshua Kimani (Kenyan), clinical research director
p.(None): at Partners for Health and Development in Africa, University of Manitoba field office in Kenya, co-author of the GCC
p.(None): Many of my company’s clients are not ethicists, but they want to undertake their research ethically. The GCC avoids
p.(None): ethics jargon and is concise and clear. – Elena Tavlaki (Greek), director of Signosis Sprl, co-author of the GCC
p.(None):
p.(None): 9 Towards Equitable Research Partnership
p.(None): 111
p.(None):
p.(None): Good practices know no regional or political boundaries: research that is unethi- cal in Europe is unethical in Africa.
p.(None): That’s why the GCC is needed. – Dr Michael Makanga (Ugandan), executive director of the European & Developing Countries
p.(None): Clinical Trials Partnership, co-author of the GCC
p.(None): The world is unfair. We are talking about R&D in an unfair world ... The Code of Conduct [GCC] is exquisitely clear
p.(None): that it is unethical to do research in one place for the sake of another. (TRUST 2018) – Professor Jeffrey Sachs
p.(None): (American), speaking at the GCC launch in the European Parliament
p.(None): The new four-values system around fairness, respect, care and honesty is highly appreciated in Asia. People find it
p.(None): intuitive – in fact, most audiences loved it. – Dr Vasantha Muthuswamy (Indian), president of the Forum
p.(None): for Ethics Review Committees in India, co-author of the GCC
p.(None): Zhai Xiaomei [Chinese], the executive director of the Centre for Bioethics at the Chinese Academy of Medical Sciences,
p.(None): in Beijing, who is also deputy director of the health ministry’s ethics committee, welcomes what TRUST2 has done.
p.(None): (Economist 2018)
p.(None): To deliver our mission to end world hunger, we need to undertake research. Applying the GCC will assist us
p.(None): greatly. No previous code was designed so clearly for work with highly vulnerable populations in resource-poor
p.(None): settings. – Myriam Ait Aissa (French), head of Research and Analysis at Action contre la Faim, co-author of the GCC
...
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p.(None):
p.(None):
p.(None): Honesty
p.(None): Article 20
p.(None):
p.(None): A clear understanding should be reached among collaborators with regard to their roles, responsibilities and conduct
p.(None): throughout the research cycle, from study design through to study implementation, review and dissemination.
p.(None): Capacity-building plans for local researchers should be part of these discussions.
p.(None):
p.(None):
p.(None): Article 21
p.(None):
p.(None): Lower educational standards, illiteracy or language barriers can never be an excuse for hiding information or providing
p.(None): it incompletely. Information must always be presented honestly and as clearly as possible. Plain language and a
p.(None): non-patronising style in the appropriate local languages should be adopted in communication with research participants
p.(None): who may have difficulties comprehending the research process and requirements.
p.(None):
p.(None):
p.(None): Article 22
p.(None):
p.(None): Corruption and bribery of any kind cannot be accepted or supported by researchers from any countries.
p.(None):
p.(None): Honesty
p.(None): 11
p.(None):
p.(None): Article 23
p.(None):
p.(None): Lower local data protection standards or compliance procedures can never be an excuse to tolerate the potential for
p.(None): privacy breaches. Special attention must be paid to research participants who are at risk of stigmatization,
p.(None): discrimination or incrimi- nation through the research participation.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 3
p.(None): The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract Values inspire, motivate and engage people to discharge obligations or duties. This chapter defends the
p.(None): values approach in the context of guarding against ethics dumping, the practice of exporting unethical research from
...
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p.(None): achieved by 2030. Successes in efforts to end extreme poverty, achieve food security and ensure healthy lives, as well
p.(None): as suc- cesses towards all other goals, depend not only on goal-oriented societal reforms and the mobilization of
p.(None): substantial financial and technical assistance, but also on significant technological, biomedical and other
p.(None): innovations.
p.(None): Ensuring the success of the Agenda 2030 requires massive research and develop- ment efforts as well new forms of
p.(None): research co-creation on a level playing field and with a universal professional ethos.
p.(None): Leaving no one behind does not “only” include reducing income and wealth inequalities, and affirmative
p.(None): action in support of better opportunities for self- determined living within and among countries. It also
p.(None): implies reaching those most at risk from poverty and its impacts. This again necessitates research focused on the needs
p.(None): of the poor in a way that does not infringe their human rights.
p.(None): Research and innovation can only be sustainably successful when based on soci- etal trust. The precondition for
p.(None): societal trust and public acceptance is the perception that work is done with integrity and based on fundamental values
p.(None): shared by the global community. Trust depends not only on research work being compliant with laws and regulations, but
p.(None): also, more than ever, on its legitimacy.
p.(None): Such legitimacy can be achieved through inclusion and, importantly, the co- design of solutions with
p.(None): vulnerable populations. Leaving no one behind also means leaving no one behind throughout the research process, aiming
p.(None): for research with, not about, vulnerable populations.
p.(None):
p.(None): vii
p.(None):
p.(None): viii
p.(None): Foreword
p.(None):
p.(None): The results of the TRUST Project, whose Global Code of Conduct for Research in Resource-Poor Settings (GCC) this book
p.(None): celebrates, contribute to realizing the European Union’s ambition of a more inclusive, equal and sustainable global
p.(None): soci- ety – a profound expectation of people all over the world.
p.(None): The fact that the GCC now exists and has been welcomed by the European Commission as a precondition for
p.(None): its research grants is only a beginning.
p.(None): My hope is that enlightened stakeholders in public institutions, foundations and the private sector will now start a
p.(None): discourse and apply moral imagination to the concrete consequences of the GCC. This relates to the processes and
p.(None): content of their research endeavours as well as the selection criteria for hiring, promoting and remu- nerating the
p.(None): research workforce.
p.(None): Research excellence is no longer only defined by playing by the rules and being “successful”. The results of discourses
p.(None): about the operationalization of the TRUST values of fairness, respect, care and honesty are the new
p.(None): benchmark for excellence.
p.(None):
p.(None): Basel, Switzerland Klaus Leisinger
p.(None):
p.(None):
p.(None): Reference
p.(None):
p.(None): UN (2015) Transforming our world: the 2030 agenda for sustainable development. United Nations.
p.(None): https://www.un.org/development/desa/dspd/2015/08/transforming-our-world-the-2030- agenda-for-sustainable-development/
p.(None):
p.(None):
...
p.(None): having the GCC checked by the EC legal department in time for our event at the European Parliament in June 2018.
p.(None): Without Dorian’s efforts, the code would not have the standing it has now, as a mandatory reference
p.(None): document for EC framework programmes.
p.(None): Thanks to Roberta for believing in our work and for being a most enthusiastic, supportive and interested project
p.(None): officer, despite several amendments. Thanks to Wolfgang for facilitating one of those amendments very
p.(None): professionally and in record time during a summer break.
p.(None): Thanks to Louiza for providing insightful funder input during the GCC develop- ment phase. Thanks to Edyta for
p.(None): organizing a very stimulating training event for EC staff on the GCC. Thanks to Yves Dumont for inventing the term
p.(None): “ethics dumping” in 2013.
p.(None): ix
p.(None):
p.(None): x
p.(None): Acknowledgements
p.(None):
p.(None): Thanks to Stelios Kouloglou, MEP, and Dr Mihalis Kritikos for giving us the opportunity to present the GCC at a
p.(None): European Parliament event.
p.(None): Thanks to Dr Wolfgang Burtscher, the EC’s deputy director-general for Research and Innovation, for announcing in person
p.(None): at the European Parliament event that the GCC would henceforth be a mandatory reference document for EC
p.(None): framework programmes.
p.(None): Thanks to the University of Cape Town for being the first university to adopt the GCC in April 2019. This is owed to
p.(None): Prof. Rachel Wynberg’s long-term commitment to equitable research partnerships and the protection of vulnerable
p.(None): populations in research.
p.(None): Thanks to Joyce Adhiambo Odhiambo and her colleagues in Nairobi for prepar- ing the excellent speech on the four values
p.(None): of the GCC – fairness, respect, care and honesty – that she presented at the European Parliament (TRUST 2018).
p.(None): Thanks to Leana Snyders, the director of the South African San Council, for tak- ing the place of Reverend Mario
p.(None): Mahongo at the Stockholm GCC launch event and for doing so brilliantly, despite the shock of his tragic death. Thanks
p.(None): also for her speech at the European Parliament event.
p.(None): Thanks to Professor Jeffrey Sachs, Dr Leonardo Simão, Dr Mahnaz Vahedi and Vivienne Parry MBE for joining the TRUST
p.(None): team at the European Parliament event. Thanks to Fritz Schmuhl, the senior editor at Springer, who is still the best
p.(None): book editor I know. This is my sixth Springer book with him, which says it all. Thanks also to George Solomon, the
p.(None): project co-ordinator for this book, for dealing swiftly and efficiently with all questions and for smoothing out any
p.(None): complications in the book production process. Finally, thanks to Ramkumar Rathika for expertly guiding
p.(None): the e-proofing process.
p.(None): This is also the sixth book for which Paul Wise in South Africa has been the professional copy-editor. Copy-editing
p.(None): sounds like checking that references are in the right format, but that’s comparing a mouse to a lion. Paul does a
p.(None): lion’s work; he even found a factual mistake in an author biography – written by the author. Thanks, Paul! I hope
p.(None): you’re around for the seventh book.
p.(None): Thanks to Professor Michael Parker, the director of Ethox at Oxford University, for giving a team of us (Joshua Kimani,
p.(None): Leana Snyders, Joyce Adhiambo Odhiambo and me) the floor in his distinguished institute to introduce the GCC.
...
p.(None): rights
p.(None): LMICs low- and middle-income countries NGO nongovernmental organization
p.(None): PHDA Partners for Health and Development in Africa REC research ethics committee
p.(None): SASC South African San Council SASI South African San Institute
p.(None): SWOP Sex Workers Outreach Programme
p.(None): UNESCO United Nations Educational, Scientific and Cultural Organization WIMSA Working Group of Indigenous
p.(None): Minorities in Southern Africa
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xix
p.(None):
p.(None): Chapter 1
p.(None): Ethics Dumping and the Need for a Global Code of Conduct
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The UN’s 2030 Agenda for Sustainable Development calls for more research and innovation to end
p.(None): poverty, leaving no one behind – and yet the export of unethical practices from high-income to lower-income settings is
p.(None): still a major concern. Such ethics dumping occurs in all academic disciplines. When research is regarded, on the one
p.(None): hand, as a dirty word among vulnerable populations who face ethics dumping, and, on the other, as a solution to many of
p.(None): humanity’s problems, how can the resulting gulf be bridged? This book describes one initiative to counter ethics
p.(None): dumping: the development and promotion of the Global Code of Conduct for Research in Resource-Poor Settings.
p.(None):
p.(None): Keywords Ethics dumping · Global research ethics · Exploitation · Vulnerability · Research governance
p.(None):
p.(None):
p.(None): Research has become a global enterprise. Individual researchers around the world are encouraged to be as mobile as
p.(None): possible (Sugimoto et al. 2017). At the same time, the activities of mobile researchers have made research “one of the
p.(None): dirtiest words in the indigenous world’s vocabulary” (Tuhiwai Smith 1999: 1). The indigenous com- munities in which
p.(None): Tuhiwai Smith, a Māori professor, grew up saw research as some- thing that “told us things already known, suggested
p.(None): things that would not work, and made careers for people who already had jobs” (Tuhiwai Smith 1999: 3).
p.(None): There is a gulf between those advocating more researcher mobility because “sci- ence is the engine of prosperity”
p.(None): (Rodrigues et al. 2016) and those who argue that research can represent harmful “visits by inquisitive and
...
p.(None): high-income country (HIC). The second is exploitation based on insufficient knowledge or ethics awareness on the part
p.(None): of the mobile researcher. In both cases a lack of adequate oversight mechanisms in the host LMIC is likely to
p.(None): exacerbate the problem (Schroeder et al. 2018).
p.(None): Examples of ethics dumping in the 21st century include:
p.(None): • In clinical research, misinterpreting the standard of care, leading to the avoidable deaths of research
p.(None): participants (Srinivasan et al. 2018).
p.(None): • Research among indigenous populations that led to the publication of “private, pejorative, discriminatory and
p.(None): inappropriate” conclusions and a refusal to engage with indigenous leaders on the informed consent process
p.(None): (Chennells and Steenkamp 2018).
p.(None): • The export of valuable blood samples from a rural area in China to a US genetic bank, leading to a large amount of
p.(None): research funding for the US team (Zhao and Zhang 2018).
p.(None): • The use of wild-caught non-human primates in research by a UK researcher who undertook his experiments in Kenya,
p.(None): thus “bypassing British law” (Chatfield and Morton 2018).
p.(None): • An attempt to seek retrospective ethics approval for a highly sensitive social sci- ence study undertaken among
p.(None): vulnerable populations following a local Ebola crisis (Tegli 2018).
p.(None): How can one reconcile recent cases of ethics dumping with our generation’s highly ambitious call for more
p.(None): research and innovation? The United Nations 2030 Agenda for Sustainable Development aims “to end all forms of poverty…
p.(None): while ensuring that no one is left behind” (UN ndb). To achieve these aims, the UN encourages “fostering
p.(None): innovation” (Goal 9 of Agenda 2030), as “without innovation
p.(None): …, development will not happen” (UN nda).
p.(None): This book describes one initiative to counter ethics dumping: the development and promotion of the Global Code of
p.(None): Conduct for Research in Resource-Poor Settings (GCC) and its sister code, the San Code of Research Ethics.
p.(None): The GCC recognizes the considerable power imbalances that may be involved in international collaborative research and
p.(None): provides guidance across all disciplines. It is based on a new ethical framework that is predicated on the values of
p.(None): fairness, respect, care and honesty; values that are imperative for avoiding ethics dumping. The GCC opposes all double
p.(None): standards in research and supports long-term equitable research relationships between partners in lower-income
p.(None): and higher-income set- tings. This book introduces the GCC in the following manner:
p.(None): • Chapter 2 reproduces the GCC as launched in the European Parliament in June 2018 and adopted as a mandatory
p.(None): reference document by the European Commission (ndb).
...
p.(None): often broad ethics terms. For instance, according to Google (2018), synonyms for “honesty” are:
p.(None): moral correctness, uprightness, honourableness, honour, integrity, morals, morality, ethics, principle, (high)
p.(None): principles, nobility, righteousness, rectitude, right-mindedness, upstandingness
p.(None):
p.(None): 24 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): What does need explaining, however, is the scope of the value of honesty in the context of global research ethics.
p.(None): Telling lies is only one possible wrongdoing in the context of a broad understanding of honesty. For instance, in
p.(None): research ethics it is equally unacceptable to leave out salient features from an informed consent process. While this
p.(None): might, strictly speaking, not involve a lie, concealing important informa- tion that might make a difference to
p.(None): someone’s consent violates the value of honesty as much as lying. For this reason, research ethicists often use the
p.(None): terms “transpar- ency” and “open communication” to ensure that all relevant information is provided so that research
p.(None): participants can make an informed choice about whether to partici- pate or not.
p.(None): In addition to lying and withholding information, there are other ways of being dishonest, in the sense of not
p.(None): communicating openly and transparently. For instance, in a vulnerable population with high levels of illiteracy, it can
p.(None): be predicted that a printed information sheet about research will not achieve informed consent. The same can be said
p.(None): for a conscious failure to overcome language barriers in a mean- ingful way: leaving highly technical English
p.(None): terms untranslated in information sheets can easily lead to misunderstandings.
p.(None): Honesty is also related to research conduct other than interaction with research participants. Most prominently, the
p.(None): duties of honesty are described in research integrity frameworks: do not manipulate your data, do not put your
p.(None): name onto pub- lications to which you have not contributed, do not waste research funds, to give only three examples.
p.(None): However, while the latter prescriptions for conduct with integ- rity in research are important, they are not directly
p.(None): linked to exploitation in global research collaboration and are not covered in the GCC. In this context, the European
p.(None): Code of Conduct for Research Integrity (ALLEA, 2017) is very helpful.
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): Standards, principles, values, virtues and ideals can guide moral action. At the foun- dation of the GCC are values.
p.(None): Why? For three main reasons:
p.(None): 1. Values inspire action; they motivate people to do things. For instance, when the value of fairness is threatened,
p.(None): people normally respond with action.
p.(None): 2. Values provide the golden middle way between being overly prescriptive and overly aspirational. Standards and
p.(None): principles require too much precision in their formulation and are too prescriptive in international collaborative
...
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 5
p.(None): Exploitation Risks in Collaborative International Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract Ethics dumping occurs in collaborative international research when peo- ple, communities, animals and/or
p.(None): environments are exploited by researchers. Exploitation is made possible by serious poverty and extreme power
p.(None): differentials between researchers from high-income countries and research stakeholders from low- and middle-income
p.(None): countries (LMICs). To prevent its occurrence, the risks of exploitation have to be tackled. This chapter describes 88
p.(None): risks identified for col- laborative international research, categorized according to four values: fairness,
p.(None): respect, care and honesty. The risks were identified in a broad-based consultative exercise, which included more than
p.(None): 30 members and chairs of ethics committees in LMICs, representatives from vulnerable populations in LMICs, and an open
p.(None): call for case studies of exploitation. The findings of the exercise contributed to the develop- ment of the Global Code
p.(None): of Conduct for Research in Resource-Poor Settings.
p.(None):
p.(None): Keywords Exploitation · Ethics dumping · Collaborative research · Vulnerability · Research ethics · Ethics codes
p.(None):
p.(None):
p.(None): Ethics dumping1 occurs in collaborative international research when people, com- munities, animals and/or environments
p.(None): are exploited by researchers. In order to pre- vent ethics dumping, such exploitation needs to stop. This chapter
p.(None): describes our investigation into the risks of exploitation in low- and middle-income countries (LMICs),
p.(None): uncovering what makes exploitation more likely to occur due to vulnera- bilities that can be exploited, either
p.(None): knowingly or unknowingly.
p.(None): This undertaking was vital for the development of a Global Code of Conduct for Research in Resource-Poor Settings (GCC)
p.(None): that can address real-world risks for exploitation in research. Many such risks are not well described in the
p.(None): literature, and hence there was an empirical component to our activities. Furthermore, this process was necessary to
p.(None): ensure that the GCC was more than a compilation of existing
p.(None):
p.(None):
p.(None):
...
p.(None): promote their own interests (Hughes 2010). While there is a morally neutral sense of exploitation (the exploitation of
p.(None): natural talents to create art, for example), the term is generally used to describe a moral failing.
p.(None): Exploitation of people is very often unjust, unfair, harmful or just plain wrong. What is it, then, that
p.(None): distinguishes morally unacceptable exploitation from neutral exploitation?
p.(None): Some argue that exploitation is wrong because it is coercive (Schwartz 1995). If the only way for a woman in an LMIC to
p.(None): access antiretroviral drugs to prevent the transmission of HIV to her unborn baby is to participate in a
p.(None): placebo-controlled clinical trial,2 despite the existence of a proven standard of care,3 then one could say she has
p.(None): been coerced into enrolling (Annas and Grodin 1998). In this sense, exploi- tation occurs where one party takes
p.(None): advantage of another by making them an offer they cannot refuse; they are then coerced to accept simply because there
p.(None): is no alter- native. Others argue that exploitation is wrong because it treats human beings as means rather than ends
p.(None): (Wood 1995). In other words, exploitation instrumentalizes people. Yet others claim that exploitation is wrong
p.(None): because it disadvantages the vulnerable (Macklin 2003).
p.(None): Our investigation was concerned with the risks or vulnerabilities for exploitation, so we adopted Macklin’s definition
p.(None): of exploitation. However, it is important to bear in mind that situations that are conducive to exploitation do not
p.(None): necessarily lead to exploitation. For instance, if a pharmaceutical company is due to test new antiretro- viral drugs
p.(None): to prevent the transmission of HIV to unborn babies, and the company operates in a country where poor mothers have no
p.(None): or very limited access to health care, it does not mean that exploitation will necessarily occur. The company may
p.(None): decide not to exploit vulnerable research participants and offer the accepted stan- dard of care to those in the
p.(None): control arm, rather than a placebo.
p.(None): Exploitation usually requires a moral decision on the part of the potential exploiter, but it can also occur
p.(None): through ignorance. Whether intended or unintended, the effects of exploitation are the same for the exploited. Hence,
p.(None): ignorance is not a legitimate justification for exploitation. Uncovering the primary risks of exploitation
p.(None):
p.(None): 2 A placebo-controlled trial involves some participants being given a medicine with active ingredi- ents, for instance
p.(None): a new drug against malaria, while others, the control group, are given a substance that should have no effect (the
p.(None): placebo), so that the outcomes can be compared.
p.(None): 3 One speaks of a proven standard of care when a treatment already exists for the illness under consideration in a
p.(None): trial. Hence, the ethical demand of testing any new drug against an existing one rather than a placebo is known as the
p.(None): “standard of care” debate.
p.(None):
p.(None): Our Method
p.(None): 39
p.(None):
p.(None): can help to increase awareness but, in our case, it also ensures that the GCC is designed in such a way
p.(None): that researchers are compelled to consider these factors. It is a unique facet of the GCC that it focuses the attention
...
p.(None): achieved via thorough exploration of the risks from many perspectives, both top-down and bottom-up.
p.(None):
p.(None):
p.(None): Our Method
p.(None):
p.(None): The aim of this investigation was to identify the critical vulnerabilities that engender susceptibility to exploitation
p.(None): in LMIC-HIC collaborative research. Investigation of this vast subject would be impossible from a traditional
p.(None): literature-based approach, or through investigation in a single geographical region. Many of these vulnerabili- ties
p.(None): are poorly represented in the literature, and they can differ between countries, cultures and types of research. For
p.(None): example, clinical trials, social science, animal experiments, environmental science and research in emergency settings
p.(None): may pose a diverse array of risks that are largely determined by the local context. Consequently, a creative approach
p.(None): to data collection was needed to capture as many risks and vul- nerabilities as possible.
p.(None): In this regard it was very helpful that the interdisciplinary TRUST project con- sortium comprised multilevel ethics
p.(None): bodies, policy advisers and policymakers, civil society organizations, funding organizations, industry and academic
p.(None): scholars from a range of disciplines. With input from each of these perspectives, a broad-based consultative exercise4
p.(None): was possible which included input from these collaborators as well as more than 30 members and chairs of ethics
p.(None): committees in LMICs, represen- tatives from vulnerable populations in LMICs, and an open call for case studies of
p.(None): exploitation in research in LMICs (Chapter 6).
p.(None): For example, extensive input from members and chairs of ethics committees was sought in both India and Kenya. In India,
p.(None): the Forum for Ethics Review Committees in India (FERCI) hosted a two-day workshop in Mumbai on 11 and 12 March 2016. At
p.(None): this workshop, approximately 30 leading bioethicists from around India came together to share their experiences and
p.(None): discuss cases of exploitation in research. In Nairobi on 23 and 24 May 2016, three esteemed chairs of national ethics
p.(None): commit- tees shared their experiences and opinions about the primary ethical challenges for LMIC-HIC collaborative
p.(None): research in Kenya. Findings from both events revealed multiple risks of exploitation that are characteristic of
p.(None): research in some LMIC set- tings. These included traditional requirements for appropriate community
p.(None):
p.(None): 4 This type of consultative exercise is of proven value in the development of ethical codes that are broadly
p.(None): representative and can have wide-ranging impact. For example, the principles of the “Three Rs”, which are
p.(None): globally accepted as a reasonable measure for ethical conduct in animal research, arose from a broad consultation with
p.(None): stakeholders undertaken by Russell and Burch in the 1950s. See Russell et al. (1959).
p.(None):
p.(None): 40 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): consultations and permissions, and specific cultural beliefs and customs that must be respected.
p.(None): Ongoing consultation with representatives from two vulnerable groups that have first-hand accounts of the risks
p.(None): for exploitation were undertaken. From Nairobi, Kenya, sex worker peer educators and, from South Africa, members
p.(None): of the San com- munity shared their experiences of being the subjects of exploitation and their opin- ions about how
p.(None): they want to be treated in future. Among many other insights, both groups described a lack of benefits from research
p.(None): projects (which are often highly beneficial to the researchers), as well as risks of stigmatization from the manner in
p.(None): which they were involved in the study.
p.(None): 12 months of in-depth and far-reaching investigation produced a considerable amount of data (Chapter 6). From this
p.(None): data, individual vulnerabilities and risks of exploitation were extracted, organized and tabulated on an Excel
p.(None): spreadsheet with source details and descriptions of the vulnerability or risk. Care was taken to ensure that each
p.(None): individual entry was based upon real-world experience rather than hypo- thetical suppositions. Our lists were compared
p.(None): with risks mentioned in the literature and, where necessary, additional information sought to address gaps.
p.(None): Once collated, the raw data was streamlined to group similar vulnerabilities together. For instance, there
p.(None): were many different examples of how people living in resource-poor circumstances may be unfairly enticed to participate
p.(None): in research by the prospect of payment or reward. Such examples were grouped under the label “undue inducement”.
...
p.(None): Environmental • Variations in customs, norms and attitudes regarding the environment
p.(None):
p.(None): Animals and environments are also at risk of exploitation because of variations in customs and norms. What is
p.(None): considered “animal cruelty” or “inhumane practice” in animal experimentation varies greatly between cultures.
p.(None): Additionally, some ani- mals are awarded greater protection in certain cultures than others, for example, dogs and cats
p.(None): in the United Kingdom and cows in India. Animal experimentation on non-human primates is particularly controversial
p.(None): in most countries, but in some certain non-human primates are viewed as “pests” (Hill and Webber 2010). Different
p.(None): partners in collaborative research may have different philosophies related to the environment. Environmental
p.(None): protection is sometimes regarded as a colonial con- struct that has negative impacts on local communities in LMICs, and
p.(None): research agen- das likewise. There may therefore be a philosophical or paradigmatic difference between
p.(None): research partners that needs to be identified and addressed.
p.(None):
p.(None):
p.(None): Care
p.(None):
p.(None): Researchers who take good care in their research combine two elements: they care about research participants, in the
p.(None): sense that they are important to them, and they feel responsible for the welfare of those who contribute to their
p.(None): research, or might suffer as a result of it. In work with vulnerable communities, this might, for exam- ple, entail
p.(None): the tailoring of informed consent procedures to local requirements
p.(None):
p.(None): Our Findings
p.(None): 45
p.(None):
p.(None): (language, literacy, education levels) to achieve genuine understanding. Table 5.4 shows the primary risks related to
p.(None): care for persons, institutions, communities, coun- tries, animals and the environment.
p.(None): At the individual level, variations in spoken language, understanding, levels of literacy and use of terminology are
p.(None): just some of the issues that can lead to exploita- tion. The number of different ways in which individuals can suffer
p.(None): harm as a result of their involvement in research is vast. At the community level, the mere presence of a research team
p.(None): can have a great impact upon a local community. Research teams require food and accommodation, purchase local goods and
p.(None): services, and form rela- tionships with local people.
p.(None): At a national and international level, the rapid emergence of high-risk applica- tions of technologies such as genome
p.(None): editing7 challenges not only safety risk assess- ments but also existing governance tools. This creates an environment
p.(None): where risky experiments might be carried out in countries with an inadequate legal framework,
p.(None):
p.(None): Table 5.4 Primary risks for care
...
p.(None): The earliest research ethics codes were written solely for researchers:
p.(None): The Nuremberg Code (1949) and the original Declaration of Helsinki (1964) made no men- tion of committee review; these
p.(None): documents placed on the investigator all responsibility for safeguarding the rights and welfare of research subjects.
p.(None): (Levine 2004: 2312)
p.(None): In 1966, the surgeon general of the US Public Health Service issued a policy statement requesting the establishment
p.(None): of research ethics review committees or institutional review boards (Levine 2004: 2312). At this point in
p.(None): history, ethics codes would have had two main target audiences: researchers and research ethics committees.
p.(None): The Global Code of Conduct for Research in Resource-Poor Settings (GCC) was developed from the start with three
p.(None): audiences in mind: researchers, research ethics
p.(None):
p.(None):
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 51
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_6
p.(None):
p.(None): 52 6 How the Global Code of Conduct Was
p.(None): Built
p.(None): Consultation Fact-finding
p.(None):
p.(None): Vulnerable populations
p.(None): Industry Funders
p.(None): Literature Case studies
p.(None):
p.(None): Ethics committees
p.(None): Researchers Policy-
p.(None): Legal instruments
p.(None): Existing guidelines
p.(None):
p.(None): Risks and good practice ,
p.(None): Drafting
p.(None):
p.(None): Global Code of Conduct,
p.(None):
p.(None): Fig. 6.1 Input into the GCC
p.(None):
p.(None): committees and research participants (and/or their communities and support groups). To achieve a good match
p.(None): with these anticipated audiences, it was essential that all relevant stakeholders1, in particular highly
p.(None): vulnerable populations, be included at all stages of the drafting process of the GCC. This inclusion was later
p.(None): praised by the Deputy Director-General for Research and Innovation of the European Commission (EC) as “impressive” and
p.(None): a Horizon 2020 success story, [which] demonstrates that, in order to actively combat ethics dumping,2 a coordination
p.(None): of stakeholder efforts is required. Moreover, following the exam- ple of TRUST,3 such efforts should be based on a
p.(None): bottom-up approach that empowers local communities involved, as equal partners. (Burtscher 2018: 1)
p.(None): A major benefit of the bottom-up approach is that it resulted in a short, clear code that is focused on practical
p.(None): matters and accessible to nonspecialists. The develop- ment process consisted of a range of activities, which are
p.(None): summarized in Figure 6.1. Case studies were collected prior to the drafting of the GCC and published in a book
p.(None): entitled Ethics Dumping: Case Studies from North-South Research Collaborations (Schroeder et al. 2018).
p.(None): The foundation of the GCC, the risk matrix,
p.(None): has been introduced in Chapter 5 of this book.
p.(None):
p.(None): 1 “Stakeholders” is an increasingly contested term, as it may imply that all parties hold an equal stake. Some prefer
p.(None): the term “actors”, yet this brings its own complexities. While acknowledging the debate, we use the well-established
p.(None): term “stakeholders” throughout.
p.(None): 2 The export of unethical research from a high-income setting to a resource-poor setting with weaker
p.(None): compliance structures or legal governance mechanisms.
p.(None): 3 The TRUST project (http://trust-project.eu/) was funded by the European Commission from 2015 to 2018. One of its
p.(None): outputs was the GCC.
p.(None):
p.(None): Meaningful Consultation with Diverse Stakeholders 53
p.(None):
p.(None): This chapter will outline the following steps in the development of the GCC:
p.(None): • The consultations with various stakeholders over two and a half years
p.(None): • The comparative analysis of existing guidelines and relevant legal instruments
p.(None): • The drafting process.
p.(None):
p.(None):
p.(None): Meaningful Consultation with Diverse Stakeholders
p.(None):
p.(None): “They could take you out for coffee and call it consultation!” (Youdelis 2016)
p.(None): Consultation, engagement, community engagement, guided discussions, focus groups and interviews: these are all means of
p.(None): obtaining relevant input from stake- holders prior to action. When a problem affects a range of people or groups and a
p.(None): feasible and implementable solution is sought, stakeholder input and community engagement are essential (Hebert et
p.(None): al. 2009; Cook 2008; Bassler et al. 2008; Dunn 2011).
p.(None): This section shows how a wide range of stakeholders were consulted on ethics dumping concerns and potential
p.(None): solutions, with the specific aim of drafting the GCC. (Chapter 8 provides more general advice on community
p.(None): engagement with vulnerable populations (Chapter 8).)
p.(None):
p.(None):
p.(None): Broad Consultation
p.(None):
p.(None): Governance mechanisms such as ethics codes require evidence of legitimacy. Why should a particular ethics code be
p.(None): followed by researchers? The answer that can be given for the GCC is fourfold. First, the funder that supported the
p.(None): development of the GCC – the European Commission – requested a new code to guard against ethics dumping. Hence, instead
p.(None): of engaging in a long-term process to negotiate the addi- tion of specific sections on international collaborative
p.(None): research to existing ethics codes and governance mechanisms, a funder with an interest in the output opted for a new
p.(None): and independent code. Second, in 2015 the TRUST consortium’s bid was chosen by peer reviewers from a range of proposals
p.(None): to tackle ethics dumping. The criteria for the selection were excellence and impact, as well as the quality and effi-
p.(None): ciency of the proposed implementation (Horizon 2020 nd). Third, upon the comple- tion and launch of the GCC in 2018,
p.(None): the EC ethics and integrity sector and the EC legal department assessed the code and the decision was taken to make it
p.(None): a manda- tory reference document for European Union (EU) framework programmes (Burtscher 2018).
p.(None): However, the most important element for the GCC’s credibility may be the fourth element, the fact that the TRUST
...
p.(None): Researchers The Centre for Professional Ethics at the University of Central Lancashire is one of the oldest
p.(None): research-only ethics centres in Europe, with specialist expertise in global justice issues.
p.(None): The Bio-Economy Research Chair at the University of Cape Town and her team focus on engagement with communities,
p.(None): indigenous knowledge holders and policymakers to ensure environmentally sustainable poverty reduction. The Law School
p.(None): of the University of the Witwatersrand, Johannesburg, contributed specialist human rights and legal frameworks
p.(None): expertise.
p.(None):
p.(None): Research participants
p.(None):
p.(None):
p.(None): Research advocates (support organizations)
p.(None): Many of the individuals involved in drafting the GCC have previously been research participants. Of particular
p.(None): importance in this process were the indigenous peoples and sex worker representatives who were involved through SASI
p.(None): and PHDA (see “Research communities” below).
p.(None): The Council on Health Research for Development (COHRED) helps promote the health and development of populations in low-
p.(None): and middle- income countries.
p.(None): Action Contre La Faim (ACF) is recognized as one of the leading organizations in the fight against hunger worldwide.
p.(None): ACF undertakes its own research on highly vulnerable populations.
p.(None):
p.(None): 56 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.1 (continued)
p.(None): Stakeholder
p.(None): type TRUST partner
p.(None):
p.(None): Research communities
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research ethics reviewers
p.(None): The South African San Institute (SASI) is dedicated to serving the San communities of southern Africa through legal,
p.(None): advocacy, socio- anthropological and related services.
p.(None): Partners for Health and Development in Africa (PHDA) supports female and male sex workers in the low socio-economic
p.(None): strata who reside in the informal settlements of Nairobi.
p.(None): The Forum for Ethics Review Committees in India (FERCI) promotes the effective implementation of the ethical review of
p.(None): biomedical research studies in India.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): • Advisory board
p.(None): • Engagement panel
p.(None): • Stakeholder inventory
p.(None): • Project deliverables
p.(None): • Publications
p.(None): • eNewsletters
p.(None):
p.(None): • Funder platform
p.(None): • Industry platform
p.(None): • Case study competition
p.(None): Enablers
p.(None): • Project website
p.(None): • Social media
p.(None): • Brochure
p.(None): • Project conferences and consultation meetings
p.(None): • Films
p.(None): • Interviews
p.(None): • Conference presentations
p.(None): Outputs
p.(None):
p.(None):
p.(None):
p.(None): Fig. 6.3 TRUST communication and engagement strategy
p.(None):
...
p.(None): were selected for inclusion in Ethics Dumping: Case Studies from North- South Research Collaborations (Schroeder et al.
p.(None): 2018) or as learning materials for the GCC website (http://www.globalcodeofconduct.org). This mechanism expanded the
p.(None): material available for the development of the risk matrix considerably.
p.(None):
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates
p.(None):
p.(None): “Around the world, millions of meetings are being held every day – most of them unproductive” (Koshy et al. 2017). In
p.(None): “Not Another Meeting!” Rogelberg et al. (2006) establish that perceived meeting effectiveness has a strong, direct
p.(None): relationship with posi- tive job attitudes and wellbeing at work. In the literature, meeting efficiency is linked to
p.(None): questions such as, “Is a meeting necessary?” (Koshy et al. 2017), or “Is a meeting the most cost-effective way of
p.(None): obtaining an outcome?” (Rogelberg et al. 2006). In addition, advice is given on how to make meetings more efficient,
p.(None): such as, “Prepare the agenda in advance,” and “Start with the most strategic items,” (Rogelberg et al. 2006).
p.(None): For the TRUST consortium, the most important question ahead of all major consul- tation meetings was: “Who are the
p.(None): external delegates?” On the one hand, are they senior and/or from influential institutions? Or, on the other hand, do
p.(None): they have first- hand experience of ethics dumping? In other words, the consortium aimed for senior decision-maker
p.(None): representation as well as vulnerable population representation. To give an example of the former, Table 6.2
p.(None): shows the funders and companies which were represented at the funder and industry consultation. The consultation with
p.(None): vulnerable populations on engagement with research participants will be described below.
p.(None): As noted above, millions of meetings are held every day around the world, and many of them affect job satisfaction and
p.(None): wellbeing negatively. How, then, could a meeting hosted on behalf of a three-year research project achieve such
p.(None): impressive representation? There were four reasons for this success:
p.(None): 1. A convincing justification for the meeting secured a Wellcome Trust venue in central London. The Wellcome Trust
p.(None): is the largest private funder of medical research globally (Jack 2012), with a very high standing in research
p.(None): circles.
p.(None):
p.(None): Table 6.2 Funders and industry members represented at consultation meeting, London 2017
p.(None): Funders Industry members
p.(None):
p.(None): Wellcome Trust European Commission.
p.(None): Medical Research Council UKRI
p.(None): World Health Organization TDR Calouste Gulbenkian Foundation Global Forum on Bioethics in Research
p.(None): European Federation of Pharmaceutical Industries and Associations (EFPIA)
p.(None): Sanofi Roche Novartis
p.(None): GlaxoSmithKline Boehringer Ingelheim
p.(None):
p.(None): 58 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): 2. Invitations to funders were issued by the European and Developing Countries Clinical Trials Partnership (EDCTP),
p.(None): the high-profile funding institution repre- sented on the TRUST consortium.
p.(None): 3. Invitations to industry were issued by Professor Klaus Leisinger, a member of the TRUST consortium and former
...
p.(None):
p.(None): 60 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Returning to the six research stakeholder groups identified earlier, the next sec- tion details how each group was
p.(None): reached through project conferences and consulta- tion meetings.
p.(None):
p.(None):
p.(None): External Engagement with Research Policymakers
p.(None):
p.(None): National research foundations, research councils and government ministries guide the strategic direction of research.
p.(None): Representatives from all of these groups attended the TRUST plenary in Cape Town in 2017, in particular senior
p.(None): representatives from the following national bodies:
p.(None): • The South African Department of Science and Technology
p.(None): • The South African Department of Environmental Affairs
p.(None): • The South African National Research Foundation
p.(None): • The Zimbabwean Agricultural Research Council
p.(None): To give an example of input, articles 17 and 48 of the GCC are directly linked to input from research
p.(None): policymakers. Dr Isaiah Mharapara from the Zimbabwean Agricultural Research Council argued that agricultural
p.(None): research in Africa had largely been based on foreign principles, meaning that the continent’s own crops, fruits,
p.(None): insects, fish and animals had been ignored. Through the historical introduc- tion of Western agricultural systems
p.(None): and cash crops such as tobacco, as well as genetically engineered crops, Africa had failed to develop
p.(None): agricultural solutions adapted to local conditions. According to Dr Mharapara, a lack of financial resources meant
p.(None): that African nations had been, and still were, vulnerable to exploitation by foreign researchers. This had resulted in
p.(None): damage to ecological systems, the loss of soils, fertility, biodiversity and natural resilience, and the
p.(None): erosion of indigenous knowledge. He advocated inclusive, consultative, robust and agreed processes to establish
p.(None): equitable research partnerships (Van Niekerk et al. 2017).
p.(None):
p.(None):
p.(None): External Engagement with Research Funders
p.(None):
p.(None): Estimates for research and development expenditure in the European Union in 2016 indicate that 56.6% of all such
p.(None): expenditure comes from the business sector, 30.9% from the government sector and the remainder mostly from charitable
p.(None): foundations (Eurostat 2018). TRUST’s main consultation workshop for research funders was held in London in 2017
p.(None): and involved all three sectors: public funders, private
p.(None):
p.(None): 7 Local relevance of research … should be determined in collaboration with local partners.
p.(None): 8 Local researchers should be included, wherever possible, throughout the research process, includ- ing in study
p.(None): design, study implementation, data ownership, intellectual property and authorship of publications.
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 61
p.(None): Table 6.3 Good practice input from funders and industry with GCC output
p.(None): Good practice Relevant GCC article
p.(None):
p.(None): Ensuring double ethics review Community
p.(None): engagement
p.(None): Clear roles and responsibilities
...
p.(None): determined in collaboration with local partners.” This could only be set out in more detail if there were a single
p.(None): process that would fit every situation – and that is not the case. What an equitable process for determining research
p.(None): goals should look like in an interna- tional collaborative research project is one of the things that need to be agreed
p.(None): on within the process of that project. Hence, prescriptive details would have been coun-
p.(None): terproductive to the very spirit of the article.
p.(None): Instead of attempting to formulate a range of possibilities to fill the process ele- ments with substance, we opted to
p.(None): provide educational material to support the GCC online,11 because any process requirements are best agreed
p.(None): between the relevant partners rather than imposed prescriptively by code drafters. Hence, our educational materials
p.(None): future-proof the GCC, as they can be updated in real time for use by early career (or any other) researchers, and,
p.(None): unlike the GCC itself, they are not mandatory.
p.(None):
p.(None):
p.(None): 10 Personal communication from Dr Vasantha Muthuswamy, a TRUST project team member, after a GCC presentation in Taiwan.
p.(None): 11 http://www.globalcodeofconduct.org/
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 63
p.(None):
p.(None): Engagement with Research Participants and Research Communities
p.(None):
p.(None): The inclusion of the perspectives of research participants and research communities who are vulnerable to exploitation,
p.(None): and therefore to ethics dumping, was essential to our bottom-up approach. It is also the ethical approach, as
p.(None): stipulated in article 2 of the GCC:
p.(None): Local communities and research participants should be included throughout the research process, wherever possible, from
p.(None): planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly
p.(None): represented. This approach represents Good Participatory Practice.
p.(None): Two NGO partners in the TRUST project were tasked specifically with ensuring that the voices of vulnerable populations
p.(None): were heard and acted upon. First, the South African San Institute (SASI) made the inclusion of indigenous peoples from
p.(None): South Africa possible. While San leaders and representatives were involved in all the work of the TRUST project,
p.(None): including the drafting of the GCC, the full impact of their contribution is best understood through the account in
p.(None): Chapter 7 of this book of the development of the San Code of Research Ethics. Second, Partners for Health and
p.(None): Development in Africa (PHDA) made the inclusion of sex workers from the Majengo area of Nairobi possible. At this point
p.(None): we will focus on their involvement in order to illustrate the bottom-up approach of the GCC drafting process.
p.(None): PHDA is a nonprofit organization that undertakes work in the fields of health and development in Kenya. Its mission is
p.(None): to increase access to health for disadvantaged communities in Africa by strengthening health systems, research,
p.(None): programme devel- opment and partnerships. PHDA’s programmes are implemented by a collaborative group of scientists and
p.(None): public health professionals from the University of Manitoba (Canada), the University of Nairobi and the government of
p.(None): Kenya. Its work focuses mainly on HIV prevention, treatment and care, research, capacity-building and
p.(None): training.
p.(None): The Sex Workers Outreach Programme (SWOP) is a PHDA initiative that under- takes active community engagement and
...
p.(None):
p.(None): “We need feedback to the community from the research in simple and non-scientific language. Some results have been
p.(None): shared with us in the past, but I did not know what they meant. Do not give us results in scientific language. It puts
p.(None): us at risk if we do not understand the results. … Come back with the results and tell us how we can make our lives
p.(None): better.”
p.(None): “We know that the samples that are collected from us are sometimes sent to other countries. What happens to them? In my
p.(None): culture – if my blood is taken, it must come back to me and I bury it. … [L]ocal and cultural values should be taken
p.(None): into account.”
p.(None): Article 3: Feedback about the findings of the research must be given to local communities and research participants. It
p.(None): should be provided in a way that is meaningful, appropriate and readily comprehended.
p.(None):
p.(None):
p.(None):
p.(None): Article 8: Potential cultural sensitivities should be explored in advance of research with local communities, research
p.(None): participants and local researchers to avoid violating customary practices. … If researchers from high-income settings
p.(None): cannot agree on a way of undertaking the research that is acceptable to local stakeholders, it should not take place.
p.(None):
p.(None): The main message that the TRUST team has been promoting since the meetings with the Nairobi sex workers has been: “Let
p.(None): representatives of vulnerable popula- tions speak for themselves” (Schroeder and Tavlaki 2018). As a result, a former
p.(None): sex worker from Nairobi brought the demands of her community to the European Parliament to great acclaim
p.(None): (TRUST 2018).
p.(None):
p.(None):
p.(None): Advocate Voices for Animals
p.(None):
p.(None): A senior veterinarian, Professor David Morton, was involved throughout the TRUST project as an adviser. At a plenary
p.(None): meeting in Cape Town, he described how animals had no voice and therefore no choice about involvement in
p.(None): research. He asked: “Who consents on behalf of animals?”
p.(None): There are currently no globally agreed ethical standards for research involving animal experimentation, and regulation
p.(None): varies from country to country. In the EU, animal experiments are governed by Directive 2010/63/EU, known as the Animal
p.(None): Experiments Directive, which stipulates measures that must be taken to replace, reduce and refine (the “Three
p.(None): Rs”12) the use of animals in scientific research. Among other requirements, it lays down minimum standards for housing
p.(None): and care and regu-
p.(None):
p.(None):
p.(None):
p.(None): 12 The “Three Rs” are the underpinning requirements of most policies and regulations in animal research:
p.(None): → Replacement: Methods that avoid or replace the use of animals.
p.(None): → Reduction: Methods that minimize the number of animals used per experiment.
p.(None): → Refinement: Methods that minimize suffering and improve welfare.
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 65
p.(None):
...
p.(None): consent of the owners or custodians. Formal agreements should govern the transfer of any material or knowledge to
p.(None): researchers, on terms that are co-developed with resource custodians or knowledge holders.
p.(None):
p.(None): Analysis of Existing Guidelines
p.(None):
p.(None): We have summarized above the extensive consultation activities of the TRUST project prior to the actual
p.(None): drafting of the GCC. Aside from these valuable contribu- tions, it was also vital that the GCC should not set out to
p.(None): “reinvent the wheel”. Given the vast number of existing guidelines, and the significant expertise that went into
p.(None): drafting them, it was important for us to link the GCC to those existing guide- lines so as to produce something
p.(None): that did not replicate earlier work, but rather complemented it.
p.(None): Research ethics committees have been in operation since the 1960s (Levine 2004). The earliest codes of
p.(None): research ethics are even older (Levine 2004). Yet the ethics dumping cases identified as part of the
p.(None): fact-finding mission for the GCC occurred mostly in the 2010s (Schroeder et al. 2018), more than 50 years after the
p.(None): first codes and committees became operational. There are many reasons why ethics dumping in research persists, one of
p.(None): which is that the constraints on research ethics committees in LMICs make them vulnerable to exploitation, often across
p.(None): the North– South global divide. Some such constraints are summarized in Table 6.6 (modified from Nyika et al. 2009).
p.(None): A new code of ethics cannot, by itself, resolve these issues, for instance the lack of resources to fund effective
p.(None): ethics review. However, it can tailor requirements to LMIC needs. To do so most effectively, the TRUST team decided
p.(None): that it would not base the drafting process on existing ethics guidelines, because, as is also noted in Chapter 4, the
p.(None): history of research ethics review is heavily built on the United States experience and context and focused on medical
p.(None): research (see also Levine 2004). To avoid any potential bias, the following approach was agreed upon. First, the
p.(None): exercise of identifying ethics dumping risks was to be carried out without reference to exist- ing ethics guidelines.
p.(None): Second, only once the risks had been identified through fact-
p.(None):
p.(None): Drafting Process
p.(None): 67
p.(None):
p.(None): Table 6.6 Constraints on African research ethics committees
p.(None): Insufficiency of resources No or poor support by the hosting institution
p.(None): Lack of or insufficient expertise on ethical review Not completely independent Pressure from researchers
p.(None): Pressure from sponsors
p.(None):
p.(None): Lack of active or consistent participation of members
...
p.(None): of guidance on risk management approaches to biosafety and biosecurity was discovered in this way (Singh
p.(None): and Schroeder 2017), leading to article 1813 of the GCC.
p.(None): Once the fact-finding, consultations and analysis had been done, the drafting process began.
p.(None):
p.(None):
p.(None): Drafting Process
p.(None):
p.(None): The drafting committee of the GCC consisted of four people, following Michael Davis’s (2007) advice:
p.(None): Keep the drafting committee small. Preparing a first draft of a code is not an activity made lighter “by many hands”.
p.(None): It is more like the soup that “too many cooks” spoil.”
p.(None):
p.(None): 13 In situations where environmental protection and biorisk-related regulations are inadequate or non-existent in the
p.(None): local setting compared with the country of origin of the researcher, research should always be undertaken in line with
p.(None): the higher standards of environmental protection.
p.(None):
p.(None): 68 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.7 GCC drafting committee
p.(None): Region of
p.(None): Drafter origin Focus Background Roles
p.(None):
p.(None): Schroeder North All engagement and
p.(None): fact-finding
p.(None): Philosophy, politics, economics
p.(None): Full first draft
p.(None):
p.(None): Chennells South Vulnerable populations
p.(None): Law Drafting articles to protect vulnerable populations
p.(None):
p.(None): Chatfield North Risks Social science, philosophy
p.(None): Redrafting to ensure all risks were covered
p.(None): Singh South Existing guidelines Public health Redrafting with a focus on
p.(None): existing guidelines
p.(None):
p.(None): Table 6.7 shows the configuration of the four-person drafting committee. The emphasis was on 50% North and 50% South
p.(None): membership, taking into account the expertise needed and relevant background.
p.(None): The four-values approach, featuring fairness, respect, care and honesty, had been adopted by the consortium at an
p.(None): earlier stage (chapter 3). Based on these values and the inputs into the GCC from consultations and fact-finding
p.(None): activities over two years (see Fig. 6.1), the lead author, Professor Doris Schroeder, drafted the first version, which
p.(None): contained 20 articles, three fewer than the final version.
p.(None): For instance, article 15 on the risks of stigmatization, incrimination, discrimina- tion and indeterminate personal
p.(None): risk was added during the peer review process by Professor Morton, the veterinary expert in the consortium.
p.(None): Professor Schroeder’s first draft was refined considerably by the social science and risk expert on the drafting
p.(None): committee, Dr Kate Chatfield. Dr Roger Chennells, the expert on involving vulnerable populations in research,
p.(None): who also provided a legal perspective, drafted his own articles on the prevention of ethics dumping. Many
p.(None): of these addressed the same issues identified by the lead author, but now illu- minated by a legal reading. For
p.(None): example, article 20 on the clear understanding of roles and responsibilities was an important addition. Finally, the
p.(None): expert on existing guidelines, Dr Michelle Singh, checked the draft code for oversights relevant to
p.(None): countering ethics dumping and also, for example, added article 7 on the importance of compensating local support
p.(None): systems.
p.(None): The first full draft agreed by the four-person committee then went through a rigorous internal peer
p.(None): review process in the consortium, including detailed discussions at a plenary meeting in Germany in
p.(None): February 2018. Each draft article was analysed in depth. Changes at this stage included:
p.(None): • A different order to demonstrate importance through emphasis: for example, the assertion that the local relevance
p.(None): of research is essential became article 1.
p.(None): • Different wording: for example, the word “gatekeeper’ in article 7 was replaced with “local coordinator”, and
p.(None): “community approval” in article 9 was changed to “community assent”.
p.(None): • Regrouping to connect with a different value: for example, local ethics review was moved from the “fairness”
p.(None): section to “respect”.
p.(None):
p.(None): Drafting Process
p.(None): 69
p.(None):
...
p.(None): sector and the legal services of the EC since March 2018. This allowed Dr Wolfgang Burtscher, Deputy
p.(None): Director-General for Research and Innovation of the EC, to announce the big news at the European Parliament event:
p.(None): the GCC would be a mandatory reference document for the framework programmes that fund European research. What this
p.(None): means was expressed succinctly in a Nature article.
p.(None): Ron Iphofen, an adviser on research ethics to the European Commission, believes the code will have a profound impact on
p.(None): how funding proposals to the EU are designed and reviewed. “I could envisage reviewers now looking suspiciously
p.(None): at any application for funds that entailed research by wealthy nations on the less wealthy that did not mention
p.(None): the code,” he says. (Nordling 2018)
p.(None): Two months later, in August 2018, the EDCTP announced that henceforth its applicants would be required to comply with
p.(None): the GCC. In April 2019, the Senate of the University of Cape Town (UCT) adopted the GCC as the first university
p.(None): globally to ensure that UCT researchers maintain the highest ethical standards.
p.(None): The groundwork for developing the GCC included a broad collation of ethics dumping case studies, as well as good
p.(None): practice examples from international collab- orative research, and extensive consultation with representatives from a
p.(None): range of stakeholder groups: research policymakers, research funders including private industry, researchers,
p.(None): research communities, research ethics committees and, most importantly, vulnerable research participants and those who
p.(None): support them. Building on 88 generic risks identified in the fact-finding and consultation phases of the
p.(None): TRUST project, and taking existing guidelines into account, a code was built which will provide guidance across all
p.(None): research disciplines. It focuses on research collabo- rations between LMIC and HIC partners, which often involve
p.(None): considerable imbal- ances of power, resources and knowledge. The GCC is presented in 23 clear, short statements in
p.(None): order to achieve the highest possible cross-cultural accessibility for researchers, funders and vulnerable populations
p.(None): alike.
p.(None): Those who apply the GCC are demonstrating that they oppose double standards in research and support long-term equitable
p.(None): research relationships between partners from LMIC and HIC settings, based upon the values of fairness, respect, care
p.(None): and honesty.
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Bassler A, Brasier K, Fogel N, Taverno R (2008) Developing effective citizen engagement: a how- to guide for community
p.(None): leaders. Center for Rural Pennsylvania, Harrisburg PA. http://www.
p.(None): rural.palegislature.us/effective_citizen_engagement.pdf
p.(None):
p.(None): References
p.(None): 71
p.(None):
p.(None): Burtscher W (2018) TRUST Global Code of Conduct to be a reference document applied by all research projects applying
p.(None): for H2020 funding. TRUST eNewsletter Issue 5. http://www.global-
p.(None): codeofconduct.org/wp-content/uploads/2018/12/TRUSTNewsletter_2018_Issue5.pdf
p.(None): Chatfield K, Schroeder D, Kimani J (2016a) Vulnerable populations in North-South collabora- tive research: Nairobi
p.(None): plenary 2016. A report for TRUST. http://trust-project.eu/wp-content/
p.(None): uploads/2016/11/Meeting-Report-TRUST-Nairobi-Final.pdf
p.(None): Chatfield K, Schroeder D, Muthuswamy V (2016b) Mumbai case studies meeting. A report for TRUST.
p.(None): http://trust-project.eu/wp-content/uploads/2016/06/Mumbai-Case-Studies-Workshop. pdf
p.(None): Cook WK (2008) Integrating research and action: a systematic review of community-based par- ticipatory research to
p.(None): address health disparities in environmental and occupational health in the United States. Journal of Epidemiology and
p.(None): Community Health 62(8):668–676. https://doi. org/10.1136/jech.2007.067645
p.(None): Dammann J, Cavallaro F (2017) First engagement report. A report for TRUST. http://trust-project.
p.(None): eu/wp-content/uploads/2016/03/TRUST-1st-Engagement-Report_Final.pdf
p.(None): Dammann J, Schroeder D (2018) Second engagement report. A report for TRUST. http://trust-
p.(None): project.eu/wp-content/uploads/2018/12/TRUST-2nd-Engagement-Report-Final.pdf
p.(None): Davis M (2007) Eighteen rules for writing a code of professional ethics. Science and Engineering Ethics 13(2):171–189.
p.(None): Dunn A (2011) Community engagement: under the microscope. Wellcome Trust, London. https://
p.(None): wellcome.ac.uk/sites/default/files/wtvm054326_0.pdf
p.(None): European Commission (2013) Declarations of the Commission (framework programme) 2013/C 373/02. Official Journal of
p.(None): the European Union 20 December. http://ec.europa.eu/research/
p.(None): participants/data/ref/h2020/legal_basis/fp/h2020-eu-decl-fp_en.pdf
...
p.(None):
p.(None): Institution Building and Supportive NGOs
p.(None): 75
p.(None):
p.(None): The fate suffered by the San peoples in Africa is similar to that of many indige- nous peoples in other parts of the
p.(None): world. Expansion and conquest, firstly by asser- tive local pastoralist and agriculturalist communities, followed later
p.(None): and with similar devastation by colonial powers, all but obliterated their former existence. The San history over the
p.(None): centuries has been one of dispossession, enslavement, cultural extinction and recorded patterns of officially
p.(None): sanctioned genocide (Penn 2013).
p.(None): For many reasons, including their lifestyle until recent times as hunter-gatherer peoples, and their unique genetic
p.(None): properties as descendants of possibly the earliest members of the human race, the San have found themselves
p.(None): in high demand as research populations.
p.(None): Modern San leaders faced with increasing societal challenges had no means of communicating their problems with other
p.(None): leaders, of learning about their human rights, or of discussing ways in which they might legitimately
p.(None): challenge the unwanted interventions of researchers and other outsiders such as media practitioners.
p.(None): In addition, the San world view is generally one of seeking harmony, and avoid- ing all forms of conflict. Several
p.(None): scholars of conflict resolution have based their principles of good practice on ancient San systems, in which the
p.(None): prevention of dis- putes and the reconciliation of interests are deeply ingrained (Ury 1995).
p.(None): The outside world regarded the San as a classic example of a “vulnerable popula- tion”, lacking the means to organize a
p.(None): collective expression of their common inter- ests and concerns (Chennells 2009). Prior to the year 2000, virtually all
p.(None): research was externally conceived, and was perceived by the San as being disruptive and on occasion harmful to the
p.(None): research populations (Chennells and Steenkamp 2018).
p.(None): Internet searches of the words San, Khoisan3 and Bushmen throw up thousands of papers, books and research theses,
p.(None): supporting the assertion that they are among the most researched peoples in the world. Until they formed their own
p.(None): representa- tive organizations, they did not have a unified voice and thus remained powerless to resist unwanted
p.(None): attention from outsiders.
p.(None):
p.(None):
p.(None): Institution Building and Supportive NGOs
p.(None):
p.(None): The most important step towards the San Code of Research Ethics was local institution-building, an
p.(None): initiative that made all further successes possible.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 3 While the term “Khoisan” is frequently used in general discourse as a collective name for two distinct groupings in
p.(None): southern Africa, namely the Khoi, or KhoiKhoi, and the San, this umbrella term is not relevant to a discussion of the
p.(None): San peoples. The Khoi or KhoiKhoi, formerly known in South Africa as Hottentots, are regarded as pastoral, and of more
p.(None): recent origin (Barnard 1992).
p.(None):
p.(None): 76 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): WIMSA: The Catalyst Institution
p.(None):
...
p.(None): of basic agreements with government, funders and other external actors all require the ser- vices of a lawyer to
p.(None): protect the San’s interests.
p.(None): WIMSA and SASI have, from the outset, retained the services of an in-house lawyer. This ensures that they receive basic
p.(None): institutional legal support, as well as strategic legal support, in their various advocacy programmes. Apart
p.(None): from basic institutional legal support, the most visible advocacy successes of the San have all relied upon close
p.(None): collaboration with a legal adviser.
p.(None):
p.(None): 80 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): San policy interventions at the United Nations, land claims and successful San claims for intellectual property
p.(None): rights related to their traditional knowledge (on Hoodia, buchu, Sceletium, rooibos etc), which raised the
p.(None): international profile of the San as indigenous peoples, all required committed legal support. This was made available
p.(None): mostly via SASI.
p.(None): The prohibitive cost of standard commercial lawyers is a well-known deterrent to obtaining legal advice and assistance.
p.(None): In addition, utilizing lawyers who are not familiar with the ethos and needs of the community can lead to expensive
p.(None): mistakes and misunderstandings. Lawyers who are willing to represent the community legally on a pro bono or
p.(None): noncommercial basis can therefore give a vulnerable com- munity a significant advantage.
p.(None): Dr Roger Chennells, SASI’s lawyer, also provided a legal editing service for the San Code of Research Ethics.
p.(None):
p.(None):
p.(None): Supportive Research Collaborations
p.(None):
p.(None): Formulating ethics codes is a time-consuming business that requires funding, in particular to support
p.(None): workshops where San traditional leaders and San community members can discuss their concerns and ways forward. Sceptics
p.(None): may point out that the same individuals always attend such workshops largely out of appreciation for the food provided,
p.(None): and leave without any tangible or lasting benefits.
p.(None): By contrast, there is much anecdotal evidence of San colleagues who reported, after attending workshops, that their
p.(None): thinking, and indeed sometimes their lives, had forever been altered by an insight gained at the workshop. The San
p.(None): development programmes conducted by WIMSA, SASI and the SASC held capacity-building workshops on a range of topics. Of
p.(None): particular relevance to the San Code of Research Ethics were the workshops funded by two successive EU projects,
p.(None): ProGReSS5 and TRUST.6
p.(None): The ProGReSS project, under the leadership of Professor Doris Schroeder, ran from 2013 to 2016 with SASI as a partner
p.(None): with its own budget. The project funded two workshops to revise the WIMSA Research and Media Contract, among other
p.(None): things. By the conclusion of ProGReSS, it became clear that a new San ethics code might realize San interests more
p.(None): effectively in the future.
...
p.(None): research contract, and by the development of what was to become the San Code of Research Ethics.7
p.(None): During this important workshop, the San developed a range of general principles that applied to their own community.
p.(None): These principles were as follows and were used for a first draft of the San Code of Research Ethics:
p.(None): • The San require respect to the environment, to San leaders and individuals, and to cultural values.
p.(None): • Honesty, integrity and honour are important between all partners.
p.(None): • Cultural and spiritual values must be fully honoured and respected in all research and media projects.
p.(None): • The right formal process should be followed to protect communities in research.
p.(None): • Informed consent is central to all research.
p.(None): • Genetics samples should only be used for the purpose stated in the research contract.
p.(None): • Researchers should not enter a community without being guided and led by members of the community
p.(None): itself.
p.(None): • Both researcher and community should benefit from the interaction.
p.(None): In November 2016, SASI organized a third workshop with the same delegates and some of the earlier external contributors
p.(None): to finalize the content of the San Code of Research Ethics. The overall goal was to achieve fair research partnerships.
p.(None): The following threats and weaknesses were discussed.
p.(None): • Vulnerable and far-flung populations and serious poverty
p.(None): • Undue influence by researchers, due to poverty
p.(None): • “Free riders” who do not support San community concerns when taking part in research for cash
p.(None): • Exploitation possibilities due to illiteracy
p.(None): • Lack of knowledge of research, what it means and what its risks are
p.(None): • Lack of knowledge about the San leadership’s approach to research
p.(None): • Lack of assistance from the government
p.(None): • Low self-esteem in engaging with outside individuals and agencies
p.(None): • Earlier theft of traditional knowledge leading to mistrust of researchers
p.(None): • Lack of system to combat the problems
p.(None): • Lack of institutional and financial support to the leadership who aim to improve the situation
p.(None): With these challenges in mind, the initial draft of the San Code of Research Ethics was revised and
p.(None): refined. In addition, each element of the new draft code was grouped into one of the four TRUST ethical values of
p.(None): fairness, respect, care, and honesty. These values had been agreed on previously by the TRUST group, with San input.
p.(None): The four core values were to be supported by a fifth value, which the San
p.(None):
p.(None): 7 A short video presentation about the workshop is available at https://www.youtube.com/ watch?v=HOdw3mv7JSo.
p.(None):
p.(None): The San Code of Research Ethics
p.(None): 83
p.(None):
p.(None): delegates deemed essential, namely proper process. In small groups the key points of each value were written out in
p.(None): greater detail.
...
p.(None): Dumping
p.(None):
p.(None): and interests of all stakeholders,2 particularly those who are likely to be subject to the codes (Lawton 2004), are
p.(None): taken into account during development. This helps ensure that the code is aligned with real needs and has practical
p.(None): value. Hence the bottom-up approach that was taken during development, which has facilitated an “insider” perspective,
p.(None): should help to increase effectiveness and counter the view that ethics codes are no more than a bureaucratic
p.(None): tool imposed from above. Additionally, the GCC does not replicate existing codes, nor does it seek to replace them.
p.(None): Rather, the GCC can be viewed as complementary to other codes, and this helps to avoid the confusion that can arise
p.(None): when codes seem contradictory.
p.(None): However, even the most conscientiously developed codes are open to differences in interpretation, and researchers need
p.(None): an ethical foundation for making decisions about application in particular situations (Eriksson et al. 2008).
p.(None): Furthermore, codes must form part of a wider framework that also includes mechanisms for compliance, accountability and
p.(None): addressing legal concerns.
p.(None): This chapter seeks to address these issues with practical guidance for implemen- tation. We show how the four values of
p.(None): fairness, respect, care and honesty can serve as an ethical foundation for decision-making. Specifically, we highlight
p.(None): the impor- tance of ethical techniques for engagement with local communities and a complaints procedure which is
p.(None): accessible to highly vulnerable populations, and finally we sum- marize a resource built in parallel to the code: a
p.(None): fair research contracting tool.
p.(None):
p.(None):
p.(None): The Values as an Ethical Foundation
p.(None):
p.(None): The four values constitute the foundation for ethical research collaborations and can be applied in virtually any
p.(None): situation to guide decision-making. When researchers keep the values at the heart of their activities, they can
p.(None): recognize and respond to ethical challenges more effectively. This requires reflexivity3 on the part of the
p.(None): researchers such that they consciously and regularly “stand back” from their activi- ties to ask whether their
p.(None): activities are aligned with the values. At any stage research- ers must ask themselves: Am I behaving with fairness,
p.(None): respect, care and honesty? We call this practical application of the values the “values compass” (see Fig. 8.1). The
p.(None): compass can be used continually as a tool for ethical reflection, but is par- ticularly helpful at key stages of the
p.(None): research process when important decisions are
p.(None): made.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 2 As noted earlier, “stakeholders” is an increasingly contested term, as it may imply that all parties hold an equal
p.(None): stake. Some prefer the term “actors”, yet this brings its own complexities. While acknowledging the debate, we use the
p.(None): well-established term “stakeholders” throughout.
p.(None): 3 “Reflexivity” can be thought of as a researcher’s ongoing critical reflection upon his or her own biases and
p.(None): assumptions and how these impact upon their relationship to the research, the course of the research and knowledge
p.(None): production.
p.(None):
p.(None): Ethical Engagement with Communities
p.(None): 91
p.(None):
p.(None): Fig. 8.1 The values compass
p.(None): FAIRNESS
p.(None):
...
p.(None): time. Members of a community gain their personal and social identity by sharing common beliefs, values and norms which
p.(None): have been developed by the community in the past and may be modified in the future (WHO 1998: 5)
p.(None): As we can infer from this definition, there are many different types of communi- ties and also communities within
p.(None): communities. For example, indigenous communi- ties, having a historical continuity with preinvasion and precolonial
p.(None): societies that developed on their territories, may consider themselves distinct from other sectors of the societies
p.(None): that now prevail on those territories, or parts of them. They generally form nondominant sectors of society and can be
p.(None): intent on preserving, developing and transmitting to future generations their ancestral territories and their
p.(None): ethnic identity, as the basis of their continued existence as peoples, in accordance with their own cultural patterns,
p.(None): social institutions and legal systems (Martínez Cobo
p.(None):
p.(None): 92 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): 2014). They often have particular relationships with advocacy groups who work to protect or represent their interests.4
p.(None): The concept of communities within communities also includes groups of people who are vulnerable because of a
p.(None): range of physical (disabilities, for example) or cultural (religion, for example) characteristics. For instance,
p.(None): sex workers, injecting drug users and men who have sex with men are often marginalized within their own broader
p.(None): communities.5 People from such groups are frequently sought for interna- tional research and yet the community at
p.(None): large or the community leaders are often unable to provide the input needed to ensure ethical management of
p.(None): research projects. Communities and their leaders may be unaware of the specific circumstances of these people and their
p.(None): lives, and they may even be openly hostile. We therefore need mechanisms for ensuring that the voice of
p.(None): marginalized and vulnerable populations is heard, and that their interests in research are represented.
p.(None): In the 1990s, community engagement assumed prominence as the new guiding light of public health efforts; research and
p.(None): health-improvement programmes that involved communities had better results than programmes led by government alone (NIH
p.(None): 2011). At the same time, the limitations of existing guidelines for the protec- tion of communities in genetic research
p.(None): was becoming increasingly apparent (Weijer et al. 1999). The benefits of community engagement in all types of research
p.(None): are now widely acknowledged, and numerous publications describe many potential benefits such as:
p.(None): • increasing community understanding and acceptance of the studies
p.(None): • enhancing researchers’ ability to understand and address community priorities
p.(None): • improving logistics and the running of studies
p.(None): • strengthening the quality of the information collected
p.(None): • ensuring culturally sensitive communications and research approaches
p.(None): • enhancing opportunities for capacity building (Hebert et al. 2009; Cook 2008; Bassler et al. 2008; Dunn 2011).
p.(None): Community engagement is an ethical imperative (a “must”) for researchers oper- ating globally. Research participants,
p.(None): their local communities and research partners in international locations should be equal stakeholders in the pursuit of
p.(None): research- related gains (Anderson et al. 2012). Ahmed and Palermo (2010) provide a salient definition of community
p.(None): engagement in research as
p.(None): a process of inclusive participation that supports mutual respect of values, strategies, and actions for authentic
...
p.(None): Agricultural
p.(None): Social science Clinical trials Animal experimentation research
p.(None): Research participants Research participants Local community Local farmers Local community
p.(None): Local community Local researchers Broader local
p.(None): community
p.(None): Local researchers Local researchers Local animal handlers Local researchers
p.(None):
p.(None): Local research organizations
p.(None): Local research organizations
p.(None): Local animal research centres
p.(None):
p.(None): 102 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): A Values-Based Approach to Developing a Complaints Procedure
p.(None):
p.(None): A complaints procedure that works perfectly well in one location and for one pur- pose cannot simply be transposed to a
p.(None): different situation without due consideration of its applicability. Local relevance and accessibility are vital keys in
p.(None): the design of an effective complaints procedure. Rather than a formally laid-down set of “rules” for complaints
p.(None): procedures, a strategic values-based approach needs to be imple- mented to deal with different levels and types of
p.(None): complaints, so that individuals and communities feel respected, cared for, fairly treated, fully informed and empow-
p.(None): ered. The four values can provide a framework for the development of an appropri- ate procedure, as shown in Table 8.7.
p.(None): Any complaints procedure for a research study involving LMIC populations, especially vulnerable groups or
p.(None): communities, must first consider the circumstances, situation and culture of such communities and the individuals to be
p.(None): recruited to the study. A critical step in this process is engagement with the community that will be
p.(None):
p.(None):
p.(None):
p.(None): Table 8.7 Values-based considerations for the development of a complaints procedure
p.(None): Fairness Respect
p.(None): Responses to complaints should be timely The procedure for complaints should be respectful
p.(None):
p.(None): All complaints should be taken seriously
p.(None): of local needs and preferences
p.(None): and investigated fully Appropriate levels of confidentiality and privacy
p.(None):
p.(None): Records of complaints and responses should be maintained to enable reporting and monitoring of complaints
p.(None): The nature and types of redress should be acceptable to the local community
p.(None): The lodging of honest complaints should be encouraged, and even facilitated, in order to overcome power imbalances.
p.(None): should be maintained throughout the procedure (including for all documentation, investigations, discussions and
p.(None): hearings)
p.(None): Researchers and/or appropriate staff should be fully equipped and trained for implementation of the complaints
p.(None): procedure.
p.(None): Honesty Care
p.(None):
p.(None): The purpose and limitations of the complaints procedure should be clearly communicated to all involved in the research
p.(None): The process for making a complaint should be clearly communicated to all involved in the research
p.(None): This process should be as simple and straightforward as possible
p.(None): The local community should be involved at an early stage in the development of the complaints procedure
p.(None):
p.(None): Advice should be taken from the local community about the accessibility and viability of the complaints procedure. This
p.(None): may mean offering a range of methods for information sharing and complaint acceptance – verbal, written, and through
p.(None): trusted spokespersons and community groups etc.
p.(None):
p.(None): A Fair Research Contracting Tool
p.(None): 103
p.(None):
p.(None): involved with or affected by the research so that they can help guide the develop- ment of appropriate procedures.
p.(None): Additionally, strategies8 will need to be developed for dealing with different types of complaints. It is
p.(None): important to try to avoid complex and overly burdensome strategies which all too easily become legalistic and
p.(None): formalized. In practice this can mean that nothing is set up at all, or that what is established becomes little more
p.(None): than an ineffective bureaucratic exercise. While more formal approaches and struc- tures may work in “Western”
p.(None): settings, these are unlikely to be effective in the kinds of vulnerable communities where care is needed to safeguard
p.(None): and empower; they may even have the opposite effect, and discourage any engagement at all on com- plaints issues.
p.(None): Equally, the challenges in establishing an effective strategy should not act as an excuse for researchers to adopt an
p.(None): oversimplified model (such as a contact name on the information sheet) that is of little or no benefit to anyone. For
p.(None): each unique situ- ation, researchers should work with communities to cocreate effective strategies that take
p.(None): into account the circumstances, situation and culture of that community and the individuals to be recruited to the
p.(None): study.
p.(None): While it is not possible for us to specify a single “model” complaints procedure, we have shown how the values can
p.(None): provide the basis of any complaints procedure. With these values embedded in the thinking of the research community,
p.(None): they can then seek to work with whatever procedures and structures are available, adapting, improving and tailoring
p.(None): them for application in the real world. The individuals and groups involved should feel respected, cared for, fully
p.(None): informed, treated fairly and empowered.
p.(None): Most protective mechanisms, including complaints procedures, are strengthened when supported by legal systems, but
p.(None): participants, communities, researchers and institutions in LMICs often have no or very limited access to legal advice
p.(None): or protec- tion. The next section introduces an online toolkit that will be helpful in such situations.
p.(None):
p.(None):
p.(None): A Fair Research Contracting Tool
p.(None):
p.(None): The need for fair research contracts is best illustrated by the situation in interna- tional collaborative health
...
p.(None): toolkit relevant for all types of research.
p.(None): The FRC online toolkit9 now provides information, tips and case studies in six key areas:
p.(None): • Negotiation strategies: for understanding the various aspects of negotiations, whether a research partner
p.(None): is at a basic starting point or an advanced level in the development of contract negotiations
p.(None): • Research contracting: for a basic understanding of contracts and contracting so that a research partner can better
p.(None): manage responsibilities, opportunities and risks that impact the research partnership
p.(None): • Research data: providing the essential principles concerning rights and responsi- bilities, including
p.(None): accountability and access to data in collaborative research
p.(None): • Intellectual property: providing an introduction to some of the key general prin- ciples that require
p.(None): consideration before participation in collaborative research agreements
p.(None): • Research costing: providing research partners with a basic understanding of cost considerations when developing a
p.(None): full cost research budget proposal
p.(None):
p.(None):
p.(None):
p.(None): 9 The entire online toolkit is available at http://frcweb.cohred.org/
p.(None):
p.(None): Conclusion
p.(None): 105
p.(None):
p.(None): • Technology transfer and capacity: concerning the flow of knowledge, experience and materials from one partner to
p.(None): another, and the ability of people and organiza- tions to manage their affairs and reach objectives successfully.
p.(None): The development of this resource means that vulnerable groups, such as com- munities or researchers without legal
p.(None): support, have access to resources that can help develop a good understanding of research contracting for equitable
p.(None): research part- nerships and avoid exploitation in research.
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): According to Eriksson et al. (2008), a serious flaw in most new ethics guidelines is that they are produced with the
p.(None): pretension that there are no other guidelines in exis- tence, and it would be much better if they just stated what they
p.(None): added to existing guidelines. Such is the case with the GCC, which focuses solely on factors that are specific to
p.(None): collaborative research ventures in resource-poor (primarily LMIC) set- tings. The GCC is succinct and written in plain
p.(None): language; it is meant to be equally accessible to researchers in HICs and to their intended partners in LMICs. In these
p.(None): respects, the GCC is very straightforward, but its simplicity will inevitably generate questions about how it should be
p.(None): implemented.
p.(None): For example, article 13 of the GCC states that a clear procedure for feedback, complaints or allegations of
p.(None): misconduct must be offered that gives genuine and appropriate access to all research participants and local
p.(None): partners to express any con- cerns they may have with the research process. Aside from the injunction that the
p.(None): procedure must be agreed with local partners at the outset of the research, there is no guidance on what this procedure
...
p.(None):
p.(None): 9 Towards Equitable Research Partnership
p.(None): 111
p.(None):
p.(None): Good practices know no regional or political boundaries: research that is unethi- cal in Europe is unethical in Africa.
p.(None): That’s why the GCC is needed. – Dr Michael Makanga (Ugandan), executive director of the European & Developing Countries
p.(None): Clinical Trials Partnership, co-author of the GCC
p.(None): The world is unfair. We are talking about R&D in an unfair world ... The Code of Conduct [GCC] is exquisitely clear
p.(None): that it is unethical to do research in one place for the sake of another. (TRUST 2018) – Professor Jeffrey Sachs
p.(None): (American), speaking at the GCC launch in the European Parliament
p.(None): The new four-values system around fairness, respect, care and honesty is highly appreciated in Asia. People find it
p.(None): intuitive – in fact, most audiences loved it. – Dr Vasantha Muthuswamy (Indian), president of the Forum
p.(None): for Ethics Review Committees in India, co-author of the GCC
p.(None): Zhai Xiaomei [Chinese], the executive director of the Centre for Bioethics at the Chinese Academy of Medical Sciences,
p.(None): in Beijing, who is also deputy director of the health ministry’s ethics committee, welcomes what TRUST2 has done.
p.(None): (Economist 2018)
p.(None): To deliver our mission to end world hunger, we need to undertake research. Applying the GCC will assist us
p.(None): greatly. No previous code was designed so clearly for work with highly vulnerable populations in resource-poor
p.(None): settings. – Myriam Ait Aissa (French), head of Research and Analysis at Action contre la Faim, co-author of the GCC
p.(None): Fairness, respect, care and honesty: four simple words with clear meaning to help researchers enter the house through
p.(None): the door and no longer through the win- dow.3 – Dr François Hirsch (French), former head of the Inserm (French
p.(None): National Institute of Health and Medical Research) Office for Ethics, co-author of the GCC
p.(None): Ron Iphofen [British], an adviser on research ethics to the European Commission, believes the code will have a profound
p.(None): impact on how funding proposals to the EU are designed and reviewed. “I could envisage reviewers [of EU-funded
p.(None): research proposals] now looking suspiciously at any application for funds that entailed research by wealthy
p.(None): nations on the less wealthy that did not mention the code,” he says. (Nordling 2018)
p.(None): The emphasis in the GCC on fairness, respect, care and honesty resonates with our work at UNESCO. – Dr Dafna
p.(None): Feinholz (Mexican), UNESCO’s chief of Bioethics and Ethics of Science and Technology, co-author of the GCC
p.(None):
p.(None):
p.(None):
p.(None): 2 The EU-funded consortium that developed the GCC.
p.(None): 3 This refers to Andries Steenkamp’s iconic request to researchers, namely to enter San communi- ties through the
p.(None): metaphorical “front door” – that is, the San Council – and not, like thieves, through the window.
p.(None):
p.(None): 112 9 Towards Equitable Research
p.(None): Partnership
p.(None):
p.(None): TRUST was a game changer.4
p.(None): Ethics dumping is a real threat to the quality of science and the GCC is now a mandatory reference document for EU
p.(None): framework program funding to guard against it. – Dorian Karatzas (Greek), head of Ethics and Research Integrity,
p.(None): European Commission
p.(None): Best science for the most neglected, also means best ethical standards. That’s why the GCC aims high: to protect the
p.(None): most neglected. – Dr François Bompart (French), director of Paediatric HIV/Hepatitis C Programmes at the Drugs
p.(None): for Neglected Diseases initiative (DNDi), former vice president, Access to Medicines at Sanofi, co-author of the GCC
p.(None): We get given consent forms and documents, often in a hurry. We sign because we need the money and then end up with
p.(None): regret. It feels like a form of abuse. They want something from us and they know how to get it. Because of our
p.(None): socio-economic conditions, we will always be vulnerable to those from the North. A code of ethics is needed that
p.(None): protects indigenous people.5 – Andries Steenkamp (1960–2016) (South African), former chair of the South African
p.(None): San Council, co-author of both codes
p.(None): I don’t want researchers to see us as museums who cannot speak for themselves and who don’t expect something in return.
p.(None): As humans, we need support.6 – Reverend Mario Mahongo (1952–2018) (Angolan), co-author of both codes
p.(None): We want to be treated by researchers with fairness, respect, care and honesty. Is that too much to ask?7 – Joyce
p.(None): Adhiambo Odhiambo (Kenyan), health activist and former sex worker, co-author of the GCC
p.(None): Indeed, is that too much to ask?
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Burtscher W (2018) TRUST Global Code of Conduct to be a reference document applied by all research projects applying
p.(None): for H2020 funding. TRUST eNewsletter Issue 5. http://www.global-
p.(None): codeofconduct.org/wp-content/uploads/2018/12/TRUSTNewsletter_2018_Issue5.pdf
p.(None): Economist (2018) Recent events highlight an unpleasant scientific practice: ethics dumping. The Economist, 31
p.(None): January. https://www.economist.com/science-and-technology/2019/02/02/
p.(None): recent-events-highlight-an-unpleasant-scientific-practice-ethics-dumping
p.(None): IIT (nd) The ethics codes collection. Center for the Study of Ethics in the Professions, Illinois Institute of
...
p.(None): • Indian Council of Medical Research: National Ethical Guidelines for Biomedical and Health Research Involving Human
p.(None): Participants
p.(None): • International Society of Ethnobiology: ISE Code of Ethics
p.(None): • Research Councils UK: RCUK Common Principles on Data Policy
p.(None): • Roche: Animal Research − Roche Principles of Care and Use
p.(None): • Sanofi: Corporate Social Responsibility Factsheet on Biodiversity and Biopiracy
p.(None): • South African Medical Research Council. Use of Animals in Research and Training
p.(None): • South African San Institute, South African San Council and TRUST project: San Code of Research Ethics
p.(None): • Swiss Academy of Sciences, Commission for Research Partnerships with Developing Countries: 11
p.(None): Principles & 7 Questions. KFPE’s Guide for Transboundary Research Partnerships
p.(None): • 3rd World Conference on Research Integrity: Montreal Statement on Research Integrity in Cross-boundary Research
p.(None): Collaborations
p.(None): • UNESCO: Universal Declaration on Bioethics and Human Rights 2005
p.(None): • World Medical Association: Declaration of Helsinki – Ethical Principles for Medical Research Involving
p.(None): Human Subjects
p.(None): The GCC was developed using a mission statement (Fig. 1).
p.(None):
p.(None): 118
p.(None): Appendix
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): We work for global, inclusive and fair research without double standards.
p.(None): We build equitable research partnerships.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): We include the voices of vulnerable populations.
p.(None): We encourage others to do the same.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Fig. 1 Mission statement of the GCC authors
p.(None):
p.(None): Index
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): A
p.(None): Accountability, 90, 104
p.(None): Africa, 56, 60, 63, 73–76, 110, 111
p.(None): Agriculture, 7, 46, 60, 101, 110
p.(None): America, 49, 61, 66, 116
p.(None): Animal welfare, 9, 42, 44, 48, 65
p.(None): Anthropological research, 56
p.(None): Asia, 111
p.(None):
p.(None):
p.(None): B
p.(None): Benefits, 6, 7, 15, 17, 21, 33, 40–42, 52,
p.(None): 80–82, 84, 86, 92, 94, 95, 98, 100,
p.(None): 103, 104
p.(None): Benefit sharing, 7, 20, 41, 42, 69, 76–78,
p.(None): 84, 86
p.(None): Biomedical research, 55, 56, 65, 117
p.(None): Biosafety, 45, 67, 116
p.(None): Biosecurity, 45, 67
p.(None): Blood samples, 2, 47
p.(None): Bribery, 10, 16, 47
p.(None): Buddhist ethics, 35
p.(None):
p.(None):
p.(None): C
p.(None): Capacity building, 10, 41, 63, 80, 92,
p.(None): 94, 104
p.(None): Care, 2, 5, 6, 8–10, 13–24, 27–31, 33, 34, 38,
p.(None): 40, 41, 44–46, 48, 63, 64, 68, 70, 74,
p.(None): 82, 85, 90, 93, 95–98, 102, 103,
p.(None): 110–112, 117
p.(None): Children, 83
p.(None): China, 2, 49, 61, 116
p.(None):
p.(None): Civil society, 39, 42
p.(None): Clinical trial, 38, 39, 55, 58, 101, 103, 111,
p.(None): 116, 117
p.(None): Co-creation, 103
p.(None): Colonialism, 48, 49
p.(None): Commercial, 47, 77, 80
p.(None): Common morality, 29, 31–35
p.(None): Communication, 10, 24, 56, 58, 62, 74, 84, 85,
...
p.(None): Social science, 2, 18, 39, 61, 68, 101
p.(None): Socio-anthropological research, 56
p.(None): South Africa, 18, 40, 61, 63, 69, 74–77, 79,
p.(None): 84–86, 110, 115, 116
p.(None): South African San Council (SASC), 18, 76–81, 86, 112, 116, 117
p.(None): Spokespersons, 93, 94, 102
p.(None): Stakeholder engagements, 3, 92
p.(None): Standards, 2, 3, 6, 9–11, 13, 16–18, 22, 24, 38,
p.(None): 41, 42, 48, 58, 62, 64, 65, 67, 70, 80,
p.(None): 85, 112
p.(None): Stigmatization, 9, 11, 40, 45, 68, 100
p.(None): Stigmatized, 42
p.(None): Sub-Saharan Africa, 55
p.(None):
p.(None): 122
p.(None):
p.(None): T
p.(None): Traditional knowledge, 7, 42, 54, 76–78, 80,
p.(None): 82, 84, 95, 97
p.(None): Training, 19, 63, 81, 95, 112, 117
p.(None): Transparency, 24, 46, 47, 84, 95
p.(None): Trust, 14, 15, 43, 47, 57, 78, 79, 84, 86, 93,
p.(None): 97, 100, 102, 116
p.(None): TRUST project, 14, 16, 17, 20, 28, 39, 49,
p.(None): 52–58, 60–66, 70, 77, 79–82, 100, 104,
p.(None): 111, 112, 117
p.(None): 2030 Agenda for Sustainable Development, 2
p.(None):
p.(None):
p.(None): U
p.(None): Undue inducement, 40, 41
p.(None): United Nations (UN), 2, 13, 21, 49, 58, 70, 77,
p.(None): 80, 116
p.(None): Universal Declaration of Human Rights, 13, 21
p.(None): Index
p.(None):
p.(None): V
p.(None): Values, 2, 3, 5–11, 13–24, 27–35, 39, 40, 43,
p.(None): 44, 46, 49, 62, 64, 68, 70, 74, 78, 82,
p.(None): 89–93, 97, 98, 102, 103, 110, 111, 116
p.(None): Values compass, 90, 91, 93
p.(None): Virtues, 3, 16, 17, 19, 20, 24
p.(None): Vulnerability, 37–40, 74
p.(None): Vulnerable, 2, 24, 29, 38, 39, 44, 52, 53, 55,
p.(None): 57, 60, 63, 64, 66, 68, 70, 75, 80, 82,
p.(None): 90, 92, 99, 103, 111, 112
p.(None): Vulnerable groups, 40, 92, 102, 105
p.(None):
p.(None):
p.(None): W
p.(None): Women, 49
p.(None):
p.(None):
p.(None): X
...
Searching for indicator vulnerability:
(return to top)
p.(None): Minorities in Southern Africa
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xix
p.(None):
p.(None): Chapter 1
p.(None): Ethics Dumping and the Need for a Global Code of Conduct
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The UN’s 2030 Agenda for Sustainable Development calls for more research and innovation to end
p.(None): poverty, leaving no one behind – and yet the export of unethical practices from high-income to lower-income settings is
p.(None): still a major concern. Such ethics dumping occurs in all academic disciplines. When research is regarded, on the one
p.(None): hand, as a dirty word among vulnerable populations who face ethics dumping, and, on the other, as a solution to many of
p.(None): humanity’s problems, how can the resulting gulf be bridged? This book describes one initiative to counter ethics
p.(None): dumping: the development and promotion of the Global Code of Conduct for Research in Resource-Poor Settings.
p.(None):
p.(None): Keywords Ethics dumping · Global research ethics · Exploitation · Vulnerability · Research governance
p.(None):
p.(None):
p.(None): Research has become a global enterprise. Individual researchers around the world are encouraged to be as mobile as
p.(None): possible (Sugimoto et al. 2017). At the same time, the activities of mobile researchers have made research “one of the
p.(None): dirtiest words in the indigenous world’s vocabulary” (Tuhiwai Smith 1999: 1). The indigenous com- munities in which
p.(None): Tuhiwai Smith, a Māori professor, grew up saw research as some- thing that “told us things already known, suggested
p.(None): things that would not work, and made careers for people who already had jobs” (Tuhiwai Smith 1999: 3).
p.(None): There is a gulf between those advocating more researcher mobility because “sci- ence is the engine of prosperity”
p.(None): (Rodrigues et al. 2016) and those who argue that research can represent harmful “visits by inquisitive and
p.(None): acquisitive strangers” (Tuhiwai Smith 1999: 3). When concerns about ethics dumping1 are added, this gulf becomes
p.(None): almost unbridgeable.
p.(None):
p.(None):
p.(None): 1 The term was introduced by the Science with and for Society Unit of the European Commission: “Due to the progressive
p.(None): globalisation of research activities, the risk is higher that research with sensitive ethical issues is conducted by
p.(None): European organisations outside the EU in a way that would not be accepted in Europe from an ethical point of view. This
p.(None): exportation of these non-compliant research practices is called ethics dumping” (European Commission nda).
p.(None):
...
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 5
p.(None): Exploitation Risks in Collaborative International Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract Ethics dumping occurs in collaborative international research when peo- ple, communities, animals and/or
p.(None): environments are exploited by researchers. Exploitation is made possible by serious poverty and extreme power
p.(None): differentials between researchers from high-income countries and research stakeholders from low- and middle-income
p.(None): countries (LMICs). To prevent its occurrence, the risks of exploitation have to be tackled. This chapter describes 88
p.(None): risks identified for col- laborative international research, categorized according to four values: fairness,
p.(None): respect, care and honesty. The risks were identified in a broad-based consultative exercise, which included more than
p.(None): 30 members and chairs of ethics committees in LMICs, representatives from vulnerable populations in LMICs, and an open
p.(None): call for case studies of exploitation. The findings of the exercise contributed to the develop- ment of the Global Code
p.(None): of Conduct for Research in Resource-Poor Settings.
p.(None):
p.(None): Keywords Exploitation · Ethics dumping · Collaborative research · Vulnerability · Research ethics · Ethics codes
p.(None):
p.(None):
p.(None): Ethics dumping1 occurs in collaborative international research when people, com- munities, animals and/or environments
p.(None): are exploited by researchers. In order to pre- vent ethics dumping, such exploitation needs to stop. This chapter
p.(None): describes our investigation into the risks of exploitation in low- and middle-income countries (LMICs),
p.(None): uncovering what makes exploitation more likely to occur due to vulnera- bilities that can be exploited, either
p.(None): knowingly or unknowingly.
p.(None): This undertaking was vital for the development of a Global Code of Conduct for Research in Resource-Poor Settings (GCC)
p.(None): that can address real-world risks for exploitation in research. Many such risks are not well described in the
p.(None): literature, and hence there was an empirical component to our activities. Furthermore, this process was necessary to
p.(None): ensure that the GCC was more than a compilation of existing
p.(None):
p.(None):
p.(None):
p.(None): 1 The export of unethical research from a high-income setting to a resource-poor setting with weaker
p.(None): compliance structures or legal governance mechanisms.
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 37
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_5
p.(None):
...
p.(None): representative and can have wide-ranging impact. For example, the principles of the “Three Rs”, which are
p.(None): globally accepted as a reasonable measure for ethical conduct in animal research, arose from a broad consultation with
p.(None): stakeholders undertaken by Russell and Burch in the 1950s. See Russell et al. (1959).
p.(None):
p.(None): 40 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): consultations and permissions, and specific cultural beliefs and customs that must be respected.
p.(None): Ongoing consultation with representatives from two vulnerable groups that have first-hand accounts of the risks
p.(None): for exploitation were undertaken. From Nairobi, Kenya, sex worker peer educators and, from South Africa, members
p.(None): of the San com- munity shared their experiences of being the subjects of exploitation and their opin- ions about how
p.(None): they want to be treated in future. Among many other insights, both groups described a lack of benefits from research
p.(None): projects (which are often highly beneficial to the researchers), as well as risks of stigmatization from the manner in
p.(None): which they were involved in the study.
p.(None): 12 months of in-depth and far-reaching investigation produced a considerable amount of data (Chapter 6). From this
p.(None): data, individual vulnerabilities and risks of exploitation were extracted, organized and tabulated on an Excel
p.(None): spreadsheet with source details and descriptions of the vulnerability or risk. Care was taken to ensure that each
p.(None): individual entry was based upon real-world experience rather than hypo- thetical suppositions. Our lists were compared
p.(None): with risks mentioned in the literature and, where necessary, additional information sought to address gaps.
p.(None): Once collated, the raw data was streamlined to group similar vulnerabilities together. For instance, there
p.(None): were many different examples of how people living in resource-poor circumstances may be unfairly enticed to participate
p.(None): in research by the prospect of payment or reward. Such examples were grouped under the label “undue inducement”.
p.(None): Further thematic analysis resulted in distinctions between the various potential subjects of exploitation, or levels of
p.(None): risk for exploitation (persons, institutions,5 local communities, countries, animals and the environment). In
p.(None): the final stage of the analysis the vulnerabilities were grouped according to the four values of fairness, respect,
p.(None): care and honesty.
p.(None):
p.(None):
p.(None): Our Findings
p.(None):
p.(None): The remainder of this chapter is devoted to presenting and explaining our findings. For each value, an exploitation
p.(None): risk table details the main risks for persons, institu- tions, local communities, countries, animals and the
p.(None): environment. Each entry on the tables describes a vulnerability that could lead to exploitation (deliberate or unin-
p.(None): tentional) in LMIC-HIC research collaborations and all are grounded in real-world experience. Additionally, for each
p.(None): value, certain examples are described in more detail to further illustrate the risks.
p.(None): It has to be noted that some entries could have been linked to more than one value. For instance, if a research
p.(None): participant suffered from a therapeutic misconception, the researcher might not have taken enough care to explain that
p.(None): research is different from treatment because s/he was not aware that this might be problematic in some settings, or
p.(None): otherwise because s/he deliberately and dishonestly wanted to avoid explaining the difference, in which case the value
p.(None): of honesty would have been violated. To avoid overburdening the tables, we made a decision to prioritize one value in
p.(None): each case.
p.(None):
p.(None): 5 “Institutions” includes local researchers as well as their organizations.
p.(None):
p.(None): Our Findings
p.(None): 41
p.(None):
p.(None): Fairness
p.(None):
p.(None): Our data revealed many risks for exploitation that might be categorized as issues of fairness (or unfairness) that are
p.(None): varied in nature and pertain to different aspects of fairness. Philosophers commonly distinguish between different
p.(None): types of justice or fairness (Pogge 2006) (Chapter 3), but the most relevant fairness concepts for global research
p.(None): ethics are fairness in exchange and corrective fairness.
p.(None): Fairness in exchange concerns the equity of transactions that occur between par- ties. In collaborative research,
p.(None): ventures should aim to be mutually beneficial. Where the collaboration is between HIC and LMIC partners, typical
...
p.(None): Annas G, Grodin M (1998) Human rights and maternal-fetal HIV transmission prevention trials in Africa. American Journal
p.(None): of Public Health 88(4):560–563
p.(None): Bhatt K (2016) Concerns for Kenyan National Bioethics Committee when approving North-South collaborative projects. In:
p.(None): Chatfield K, Schroeder D, Kimani J (eds) Nairobi plenary meeting report, TRUST Project.
p.(None): http://trust-project.eu/wp-content/uploads/2016/11/Meeting-Report- TRUST-Nairobi-Final.pdf
p.(None): EU (2010) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of
p.(None): animals used for scientific purposes (text with EEA relevance). OJ L 276/33.
p.(None): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32010L0063
p.(None): Hill CM, Webber AD (2010) Perceptions of nonhuman primates in human–wildlife conflict sce- narios. American Journal of
p.(None): Primatology 72(10):919−924
p.(None): Hughes J (2010) European textbook on ethics in research. European Commission, Brussels
p.(None):
p.(None): 50 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): Luc G, Altare C. (2018) Social science research in a humanitarian emergency context. In: Schroeder D, Cook J, Hirsch F,
p.(None): Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North- South research collaborations, Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 9-14
p.(None): Macklin R (2003) Vulnerability and protection. Bioethics 17(5–6):472–486
p.(None): Pogge T (2006) Justice. In: Borchert DM (ed) Encyclopedia of philosophy, 2nd edn, vol 4.
p.(None): Macmillan Reference, Detroit, pp 862–870
p.(None): Russell WMS, Burch RL, Hume CW (1959) The principles of humane experimental technique.
p.(None): Methuen & Co, London
p.(None): Schwartz J (1995) What’s wrong with exploitation? Nous 29:158–164
p.(None): Stone CD (2010) Should trees have standing? Law, morality, and the environment, 3rd edn. Oxford University Press,
p.(None): Oxford
p.(None): Smith, LT (2012) Decolonizing methodologies: research and indigenous peoples. Zed Books, London
p.(None): Universities UK (2015) The concordat to support research integrity. Universities UK, London Wood A (1995) Exploitation.
p.(None): Social Philosophy and Policy 12:150–151
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
...
p.(None): with a simple process of community approval.
p.(None): This chapter introduces the San of southern Africa and the main San support institutions involved in producing the San
p.(None): Code of Research Ethics. It goes on to describe key elements in the development and the launch of the code, namely
p.(None): lead- ers of integrity, legal support, supportive research collaborations and the process of drafting. Finally, the
p.(None): code is reproduced in full.
p.(None):
p.(None):
p.(None): The San of Southern Africa
p.(None):
p.(None): The San peoples of Africa are iconic, widely known as the quintessential hunter- gatherers of Africa and said to be the
p.(None): oldest genetic ancestors of modern humans (Knight et al. 2003). Once ranging over the whole of southern Africa, their
p.(None): numbers have now dwindled to approximately 100,000 San living primarily in Botswana, Namibia and South Africa, with
p.(None): small remnant populations in Angola, Zimbabwe and Zambia (Hitchcock et al. 2006). Although they speak at least
p.(None): seven distinct languages2 with numerous subdialects, they nevertheless recognize a common cul- tural identity which
p.(None): is readily identified as a hunter-gatherer heritage, with a shared ancestry also confirmed by genetic research
p.(None): (Soodyall 2006).
p.(None): Prior to 1990, the San peoples lived typically in extended families and small clans in the remote reaches
p.(None): of South Africa, Botswana and Namibia, as well as in smaller scattered populations in Zimbabwe, Zambia and Angola. The
p.(None): fact that the San generally lived in small groups in remote locations added to their isolation, and contributed towards
p.(None): their vulnerability to exploitation by others.
p.(None): Generally impoverished, marginalized and cut off from the modern world, they received minimal support from their
p.(None): respective governments. Almost no communi- cation took place between the leaders of these far-flung communities, with
p.(None): the result that their ability to share information and empower their peoples remained structur- ally constrained.
p.(None):
p.(None):
p.(None):
p.(None): 2 The following are the most common major San languages currently spoken in the region. Botswana hosts
p.(None): Nharo, Gwi, G/anna and Khwe; Namibia hosts Ju/huasi, Hei//om, Kung, !Xun and Khwe; South Africa hosts the !Khomani, the
p.(None): !Xun and the Khwe; Zimbabwe hosts the Tyua.
p.(None):
p.(None): Institution Building and Supportive NGOs
p.(None): 75
p.(None):
p.(None): The fate suffered by the San peoples in Africa is similar to that of many indige- nous peoples in other parts of the
p.(None): world. Expansion and conquest, firstly by asser- tive local pastoralist and agriculturalist communities, followed later
p.(None): and with similar devastation by colonial powers, all but obliterated their former existence. The San history over the
p.(None): centuries has been one of dispossession, enslavement, cultural extinction and recorded patterns of officially
p.(None): sanctioned genocide (Penn 2013).
p.(None): For many reasons, including their lifestyle until recent times as hunter-gatherer peoples, and their unique genetic
p.(None): properties as descendants of possibly the earliest members of the human race, the San have found themselves
p.(None): in high demand as research populations.
p.(None): Modern San leaders faced with increasing societal challenges had no means of communicating their problems with other
...
p.(None): exuded an air of confidence and open curiosity, quick to understand and appreciate the persons across the table, and
p.(None): slow to take personal offence. Their personal integ- rity shone through, and the trust that they generated in others
p.(None): translated into untold benefits for the San.
p.(None): This approach ensured that the San Council is highly respected in South Africa. In addition, relationships of trust
p.(None): developed with international researchers, generat- ing funding for research and policy projects. One of the many
p.(None): results of the open- ness of San leaders to collaboration with the world is the San Code of Research Ethics, which, it
p.(None): is hoped, will put all future relationships with outsiders onto an equitable basis. As Leana Snyders put it:
p.(None): The San Code of Research Ethics is the voice of a community that have been exploited for so many years. This code
p.(None): manages to bridge the gap between the research community and the San Community through dialogue. By taking ownership of
p.(None): the code, the San Community will ensure that this document will remain relevant for generations to come. (Chennells and
p.(None): Schroeder 2019)
p.(None):
p.(None): References
p.(None): 87
p.(None):
p.(None): References
p.(None):
p.(None): Barnard A (1992) Hunters and herders of southern Africa: a comparative ethnography of the Khoisan peoples.
p.(None): Cambridge University Press, New York and Cambridge
p.(None): CallawayE(2017)SouthAfrica’sSanpeopleissueethicscodetoscientists.Nature543:475–476.https://
p.(None): www.nature.com/news/south-africa-s-san-people-issue-ethics-code-to-scientists-1.21684
p.(None): Chennells R (2009) Vulnerability and indigenous communities: are the San of South Africa a vul- nerable people?
p.(None): Cambridge Quarterly of Healthcare Ethics 8(2):147–154
p.(None): Chennells R, Steenkamp A (2018) International genomics research involving the San people. In: Schroeder D, Cook J,
p.(None): Hirsch F, Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North–South research collaborations. Springer,
p.(None): Berlin, p 15–22
p.(None): Chennells R, Schroeder D (2019) The San Code of Research Ethics: its origins and history, a report for TRUST.
p.(None): http://www.globalcodeofconduct.org/affiliated-codes/
p.(None): Hitchcock RK, Ikeya K, Biesele M, Lee RB (2006) Introduction. In: Hitchcock RK, Ikeya K, Biesele M, Lee
p.(None): RB (eds) Updating the San: image and reality of an African people in the 21st century. Senri Technological Studies 70.
p.(None): National Museum of Ethnology, Osaka, p 4
p.(None): Knight A, Underhill PA, Mortensen HM, Zhivotovsky, LA, Lin AA, Henn BM, Louis D, Ruhlen M, Mountain JL (2003). African
p.(None): Y chromosome and mtDNA divergence provides insight into the history of click languages. Current Biology 13(6):464–473
p.(None): Penn N (2013) The British and the ‘Bushmen’: the massacre of the Cape San, 1795 to 1828. Journal of
p.(None): Genocide Research 15(2):183–200 https://doi.org/10.1080/14623528.2013.793081 TRUST Project Global Research Ethics.
p.(None): (2018a) Andries Steenkamp and Petrus Vaalbooi inter-
p.(None): views – TRUST Project. https://www.youtube.com/watch?v=A4_Mvdwl_Gc
...
p.(None): 109, 110, 117
p.(None): Security, 10, 15, 19, 45, 49, 116
p.(None): SexXworkers, 40, 55, 56, 63, 64, 92, 100, 112
p.(None): Social science, 2, 18, 39, 61, 68, 101
p.(None): Socio-anthropological research, 56
p.(None): South Africa, 18, 40, 61, 63, 69, 74–77, 79,
p.(None): 84–86, 110, 115, 116
p.(None): South African San Council (SASC), 18, 76–81, 86, 112, 116, 117
p.(None): Spokespersons, 93, 94, 102
p.(None): Stakeholder engagements, 3, 92
p.(None): Standards, 2, 3, 6, 9–11, 13, 16–18, 22, 24, 38,
p.(None): 41, 42, 48, 58, 62, 64, 65, 67, 70, 80,
p.(None): 85, 112
p.(None): Stigmatization, 9, 11, 40, 45, 68, 100
p.(None): Stigmatized, 42
p.(None): Sub-Saharan Africa, 55
p.(None):
p.(None): 122
p.(None):
p.(None): T
p.(None): Traditional knowledge, 7, 42, 54, 76–78, 80,
p.(None): 82, 84, 95, 97
p.(None): Training, 19, 63, 81, 95, 112, 117
p.(None): Transparency, 24, 46, 47, 84, 95
p.(None): Trust, 14, 15, 43, 47, 57, 78, 79, 84, 86, 93,
p.(None): 97, 100, 102, 116
p.(None): TRUST project, 14, 16, 17, 20, 28, 39, 49,
p.(None): 52–58, 60–66, 70, 77, 79–82, 100, 104,
p.(None): 111, 112, 117
p.(None): 2030 Agenda for Sustainable Development, 2
p.(None):
p.(None):
p.(None): U
p.(None): Undue inducement, 40, 41
p.(None): United Nations (UN), 2, 13, 21, 49, 58, 70, 77,
p.(None): 80, 116
p.(None): Universal Declaration of Human Rights, 13, 21
p.(None): Index
p.(None):
p.(None): V
p.(None): Values, 2, 3, 5–11, 13–24, 27–35, 39, 40, 43,
p.(None): 44, 46, 49, 62, 64, 68, 70, 74, 78, 82,
p.(None): 89–93, 97, 98, 102, 103, 110, 111, 116
p.(None): Values compass, 90, 91, 93
p.(None): Virtues, 3, 16, 17, 19, 20, 24
p.(None): Vulnerability, 37–40, 74
p.(None): Vulnerable, 2, 24, 29, 38, 39, 44, 52, 53, 55,
p.(None): 57, 60, 63, 64, 66, 68, 70, 75, 80, 82,
p.(None): 90, 92, 99, 103, 111, 112
p.(None): Vulnerable groups, 40, 92, 102, 105
p.(None):
p.(None):
p.(None): W
p.(None): Women, 49
p.(None):
p.(None):
p.(None): X
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p.(None): • establishes which punishment is appropriate for any given crime.
p.(None):
p.(None): These are questions about fairness in exchange. For instance, LMIC research participants contribute to the progress of
p.(None): science, but this is only fair if the research is relevant to their own community or if other benefits are received
p.(None): where this is not possible. For instance, to carry the burden of a clinical study is only worthwhile for a community if
p.(None): the disease under investigation occurs locally and the end product will become available locally.
p.(None): Corrective fairness, which presupposes the availability of legal instruments and access to mechanisms to right a wrong
p.(None): (e.g. a complaints procedure, a court, an eth- ics committee) is also important in global research collaborations. For
p.(None): instance, if no host country research ethics structure exists, corrective fairness is limited to the research ethics
p.(None): structure in the HIC, which may not have the capacity to make cul- turally sensitive decisions.
p.(None): The broader question of what HICs owe LMICs falls under distributive fairness. One can illustrate the difference
p.(None): between fairness in exchange and distributive fair- ness using the example of post-study access to successfully tested
p.(None): drugs. In the first case (fairness in exchange) one could argue that research participants have contrib- uted to the
p.(None): marketing of a particular drug and are therefore owed post-study access to it (should they need the drug to promote
p.(None): their health and wellbeing, and should they not otherwise have access to it). In the second case (distributive
p.(None): fairness) one could provide a range of arguments, for instance being a signatory to the Universal Declaration of Human
p.(None): Rights (UN 1948), to maintain that all human beings who need the drug should have access to it, and not just the
p.(None): research participants. These wider fairness issues cannot be resolved by researchers and are therefore not directly
p.(None): included in the GCC. Likewise, retributive fairness is less relevant as few ethics violations fall under the punitive
p.(None): and criminal law, and if they do, it is indeed crimi- nal law that should be used to deal with a fairness violation.
p.(None):
p.(None): 22 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Respect
p.(None):
p.(None): The term “respect” is used in many ethics frameworks. For instance, the Declaration of Helsinki (WMA 2013) notes in
p.(None): article 7:
p.(None): Medical research is subject to ethical standards that promote and ensure respect for all human subjects
p.(None): and protect their health and rights. (emphasis added)
p.(None): Its ubiquitous use does not, however, mean that “respect” is a clear term. In everyday life, it is used in
p.(None): the sense of deep admiration. For instance, somebody could say, “I respect the achievements of Nelson Mandela”.
p.(None): However, that is not what is meant by respect in research ethics. The statement from the Declaration of Helsinki does
p.(None): not mean that research participants must be admired. To be respected in research ethics is almost the opposite. It
...
p.(None): Our investigation was concerned with the risks or vulnerabilities for exploitation, so we adopted Macklin’s definition
p.(None): of exploitation. However, it is important to bear in mind that situations that are conducive to exploitation do not
p.(None): necessarily lead to exploitation. For instance, if a pharmaceutical company is due to test new antiretro- viral drugs
p.(None): to prevent the transmission of HIV to unborn babies, and the company operates in a country where poor mothers have no
p.(None): or very limited access to health care, it does not mean that exploitation will necessarily occur. The company may
p.(None): decide not to exploit vulnerable research participants and offer the accepted stan- dard of care to those in the
p.(None): control arm, rather than a placebo.
p.(None): Exploitation usually requires a moral decision on the part of the potential exploiter, but it can also occur
p.(None): through ignorance. Whether intended or unintended, the effects of exploitation are the same for the exploited. Hence,
p.(None): ignorance is not a legitimate justification for exploitation. Uncovering the primary risks of exploitation
p.(None):
p.(None): 2 A placebo-controlled trial involves some participants being given a medicine with active ingredi- ents, for instance
p.(None): a new drug against malaria, while others, the control group, are given a substance that should have no effect (the
p.(None): placebo), so that the outcomes can be compared.
p.(None): 3 One speaks of a proven standard of care when a treatment already exists for the illness under consideration in a
p.(None): trial. Hence, the ethical demand of testing any new drug against an existing one rather than a placebo is known as the
p.(None): “standard of care” debate.
p.(None):
p.(None): Our Method
p.(None): 39
p.(None):
p.(None): can help to increase awareness but, in our case, it also ensures that the GCC is designed in such a way
p.(None): that researchers are compelled to consider these factors. It is a unique facet of the GCC that it focuses the attention
p.(None): of researchers directly upon the primary risks of exploitation in collaborative HIC-LMIC research. This could only be
p.(None): achieved via thorough exploration of the risks from many perspectives, both top-down and bottom-up.
p.(None):
p.(None):
p.(None): Our Method
p.(None):
p.(None): The aim of this investigation was to identify the critical vulnerabilities that engender susceptibility to exploitation
p.(None): in LMIC-HIC collaborative research. Investigation of this vast subject would be impossible from a traditional
p.(None): literature-based approach, or through investigation in a single geographical region. Many of these vulnerabili- ties
p.(None): are poorly represented in the literature, and they can differ between countries, cultures and types of research. For
p.(None): example, clinical trials, social science, animal experiments, environmental science and research in emergency settings
p.(None): may pose a diverse array of risks that are largely determined by the local context. Consequently, a creative approach
p.(None): to data collection was needed to capture as many risks and vul- nerabilities as possible.
p.(None): In this regard it was very helpful that the interdisciplinary TRUST project con- sortium comprised multilevel ethics
...
p.(None): communities. For example, indigenous communi- ties, having a historical continuity with preinvasion and precolonial
p.(None): societies that developed on their territories, may consider themselves distinct from other sectors of the societies
p.(None): that now prevail on those territories, or parts of them. They generally form nondominant sectors of society and can be
p.(None): intent on preserving, developing and transmitting to future generations their ancestral territories and their
p.(None): ethnic identity, as the basis of their continued existence as peoples, in accordance with their own cultural patterns,
p.(None): social institutions and legal systems (Martínez Cobo
p.(None):
p.(None): 92 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): 2014). They often have particular relationships with advocacy groups who work to protect or represent their interests.4
p.(None): The concept of communities within communities also includes groups of people who are vulnerable because of a
p.(None): range of physical (disabilities, for example) or cultural (religion, for example) characteristics. For instance,
p.(None): sex workers, injecting drug users and men who have sex with men are often marginalized within their own broader
p.(None): communities.5 People from such groups are frequently sought for interna- tional research and yet the community at
p.(None): large or the community leaders are often unable to provide the input needed to ensure ethical management of
p.(None): research projects. Communities and their leaders may be unaware of the specific circumstances of these people and their
p.(None): lives, and they may even be openly hostile. We therefore need mechanisms for ensuring that the voice of
p.(None): marginalized and vulnerable populations is heard, and that their interests in research are represented.
p.(None): In the 1990s, community engagement assumed prominence as the new guiding light of public health efforts; research and
p.(None): health-improvement programmes that involved communities had better results than programmes led by government alone (NIH
p.(None): 2011). At the same time, the limitations of existing guidelines for the protec- tion of communities in genetic research
p.(None): was becoming increasingly apparent (Weijer et al. 1999). The benefits of community engagement in all types of research
p.(None): are now widely acknowledged, and numerous publications describe many potential benefits such as:
p.(None): • increasing community understanding and acceptance of the studies
p.(None): • enhancing researchers’ ability to understand and address community priorities
p.(None): • improving logistics and the running of studies
p.(None): • strengthening the quality of the information collected
p.(None): • ensuring culturally sensitive communications and research approaches
...
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p.(None): value to exist, there must be an agent (a per- son) who is doing the valuing, and the feature or entity must be worth
p.(None): something to this agent (Klein 2017). The values of one individual can be very different from those of another person.
p.(None): For instance, a regular income is worth a lot to a person who values routine and security; it can contribute to their
p.(None): wellbeing and happiness. Others, who value personal freedom more than routine and security, might be just as happy with
p.(None): occasional income, as long as they are not bound to a nine-to-five job. If most humans around the world value a
p.(None): particular thing, it can be described as a universal value.
p.(None): Thirdly, values can refer to goals and ambitions, with a moral connotation. In business literature, for example, one
p.(None): often finds reference to value-led management or organizational values, and many institutions make a point of
p.(None): establishing, pro- moting and broadcasting their values. For instance, the stated values of the University of Central
p.(None): Lancashire (UCLan), at which several of the authors of this book are based, are: common sense, compassion,
p.(None): teamwork, attention to detail and trust (UCLan nd). These values are all morally positive and they are intended to
p.(None): guide the actions of students, staff and the institution itself. In this third sense of the word, moral values “will
p.(None): enable us to determine what is morally right or what is valuable in particular circumstances” (Raz 2001: 208). If
p.(None): most humans around the world share a particular moral value, it can be described as a universal moral value.
p.(None): There are numerous advantages to having credible moral values at the level of organizations. Such values influence the
p.(None): culture of an organization (Martins and Coetzee 2011), which in turn has a positive impact upon corporate performance
p.(None): (Ofori and Sokro 2010), and job stress and satisfaction (Mansor and Tayib 2010), as well as business performance and
p.(None): competitive advantage (Crabb 2011). Furthermore, when employees’ values are aligned with organizational values, this
p.(None): benefits both the wellbeing of individuals and the success of the organization (Posner 2010).
p.(None): There are many internet sites that offer lists of core values. One of them (Threads Culture nd) includes 500 values,
p.(None): from “above and beyond” to “work life balance”.
p.(None):
p.(None): 16 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Not all of these are moral values. For instance, this particular list includes values such as clean, exuberant,
p.(None): hygienic, neat, poised and winning (Threads Culture nd). Another site lists 50 values, including authenticity, loyalty
p.(None): and wisdom, and advises that fewer than five should be selected for leadership purposes (Clear nd).
p.(None): The GCC is structured around four moral values: fairness, respect, care and hon- esty. These four values were not
p.(None): chosen from any existing lists; they emerged through in-depth consultation efforts around the globe (chapter 6).
p.(None): But why did the TRUST team choose moral values rather than other action-guiding moral modes for the GCC?
p.(None):
p.(None):
p.(None): What Can Guide Moral Action?
p.(None):
p.(None): The GCC is based on moral values, but the code authors could have opted to frame the code and guide action in other
p.(None): ways, including the following:
...
p.(None): committee operates, then it may be perfectly ethical to proceed.
p.(None): The San community in South Africa, for instance, has no facility for providing ethics committee approval, but the South
p.(None): African San Council can provide commu- nity approval for research projects in the community (Chapter 7). A standard of
p.(None): double ethics review would forbid any research in the San community until an eth- ics committee were established, which
p.(None): might even undermine the San people’s self- determined research governance structures. For this reason, it is clear
p.(None): that standards are too prescriptive to be applied to every setting, and might hinder valuable research.
p.(None): This leaves ethical values, which operate as guides on the route to doing the right thing and are not overly
p.(None): prescriptive. They do not undermine the need to develop bespoke agreements across cultures via discussions
p.(None): between research teams and communities. At the same time, there is another, positive reason to choose values as the
p.(None): foundation for the GCC. Values inspire and motivate people to take action – and that is exactly what is needed to guard
p.(None): against ethics dumping.
p.(None):
p.(None):
p.(None): Values and Their Motivating Power
p.(None):
p.(None): Research stakeholders who are guided by values will hopefully be inspired and motivated by the GCC and not
p.(None): just follow its rules reluctantly or grudgingly. Why is that? Values can serve as motivating factors in promoting or
p.(None): inhibiting human action (Marcum 2008, Locke 1991, Ogletree 2004). The influence of personal val- ues upon behaviour has
p.(None): become a subject of extensive research in the social sci- ences and in psychology, particularly over the past forty
p.(None): years, with just about every area of life being examined through the lens of personal values – for example, con- sumer
p.(None): practices (Pinto et al. 2011), political voting habits (Kaufmann 2016), employee creativity (Sousa and Coelho
p.(None): 2011), healthcare decisions (Huijer and Van Leeuwen 2000), investment decisions (Pasewark and Riley 2010), and
p.(None): sexuality and disability (Wolfe 1997), to name but a few.
p.(None):
p.(None):
p.(None): 4 Local ethics review should be sought wherever possible. It is of vital importance that research projects are approved
p.(None): by a research ethics committee in the host country, wherever this exists, even if ethics approval has already been
p.(None): obtained in the high-income setting.
p.(None):
p.(None): From Values to Action
p.(None): 19
p.(None):
p.(None): Arguably the most prominent theory of the motivational power of human values was developed by social psychologist
p.(None): Shalom Schwartz, back in 1992. Schwartz’s theory of basic values is distinctive because, unlike most other theories, it
p.(None): has been tested via extensive empirical investigation. Studies undertaken since the early 1990s have generated
...
p.(None): Martins N, Coetzee M (2011) Staff perceptions of organisational values in a large South African manufacturing company:
p.(None): exploring socio-demographic differences. SA Journal of Industrial Psychology 37(1):1–11
p.(None): Mitchell LA (2015) Integrity and virtue: the forming of good character. The Linacre Quarterly 82(2):149–169
p.(None): NMC (2018) The code: professional standards of practice and behaviour for nurses, midwives and nursing associates.
p.(None): Nursing & Midwifery Council. https://www.nmc.org.uk/standards/code/ Ofori DF, Sokro E (2010). Examining the impact of
p.(None): organisational values on corporate perfor-
p.(None): mance in selected Ghanaian companies. Global Management Journal 2(1)
p.(None): Ogletree TW (2004) Value and valuation. In: Post SG (ed) Encyclopedia of bioethics, 3rd edn.
p.(None): MacMillan Reference USA, New York, p 2539–2545
p.(None): Owen R, Stilgoe J, Macnaghten P, Gorman M, Fisher E, Guston D (2013) A framework for respon- sible innovation. In:
p.(None): Owen, R, Bessant J, Heintz M (eds) Responsible innovation: managing the responsible emergence of science and innovation
p.(None): in society. John Wiley, London, p 27–50
p.(None):
p.(None): 26 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Pasewark WR, Riley ME (2010) It’s a matter of principle: the role of personal values in investment decisions. Journal
p.(None): of Business Ethics 93(2):237–253
p.(None): Philippa Foot P (1978) Virtues and vices. In: Virtues and vices and other essays in moral philoso- phy. Blackwell,
p.(None): Oxford, p 1–18
p.(None): Pinto DC, Nique WM, Añaña EDS, Herter MM (2011) Green consumer values: how do personal values influence
p.(None): environmentally responsible water consumption? International Journal of Consumer Studies 35(2):122–131
p.(None): Pogge T (2006) Justice. In: Borchert DM (ed) Encyclopedia of philosophy, 2nd edn (vol 4).
p.(None): Macmillan Reference, Detroit MI, p 862–870
p.(None): Posner BZ (2010) Another look at the impact of personal and organizational values congruency.
p.(None): Journal of Business Ethics 97(4):535–541
p.(None): Rawls J (1999) A theory of justice, revised edn. Oxford University Press, Oxford
p.(None): Raz J (2001) Engaging reason: On the theory of value and action. Oxford University Press, Oxford Resnik DB (2012)
p.(None): Ethical virtues in scientific research. Accountability in Research 19(6):329–343 Russell D C (2015) Aristotle on
p.(None): cultivating virtue. In: Snow, N (ed) Cultivating virtue: perspectives
p.(None): from philosophy, theology, and psychology. Oxford University Press, Oxford, p 37–38 Schwartz SH (2012) An overview
p.(None): of the Schwartz theory of basic values. Online Readings in
p.(None): Psychology and Culture 2(1):11
p.(None): Sousa CM, Coelho F (2011) From personal values to creativity: evidence from frontline service employees. European
p.(None): Journal of Marketing 45(7/8):1029–1050
p.(None): Threads Culture (nd) Core values examples. https://www.threadsculture.com/
p.(None): core-values-examples/
p.(None): UCLan (nd) The UCLan values. University of Central Lancashire. https://www.uclan.ac.uk/work/ life-at-uclan.php
p.(None): UN (1948) Universal Declaration of Human Rights. http://www.un.org/en/
p.(None): universal-declaration-human-rights/
p.(None): UN (1992) Convention on Biological Diversity. https://www.cbd.int/doc/legal/cbd-en.pdf
p.(None): Wang X, Li F, Sun Q (2018) Confucian ethics, moral foundations, and shareholder value perspec- tives: an exploratory
p.(None): study. Business Ethics: A European Review 27(3):260–271
p.(None): WMA (2013) Declaration of Helsinki. World Medical Association. https://www.wma.net/policies-
p.(None): post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human- subjects/
p.(None): Wolfe PS (1997) The influence of personal values on issues of sexuality and disability. Sexuality and disability
p.(None): 15(2):69–90
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 4
p.(None): Respect and a Global Code of Conduct?
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The Global Code of Conduct for Research in Resource-Poor Settings claims global applicability and
p.(None): promotes respect as one of its four values. Hence, the code anticipates potentially unresolvable differences
p.(None): between cultures, while maintaining it is globally valid. Examining, but discarding, several possibilities to deal
...
p.(None): to increase access to health for disadvantaged communities in Africa by strengthening health systems, research,
p.(None): programme devel- opment and partnerships. PHDA’s programmes are implemented by a collaborative group of scientists and
p.(None): public health professionals from the University of Manitoba (Canada), the University of Nairobi and the government of
p.(None): Kenya. Its work focuses mainly on HIV prevention, treatment and care, research, capacity-building and
p.(None): training.
p.(None): The Sex Workers Outreach Programme (SWOP) is a PHDA initiative that under- takes active community engagement and
p.(None): provides clinical and preventative services to 33,000 sex workers residing in Nairobi. These sex workers would
p.(None): otherwise find access to medical services in public health facilities extremely limited due to stigma and
p.(None): discrimination. Those enrolled in the sex workers cohort for HIV prevention services are free to volunteer for
p.(None): available research studies after providing informed consent. Most studies are on the epidemiology of sexually
p.(None): transmitted diseases, and on host genetic factors that influence infectivity and disease progression.
p.(None): Given that sex work is illegal in Kenya, we cannot assign input to specific, named individuals here. Suffice to say
p.(None): that the personal contributions of courageous and admirable sex workers, both female and male, provided the TRUST team
p.(None): not only with practical advice that took shape in specific articles of the GCC, but also with inspiration. Table 6.4
p.(None): presents two examples of issues raised by the Nairobi sex workers (Chatfield et al. 2016a) that were implemented in the
p.(None): GCC.
p.(None):
p.(None): 64 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.4 Input from sex workers and GCC connection
p.(None): Issues raised by sex workers Relevant GCC Article
p.(None):
p.(None): “We need feedback to the community from the research in simple and non-scientific language. Some results have been
p.(None): shared with us in the past, but I did not know what they meant. Do not give us results in scientific language. It puts
p.(None): us at risk if we do not understand the results. … Come back with the results and tell us how we can make our lives
p.(None): better.”
p.(None): “We know that the samples that are collected from us are sometimes sent to other countries. What happens to them? In my
...
p.(None): • increasing community understanding and acceptance of the studies
p.(None): • enhancing researchers’ ability to understand and address community priorities
p.(None): • improving logistics and the running of studies
p.(None): • strengthening the quality of the information collected
p.(None): • ensuring culturally sensitive communications and research approaches
p.(None): • enhancing opportunities for capacity building (Hebert et al. 2009; Cook 2008; Bassler et al. 2008; Dunn 2011).
p.(None): Community engagement is an ethical imperative (a “must”) for researchers oper- ating globally. Research participants,
p.(None): their local communities and research partners in international locations should be equal stakeholders in the pursuit of
p.(None): research- related gains (Anderson et al. 2012). Ahmed and Palermo (2010) provide a salient definition of community
p.(None): engagement in research as
p.(None): a process of inclusive participation that supports mutual respect of values, strategies, and actions for authentic
p.(None): partnership of people affiliated with or self-identified by geographic proximity, special interest, or similar
p.(None): situations to address issues affecting the well-being of the community of focus.
p.(None): To be effective in international research, community engagement requires the development of partnerships with
p.(None): “local” stakeholders (for example, national,
p.(None):
p.(None): 4 Advocacy groups (also known as pressure groups, lobby groups, campaign groups, interest groups or special interest
p.(None): groups) use various forms of advocacy in order to influence public opinion and/ or policy.
p.(None): 5 Here “broader community” can refer to a village, town, ethnic group etc.
p.(None):
p.(None): Ethical Engagement with Communities
p.(None): 93
p.(None):
p.(None): regional or advocacy groups), involving them in assessing local challenges and research priorities,
p.(None): determining the value of research, planning, conducting and overseeing research, and integrating the
p.(None): results with local needs where relevant (Jones and Wells 2007). Moreover, it requires members of the
p.(None): research team to become part of the community, and members of the community to become part of the research team to
p.(None): create bespoke working environments before, during and after the research.
p.(None): Many models have been proposed for effective community engagement in research,6 and many written guides
p.(None): already exist. Rather than add an invention of our own to the numerous existing models, we show here how reference to
p.(None): the four values of fairness, respect, care and honesty can highlight the primary ethical con- siderations for
p.(None): organizations or researchers engaging with communities over the course of a research project. After all, as Dunn
p.(None): (2011: 5) points out, “Engagement is not a benchmark for ethics. Ethics does not stop when community engagement takes
p.(None): place. Engagement itself has ethical implications.”
p.(None): Our guidance for community engagement is intended to be useful; we show how application of the values compass at key
p.(None): stages of the research process can invoke particular questions for contemplation. There may be other relevant
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p.(None): among which are our four values – in addition to some genuine cross-cultural normative variation.
p.(None): Finally we introduce an approach that has much in common with the TRUST2 approach: the “four-principles approach”
p.(None): presented by Tom Beauchamp and James Childress in successive editions of their book Principles of Biomedical
p.(None): Ethics (2013). Beauchamp and Childress maintain that there are four central values/prin- ciples3 (see the box below
p.(None): for the difference between the two) that are especially applicable to their own area of ethical interest, biomedical
p.(None): ethics. They use the term principles, and identify them as respect for autonomy, non-maleficence (do no
p.(None): harm), beneficence and justice (Beauchamp and Childress 2013).
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): voluntary exercise for research participants. It is not a mission-driven exercise to impose different ethical values.
p.(None): If researchers from high-income settings cannot agree on a way of undertaking the research that is acceptable to local
p.(None): stakeholders, it should not take place.
p.(None): 2 EU-funded research project, which developed the GCC from 2015 to 2018.
p.(None): 3 According to the definition of values in the box (and in Chapter 3 of this book), the four-principles approach should
p.(None): be called the four-values approach, but this makes no difference in substance.
p.(None):
p.(None): Introduction
p.(None): 29
p.(None):
p.(None):
p.(None): Values and Principles
p.(None): The words “values” and “principles” are often used interchangeably. We will distinguish them as below.
p.(None): If people value something, they hold it dear, and they believe it is of high importance. This could be power, money or
p.(None): kindness; values are not necessar- ily morally positive. Ethical values, on the other hand, are guides on the route to
p.(None): doing the right thing or developing a moral character. They are by definition morally positive. For example, greed is
p.(None): not an ethical value, but generosity is. A principle is a behavioural rule for concrete action. When you know the
p.(None): principle, you know what to do. For instance, the principle in dubio pro reo has saved many innocent people from going
p.(None): to jail as it gives courts very con- crete advice. It means, “When in doubt, then favour the accused,” (in other words,
p.(None): “innocent until proven guilty”) and goes back to both Aristotle and
p.(None): Roman law.
p.(None):
p.(None): Beauchamp and Childress maintain that their four principles are globally appli- cable – that is to say, they are
p.(None): universally relevant to the sorts of ethical questions that arise in biomedicine; they are every bit as integral to the
p.(None): understanding and resolution of medical ethics problems in Bangkok as they are in Boston, equally pertinent in both
p.(None): Cape Town and Copenhagen. Their status as globally applicable is, according to Beauchamp and Childress, underwritten by
p.(None): their forming part of what they call “the common morality”, understood as a system of general norms that will be
...
p.(None): of exploitation. However, it is important to bear in mind that situations that are conducive to exploitation do not
p.(None): necessarily lead to exploitation. For instance, if a pharmaceutical company is due to test new antiretro- viral drugs
p.(None): to prevent the transmission of HIV to unborn babies, and the company operates in a country where poor mothers have no
p.(None): or very limited access to health care, it does not mean that exploitation will necessarily occur. The company may
p.(None): decide not to exploit vulnerable research participants and offer the accepted stan- dard of care to those in the
p.(None): control arm, rather than a placebo.
p.(None): Exploitation usually requires a moral decision on the part of the potential exploiter, but it can also occur
p.(None): through ignorance. Whether intended or unintended, the effects of exploitation are the same for the exploited. Hence,
p.(None): ignorance is not a legitimate justification for exploitation. Uncovering the primary risks of exploitation
p.(None):
p.(None): 2 A placebo-controlled trial involves some participants being given a medicine with active ingredi- ents, for instance
p.(None): a new drug against malaria, while others, the control group, are given a substance that should have no effect (the
p.(None): placebo), so that the outcomes can be compared.
p.(None): 3 One speaks of a proven standard of care when a treatment already exists for the illness under consideration in a
p.(None): trial. Hence, the ethical demand of testing any new drug against an existing one rather than a placebo is known as the
p.(None): “standard of care” debate.
p.(None):
p.(None): Our Method
p.(None): 39
p.(None):
p.(None): can help to increase awareness but, in our case, it also ensures that the GCC is designed in such a way
p.(None): that researchers are compelled to consider these factors. It is a unique facet of the GCC that it focuses the attention
p.(None): of researchers directly upon the primary risks of exploitation in collaborative HIC-LMIC research. This could only be
p.(None): achieved via thorough exploration of the risks from many perspectives, both top-down and bottom-up.
p.(None):
p.(None):
p.(None): Our Method
p.(None):
p.(None): The aim of this investigation was to identify the critical vulnerabilities that engender susceptibility to exploitation
p.(None): in LMIC-HIC collaborative research. Investigation of this vast subject would be impossible from a traditional
p.(None): literature-based approach, or through investigation in a single geographical region. Many of these vulnerabili- ties
p.(None): are poorly represented in the literature, and they can differ between countries, cultures and types of research. For
...
p.(None): Uganda. However, it turned out that existing local varieties provided a higher vitamin content than the envisaged GM
p.(None): variety. The question of whether that should count as ethics dumping goes back to a long-standing dilemma for ethics
p.(None): committees: Is bad sci- ence bad ethics? (Levine 2004) Wasteful research cannot be put into the same cat- egory as the
p.(None): wilful exploitation of lower regulatory standards to exploit research populations in LMICs for individual gain. But at
p.(None): the same time, with such a pressing need for innovative solutions to LMIC problems, the violation of article 1 of the
p.(None): GCC (local relevance of research) and the avoidable waste of limited funding resources must count as
p.(None): unethical.
p.(None): A second recurring response to the GCC from researchers has been that “every- one loved our values”.10 Audiences in
p.(None): HICs – England, for instance – even asked whether they could use the four values in national research in their own
p.(None): countries. Hence, rather than seeing the values as solely applicable when there are vast power differentials between
p.(None): researchers and research participants (as between HICs and LMICs), they were keen to use them in any research.
p.(None): A third recurring issue for researchers has been the following: “We appreciate that the code is short and accessible,
p.(None): but wouldn’t a longer, more detailed code give more support to early career researchers?” The TRUST consortium agreed
p.(None): upon a concise code because it is vital that the demands of substance for each article be clear and straightforward,
p.(None): while the process demands remain flexible. Let us take article 1 as an example:
p.(None): The substance element of article 1 is: “Local relevance of research is essential”. Further information would not be
p.(None): helpful to early career (or any other) researchers. The process element of article 1 is: “[Local relevance] should be
p.(None): determined in collaboration with local partners.” This could only be set out in more detail if there were a single
p.(None): process that would fit every situation – and that is not the case. What an equitable process for determining research
p.(None): goals should look like in an interna- tional collaborative research project is one of the things that need to be agreed
p.(None): on within the process of that project. Hence, prescriptive details would have been coun-
p.(None): terproductive to the very spirit of the article.
p.(None): Instead of attempting to formulate a range of possibilities to fill the process ele- ments with substance, we opted to
p.(None): provide educational material to support the GCC online,11 because any process requirements are best agreed
p.(None): between the relevant partners rather than imposed prescriptively by code drafters. Hence, our educational materials
p.(None): future-proof the GCC, as they can be updated in real time for use by early career (or any other) researchers, and,
p.(None): unlike the GCC itself, they are not mandatory.
p.(None):
p.(None):
p.(None): 10 Personal communication from Dr Vasantha Muthuswamy, a TRUST project team member, after a GCC presentation in Taiwan.
p.(None): 11 http://www.globalcodeofconduct.org/
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 63
p.(None):
p.(None): Engagement with Research Participants and Research Communities
p.(None):
p.(None): The inclusion of the perspectives of research participants and research communities who are vulnerable to exploitation,
p.(None): and therefore to ethics dumping, was essential to our bottom-up approach. It is also the ethical approach, as
p.(None): stipulated in article 2 of the GCC:
p.(None): Local communities and research participants should be included throughout the research process, wherever possible, from
p.(None): planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly
p.(None): represented. This approach represents Good Participatory Practice.
p.(None): Two NGO partners in the TRUST project were tasked specifically with ensuring that the voices of vulnerable populations
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p.(None): Dumping
p.(None):
p.(None): • lower regulatory barriers for research in LMICs
p.(None): • international harmonization of intellectual property rights protection
p.(None): To take full advantage of the benefits of conducting medical research in LMICs, research institutions in HICs have
p.(None): invested substantially in building legal and con- tracting expertise for the benefit of their own institutions and
p.(None): stakeholders. Such expertise may not be as easily available in LMIC institutions. As a result, the benefits of research
p.(None): collaborations remain heavily skewed towards the beneficiaries based in HICs (Sack et al. 2009).
p.(None): In 2011 the Council on Health Research for Development (COHRED) commit- ted itself to launching its Fair Research
p.(None): Contracting (FRC) initiative to support LMIC partners when negotiating equitable research partnerships. FRC
p.(None): aimed to identify best practices for the research contracting process that would be useful in the following three
p.(None): scenarios:
p.(None): • where there is no lawyer
p.(None): • where there may be lay personnel who could be trained
p.(None): • where there is a lawyer or legal expertise
p.(None): A basic framework was subsequently developed by COHRED and partners to assist LMIC collaborators in making
p.(None): contractual demands on HIC collaborators without requiring large legal teams of their own. This focused on the fair
p.(None): distribu- tion of post-research benefits, intellectual property rights, data and data ownerships, specimen ownership
p.(None): and usage, technology transfer and institutional capacity build- ing as key outcomes of the FRC process. Between 2015
p.(None): and 2018, and as part of the TRUST project, the existing FRC framework was enhanced and expanded to pro- vide an online
p.(None): toolkit relevant for all types of research.
p.(None): The FRC online toolkit9 now provides information, tips and case studies in six key areas:
p.(None): • Negotiation strategies: for understanding the various aspects of negotiations, whether a research partner
p.(None): is at a basic starting point or an advanced level in the development of contract negotiations
p.(None): • Research contracting: for a basic understanding of contracts and contracting so that a research partner can better
p.(None): manage responsibilities, opportunities and risks that impact the research partnership
p.(None): • Research data: providing the essential principles concerning rights and responsi- bilities, including
p.(None): accountability and access to data in collaborative research
p.(None): • Intellectual property: providing an introduction to some of the key general prin- ciples that require
p.(None): consideration before participation in collaborative research agreements
p.(None): • Research costing: providing research partners with a basic understanding of cost considerations when developing a
p.(None): full cost research budget proposal
p.(None):
p.(None):
p.(None):
p.(None): 9 The entire online toolkit is available at http://frcweb.cohred.org/
p.(None):
p.(None): Conclusion
p.(None): 105
p.(None):
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p.(None): ensure that the GCC was more than a compilation of existing
p.(None):
p.(None):
p.(None):
p.(None): 1 The export of unethical research from a high-income setting to a resource-poor setting with weaker
p.(None): compliance structures or legal governance mechanisms.
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 37
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_5
p.(None):
p.(None): 38 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): codes, most of which had not been written with LMIC-HIC (high-income country) collaborations in mind.
p.(None):
p.(None):
p.(None): The Nature of Exploitation
p.(None):
p.(None): The potential to be exploited is part of the human condition. Exploiters take advan- tage of others’ vulnerabilities to
p.(None): promote their own interests (Hughes 2010). While there is a morally neutral sense of exploitation (the exploitation of
p.(None): natural talents to create art, for example), the term is generally used to describe a moral failing.
p.(None): Exploitation of people is very often unjust, unfair, harmful or just plain wrong. What is it, then, that
p.(None): distinguishes morally unacceptable exploitation from neutral exploitation?
p.(None): Some argue that exploitation is wrong because it is coercive (Schwartz 1995). If the only way for a woman in an LMIC to
p.(None): access antiretroviral drugs to prevent the transmission of HIV to her unborn baby is to participate in a
p.(None): placebo-controlled clinical trial,2 despite the existence of a proven standard of care,3 then one could say she has
p.(None): been coerced into enrolling (Annas and Grodin 1998). In this sense, exploi- tation occurs where one party takes
p.(None): advantage of another by making them an offer they cannot refuse; they are then coerced to accept simply because there
p.(None): is no alter- native. Others argue that exploitation is wrong because it treats human beings as means rather than ends
p.(None): (Wood 1995). In other words, exploitation instrumentalizes people. Yet others claim that exploitation is wrong
p.(None): because it disadvantages the vulnerable (Macklin 2003).
p.(None): Our investigation was concerned with the risks or vulnerabilities for exploitation, so we adopted Macklin’s definition
p.(None): of exploitation. However, it is important to bear in mind that situations that are conducive to exploitation do not
p.(None): necessarily lead to exploitation. For instance, if a pharmaceutical company is due to test new antiretro- viral drugs
p.(None): to prevent the transmission of HIV to unborn babies, and the company operates in a country where poor mothers have no
p.(None): or very limited access to health care, it does not mean that exploitation will necessarily occur. The company may
p.(None): decide not to exploit vulnerable research participants and offer the accepted stan- dard of care to those in the
p.(None): control arm, rather than a placebo.
p.(None): Exploitation usually requires a moral decision on the part of the potential exploiter, but it can also occur
p.(None): through ignorance. Whether intended or unintended, the effects of exploitation are the same for the exploited. Hence,
p.(None): ignorance is not a legitimate justification for exploitation. Uncovering the primary risks of exploitation
p.(None):
p.(None): 2 A placebo-controlled trial involves some participants being given a medicine with active ingredi- ents, for instance
p.(None): a new drug against malaria, while others, the control group, are given a substance that should have no effect (the
p.(None): placebo), so that the outcomes can be compared.
p.(None): 3 One speaks of a proven standard of care when a treatment already exists for the illness under consideration in a
...
p.(None): 2012).
p.(None): We close this chapter with a comment from the TRUST gender adviser, Prof.
p.(None): Fatima Alvarez-Castillo (2016):
p.(None): A culture’s worldview, expressed in language, contains norms and values about power and relations of power. For
p.(None): example, the word “expert” imbues persons with authority and assigns higher credibility to their claims than
p.(None): those of non-experts. The public is expected to defer to their opinions on matters of their expertise. It was not until
p.(None): about the 1960s when the usual understanding of expertise was challenged by feminists, who argued that
p.(None): unschooled women have more expertise about their own situation than the experts. This ushered in a new research
p.(None): philosophy that valorizes poor women’s stories and their own versions of their realities.
p.(None):
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Alvarez-Castillo F (2016) Gender sensitivity: writing and language. In: Chatfield K, Schroeder D, Kimani J (eds)
p.(None): Nairobi plenary meeting report, TRUST Project. http://trust-project.eu/wp-
p.(None): content/uploads/2016/11/Meeting-Report-TRUST-Nairobi-Final.pdf
p.(None): Annas G, Grodin M (1998) Human rights and maternal-fetal HIV transmission prevention trials in Africa. American Journal
p.(None): of Public Health 88(4):560–563
p.(None): Bhatt K (2016) Concerns for Kenyan National Bioethics Committee when approving North-South collaborative projects. In:
p.(None): Chatfield K, Schroeder D, Kimani J (eds) Nairobi plenary meeting report, TRUST Project.
p.(None): http://trust-project.eu/wp-content/uploads/2016/11/Meeting-Report- TRUST-Nairobi-Final.pdf
p.(None): EU (2010) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of
p.(None): animals used for scientific purposes (text with EEA relevance). OJ L 276/33.
p.(None): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32010L0063
p.(None): Hill CM, Webber AD (2010) Perceptions of nonhuman primates in human–wildlife conflict sce- narios. American Journal of
p.(None): Primatology 72(10):919−924
p.(None): Hughes J (2010) European textbook on ethics in research. European Commission, Brussels
p.(None):
p.(None): 50 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): Luc G, Altare C. (2018) Social science research in a humanitarian emergency context. In: Schroeder D, Cook J, Hirsch F,
p.(None): Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North- South research collaborations, Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 9-14
p.(None): Macklin R (2003) Vulnerability and protection. Bioethics 17(5–6):472–486
...
p.(None): represented. This approach represents Good Participatory Practice.
p.(None): Two NGO partners in the TRUST project were tasked specifically with ensuring that the voices of vulnerable populations
p.(None): were heard and acted upon. First, the South African San Institute (SASI) made the inclusion of indigenous peoples from
p.(None): South Africa possible. While San leaders and representatives were involved in all the work of the TRUST project,
p.(None): including the drafting of the GCC, the full impact of their contribution is best understood through the account in
p.(None): Chapter 7 of this book of the development of the San Code of Research Ethics. Second, Partners for Health and
p.(None): Development in Africa (PHDA) made the inclusion of sex workers from the Majengo area of Nairobi possible. At this point
p.(None): we will focus on their involvement in order to illustrate the bottom-up approach of the GCC drafting process.
p.(None): PHDA is a nonprofit organization that undertakes work in the fields of health and development in Kenya. Its mission is
p.(None): to increase access to health for disadvantaged communities in Africa by strengthening health systems, research,
p.(None): programme devel- opment and partnerships. PHDA’s programmes are implemented by a collaborative group of scientists and
p.(None): public health professionals from the University of Manitoba (Canada), the University of Nairobi and the government of
p.(None): Kenya. Its work focuses mainly on HIV prevention, treatment and care, research, capacity-building and
p.(None): training.
p.(None): The Sex Workers Outreach Programme (SWOP) is a PHDA initiative that under- takes active community engagement and
p.(None): provides clinical and preventative services to 33,000 sex workers residing in Nairobi. These sex workers would
p.(None): otherwise find access to medical services in public health facilities extremely limited due to stigma and
p.(None): discrimination. Those enrolled in the sex workers cohort for HIV prevention services are free to volunteer for
p.(None): available research studies after providing informed consent. Most studies are on the epidemiology of sexually
p.(None): transmitted diseases, and on host genetic factors that influence infectivity and disease progression.
p.(None): Given that sex work is illegal in Kenya, we cannot assign input to specific, named individuals here. Suffice to say
p.(None): that the personal contributions of courageous and admirable sex workers, both female and male, provided the TRUST team
p.(None): not only with practical advice that took shape in specific articles of the GCC, but also with inspiration. Table 6.4
p.(None): presents two examples of issues raised by the Nairobi sex workers (Chatfield et al. 2016a) that were implemented in the
p.(None): GCC.
p.(None):
p.(None): 64 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.4 Input from sex workers and GCC connection
p.(None): Issues raised by sex workers Relevant GCC Article
p.(None):
p.(None): “We need feedback to the community from the research in simple and non-scientific language. Some results have been
...
p.(None): research proposals] now looking suspiciously at any application for funds that entailed research by wealthy
p.(None): nations on the less wealthy that did not mention the code,” he says. (Nordling 2018)
p.(None): The emphasis in the GCC on fairness, respect, care and honesty resonates with our work at UNESCO. – Dr Dafna
p.(None): Feinholz (Mexican), UNESCO’s chief of Bioethics and Ethics of Science and Technology, co-author of the GCC
p.(None):
p.(None):
p.(None):
p.(None): 2 The EU-funded consortium that developed the GCC.
p.(None): 3 This refers to Andries Steenkamp’s iconic request to researchers, namely to enter San communi- ties through the
p.(None): metaphorical “front door” – that is, the San Council – and not, like thieves, through the window.
p.(None):
p.(None): 112 9 Towards Equitable Research
p.(None): Partnership
p.(None):
p.(None): TRUST was a game changer.4
p.(None): Ethics dumping is a real threat to the quality of science and the GCC is now a mandatory reference document for EU
p.(None): framework program funding to guard against it. – Dorian Karatzas (Greek), head of Ethics and Research Integrity,
p.(None): European Commission
p.(None): Best science for the most neglected, also means best ethical standards. That’s why the GCC aims high: to protect the
p.(None): most neglected. – Dr François Bompart (French), director of Paediatric HIV/Hepatitis C Programmes at the Drugs
p.(None): for Neglected Diseases initiative (DNDi), former vice president, Access to Medicines at Sanofi, co-author of the GCC
p.(None): We get given consent forms and documents, often in a hurry. We sign because we need the money and then end up with
p.(None): regret. It feels like a form of abuse. They want something from us and they know how to get it. Because of our
p.(None): socio-economic conditions, we will always be vulnerable to those from the North. A code of ethics is needed that
p.(None): protects indigenous people.5 – Andries Steenkamp (1960–2016) (South African), former chair of the South African
p.(None): San Council, co-author of both codes
p.(None): I don’t want researchers to see us as museums who cannot speak for themselves and who don’t expect something in return.
p.(None): As humans, we need support.6 – Reverend Mario Mahongo (1952–2018) (Angolan), co-author of both codes
p.(None): We want to be treated by researchers with fairness, respect, care and honesty. Is that too much to ask?7 – Joyce
p.(None): Adhiambo Odhiambo (Kenyan), health activist and former sex worker, co-author of the GCC
p.(None): Indeed, is that too much to ask?
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Burtscher W (2018) TRUST Global Code of Conduct to be a reference document applied by all research projects applying
p.(None): for H2020 funding. TRUST eNewsletter Issue 5. http://www.global-
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p.(None): that standards are too prescriptive to be applied to every setting, and might hinder valuable research.
p.(None): This leaves ethical values, which operate as guides on the route to doing the right thing and are not overly
p.(None): prescriptive. They do not undermine the need to develop bespoke agreements across cultures via discussions
p.(None): between research teams and communities. At the same time, there is another, positive reason to choose values as the
p.(None): foundation for the GCC. Values inspire and motivate people to take action – and that is exactly what is needed to guard
p.(None): against ethics dumping.
p.(None):
p.(None):
p.(None): Values and Their Motivating Power
p.(None):
p.(None): Research stakeholders who are guided by values will hopefully be inspired and motivated by the GCC and not
p.(None): just follow its rules reluctantly or grudgingly. Why is that? Values can serve as motivating factors in promoting or
p.(None): inhibiting human action (Marcum 2008, Locke 1991, Ogletree 2004). The influence of personal val- ues upon behaviour has
p.(None): become a subject of extensive research in the social sci- ences and in psychology, particularly over the past forty
p.(None): years, with just about every area of life being examined through the lens of personal values – for example, con- sumer
p.(None): practices (Pinto et al. 2011), political voting habits (Kaufmann 2016), employee creativity (Sousa and Coelho
p.(None): 2011), healthcare decisions (Huijer and Van Leeuwen 2000), investment decisions (Pasewark and Riley 2010), and
p.(None): sexuality and disability (Wolfe 1997), to name but a few.
p.(None):
p.(None):
p.(None): 4 Local ethics review should be sought wherever possible. It is of vital importance that research projects are approved
p.(None): by a research ethics committee in the host country, wherever this exists, even if ethics approval has already been
p.(None): obtained in the high-income setting.
p.(None):
p.(None): From Values to Action
p.(None): 19
p.(None):
p.(None): Arguably the most prominent theory of the motivational power of human values was developed by social psychologist
p.(None): Shalom Schwartz, back in 1992. Schwartz’s theory of basic values is distinctive because, unlike most other theories, it
p.(None): has been tested via extensive empirical investigation. Studies undertaken since the early 1990s have generated
p.(None): large data sets from 82 countries, including highly diverse geographic, cultural, religious, age and occupational
p.(None): groups (Schwartz 2012). Findings from Schwartz’s global studies indicate that values are inextricably linked to
p.(None): affect. He claims that when values are activated, they become infused with feel- ing (Schwartz 2012). For example,
p.(None): people for whom routine and security are impor- tant values will become disturbed when their employment is threatened
p.(None): and may fall into despair if they actually lose their jobs. Correspondingly, when moral values like fairness or respect
p.(None): are important, people will react when they witness instances of unfairness or disrespect; they will feel motivated to
p.(None): respond in some way.
...
p.(None): cultivating virtue. In: Snow, N (ed) Cultivating virtue: perspectives
p.(None): from philosophy, theology, and psychology. Oxford University Press, Oxford, p 37–38 Schwartz SH (2012) An overview
p.(None): of the Schwartz theory of basic values. Online Readings in
p.(None): Psychology and Culture 2(1):11
p.(None): Sousa CM, Coelho F (2011) From personal values to creativity: evidence from frontline service employees. European
p.(None): Journal of Marketing 45(7/8):1029–1050
p.(None): Threads Culture (nd) Core values examples. https://www.threadsculture.com/
p.(None): core-values-examples/
p.(None): UCLan (nd) The UCLan values. University of Central Lancashire. https://www.uclan.ac.uk/work/ life-at-uclan.php
p.(None): UN (1948) Universal Declaration of Human Rights. http://www.un.org/en/
p.(None): universal-declaration-human-rights/
p.(None): UN (1992) Convention on Biological Diversity. https://www.cbd.int/doc/legal/cbd-en.pdf
p.(None): Wang X, Li F, Sun Q (2018) Confucian ethics, moral foundations, and shareholder value perspec- tives: an exploratory
p.(None): study. Business Ethics: A European Review 27(3):260–271
p.(None): WMA (2013) Declaration of Helsinki. World Medical Association. https://www.wma.net/policies-
p.(None): post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human- subjects/
p.(None): Wolfe PS (1997) The influence of personal values on issues of sexuality and disability. Sexuality and disability
p.(None): 15(2):69–90
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 4
p.(None): Respect and a Global Code of Conduct?
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The Global Code of Conduct for Research in Resource-Poor Settings claims global applicability and
p.(None): promotes respect as one of its four values. Hence, the code anticipates potentially unresolvable differences
p.(None): between cultures, while maintaining it is globally valid. Examining, but discarding, several possibilities to deal
p.(None): with normative relativism, this chapter argues, with Beauchamp and Childress (2013, Principles of Biomedical Ethics,
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Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.(None): Commission 2013), which means it is outside the activity range of researchers.
p.(None): 2. A second highly influential stakeholder group consists of research funders. Without specific funding, most
p.(None): research is not possible. Whether research fund- ing is provided by industry, charitable foundations or state-funded
p.(None): research pro- grammes makes no significant difference. All funders are of particular importance in tackling ethics
p.(None): dumping, as they often set specific ethical rules that the researchers they fund must adhere to.
p.(None): 3. Researchers design research projects and work directly with participants and communities during
p.(None): implementation. It is normally they who are responsible for ethics dumping, whether deliberate or inadvertent.
p.(None): 4. Many studies involve human research participants who are directly affected by the research. As ethics dumping can
p.(None): also affect animals and the environment, groups working to defend them against unethical treatment could count as advo-
p.(None): cates – that is, persons who act on behalf of other entities. The same applies to nongovernmental organizations (NGOs)
p.(None): or think-tanks that promote the interests of those who cannot defend themselves against exploitation, or who struggle
p.(None): to do so. Hence, these groups are included in the list of stakeholders.
p.(None): 5. Negative impacts from unethical research conduct can extend beyond research participants and cause harm to
p.(None): community members. In genetic research, for instance, research results are likely to be relevant to close family
p.(None): members who were not involved in the study (Gallo et al. 2009). Similarly, a research partici- pant might divulge
p.(None): valuable traditional knowledge held by a community, which cannot be used ethically (or even, sometimes, legally) by the
p.(None): researcher unless s/he has also engaged the wider community (Wynberg et al. 2009).
p.(None): 6. The final group that can count as a major stakeholder in research consists of research ethics committees, which
p.(None): review and approve research proposals on behalf of funders or research institutions. This is especially important
p.(None): when tack- ling ethics dumping, as the role of research ethics committees is to safeguard the rights and welfare of
p.(None): those involved in research (Levine 2004: 2312).
p.(None): Figure 6.2 graphically depicts the main parties involved in research, and there- fore represents the research
p.(None): stakeholders in the fight against ethics dumping.
p.(None): There were budget-holding representatives from each of these research stake- holder groups in the TRUST project
p.(None): consortium (see Table 6.1). This meant that even before outward engagement to draft the GCC, a lot of information could
p.(None): be generated internally.
p.(None): As Table 6.1 shows, considerable expertise from different stakeholder perspec- tives was available internally. In
p.(None): addition, input was sought from external experts, who engaged through four channels, facilitated by six enablers, to
p.(None): participate in the development of a range of project outputs, one of which was the GCC. This approach is detailed in
...
p.(None): With the legal knowledge gained from negotiating benefit sharing agreements resulting from our traditional knowledge,
p.(None): the San have become acknowledged leaders in this field. (Chennells and Schroeder 2019)
p.(None):
p.(None):
p.(None):
p.(None): Leaders of Integrity
p.(None):
p.(None): It is perhaps a truism that collective progress is impossible without leaders of vision and integrity. When the San
p.(None): began their process of institutional development in 1996, they were fortunate to have a group of pioneering
p.(None): leaders who drove and sup- ported the vision to end the isolation of the past and to enter the
p.(None): organizational modern world. The San were blessed during this period with strong leaders, some of whom are still
p.(None): active, who had the wisdom to support change and the ability to engender consensus among sometimes differing opinions
p.(None): while retaining the confi- dence and trust of their people.
p.(None): One can be forgiven, however, for singling out the following leaders, who died prematurely while dedicated to the
p.(None): process of empowering their people: Kipi George (Khwe), /Xau Moses (Ju//Huansi), Augustino Victorino
p.(None): (!Xun), Robert Derenge (Khwe), Dawid Kruiper (!Khomani), Andries Steenkamp (!Khomani), and Mario Mahongo (!Xun).
p.(None): These leaders rose above their peers for many reasons, including the following, which are drawn from the many eulogies
p.(None): delivered upon their passing: they were strong and able to take difficult decisions, without losing an element of
p.(None): softness and humanity; each was regarded as honest and dedicated to his people, rather than to his immediate family and
p.(None): clan; they were respected both by their own communities and by outsiders for their intelligence, integrity and wisdom.
p.(None): These factors alone made them unique, and, like Nelson Mandela, they are constantly invoked as icons of leadership.
p.(None): The two San leaders who contributed most to the San Code of Research Ethics were Andries Steenkamp and Mario Mahongo.
p.(None): Two messages to researchers made by them have meanwhile achieved iconic status:
p.(None):
p.(None): Legal Support
p.(None): 79
p.(None):
p.(None): I don’t want researchers to see us as museums who cannot speak for themselves and who don’t expect something in return.
p.(None): As humans we need support. (TRUST Project Global Research Ethics 2018b)
p.(None): – Reverend Mario Mahongo (1952–2018)
p.(None):
p.(None): Your house must have a door so that nobody needs to come in through the window. You must come in via the door,
p.(None): that is to say via the San Council. (TRUST Project Global Research Ethics 2018a)
p.(None): – Andries Steenkamp (1960–2016)
p.(None): The last statement has even made it into the San Code of Research Ethics (see below), which notes:
p.(None): Andries Steenkamp, the respected San leader who contributed to this Code of Ethics until he passed away in 2016, asked
p.(None): researchers to come through the door, not the window. The door stands for the San processes. When researchers respect
p.(None): the door, the San can have research that is positive for us.
p.(None): The leaders who have succeeded Andries and Mario are focusing on many unre- solved questions, in particular:
...
Health / Physically Disabled
Searching for indicator illness:
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p.(None): to prevent the transmission of HIV to unborn babies, and the company operates in a country where poor mothers have no
p.(None): or very limited access to health care, it does not mean that exploitation will necessarily occur. The company may
p.(None): decide not to exploit vulnerable research participants and offer the accepted stan- dard of care to those in the
p.(None): control arm, rather than a placebo.
p.(None): Exploitation usually requires a moral decision on the part of the potential exploiter, but it can also occur
p.(None): through ignorance. Whether intended or unintended, the effects of exploitation are the same for the exploited. Hence,
p.(None): ignorance is not a legitimate justification for exploitation. Uncovering the primary risks of exploitation
p.(None):
p.(None): 2 A placebo-controlled trial involves some participants being given a medicine with active ingredi- ents, for instance
p.(None): a new drug against malaria, while others, the control group, are given a substance that should have no effect (the
p.(None): placebo), so that the outcomes can be compared.
p.(None): 3 One speaks of a proven standard of care when a treatment already exists for the illness under consideration in a
p.(None): trial. Hence, the ethical demand of testing any new drug against an existing one rather than a placebo is known as the
p.(None): “standard of care” debate.
p.(None):
p.(None): Our Method
p.(None): 39
p.(None):
p.(None): can help to increase awareness but, in our case, it also ensures that the GCC is designed in such a way
p.(None): that researchers are compelled to consider these factors. It is a unique facet of the GCC that it focuses the attention
p.(None): of researchers directly upon the primary risks of exploitation in collaborative HIC-LMIC research. This could only be
p.(None): achieved via thorough exploration of the risks from many perspectives, both top-down and bottom-up.
p.(None):
p.(None):
p.(None): Our Method
p.(None):
p.(None): The aim of this investigation was to identify the critical vulnerabilities that engender susceptibility to exploitation
p.(None): in LMIC-HIC collaborative research. Investigation of this vast subject would be impossible from a traditional
p.(None): literature-based approach, or through investigation in a single geographical region. Many of these vulnerabili- ties
p.(None): are poorly represented in the literature, and they can differ between countries, cultures and types of research. For
p.(None): example, clinical trials, social science, animal experiments, environmental science and research in emergency settings
p.(None): may pose a diverse array of risks that are largely determined by the local context. Consequently, a creative approach
p.(None): to data collection was needed to capture as many risks and vul- nerabilities as possible.
...
p.(None): Anderson EE, Solomon S, Heitman E, DuBois JM, Fisher CB, Kost RG, Ross LF (2012) Research ethics education for
p.(None): community-engaged research: a review and research agenda. Journal of Empirical Research on Human Research Ethics
p.(None): 7(2):322–319
p.(None): Bassler A, Brasier K, Fogel N, Taverno R (2008) Developing effective citizen engagement: a how- to guide for community
p.(None): leaders. Center for Rural Pennsylvania, Harrisburg PA. http://www.
p.(None): rural.palegislature.us/effective_citizen_engagement.pdf
p.(None): Bowman JS (2000) Towards a professional ethos: from regulatory to reflective codes. International Review of
p.(None): Administrative Sciences 66:673–687
p.(None): Cook WK (2008) Integrating research and action: a systematic review of community-based par- ticipatory research to
p.(None): address health disparities in environmental and occupational health in the United States. Journal of Epidemiology and
p.(None): Community Health 62(8):668–676. https://doi. org/10.1136/jech.2007.067645
p.(None): Cowan D, Halliday S (2003) The appeal of internal review: law, administrative justice and the (non-) emergence of
p.(None): disputes. Hart, Oxford
p.(None): Day G (2006) Community and everyday life. Routledge, London
p.(None): Dunn A (2011) Community engagement: under the microscope. Wellcome Trust, London Edwards C, Staniszweska S, Crichton N
p.(None): (2004) Investigation of the ways in which patients’ reports
p.(None): of their satisfaction with healthcare are constructed. Sociology of Health and Illness 26(2):159 Eriksson S, Höglund
p.(None): AT, Helgesson G (2008) Do ethical guidelines give guidance? A critical examination of eight ethics
p.(None): regulations. Cambridge Quarterly of Healthcare Ethics 17(1):15–29 Giorgini V, Mecca JT, Gibson C, Medeiros K, Mumford
p.(None): MD, Connelly S, Devenport LD (2015) Researcher perceptions of ethical guidelines and codes of conduct. Accountability
p.(None): in Research
p.(None): 22(3):123–138
p.(None): Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, Schulman KA (2009) Ethical and
p.(None): scientific implications of the globalization of clinical research. New England Journal of Medicine 360:816–823.
p.(None): https://doi.org/10.1056/NEJMsb0803929
p.(None): Hebert JR, Brandt HM, Armstead CA, Adams SA, Steck SE (2009) Interdisciplinary, translational, and community-based
p.(None): participatory research: finding a common language to improve can- cer research. Cancer Epidemiology, Biomarkers
p.(None): & Prevention 18(4):1213–1217. https://doi. org/10.1158/1055-9965.EPI-08-1166
p.(None): Henwood F, Wyatt S, Hart A, Smith, J (2003) Ignorance is bliss sometimes: constraints on the emergence of the
p.(None): “informed patient” in the changing landscapes of health information. Sociology of Health and Illness
p.(None): 25(6):589–607
p.(None): HPC (2009) Scoping report on existing research on complaints mechanisms. Health
p.(None): Professions Council. https://www.hcpc-uk.org/resources/reports/2009/
p.(None): scoping-report-on-existing-research-on-complaints-mechanisms/
p.(None): Jones L, Wells K (2007) Strategies for academic and clinician engagement in community- participatory
p.(None): partnered research. Journal of the American Medical Association 297(4):407–410 Lawton A (2004) Developing and
p.(None): implementing codes of ethics. Viešoji politika ir administravi-
p.(None): mas 7:94–101
p.(None): Martínez Cobo M (2014) Study on the problem of discrimination against indigenous populations. United Nations Department
p.(None): of Economic and Social Affairs. https://www.un.org/development/
p.(None): desa/indigenouspeoples/publications/2014/09/martinez-cobo-study/
p.(None): NIH (2011) Principles of community engagement. Washington, DC: CTSA Community Engagement Key
p.(None): Function Committee Task Force on the Principles of Community Engagement, National Institutes of Health.
p.(None): https://www.atsdr.cdc.gov/communityengagement/ pdf/PCE_Report_508_FINAL.pdf
p.(None):
p.(None): References
p.(None): 107
p.(None):
p.(None): Pleasence P, Buck A, Balmer N, O’Grady A, Genn H, Smith M (2006) Causes of action: civil law and social justice. The
p.(None): Stationery Office, Norwich
p.(None): Sack DA, Brooks V, Behan M, Cravioto A, Kennedy A, IJsselmuiden C, Sewankambo N (2009) Improving international research
p.(None): contracting. WHO Bulletin 87:487–488
...
Health / breastfeeding
Searching for indicator breastfeeding:
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p.(None): its ethical dimensions.
p.(None): The subsequent draft, which had been edited from both a legal and an ethical perspective, was then presented to the San
p.(None): leadership for adoption. Further minor changes were made, until the code was unanimously adopted and declared ready to
p.(None): be launched by the San leadership.
p.(None):
p.(None):
p.(None): The San Code of Research Ethics
p.(None): Respect
p.(None):
p.(None): We require respect, not only for individuals but also for the community.
p.(None): We require respect for our culture, which also includes our history. We have cer- tain sensitivities that are not known
p.(None): by others. Respect is shown when we can input into all research endeavours at all stages so that we can explain these
p.(None): sensitivities.
p.(None): Respect for our culture includes respect for our relationship with the environment.
p.(None): Respect for individuals requires the protection of our privacy at all times. Respect requires that our contribution to
p.(None): research is acknowledged at all times. Respect requires that promises made by researchers need to be met.
p.(None): Respectful researchers engage with us in advance of carrying out research. There should be no assumption that
p.(None): San will automatically approve of any research projects that are brought to us.
p.(None): We have encountered lack of respect in many instances in the past. In Genomics research, our leaders were avoided, and
p.(None): respect was not shown to them. Researchers took photographs of individuals in their homes, of breastfeeding
p.(None): mothers, or of underage children, whilst ignoring our social customs and norms. Bribes or other advantages were
p.(None): offered. Failure by researchers to meet their promises to provide feedback is an example of disrespect which is
p.(None): encountered frequently.
p.(None):
p.(None):
p.(None): Honesty
p.(None):
p.(None): We require honesty from all those who come to us with research proposals.
p.(None): We require an open and clear exchange between the researchers and our leaders. The language must be clear, not
p.(None): academic. Complex issues must be carefully and
p.(None):
p.(None): 84 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): correctly described, not simply assuming the San cannot understand. There must be a totally honest sharing of
p.(None): information.
p.(None): Open exchange should not patronise the San. Open exchanges implies that an assessment was made of possible harms or
p.(None): problems for the San resulting from the research and that these possible harms are honestly communicated.
p.(None): Prior informed consent can only be based on honesty in the communications, which needs to be carefully documented.
p.(None): Honesty also means absolute transparency in all aspects of the engagement, including the funding situation, the purpose
p.(None): of the research, and any changes that might occur during the process.
p.(None): Honesty requires an open and continuous mode of communication between the San and researchers.
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Health / stem cells
Searching for indicator stem cells:
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p.(None): • Indirect risks, such as stigmatization
p.(None):
p.(None): Researcher/ institutional
p.(None): • No host country research ethics structures or inappropriate match with requirements
p.(None): • No capacity in existing REC
p.(None): • REC members are poorly trained and lack specialized expertise to review ALL types of research protocols
p.(None): • REC meetings are either too few or too sporadic
p.(None): • REC does not have local or national government or ministry support to conduct its activities
p.(None): Community • Localized physical effects from research team presence Country • Insufficient data
p.(None): security measures
p.(None): • Insufficient safeguarding protocols
p.(None): • Lack of risk management approaches to biosafety
p.(None): • Lack of risk management approaches to biosecurity
p.(None): Animal • Animal research centres established in countries where regulation is less stringent
p.(None): • Lack of resources for humane animal care
p.(None): Environmental • Inadequate consideration of unintended consequences for biodiversity and the environment
p.(None): • Inadequate consideration of local environmental contexts
p.(None): • Disregard for long-term effects upon local environment
p.(None): • Lack of resources for environmental protection
p.(None): • Insufficient information for assessment of environmental effects
p.(None):
p.(None):
p.(None): 7 For example, applying genome editing technologies to human embryonic stem cells.
p.(None):
p.(None): 46 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): or in countries where although legal frameworks exist, their effective implementa- tion is prevented by limited
p.(None): resources.
p.(None): Most LMICs have processes in place for ethical approval of research, but they are hindered by resource issues. Even
p.(None): where research ethics committees are well established, they may have limited capacity and expertise. For effective
p.(None): governance, the wide-ranging and dynamic nature of research requires extensive and cutting- edge expertise from
p.(None): research ethics committees. This can be particularly difficult in resource-poor areas.
p.(None): Inadequate environmental information in LMICs means that research decisions and directions may be developed in a vacuum
p.(None): and result in long-term harm. For example, research programmes may introduce exotic species that deplete water
p.(None): resources, displace traditional varieties − thereby impacting upon agricultural bio- diversity or “escape” and become
p.(None): invasive, thus threatening biodiversity.
p.(None):
p.(None):
p.(None): Honesty
p.(None):
p.(None): In all cultures and nations, “do not lie” is a basic rule of ethical human interaction. However, the value of honesty
p.(None): has a broader scope in the context of global research ethics. Lying is only one possible contravention. In
...
Social / Access to Social Goods
Searching for indicator social goods:
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p.(None): Virtues can be regarded as embodied ethical values because they are manifested in persons. One can learn a lot by
p.(None): observing real people (such as Mother Theresa or Nelson Mandela) and following their example. This makes virtue
p.(None): approaches very useful in leadership and mentoring (Resnik 2012). But not every researcher has access to
p.(None): mentors and learning via example. Besides, early career researchers are said to benefit more from rule-based approaches
p.(None): (Resnik 2012). Hence, while vir- tues were considered as a possibility for the foundation of the GCC, they
p.(None): were excluded because of their strong reliance upon the availability of role models.
p.(None): Principles have a long-standing tradition in practical moral frameworks, espe- cially principlism, the moral
p.(None): framework relating to bioethics developed by Beauchamp and Childress (2013). As argued in Chapter 4, we
p.(None): believe that the four principles of Beauchamp and Childress – autonomy, non-maleficence (do no harm), beneficence and
p.(None): justice – should instead be called values. Principles, as we under- stand them, are more concrete than values.
p.(None): Principles can provide almost immediate and very straightforward answers to ethical questions.
p.(None): A famous principle in political philosophy is Rawls’s difference principle. The principle holds that divergence from an
p.(None): egalitarian distribution of social goods (e.g. income, wealth, power) is only allowed when this non-egalitarian
p.(None): distribution favours the least advantaged in society (Rawls 1999: 65–70). In other words, if a particularly talented
p.(None): wealth creator increases the overall wealth pie so that the least advantaged in society are better off, she can receive
p.(None): a bigger share of the pie than others. Knowing about this principle gives answers to social philosophy questions, which
p.(None): the value of fairness or justice would not. Rawls applied the value of fairness to derive the more concrete difference
p.(None): principle. Principles are therefore too con- crete and too prescriptive to form the foundation of the GCC. They would
p.(None): not leave enough room for local agreements between partners from high- and lower-income settings as envisaged by
p.(None): various GCC articles, such as article 1: “Local relevance of research … should be determined in collaboration with
p.(None): local partners.”
p.(None):
p.(None): 18 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Standards are even more specific than principles and have an even stronger action-guiding function. They
p.(None): prescribe very concrete activities in given settings. To formulate standards for ethical interaction between partners
p.(None): from different settings would certainly be too prescriptive. A standard cannot be diverged from (for exam- ple, a limit
p.(None): to vehicle emissions). For instance, if article 104 were a standard, no exception to double ethics review would be
...
Searching for indicator access:
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p.(None):
p.(None):
p.(None): More information about this series at http://www.springer.com/series/13811
p.(None):
p.(None): Doris Schroeder • Kate Chatfield Michelle Singh • Roger Chennells Peter Herissone-Kelly
p.(None):
p.(None):
p.(None):
p.(None): Equitable Research Partnerships
p.(None): A Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None):
p.(None):
p.(None): Foreword by Klaus Leisinger
p.(None):
p.(None): Doris Schroeder
p.(None): Centre for Professional Ethics University of Central Lancashire Preston, Lancashire, UK
p.(None):
p.(None): Michelle Singh Africa Office
p.(None): European & Developing Countries Clinical Trials Partnership
p.(None): Cape Town, South Africa
p.(None):
p.(None): Peter Herissone-Kelly
p.(None): School of Humanities and Social Sciences University of Central Lancashire
p.(None): Preston, Lancashire, UK
p.(None): Kate Chatfield
p.(None): Centre for Professional Ethics University of Central Lancashire Preston, Lancashire, UK
p.(None):
p.(None): Roger Chennells
p.(None): Chennells Albertyn Attorneys Stellenbosch, South Africa
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ISSN 2452-0519 ISSN 2452-0527 (electronic)
p.(None): SpringerBriefs in Research and Innovation Governance
p.(None): ISBN 978-3-030-15744-9 ISBN 978-3-030-15745-6 (eBook)
p.(None): https://doi.org/10.1007/978-3-030-15745-6
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019. This book is an open access
p.(None): publication.
p.(None): Open Access This book is licensed under the terms of the Creative Commons Attribution 4.0
p.(None): International License (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing,
p.(None): adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the
p.(None): original author(s) and the source, provide a link to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this book are included in the book’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the book’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None): The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not
p.(None): imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and
p.(None): regulations and therefore free for general use.
p.(None): The publisher, the authors, and the editors are safe to assume that the advice and information in this book are
p.(None): believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give
p.(None): a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may
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p.(None): affiliations.
p.(None):
p.(None): This Springer imprint is published by the registered company Springer Nature Switzerland AG. The registered company
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p.(None):
p.(None): Sugimoto CR, Robinson-Garcia N, Murray DS, Yegros-Yegros A, Costas R and Larivière V (2017) Scientists have most impact
p.(None): when they’re free to move. Nature 550(7674):29–31
p.(None): Tegli J (2018) Seeking retrospective approval for a study in resource-constrained Liberia. In: Schroeder D,
p.(None): Cook J, Hirsch F, Fenet S, Muthuswamy V (eds) Ethics dumping: case stud- ies from North-South research
p.(None): collaborations. Springer Briefs in Research and Innovation Governance, Berlin, p 115-119
p.(None): Tuhiwai Smith, Linda (1999) Decolonizing methodologies: research and indigenous Peoples. Zed Books, London and New York
p.(None): UN (ndb) The sustainable development agenda. Sustainable Development Goals. https://www.
p.(None): un.org/sustainabledevelopment/development-agenda/
p.(None): UN (nda) Goal 9. Sustainable Development Goals. https://www.un.org/sustainabledevelopment/
p.(None): infrastructure-industrialization/
p.(None): Zhao Y, Zhang W (2018) An international collaborative genetic research project conducted in China. In:
p.(None): Schroeder D, Cook J, Hirsch F, Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North-South research
p.(None): collaborations. Springer Briefs in Research and Innovation Governance, Berlin, p 71–80
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 2
p.(None): A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The Global Code of Conduct for Research in Resource-Poor Settings (GCC) is designed to counter
p.(None): ethics dumping, i.e. the practice of moving research from a high-income setting to a lower-income setting to circumvent
p.(None): ethical barriers. The GCC is reprinted here. It was completed in May 2018 and adopted by the European
p.(None): Commission as a mandatory reference document for Horizon 2020 in August 2018. For more information on the GCC,
p.(None): please visit: http://www.global- codeofconduct.org/
p.(None):
...
p.(None): https://doi.org/10.1007/978-3-030-15745-6_2
p.(None):
p.(None): 6 2 A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None): Those applying the Code oppose double standards in research and support long- term equitable research relationships
p.(None): between partners in lower-income and high- income settings based on fairness, respect, care and honesty.
p.(None):
p.(None):
p.(None): Fairness
p.(None): Article 1
p.(None):
p.(None): Local relevance of research is essential and should be determined in collaboration with local partners. Research that
p.(None): is not relevant in the location where it is under- taken imposes burdens without benefits.
p.(None):
p.(None):
p.(None): Article 2
p.(None):
p.(None): Local communities and research participants should be included throughout the research process, wherever
p.(None): possible, from planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly
p.(None): represented. This approach represents Good Participatory Practice.
p.(None):
p.(None):
p.(None): Article 3
p.(None):
p.(None): Feedback about the findings of the research must be given to local communities and research participants. It should be
p.(None): provided in a way that is meaningful, appropriate and readily comprehended.
p.(None):
p.(None):
p.(None): Article 4
p.(None):
p.(None): Local researchers should be included, wherever possible, throughout the research process, including in study design,
p.(None): study implementation, data ownership, intellec- tual property and authorship of publications.
p.(None):
p.(None): Respect
p.(None): 7
p.(None):
p.(None): Article 5
p.(None):
p.(None): Access by researchers to any biological or agricultural resources, human biological materials, traditional knowledge,
p.(None): cultural artefacts or non-renewable resources such as minerals should be subject to the free and prior informed consent
p.(None): of the owners or custodians. Formal agreements should govern the transfer of any material or knowledge to
p.(None): researchers, on terms that are co-developed with resource custodians or knowledge holders.
p.(None):
p.(None):
p.(None): Article 6
p.(None):
p.(None): Any research that uses biological materials and associated information such as tra- ditional knowledge or genetic
p.(None): sequence data should clarify to participants the poten- tial monetary and non-monetary benefits that might arise. A
p.(None): culturally appropriate plan to share benefits should be agreed to by all relevant stakeholders, and reviewed regularly
p.(None): as the research evolves. Researchers from high-income settings need to be aware of the power and resource differentials
p.(None): in benefit-sharing discussions, with sustained efforts to bring lower-capacity parties into the dialogue.
p.(None):
p.(None):
p.(None): Article 7
p.(None):
p.(None): It is essential to compensate local research support systems, for instance translators, interpreters or local
p.(None): coordinators, fairly for their contribution to research projects.
p.(None):
p.(None):
p.(None): Respect
p.(None): Article 8
p.(None):
p.(None): Potential cultural sensitivities should be explored in advance of research with local communities, research
...
p.(None):
p.(None): 8 2 A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None): Article 9
p.(None):
p.(None): Community assent should be obtained through recognized local structures, if required locally. While individual
p.(None): consent must not be compromised, assent from the community may be an ethical prerequisite and a sign of respect for the
p.(None): entire community. It is the responsibility of the researcher to find out local requirements.
p.(None):
p.(None):
p.(None): Article 10
p.(None):
p.(None): Local ethics review should be sought wherever possible. It is of vital importance that research projects are approved
p.(None): by a research ethics committee in the host coun- try, wherever this exists, even if ethics approval has already been
p.(None): obtained in the high-income setting.
p.(None):
p.(None):
p.(None): Article 11
p.(None):
p.(None): Researchers from high-income settings should show respect to host country research ethics committees.
p.(None):
p.(None):
p.(None): Care
p.(None): Article 12
p.(None):
p.(None): Informed consent procedures should be tailored to local requirements to achieve genuine understanding and well-founded
p.(None): decision-making.
p.(None):
p.(None):
p.(None): Article 13
p.(None):
p.(None): A clear procedure for feedback, complaints or allegations of misconduct must be offered that gives genuine and
p.(None): appropriate access to all research participants and local partners to express any concerns they may have with the
p.(None): research process. This procedure must be agreed with local partners at the outset of the research.
p.(None):
p.(None): Care
p.(None): 9
p.(None):
p.(None): Article 14
p.(None):
p.(None): Research that would be severely restricted or prohibited in a high-income setting should not be carried out in a
p.(None): lower-income setting. Exceptions might be permissi- ble in the context of specific local conditions (e.g. diseases not
p.(None): prevalent in high- income countries).
p.(None): If and when such exceptions are dealt with, the internationally acknowledged compliance commandment “comply or
p.(None): explain” must be used, i.e. exceptions agreed upon by the local stakeholders and researchers must be explicitly
p.(None): and trans- parently justified and made easily accessible to interested parties.
p.(None):
p.(None):
p.(None): Article 15
p.(None):
p.(None): Where research involvement could lead to stigmatization (e.g. research on sexually transmitted diseases), incrimination
p.(None): (e.g. sex work), discrimination or indetermi- nate personal risk (e.g. research on political beliefs), special measures
p.(None): to ensure the safety and wellbeing of research participants need to be agreed with local partners.
p.(None):
p.(None):
p.(None): Article 16
p.(None):
p.(None): Ahead of the research it should be determined whether local resources will be depleted to provide staff or
...
p.(None):
p.(None):
p.(None): Article 21
p.(None):
p.(None): Lower educational standards, illiteracy or language barriers can never be an excuse for hiding information or providing
p.(None): it incompletely. Information must always be presented honestly and as clearly as possible. Plain language and a
p.(None): non-patronising style in the appropriate local languages should be adopted in communication with research participants
p.(None): who may have difficulties comprehending the research process and requirements.
p.(None):
p.(None):
p.(None): Article 22
p.(None):
p.(None): Corruption and bribery of any kind cannot be accepted or supported by researchers from any countries.
p.(None):
p.(None): Honesty
p.(None): 11
p.(None):
p.(None): Article 23
p.(None):
p.(None): Lower local data protection standards or compliance procedures can never be an excuse to tolerate the potential for
p.(None): privacy breaches. Special attention must be paid to research participants who are at risk of stigmatization,
p.(None): discrimination or incrimi- nation through the research participation.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 3
p.(None): The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract Values inspire, motivate and engage people to discharge obligations or duties. This chapter defends the
p.(None): values approach in the context of guarding against ethics dumping, the practice of exporting unethical research from
p.(None): higher-income to lower-income settings. A number of essential questions will be answered: What are values? What is the
p.(None): meaning of the word “value”? Why does it make sense to choose values as an instrument to guide ethical action in
p.(None): preference to other possibilities? And what is meant by fairness, respect, care and honesty? It is concluded that
...
p.(None):
p.(None): What Can Guide Moral Action?
p.(None): 17
p.(None):
p.(None): So why were values chosen as the foundation for the GCC rather than standards, principles, virtues or ideals?
p.(None): Ideals are the most aspirational of the concepts available to guide ethical action. However, hardly anybody can live up
p.(None): to all of their ideals. If one phrased an ethics code around ideals, those who should be led by the code might suggest
p.(None): that not reaching the ideals on every occasion would be acceptable. This is not the case. The 23 articles of the GCC
p.(None): (chapter 2) are not aspirational. They are mandatory.
p.(None): Virtues are found both historically and internationally in many important docu- ments of learning and wisdom. Famously,
p.(None): Aristotle (384–322 BC) linked human “happiness and wellbeing” to “leading an ethical life”, guided by the cardinal
p.(None): values of courage, justice, modesty and wisdom (Aristotle 2004). According to Confucianism, the most
p.(None): important traditional virtues are said to be benevolence, righteousness, propriety, wisdom, trustworthiness, filial
p.(None): piety, loyalty and reciproc- ity (Wang et al. 2018). Virtues are a good way to drive ethical action, in particular
p.(None): global ethical action, but the TRUST team had good reason not to use virtues as the foundation of the GCC.
p.(None): Virtues can be regarded as embodied ethical values because they are manifested in persons. One can learn a lot by
p.(None): observing real people (such as Mother Theresa or Nelson Mandela) and following their example. This makes virtue
p.(None): approaches very useful in leadership and mentoring (Resnik 2012). But not every researcher has access to
p.(None): mentors and learning via example. Besides, early career researchers are said to benefit more from rule-based approaches
p.(None): (Resnik 2012). Hence, while vir- tues were considered as a possibility for the foundation of the GCC, they
p.(None): were excluded because of their strong reliance upon the availability of role models.
p.(None): Principles have a long-standing tradition in practical moral frameworks, espe- cially principlism, the moral
p.(None): framework relating to bioethics developed by Beauchamp and Childress (2013). As argued in Chapter 4, we
p.(None): believe that the four principles of Beauchamp and Childress – autonomy, non-maleficence (do no harm), beneficence and
p.(None): justice – should instead be called values. Principles, as we under- stand them, are more concrete than values.
p.(None): Principles can provide almost immediate and very straightforward answers to ethical questions.
p.(None): A famous principle in political philosophy is Rawls’s difference principle. The principle holds that divergence from an
p.(None): egalitarian distribution of social goods (e.g. income, wealth, power) is only allowed when this non-egalitarian
p.(None): distribution favours the least advantaged in society (Rawls 1999: 65–70). In other words, if a particularly talented
p.(None): wealth creator increases the overall wealth pie so that the least advantaged in society are better off, she can receive
...
p.(None):
p.(None): 5 Local communities and research participants should be included throughout the research process, wherever possible,
p.(None): from planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly represented.
p.(None): This approach represents Good Participatory Practice.
p.(None): 6 Local researchers should be included, wherever possible, throughout the research process, includ- ing in study
p.(None): design, study implementation, data ownership, intellectual property and authorship of publications.
p.(None):
p.(None): The Four Values
p.(None): 21
p.(None):
p.(None): Fairness in
p.(None): exchange
p.(None): • establishes the equity of transactions between at least two parties.
p.(None):
p.(None): Distributive fairness
p.(None): • deals with the division of existing, scarce resources among qualifying recipients.
p.(None):
p.(None): Corrective fairness
p.(None): • rights a wrong that one has brought upon another, often through a court.
p.(None):
p.(None): Retributive fairness
p.(None): Fig. 3.2 Types of fairness
p.(None): • establishes which punishment is appropriate for any given crime.
p.(None):
p.(None): These are questions about fairness in exchange. For instance, LMIC research participants contribute to the progress of
p.(None): science, but this is only fair if the research is relevant to their own community or if other benefits are received
p.(None): where this is not possible. For instance, to carry the burden of a clinical study is only worthwhile for a community if
p.(None): the disease under investigation occurs locally and the end product will become available locally.
p.(None): Corrective fairness, which presupposes the availability of legal instruments and access to mechanisms to right a wrong
p.(None): (e.g. a complaints procedure, a court, an eth- ics committee) is also important in global research collaborations. For
p.(None): instance, if no host country research ethics structure exists, corrective fairness is limited to the research ethics
p.(None): structure in the HIC, which may not have the capacity to make cul- turally sensitive decisions.
p.(None): The broader question of what HICs owe LMICs falls under distributive fairness. One can illustrate the difference
p.(None): between fairness in exchange and distributive fair- ness using the example of post-study access to successfully tested
p.(None): drugs. In the first case (fairness in exchange) one could argue that research participants have contrib- uted to the
p.(None): marketing of a particular drug and are therefore owed post-study access to it (should they need the drug to promote
p.(None): their health and wellbeing, and should they not otherwise have access to it). In the second case (distributive
p.(None): fairness) one could provide a range of arguments, for instance being a signatory to the Universal Declaration of Human
p.(None): Rights (UN 1948), to maintain that all human beings who need the drug should have access to it, and not just the
p.(None): research participants. These wider fairness issues cannot be resolved by researchers and are therefore not directly
p.(None): included in the GCC. Likewise, retributive fairness is less relevant as few ethics violations fall under the punitive
p.(None): and criminal law, and if they do, it is indeed crimi- nal law that should be used to deal with a fairness violation.
p.(None):
p.(None): 22 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Respect
p.(None):
p.(None): The term “respect” is used in many ethics frameworks. For instance, the Declaration of Helsinki (WMA 2013) notes in
p.(None): article 7:
p.(None): Medical research is subject to ethical standards that promote and ensure respect for all human subjects
p.(None): and protect their health and rights. (emphasis added)
p.(None): Its ubiquitous use does not, however, mean that “respect” is a clear term. In everyday life, it is used in
p.(None): the sense of deep admiration. For instance, somebody could say, “I respect the achievements of Nelson Mandela”.
p.(None): However, that is not what is meant by respect in research ethics. The statement from the Declaration of Helsinki does
p.(None): not mean that research participants must be admired. To be respected in research ethics is almost the opposite. It
p.(None): means that one must accept a decision or a way of approaching a matter, even if one disagrees strongly. A case in point
...
p.(None): of the Schwartz theory of basic values. Online Readings in
p.(None): Psychology and Culture 2(1):11
p.(None): Sousa CM, Coelho F (2011) From personal values to creativity: evidence from frontline service employees. European
p.(None): Journal of Marketing 45(7/8):1029–1050
p.(None): Threads Culture (nd) Core values examples. https://www.threadsculture.com/
p.(None): core-values-examples/
p.(None): UCLan (nd) The UCLan values. University of Central Lancashire. https://www.uclan.ac.uk/work/ life-at-uclan.php
p.(None): UN (1948) Universal Declaration of Human Rights. http://www.un.org/en/
p.(None): universal-declaration-human-rights/
p.(None): UN (1992) Convention on Biological Diversity. https://www.cbd.int/doc/legal/cbd-en.pdf
p.(None): Wang X, Li F, Sun Q (2018) Confucian ethics, moral foundations, and shareholder value perspec- tives: an exploratory
p.(None): study. Business Ethics: A European Review 27(3):260–271
p.(None): WMA (2013) Declaration of Helsinki. World Medical Association. https://www.wma.net/policies-
p.(None): post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human- subjects/
p.(None): Wolfe PS (1997) The influence of personal values on issues of sexuality and disability. Sexuality and disability
p.(None): 15(2):69–90
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 4
p.(None): Respect and a Global Code of Conduct?
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The Global Code of Conduct for Research in Resource-Poor Settings claims global applicability and
p.(None): promotes respect as one of its four values. Hence, the code anticipates potentially unresolvable differences
p.(None): between cultures, while maintaining it is globally valid. Examining, but discarding, several possibilities to deal
p.(None): with normative relativism, this chapter argues, with Beauchamp and Childress (2013, Principles of Biomedical Ethics,
p.(None): 7th edn. Oxford University Press, New York) that values can be internal to morality itself, allowing their global
p.(None): applicability.
p.(None):
...
p.(None): Sons, Chichester, p 105–116
p.(None): Foot P (2002) Moral dilemmas. Oxford University Press, Oxford
p.(None): Herissone-Kelly P (2003) The principlist approach to bioethics, and its stormy journey overseas. In: Häyry M, Takala
p.(None): T (eds) Scratching the surface of bioethics. Rodopi, Amsterdam and New York, p 65–77
p.(None): Huemer M (2005) Ethical intuitionism. Palgrave Macmillan, New York
p.(None): Huxtable R (2013) For and against the four principles of biomedical ethics. Clinical Ethics 8(2–3):39–43
p.(None): Kara M A (2007) Applicability of the principle of respect for autonomy: the perspective of Turkey.
p.(None): Journal of Medical Ethics 33(11):627–630
p.(None): Kiak Min MT (2017) Beyond a Western bioethics in Asia and its implication on autonomy. The New Bioethics 23(2):154–164
p.(None): Williams B (1972) Morality: an introduction to ethics. Cambridge University Press, Cambridge Wong D (1991) Relativism.
p.(None): In: Singer P (ed) A companion to ethics. Blackwell, Oxford, p 442–450 Wong D (2009) Natural moralities: a defense of
p.(None): pluralistic relativism. Oxford University Press,
p.(None): New York
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 5
p.(None): Exploitation Risks in Collaborative International Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract Ethics dumping occurs in collaborative international research when peo- ple, communities, animals and/or
p.(None): environments are exploited by researchers. Exploitation is made possible by serious poverty and extreme power
p.(None): differentials between researchers from high-income countries and research stakeholders from low- and middle-income
p.(None): countries (LMICs). To prevent its occurrence, the risks of exploitation have to be tackled. This chapter describes 88
p.(None): risks identified for col- laborative international research, categorized according to four values: fairness,
...
p.(None): literature, and hence there was an empirical component to our activities. Furthermore, this process was necessary to
p.(None): ensure that the GCC was more than a compilation of existing
p.(None):
p.(None):
p.(None):
p.(None): 1 The export of unethical research from a high-income setting to a resource-poor setting with weaker
p.(None): compliance structures or legal governance mechanisms.
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 37
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_5
p.(None):
p.(None): 38 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): codes, most of which had not been written with LMIC-HIC (high-income country) collaborations in mind.
p.(None):
p.(None):
p.(None): The Nature of Exploitation
p.(None):
p.(None): The potential to be exploited is part of the human condition. Exploiters take advan- tage of others’ vulnerabilities to
p.(None): promote their own interests (Hughes 2010). While there is a morally neutral sense of exploitation (the exploitation of
p.(None): natural talents to create art, for example), the term is generally used to describe a moral failing.
p.(None): Exploitation of people is very often unjust, unfair, harmful or just plain wrong. What is it, then, that
p.(None): distinguishes morally unacceptable exploitation from neutral exploitation?
p.(None): Some argue that exploitation is wrong because it is coercive (Schwartz 1995). If the only way for a woman in an LMIC to
p.(None): access antiretroviral drugs to prevent the transmission of HIV to her unborn baby is to participate in a
p.(None): placebo-controlled clinical trial,2 despite the existence of a proven standard of care,3 then one could say she has
p.(None): been coerced into enrolling (Annas and Grodin 1998). In this sense, exploi- tation occurs where one party takes
p.(None): advantage of another by making them an offer they cannot refuse; they are then coerced to accept simply because there
p.(None): is no alter- native. Others argue that exploitation is wrong because it treats human beings as means rather than ends
p.(None): (Wood 1995). In other words, exploitation instrumentalizes people. Yet others claim that exploitation is wrong
p.(None): because it disadvantages the vulnerable (Macklin 2003).
p.(None): Our investigation was concerned with the risks or vulnerabilities for exploitation, so we adopted Macklin’s definition
p.(None): of exploitation. However, it is important to bear in mind that situations that are conducive to exploitation do not
p.(None): necessarily lead to exploitation. For instance, if a pharmaceutical company is due to test new antiretro- viral drugs
p.(None): to prevent the transmission of HIV to unborn babies, and the company operates in a country where poor mothers have no
p.(None): or very limited access to health care, it does not mean that exploitation will necessarily occur. The company may
p.(None): decide not to exploit vulnerable research participants and offer the accepted stan- dard of care to those in the
p.(None): control arm, rather than a placebo.
p.(None): Exploitation usually requires a moral decision on the part of the potential exploiter, but it can also occur
p.(None): through ignorance. Whether intended or unintended, the effects of exploitation are the same for the exploited. Hence,
p.(None): ignorance is not a legitimate justification for exploitation. Uncovering the primary risks of exploitation
p.(None):
p.(None): 2 A placebo-controlled trial involves some participants being given a medicine with active ingredi- ents, for instance
p.(None): a new drug against malaria, while others, the control group, are given a substance that should have no effect (the
p.(None): placebo), so that the outcomes can be compared.
p.(None): 3 One speaks of a proven standard of care when a treatment already exists for the illness under consideration in a
p.(None): trial. Hence, the ethical demand of testing any new drug against an existing one rather than a placebo is known as the
p.(None): “standard of care” debate.
p.(None):
p.(None): Our Method
p.(None): 39
p.(None):
...
p.(None): of honesty would have been violated. To avoid overburdening the tables, we made a decision to prioritize one value in
p.(None): each case.
p.(None):
p.(None): 5 “Institutions” includes local researchers as well as their organizations.
p.(None):
p.(None): Our Findings
p.(None): 41
p.(None):
p.(None): Fairness
p.(None):
p.(None): Our data revealed many risks for exploitation that might be categorized as issues of fairness (or unfairness) that are
p.(None): varied in nature and pertain to different aspects of fairness. Philosophers commonly distinguish between different
p.(None): types of justice or fairness (Pogge 2006) (Chapter 3), but the most relevant fairness concepts for global research
p.(None): ethics are fairness in exchange and corrective fairness.
p.(None): Fairness in exchange concerns the equity of transactions that occur between par- ties. In collaborative research,
p.(None): ventures should aim to be mutually beneficial. Where the collaboration is between HIC and LMIC partners, typical
p.(None): fairness in exchange issues might include:
p.(None): The relevance of the research to local needs Whether reasonable benefit sharing is taking place
p.(None): Whether LMIC researchers are involved in meaningful ways
p.(None): Table 5.1 shows the primary risks related to fairness in exchange for persons, institutions, communities, countries and
p.(None): the environment.
p.(None):
p.(None): Table 5.1 Primary risks for fairness in exchange
p.(None): Level of risk Nature of risk
p.(None): Personal • In medical research:
p.(None): - Multiple trial enrolment
p.(None): - No post-study access to treatment
p.(None): • In all research:
p.(None): - Undue inducement
p.(None): - No access to results or benefits of research
p.(None):
p.(None): Researcher/ institutional
p.(None): • Research priorities driven by HIC partners:
p.(None): - Mismatch to local research needs
p.(None): • Poor representation of LMIC (host) partners on research teams:
p.(None): - Responsible for menial tasks only
p.(None): - Not acknowledged or represented appropriately in publications
p.(None): • “Helicopter research” by HIC partners:
p.(None): - No knowledge transfer or capacity building/strengthening
p.(None): Community • Research priorities driven by HIC partners:
p.(None): - Mismatch to local research needs
p.(None): • Little or no input from marginalized communities into research
p.(None): • Undue inducement
p.(None): • No benefit sharing or feedback
p.(None): • Support for foreign-sponsored research drains local system of staff Country • No universal access
p.(None): to health care for population:
p.(None): - Differences in standards of “usual” care
p.(None): • Placebo-controlled trials approved
p.(None): • Support for foreign-sponsored research drains local systems and resources
p.(None): • Medical science research shaped by the “para state”
p.(None): Animal
p.(None): Environmental • Study leads to reduction of natural resources
p.(None): • Lack of benefit sharing for the environment
p.(None):
p.(None): 42 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): A primary risk in the exploitation of individuals and communities is that they may not have access to the results or
p.(None): benefits of research. This occurs when the research is designed to benefit people in other countries or settings and
p.(None): the individu- als who contributed to the study never get a chance to benefit from it. This happened with a clinical
p.(None): study of the hepatitis B vaccine in Kenya. Although the research was undertaken in Kenya, for many years afterwards
p.(None): people in Kenya could not afford to purchase the vaccine and therefore could not benefit (Bhatt 2016). When research
p.(None): aims are driven by, and in the interests of, high-income researchers or institutions with no real benefit to the local
p.(None): community or participants, we must ask why it is being conducted there.
p.(None): Local LMIC researchers are exploited when used only for tasks such as data col- lection, or when, having participated
p.(None): in a research project, they are then not properly represented, or not represented at all, in subsequent publications.
p.(None): Local environ- ments are exploited when environmental studies fail to benefit them. Research agreements
p.(None): focused on the use of biodiversity and traditional knowledge typically ignore the environmental component, and the
p.(None): common approaches to benefit shar- ing from research activities include only humans (Stone 2010).
p.(None): Corrective fairness presupposes the availability of legal instruments and access to mechanisms for righting wrongs
p.(None): (e.g. a complaints procedure, a court or an ethics committee). For instance, if no research ethics structure exists in
p.(None): the host country, corrective fairness is limited to the research ethics structure in the HIC country, which may not
p.(None): have the capacity to make culturally sensitive decisions. Table 5.2
p.(None):
p.(None):
p.(None):
p.(None): Table 5.2 Primary risks for corrective fairness
p.(None): Level of risk Nature of risk
p.(None): Personal • Difficult or no access to legal system or legal aid
p.(None): • Human rights violations not taken up by civil society
p.(None):
p.(None): Researcher/ institutional
p.(None): • Lack of protection of IPR for LMIC institutions
p.(None): • Lack of clear standards for operating systems and timelines for RECs
p.(None): • No capacity/procedures for study oversight to ensure compliance with REC decisions
p.(None): Community • Lack of protection of IPR or traditional knowledge for local communities
p.(None): • Human rights violations not taken up by civil society
p.(None): • Absence of systems for community approvals Country • No relevant legal instruments for ethics committees
p.(None): • Poor research governance frameworks to ensure adherence to ethical standards
p.(None): • No cross-border legal recourse in cases of exploitation
p.(None): • Discriminatory laws that may create stigmatized minorities Animal • Variations in regulatory standards
p.(None): for animal experimentation
p.(None): • Inadequate systems to ensure compliance with animal welfare standards
p.(None): Environmental • Variations in governance of natural resources
p.(None): • Variations in procedural rights
p.(None): • Environmental protection not well policed by civil society
p.(None):
p.(None): Our Findings
p.(None): 43
p.(None):
p.(None): shows the primary risks related to corrective fairness for persons, institutions, com- munities, countries, animals and
p.(None): the environment.
...
p.(None): Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North- South research collaborations, Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 9-14
p.(None): Macklin R (2003) Vulnerability and protection. Bioethics 17(5–6):472–486
p.(None): Pogge T (2006) Justice. In: Borchert DM (ed) Encyclopedia of philosophy, 2nd edn, vol 4.
p.(None): Macmillan Reference, Detroit, pp 862–870
p.(None): Russell WMS, Burch RL, Hume CW (1959) The principles of humane experimental technique.
p.(None): Methuen & Co, London
p.(None): Schwartz J (1995) What’s wrong with exploitation? Nous 29:158–164
p.(None): Stone CD (2010) Should trees have standing? Law, morality, and the environment, 3rd edn. Oxford University Press,
p.(None): Oxford
p.(None): Smith, LT (2012) Decolonizing methodologies: research and indigenous peoples. Zed Books, London
p.(None): Universities UK (2015) The concordat to support research integrity. Universities UK, London Wood A (1995) Exploitation.
p.(None): Social Philosophy and Policy 12:150–151
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 6
p.(None): How the Global Code of Conduct Was Built
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract How can an ethics code achieve impact? The answer is twofold. First, through adoption by influential research
p.(None): funders, who then make it mandatory for their award recipients. This is the case with the Global Code of Conduct for
p.(None): Research in Resource-Poor Settings, which was adopted by both the European Commission and the European and Developing
p.(None): Countries Clinical Trials Partnership shortly after its launch in 2018. Second, an ethics code can achieve impact when
p.(None): researchers use it for guidance whether it is compulsory or not. This is most likely to happen with codes that were
...
p.(None): identified.
p.(None): • Personal invitations to the funder consultation meeting in London.
p.(None): • Personal, tailored follow-up communication after the meeting.
p.(None): Policymakers at the highest UN level have selected the pharmaceutical sector for special responsibilities towards
p.(None): LMICs, and therefore this sector was chosen for engagement activities with industry in TRUST. Both the Millennium
p.(None): Development Goals4 and the Sustainable Development Goals5 call on the pharmaceutical industry for special assistance to
p.(None): LMICs. In addition, the sector suffers from considerable mistrust among the general population with regard to
p.(None): international collaborative research and the potential exploitation of LMICs (Kessel 2014).
p.(None): TRUST’s Industry Platform was established in 2016 by Professor Leisinger in the same manner as the Funder Platform,
p.(None): with the following addition:
p.(None): • Webinars and personal meetings were organized through EFPIA, at which Professor Leisinger explained the
p.(None): ambitions of the TRUST project and the need for pharmaceutical companies to contribute.
p.(None): Through this extensive preparation, it was possible to introduce draft ideas for the GCC at a high-profile and
p.(None): well-attended consultation meeting in London in June 2017, and to engage delegates sufficiently to secure further
p.(None): input, nine months later, on the first semipublic draft of the GCC.
p.(None): Figure 6.4 gives an overview of the various project conferences and consultation meetings at which information was
p.(None): sought to counter ethics dumping.6
p.(None):
p.(None): 4 Goal 8, Target 4: “in cooperation with pharmaceutical companies, provide access to affordable essential drugs in
p.(None): developing countries” (United Nations ndb).
p.(None): 5 Goal 3, Target 3.8: “Achieve universal … access to safe, effective, quality and affordable essential medicines and
p.(None): vaccines for all” (United Nations nda).
p.(None): 6 The meetings had a range of other purposes, many of which are not relevant here and are therefore not included in
p.(None): this summary.
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 59
p.(None):
p.(None): 60 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Returning to the six research stakeholder groups identified earlier, the next sec- tion details how each group was
p.(None): reached through project conferences and consulta- tion meetings.
p.(None):
p.(None):
p.(None): External Engagement with Research Policymakers
p.(None):
p.(None): National research foundations, research councils and government ministries guide the strategic direction of research.
p.(None): Representatives from all of these groups attended the TRUST plenary in Cape Town in 2017, in particular senior
p.(None): representatives from the following national bodies:
p.(None): • The South African Department of Science and Technology
p.(None): • The South African Department of Environmental Affairs
p.(None): • The South African National Research Foundation
p.(None): • The Zimbabwean Agricultural Research Council
p.(None): To give an example of input, articles 17 and 48 of the GCC are directly linked to input from research
p.(None): policymakers. Dr Isaiah Mharapara from the Zimbabwean Agricultural Research Council argued that agricultural
p.(None): research in Africa had largely been based on foreign principles, meaning that the continent’s own crops, fruits,
p.(None): insects, fish and animals had been ignored. Through the historical introduc- tion of Western agricultural systems
...
p.(None):
p.(None):
p.(None): External Engagement with Researchers
p.(None):
p.(None): The consortium that drafted the GCC represented a wide range of academic disci- plines, namely ethics, medicine,
p.(None): economics, bioethics, law, social psychology, soci- ology, psychology, gender studies, chemistry, social sciences,
p.(None): psychiatry, biology, zoology, veterinary medicine, political science and management. The multidisci- plinary
p.(None): nature of the consortium’s expertise enabled broad engagement with the wider academic community. For example,
p.(None): academic presentations that included the GCC were delivered in Belgium, China, Congo, Cyprus, Germany, India, Kenya,
p.(None): Latvia, the Netherlands, the Philippines, Portugal, Rwanda, South Africa, Sweden, Taiwan, Uganda, Vatican City, the UK
p.(None): and the USA (Dammann and Schroeder 2018). The feedback from researchers was essentially threefold. First, researchers
p.(None): were interested in the potential “grey areas” of ethics dumping. A question in this context, asked on many occasions by
p.(None): different audiences, was: “If a particular research study has no real local relevance to LMICs, and the
p.(None): research money spent by well- intentioned researchers from HICs (who genuinely believe that they are improving the
p.(None): world) is in fact being wasted, does that count as ethics dumping?” A case in
p.(None):
p.(None):
p.(None): 9 A fourth good practice element that was emphasized at the funder and industry workshop was the provision of
p.(None): post-trial access to successfully marketed drugs. This requirement was not included in the GCC for two main reasons.
p.(None): First, the GCC was designed to be applicable to all disciplines, and hence articles with limited applicability were
p.(None): avoided. Second, post-trial access is clearly indicated in existing guidelines, in particular in the Declaration of
p.(None): Helsinki (WMA 2013). A good practice example of post-trial access was included in a TRUST special symposium on industry
p.(None): obligations towards LMICs (see Kelman et al. 2019).
p.(None):
p.(None): 62 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): point has been described by Van Niekerk and Wynberg (2018). Northern researchers were working on a genetically modified
p.(None): banana with a purportedly enhanced vita- min content, the ultimate aim being to alleviate nutritional deficiencies in
p.(None): Uganda. However, it turned out that existing local varieties provided a higher vitamin content than the envisaged GM
p.(None): variety. The question of whether that should count as ethics dumping goes back to a long-standing dilemma for ethics
p.(None): committees: Is bad sci- ence bad ethics? (Levine 2004) Wasteful research cannot be put into the same cat- egory as the
p.(None): wilful exploitation of lower regulatory standards to exploit research populations in LMICs for individual gain. But at
p.(None): the same time, with such a pressing need for innovative solutions to LMIC problems, the violation of article 1 of the
p.(None): GCC (local relevance of research) and the avoidable waste of limited funding resources must count as
p.(None): unethical.
p.(None): A second recurring response to the GCC from researchers has been that “every- one loved our values”.10 Audiences in
p.(None): HICs – England, for instance – even asked whether they could use the four values in national research in their own
p.(None): countries. Hence, rather than seeing the values as solely applicable when there are vast power differentials between
...
p.(None): and therefore to ethics dumping, was essential to our bottom-up approach. It is also the ethical approach, as
p.(None): stipulated in article 2 of the GCC:
p.(None): Local communities and research participants should be included throughout the research process, wherever possible, from
p.(None): planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly
p.(None): represented. This approach represents Good Participatory Practice.
p.(None): Two NGO partners in the TRUST project were tasked specifically with ensuring that the voices of vulnerable populations
p.(None): were heard and acted upon. First, the South African San Institute (SASI) made the inclusion of indigenous peoples from
p.(None): South Africa possible. While San leaders and representatives were involved in all the work of the TRUST project,
p.(None): including the drafting of the GCC, the full impact of their contribution is best understood through the account in
p.(None): Chapter 7 of this book of the development of the San Code of Research Ethics. Second, Partners for Health and
p.(None): Development in Africa (PHDA) made the inclusion of sex workers from the Majengo area of Nairobi possible. At this point
p.(None): we will focus on their involvement in order to illustrate the bottom-up approach of the GCC drafting process.
p.(None): PHDA is a nonprofit organization that undertakes work in the fields of health and development in Kenya. Its mission is
p.(None): to increase access to health for disadvantaged communities in Africa by strengthening health systems, research,
p.(None): programme devel- opment and partnerships. PHDA’s programmes are implemented by a collaborative group of scientists and
p.(None): public health professionals from the University of Manitoba (Canada), the University of Nairobi and the government of
p.(None): Kenya. Its work focuses mainly on HIV prevention, treatment and care, research, capacity-building and
p.(None): training.
p.(None): The Sex Workers Outreach Programme (SWOP) is a PHDA initiative that under- takes active community engagement and
p.(None): provides clinical and preventative services to 33,000 sex workers residing in Nairobi. These sex workers would
p.(None): otherwise find access to medical services in public health facilities extremely limited due to stigma and
p.(None): discrimination. Those enrolled in the sex workers cohort for HIV prevention services are free to volunteer for
p.(None): available research studies after providing informed consent. Most studies are on the epidemiology of sexually
p.(None): transmitted diseases, and on host genetic factors that influence infectivity and disease progression.
p.(None): Given that sex work is illegal in Kenya, we cannot assign input to specific, named individuals here. Suffice to say
p.(None): that the personal contributions of courageous and admirable sex workers, both female and male, provided the TRUST team
p.(None): not only with practical advice that took shape in specific articles of the GCC, but also with inspiration. Table 6.4
p.(None): presents two examples of issues raised by the Nairobi sex workers (Chatfield et al. 2016a) that were implemented in the
p.(None): GCC.
p.(None):
p.(None): 64 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.4 Input from sex workers and GCC connection
...
p.(None): shared their respective experi- ences, concerns and insights. Table 6.5 summarizes some of the issues raised
p.(None): (Chatfield et al. 2016b) and their relationship to the final GCC.
p.(None):
p.(None): 66 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.5 Input from research ethics committee chairs and GCC output
p.(None): Input Relevant GCC article
p.(None):
p.(None): Intellectual property rights are often held only in the North.
p.(None):
p.(None): Attempts at gaining ethics approvals can be extremely late.
p.(None): LMIC partners’ tasks are restricted to obtaining data.
p.(None):
p.(None): Why does biological material need to be shipped abroad?
p.(None): Article 4: Local researchers should be included, wherever possible, throughout the research process, including in study
p.(None): design, study implementation, data ownership, intellectual property and authorship of publications.
p.(None): Article 11: Researchers from high-income settings should show respect to host country research ethics committees.
p.(None):
p.(None): Article 4 (see above)
p.(None): Article 20: A clear understanding should be reached among collaborators with regard to their roles, responsibilities
p.(None): and conduct throughout the research cycle.
p.(None): Article 5: Access by researchers to any … human biological materials … should be subject to the free and prior informed
p.(None): consent of the owners or custodians. Formal agreements should govern the transfer of any material or knowledge to
p.(None): researchers, on terms that are co-developed with resource custodians or knowledge holders.
p.(None):
p.(None): Analysis of Existing Guidelines
p.(None):
p.(None): We have summarized above the extensive consultation activities of the TRUST project prior to the actual
p.(None): drafting of the GCC. Aside from these valuable contribu- tions, it was also vital that the GCC should not set out to
p.(None): “reinvent the wheel”. Given the vast number of existing guidelines, and the significant expertise that went into
p.(None): drafting them, it was important for us to link the GCC to those existing guide- lines so as to produce something
p.(None): that did not replicate earlier work, but rather complemented it.
p.(None): Research ethics committees have been in operation since the 1960s (Levine 2004). The earliest codes of
p.(None): research ethics are even older (Levine 2004). Yet the ethics dumping cases identified as part of the
p.(None): fact-finding mission for the GCC occurred mostly in the 2010s (Schroeder et al. 2018), more than 50 years after the
p.(None): first codes and committees became operational. There are many reasons why ethics dumping in research persists, one of
...
p.(None): Dunn A (2011) Community engagement: under the microscope. Wellcome Trust, London. https://
p.(None): wellcome.ac.uk/sites/default/files/wtvm054326_0.pdf
p.(None): European Commission (2013) Declarations of the Commission (framework programme) 2013/C 373/02. Official Journal of
p.(None): the European Union 20 December. http://ec.europa.eu/research/
p.(None): participants/data/ref/h2020/legal_basis/fp/h2020-eu-decl-fp_en.pdf
p.(None): Eurostat (2018) Intramural R&D expenditure (GERD) by source of funds. https://ec.europa.eu/
p.(None): eurostat/web/products-datasets/product?code=rd_e_gerdfund
p.(None): Gallo AM., Angst DB, Knafl KA (2009) Disclosure of genetic information within families. The American Journal of Nursing
p.(None): 109(4):65–69. http://www.ncbi.nlm.nih.gov/pubmed/19325321
p.(None): Hebert JR, Brandt HM, Armstead CA, Adams SA, Steck SE (2009) Interdisciplinary, translational, and community-based
p.(None): participatory research: finding a common language to improve can- cer research. Cancer Epidemiology, Biomarkers
p.(None): & Prevention 18(4):1213–1217. https://doi. org/10.1158/1055-9965.EPI-08-1166
p.(None): Horizon 2020 (nd) Evaluation of proposals. Research and Innovation, European Commission.
p.(None): http://ec.europa.eu/research/participants/docs/h2020-funding-guide/grants/
p.(None): from-evaluation-to-grant-signature/evaluation-of-proposals_en.htm
p.(None): Jack A (2012) Wellcome challenges science journals. Financial Times, 10 April. https://www.
p.(None): ft.com/content/81529c58-8330-11e1-ab78-00144feab49a
p.(None): Kelman A, Kang A, Crawford B (2019) Continued access to investigational medicinal products for clinical trial
p.(None): participants: an industry approach. Cambridge Quarterly of Healthcare Ethics 28(1):124–133.
p.(None): https://www.cambridge.org/core/product/identifier/S0963180118000464/ type/journal_article
p.(None): Kessel M (2014) Restoring the pharmaceutical industry’s reputation. Nature Biotechnology 32:983–990.
p.(None): https://doi.org/10.1038/nbt.3036
p.(None): Koshy K, Liu A, Whitehurst K, Gundogan B, Al Omran Y (2017) How to hold an effective meet- ing. International Journal
p.(None): of Surgery: Oncology 2(5):e22. Available at: http://www.ncbi.nlm. nih.gov/pubmed/29732455
p.(None): Levine R (2004) Research ethics committees. In: Post S (ed) Encyclopedia of bioethics, 3rd edn.
p.(None): Thomson & Gale, New York, p 2311–2316
p.(None): Montreal Statement (2013) Montreal statement on research integrity in cross-boundary research collaborations.
p.(None): http://ethics.iit.edu/codes/WCRI%202013.pdf
p.(None): Morton D, Chatfield K (2018) The use of non-human primates in research. In: Schroeder D, Cook J, Hirsch F, Fenet S,
p.(None): Muthuswamy V (eds) Ethics dumping: case studies from North-South research collaborations. Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 81–89
p.(None):
p.(None): 72 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Nordling L (2018) Europe’s biggest research fund cracks down on “ethics dumping”. Nature 559:17–18.
p.(None): https://www.nature.com/articles/d41586-018-05616-w
...
p.(None): TRUST (2018) Strong speech by Nairobi activist in European Parliament. http://trust-project.eu/
p.(None): strong-speech-by-nairobi-activist-in-european-parliament/
p.(None): United Nations (nda) Goal 3. Sustainable Development Goals. https://www.un.org/
p.(None): sustainabledevelopment/health/
p.(None): United Nations (ndb) Goal 8. Millennium Development Goals. http://www.un.org/millennium- goals/global.shtml
p.(None): Van Niekerk J, Wynberg R (2018) Human food trial of a transgenic fruit. In: Schroeder D, Cook J, Hirsch F, Fenet S,
p.(None): Muthuswamy V (eds) Ethics dumping: case studies from North-South research collaborations. Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 91–98
p.(None): Van Niekerk J, Wynberg R, Chatfield K (2017). Cape Town plenary meeting report. TRUST Project.
p.(None): http://trust-project.eu/wp-content/uploads/2017/08/TRUST-Kalk-Bay-2017-Report- Final.pdf
p.(None): WMA (2013) Declaration of Helsinki. World Medical Association. https://www.wma.net/policies-
p.(None): post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human- subjects/
p.(None): Wynberg R, Schroeder D, Chennells R (2009) Indigenous peoples, consent and benefit sharing: lessons from the San-Hoodia
p.(None): case. Springer, Berlin
p.(None): Youdelis M (2016) “They could take you out for coffee and call it consultation!” The colonial antipolitics of
p.(None): indigenous consultation in Jasper National Park. Environment and Planning A: Economy and Space 48(7):1374–1392
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 7
p.(None): The San Code of Research Ethics
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The San peoples of southern Africa have been the object of much aca- demic research over centuries. In recent
p.(None): years, San leaders have become increas- ingly convinced that most academic research on their communities has been
p.(None): neither requested, nor useful, nor protected in any meaningful way. In many cases dissatis- faction, if not actual
p.(None): harm, has been the result. In 2017, the South African San finally published the San Code of Research Ethics,
p.(None): which requires all researchers intending to engage with San communities to commit to four central values, namely
...
p.(None): San peoples. The Khoi or KhoiKhoi, formerly known in South Africa as Hottentots, are regarded as pastoral, and of more
p.(None): recent origin (Barnard 1992).
p.(None):
p.(None): 76 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): WIMSA: The Catalyst Institution
p.(None):
p.(None): WIMSA (the Working Group of Indigenous Minorities in Southern Africa) has arguably been the most important of
p.(None): a number of San support organizations operat- ing in southern Africa over the past 25 years. Reverend Mario Mahongo,
p.(None): one of the San leaders whose work on the San Code of Research Ethics was crucial, noted of a 1996 workshop: “For the
p.(None): first time we were meeting San leaders from the whole region, and we realised that this new organisation WIMSA could
p.(None): really help our people” (Chennells and Schroeder 2019).
p.(None): Table 7.1 lists the main non-governmental organizations (NGOs) that have pro- vided services to the San in South
p.(None): Africa, Botswana and Namibia.
p.(None): Supported through seed funding from Swedish and Dutch charities, German development worker Axel Thoma and
p.(None): San leaders such as Kipi George and Augustino Victorino promoted the formation of a cross-border, regional
p.(None): organiza- tion to protect the rights of all San peoples in southern Africa. The topics that emerged as
p.(None): clear priorities among San communities were:
p.(None): • Access to land
p.(None): • Benefit sharing for traditional knowledge
p.(None): • Protection of heritage and culture4
p.(None): WIMSA functioned effectively as a regional organization from its inception in 1996 until approximately 2016. The
p.(None): successes of this important San organization in raising awareness and promoting advocacy among the San cannot be
p.(None): overstated.
p.(None):
p.(None): Table 7.1 San support organizations
p.(None): Start year Organization name Organization region 1981
p.(None): Nyae Nyae Development Foundation Tsumkwe, Namibia 1988 Kuru Development Trust
p.(None): Ghanzi, Botswana
p.(None): 1991 First People of the Kalahari Ghanzi, Botswana 1992
p.(None): First Regional San Conference Windhoek, Namibia
p.(None):
p.(None): 1995 Final Regional San Conference (pre-WIMSA)
p.(None): D’Kar, Botswana
p.(None): 1996 WIMSA Windhoek, Namibia 1996
p.(None): South African San Institute (SASI) Kimberley, South Africa
p.(None):
p.(None): 1999 !Khwa ttu San Culture and Education Centre
p.(None): Darling, South Africa.
p.(None): 2001` South African San Council Upington, South Africa
p.(None): 2006 Namibia San Council Windhoek, Namibia
p.(None): 2007 Khwedom Council Gaborone, Botswana.
p.(None):
p.(None):
...
p.(None): Hitchcock RK, Ikeya K, Biesele M, Lee RB (2006) Introduction. In: Hitchcock RK, Ikeya K, Biesele M, Lee
p.(None): RB (eds) Updating the San: image and reality of an African people in the 21st century. Senri Technological Studies 70.
p.(None): National Museum of Ethnology, Osaka, p 4
p.(None): Knight A, Underhill PA, Mortensen HM, Zhivotovsky, LA, Lin AA, Henn BM, Louis D, Ruhlen M, Mountain JL (2003). African
p.(None): Y chromosome and mtDNA divergence provides insight into the history of click languages. Current Biology 13(6):464–473
p.(None): Penn N (2013) The British and the ‘Bushmen’: the massacre of the Cape San, 1795 to 1828. Journal of
p.(None): Genocide Research 15(2):183–200 https://doi.org/10.1080/14623528.2013.793081 TRUST Project Global Research Ethics.
p.(None): (2018a) Andries Steenkamp and Petrus Vaalbooi inter-
p.(None): views – TRUST Project. https://www.youtube.com/watch?v=A4_Mvdwl_Gc
p.(None): TRUST Project Global Research Ethics. (2018b) Reverend Mario Mahongo – TRUST Project.
p.(None): https://www.youtube.com/watch?v=jMhCUNw9eAo
p.(None): Soodyall H (2006) A prehistory of Africa. Jonathan Ball Publishers, Jeppetown, South Africa Ury W (1995) Conflict
p.(None): resolution amongst the Bushmen: lessons in dispute systems design.
p.(None): Harvard Negotiation Journal 11(4): 379–389
p.(None): Wynberg R. Schroeder D, Chennells R (2009) Indigenous peoples, consent and benefit sharing: lessons from the San-Hoodia
p.(None): Case. Berlin, Springer
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 8
p.(None): Good Practice to Counter Ethics Dumping
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract An ethics code is not enough to avoid ethics dumping. Ethics codes can inspire, guide and raise awareness of
p.(None): ethical issues, but they cannot, on their own, guarantee ethical outcomes; this requires a multifaceted approach. For
p.(None): research in resource-poor settings, engagement is crucial. Such engagement has been built into the Global Code of
p.(None): Conduct for Research in Resource-Poor Settings as a require- ment, but how can it be put into practice? An
p.(None): approach for ethical community engagement is presented in this chapter, which also includes suggestions
p.(None): for an accessible complaints mechanism. At the institutional level, we tackle the question of concluding fair
p.(None): research contracts when access to legal advice is limited. Throughout, at a broader level, we show how the four
p.(None): values of fairness, respect, care and honesty can be used to help guide decision-making and the practical appli- cation
p.(None): of the code.
p.(None):
p.(None): Keywords Community engagement · Complaints procedure · Research contracts · Values compass
p.(None):
p.(None):
p.(None): Introduction
p.(None):
p.(None): The Global Code of Conduct for Research in Resource-Poor Settings (GCC) is not enough to prevent ethics dumping1.
p.(None): While codes are necessary, they are not suffi- cient in themselves to ensure good governance (Webley and Werner
p.(None): 2008). For codes to be effective, researchers must know how to use them appropriately (Giorgini et al.
p.(None): 2015), and codes can be totally ineffective when badly implemented (Bowman 2000). The use of codes, especially new
p.(None): ones, invariably raises challenges of interpretation and implementation.
p.(None): The way that the GCC has been developed helps to minimize potential chal- lenges. For instance,
p.(None): implementation problems are lessened when the needs, values
p.(None):
p.(None):
p.(None): 1 The export of unethical research from a high-income setting to a resource-poor setting with weaker
p.(None): compliance structures or legal governance mechanisms.
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 89
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_8
p.(None):
...
p.(None):
p.(None): Is permission from community elders/leaders or representatives needed for this consultation?
p.(None): How are the research team familiarizing themselves with local culture – including organizational structures, history,
p.(None): traditions, relationship with the environment and sensitivities?
p.(None): the study and the study team upon the participants, their families, the local community and the environment?
p.(None):
p.(None): Designing the Study
p.(None):
p.(None): The community, as well as local researchers, need to be included in the research design process, both effectively and
p.(None): transparently. Table 8.2 sets out some of the many factors to consider.
p.(None): It is imperative that researchers consider the practical implications for the per- sons, communities and environments
p.(None): involved, as well as the scientific integrity of the research design.
p.(None):
p.(None):
p.(None): Implementing the Study
p.(None):
p.(None): Ethical research is conducted with communities rather than about communities. To ensure that this is how it actually
p.(None): happens, effective engagement is vital throughout the implementation of the project. Table 8.3 suggests questions to
p.(None): consider during the implementation phase.
p.(None):
p.(None): Ethical Engagement with Communities
p.(None): 95
p.(None): Table 8.2 Questions for reflection when designing a study
p.(None): Fairness Honesty
p.(None):
p.(None): How are the community involved in the planning and design of the study?
p.(None): Are the potential benefits and harms for the participants and the community being discussed fully?
p.(None): Have the most relevant types of benefits for the participants and communities been discussed and agreed?
p.(None): In health research, has post-study access to successfully tested treatments or interventions been agreed?
p.(None): Where relevant, have means for recognizing and protecting traditional knowledge been agreed?
p.(None): How is full transparency in all aspects of the engagement and planning being ensured?
p.(None): Are procedures for open, two-way communication in place?
p.(None): Have all details that might impact upon individuals or the community been disclosed?
p.(None): Have requirements for an accessible and user-friendly complaints mechanism been discussed and agreed? What promises are
p.(None): being made to the local community
p.(None): in the design of the study and are they likely to be
p.(None): fulfilled?
p.(None): Respect Care
p.(None):
p.(None): Are the research team complying with local/community ethics codes?
p.(None): How is community knowledge being
p.(None): How are local needs being taken into account in the design of the study?
p.(None): Is due attention being paid to the impact of the study
p.(None): respected and integrated into the design? and the study team upon the participants, their
p.(None): families, the local community and the environment?
p.(None):
p.(None): Are the relevant members of the community, as identified by the community itself, involved in the design?
p.(None): How is community culture and tradition being respected in the design of the study?
p.(None): Have the relevant persons in the community given permission/approval for the study design?
p.(None): What measures have been taken to ensure understanding (such as translators and the use of clear, non-technical
p.(None): language)
p.(None):
p.(None): Have the resource implications of this design for the local community been identified?
p.(None):
...
p.(None): understood by participants and the community?
p.(None): Are researchers paying due attention to the impact of the study and the study team upon the participants, their
p.(None): families, the local community and the environment?
p.(None): Is the community being properly resourced for participation?
p.(None):
p.(None):
p.(None): The Results Phase
p.(None):
p.(None): During this phase, results are analysed and disseminated through publications as well as being fed back to the
p.(None): community. Table 8.4 formulates some helpful ques- tions to ask during the results phase.
p.(None): Findings can be enriched when members of the community have been consulted and engaged during the analysis process and
p.(None): the interpretation of results. For some studies, sharing results with the research participants or the community can
p.(None): eluci- date aspects that were previously obscure to the researchers (for example, an under- standing of why or how
p.(None): something happens).
p.(None):
p.(None):
p.(None): Evaluating the Study
p.(None):
p.(None): Though the publication of research results and feedback to the community repre- sent, in a sense, the end of the
p.(None): research cycle, the process of further research involv- ing the same or other communities can be greatly helped by an
p.(None): evaluation of the
p.(None):
p.(None): Developing an Accessible Complaints Procedure
p.(None): 97
p.(None): Table 8.4 Questions for reflection during analysis of results
p.(None): Fairness Honesty
p.(None):
p.(None): How are members of the local community involved in analysis and interpretation of the results?
p.(None): What measures are in place to ensure access to findings that might be beneficial to the community?
p.(None): Are appropriate steps being taken to recognize and protect traditional knowledge contributions?
p.(None): Have promises that were made about access to the results been fulfilled?
p.(None): Have all findings been disclosed in an honest manner?
p.(None): Respect Care
p.(None):
p.(None): Have the community been given an opportunity to review the results and implications of the study prior to publication?
p.(None): Have the community’s knowledge and contribution been fully acknowledged in the results?
p.(None): Have community culture and tradition been taken into consideration in the interpretation of the results?
p.(None): Have rights to privacy, anonymity and confidentiality in reporting been respected?
p.(None): What measures are in place to ensure that the findings and implications of the study are accessible to and fully
p.(None): understood by participants and the community?
p.(None):
p.(None): study and, in particular in the context of this report, of the community involvement elements. Table 8.5 lists
p.(None): important questions for the evaluation phase.
p.(None): When researchers apply the values of fairness, respect, care and honesty over the course of a research project, this
p.(None): creates a relationship of trust with the community. Our main advice for ethical community engagement is to build
p.(None): long-term, mutually beneficial relationships based on the four values, applied before, during and after research
p.(None): studies.
p.(None): In addition, for a relationship of trust to develop between researchers and local communities, it is important to have
p.(None): a well-functioning complaints procedure
p.(None):
p.(None):
p.(None): Developing an Accessible Complaints Procedure
p.(None):
p.(None): The routine use of accessible complaints procedures in research forms part of the overarching strategy for reducing
p.(None): ethics dumping, because such procedures can help to ensure that experience and practice correspond with
p.(None): expectations. An effec- tive complaints procedure can give voice to those who participate in research, offer- ing a
p.(None): channel for raising concerns that might otherwise remain unheard, both during and after a study. Complaints
p.(None): procedures can contribute to the safeguarding of
p.(None):
p.(None): 98 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): Table 8.5 Questions for reflection during the evaluation of a study
p.(None): Fairness Honesty
p.(None):
p.(None): Have the agreed benefits for participation been realized?
p.(None): In health research, is the agreed
p.(None): post-study access to successfully tested treatments or interventions being made available?
p.(None): How have the community been involved in the evaluation of the research findings?
p.(None): How have the community been involved in the evaluation of the research process?
p.(None): Do the community believe that they have benefited from the research?
p.(None): Have all promises to the community been fulfilled? How have complaints been managed? Are there lessons to be learned
p.(None): and shared?
p.(None): Have implications that might impact upon individuals or the community, including potential harms and benefits, been
p.(None): disclosed?
p.(None): Respect Care
p.(None):
p.(None): Are there mechanisms in place to feedback news about broader impacts of the research?
p.(None): Has the contribution of members of the
p.(None): Do the community believe that researchers paid due attention to the impact of the study and the study team upon the
p.(None): participants, their families, the local community and the environment?
p.(None): local community been fully credited? Was the resulting project of high quality and
p.(None):
p.(None): Have the community’s knowledge and its value to the research been fully credited?
p.(None): Do the community believe that local culture and tradition have been respected?
p.(None): worthwhile so that the efforts of the community were not wasted?
p.(None):
p.(None): participants7 so that it endures beyond the ethical approval process; they offer a mechanism for
p.(None): correcting mistakes and for protecting people, animals and the envi- ronment from abuse and mistreatment.
p.(None): Significantly, complaints mechanisms offer a means of revealing lapses and failures in ethical conduct, thereby
...
p.(None): accessibility of information and the perceived “serious- ness” of the problem (Pleasence et al. 2006).
p.(None): Specifically, ethnic minority communities are less likely to use systems that they perceive as being culturally
p.(None): insensitive and are more fearful of the consequences of taking action when they feel those systems have failed them.
p.(None): Difficulties with access to information are highlighted as a barrier to making a complaint (Henwood et al. 2003),
p.(None): especially where there is “information illiteracy”; some people possess the relevant skills and confidence to seek out
p.(None): information, but many do not. In situations where levels of education and literacy are not high, this is likely to be
p.(None): exacerbated.
p.(None): The relationship between the person who brings the complaint and the bureau- cracies to which they must direct
p.(None): their complaint can be a factor (Cowan and Halliday 2003). This relationship can either encourage or
p.(None): discourage a potential complainant’s trust in complaints mechanisms. The power imbalance between par- ties in such
p.(None): relationships can be substantial. For example, when working with impoverished communities, HIC researchers
p.(None): should be aware that participation in a clinical study may provide a participant’s only access to health care or other
p.(None): much- needed benefits. Fear of retribution is often cited as a barrier to making a complaint, particularly in
p.(None): circumstances where the complainant has an ongoing relationship with the complainee (HPC 2009). In situations where
p.(None): there is a power imbalance, people may not have the confidence to complain; they may be reluctant to seem ungrateful,
p.(None): not wish to be seen as a complainer, or fear loss. Research has shown that some people even reconstruct negative
p.(None): experiences in a positive light in order to maintain relationships (Edwards et al. 2004).
p.(None): In addition to the above, participatory engagement activities in the TRUST proj- ect (Chapter 6) have revealed the
p.(None): following factors that could also act as barriers to research participants making complaints about research activities
p.(None): in LMICs:
p.(None): • Fear of damage or stigmatization from loss of confidentiality or anonymity. In Kenya, for example, where sex work
p.(None): is illegal, sex workers may be reluctant to make any formal complaints.
p.(None): • Cultural norms that preclude complaining. In some cultures, it is not acceptable to make complaints, especially
p.(None): to or about visitors and/or those in authority. Complaining may be perceived as disrespectful, ungrateful or
p.(None): inappropriate.
p.(None): • Illiteracy of research participants and communication (language) difficulties, leading to a lack of
p.(None): understanding of reasonable rights relating to informed con- sent and to reasonable expectations of the research.
p.(None):
p.(None): Developing an Accessible Complaints Procedure 101
p.(None):
p.(None): • Inability to access the means by which to file a complaint: for example, if only an email address is provided as a
p.(None): contact and one has no access to computers or internet connections.
p.(None):
p.(None):
p.(None): The Scope of a Complaints Procedure
p.(None):
p.(None): A comprehensive complaints procedure can have a broad scope; it can be used to complain about any activities that are
p.(None): associated with a research study. These may include, for example:
p.(None): • any perceived deviation from the information provided
p.(None): • any deviation from agreed processes
p.(None): • treatment by members of the research team that is considered inappropriate
p.(None): • problems with the organization of the study (for example, the competence of the researchers and their ability to
p.(None): perform duties)
p.(None): • the (mis)handling of personal or sensitive information
p.(None): • concerns about any unethical behaviour or practices by the research team
p.(None): The scope of a complaints procedure will also depend upon the intended users. Many complaints procedures are intended
p.(None): for use purely by participants in a research study. However, in collaborative ventures in LMICs, there may be a wide
p.(None): range of potential users, because HIC-LMIC collaborative research is especially prone to ethics dumping, with
p.(None): the potential for damage to entire communities.
p.(None): Table 8.6 gives examples of the potential range of users of complaints procedures for different types of research
p.(None): studies.
p.(None): While a complaints procedure can have broad scope, it is vital that there be clar- ity about its purpose and who can
p.(None): use it, as well as about what can and cannot be dealt with through this mechanism. A lack of common understanding of
p.(None): any proce- dure’s purpose can be a source of great dissatisfaction and cause wider distrust in the process.
p.(None):
p.(None):
...
p.(None): than an ineffective bureaucratic exercise. While more formal approaches and struc- tures may work in “Western”
p.(None): settings, these are unlikely to be effective in the kinds of vulnerable communities where care is needed to safeguard
p.(None): and empower; they may even have the opposite effect, and discourage any engagement at all on com- plaints issues.
p.(None): Equally, the challenges in establishing an effective strategy should not act as an excuse for researchers to adopt an
p.(None): oversimplified model (such as a contact name on the information sheet) that is of little or no benefit to anyone. For
p.(None): each unique situ- ation, researchers should work with communities to cocreate effective strategies that take
p.(None): into account the circumstances, situation and culture of that community and the individuals to be recruited to the
p.(None): study.
p.(None): While it is not possible for us to specify a single “model” complaints procedure, we have shown how the values can
p.(None): provide the basis of any complaints procedure. With these values embedded in the thinking of the research community,
p.(None): they can then seek to work with whatever procedures and structures are available, adapting, improving and tailoring
p.(None): them for application in the real world. The individuals and groups involved should feel respected, cared for, fully
p.(None): informed, treated fairly and empowered.
p.(None): Most protective mechanisms, including complaints procedures, are strengthened when supported by legal systems, but
p.(None): participants, communities, researchers and institutions in LMICs often have no or very limited access to legal advice
p.(None): or protec- tion. The next section introduces an online toolkit that will be helpful in such situations.
p.(None):
p.(None):
p.(None): A Fair Research Contracting Tool
p.(None):
p.(None): The need for fair research contracts is best illustrated by the situation in interna- tional collaborative health
p.(None): research. Research undertaken in LMICs can lead to sig- nificant benefits flowing into HICs. In 2009, Glickman et al.
p.(None): undertook a systematic review to examine what had led to a “dramatic shift in the location of clinical trials” and
p.(None): concluded that important factors were:
p.(None): • shortened timelines for clinical testing due to a larger pool of research participants
p.(None):
p.(None): 8 These might include internal resolution through study-specific schemes; internal resolution through research
p.(None): ethics committees; litigation through the courts; or alternative dispute resolution mechanisms such as mediation,
p.(None): adjudication and arbitration.
p.(None):
p.(None): 104 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): • lower regulatory barriers for research in LMICs
p.(None): • international harmonization of intellectual property rights protection
p.(None): To take full advantage of the benefits of conducting medical research in LMICs, research institutions in HICs have
p.(None): invested substantially in building legal and con- tracting expertise for the benefit of their own institutions and
...
p.(None): aimed to identify best practices for the research contracting process that would be useful in the following three
p.(None): scenarios:
p.(None): • where there is no lawyer
p.(None): • where there may be lay personnel who could be trained
p.(None): • where there is a lawyer or legal expertise
p.(None): A basic framework was subsequently developed by COHRED and partners to assist LMIC collaborators in making
p.(None): contractual demands on HIC collaborators without requiring large legal teams of their own. This focused on the fair
p.(None): distribu- tion of post-research benefits, intellectual property rights, data and data ownerships, specimen ownership
p.(None): and usage, technology transfer and institutional capacity build- ing as key outcomes of the FRC process. Between 2015
p.(None): and 2018, and as part of the TRUST project, the existing FRC framework was enhanced and expanded to pro- vide an online
p.(None): toolkit relevant for all types of research.
p.(None): The FRC online toolkit9 now provides information, tips and case studies in six key areas:
p.(None): • Negotiation strategies: for understanding the various aspects of negotiations, whether a research partner
p.(None): is at a basic starting point or an advanced level in the development of contract negotiations
p.(None): • Research contracting: for a basic understanding of contracts and contracting so that a research partner can better
p.(None): manage responsibilities, opportunities and risks that impact the research partnership
p.(None): • Research data: providing the essential principles concerning rights and responsi- bilities, including
p.(None): accountability and access to data in collaborative research
p.(None): • Intellectual property: providing an introduction to some of the key general prin- ciples that require
p.(None): consideration before participation in collaborative research agreements
p.(None): • Research costing: providing research partners with a basic understanding of cost considerations when developing a
p.(None): full cost research budget proposal
p.(None):
p.(None):
p.(None):
p.(None): 9 The entire online toolkit is available at http://frcweb.cohred.org/
p.(None):
p.(None): Conclusion
p.(None): 105
p.(None):
p.(None): • Technology transfer and capacity: concerning the flow of knowledge, experience and materials from one partner to
p.(None): another, and the ability of people and organiza- tions to manage their affairs and reach objectives successfully.
p.(None): The development of this resource means that vulnerable groups, such as com- munities or researchers without legal
p.(None): support, have access to resources that can help develop a good understanding of research contracting for equitable
p.(None): research part- nerships and avoid exploitation in research.
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): According to Eriksson et al. (2008), a serious flaw in most new ethics guidelines is that they are produced with the
p.(None): pretension that there are no other guidelines in exis- tence, and it would be much better if they just stated what they
p.(None): added to existing guidelines. Such is the case with the GCC, which focuses solely on factors that are specific to
p.(None): collaborative research ventures in resource-poor (primarily LMIC) set- tings. The GCC is succinct and written in plain
p.(None): language; it is meant to be equally accessible to researchers in HICs and to their intended partners in LMICs. In these
p.(None): respects, the GCC is very straightforward, but its simplicity will inevitably generate questions about how it should be
p.(None): implemented.
p.(None): For example, article 13 of the GCC states that a clear procedure for feedback, complaints or allegations of
p.(None): misconduct must be offered that gives genuine and appropriate access to all research participants and local
p.(None): partners to express any con- cerns they may have with the research process. Aside from the injunction that the
p.(None): procedure must be agreed with local partners at the outset of the research, there is no guidance on what this procedure
p.(None): should look like. This “thin approach” was used for a reason: no complaints mechanism will fit all situations. Hence,
p.(None): the emphasis is on the process, namely to agree with local partners on an approach. Codes are not enough in themselves
p.(None): to ensure ethical conduct; they need buy-in from all those involved, and such buy-in needs to be generated
p.(None): through effective engagement mechanisms.
p.(None): Researchers should therefore see community engagement as the gateway to effective implementation of the GCC.
p.(None): For example, when considering the local rel- evance of the proposed research (article 1), who better to ask than
p.(None): members of the local community? When wondering how best to seek informed consent, who better to ask than members of the
p.(None): local community? Consultation with the community offers the most direct route to addressing questions about
p.(None): implementation and to realizing the essence of the GCC: a global collaborative effort to eradicate ethics dumping.
p.(None):
p.(None): 106 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): References
p.(None):
p.(None): Ahmed SM, Palermo AGS (2010) Community engagement in research: frameworks for educa- tion and peer review. American
p.(None): Journal of Public Health 100(8):1380–1387. https://doi. org/10.2105/AJPH.2009.178137
...
p.(None): desa/indigenouspeoples/publications/2014/09/martinez-cobo-study/
p.(None): NIH (2011) Principles of community engagement. Washington, DC: CTSA Community Engagement Key
p.(None): Function Committee Task Force on the Principles of Community Engagement, National Institutes of Health.
p.(None): https://www.atsdr.cdc.gov/communityengagement/ pdf/PCE_Report_508_FINAL.pdf
p.(None):
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p.(None): Stationery Office, Norwich
p.(None): Sack DA, Brooks V, Behan M, Cravioto A, Kennedy A, IJsselmuiden C, Sewankambo N (2009) Improving international research
p.(None): contracting. WHO Bulletin 87:487–488
p.(None): Webley S, Werner A (2008) Corporate codes of ethics: necessary but not sufficient. Business Ethics: A
p.(None): European Review 17(4):405–415
p.(None): Weijer C, Goldsand G, Emanuel EJ (1999) Protecting communities in research: current guidelines and limits of
p.(None): extrapolation. Nature Genetics 23(3):275
p.(None): WHO (1998) Health promotion glossary. World Health Organization, Geneva. http://www.who.
p.(None): int/healthpromotion/about/HPR%20Glossary%201998.pdf, page 5.
p.(None):
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p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 9
p.(None): Towards Equitable Research Partnership
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The world’s largest collection of professional ethics codes already holds more than 2,500 codes. What can
p.(None): the Global Code of Conduct for Research in Resource-Poor Settings (GCC) add? This brief chapter gives
p.(None): co-authors and sup- porters of the GCC the opportunity to show why a code with the single-minded aim of eradicating
p.(None): ethics dumping is needed.
p.(None):
...
p.(None): nations on the less wealthy that did not mention the code,” he says. (Nordling 2018)
p.(None): The emphasis in the GCC on fairness, respect, care and honesty resonates with our work at UNESCO. – Dr Dafna
p.(None): Feinholz (Mexican), UNESCO’s chief of Bioethics and Ethics of Science and Technology, co-author of the GCC
p.(None):
p.(None):
p.(None):
p.(None): 2 The EU-funded consortium that developed the GCC.
p.(None): 3 This refers to Andries Steenkamp’s iconic request to researchers, namely to enter San communi- ties through the
p.(None): metaphorical “front door” – that is, the San Council – and not, like thieves, through the window.
p.(None):
p.(None): 112 9 Towards Equitable Research
p.(None): Partnership
p.(None):
p.(None): TRUST was a game changer.4
p.(None): Ethics dumping is a real threat to the quality of science and the GCC is now a mandatory reference document for EU
p.(None): framework program funding to guard against it. – Dorian Karatzas (Greek), head of Ethics and Research Integrity,
p.(None): European Commission
p.(None): Best science for the most neglected, also means best ethical standards. That’s why the GCC aims high: to protect the
p.(None): most neglected. – Dr François Bompart (French), director of Paediatric HIV/Hepatitis C Programmes at the Drugs
p.(None): for Neglected Diseases initiative (DNDi), former vice president, Access to Medicines at Sanofi, co-author of the GCC
p.(None): We get given consent forms and documents, often in a hurry. We sign because we need the money and then end up with
p.(None): regret. It feels like a form of abuse. They want something from us and they know how to get it. Because of our
p.(None): socio-economic conditions, we will always be vulnerable to those from the North. A code of ethics is needed that
p.(None): protects indigenous people.5 – Andries Steenkamp (1960–2016) (South African), former chair of the South African
p.(None): San Council, co-author of both codes
p.(None): I don’t want researchers to see us as museums who cannot speak for themselves and who don’t expect something in return.
p.(None): As humans, we need support.6 – Reverend Mario Mahongo (1952–2018) (Angolan), co-author of both codes
p.(None): We want to be treated by researchers with fairness, respect, care and honesty. Is that too much to ask?7 – Joyce
p.(None): Adhiambo Odhiambo (Kenyan), health activist and former sex worker, co-author of the GCC
p.(None): Indeed, is that too much to ask?
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Burtscher W (2018) TRUST Global Code of Conduct to be a reference document applied by all research projects applying
p.(None): for H2020 funding. TRUST eNewsletter Issue 5. http://www.global-
p.(None): codeofconduct.org/wp-content/uploads/2018/12/TRUSTNewsletter_2018_Issue5.pdf
...
p.(None): Technology, Chicago. http://ethicscodescollection.org/
p.(None):
p.(None): 4 Opening words during European Commission ethics staff training on the GCC, 3 Dec 2019, Covent Garden
p.(None): Building, Brussels.
p.(None): 5 Recorded message from Nairobi TRUST meeting, 23 May 2016.
p.(None): 6 Recorded video message from Kimberley TRUST meeting, Feb 2017.
p.(None): 7 European Parliament, TRUST event, 29 June 2018.
p.(None):
p.(None): References
p.(None): 113
p.(None):
p.(None): Nordling L (2018) Europe’s biggest research fund cracks down on “ethics dumping”. Nature 559:17–18.
p.(None): https://www.nature.com/articles/d41586-018-05616-w
p.(None): Schroeder D, Cook J, Hirsch F, Fenet S, Muthuswamy V (eds) (2018) Ethics dumping: case stud- ies from North-South
p.(None): research collaborations. Springer Briefs in Research and Innovation Governance, Berlin
p.(None): TRUST (2018) Major TRUST event successfully held at European Parliament. TRUST eNewsletter Issue
p.(None): 5. http://www.globalcodeofconduct.org/wp-content/uploads/2018/12/ TRUSTNewsletter_2018_Issue5.pdf
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Appendix
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Global Code of Conduct for Research in Resource-Poor Settings (GCC)
p.(None):
p.(None): Authors and Sources of Inspiration
p.(None): Lead Author: Doris Schroeder University of Central Lancashire, UK Authors in alphabetical order:
p.(None): • Joyce Adhiambo Partners for Health and Development, Kenya
p.(None): • Chiara Altare Action contre la Faim, France
p.(None): • Fatima Alvarez-Castillo University of the Philippines, Philippines
p.(None): • Pamela Andanda University of the Witwatersrand, South Africa
p.(None): • François Bompart Drugs for Neglected Diseases Initiative, Switzerland
p.(None): • Francesca I. Cavallaro UNESCO, France
p.(None): • Kate Chatfield University of Central Lancashire, UK
p.(None): • Roger Chennells South African San Institute, South Africa
...
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p.(None):
p.(None): It is known from studies in the field of dispute resolution that people often feel reluctant to make
p.(None): complaints and that this can be related to a variety of complex factors. In 2009 the Health Professions
p.(None): Council in the UK published a
p.(None):
p.(None): 100 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): comprehensive scoping review of existing mechanisms for complaints about health professionals (HPC 2009). In this
p.(None): report, the HPC describes a range of factors that can act as barriers to making a specific complaint. As there are no
p.(None): equivalent publi- cations about complaints procedures in LMICs, we summarize here the factors that are relevant to
p.(None): research in LMICs.
p.(None): Readiness to complain in any environment can be influenced by gender, ethnic- ity, age, education, income,
p.(None): accessibility of information and the perceived “serious- ness” of the problem (Pleasence et al. 2006).
p.(None): Specifically, ethnic minority communities are less likely to use systems that they perceive as being culturally
p.(None): insensitive and are more fearful of the consequences of taking action when they feel those systems have failed them.
p.(None): Difficulties with access to information are highlighted as a barrier to making a complaint (Henwood et al. 2003),
p.(None): especially where there is “information illiteracy”; some people possess the relevant skills and confidence to seek out
p.(None): information, but many do not. In situations where levels of education and literacy are not high, this is likely to be
p.(None): exacerbated.
p.(None): The relationship between the person who brings the complaint and the bureau- cracies to which they must direct
p.(None): their complaint can be a factor (Cowan and Halliday 2003). This relationship can either encourage or
p.(None): discourage a potential complainant’s trust in complaints mechanisms. The power imbalance between par- ties in such
p.(None): relationships can be substantial. For example, when working with impoverished communities, HIC researchers
p.(None): should be aware that participation in a clinical study may provide a participant’s only access to health care or other
p.(None): much- needed benefits. Fear of retribution is often cited as a barrier to making a complaint, particularly in
p.(None): circumstances where the complainant has an ongoing relationship with the complainee (HPC 2009). In situations where
p.(None): there is a power imbalance, people may not have the confidence to complain; they may be reluctant to seem ungrateful,
p.(None): not wish to be seen as a complainer, or fear loss. Research has shown that some people even reconstruct negative
p.(None): experiences in a positive light in order to maintain relationships (Edwards et al. 2004).
p.(None): In addition to the above, participatory engagement activities in the TRUST proj- ect (Chapter 6) have revealed the
...
Social / Age
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p.(None): become a subject of extensive research in the social sci- ences and in psychology, particularly over the past forty
p.(None): years, with just about every area of life being examined through the lens of personal values – for example, con- sumer
p.(None): practices (Pinto et al. 2011), political voting habits (Kaufmann 2016), employee creativity (Sousa and Coelho
p.(None): 2011), healthcare decisions (Huijer and Van Leeuwen 2000), investment decisions (Pasewark and Riley 2010), and
p.(None): sexuality and disability (Wolfe 1997), to name but a few.
p.(None):
p.(None):
p.(None): 4 Local ethics review should be sought wherever possible. It is of vital importance that research projects are approved
p.(None): by a research ethics committee in the host country, wherever this exists, even if ethics approval has already been
p.(None): obtained in the high-income setting.
p.(None):
p.(None): From Values to Action
p.(None): 19
p.(None):
p.(None): Arguably the most prominent theory of the motivational power of human values was developed by social psychologist
p.(None): Shalom Schwartz, back in 1992. Schwartz’s theory of basic values is distinctive because, unlike most other theories, it
p.(None): has been tested via extensive empirical investigation. Studies undertaken since the early 1990s have generated
p.(None): large data sets from 82 countries, including highly diverse geographic, cultural, religious, age and occupational
p.(None): groups (Schwartz 2012). Findings from Schwartz’s global studies indicate that values are inextricably linked to
p.(None): affect. He claims that when values are activated, they become infused with feel- ing (Schwartz 2012). For example,
p.(None): people for whom routine and security are impor- tant values will become disturbed when their employment is threatened
p.(None): and may fall into despair if they actually lose their jobs. Correspondingly, when moral values like fairness or respect
p.(None): are important, people will react when they witness instances of unfairness or disrespect; they will feel motivated to
p.(None): respond in some way.
p.(None): Schwartz’s research investigated motivational values in general (combining our second and third meanings of “value”),
p.(None): and not just moral values. As noted earlier, people can be motivated by many different values, but interestingly, when
p.(None): asked to rank values in order of importance, the participants in Schwartz’s studies consis- tently rated those with
p.(None): explicit moral connotations as the most important values (Schwartz 2012). This suggests that people hold their
p.(None): moral values in high esteem and can be strongly influenced by them.
p.(None):
p.(None):
p.(None): From Values to Action
p.(None):
p.(None): Ethical values give us direction but are not sufficient to make us ethical researchers who avoid ethics dumping. One
p.(None): can hold the value of honesty and yet fail to be an honest person. One can hold the value of respect and yet cause harm
p.(None): when disre- specting local customs. Values can motivate and they can help to establish moral goals, but they do not
p.(None): explain how to achieve them. A means of operationalizing values is needed.
...
p.(None): might preclude complaints from the most vulner- able research participants.
p.(None): For collaborative research undertaken in resource-poor settings, especially low and middle-income countries (LMICs),
p.(None): the accessibility of a complaints procedure may be affected by many factors that are unfamiliar to researchers from a
p.(None): high- income country (HIC). A concerted effort is therefore required to understand local needs and preferences so that
p.(None): a complaints mechanism can be implemented that is both user-friendly and fit for purpose.
p.(None):
p.(None):
p.(None): Factors Affecting Accessibility
p.(None):
p.(None): It is known from studies in the field of dispute resolution that people often feel reluctant to make
p.(None): complaints and that this can be related to a variety of complex factors. In 2009 the Health Professions
p.(None): Council in the UK published a
p.(None):
p.(None): 100 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): comprehensive scoping review of existing mechanisms for complaints about health professionals (HPC 2009). In this
p.(None): report, the HPC describes a range of factors that can act as barriers to making a specific complaint. As there are no
p.(None): equivalent publi- cations about complaints procedures in LMICs, we summarize here the factors that are relevant to
p.(None): research in LMICs.
p.(None): Readiness to complain in any environment can be influenced by gender, ethnic- ity, age, education, income,
p.(None): accessibility of information and the perceived “serious- ness” of the problem (Pleasence et al. 2006).
p.(None): Specifically, ethnic minority communities are less likely to use systems that they perceive as being culturally
p.(None): insensitive and are more fearful of the consequences of taking action when they feel those systems have failed them.
p.(None): Difficulties with access to information are highlighted as a barrier to making a complaint (Henwood et al. 2003),
p.(None): especially where there is “information illiteracy”; some people possess the relevant skills and confidence to seek out
p.(None): information, but many do not. In situations where levels of education and literacy are not high, this is likely to be
p.(None): exacerbated.
p.(None): The relationship between the person who brings the complaint and the bureau- cracies to which they must direct
p.(None): their complaint can be a factor (Cowan and Halliday 2003). This relationship can either encourage or
p.(None): discourage a potential complainant’s trust in complaints mechanisms. The power imbalance between par- ties in such
p.(None): relationships can be substantial. For example, when working with impoverished communities, HIC researchers
p.(None): should be aware that participation in a clinical study may provide a participant’s only access to health care or other
...
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p.(None): My hope is that enlightened stakeholders in public institutions, foundations and the private sector will now start a
p.(None): discourse and apply moral imagination to the concrete consequences of the GCC. This relates to the processes and
p.(None): content of their research endeavours as well as the selection criteria for hiring, promoting and remu- nerating the
p.(None): research workforce.
p.(None): Research excellence is no longer only defined by playing by the rules and being “successful”. The results of discourses
p.(None): about the operationalization of the TRUST values of fairness, respect, care and honesty are the new
p.(None): benchmark for excellence.
p.(None):
p.(None): Basel, Switzerland Klaus Leisinger
p.(None):
p.(None):
p.(None): Reference
p.(None):
p.(None): UN (2015) Transforming our world: the 2030 agenda for sustainable development. United Nations.
p.(None): https://www.un.org/development/desa/dspd/2015/08/transforming-our-world-the-2030- agenda-for-sustainable-development/
p.(None):
p.(None):
p.(None): Professor Klaus Leisinger, a social scientist and economist, is the President of the Global Values Alliance in Basel,
p.(None): Switzerland. He served as an adviser on corporate responsibility to UN Secretaries-General Kofi Annan and Ban Ki-moon.
p.(None): He is cur- rently a member of the Leadership Council of the UN Sustainable Development Solutions Network. In 2011, he
p.(None): was awarded the first ever Outstanding Contribution to Global Health Award by South-South Awards for his successful
p.(None): work on eradicat- ing leprosy.
p.(None):
p.(None): Acknowledgements
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Writing a book is child’s play compared to writing a new ethics code – a monumental task achieved by the 56 individuals
p.(None): named in the Appendix as the proud authors of the Global Code of Conduct for Research in Resource-Poor Settings (GCC).
p.(None): Thus, by the time we started writing this book, the bulk of the work had already been done. The task of conveying the
p.(None): collective pride of these 56 authors to the world was entrusted to the Reverend Mario Mahongo, an honoured San Leader
p.(None): born in Angola. He was due to travel from the Kalahari Desert to Stockholm, Sweden, in May 2018 to launch the GCC. Just
p.(None): one day before flying to Europe, he died in a car crash. This book is dedicated to Mario. His last recorded statement
p.(None): about research ethics was: “I don’t want researchers to see us as museums who cannot speak for themselves and who don’t
p.(None): expect something in return” (Chapter 7). This statement expresses
p.(None): the fairness element of the GCC beautifully.
p.(None): The GCC was produced by the TRUST project, an initiative funded by the European Commission (EC) Horizon
p.(None): 2020 Programme, agreement number 664771. Dorian Karatzas, Roberta Monachello, Dr Louiza Kalokairinou, Edyta Sikorska,
p.(None): Yves Dumont and Wolfgang Bode formed the magnificent EC team supporting the
p.(None): TRUST project.
p.(None): Thanks to Dorian for ensuring that the GCC was brought to the attention of the highest level of decision-making on
p.(None): ethics in the EC, for suggesting TRUST as a research and development success story of Horizon 2020 (EC 2018) and for
...
p.(None): References 106
p.(None): 9 Towards Equitable Research Partnership 109
p.(None): References 112
p.(None): Appendix
p.(None): 115
p.(None): Index
p.(None): 119
p.(None):
p.(None): About the Authors
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Doris Schroeder is director of the Centre for Professional Ethics at the University of Central Lancashire, and
p.(None): professor of moral philosophy at the School of Law, UCLan Cyprus. She is the lead author of the Global Code of Conduct
p.(None): for Research in Resource-Poor Settings.
p.(None):
p.(None): Kate Chatfield is deputy director of the Centre for Professional Ethics, University of Central Lancashire, UK. She is a
p.(None): social science researcher and ethicist special- izing in global justice, research ethics, animal ethics and responsible
p.(None): innovation.
p.(None):
p.(None): Michelle Singh is a project officer at the European & Developing Countries Clinical Trials Partnership in Cape Town,
p.(None): South Africa. She holds a medical PhD and previ- ously managed maternal and child health research studies and clinical
p.(None): trials at the South African Medical Research Council.
p.(None):
p.(None): Roger Chennells works as legal adviser to the South African San Institute and is a founder-partner in the human rights
p.(None): law practice Chennells Albertyn, Stellenbosch, established in 1981. Specializing in labour, land, environmental and
p.(None): human rights law, he has also worked for Aboriginal people in Australia.
p.(None):
p.(None): Peter Herissone-Kelly is senior lecturer in philosophy, University of Central Lancashire, UK. He is a
p.(None): specialist in Kantian ethics as well as bioethics, analytic philosophy of language and metaethics.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xvii
p.(None):
p.(None): Abbreviations
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ACF Action contre la Faim
p.(None): CBD UN Convention on Biological Diversity COHRED Council on Health Research for Development EC
p.(None): European Commission (EC)
p.(None): EDCTP European and Developing Countries Clinical Trials Partnership EFPIA European Federation of
p.(None): Pharmaceutical Industries and Associations FERCI Forum for Ethics Review Committees in India
p.(None): GCC Global Code of Conduct for Research in Resource-Poor Settings GVA Global Values Alliance
p.(None): HIC high-income country
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p.(None): leadership for adoption. Further minor changes were made, until the code was unanimously adopted and declared ready to
p.(None): be launched by the San leadership.
p.(None):
p.(None):
p.(None): The San Code of Research Ethics
p.(None): Respect
p.(None):
p.(None): We require respect, not only for individuals but also for the community.
p.(None): We require respect for our culture, which also includes our history. We have cer- tain sensitivities that are not known
p.(None): by others. Respect is shown when we can input into all research endeavours at all stages so that we can explain these
p.(None): sensitivities.
p.(None): Respect for our culture includes respect for our relationship with the environment.
p.(None): Respect for individuals requires the protection of our privacy at all times. Respect requires that our contribution to
p.(None): research is acknowledged at all times. Respect requires that promises made by researchers need to be met.
p.(None): Respectful researchers engage with us in advance of carrying out research. There should be no assumption that
p.(None): San will automatically approve of any research projects that are brought to us.
p.(None): We have encountered lack of respect in many instances in the past. In Genomics research, our leaders were avoided, and
p.(None): respect was not shown to them. Researchers took photographs of individuals in their homes, of breastfeeding
p.(None): mothers, or of underage children, whilst ignoring our social customs and norms. Bribes or other advantages were
p.(None): offered. Failure by researchers to meet their promises to provide feedback is an example of disrespect which is
p.(None): encountered frequently.
p.(None):
p.(None):
p.(None): Honesty
p.(None):
p.(None): We require honesty from all those who come to us with research proposals.
p.(None): We require an open and clear exchange between the researchers and our leaders. The language must be clear, not
p.(None): academic. Complex issues must be carefully and
p.(None):
p.(None): 84 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): correctly described, not simply assuming the San cannot understand. There must be a totally honest sharing of
p.(None): information.
p.(None): Open exchange should not patronise the San. Open exchanges implies that an assessment was made of possible harms or
p.(None): problems for the San resulting from the research and that these possible harms are honestly communicated.
p.(None): Prior informed consent can only be based on honesty in the communications, which needs to be carefully documented.
p.(None): Honesty also means absolute transparency in all aspects of the engagement, including the funding situation, the purpose
p.(None): of the research, and any changes that might occur during the process.
p.(None): Honesty requires an open and continuous mode of communication between the San and researchers.
p.(None): We have encountered lack of honesty in many instances in the past. Researchers have deviated from the stated purpose of
...
p.(None): Appendix
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): We work for global, inclusive and fair research without double standards.
p.(None): We build equitable research partnerships.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): We include the voices of vulnerable populations.
p.(None): We encourage others to do the same.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Fig. 1 Mission statement of the GCC authors
p.(None):
p.(None): Index
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): A
p.(None): Accountability, 90, 104
p.(None): Africa, 56, 60, 63, 73–76, 110, 111
p.(None): Agriculture, 7, 46, 60, 101, 110
p.(None): America, 49, 61, 66, 116
p.(None): Animal welfare, 9, 42, 44, 48, 65
p.(None): Anthropological research, 56
p.(None): Asia, 111
p.(None):
p.(None):
p.(None): B
p.(None): Benefits, 6, 7, 15, 17, 21, 33, 40–42, 52,
p.(None): 80–82, 84, 86, 92, 94, 95, 98, 100,
p.(None): 103, 104
p.(None): Benefit sharing, 7, 20, 41, 42, 69, 76–78,
p.(None): 84, 86
p.(None): Biomedical research, 55, 56, 65, 117
p.(None): Biosafety, 45, 67, 116
p.(None): Biosecurity, 45, 67
p.(None): Blood samples, 2, 47
p.(None): Bribery, 10, 16, 47
p.(None): Buddhist ethics, 35
p.(None):
p.(None):
p.(None): C
p.(None): Capacity building, 10, 41, 63, 80, 92,
p.(None): 94, 104
p.(None): Care, 2, 5, 6, 8–10, 13–24, 27–31, 33, 34, 38,
p.(None): 40, 41, 44–46, 48, 63, 64, 68, 70, 74,
p.(None): 82, 85, 90, 93, 95–98, 102, 103,
p.(None): 110–112, 117
p.(None): Children, 83
p.(None): China, 2, 49, 61, 116
p.(None):
p.(None): Civil society, 39, 42
p.(None): Clinical trial, 38, 39, 55, 58, 101, 103, 111,
p.(None): 116, 117
p.(None): Co-creation, 103
p.(None): Colonialism, 48, 49
p.(None): Commercial, 47, 77, 80
p.(None): Common morality, 29, 31–35
p.(None): Communication, 10, 24, 56, 58, 62, 74, 84, 85,
p.(None): 92, 94–96, 100, 109
p.(None): Communities, 1, 6, 18, 32, 37, 52, 73, 90, 110
p.(None): Community assent, 8, 68, 69, 96
p.(None): Community engagement, 3, 44, 53–55, 61,
p.(None): 63–64, 74, 91–94, 96, 97, 102,
p.(None): 105, 110
p.(None): Compensation, 43
p.(None): Complaints, 3, 8, 21, 42, 90, 91,
p.(None): 95–103, 105
p.(None): Complaints procedure, 3, 21, 42, 90, 91,
p.(None): 97–103
p.(None): Compliance, 9, 11, 14, 37, 42, 43, 47, 52, 81,
p.(None): 84, 89, 90, 96, 98
p.(None): Confidentiality, 96, 97, 100, 102 Conflicts of interest, 32
p.(None): Consent, 2, 7, 8, 24, 43–48, 63, 64, 66, 74, 82,
p.(None): 84, 96, 100, 105, 112
p.(None): Convention on Biological Diversity (CBD), 13, 77, 78, 117
p.(None): Corruption, 10
p.(None): Cultural sensitivities, 7, 27, 64
p.(None): Cultures, 14, 15, 18, 20, 23, 28–33, 35, 39, 43,
p.(None): 44, 46, 47, 49, 64, 76–78, 83, 91,
p.(None): 94–98, 100, 102, 103
p.(None): Customs, 19, 20, 40, 43, 44, 47, 83
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6
p.(None): 119
p.(None):
p.(None): 120
p.(None):
p.(None): D
p.(None): Data, 6, 7, 11, 19, 20, 24, 39–42, 45–47, 60,
p.(None): 66, 104, 117
p.(None): Data ownership, 6, 20, 60, 66, 104
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p.(None):
p.(None):
p.(None): RESPECT
p.(None):
p.(None):
p.(None): In the following sections we show how the practical application of the values can help guide two important activities
p.(None): in collaborative research: community engage- ment and the development of an accessible complaints procedure.
p.(None):
p.(None):
p.(None): Ethical Engagement with Communities
p.(None):
p.(None): The term “community” is contentious and contextual, and can be difficult to define (Day 2006). For the purposes of this
p.(None): chapter, we use an early definition from the World Health Organization which describes a community as:
p.(None): A specific group of people, often living in a defined geographical area, who share a com- mon culture, values and
p.(None): norms, are arranged in a social structure according to relationships which the community has developed over a period of
p.(None): time. Members of a community gain their personal and social identity by sharing common beliefs, values and norms which
p.(None): have been developed by the community in the past and may be modified in the future (WHO 1998: 5)
p.(None): As we can infer from this definition, there are many different types of communi- ties and also communities within
p.(None): communities. For example, indigenous communi- ties, having a historical continuity with preinvasion and precolonial
p.(None): societies that developed on their territories, may consider themselves distinct from other sectors of the societies
p.(None): that now prevail on those territories, or parts of them. They generally form nondominant sectors of society and can be
p.(None): intent on preserving, developing and transmitting to future generations their ancestral territories and their
p.(None): ethnic identity, as the basis of their continued existence as peoples, in accordance with their own cultural patterns,
p.(None): social institutions and legal systems (Martínez Cobo
p.(None):
p.(None): 92 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): 2014). They often have particular relationships with advocacy groups who work to protect or represent their interests.4
p.(None): The concept of communities within communities also includes groups of people who are vulnerable because of a
p.(None): range of physical (disabilities, for example) or cultural (religion, for example) characteristics. For instance,
p.(None): sex workers, injecting drug users and men who have sex with men are often marginalized within their own broader
p.(None): communities.5 People from such groups are frequently sought for interna- tional research and yet the community at
p.(None): large or the community leaders are often unable to provide the input needed to ensure ethical management of
p.(None): research projects. Communities and their leaders may be unaware of the specific circumstances of these people and their
p.(None): lives, and they may even be openly hostile. We therefore need mechanisms for ensuring that the voice of
...
p.(None): • improving logistics and the running of studies
p.(None): • strengthening the quality of the information collected
p.(None): • ensuring culturally sensitive communications and research approaches
p.(None): • enhancing opportunities for capacity building (Hebert et al. 2009; Cook 2008; Bassler et al. 2008; Dunn 2011).
p.(None): Community engagement is an ethical imperative (a “must”) for researchers oper- ating globally. Research participants,
p.(None): their local communities and research partners in international locations should be equal stakeholders in the pursuit of
p.(None): research- related gains (Anderson et al. 2012). Ahmed and Palermo (2010) provide a salient definition of community
p.(None): engagement in research as
p.(None): a process of inclusive participation that supports mutual respect of values, strategies, and actions for authentic
p.(None): partnership of people affiliated with or self-identified by geographic proximity, special interest, or similar
p.(None): situations to address issues affecting the well-being of the community of focus.
p.(None): To be effective in international research, community engagement requires the development of partnerships with
p.(None): “local” stakeholders (for example, national,
p.(None):
p.(None): 4 Advocacy groups (also known as pressure groups, lobby groups, campaign groups, interest groups or special interest
p.(None): groups) use various forms of advocacy in order to influence public opinion and/ or policy.
p.(None): 5 Here “broader community” can refer to a village, town, ethnic group etc.
p.(None):
p.(None): Ethical Engagement with Communities
p.(None): 93
p.(None):
p.(None): regional or advocacy groups), involving them in assessing local challenges and research priorities,
p.(None): determining the value of research, planning, conducting and overseeing research, and integrating the
p.(None): results with local needs where relevant (Jones and Wells 2007). Moreover, it requires members of the
p.(None): research team to become part of the community, and members of the community to become part of the research team to
p.(None): create bespoke working environments before, during and after the research.
p.(None): Many models have been proposed for effective community engagement in research,6 and many written guides
p.(None): already exist. Rather than add an invention of our own to the numerous existing models, we show here how reference to
p.(None): the four values of fairness, respect, care and honesty can highlight the primary ethical con- siderations for
p.(None): organizations or researchers engaging with communities over the course of a research project. After all, as Dunn
p.(None): (2011: 5) points out, “Engagement is not a benchmark for ethics. Ethics does not stop when community engagement takes
p.(None): place. Engagement itself has ethical implications.”
p.(None): Our guidance for community engagement is intended to be useful; we show how application of the values compass at key
p.(None): stages of the research process can invoke particular questions for contemplation. There may be other relevant
p.(None): questions, depending upon the circumstances, but these questions are a useful starting point.
p.(None): The key stages we consider are:
...
p.(None): might preclude complaints from the most vulner- able research participants.
p.(None): For collaborative research undertaken in resource-poor settings, especially low and middle-income countries (LMICs),
p.(None): the accessibility of a complaints procedure may be affected by many factors that are unfamiliar to researchers from a
p.(None): high- income country (HIC). A concerted effort is therefore required to understand local needs and preferences so that
p.(None): a complaints mechanism can be implemented that is both user-friendly and fit for purpose.
p.(None):
p.(None):
p.(None): Factors Affecting Accessibility
p.(None):
p.(None): It is known from studies in the field of dispute resolution that people often feel reluctant to make
p.(None): complaints and that this can be related to a variety of complex factors. In 2009 the Health Professions
p.(None): Council in the UK published a
p.(None):
p.(None): 100 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): comprehensive scoping review of existing mechanisms for complaints about health professionals (HPC 2009). In this
p.(None): report, the HPC describes a range of factors that can act as barriers to making a specific complaint. As there are no
p.(None): equivalent publi- cations about complaints procedures in LMICs, we summarize here the factors that are relevant to
p.(None): research in LMICs.
p.(None): Readiness to complain in any environment can be influenced by gender, ethnic- ity, age, education, income,
p.(None): accessibility of information and the perceived “serious- ness” of the problem (Pleasence et al. 2006).
p.(None): Specifically, ethnic minority communities are less likely to use systems that they perceive as being culturally
p.(None): insensitive and are more fearful of the consequences of taking action when they feel those systems have failed them.
p.(None): Difficulties with access to information are highlighted as a barrier to making a complaint (Henwood et al. 2003),
p.(None): especially where there is “information illiteracy”; some people possess the relevant skills and confidence to seek out
p.(None): information, but many do not. In situations where levels of education and literacy are not high, this is likely to be
p.(None): exacerbated.
p.(None): The relationship between the person who brings the complaint and the bureau- cracies to which they must direct
p.(None): their complaint can be a factor (Cowan and Halliday 2003). This relationship can either encourage or
p.(None): discourage a potential complainant’s trust in complaints mechanisms. The power imbalance between par- ties in such
p.(None): relationships can be substantial. For example, when working with impoverished communities, HIC researchers
p.(None): should be aware that participation in a clinical study may provide a participant’s only access to health care or other
p.(None): much- needed benefits. Fear of retribution is often cited as a barrier to making a complaint, particularly in
p.(None): circumstances where the complainant has an ongoing relationship with the complainee (HPC 2009). In situations where
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p.(None):
p.(None): Not all of these are moral values. For instance, this particular list includes values such as clean, exuberant,
p.(None): hygienic, neat, poised and winning (Threads Culture nd). Another site lists 50 values, including authenticity, loyalty
p.(None): and wisdom, and advises that fewer than five should be selected for leadership purposes (Clear nd).
p.(None): The GCC is structured around four moral values: fairness, respect, care and hon- esty. These four values were not
p.(None): chosen from any existing lists; they emerged through in-depth consultation efforts around the globe (chapter 6).
p.(None): But why did the TRUST team choose moral values rather than other action-guiding moral modes for the GCC?
p.(None):
p.(None):
p.(None): What Can Guide Moral Action?
p.(None):
p.(None): The GCC is based on moral values, but the code authors could have opted to frame the code and guide action in other
p.(None): ways, including the following:
p.(None): • Standards is a technical term used to achieve desired action. Standards are pre- cise and give exact
p.(None): specifications, which are in many cases measurable, as in the maximum vehicle emissions allowed for cars. Standards can
p.(None): also be used in eth- ics. For instance, a well-known voluntary standard to guide ethical action is ISO 26000 (ISO
p.(None): not dated), developed by the International Organization for Standardization. ISO 26000 assesses the
p.(None): social responsibility of companies. Its guidance includes prohibitions against bribery, and the requirement to
p.(None): be accountable for any environmental damage caused.
p.(None): • Principles are behavioural rules for concrete action. When you know the princi- ple, you know what to do. For
p.(None): instance, in dubio pro reo has saved many innocent people from going to jail as it gives the courts very concrete
p.(None): advice. Literally translated, it means, “when in doubt, then for the accused” (a person remains innocent until proven
p.(None): guilty). This principle goes back to both Aristotle and Roman law.
p.(None): • Virtues are beneficial character traits that human beings need to flourish (Foot 1978: 2f). One can observe
p.(None): them in real people or in fictional characters. England’s semimythical Robin Hood, for instance, is seen as
p.(None): courageous and benevolent. He fights a David-and-Goliath battle against the Sheriff of Nottingham
p.(None): (courage) so that the poor have food (benevolence). Like values, for virtues to exist, there must be an agent (a
p.(None): person) who is being virtuous; virtues focus on the moral agent rather than on the standard or principle that underlies
p.(None): a decision.
p.(None): • Ideals drive towards perfection and are highly aspirational. Some people will say “in an ideal world” to denote
p.(None): that something is unrealistic from the start. The ancient Greek philosopher Aristotle argued that we should strive
p.(None): towards perfec- tion of character and that ideals can be guiding lights in character building. “Good
p.(None): character is an ideal outside of oneself that all strive for” (Mitchell 2015).
p.(None):
p.(None): What Can Guide Moral Action?
p.(None): 17
p.(None):
p.(None): So why were values chosen as the foundation for the GCC rather than standards, principles, virtues or ideals?
p.(None): Ideals are the most aspirational of the concepts available to guide ethical action. However, hardly anybody can live up
p.(None): to all of their ideals. If one phrased an ethics code around ideals, those who should be led by the code might suggest
...
p.(None): harm), beneficence and justice (Beauchamp and Childress 2013).
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): voluntary exercise for research participants. It is not a mission-driven exercise to impose different ethical values.
p.(None): If researchers from high-income settings cannot agree on a way of undertaking the research that is acceptable to local
p.(None): stakeholders, it should not take place.
p.(None): 2 EU-funded research project, which developed the GCC from 2015 to 2018.
p.(None): 3 According to the definition of values in the box (and in Chapter 3 of this book), the four-principles approach should
p.(None): be called the four-values approach, but this makes no difference in substance.
p.(None):
p.(None): Introduction
p.(None): 29
p.(None):
p.(None):
p.(None): Values and Principles
p.(None): The words “values” and “principles” are often used interchangeably. We will distinguish them as below.
p.(None): If people value something, they hold it dear, and they believe it is of high importance. This could be power, money or
p.(None): kindness; values are not necessar- ily morally positive. Ethical values, on the other hand, are guides on the route to
p.(None): doing the right thing or developing a moral character. They are by definition morally positive. For example, greed is
p.(None): not an ethical value, but generosity is. A principle is a behavioural rule for concrete action. When you know the
p.(None): principle, you know what to do. For instance, the principle in dubio pro reo has saved many innocent people from going
p.(None): to jail as it gives courts very con- crete advice. It means, “When in doubt, then favour the accused,” (in other words,
p.(None): “innocent until proven guilty”) and goes back to both Aristotle and
p.(None): Roman law.
p.(None):
p.(None): Beauchamp and Childress maintain that their four principles are globally appli- cable – that is to say, they are
p.(None): universally relevant to the sorts of ethical questions that arise in biomedicine; they are every bit as integral to the
p.(None): understanding and resolution of medical ethics problems in Bangkok as they are in Boston, equally pertinent in both
p.(None): Cape Town and Copenhagen. Their status as globally applicable is, according to Beauchamp and Childress, underwritten by
p.(None): their forming part of what they call “the common morality”, understood as a system of general norms that will be
p.(None): specified differently in different cultures, but to which all morally committed persons everywhere will subscribe.
p.(None): We want to argue that the four values – fairness, respect, care and honesty – are rooted in a globally applicable
p.(None): common morality, the norms of which can be speci- fied in various ways in disparate cultures. Insofar as this is the
p.(None): case, our argumenta- tional strategy will be similar to that of Beauchamp and Childress.
p.(None): However, we want to maintain that the four GCC values, taken together, have a less contentious claim to be globally
p.(None): applicable than Beauchamp and Childress’s principles, for two reasons.
p.(None): 1. One of Beauchamp and Childress’s principles – respect for autonomy – has often, and with some
p.(None): justification, been criticized for being culturally bound rather than universal (Huxtable 2013, Kara 2007,
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p.(None): entire community. It is the responsibility of the researcher to find out local requirements.
p.(None):
p.(None):
p.(None): Article 10
p.(None):
p.(None): Local ethics review should be sought wherever possible. It is of vital importance that research projects are approved
p.(None): by a research ethics committee in the host coun- try, wherever this exists, even if ethics approval has already been
p.(None): obtained in the high-income setting.
p.(None):
p.(None):
p.(None): Article 11
p.(None):
p.(None): Researchers from high-income settings should show respect to host country research ethics committees.
p.(None):
p.(None):
p.(None): Care
p.(None): Article 12
p.(None):
p.(None): Informed consent procedures should be tailored to local requirements to achieve genuine understanding and well-founded
p.(None): decision-making.
p.(None):
p.(None):
p.(None): Article 13
p.(None):
p.(None): A clear procedure for feedback, complaints or allegations of misconduct must be offered that gives genuine and
p.(None): appropriate access to all research participants and local partners to express any concerns they may have with the
p.(None): research process. This procedure must be agreed with local partners at the outset of the research.
p.(None):
p.(None): Care
p.(None): 9
p.(None):
p.(None): Article 14
p.(None):
p.(None): Research that would be severely restricted or prohibited in a high-income setting should not be carried out in a
p.(None): lower-income setting. Exceptions might be permissi- ble in the context of specific local conditions (e.g. diseases not
p.(None): prevalent in high- income countries).
p.(None): If and when such exceptions are dealt with, the internationally acknowledged compliance commandment “comply or
p.(None): explain” must be used, i.e. exceptions agreed upon by the local stakeholders and researchers must be explicitly
p.(None): and trans- parently justified and made easily accessible to interested parties.
p.(None):
p.(None):
p.(None): Article 15
p.(None):
p.(None): Where research involvement could lead to stigmatization (e.g. research on sexually transmitted diseases), incrimination
p.(None): (e.g. sex work), discrimination or indetermi- nate personal risk (e.g. research on political beliefs), special measures
p.(None): to ensure the safety and wellbeing of research participants need to be agreed with local partners.
p.(None):
p.(None):
p.(None): Article 16
p.(None):
p.(None): Ahead of the research it should be determined whether local resources will be depleted to provide staff or
p.(None): other resources for the new project (e.g. nurses or labo- ratory staff). If so, the implications should be discussed in
p.(None): detail with local com- munities, partners and authorities and monitored during the study.
p.(None):
p.(None):
p.(None): Article 17
p.(None):
p.(None): In situations where animal welfare regulations are inadequate or non-existent in the local setting compared with the
...
p.(None): imposing one’s own approach and carelessly accepting human rights violations, but that is the balance researchers
p.(None): should strive for.
p.(None):
p.(None):
p.(None): Care
p.(None):
p.(None): Sometimes one word describes different concepts. This is the case with “care”. The statement, “I care for my
p.(None): grandfather,” can mean two diametrically opposed things. First, it could mean that the person is very attached to her
p.(None): grandfather even though she hardly ever sees him. Second, it could mean that she is the person who injects
p.(None):
p.(None): The Four Values
p.(None): 23
p.(None):
p.(None): her grandfather with insulin, cooks his meals, and makes sure that his needs are taken care of every day, even if there
p.(None): is antipathy between them.
p.(None): The meaning of the value of care in the context of global research ethics links more to the second use of the term; to
p.(None): look after or take care of somebody or some- thing. As a main priority, one should take care of the interests of those
p.(None): enrolled in research studies to the extent that one always prioritizes their welfare over any other goals – for
p.(None): example, accepting the decisions of those who choose to withdraw from an ongoing study, even if this impairs the
p.(None): project’s results. In line with article 8 of the Declaration of Helsinki (WMA 2013) that means:
p.(None): While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over
p.(None): the rights and interests of individual research subjects.
p.(None): This care applies across disciplines, not only in medical research, and it is not restricted to human research
p.(None): participants. Article 21 of the Declaration of Helsinki (WMA 2013) extends the care for research subjects’ welfare to
p.(None): research animals. Likewise, care for environmental protection is increasingly included in research ethics
p.(None): processes and frameworks for responsible research. For instance, the European Commission’s Horizon 2020 ethics
p.(None): review process addresses potentially negative impacts on the environment (Directorate General for Research 2019: sec-
p.(None): tion 7). Richard Owen et al. (2013) define responsible research and innovation as “a collective commitment of care for
p.(None): the future through responsive stewardship of sci- ence and innovation in the present”, a statement that has clear
p.(None): relevance to environ- mental protection.
p.(None): Researchers who take care to avoid negative impacts in their work will not “heli- copter” in and out of a research area
p.(None): they are not familiar with, but will use systems of due diligence to ensure that risks are assessed and mitigated. For
p.(None): instance, an HIC research team that strips a local area of all doctors and nurses by attracting them into their
p.(None): high-tech research facility is not acting carefully and ethically.
p.(None): Ideally, researchers who take good care will combine the two concepts men- tioned above: they care about
p.(None): research participants, in the sense that the participants are important to them, and they feel responsible for the
...
p.(None): and involved all three sectors: public funders, private
p.(None):
p.(None): 7 Local relevance of research … should be determined in collaboration with local partners.
p.(None): 8 Local researchers should be included, wherever possible, throughout the research process, includ- ing in study
p.(None): design, study implementation, data ownership, intellectual property and authorship of publications.
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 61
p.(None): Table 6.3 Good practice input from funders and industry with GCC output
p.(None): Good practice Relevant GCC article
p.(None):
p.(None): Ensuring double ethics review Community
p.(None): engagement
p.(None): Clear roles and responsibilities
p.(None): Article 10: Local ethics review should be sought wherever possible.
p.(None):
p.(None): Article 2: Local communities and research participants should be included throughout the research process.
p.(None): Article 20: A clear understanding should be reached among collaborators with regard to their roles, responsibilities
p.(None): and conduct throughout the research cycle.
p.(None):
p.(None): funders and charitable funders of research (see Table 6.2). The three main good practice elements9 raised by funders
p.(None): and industry to stop ethics dumping are listed in Table 6.3, with their corresponding GCC articles (Singh and Makanga
p.(None): 2017).
p.(None): As already indicated, engagement with research funders was not restricted to one meeting, but took place over
p.(None): approximately two years via the funder and industry platforms described above. Additionally, the first draft of the GCC
p.(None): was distributed to all members of the platforms nine months after the workshop. Both groups pro- vided further comments
p.(None): on the draft.
p.(None):
p.(None):
p.(None): External Engagement with Researchers
p.(None):
p.(None): The consortium that drafted the GCC represented a wide range of academic disci- plines, namely ethics, medicine,
p.(None): economics, bioethics, law, social psychology, soci- ology, psychology, gender studies, chemistry, social sciences,
p.(None): psychiatry, biology, zoology, veterinary medicine, political science and management. The multidisci- plinary
p.(None): nature of the consortium’s expertise enabled broad engagement with the wider academic community. For example,
p.(None): academic presentations that included the GCC were delivered in Belgium, China, Congo, Cyprus, Germany, India, Kenya,
p.(None): Latvia, the Netherlands, the Philippines, Portugal, Rwanda, South Africa, Sweden, Taiwan, Uganda, Vatican City, the UK
p.(None): and the USA (Dammann and Schroeder 2018). The feedback from researchers was essentially threefold. First, researchers
p.(None): were interested in the potential “grey areas” of ethics dumping. A question in this context, asked on many occasions by
p.(None): different audiences, was: “If a particular research study has no real local relevance to LMICs, and the
p.(None): research money spent by well- intentioned researchers from HICs (who genuinely believe that they are improving the
...
p.(None): by many senior research ethics committee chairs and members, was an important fact-finding mission in the early stages
p.(None): of the project. Cases of exploita- tion were collated and good practice in research involving LMICs discussed
p.(None): (Chatfield et al. 2016b).
p.(None): Further in-depth consultation with ethics committee chairs formed part of a ple- nary workshop in Nairobi in 2017.
p.(None): TRUST received valuable input from three esteemed ethicists: Professor Elizabeth Bukusi (Deputy Director
p.(None): Research and Development, Kenya Medical Research Institute), Professor Anastasia Guantai (Kenyatta National
p.(None): Hospital) and Professor Kirana Bhatt (Chair of the National Bioethics Committee, University of Nairobi), who
p.(None): shared their respective experi- ences, concerns and insights. Table 6.5 summarizes some of the issues raised
p.(None): (Chatfield et al. 2016b) and their relationship to the final GCC.
p.(None):
p.(None): 66 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.5 Input from research ethics committee chairs and GCC output
p.(None): Input Relevant GCC article
p.(None):
p.(None): Intellectual property rights are often held only in the North.
p.(None):
p.(None): Attempts at gaining ethics approvals can be extremely late.
p.(None): LMIC partners’ tasks are restricted to obtaining data.
p.(None):
p.(None): Why does biological material need to be shipped abroad?
p.(None): Article 4: Local researchers should be included, wherever possible, throughout the research process, including in study
p.(None): design, study implementation, data ownership, intellectual property and authorship of publications.
p.(None): Article 11: Researchers from high-income settings should show respect to host country research ethics committees.
p.(None):
p.(None): Article 4 (see above)
p.(None): Article 20: A clear understanding should be reached among collaborators with regard to their roles, responsibilities
p.(None): and conduct throughout the research cycle.
p.(None): Article 5: Access by researchers to any … human biological materials … should be subject to the free and prior informed
p.(None): consent of the owners or custodians. Formal agreements should govern the transfer of any material or knowledge to
p.(None): researchers, on terms that are co-developed with resource custodians or knowledge holders.
p.(None):
p.(None): Analysis of Existing Guidelines
p.(None):
p.(None): We have summarized above the extensive consultation activities of the TRUST project prior to the actual
p.(None): drafting of the GCC. Aside from these valuable contribu- tions, it was also vital that the GCC should not set out to
p.(None): “reinvent the wheel”. Given the vast number of existing guidelines, and the significant expertise that went into
p.(None): drafting them, it was important for us to link the GCC to those existing guide- lines so as to produce something
p.(None): that did not replicate earlier work, but rather complemented it.
...
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p.(None): for Research in Resource-Poor Settings.
p.(None):
p.(None): Kate Chatfield is deputy director of the Centre for Professional Ethics, University of Central Lancashire, UK. She is a
p.(None): social science researcher and ethicist special- izing in global justice, research ethics, animal ethics and responsible
p.(None): innovation.
p.(None):
p.(None): Michelle Singh is a project officer at the European & Developing Countries Clinical Trials Partnership in Cape Town,
p.(None): South Africa. She holds a medical PhD and previ- ously managed maternal and child health research studies and clinical
p.(None): trials at the South African Medical Research Council.
p.(None):
p.(None): Roger Chennells works as legal adviser to the South African San Institute and is a founder-partner in the human rights
p.(None): law practice Chennells Albertyn, Stellenbosch, established in 1981. Specializing in labour, land, environmental and
p.(None): human rights law, he has also worked for Aboriginal people in Australia.
p.(None):
p.(None): Peter Herissone-Kelly is senior lecturer in philosophy, University of Central Lancashire, UK. He is a
p.(None): specialist in Kantian ethics as well as bioethics, analytic philosophy of language and metaethics.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xvii
p.(None):
p.(None): Abbreviations
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ACF Action contre la Faim
p.(None): CBD UN Convention on Biological Diversity COHRED Council on Health Research for Development EC
p.(None): European Commission (EC)
p.(None): EDCTP European and Developing Countries Clinical Trials Partnership EFPIA European Federation of
p.(None): Pharmaceutical Industries and Associations FERCI Forum for Ethics Review Committees in India
p.(None): GCC Global Code of Conduct for Research in Resource-Poor Settings GVA Global Values Alliance
p.(None): HIC high-income country
p.(None): Inserm Institut national de la santé et de la recherche médicale IPR intellectual property
p.(None): rights
p.(None): LMICs low- and middle-income countries NGO nongovernmental organization
p.(None): PHDA Partners for Health and Development in Africa REC research ethics committee
p.(None): SASC South African San Council SASI South African San Institute
p.(None): SWOP Sex Workers Outreach Programme
...
p.(None): A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The Global Code of Conduct for Research in Resource-Poor Settings (GCC) is designed to counter
p.(None): ethics dumping, i.e. the practice of moving research from a high-income setting to a lower-income setting to circumvent
p.(None): ethical barriers. The GCC is reprinted here. It was completed in May 2018 and adopted by the European
p.(None): Commission as a mandatory reference document for Horizon 2020 in August 2018. For more information on the GCC,
p.(None): please visit: http://www.global- codeofconduct.org/
p.(None):
p.(None): Keywords Global ethics · Research ethics · International co-operation · Ethics dumping · Low- and middle-income
p.(None): countries
p.(None):
p.(None):
p.(None): Research partnerships between high-income and lower-income settings can be highly advantageous for both
p.(None): parties. Or they can lead to ethics dumping, the prac- tice of exporting unethical research practices to lower-income
p.(None): settings.
p.(None): This Global Code of Conduct for Research in Resource-Poor Settings counters ethics dumping by:
p.(None): Providing guidance across all research disciplines
p.(None): presenting clear, short statements in simple language to achieve the highest possible accessibility
p.(None): focusing on research collaborations that entail considerable imbalances of power, resources and knowledge
p.(None): using a new framework based on the values of fairness, respect, care and honesty offering a wide range of learning
p.(None): materials and affiliated information to support the
p.(None): Code, and
p.(None): complementing the European Code of Conduct for Research Integrity through a particular focus on research in
p.(None): resource-poor settings.
p.(None):
p.(None):
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 5
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_2
p.(None):
p.(None): 6 2 A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None): Those applying the Code oppose double standards in research and support long- term equitable research relationships
p.(None): between partners in lower-income and high- income settings based on fairness, respect, care and honesty.
p.(None):
p.(None):
p.(None): Fairness
p.(None): Article 1
p.(None):
p.(None): Local relevance of research is essential and should be determined in collaboration with local partners. Research that
p.(None): is not relevant in the location where it is under- taken imposes burdens without benefits.
p.(None):
p.(None):
p.(None): Article 2
p.(None):
p.(None): Local communities and research participants should be included throughout the research process, wherever
p.(None): possible, from planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly
...
p.(None): country of origin of the researcher, animal experi- mentation should always be undertaken in line with the higher
p.(None): standards of protec- tion for animals.
p.(None):
p.(None): 10 2 A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None): Article 18
p.(None):
p.(None): In situations where environmental protection and biorisk-related regulations are inadequate or non-existent in
p.(None): the local setting compared with the country of origin of the researcher, research should always be undertaken in line
p.(None): with the higher stan- dards of environmental protection.
p.(None):
p.(None):
p.(None): Article 19
p.(None):
p.(None): Where research may involve health, safety or security risks for researchers or expose researchers to conflicts of
p.(None): conscience, tailored risk management plans should be agreed in advance of the research between the research team, local
p.(None): partners and employers.
p.(None):
p.(None):
p.(None): Honesty
p.(None): Article 20
p.(None):
p.(None): A clear understanding should be reached among collaborators with regard to their roles, responsibilities and conduct
p.(None): throughout the research cycle, from study design through to study implementation, review and dissemination.
p.(None): Capacity-building plans for local researchers should be part of these discussions.
p.(None):
p.(None):
p.(None): Article 21
p.(None):
p.(None): Lower educational standards, illiteracy or language barriers can never be an excuse for hiding information or providing
p.(None): it incompletely. Information must always be presented honestly and as clearly as possible. Plain language and a
p.(None): non-patronising style in the appropriate local languages should be adopted in communication with research participants
p.(None): who may have difficulties comprehending the research process and requirements.
p.(None):
p.(None):
p.(None): Article 22
p.(None):
p.(None): Corruption and bribery of any kind cannot be accepted or supported by researchers from any countries.
p.(None):
p.(None): Honesty
p.(None): 11
p.(None):
p.(None): Article 23
p.(None):
p.(None): Lower local data protection standards or compliance procedures can never be an excuse to tolerate the potential for
p.(None): privacy breaches. Special attention must be paid to research participants who are at risk of stigmatization,
p.(None): discrimination or incrimi- nation through the research participation.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
...
p.(None): principles, nobility, righteousness, rectitude, right-mindedness, upstandingness
p.(None):
p.(None): 24 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): What does need explaining, however, is the scope of the value of honesty in the context of global research ethics.
p.(None): Telling lies is only one possible wrongdoing in the context of a broad understanding of honesty. For instance, in
p.(None): research ethics it is equally unacceptable to leave out salient features from an informed consent process. While this
p.(None): might, strictly speaking, not involve a lie, concealing important informa- tion that might make a difference to
p.(None): someone’s consent violates the value of honesty as much as lying. For this reason, research ethicists often use the
p.(None): terms “transpar- ency” and “open communication” to ensure that all relevant information is provided so that research
p.(None): participants can make an informed choice about whether to partici- pate or not.
p.(None): In addition to lying and withholding information, there are other ways of being dishonest, in the sense of not
p.(None): communicating openly and transparently. For instance, in a vulnerable population with high levels of illiteracy, it can
p.(None): be predicted that a printed information sheet about research will not achieve informed consent. The same can be said
p.(None): for a conscious failure to overcome language barriers in a mean- ingful way: leaving highly technical English
p.(None): terms untranslated in information sheets can easily lead to misunderstandings.
p.(None): Honesty is also related to research conduct other than interaction with research participants. Most prominently, the
p.(None): duties of honesty are described in research integrity frameworks: do not manipulate your data, do not put your
p.(None): name onto pub- lications to which you have not contributed, do not waste research funds, to give only three examples.
p.(None): However, while the latter prescriptions for conduct with integ- rity in research are important, they are not directly
p.(None): linked to exploitation in global research collaboration and are not covered in the GCC. In this context, the European
p.(None): Code of Conduct for Research Integrity (ALLEA, 2017) is very helpful.
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): Standards, principles, values, virtues and ideals can guide moral action. At the foun- dation of the GCC are values.
p.(None): Why? For three main reasons:
p.(None): 1. Values inspire action; they motivate people to do things. For instance, when the value of fairness is threatened,
p.(None): people normally respond with action.
p.(None): 2. Values provide the golden middle way between being overly prescriptive and overly aspirational. Standards and
p.(None): principles require too much precision in their formulation and are too prescriptive in international collaborative
p.(None): research, while virtues and ideals are too aspirational in their demands of researchers.
p.(None): 3. Values emerged naturally from the major engagement activities undertaken prior to developing the GCC.
...
p.(None): considered “animal cruelty” or “inhumane practice” in animal experimentation varies greatly between cultures.
p.(None): Additionally, some ani- mals are awarded greater protection in certain cultures than others, for example, dogs and cats
p.(None): in the United Kingdom and cows in India. Animal experimentation on non-human primates is particularly controversial
p.(None): in most countries, but in some certain non-human primates are viewed as “pests” (Hill and Webber 2010). Different
p.(None): partners in collaborative research may have different philosophies related to the environment. Environmental
p.(None): protection is sometimes regarded as a colonial con- struct that has negative impacts on local communities in LMICs, and
p.(None): research agen- das likewise. There may therefore be a philosophical or paradigmatic difference between
p.(None): research partners that needs to be identified and addressed.
p.(None):
p.(None):
p.(None): Care
p.(None):
p.(None): Researchers who take good care in their research combine two elements: they care about research participants, in the
p.(None): sense that they are important to them, and they feel responsible for the welfare of those who contribute to their
p.(None): research, or might suffer as a result of it. In work with vulnerable communities, this might, for exam- ple, entail
p.(None): the tailoring of informed consent procedures to local requirements
p.(None):
p.(None): Our Findings
p.(None): 45
p.(None):
p.(None): (language, literacy, education levels) to achieve genuine understanding. Table 5.4 shows the primary risks related to
p.(None): care for persons, institutions, communities, coun- tries, animals and the environment.
p.(None): At the individual level, variations in spoken language, understanding, levels of literacy and use of terminology are
p.(None): just some of the issues that can lead to exploita- tion. The number of different ways in which individuals can suffer
p.(None): harm as a result of their involvement in research is vast. At the community level, the mere presence of a research team
p.(None): can have a great impact upon a local community. Research teams require food and accommodation, purchase local goods and
p.(None): services, and form rela- tionships with local people.
p.(None): At a national and international level, the rapid emergence of high-risk applica- tions of technologies such as genome
p.(None): editing7 challenges not only safety risk assess- ments but also existing governance tools. This creates an environment
p.(None): where risky experiments might be carried out in countries with an inadequate legal framework,
p.(None):
p.(None): Table 5.4 Primary risks for care
p.(None): Level of risk Nature of risk
p.(None): Personal • In medical research: therapeutic misconception
p.(None): • Misunderstanding of research aims
p.(None): • Procedures for informed consent not tailored to individual
p.(None): • Lack of possible actions to address adverse effects of participation
p.(None): • Direct risks, such as physical side effects
p.(None): • Indirect risks, such as stigmatization
p.(None):
p.(None): Researcher/ institutional
...
p.(None): been conducted in a manner that is consistent with high ethical standards such as EU Directive 2010/63 (EU 2010).
p.(None):
p.(None): References
p.(None): 49
p.(None):
p.(None): maintaining power differentials. To give one striking example, the United Nations Security Council has 15 members. Of
p.(None): these, ten are elected by the General Assembly for periods of two years while five (China, France, Russia, the United
p.(None): Kingdom and the United States) have been permanent members with “veto power” since 1946. More than 60 United
p.(None): Nations member states have never been members of the Security Council and hence have never even had voting
p.(None): rights, let alone veto power.
p.(None):
p.(None):
p.(None): Past History of Colonialism
p.(None):
p.(None): Does the history of colonialism still bear upon research today? We believe it does, as can be seen from the experience
p.(None): of indigenous peoples in research. Linda Tuhiwai Smith has powerfully shown that indigenous peoples often
p.(None): consider research a “dirty word”. She describes how “imperialism frames the indigenous experience” and how
p.(None): “indigenous peoples had to challenge, understand and have a shared lan- guage for talking about ... colonialism” (Smith
p.(None): 2012).
p.(None): We close this chapter with a comment from the TRUST gender adviser, Prof.
p.(None): Fatima Alvarez-Castillo (2016):
p.(None): A culture’s worldview, expressed in language, contains norms and values about power and relations of power. For
p.(None): example, the word “expert” imbues persons with authority and assigns higher credibility to their claims than
p.(None): those of non-experts. The public is expected to defer to their opinions on matters of their expertise. It was not until
p.(None): about the 1960s when the usual understanding of expertise was challenged by feminists, who argued that
p.(None): unschooled women have more expertise about their own situation than the experts. This ushered in a new research
p.(None): philosophy that valorizes poor women’s stories and their own versions of their realities.
p.(None):
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Alvarez-Castillo F (2016) Gender sensitivity: writing and language. In: Chatfield K, Schroeder D, Kimani J (eds)
p.(None): Nairobi plenary meeting report, TRUST Project. http://trust-project.eu/wp-
p.(None): content/uploads/2016/11/Meeting-Report-TRUST-Nairobi-Final.pdf
p.(None): Annas G, Grodin M (1998) Human rights and maternal-fetal HIV transmission prevention trials in Africa. American Journal
p.(None): of Public Health 88(4):560–563
p.(None): Bhatt K (2016) Concerns for Kenyan National Bioethics Committee when approving North-South collaborative projects. In:
p.(None): Chatfield K, Schroeder D, Kimani J (eds) Nairobi plenary meeting report, TRUST Project.
p.(None): http://trust-project.eu/wp-content/uploads/2016/11/Meeting-Report- TRUST-Nairobi-Final.pdf
p.(None): EU (2010) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of
p.(None): animals used for scientific purposes (text with EEA relevance). OJ L 276/33.
p.(None): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32010L0063
p.(None): Hill CM, Webber AD (2010) Perceptions of nonhuman primates in human–wildlife conflict sce- narios. American Journal of
p.(None): Primatology 72(10):919−924
p.(None): Hughes J (2010) European textbook on ethics in research. European Commission, Brussels
p.(None):
p.(None): 50 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): Luc G, Altare C. (2018) Social science research in a humanitarian emergency context. In: Schroeder D, Cook J, Hirsch F,
...
p.(None): available research studies after providing informed consent. Most studies are on the epidemiology of sexually
p.(None): transmitted diseases, and on host genetic factors that influence infectivity and disease progression.
p.(None): Given that sex work is illegal in Kenya, we cannot assign input to specific, named individuals here. Suffice to say
p.(None): that the personal contributions of courageous and admirable sex workers, both female and male, provided the TRUST team
p.(None): not only with practical advice that took shape in specific articles of the GCC, but also with inspiration. Table 6.4
p.(None): presents two examples of issues raised by the Nairobi sex workers (Chatfield et al. 2016a) that were implemented in the
p.(None): GCC.
p.(None):
p.(None): 64 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.4 Input from sex workers and GCC connection
p.(None): Issues raised by sex workers Relevant GCC Article
p.(None):
p.(None): “We need feedback to the community from the research in simple and non-scientific language. Some results have been
p.(None): shared with us in the past, but I did not know what they meant. Do not give us results in scientific language. It puts
p.(None): us at risk if we do not understand the results. … Come back with the results and tell us how we can make our lives
p.(None): better.”
p.(None): “We know that the samples that are collected from us are sometimes sent to other countries. What happens to them? In my
p.(None): culture – if my blood is taken, it must come back to me and I bury it. … [L]ocal and cultural values should be taken
p.(None): into account.”
p.(None): Article 3: Feedback about the findings of the research must be given to local communities and research participants. It
p.(None): should be provided in a way that is meaningful, appropriate and readily comprehended.
p.(None):
p.(None):
p.(None):
p.(None): Article 8: Potential cultural sensitivities should be explored in advance of research with local communities, research
p.(None): participants and local researchers to avoid violating customary practices. … If researchers from high-income settings
p.(None): cannot agree on a way of undertaking the research that is acceptable to local stakeholders, it should not take place.
p.(None):
p.(None): The main message that the TRUST team has been promoting since the meetings with the Nairobi sex workers has been: “Let
p.(None): representatives of vulnerable popula- tions speak for themselves” (Schroeder and Tavlaki 2018). As a result, a former
p.(None): sex worker from Nairobi brought the demands of her community to the European Parliament to great acclaim
p.(None): (TRUST 2018).
p.(None):
p.(None):
p.(None): Advocate Voices for Animals
p.(None):
...
p.(None): organizations from around the world, the agreed draft was released to the previously engaged external stakeholders, in
p.(None): line with further advice from Michael Davis (2007):
p.(None): Make the procedure as open as possible once there is a first draft. The openness … protects the drafting committee not
p.(None): only from the eccentricities of those outside the committee but from the tendency of drafting committees to forget
p.(None): practical constraints.
p.(None): All articles were accordingly submitted to a much broader peer review by those who had previously taken part in
p.(None): consultations, and their comments were obtained. Many of these comments were acted upon, including:
p.(None): • An industry representative’s suggestion to remove the following closing sen- tence from the draft article
p.(None): on community assent: “Developing personal, long- standing relationships with local communities produces the bedrock of
p.(None): respect.” This was on the basis that the statement did not apply to all international collab- orative research, and
p.(None): also that no other GCC article had such a commentary.
p.(None): • The request by several external stakeholders from various backgrounds that the qualification “wherever possible” be
p.(None): added to articles 2, 4 and 10, in order to be more realistic.
p.(None): • The proposal that “vehicle drivers” be removed from the examples of local research support systems given
p.(None): in article 7.
p.(None): After this extensive peer review, three further activities were undertaken. First, the final draft was reworked by a
p.(None): professional editor (Paul Wise in South Africa) to achieve the clearest, most precise and most accessible language.
p.(None): Second, the code was professionally designed for publication (CD Marketing Ltd, UK). Third, fund- ing was obtained
p.(None): (from the University of Central Lancashire, UK, and the EDCTP) to translate the code into Russian, French, Spanish,
p.(None): German, Portuguese, Mandarin, Japanese, and Hindi.14 Arabic and isiXhosa translations are in progress as this book goes
p.(None): to press.
p.(None):
p.(None): 14 The translations can be found at http://www.globalcodeofconduct.org/open-to-the-world/
p.(None):
p.(None): 70 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Early Adopters and Conclusion
p.(None):
p.(None): After an intensive and scrupulous development process, the GCC was launched at two high-profile events. First, at
p.(None): a meeting of the UN Leadership Council for Sustainable Development in Stockholm, Sweden, in May 2018,
p.(None): and then at the European Parliament in June 2018. The GCC had been under examination by the ethics and integrity
p.(None): sector and the legal services of the EC since March 2018. This allowed Dr Wolfgang Burtscher, Deputy
p.(None): Director-General for Research and Innovation of the EC, to announce the big news at the European Parliament event:
p.(None): the GCC would be a mandatory reference document for the framework programmes that fund European research. What this
p.(None): means was expressed succinctly in a Nature article.
p.(None): Ron Iphofen, an adviser on research ethics to the European Commission, believes the code will have a profound impact on
p.(None): how funding proposals to the EU are designed and reviewed. “I could envisage reviewers now looking suspiciously
...
p.(None): address health disparities in environmental and occupational health in the United States. Journal of Epidemiology and
p.(None): Community Health 62(8):668–676. https://doi. org/10.1136/jech.2007.067645
p.(None): Dammann J, Cavallaro F (2017) First engagement report. A report for TRUST. http://trust-project.
p.(None): eu/wp-content/uploads/2016/03/TRUST-1st-Engagement-Report_Final.pdf
p.(None): Dammann J, Schroeder D (2018) Second engagement report. A report for TRUST. http://trust-
p.(None): project.eu/wp-content/uploads/2018/12/TRUST-2nd-Engagement-Report-Final.pdf
p.(None): Davis M (2007) Eighteen rules for writing a code of professional ethics. Science and Engineering Ethics 13(2):171–189.
p.(None): Dunn A (2011) Community engagement: under the microscope. Wellcome Trust, London. https://
p.(None): wellcome.ac.uk/sites/default/files/wtvm054326_0.pdf
p.(None): European Commission (2013) Declarations of the Commission (framework programme) 2013/C 373/02. Official Journal of
p.(None): the European Union 20 December. http://ec.europa.eu/research/
p.(None): participants/data/ref/h2020/legal_basis/fp/h2020-eu-decl-fp_en.pdf
p.(None): Eurostat (2018) Intramural R&D expenditure (GERD) by source of funds. https://ec.europa.eu/
p.(None): eurostat/web/products-datasets/product?code=rd_e_gerdfund
p.(None): Gallo AM., Angst DB, Knafl KA (2009) Disclosure of genetic information within families. The American Journal of Nursing
p.(None): 109(4):65–69. http://www.ncbi.nlm.nih.gov/pubmed/19325321
p.(None): Hebert JR, Brandt HM, Armstead CA, Adams SA, Steck SE (2009) Interdisciplinary, translational, and community-based
p.(None): participatory research: finding a common language to improve can- cer research. Cancer Epidemiology, Biomarkers
p.(None): & Prevention 18(4):1213–1217. https://doi. org/10.1158/1055-9965.EPI-08-1166
p.(None): Horizon 2020 (nd) Evaluation of proposals. Research and Innovation, European Commission.
p.(None): http://ec.europa.eu/research/participants/docs/h2020-funding-guide/grants/
p.(None): from-evaluation-to-grant-signature/evaluation-of-proposals_en.htm
p.(None): Jack A (2012) Wellcome challenges science journals. Financial Times, 10 April. https://www.
p.(None): ft.com/content/81529c58-8330-11e1-ab78-00144feab49a
p.(None): Kelman A, Kang A, Crawford B (2019) Continued access to investigational medicinal products for clinical trial
p.(None): participants: an industry approach. Cambridge Quarterly of Healthcare Ethics 28(1):124–133.
p.(None): https://www.cambridge.org/core/product/identifier/S0963180118000464/ type/journal_article
p.(None): Kessel M (2014) Restoring the pharmaceutical industry’s reputation. Nature Biotechnology 32:983–990.
p.(None): https://doi.org/10.1038/nbt.3036
p.(None): Koshy K, Liu A, Whitehurst K, Gundogan B, Al Omran Y (2017) How to hold an effective meet- ing. International Journal
p.(None): of Surgery: Oncology 2(5):e22. Available at: http://www.ncbi.nlm. nih.gov/pubmed/29732455
p.(None): Levine R (2004) Research ethics committees. In: Post S (ed) Encyclopedia of bioethics, 3rd edn.
p.(None): Thomson & Gale, New York, p 2311–2316
p.(None): Montreal Statement (2013) Montreal statement on research integrity in cross-boundary research collaborations.
p.(None): http://ethics.iit.edu/codes/WCRI%202013.pdf
...
p.(None): We require respect for our culture, which also includes our history. We have cer- tain sensitivities that are not known
p.(None): by others. Respect is shown when we can input into all research endeavours at all stages so that we can explain these
p.(None): sensitivities.
p.(None): Respect for our culture includes respect for our relationship with the environment.
p.(None): Respect for individuals requires the protection of our privacy at all times. Respect requires that our contribution to
p.(None): research is acknowledged at all times. Respect requires that promises made by researchers need to be met.
p.(None): Respectful researchers engage with us in advance of carrying out research. There should be no assumption that
p.(None): San will automatically approve of any research projects that are brought to us.
p.(None): We have encountered lack of respect in many instances in the past. In Genomics research, our leaders were avoided, and
p.(None): respect was not shown to them. Researchers took photographs of individuals in their homes, of breastfeeding
p.(None): mothers, or of underage children, whilst ignoring our social customs and norms. Bribes or other advantages were
p.(None): offered. Failure by researchers to meet their promises to provide feedback is an example of disrespect which is
p.(None): encountered frequently.
p.(None):
p.(None):
p.(None): Honesty
p.(None):
p.(None): We require honesty from all those who come to us with research proposals.
p.(None): We require an open and clear exchange between the researchers and our leaders. The language must be clear, not
p.(None): academic. Complex issues must be carefully and
p.(None):
p.(None): 84 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): correctly described, not simply assuming the San cannot understand. There must be a totally honest sharing of
p.(None): information.
p.(None): Open exchange should not patronise the San. Open exchanges implies that an assessment was made of possible harms or
p.(None): problems for the San resulting from the research and that these possible harms are honestly communicated.
p.(None): Prior informed consent can only be based on honesty in the communications, which needs to be carefully documented.
p.(None): Honesty also means absolute transparency in all aspects of the engagement, including the funding situation, the purpose
p.(None): of the research, and any changes that might occur during the process.
p.(None): Honesty requires an open and continuous mode of communication between the San and researchers.
p.(None): We have encountered lack of honesty in many instances in the past. Researchers have deviated from the stated purpose of
p.(None): research, failed to honour a promise to show the San the research prior to publication, and published a biased paper
p.(None): based upon leading questions given to young San trainees. This lack of honesty caused much damage among the public, and
p.(None): harmed the trust between the collaborating organisation and the San. Another common lack of honesty is exaggerated
p.(None): claims of the researcher’s lack of resources, and thus the researchers’ inability to provide any benefits at all.
p.(None):
p.(None):
p.(None): Justice and Fairness
p.(None):
...
p.(None): there will be “consequences” for researchers who fail to comply with the Code.
p.(None): We have encountered lack of justice and fairness in many instances in the past. These include theft of San traditional
p.(None): knowledge by researchers. At the same time, many companies in South Africa and globally are benefitting from our
p.(None): traditional knowledge in sales of indigenous plant varieties without benefit sharing agree- ments, proving
p.(None): the need for further compliance measures to ensure fairness.
p.(None):
p.(None): Conclusion
p.(None): 85
p.(None):
p.(None): Care
p.(None):
p.(None): Research should be aligned to local needs and improve the lives of San. This means that the research process must be
p.(None): carried out with care for all involved, especially the San community.
p.(None): The caring part of research must extend to the families of those involved, as well as to the social and physical
p.(None): environment.
p.(None): Excellence in research is also required, in order for it to be positive and caring for the San. Research that is not up
p.(None): to a high standard might result in bad interac- tions, which will be lacking in care for the community.
p.(None): Caring research needs to accept the San people as they are, and take note of the cultural and social requirements of
p.(None): this Code of Ethics.
p.(None): We have encountered lack of care in many instances in the past. For instance, we were spoken down to, or confused with
p.(None): complicated scientific language, or treated as ignorant. Failing to ensure that something is left behind that improves
p.(None): the lives of the San also represents lack of care.
p.(None):
p.(None):
p.(None): Process
p.(None):
p.(None): Researchers need to follow the processes that are set out in our research protocols carefully, in order for this Code
p.(None): of Ethics to work.
p.(None): The San research protocol that the San Council will manage is an important process that we have decided on,
p.(None): which will set out specific requirements through every step of the research process.
p.(None): This process starts with a research idea that is collectively designed, through to approval of the project, and
p.(None): subsequent publications.
p.(None): The San commit to engaging fairly with researchers and manage effectively all stages of the research process, as their
p.(None): resources allow. They also commit to respect- ing the various local San structures (e.g. Communal Property
p.(None): Association, CPA leaders) in their communications between San leaders and San communities.
p.(None): Andries Steenkamp, the respected San leader who contributed to this Code of Ethics until he passed away in 2016, asked
p.(None): researchers to come through the door, not the window. The door stands for the San processes. When researchers respect
p.(None): the door, the San can have research that is positive for us.
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): Key to the achievements of the San in South Africa have been: dedicated San lead- ers of integrity, supportive NGOs,
p.(None): legal support, and long-term relationships with key individuals who also assisted with fundraising (see Fig. 7.1).
p.(None):
...
p.(None): In health research, has post-study access to successfully tested treatments or interventions been agreed?
p.(None): Where relevant, have means for recognizing and protecting traditional knowledge been agreed?
p.(None): How is full transparency in all aspects of the engagement and planning being ensured?
p.(None): Are procedures for open, two-way communication in place?
p.(None): Have all details that might impact upon individuals or the community been disclosed?
p.(None): Have requirements for an accessible and user-friendly complaints mechanism been discussed and agreed? What promises are
p.(None): being made to the local community
p.(None): in the design of the study and are they likely to be
p.(None): fulfilled?
p.(None): Respect Care
p.(None):
p.(None): Are the research team complying with local/community ethics codes?
p.(None): How is community knowledge being
p.(None): How are local needs being taken into account in the design of the study?
p.(None): Is due attention being paid to the impact of the study
p.(None): respected and integrated into the design? and the study team upon the participants, their
p.(None): families, the local community and the environment?
p.(None):
p.(None): Are the relevant members of the community, as identified by the community itself, involved in the design?
p.(None): How is community culture and tradition being respected in the design of the study?
p.(None): Have the relevant persons in the community given permission/approval for the study design?
p.(None): What measures have been taken to ensure understanding (such as translators and the use of clear, non-technical
p.(None): language)
p.(None):
p.(None): Have the resource implications of this design for the local community been identified?
p.(None):
p.(None): What measures are in place to ensure that the research is high quality and worthwhile so that the efforts of the
p.(None): community are not wasted?
p.(None):
p.(None):
p.(None): Where possible, members of the local community should be actively involved in undertaking the research. This
p.(None): may be in simple, practical operational or administrative capacities, but where appropriately qualified or
p.(None): experienced candi- dates are available, and/or where necessary training can be provided, this involve- ment should
p.(None): also include more complex tasks, with support from experienced researchers.
p.(None):
p.(None): 96 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): Table 8.3 Questions for reflection during implementation
p.(None): Fairness Honesty
p.(None):
p.(None): How are the local community engaged in the ongoing implementation of the research?
p.(None): Are local researchers and other members of the community taking active roles in the
p.(None): How are lines of communication functioning? Is there clear and transparent, two-way communication between the research
p.(None): team and the local community?
p.(None): implementation? How are the community being informed about
p.(None):
p.(None): Have measures for ensuring ethical compliance been discussed with the
p.(None): developments or any changes that occur during the research process?
p.(None): community and put in place? How is the complaints system functioning? Does
...
p.(None): much- needed benefits. Fear of retribution is often cited as a barrier to making a complaint, particularly in
p.(None): circumstances where the complainant has an ongoing relationship with the complainee (HPC 2009). In situations where
p.(None): there is a power imbalance, people may not have the confidence to complain; they may be reluctant to seem ungrateful,
p.(None): not wish to be seen as a complainer, or fear loss. Research has shown that some people even reconstruct negative
p.(None): experiences in a positive light in order to maintain relationships (Edwards et al. 2004).
p.(None): In addition to the above, participatory engagement activities in the TRUST proj- ect (Chapter 6) have revealed the
p.(None): following factors that could also act as barriers to research participants making complaints about research activities
p.(None): in LMICs:
p.(None): • Fear of damage or stigmatization from loss of confidentiality or anonymity. In Kenya, for example, where sex work
p.(None): is illegal, sex workers may be reluctant to make any formal complaints.
p.(None): • Cultural norms that preclude complaining. In some cultures, it is not acceptable to make complaints, especially
p.(None): to or about visitors and/or those in authority. Complaining may be perceived as disrespectful, ungrateful or
p.(None): inappropriate.
p.(None): • Illiteracy of research participants and communication (language) difficulties, leading to a lack of
p.(None): understanding of reasonable rights relating to informed con- sent and to reasonable expectations of the research.
p.(None):
p.(None): Developing an Accessible Complaints Procedure 101
p.(None):
p.(None): • Inability to access the means by which to file a complaint: for example, if only an email address is provided as a
p.(None): contact and one has no access to computers or internet connections.
p.(None):
p.(None):
p.(None): The Scope of a Complaints Procedure
p.(None):
p.(None): A comprehensive complaints procedure can have a broad scope; it can be used to complain about any activities that are
p.(None): associated with a research study. These may include, for example:
p.(None): • any perceived deviation from the information provided
p.(None): • any deviation from agreed processes
p.(None): • treatment by members of the research team that is considered inappropriate
p.(None): • problems with the organization of the study (for example, the competence of the researchers and their ability to
p.(None): perform duties)
p.(None): • the (mis)handling of personal or sensitive information
p.(None): • concerns about any unethical behaviour or practices by the research team
p.(None): The scope of a complaints procedure will also depend upon the intended users. Many complaints procedures are intended
p.(None): for use purely by participants in a research study. However, in collaborative ventures in LMICs, there may be a wide
...
p.(None): • Research costing: providing research partners with a basic understanding of cost considerations when developing a
p.(None): full cost research budget proposal
p.(None):
p.(None):
p.(None):
p.(None): 9 The entire online toolkit is available at http://frcweb.cohred.org/
p.(None):
p.(None): Conclusion
p.(None): 105
p.(None):
p.(None): • Technology transfer and capacity: concerning the flow of knowledge, experience and materials from one partner to
p.(None): another, and the ability of people and organiza- tions to manage their affairs and reach objectives successfully.
p.(None): The development of this resource means that vulnerable groups, such as com- munities or researchers without legal
p.(None): support, have access to resources that can help develop a good understanding of research contracting for equitable
p.(None): research part- nerships and avoid exploitation in research.
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): According to Eriksson et al. (2008), a serious flaw in most new ethics guidelines is that they are produced with the
p.(None): pretension that there are no other guidelines in exis- tence, and it would be much better if they just stated what they
p.(None): added to existing guidelines. Such is the case with the GCC, which focuses solely on factors that are specific to
p.(None): collaborative research ventures in resource-poor (primarily LMIC) set- tings. The GCC is succinct and written in plain
p.(None): language; it is meant to be equally accessible to researchers in HICs and to their intended partners in LMICs. In these
p.(None): respects, the GCC is very straightforward, but its simplicity will inevitably generate questions about how it should be
p.(None): implemented.
p.(None): For example, article 13 of the GCC states that a clear procedure for feedback, complaints or allegations of
p.(None): misconduct must be offered that gives genuine and appropriate access to all research participants and local
p.(None): partners to express any con- cerns they may have with the research process. Aside from the injunction that the
p.(None): procedure must be agreed with local partners at the outset of the research, there is no guidance on what this procedure
p.(None): should look like. This “thin approach” was used for a reason: no complaints mechanism will fit all situations. Hence,
p.(None): the emphasis is on the process, namely to agree with local partners on an approach. Codes are not enough in themselves
p.(None): to ensure ethical conduct; they need buy-in from all those involved, and such buy-in needs to be generated
p.(None): through effective engagement mechanisms.
p.(None): Researchers should therefore see community engagement as the gateway to effective implementation of the GCC.
p.(None): For example, when considering the local rel- evance of the proposed research (article 1), who better to ask than
p.(None): members of the local community? When wondering how best to seek informed consent, who better to ask than members of the
p.(None): local community? Consultation with the community offers the most direct route to addressing questions about
...
p.(None): address health disparities in environmental and occupational health in the United States. Journal of Epidemiology and
p.(None): Community Health 62(8):668–676. https://doi. org/10.1136/jech.2007.067645
p.(None): Cowan D, Halliday S (2003) The appeal of internal review: law, administrative justice and the (non-) emergence of
p.(None): disputes. Hart, Oxford
p.(None): Day G (2006) Community and everyday life. Routledge, London
p.(None): Dunn A (2011) Community engagement: under the microscope. Wellcome Trust, London Edwards C, Staniszweska S, Crichton N
p.(None): (2004) Investigation of the ways in which patients’ reports
p.(None): of their satisfaction with healthcare are constructed. Sociology of Health and Illness 26(2):159 Eriksson S, Höglund
p.(None): AT, Helgesson G (2008) Do ethical guidelines give guidance? A critical examination of eight ethics
p.(None): regulations. Cambridge Quarterly of Healthcare Ethics 17(1):15–29 Giorgini V, Mecca JT, Gibson C, Medeiros K, Mumford
p.(None): MD, Connelly S, Devenport LD (2015) Researcher perceptions of ethical guidelines and codes of conduct. Accountability
p.(None): in Research
p.(None): 22(3):123–138
p.(None): Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, Schulman KA (2009) Ethical and
p.(None): scientific implications of the globalization of clinical research. New England Journal of Medicine 360:816–823.
p.(None): https://doi.org/10.1056/NEJMsb0803929
p.(None): Hebert JR, Brandt HM, Armstead CA, Adams SA, Steck SE (2009) Interdisciplinary, translational, and community-based
p.(None): participatory research: finding a common language to improve can- cer research. Cancer Epidemiology, Biomarkers
p.(None): & Prevention 18(4):1213–1217. https://doi. org/10.1158/1055-9965.EPI-08-1166
p.(None): Henwood F, Wyatt S, Hart A, Smith, J (2003) Ignorance is bliss sometimes: constraints on the emergence of the
p.(None): “informed patient” in the changing landscapes of health information. Sociology of Health and Illness
p.(None): 25(6):589–607
p.(None): HPC (2009) Scoping report on existing research on complaints mechanisms. Health
p.(None): Professions Council. https://www.hcpc-uk.org/resources/reports/2009/
p.(None): scoping-report-on-existing-research-on-complaints-mechanisms/
p.(None): Jones L, Wells K (2007) Strategies for academic and clinician engagement in community- participatory
p.(None): partnered research. Journal of the American Medical Association 297(4):407–410 Lawton A (2004) Developing and
p.(None): implementing codes of ethics. Viešoji politika ir administravi-
p.(None): mas 7:94–101
p.(None): Martínez Cobo M (2014) Study on the problem of discrimination against indigenous populations. United Nations Department
p.(None): of Economic and Social Affairs. https://www.un.org/development/
p.(None): desa/indigenouspeoples/publications/2014/09/martinez-cobo-study/
p.(None): NIH (2011) Principles of community engagement. Washington, DC: CTSA Community Engagement Key
p.(None): Function Committee Task Force on the Principles of Community Engagement, National Institutes of Health.
p.(None): https://www.atsdr.cdc.gov/communityengagement/ pdf/PCE_Report_508_FINAL.pdf
p.(None):
p.(None): References
p.(None): 107
...
Social / Literacy
Searching for indicator illiterate:
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p.(None): Its ubiquitous use does not, however, mean that “respect” is a clear term. In everyday life, it is used in
p.(None): the sense of deep admiration. For instance, somebody could say, “I respect the achievements of Nelson Mandela”.
p.(None): However, that is not what is meant by respect in research ethics. The statement from the Declaration of Helsinki does
p.(None): not mean that research participants must be admired. To be respected in research ethics is almost the opposite. It
p.(None): means that one must accept a decision or a way of approaching a matter, even if one disagrees strongly. A case in point
p.(None): would be respecting the decision of a competent adult Jehovah’s Witness to refuse a blood transfusion for reasons of
p.(None): religious belief, even if this means certain death.
p.(None): Respect is therefore a difficult value, as there will be cases where one cannot accept another’s decision. For
p.(None): instance, if a researcher learns about female genital mutilation being used as a “cure” for diarrhoea in female babies
p.(None): (Luc and Altare 2018), respecting this approach to health care is likely to be the wrong decision – particularly as the
p.(None): practice is probably illegal. But the fact that respect may be dif- ficult to operationalize in global research
p.(None): collaborations does not mean that it is a value one can dispense with.
p.(None): There are many possible ways of showing respect that do not create conflicts of conscience. For instance, illiterate
p.(None): San community members should not be enrolled in research studies unless San leaders have been contacted first, in
p.(None): accordance with com- munity systems. And researchers from HICs should not insist that LMIC ethics com- mittees accept
p.(None): the format of the researchers’ preferred ethics approval submission; instead the HIC researchers should submit the
p.(None): study for approval in the format required by the LMIC committee. This shows respect in international collaborative
p.(None): research.
p.(None): While it may be difficult to imagine a situation where an HIC researcher is accused of being too fair, too
p.(None): honest or too caring, it is possible to be accused of being “too respectful” – for instance, if one tolerates major
p.(None): violations of human rights. It is indeed sometimes difficult to strike a balance between dogmatically
p.(None): imposing one’s own approach and carelessly accepting human rights violations, but that is the balance researchers
p.(None): should strive for.
p.(None):
p.(None):
p.(None): Care
p.(None):
p.(None): Sometimes one word describes different concepts. This is the case with “care”. The statement, “I care for my
p.(None): grandfather,” can mean two diametrically opposed things. First, it could mean that the person is very attached to her
p.(None): grandfather even though she hardly ever sees him. Second, it could mean that she is the person who injects
p.(None):
p.(None): The Four Values
p.(None): 23
p.(None):
p.(None): her grandfather with insulin, cooks his meals, and makes sure that his needs are taken care of every day, even if there
p.(None): is antipathy between them.
...
p.(None): Table 5.5 Primary risks for honesty through transparency
p.(None): Level of risk Nature of risk
p.(None): Personal • Inability of participant to provide fully informed individual consent:
p.(None): - Incomplete information provided
p.(None): - Information provided in an inappropriate format
p.(None): • Potential effects of participation not fully explained
p.(None): • Dual roles of researcher
p.(None):
p.(None): Researcher/ institutional
p.(None): • REC not fully independent
p.(None): • Cryptic research procedures
p.(None): Community Inability to provide fully informed community consent:
p.(None): - Incomplete information provided
p.(None): - Information provided in inappropriate format
p.(None): • Potential effects of participation not fully explained
p.(None): • Dual roles of researcher
p.(None): Country • Lack of data sharing Animal
p.(None): Environmental • Incomplete information about potential risks or harm to the environment
p.(None):
p.(None): Our Findings
p.(None): 47
p.(None):
p.(None): honesty through transparency for persons, institutions, communities, countries and the environment.
p.(None): There are many ways in which the informed consent process can be inadequate. For example, where there are
p.(None): omissions and/or inappropriate or misleading lan- guage for the context in which consent is being sought; when
p.(None): potential participants (some of whom may be illiterate) are not taken through any kind of suitable consent process but
p.(None): are, instead, provided with written information sheets to take home and told to come back with a signed consent form;
p.(None): or when information does not fully explain the potential (possibly harmful) consequences of
p.(None): participation. Misunderstanding can lead to a violation of trust: for example, where the research- ers are also aid
p.(None): workers or health care providers, potential participants may believe that they have to participate in order to receive
p.(None): the aid or treatment.
p.(None): A lack of transparency concerning research processes can make it very difficult to hold anyone accountable when things
p.(None): go wrong. For example, where numerous bodies are engaged in collaborative research and their separate activities and
p.(None): respon- sibilities are not clear, then it may be impossible to say where things have gone wrong and who is responsible.
p.(None): Honesty is also the foundation of research integrity. Honesty is essential in all aspects of research, including
p.(None): in the presentation of research goals, intentions and findings; in reporting on research meth- ods and procedures;
p.(None): in gathering data; in using and acknowledging the work of other researchers; and in conveying valid
p.(None): interpretations and making justifiable claims based on research findings (Universities UK 2015).
p.(None): Table 5.6 shows the primary risks for honesty through integrity for persons, insti- tutions, communities, countries,
p.(None): animals and the environment.
p.(None): Research misconduct can happen anywhere; it is not unique to collaborative ven- tures in LMICs. However, variations in
...
p.(None): Exploitative, 19, 38, 40, 41
p.(None):
p.(None):
p.(None): F
p.(None): Fairness, 2, 5–7, 13–24, 27–31, 33, 40–43, 68,
p.(None): 70, 74, 77–78, 82, 84, 90, 93, 95–98,
p.(None): 102, 110–112, 117
p.(None): Index
p.(None):
p.(None): Fair research contract (FRC), 90, 103, 104
p.(None): Farmers, 101
p.(None): Feedback, 6, 8, 20, 41, 48, 61, 63, 64, 83,
p.(None): 96, 105
p.(None): Four values framework, 13–24, 30, 102 Free and prior informed consent, 7, 66 Funders, 53–58, 60, 61, 70, 79, 116
p.(None):
p.(None):
p.(None): G
p.(None): Gender, 44, 49, 61, 100
p.(None): Genetic research, 54, 74, 92
p.(None): Genetics, 2, 7, 13, 60, 62, 63, 74, 75,
p.(None): 81, 82
p.(None): Global Code of Conduct for Research in Resource-Poor Settings, 2, 5, 14, 27,
p.(None): 37, 51, 80, 89, 109, 115–117
p.(None): Good Participatory Practice, 6, 20, 63
p.(None):
p.(None):
p.(None): H
p.(None): Harm, 1, 17, 19, 28, 34, 35, 38, 43, 45–47, 54,
p.(None): 65, 73, 75, 84, 95, 98
p.(None): Health and safety, 9, 10
p.(None): HealthyXvolunteers, 63
p.(None): Helicopter research, 23, 41
p.(None): High-income countries (HICs), 2, 9, 20–23,
p.(None): 38–44, 47, 48, 56, 65, 70, 99–101, 104
p.(None): Honesty, 2, 5, 6, 10–11, 13–24, 27–31, 33, 40,
p.(None): 46–48, 68, 70, 74, 82, 83, 90, 93,
p.(None): 95–98, 102, 110–112
p.(None): Horizon 2020, 23, 52, 53
p.(None): Human participants, 65, 117
p.(None): Human rights, 22, 42, 44, 55, 75
p.(None):
p.(None):
p.(None): I
p.(None): Ideals, 3, 16, 17, 24, 32
p.(None): Illegal, 22, 43, 63, 65, 100
p.(None): Illiterate populations, 22, 47
p.(None): Incrimination, 9, 11, 68
p.(None): India, 39, 44, 56, 61, 65, 110, 111, 115, 116
p.(None): Indigenous peoples, 49, 55, 63, 73, 75,
p.(None): 80, 112
p.(None): Industry, 39, 54–58, 61, 69, 70, 117
p.(None): Inequalities, vii
p.(None): Information sheets, 24, 47, 98, 103
p.(None): Informed consent, 2, 7, 8, 24, 44–47, 63, 66,
p.(None): 74, 82, 84, 100, 105
p.(None): Integrity, 5, 23, 24, 46–48, 53, 67, 70, 74,
p.(None): 78–79, 82, 85, 86, 94, 112, 117
p.(None): Intellectual property, 6, 20, 43, 60, 66,
p.(None): 80, 104
p.(None):
p.(None): Index
p.(None): 121
p.(None):
p.(None):
p.(None): K
p.(None): Kenya, 2, 39, 40, 42, 61, 63, 65, 100, 110,
p.(None): 115, 116
p.(None): !Khomani, 74, 77, 78, 81, 86
p.(None): Khwe, 74, 77, 78, 81
p.(None): Knowledge holders, 7, 55, 66
p.(None):
p.(None):
p.(None): L
p.(None): Lawyers, 79, 80, 104
p.(None): Legal framework, 45, 55
p.(None): Legal support, 74, 79, 80, 85, 105
p.(None): Local communities, 6, 7, 9, 20, 27, 40,
p.(None): 42–45, 52, 61, 63, 64, 69, 90, 92,
p.(None): 94–98, 105
p.(None): Local relevance, 6, 17, 60–62, 68, 102, 105
p.(None): Local researchers, 6, 7, 10, 20, 27, 40, 48, 60,
p.(None): 64, 66, 94, 96, 101
p.(None): Low- and middle-income countries (LMICs), 2, 20–22, 37–44, 46–48, 55, 56, 58, 61,
p.(None): 62, 65, 66, 69, 70, 99–105
p.(None):
p.(None):
p.(None): M
p.(None): Majengo, 63
p.(None): Medical research, 22, 23, 41, 45, 57, 65, 66,
p.(None): 104, 111, 116, 117
p.(None): Metaethical relativism, 30–32
p.(None): Misconduct, 8, 47, 105
p.(None):
p.(None):
p.(None): N
p.(None): Non-compliance, 1
p.(None): Non-governmental organisations (NGOs), 54, 63, 75–78, 85
p.(None): Non-human primates, 2, 44, 65
...
Searching for indicator literacy:
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p.(None): considered “animal cruelty” or “inhumane practice” in animal experimentation varies greatly between cultures.
p.(None): Additionally, some ani- mals are awarded greater protection in certain cultures than others, for example, dogs and cats
p.(None): in the United Kingdom and cows in India. Animal experimentation on non-human primates is particularly controversial
p.(None): in most countries, but in some certain non-human primates are viewed as “pests” (Hill and Webber 2010). Different
p.(None): partners in collaborative research may have different philosophies related to the environment. Environmental
p.(None): protection is sometimes regarded as a colonial con- struct that has negative impacts on local communities in LMICs, and
p.(None): research agen- das likewise. There may therefore be a philosophical or paradigmatic difference between
p.(None): research partners that needs to be identified and addressed.
p.(None):
p.(None):
p.(None): Care
p.(None):
p.(None): Researchers who take good care in their research combine two elements: they care about research participants, in the
p.(None): sense that they are important to them, and they feel responsible for the welfare of those who contribute to their
p.(None): research, or might suffer as a result of it. In work with vulnerable communities, this might, for exam- ple, entail
p.(None): the tailoring of informed consent procedures to local requirements
p.(None):
p.(None): Our Findings
p.(None): 45
p.(None):
p.(None): (language, literacy, education levels) to achieve genuine understanding. Table 5.4 shows the primary risks related to
p.(None): care for persons, institutions, communities, coun- tries, animals and the environment.
p.(None): At the individual level, variations in spoken language, understanding, levels of literacy and use of terminology are
p.(None): just some of the issues that can lead to exploita- tion. The number of different ways in which individuals can suffer
p.(None): harm as a result of their involvement in research is vast. At the community level, the mere presence of a research team
p.(None): can have a great impact upon a local community. Research teams require food and accommodation, purchase local goods and
p.(None): services, and form rela- tionships with local people.
p.(None): At a national and international level, the rapid emergence of high-risk applica- tions of technologies such as genome
p.(None): editing7 challenges not only safety risk assess- ments but also existing governance tools. This creates an environment
p.(None): where risky experiments might be carried out in countries with an inadequate legal framework,
p.(None):
p.(None): Table 5.4 Primary risks for care
p.(None): Level of risk Nature of risk
p.(None): Personal • In medical research: therapeutic misconception
p.(None): • Misunderstanding of research aims
p.(None): • Procedures for informed consent not tailored to individual
p.(None): • Lack of possible actions to address adverse effects of participation
p.(None): • Direct risks, such as physical side effects
p.(None): • Indirect risks, such as stigmatization
p.(None):
p.(None): Researcher/ institutional
p.(None): • No host country research ethics structures or inappropriate match with requirements
...
p.(None): Dumping
p.(None):
p.(None): comprehensive scoping review of existing mechanisms for complaints about health professionals (HPC 2009). In this
p.(None): report, the HPC describes a range of factors that can act as barriers to making a specific complaint. As there are no
p.(None): equivalent publi- cations about complaints procedures in LMICs, we summarize here the factors that are relevant to
p.(None): research in LMICs.
p.(None): Readiness to complain in any environment can be influenced by gender, ethnic- ity, age, education, income,
p.(None): accessibility of information and the perceived “serious- ness” of the problem (Pleasence et al. 2006).
p.(None): Specifically, ethnic minority communities are less likely to use systems that they perceive as being culturally
p.(None): insensitive and are more fearful of the consequences of taking action when they feel those systems have failed them.
p.(None): Difficulties with access to information are highlighted as a barrier to making a complaint (Henwood et al. 2003),
p.(None): especially where there is “information illiteracy”; some people possess the relevant skills and confidence to seek out
p.(None): information, but many do not. In situations where levels of education and literacy are not high, this is likely to be
p.(None): exacerbated.
p.(None): The relationship between the person who brings the complaint and the bureau- cracies to which they must direct
p.(None): their complaint can be a factor (Cowan and Halliday 2003). This relationship can either encourage or
p.(None): discourage a potential complainant’s trust in complaints mechanisms. The power imbalance between par- ties in such
p.(None): relationships can be substantial. For example, when working with impoverished communities, HIC researchers
p.(None): should be aware that participation in a clinical study may provide a participant’s only access to health care or other
p.(None): much- needed benefits. Fear of retribution is often cited as a barrier to making a complaint, particularly in
p.(None): circumstances where the complainant has an ongoing relationship with the complainee (HPC 2009). In situations where
p.(None): there is a power imbalance, people may not have the confidence to complain; they may be reluctant to seem ungrateful,
p.(None): not wish to be seen as a complainer, or fear loss. Research has shown that some people even reconstruct negative
p.(None): experiences in a positive light in order to maintain relationships (Edwards et al. 2004).
p.(None): In addition to the above, participatory engagement activities in the TRUST proj- ect (Chapter 6) have revealed the
p.(None): following factors that could also act as barriers to research participants making complaints about research activities
p.(None): in LMICs:
p.(None): • Fear of damage or stigmatization from loss of confidentiality or anonymity. In Kenya, for example, where sex work
...
Social / Marital Status
Searching for indicator single:
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p.(None): One can observe different moral norms
p.(None): There are no universal or extra-cultural moral truths
p.(None): We have to "live and let live"
p.(None): Fig. 4.1 Different types of relativism and their relationship
p.(None):
p.(None): which he calls normative relativism “possibly the most absurd view to have been advanced even in moral philosophy”. He
p.(None): writes:
p.(None): [T]he view is clearly inconsistent, since it makes a claim … about what is right and wrong in one’s dealings with other
p.(None): societies, which uses a nonrelative sense of “right” not allowed for in [metaethical relativism].
p.(None): In other words, metaethical relativism does not lead to any position, including normative relativism, which tells us
p.(None): what we should do in interacting with those from other cultures. This is simply because metaethical relativism itself
p.(None): tells us that there is no global “should”. Every claim about what we should do has been generated and will be bound by
p.(None): our own culture. If the imperative to treat those from other cultures with fairness, respect, care and honesty is
p.(None): thought to be one that floats free of, and exists outside, any culturally bound system of values, and we want the GCC
p.(None): to apply globally, then we cannot be metaethical relativists.
p.(None):
p.(None):
p.(None): A More Moderate Relativism
p.(None):
p.(None): It may be that we can justify the four values by appealing to the more moderate form of relativism espoused by David
p.(None): Wong (2009). According to Wong, although moral norms do indeed vary across cultures, as the descriptive
p.(None): relativist assumes, and although there is no one single true morality, there is something that is universal about
p.(None): morality, and common to all particular moralities worthy of the name.
p.(None): What is common is the central aim or purpose of morality. This aim is not itself a value in any given moral system, but
p.(None): rather what determines whether any given value is fit to figure in such a system. A consequence of this, and one which
p.(None): renders Wong’s relativism more palatable for many than more extreme versions, is that although there is no
p.(None): single true morality, some moral systems are better than others.
p.(None):
p.(None): 32 4 Respect and a Global Code of
p.(None): Conduct?
p.(None):
p.(None): Why? Because moral systems regulate interpersonal and intrapersonal conflicts. More precisely (Wong 2009: xii):
p.(None): Morality … comprises an idealized set of norms in imperatival form (“A is to do X under conditions C”) abstracted from
p.(None): the practices and institutions of a society that serves to regu- late conflicts of interest, both between persons and
p.(None): within the psychological economy of a single person.
p.(None): For instance, Western liberal democracies stress individual rights, while other systems involve a commitment to
p.(None): community goods, such as those to be found in Chinese, Indian and traditional African communities (Wong 1991: 445).
p.(None): When we consider such differences, what reason could we have for pronouncing one culture right and the others wrong? A
p.(None): relativistic approach will reply, “None.” Wong tells us (1991: 446):
p.(None): The argument for a relativistic answer may start with the claim that each type focuses on a good that may reasonably
p.(None): occupy the centre of an ethical ideal for human life. On the one hand, there is the good of belonging to and
p.(None): contributing to a community; on the other, there is the good of respect for the individual apart from any potential
p.(None): contribution to community. It would be surprising, the argument goes, if there were just one justifiable way of setting
p.(None): a priority with respect to the two goods. It should not be surprising, after all, if the range of human goods is simply
p.(None): too rich and diverse to be reconciled in just a single moral ideal.
p.(None): Wong’s approach may be more acceptable than an extreme, uncompromising metaethical relativism (and potentially
p.(None): more serviceable as a means of grounding the four GCC values), but it is not without its problems. For
p.(None): example, Michael Huemer (2005) points out a dilemma for any such relativism. That dilemma is revealed
p.(None): when we ask whether the regulation of interpersonal and intrapersonal conflicts is itself something that we
p.(None): should regard as good. If it is, then the regulation of such conflicts represents a value that transcends cultures,
p.(None): grounding any accept- able morality in any society and/or time. Hence, we would have at least one univer- sal value
p.(None): rather than a form of relativism.
p.(None): As a result, Wong’s approach still does not give us any definite universal values (at a minimum, the four values that
p.(None): feature in the GCC).
p.(None):
p.(None):
p.(None): Grounding the Global Applicability Thesis of the GCC in a Common Morality
p.(None):
p.(None): In their celebrated book Principles of Biomedical Ethics, Tom Beauchamp and James Childress have, over the
p.(None): course of 34 years and seven editions, maintained that there are four principles that are particularly applicable to
p.(None): problems in biomedical ethics: respect for autonomy, beneficence, non-maleficence and justice. As explained above,
p.(None): their claim is that these principles are globally applicable because they are part of what Beauchamp and Childress call
...
p.(None): a new drug against malaria, while others, the control group, are given a substance that should have no effect (the
p.(None): placebo), so that the outcomes can be compared.
p.(None): 3 One speaks of a proven standard of care when a treatment already exists for the illness under consideration in a
p.(None): trial. Hence, the ethical demand of testing any new drug against an existing one rather than a placebo is known as the
p.(None): “standard of care” debate.
p.(None):
p.(None): Our Method
p.(None): 39
p.(None):
p.(None): can help to increase awareness but, in our case, it also ensures that the GCC is designed in such a way
p.(None): that researchers are compelled to consider these factors. It is a unique facet of the GCC that it focuses the attention
p.(None): of researchers directly upon the primary risks of exploitation in collaborative HIC-LMIC research. This could only be
p.(None): achieved via thorough exploration of the risks from many perspectives, both top-down and bottom-up.
p.(None):
p.(None):
p.(None): Our Method
p.(None):
p.(None): The aim of this investigation was to identify the critical vulnerabilities that engender susceptibility to exploitation
p.(None): in LMIC-HIC collaborative research. Investigation of this vast subject would be impossible from a traditional
p.(None): literature-based approach, or through investigation in a single geographical region. Many of these vulnerabili- ties
p.(None): are poorly represented in the literature, and they can differ between countries, cultures and types of research. For
p.(None): example, clinical trials, social science, animal experiments, environmental science and research in emergency settings
p.(None): may pose a diverse array of risks that are largely determined by the local context. Consequently, a creative approach
p.(None): to data collection was needed to capture as many risks and vul- nerabilities as possible.
p.(None): In this regard it was very helpful that the interdisciplinary TRUST project con- sortium comprised multilevel ethics
p.(None): bodies, policy advisers and policymakers, civil society organizations, funding organizations, industry and academic
p.(None): scholars from a range of disciplines. With input from each of these perspectives, a broad-based consultative exercise4
p.(None): was possible which included input from these collaborators as well as more than 30 members and chairs of ethics
p.(None): committees in LMICs, represen- tatives from vulnerable populations in LMICs, and an open call for case studies of
p.(None): exploitation in research in LMICs (Chapter 6).
p.(None): For example, extensive input from members and chairs of ethics committees was sought in both India and Kenya. In India,
p.(None): the Forum for Ethics Review Committees in India (FERCI) hosted a two-day workshop in Mumbai on 11 and 12 March 2016. At
p.(None): this workshop, approximately 30 leading bioethicists from around India came together to share their experiences and
...
p.(None): the same time, with such a pressing need for innovative solutions to LMIC problems, the violation of article 1 of the
p.(None): GCC (local relevance of research) and the avoidable waste of limited funding resources must count as
p.(None): unethical.
p.(None): A second recurring response to the GCC from researchers has been that “every- one loved our values”.10 Audiences in
p.(None): HICs – England, for instance – even asked whether they could use the four values in national research in their own
p.(None): countries. Hence, rather than seeing the values as solely applicable when there are vast power differentials between
p.(None): researchers and research participants (as between HICs and LMICs), they were keen to use them in any research.
p.(None): A third recurring issue for researchers has been the following: “We appreciate that the code is short and accessible,
p.(None): but wouldn’t a longer, more detailed code give more support to early career researchers?” The TRUST consortium agreed
p.(None): upon a concise code because it is vital that the demands of substance for each article be clear and straightforward,
p.(None): while the process demands remain flexible. Let us take article 1 as an example:
p.(None): The substance element of article 1 is: “Local relevance of research is essential”. Further information would not be
p.(None): helpful to early career (or any other) researchers. The process element of article 1 is: “[Local relevance] should be
p.(None): determined in collaboration with local partners.” This could only be set out in more detail if there were a single
p.(None): process that would fit every situation – and that is not the case. What an equitable process for determining research
p.(None): goals should look like in an interna- tional collaborative research project is one of the things that need to be agreed
p.(None): on within the process of that project. Hence, prescriptive details would have been coun-
p.(None): terproductive to the very spirit of the article.
p.(None): Instead of attempting to formulate a range of possibilities to fill the process ele- ments with substance, we opted to
p.(None): provide educational material to support the GCC online,11 because any process requirements are best agreed
p.(None): between the relevant partners rather than imposed prescriptively by code drafters. Hence, our educational materials
p.(None): future-proof the GCC, as they can be updated in real time for use by early career (or any other) researchers, and,
p.(None): unlike the GCC itself, they are not mandatory.
p.(None):
p.(None):
p.(None): 10 Personal communication from Dr Vasantha Muthuswamy, a TRUST project team member, after a GCC presentation in Taiwan.
p.(None): 11 http://www.globalcodeofconduct.org/
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 63
p.(None):
p.(None): Engagement with Research Participants and Research Communities
p.(None):
p.(None): The inclusion of the perspectives of research participants and research communities who are vulnerable to exploitation,
...
p.(None): challenge of how unwanted research could be controlled. Without the collaborative support of international research
p.(None): partners, it is doubtful that the San Code of Research Ethics would have emerged.
p.(None):
p.(None):
p.(None): Drafting the San Code of Research Ethics
p.(None):
p.(None): Building on various earlier efforts, the San Code of Research Ethics was drafted over the course of three workshops and
p.(None): much intervening work during the year prior to its launch in March 2017.
p.(None): In March 2016, SASI organized a preparatory workshop at which San represen- tatives voiced their concerns and reported
p.(None): their past involvement in national and international research studies. Examples of good and bad research case studies
p.(None): were identified, in order to guide a revision of the San Media and Research Contract and the drafting of a San
p.(None): Code of Research Ethics. The aim was to help the South African San manage their involvement in research and
p.(None): heritage studies. Delegates included SASC members plus leaders from the !Xun, the Khwe and the !Khomani, together with
p.(None): selected invited experts from the fields of genetics, sociology, ethnol- ogy, research ethics and law. During this
p.(None): workshop the participants received back- ground information on research in the different fields, delivered by
p.(None): the experts attending the workshop.
p.(None): Based on this input, initial ideas to improve research engagement were devel- oped. The following ideas were voiced:
p.(None): • A single central body needs to be created with clear external and internal author- ity, and the capacity to manage
p.(None): research and media issues.
p.(None): • A code of ethics needs to be established, whereby researchers are able to under- stand the “dos and don’ts” of
p.(None): engaging with the San.
p.(None): • Training needs to take place, both of the leaders or local coordinators of research and among the communities and
p.(None): individuals who are required to participate.
p.(None): • Research and media contracts need to be drawn up in such a way that research is not discouraged, but is managed
p.(None): for the benefit of the community. Research which is not felt to be useful should be refused.
p.(None): • Noncommercial research or engagement should be managed with basic con- tracts. More in-depth research
p.(None): should be managed with more complex contracts as appropriate.
p.(None): • There should be consequences and penalties for failure to comply with the terms of such contracts.
p.(None): • Funds should be raised in order to establish a research monitoring and compli- ance body with the SASC.
p.(None): In May 2016, SASI organized a full workshop with 22 San representatives and a further eight external contributors,
p.(None): again from the fields of genetics, sociology, eth- nology, research ethics and law. On this occasion, work was
p.(None): undertaken to ensure
p.(None):
p.(None): 82 7 The San Code of
p.(None): Research Ethics
p.(None):
...
p.(None): may mean offering a range of methods for information sharing and complaint acceptance – verbal, written, and through
p.(None): trusted spokespersons and community groups etc.
p.(None):
p.(None): A Fair Research Contracting Tool
p.(None): 103
p.(None):
p.(None): involved with or affected by the research so that they can help guide the develop- ment of appropriate procedures.
p.(None): Additionally, strategies8 will need to be developed for dealing with different types of complaints. It is
p.(None): important to try to avoid complex and overly burdensome strategies which all too easily become legalistic and
p.(None): formalized. In practice this can mean that nothing is set up at all, or that what is established becomes little more
p.(None): than an ineffective bureaucratic exercise. While more formal approaches and struc- tures may work in “Western”
p.(None): settings, these are unlikely to be effective in the kinds of vulnerable communities where care is needed to safeguard
p.(None): and empower; they may even have the opposite effect, and discourage any engagement at all on com- plaints issues.
p.(None): Equally, the challenges in establishing an effective strategy should not act as an excuse for researchers to adopt an
p.(None): oversimplified model (such as a contact name on the information sheet) that is of little or no benefit to anyone. For
p.(None): each unique situ- ation, researchers should work with communities to cocreate effective strategies that take
p.(None): into account the circumstances, situation and culture of that community and the individuals to be recruited to the
p.(None): study.
p.(None): While it is not possible for us to specify a single “model” complaints procedure, we have shown how the values can
p.(None): provide the basis of any complaints procedure. With these values embedded in the thinking of the research community,
p.(None): they can then seek to work with whatever procedures and structures are available, adapting, improving and tailoring
p.(None): them for application in the real world. The individuals and groups involved should feel respected, cared for, fully
p.(None): informed, treated fairly and empowered.
p.(None): Most protective mechanisms, including complaints procedures, are strengthened when supported by legal systems, but
p.(None): participants, communities, researchers and institutions in LMICs often have no or very limited access to legal advice
p.(None): or protec- tion. The next section introduces an online toolkit that will be helpful in such situations.
p.(None):
p.(None):
p.(None): A Fair Research Contracting Tool
p.(None):
p.(None): The need for fair research contracts is best illustrated by the situation in interna- tional collaborative health
p.(None): research. Research undertaken in LMICs can lead to sig- nificant benefits flowing into HICs. In 2009, Glickman et al.
p.(None): undertook a systematic review to examine what had led to a “dramatic shift in the location of clinical trials” and
p.(None): concluded that important factors were:
p.(None): • shortened timelines for clinical testing due to a larger pool of research participants
p.(None):
p.(None): 8 These might include internal resolution through study-specific schemes; internal resolution through research
p.(None): ethics committees; litigation through the courts; or alternative dispute resolution mechanisms such as mediation,
p.(None): adjudication and arbitration.
p.(None):
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 9
p.(None): Towards Equitable Research Partnership
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The world’s largest collection of professional ethics codes already holds more than 2,500 codes. What can
p.(None): the Global Code of Conduct for Research in Resource-Poor Settings (GCC) add? This brief chapter gives
p.(None): co-authors and sup- porters of the GCC the opportunity to show why a code with the single-minded aim of eradicating
p.(None): ethics dumping is needed.
p.(None):
p.(None): Keywords Global ethics · Research ethics · International co-operation · Ethics dumping · Low- and middle-income
p.(None): countries
p.(None):
p.(None):
p.(None): The world’s largest collection of professional ethics codes holds more than 2,500 codes (IIT nd). Is another ethics
p.(None): code really needed? The evidence gathered on the 21st-century export of unethical research practices from
p.(None): high-income to lower- income settings says it is (Schroeder et al. 2018). Such ethics dumping still occurs despite a
p.(None): proliferation of ethics codes. This could be for either of two main possible reasons. First, an ethics code designed to
p.(None): guard against ethics dumping is not yet available. Second, ethics codes are not suitable for guarding against ethics
p.(None): dumping. We would agree with the first, but not the second.
p.(None): Instead of summarizing the book, this chapter concludes by giving the floor to co-authors and supporters of the Global
...
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p.(None): access antiretroviral drugs to prevent the transmission of HIV to her unborn baby is to participate in a
p.(None): placebo-controlled clinical trial,2 despite the existence of a proven standard of care,3 then one could say she has
p.(None): been coerced into enrolling (Annas and Grodin 1998). In this sense, exploi- tation occurs where one party takes
p.(None): advantage of another by making them an offer they cannot refuse; they are then coerced to accept simply because there
p.(None): is no alter- native. Others argue that exploitation is wrong because it treats human beings as means rather than ends
p.(None): (Wood 1995). In other words, exploitation instrumentalizes people. Yet others claim that exploitation is wrong
p.(None): because it disadvantages the vulnerable (Macklin 2003).
p.(None): Our investigation was concerned with the risks or vulnerabilities for exploitation, so we adopted Macklin’s definition
p.(None): of exploitation. However, it is important to bear in mind that situations that are conducive to exploitation do not
p.(None): necessarily lead to exploitation. For instance, if a pharmaceutical company is due to test new antiretro- viral drugs
p.(None): to prevent the transmission of HIV to unborn babies, and the company operates in a country where poor mothers have no
p.(None): or very limited access to health care, it does not mean that exploitation will necessarily occur. The company may
p.(None): decide not to exploit vulnerable research participants and offer the accepted stan- dard of care to those in the
p.(None): control arm, rather than a placebo.
p.(None): Exploitation usually requires a moral decision on the part of the potential exploiter, but it can also occur
p.(None): through ignorance. Whether intended or unintended, the effects of exploitation are the same for the exploited. Hence,
p.(None): ignorance is not a legitimate justification for exploitation. Uncovering the primary risks of exploitation
p.(None):
p.(None): 2 A placebo-controlled trial involves some participants being given a medicine with active ingredi- ents, for instance
p.(None): a new drug against malaria, while others, the control group, are given a substance that should have no effect (the
p.(None): placebo), so that the outcomes can be compared.
p.(None): 3 One speaks of a proven standard of care when a treatment already exists for the illness under consideration in a
p.(None): trial. Hence, the ethical demand of testing any new drug against an existing one rather than a placebo is known as the
...
p.(None): its ethical dimensions.
p.(None): The subsequent draft, which had been edited from both a legal and an ethical perspective, was then presented to the San
p.(None): leadership for adoption. Further minor changes were made, until the code was unanimously adopted and declared ready to
p.(None): be launched by the San leadership.
p.(None):
p.(None):
p.(None): The San Code of Research Ethics
p.(None): Respect
p.(None):
p.(None): We require respect, not only for individuals but also for the community.
p.(None): We require respect for our culture, which also includes our history. We have cer- tain sensitivities that are not known
p.(None): by others. Respect is shown when we can input into all research endeavours at all stages so that we can explain these
p.(None): sensitivities.
p.(None): Respect for our culture includes respect for our relationship with the environment.
p.(None): Respect for individuals requires the protection of our privacy at all times. Respect requires that our contribution to
p.(None): research is acknowledged at all times. Respect requires that promises made by researchers need to be met.
p.(None): Respectful researchers engage with us in advance of carrying out research. There should be no assumption that
p.(None): San will automatically approve of any research projects that are brought to us.
p.(None): We have encountered lack of respect in many instances in the past. In Genomics research, our leaders were avoided, and
p.(None): respect was not shown to them. Researchers took photographs of individuals in their homes, of breastfeeding
p.(None): mothers, or of underage children, whilst ignoring our social customs and norms. Bribes or other advantages were
p.(None): offered. Failure by researchers to meet their promises to provide feedback is an example of disrespect which is
p.(None): encountered frequently.
p.(None):
p.(None):
p.(None): Honesty
p.(None):
p.(None): We require honesty from all those who come to us with research proposals.
p.(None): We require an open and clear exchange between the researchers and our leaders. The language must be clear, not
p.(None): academic. Complex issues must be carefully and
p.(None):
p.(None): 84 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): correctly described, not simply assuming the San cannot understand. There must be a totally honest sharing of
p.(None): information.
p.(None): Open exchange should not patronise the San. Open exchanges implies that an assessment was made of possible harms or
p.(None): problems for the San resulting from the research and that these possible harms are honestly communicated.
p.(None): Prior informed consent can only be based on honesty in the communications, which needs to be carefully documented.
p.(None): Honesty also means absolute transparency in all aspects of the engagement, including the funding situation, the purpose
p.(None): of the research, and any changes that might occur during the process.
p.(None): Honesty requires an open and continuous mode of communication between the San and researchers.
p.(None): We have encountered lack of honesty in many instances in the past. Researchers have deviated from the stated purpose of
...
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p.(None):
p.(None):
p.(None): 1 The export of unethical research from a high-income setting to a resource-poor setting with weaker
p.(None): compliance structures or legal governance mechanisms.
p.(None): 2 TRUST was an EU-funded project which operated from 2015 to 2018 and developed the GCC, among other outputs.
p.(None): http://trust-project.eu/
p.(None): 3 This section draws on unpublished work by Professor Michael Davis, a philosopher specializing in professional ethics.
p.(None):
p.(None): The Meaning of “Value”
p.(None): 15
p.(None):
p.(None): Fig. 3.1 The meaning of value
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Value
p.(None):
p.(None):
p.(None):
p.(None): Measurement
p.(None):
p.(None):
p.(None): Worthy to agents
p.(None):
p.(None): Morally worthy to agents
p.(None):
p.(None):
p.(None): valued at a certain amount of money. Value, in this sense of the word, has no rela- tionship to values such as
p.(None): admiration, approval or motivation.
p.(None): Secondly, people can value certain features or entities. For instance, somebody might value money, fame or glory. For
p.(None): value to exist, there must be an agent (a per- son) who is doing the valuing, and the feature or entity must be worth
p.(None): something to this agent (Klein 2017). The values of one individual can be very different from those of another person.
p.(None): For instance, a regular income is worth a lot to a person who values routine and security; it can contribute to their
p.(None): wellbeing and happiness. Others, who value personal freedom more than routine and security, might be just as happy with
p.(None): occasional income, as long as they are not bound to a nine-to-five job. If most humans around the world value a
p.(None): particular thing, it can be described as a universal value.
p.(None): Thirdly, values can refer to goals and ambitions, with a moral connotation. In business literature, for example, one
p.(None): often finds reference to value-led management or organizational values, and many institutions make a point of
p.(None): establishing, pro- moting and broadcasting their values. For instance, the stated values of the University of Central
p.(None): Lancashire (UCLan), at which several of the authors of this book are based, are: common sense, compassion,
p.(None): teamwork, attention to detail and trust (UCLan nd). These values are all morally positive and they are intended to
p.(None): guide the actions of students, staff and the institution itself. In this third sense of the word, moral values “will
p.(None): enable us to determine what is morally right or what is valuable in particular circumstances” (Raz 2001: 208). If
p.(None): most humans around the world share a particular moral value, it can be described as a universal moral value.
p.(None): There are numerous advantages to having credible moral values at the level of organizations. Such values influence the
p.(None): culture of an organization (Martins and Coetzee 2011), which in turn has a positive impact upon corporate performance
p.(None): (Ofori and Sokro 2010), and job stress and satisfaction (Mansor and Tayib 2010), as well as business performance and
p.(None): competitive advantage (Crabb 2011). Furthermore, when employees’ values are aligned with organizational values, this
p.(None): benefits both the wellbeing of individuals and the success of the organization (Posner 2010).
p.(None): There are many internet sites that offer lists of core values. One of them (Threads Culture nd) includes 500 values,
p.(None): from “above and beyond” to “work life balance”.
p.(None):
p.(None): 16 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Not all of these are moral values. For instance, this particular list includes values such as clean, exuberant,
p.(None): hygienic, neat, poised and winning (Threads Culture nd). Another site lists 50 values, including authenticity, loyalty
p.(None): and wisdom, and advises that fewer than five should be selected for leadership purposes (Clear nd).
p.(None): The GCC is structured around four moral values: fairness, respect, care and hon- esty. These four values were not
p.(None): chosen from any existing lists; they emerged through in-depth consultation efforts around the globe (chapter 6).
p.(None): But why did the TRUST team choose moral values rather than other action-guiding moral modes for the GCC?
p.(None):
p.(None):
p.(None): What Can Guide Moral Action?
p.(None):
p.(None): The GCC is based on moral values, but the code authors could have opted to frame the code and guide action in other
p.(None): ways, including the following:
p.(None): • Standards is a technical term used to achieve desired action. Standards are pre- cise and give exact
p.(None): specifications, which are in many cases measurable, as in the maximum vehicle emissions allowed for cars. Standards can
...
p.(None): Google (nd) Honesty: synonyms. https://www.google.com/search?q=honesty&ie=&oe= Google (2018) Google search for
p.(None): “Honesty” conducted on 24 November 2018.
p.(None): Huijer M, van Leeuwen E (2000) Personal values and cancer treatment refusal. Journal of Medical Ethics 26(5):358–362
p.(None): ISO (nd) ISO 26000: social responsibility. International Organization for Standardization. https://
p.(None): www.iso.org/iso-26000-social-responsibility.html
p.(None): Kaufmann E (2016) It’s NOT the economy, stupid: Brexit as a story of personal values. British Politics and Policy.
p.(None): London School of Economics and Political Science. http://blogs.lse.ac.uk/
p.(None): politicsandpolicy/personal-values-brexit-vote/
p.(None): Klein LA (2017) A free press is necessary for a strong democracy. ABA Journal. http://www.aba-
p.(None): journal.com/magazine/article/free_press_linda_klein?icn=most_read
p.(None): Locke EA (1991) The motivation sequence, the motivation hub, and the motivation core.
p.(None): Organizational Behavior and Human Decision Processes 50(2):288–299
p.(None): Luc G, Altare C (2018) Social science research in a humanitarian emergency context. In: Schroeder D, Cook J, Hirsch F,
p.(None): Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North- South research collaborations. Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 9–14. https://link.springer.com/book/10.1007%2F978-3-319-64731-9
p.(None): Mansor M, Tayib D (2010). An empirical examination of organisational culture, job stress and job satisfaction within
p.(None): the indirect tax administration in Malaysia. International Journal of Business and Social Science 1(1):81–95
p.(None): Marcum JA (2008). Medical axiology and values. In: An introductory philosophy of medicine: humanizing modern medicine.
p.(None): Philosophy and Medicine 99. Springer Science and Business Media, p 189–205
p.(None): Martins N, Coetzee M (2011) Staff perceptions of organisational values in a large South African manufacturing company:
p.(None): exploring socio-demographic differences. SA Journal of Industrial Psychology 37(1):1–11
p.(None): Mitchell LA (2015) Integrity and virtue: the forming of good character. The Linacre Quarterly 82(2):149–169
p.(None): NMC (2018) The code: professional standards of practice and behaviour for nurses, midwives and nursing associates.
p.(None): Nursing & Midwifery Council. https://www.nmc.org.uk/standards/code/ Ofori DF, Sokro E (2010). Examining the impact of
p.(None): organisational values on corporate perfor-
p.(None): mance in selected Ghanaian companies. Global Management Journal 2(1)
p.(None): Ogletree TW (2004) Value and valuation. In: Post SG (ed) Encyclopedia of bioethics, 3rd edn.
p.(None): MacMillan Reference USA, New York, p 2539–2545
p.(None): Owen R, Stilgoe J, Macnaghten P, Gorman M, Fisher E, Guston D (2013) A framework for respon- sible innovation. In:
p.(None): Owen, R, Bessant J, Heintz M (eds) Responsible innovation: managing the responsible emergence of science and innovation
p.(None): in society. John Wiley, London, p 27–50
p.(None):
p.(None): 26 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Pasewark WR, Riley ME (2010) It’s a matter of principle: the role of personal values in investment decisions. Journal
...
p.(None): competition to describe cases of ethics dumping was launched in 2016. Applicants from around the world were invited to
p.(None): submit short abstracts of ethics dumping cases, which involved research undertaken in low- and middle- income countries
p.(None): (LMICs) conducted by researchers, sponsors or funders from high-income countries (HICs). Cases could
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 57
p.(None):
p.(None): report on events related to any research field. A judging committee selected by TRUST ranked the best ten
p.(None): abstracts, and shortlisted applicants were invited to sub- mit a full case study. Rewards for the authors of the best
p.(None): five cases were €2,000 each and €1,000 each for five runners-up. Following peer review, eight full-length case studies
p.(None): were selected for inclusion in Ethics Dumping: Case Studies from North- South Research Collaborations (Schroeder et al.
p.(None): 2018) or as learning materials for the GCC website (http://www.globalcodeofconduct.org). This mechanism expanded the
p.(None): material available for the development of the risk matrix considerably.
p.(None):
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates
p.(None):
p.(None): “Around the world, millions of meetings are being held every day – most of them unproductive” (Koshy et al. 2017). In
p.(None): “Not Another Meeting!” Rogelberg et al. (2006) establish that perceived meeting effectiveness has a strong, direct
p.(None): relationship with posi- tive job attitudes and wellbeing at work. In the literature, meeting efficiency is linked to
p.(None): questions such as, “Is a meeting necessary?” (Koshy et al. 2017), or “Is a meeting the most cost-effective way of
p.(None): obtaining an outcome?” (Rogelberg et al. 2006). In addition, advice is given on how to make meetings more efficient,
p.(None): such as, “Prepare the agenda in advance,” and “Start with the most strategic items,” (Rogelberg et al. 2006).
p.(None): For the TRUST consortium, the most important question ahead of all major consul- tation meetings was: “Who are the
p.(None): external delegates?” On the one hand, are they senior and/or from influential institutions? Or, on the other hand, do
p.(None): they have first- hand experience of ethics dumping? In other words, the consortium aimed for senior decision-maker
p.(None): representation as well as vulnerable population representation. To give an example of the former, Table 6.2
p.(None): shows the funders and companies which were represented at the funder and industry consultation. The consultation with
p.(None): vulnerable populations on engagement with research participants will be described below.
p.(None): As noted above, millions of meetings are held every day around the world, and many of them affect job satisfaction and
p.(None): wellbeing negatively. How, then, could a meeting hosted on behalf of a three-year research project achieve such
p.(None): impressive representation? There were four reasons for this success:
p.(None): 1. A convincing justification for the meeting secured a Wellcome Trust venue in central London. The Wellcome Trust
p.(None): is the largest private funder of medical research globally (Jack 2012), with a very high standing in research
p.(None): circles.
p.(None):
p.(None): Table 6.2 Funders and industry members represented at consultation meeting, London 2017
p.(None): Funders Industry members
p.(None):
p.(None): Wellcome Trust European Commission.
p.(None): Medical Research Council UKRI
p.(None): World Health Organization TDR Calouste Gulbenkian Foundation Global Forum on Bioethics in Research
p.(None): European Federation of Pharmaceutical Industries and Associations (EFPIA)
p.(None): Sanofi Roche Novartis
p.(None): GlaxoSmithKline Boehringer Ingelheim
p.(None):
p.(None): 58 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): 2. Invitations to funders were issued by the European and Developing Countries Clinical Trials Partnership (EDCTP),
p.(None): the high-profile funding institution repre- sented on the TRUST consortium.
p.(None): 3. Invitations to industry were issued by Professor Klaus Leisinger, a member of the TRUST consortium and former
p.(None): personal adviser on corporate responsibility to UN Secretary-Generals Kofi Annan and Ban Ki-moon.
p.(None): 4. Most important to the success, however, were the prior activities of the funder and industry platforms.
p.(None): TRUST’s Funder Platform was established by the EDCTP in 2016 via the fol- lowing steps:
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p.(None): collective pride of these 56 authors to the world was entrusted to the Reverend Mario Mahongo, an honoured San Leader
p.(None): born in Angola. He was due to travel from the Kalahari Desert to Stockholm, Sweden, in May 2018 to launch the GCC. Just
p.(None): one day before flying to Europe, he died in a car crash. This book is dedicated to Mario. His last recorded statement
p.(None): about research ethics was: “I don’t want researchers to see us as museums who cannot speak for themselves and who don’t
p.(None): expect something in return” (Chapter 7). This statement expresses
p.(None): the fairness element of the GCC beautifully.
p.(None): The GCC was produced by the TRUST project, an initiative funded by the European Commission (EC) Horizon
p.(None): 2020 Programme, agreement number 664771. Dorian Karatzas, Roberta Monachello, Dr Louiza Kalokairinou, Edyta Sikorska,
p.(None): Yves Dumont and Wolfgang Bode formed the magnificent EC team supporting the
p.(None): TRUST project.
p.(None): Thanks to Dorian for ensuring that the GCC was brought to the attention of the highest level of decision-making on
p.(None): ethics in the EC, for suggesting TRUST as a research and development success story of Horizon 2020 (EC 2018) and for
p.(None): having the GCC checked by the EC legal department in time for our event at the European Parliament in June 2018.
p.(None): Without Dorian’s efforts, the code would not have the standing it has now, as a mandatory reference
p.(None): document for EC framework programmes.
p.(None): Thanks to Roberta for believing in our work and for being a most enthusiastic, supportive and interested project
p.(None): officer, despite several amendments. Thanks to Wolfgang for facilitating one of those amendments very
p.(None): professionally and in record time during a summer break.
p.(None): Thanks to Louiza for providing insightful funder input during the GCC develop- ment phase. Thanks to Edyta for
p.(None): organizing a very stimulating training event for EC staff on the GCC. Thanks to Yves Dumont for inventing the term
p.(None): “ethics dumping” in 2013.
p.(None): ix
p.(None):
p.(None): x
p.(None): Acknowledgements
p.(None):
p.(None): Thanks to Stelios Kouloglou, MEP, and Dr Mihalis Kritikos for giving us the opportunity to present the GCC at a
p.(None): European Parliament event.
p.(None): Thanks to Dr Wolfgang Burtscher, the EC’s deputy director-general for Research and Innovation, for announcing in person
p.(None): at the European Parliament event that the GCC would henceforth be a mandatory reference document for EC
p.(None): framework programmes.
p.(None): Thanks to the University of Cape Town for being the first university to adopt the GCC in April 2019. This is owed to
p.(None): Prof. Rachel Wynberg’s long-term commitment to equitable research partnerships and the protection of vulnerable
p.(None): populations in research.
p.(None): Thanks to Joyce Adhiambo Odhiambo and her colleagues in Nairobi for prepar- ing the excellent speech on the four values
p.(None): of the GCC – fairness, respect, care and honesty – that she presented at the European Parliament (TRUST 2018).
p.(None): Thanks to Leana Snyders, the director of the South African San Council, for tak- ing the place of Reverend Mario
p.(None): Mahongo at the Stockholm GCC launch event and for doing so brilliantly, despite the shock of his tragic death. Thanks
...
p.(None): A Fair Research Contracting Tool 103
p.(None): Conclusion 105
p.(None): References 106
p.(None): 9 Towards Equitable Research Partnership 109
p.(None): References 112
p.(None): Appendix
p.(None): 115
p.(None): Index
p.(None): 119
p.(None):
p.(None): About the Authors
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Doris Schroeder is director of the Centre for Professional Ethics at the University of Central Lancashire, and
p.(None): professor of moral philosophy at the School of Law, UCLan Cyprus. She is the lead author of the Global Code of Conduct
p.(None): for Research in Resource-Poor Settings.
p.(None):
p.(None): Kate Chatfield is deputy director of the Centre for Professional Ethics, University of Central Lancashire, UK. She is a
p.(None): social science researcher and ethicist special- izing in global justice, research ethics, animal ethics and responsible
p.(None): innovation.
p.(None):
p.(None): Michelle Singh is a project officer at the European & Developing Countries Clinical Trials Partnership in Cape Town,
p.(None): South Africa. She holds a medical PhD and previ- ously managed maternal and child health research studies and clinical
p.(None): trials at the South African Medical Research Council.
p.(None):
p.(None): Roger Chennells works as legal adviser to the South African San Institute and is a founder-partner in the human rights
p.(None): law practice Chennells Albertyn, Stellenbosch, established in 1981. Specializing in labour, land, environmental and
p.(None): human rights law, he has also worked for Aboriginal people in Australia.
p.(None):
p.(None): Peter Herissone-Kelly is senior lecturer in philosophy, University of Central Lancashire, UK. He is a
p.(None): specialist in Kantian ethics as well as bioethics, analytic philosophy of language and metaethics.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xvii
p.(None):
p.(None): Abbreviations
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ACF Action contre la Faim
p.(None): CBD UN Convention on Biological Diversity COHRED Council on Health Research for Development EC
p.(None): European Commission (EC)
p.(None): EDCTP European and Developing Countries Clinical Trials Partnership EFPIA European Federation of
...
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p.(None): • Poor research governance frameworks to ensure adherence to ethical standards
p.(None): • No cross-border legal recourse in cases of exploitation
p.(None): • Discriminatory laws that may create stigmatized minorities Animal • Variations in regulatory standards
p.(None): for animal experimentation
p.(None): • Inadequate systems to ensure compliance with animal welfare standards
p.(None): Environmental • Variations in governance of natural resources
p.(None): • Variations in procedural rights
p.(None): • Environmental protection not well policed by civil society
p.(None):
p.(None): Our Findings
p.(None): 43
p.(None):
p.(None): shows the primary risks related to corrective fairness for persons, institutions, com- munities, countries, animals and
p.(None): the environment.
p.(None): Individuals who are harmed by their participation in research may have no means of seeking retribution or compensation
p.(None): if they cannot afford legal representation and there is no form of legal aid. For communities, a lack of awareness and
p.(None): expertise, or too much trust in the HIC researchers, may lead to the loss of intellectual property rights (IPRs) to
p.(None): local knowledge and resources. At a national and international level, researchers from HICs who choose to ignore or
p.(None): flout the research ethics and legal requirements in the host LMIC can be difficult to police. This is especially
p.(None): problem- atic in localities where there is a lack of resources and/or infrastructure to ensure ethical compliance
p.(None): through the entire research process and where the home institu- tions in HICs do not ensure that their employees comply
p.(None): with requirements.
p.(None):
p.(None):
p.(None): Respect
p.(None):
p.(None): Respect requires an acceptance of customs and cultures that may be different from one’s own, and a commitment not to
p.(None): behave in a way that causes offence. One may need to abide by decisions or ways of approaching matters with which one
p.(None): dis- agrees. This can be problematic, especially if local customs are illegal or perceived as dangerous.6 However,
p.(None): respect is important in LMIC-HIC collaborations, and there are many possible ways of showing respect that do not
p.(None): create conflicts of con- science. For instance, HIC researchers should not insist that LMIC ethics commit- tees accept
p.(None): the ethics approval submission in the HIC’s preferred format, but should rather conform with the format preferred by
p.(None): the LMIC committee. Table 5.3 shows the primary risks related to respect for persons, institutions, communities,
p.(None): countries, animals and the environment.
p.(None): Local LMIC customs, traditions, and religious and spiritual beliefs may be very different from those of the HIC
p.(None): researcher. For example, from an African cultural point of view, human body parts are sacred, whether they are obtained
...
Social / Presence of Coercion
Searching for indicator coerced:
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p.(None): compliance structures or legal governance mechanisms.
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 37
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_5
p.(None):
p.(None): 38 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): codes, most of which had not been written with LMIC-HIC (high-income country) collaborations in mind.
p.(None):
p.(None):
p.(None): The Nature of Exploitation
p.(None):
p.(None): The potential to be exploited is part of the human condition. Exploiters take advan- tage of others’ vulnerabilities to
p.(None): promote their own interests (Hughes 2010). While there is a morally neutral sense of exploitation (the exploitation of
p.(None): natural talents to create art, for example), the term is generally used to describe a moral failing.
p.(None): Exploitation of people is very often unjust, unfair, harmful or just plain wrong. What is it, then, that
p.(None): distinguishes morally unacceptable exploitation from neutral exploitation?
p.(None): Some argue that exploitation is wrong because it is coercive (Schwartz 1995). If the only way for a woman in an LMIC to
p.(None): access antiretroviral drugs to prevent the transmission of HIV to her unborn baby is to participate in a
p.(None): placebo-controlled clinical trial,2 despite the existence of a proven standard of care,3 then one could say she has
p.(None): been coerced into enrolling (Annas and Grodin 1998). In this sense, exploi- tation occurs where one party takes
p.(None): advantage of another by making them an offer they cannot refuse; they are then coerced to accept simply because there
p.(None): is no alter- native. Others argue that exploitation is wrong because it treats human beings as means rather than ends
p.(None): (Wood 1995). In other words, exploitation instrumentalizes people. Yet others claim that exploitation is wrong
p.(None): because it disadvantages the vulnerable (Macklin 2003).
p.(None): Our investigation was concerned with the risks or vulnerabilities for exploitation, so we adopted Macklin’s definition
p.(None): of exploitation. However, it is important to bear in mind that situations that are conducive to exploitation do not
p.(None): necessarily lead to exploitation. For instance, if a pharmaceutical company is due to test new antiretro- viral drugs
p.(None): to prevent the transmission of HIV to unborn babies, and the company operates in a country where poor mothers have no
p.(None): or very limited access to health care, it does not mean that exploitation will necessarily occur. The company may
p.(None): decide not to exploit vulnerable research participants and offer the accepted stan- dard of care to those in the
p.(None): control arm, rather than a placebo.
p.(None): Exploitation usually requires a moral decision on the part of the potential exploiter, but it can also occur
p.(None): through ignorance. Whether intended or unintended, the effects of exploitation are the same for the exploited. Hence,
...
Social / Property Ownership
Searching for indicator home:
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p.(None): feature in the GCC).
p.(None):
p.(None):
p.(None): Grounding the Global Applicability Thesis of the GCC in a Common Morality
p.(None):
p.(None): In their celebrated book Principles of Biomedical Ethics, Tom Beauchamp and James Childress have, over the
p.(None): course of 34 years and seven editions, maintained that there are four principles that are particularly applicable to
p.(None): problems in biomedical ethics: respect for autonomy, beneficence, non-maleficence and justice. As explained above,
p.(None): their claim is that these principles are globally applicable because they are part of what Beauchamp and Childress call
p.(None): “the common morality”, which is to be understood as a set of principles subscribed to by all morally committed people,
p.(None): whatever their culture, and whatever the time in which they live. The principles of
p.(None):
p.(None): Grounding the Global Applicability Thesis of the GCC in a Common Morality 33
p.(None):
p.(None): the common morality, then, are globally applicable, in just the way that the authors of the GCC want the four values of
p.(None): fairness, respect, care and honesty to be.
p.(None): To the rather obvious objection that no set of values/principles seems to possess the universality they ascribe to
p.(None): the common morality, given the observations of descriptive relativism, Beauchamp and Childress have two
p.(None): responses.
p.(None): 1. It is not the case that every principle that exists finds a home in the common morality: some principles are purely
p.(None): local.
p.(None): 2. More importantly, the principles of the common morality may be variously spec- ified in different cultures.
p.(None): The great benefit of the common-morality theory is that it allows an optimum balance of universality on the one hand,
p.(None): and variation across cultural settings on the other. There is a set of high-level values/principles that are internal
p.(None): to morality, but these are expressed in differing ways in particular moralities associated with par- ticular
p.(None): communities.
p.(None): If the supposed common morality is a set of general, unspecified values to which all who are morally committed
p.(None): subscribe, how do we know which these values are? Would we not first have to identify some morally committed people,
p.(None): and then carry out an empirical investigation into the values they hold? The most general values shared by them all
p.(None): would then be those that constitute the common morality. But problems loom here; circularity threatens.
p.(None): How do we determine who is morally committed in the first place? Presumably, we do so by examining what values
p.(None): they hold. If they adhere to value1, value2, value3, and so on up to valuen, then, we might want to say, they
p.(None): are morally commit- ted. But this is an unacceptable, question-begging way of proceeding. If we want to find out what
p.(None): values the morally committed hold, and thereby find what values constitute the common morality, it is no good
p.(None): defining the morally committed in terms of their subscription to a certain definite list of values settled
p.(None): in advance. There either has to be an independent way of identifying the morally committed (without reference to the
...
p.(None): • Discriminatory laws that may create stigmatized minorities Animal • Variations in regulatory standards
p.(None): for animal experimentation
p.(None): • Inadequate systems to ensure compliance with animal welfare standards
p.(None): Environmental • Variations in governance of natural resources
p.(None): • Variations in procedural rights
p.(None): • Environmental protection not well policed by civil society
p.(None):
p.(None): Our Findings
p.(None): 43
p.(None):
p.(None): shows the primary risks related to corrective fairness for persons, institutions, com- munities, countries, animals and
p.(None): the environment.
p.(None): Individuals who are harmed by their participation in research may have no means of seeking retribution or compensation
p.(None): if they cannot afford legal representation and there is no form of legal aid. For communities, a lack of awareness and
p.(None): expertise, or too much trust in the HIC researchers, may lead to the loss of intellectual property rights (IPRs) to
p.(None): local knowledge and resources. At a national and international level, researchers from HICs who choose to ignore or
p.(None): flout the research ethics and legal requirements in the host LMIC can be difficult to police. This is especially
p.(None): problem- atic in localities where there is a lack of resources and/or infrastructure to ensure ethical compliance
p.(None): through the entire research process and where the home institu- tions in HICs do not ensure that their employees comply
p.(None): with requirements.
p.(None):
p.(None):
p.(None): Respect
p.(None):
p.(None): Respect requires an acceptance of customs and cultures that may be different from one’s own, and a commitment not to
p.(None): behave in a way that causes offence. One may need to abide by decisions or ways of approaching matters with which one
p.(None): dis- agrees. This can be problematic, especially if local customs are illegal or perceived as dangerous.6 However,
p.(None): respect is important in LMIC-HIC collaborations, and there are many possible ways of showing respect that do not
p.(None): create conflicts of con- science. For instance, HIC researchers should not insist that LMIC ethics commit- tees accept
p.(None): the ethics approval submission in the HIC’s preferred format, but should rather conform with the format preferred by
p.(None): the LMIC committee. Table 5.3 shows the primary risks related to respect for persons, institutions, communities,
p.(None): countries, animals and the environment.
p.(None): Local LMIC customs, traditions, and religious and spiritual beliefs may be very different from those of the HIC
p.(None): researcher. For example, from an African cultural point of view, human body parts are sacred, whether they are obtained
p.(None): from living or deceased persons. Hence, the removal of blood or other body parts for research may have a profound
...
p.(None): - Incomplete information provided
p.(None): - Information provided in an inappropriate format
p.(None): • Potential effects of participation not fully explained
p.(None): • Dual roles of researcher
p.(None):
p.(None): Researcher/ institutional
p.(None): • REC not fully independent
p.(None): • Cryptic research procedures
p.(None): Community Inability to provide fully informed community consent:
p.(None): - Incomplete information provided
p.(None): - Information provided in inappropriate format
p.(None): • Potential effects of participation not fully explained
p.(None): • Dual roles of researcher
p.(None): Country • Lack of data sharing Animal
p.(None): Environmental • Incomplete information about potential risks or harm to the environment
p.(None):
p.(None): Our Findings
p.(None): 47
p.(None):
p.(None): honesty through transparency for persons, institutions, communities, countries and the environment.
p.(None): There are many ways in which the informed consent process can be inadequate. For example, where there are
p.(None): omissions and/or inappropriate or misleading lan- guage for the context in which consent is being sought; when
p.(None): potential participants (some of whom may be illiterate) are not taken through any kind of suitable consent process but
p.(None): are, instead, provided with written information sheets to take home and told to come back with a signed consent form;
p.(None): or when information does not fully explain the potential (possibly harmful) consequences of
p.(None): participation. Misunderstanding can lead to a violation of trust: for example, where the research- ers are also aid
p.(None): workers or health care providers, potential participants may believe that they have to participate in order to receive
p.(None): the aid or treatment.
p.(None): A lack of transparency concerning research processes can make it very difficult to hold anyone accountable when things
p.(None): go wrong. For example, where numerous bodies are engaged in collaborative research and their separate activities and
p.(None): respon- sibilities are not clear, then it may be impossible to say where things have gone wrong and who is responsible.
p.(None): Honesty is also the foundation of research integrity. Honesty is essential in all aspects of research, including
p.(None): in the presentation of research goals, intentions and findings; in reporting on research meth- ods and procedures;
p.(None): in gathering data; in using and acknowledging the work of other researchers; and in conveying valid
p.(None): interpretations and making justifiable claims based on research findings (Universities UK 2015).
p.(None): Table 5.6 shows the primary risks for honesty through integrity for persons, insti- tutions, communities, countries,
p.(None): animals and the environment.
p.(None): Research misconduct can happen anywhere; it is not unique to collaborative ven- tures in LMICs. However, variations in
p.(None): customs and a lack of facilities to ensure oversight of compliance with research ethics might encourage unscrupulous
...
p.(None): varies from country to country. In the EU, animal experiments are governed by Directive 2010/63/EU, known as the Animal
p.(None): Experiments Directive, which stipulates measures that must be taken to replace, reduce and refine (the “Three
p.(None): Rs”12) the use of animals in scientific research. Among other requirements, it lays down minimum standards for housing
p.(None): and care and regu-
p.(None):
p.(None):
p.(None):
p.(None): 12 The “Three Rs” are the underpinning requirements of most policies and regulations in animal research:
p.(None): → Replacement: Methods that avoid or replace the use of animals.
p.(None): → Reduction: Methods that minimize the number of animals used per experiment.
p.(None): → Refinement: Methods that minimize suffering and improve welfare.
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 65
p.(None):
p.(None): lates the use of animals through systematic project evaluation that requires the assessment of pain,
p.(None): suffering, distress and lasting harm caused to the animals.
p.(None): Some researchers knowingly exploit variations in standards and opt to conduct animal studies in LMICs because it
p.(None): is cheaper and/or because regulation is less strict than in HICs (Morton and Chatfield 2018). For example,
p.(None): researchers might conduct experiments on non-human primates in an LMIC setting that would be illegal in
p.(None): their HIC home country.
p.(None): For research collaborations between groups in different countries, partners may find that they are confronted with
p.(None): different ethical standards for animal experimen- tation. In such cases ethical standards should comply with the
p.(None): highest ethical stan- dards rather than be adjusted to the lowest common denominator. Hence the GCC states that
p.(None): standards for animal research in international collaborative research must comply with those that are more
p.(None): demanding and protective of animal welfare (article 17).
p.(None):
p.(None):
p.(None):
p.(None): External Engagement with Research Ethics Committees
p.(None):
p.(None): The main engagement meetings with research ethics reviewers and chairs of research ethics committees took
p.(None): place in India (2016) and Kenya (2017).
p.(None): The Forum for Ethics Review Committees in India is led by Dr Vasantha Muthuswamy, who was responsible
p.(None): for issuing the Indian Council of Medical Research’s Ethical Guidelines for Biomedical Research on Human Subjects
p.(None): in 2000 and the revised version, Ethical Guidelines for Biomedical Research on Human Participants, in 2006,
p.(None): and also contributed to the most recently launched version in 2017. At her invitation, 30 leading bioethicists from
p.(None): India came together with guests from Europe in a two-day workshop in Mumbai in 2016. This workshop, which was attended
...
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p.(None): law practice Chennells Albertyn, Stellenbosch, established in 1981. Specializing in labour, land, environmental and
p.(None): human rights law, he has also worked for Aboriginal people in Australia.
p.(None):
p.(None): Peter Herissone-Kelly is senior lecturer in philosophy, University of Central Lancashire, UK. He is a
p.(None): specialist in Kantian ethics as well as bioethics, analytic philosophy of language and metaethics.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xvii
p.(None):
p.(None): Abbreviations
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ACF Action contre la Faim
p.(None): CBD UN Convention on Biological Diversity COHRED Council on Health Research for Development EC
p.(None): European Commission (EC)
p.(None): EDCTP European and Developing Countries Clinical Trials Partnership EFPIA European Federation of
p.(None): Pharmaceutical Industries and Associations FERCI Forum for Ethics Review Committees in India
p.(None): GCC Global Code of Conduct for Research in Resource-Poor Settings GVA Global Values Alliance
p.(None): HIC high-income country
p.(None): Inserm Institut national de la santé et de la recherche médicale IPR intellectual property
p.(None): rights
p.(None): LMICs low- and middle-income countries NGO nongovernmental organization
p.(None): PHDA Partners for Health and Development in Africa REC research ethics committee
p.(None): SASC South African San Council SASI South African San Institute
p.(None): SWOP Sex Workers Outreach Programme
p.(None): UNESCO United Nations Educational, Scientific and Cultural Organization WIMSA Working Group of Indigenous
p.(None): Minorities in Southern Africa
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xix
p.(None):
p.(None): Chapter 1
p.(None): Ethics Dumping and the Need for a Global Code of Conduct
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The UN’s 2030 Agenda for Sustainable Development calls for more research and innovation to end
p.(None): poverty, leaving no one behind – and yet the export of unethical practices from high-income to lower-income settings is
p.(None): still a major concern. Such ethics dumping occurs in all academic disciplines. When research is regarded, on the one
p.(None): hand, as a dirty word among vulnerable populations who face ethics dumping, and, on the other, as a solution to many of
...
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_2
p.(None):
p.(None): 6 2 A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None): Those applying the Code oppose double standards in research and support long- term equitable research relationships
p.(None): between partners in lower-income and high- income settings based on fairness, respect, care and honesty.
p.(None):
p.(None):
p.(None): Fairness
p.(None): Article 1
p.(None):
p.(None): Local relevance of research is essential and should be determined in collaboration with local partners. Research that
p.(None): is not relevant in the location where it is under- taken imposes burdens without benefits.
p.(None):
p.(None):
p.(None): Article 2
p.(None):
p.(None): Local communities and research participants should be included throughout the research process, wherever
p.(None): possible, from planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly
p.(None): represented. This approach represents Good Participatory Practice.
p.(None):
p.(None):
p.(None): Article 3
p.(None):
p.(None): Feedback about the findings of the research must be given to local communities and research participants. It should be
p.(None): provided in a way that is meaningful, appropriate and readily comprehended.
p.(None):
p.(None):
p.(None): Article 4
p.(None):
p.(None): Local researchers should be included, wherever possible, throughout the research process, including in study design,
p.(None): study implementation, data ownership, intellec- tual property and authorship of publications.
p.(None):
p.(None): Respect
p.(None): 7
p.(None):
p.(None): Article 5
p.(None):
p.(None): Access by researchers to any biological or agricultural resources, human biological materials, traditional knowledge,
p.(None): cultural artefacts or non-renewable resources such as minerals should be subject to the free and prior informed consent
p.(None): of the owners or custodians. Formal agreements should govern the transfer of any material or knowledge to
p.(None): researchers, on terms that are co-developed with resource custodians or knowledge holders.
p.(None):
p.(None):
p.(None): Article 6
p.(None):
p.(None): Any research that uses biological materials and associated information such as tra- ditional knowledge or genetic
p.(None): sequence data should clarify to participants the poten- tial monetary and non-monetary benefits that might arise. A
p.(None): culturally appropriate plan to share benefits should be agreed to by all relevant stakeholders, and reviewed regularly
p.(None): as the research evolves. Researchers from high-income settings need to be aware of the power and resource differentials
p.(None): in benefit-sharing discussions, with sustained efforts to bring lower-capacity parties into the dialogue.
p.(None):
p.(None):
p.(None): Article 7
p.(None):
p.(None): It is essential to compensate local research support systems, for instance translators, interpreters or local
p.(None): coordinators, fairly for their contribution to research projects.
p.(None):
p.(None):
p.(None): Respect
p.(None): Article 8
p.(None):
...
p.(None): that the specification of what each value requires in a given setting needs to be determined collaboratively. As a
p.(None): result, this sketch of the content of the four values is brief and leaves room for regional variations.
p.(None):
p.(None):
p.(None): The Four Values
p.(None): Fairness
p.(None):
p.(None): The terms “fairness”, “justice” and “equity” are often used interchangeably. The TRUST consortium chose the term
p.(None): “fairness” in the belief that it would be the most widely understood globally. Philosophers commonly distinguish
p.(None): between four types of fairness (Pogge 2006) (see Fig. 3.2).
p.(None): The most relevant fairness concepts in global research ethics are fairness in exchange and corrective
p.(None): fairness. In global collaborations, at least two parties are involved in a range of transactions. Typical fairness
p.(None): issues between partners from high-income countries (HICs) and those from low- and middle-income countries (LMICs) are:
p.(None): • Is the research relevant to local research needs?
p.(None): • Will benefit sharing take place?
p.(None): • Are authors from LMICs involved in publications?
p.(None):
p.(None): 5 Local communities and research participants should be included throughout the research process, wherever possible,
p.(None): from planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly represented.
p.(None): This approach represents Good Participatory Practice.
p.(None): 6 Local researchers should be included, wherever possible, throughout the research process, includ- ing in study
p.(None): design, study implementation, data ownership, intellectual property and authorship of publications.
p.(None):
p.(None): The Four Values
p.(None): 21
p.(None):
p.(None): Fairness in
p.(None): exchange
p.(None): • establishes the equity of transactions between at least two parties.
p.(None):
p.(None): Distributive fairness
p.(None): • deals with the division of existing, scarce resources among qualifying recipients.
p.(None):
p.(None): Corrective fairness
p.(None): • rights a wrong that one has brought upon another, often through a court.
p.(None):
p.(None): Retributive fairness
p.(None): Fig. 3.2 Types of fairness
p.(None): • establishes which punishment is appropriate for any given crime.
p.(None):
p.(None): These are questions about fairness in exchange. For instance, LMIC research participants contribute to the progress of
p.(None): science, but this is only fair if the research is relevant to their own community or if other benefits are received
p.(None): where this is not possible. For instance, to carry the burden of a clinical study is only worthwhile for a community if
p.(None): the disease under investigation occurs locally and the end product will become available locally.
p.(None): Corrective fairness, which presupposes the availability of legal instruments and access to mechanisms to right a wrong
p.(None): (e.g. a complaints procedure, a court, an eth- ics committee) is also important in global research collaborations. For
p.(None): instance, if no host country research ethics structure exists, corrective fairness is limited to the research ethics
...
p.(None): Community • Lack of protection of IPR or traditional knowledge for local communities
p.(None): • Human rights violations not taken up by civil society
p.(None): • Absence of systems for community approvals Country • No relevant legal instruments for ethics committees
p.(None): • Poor research governance frameworks to ensure adherence to ethical standards
p.(None): • No cross-border legal recourse in cases of exploitation
p.(None): • Discriminatory laws that may create stigmatized minorities Animal • Variations in regulatory standards
p.(None): for animal experimentation
p.(None): • Inadequate systems to ensure compliance with animal welfare standards
p.(None): Environmental • Variations in governance of natural resources
p.(None): • Variations in procedural rights
p.(None): • Environmental protection not well policed by civil society
p.(None):
p.(None): Our Findings
p.(None): 43
p.(None):
p.(None): shows the primary risks related to corrective fairness for persons, institutions, com- munities, countries, animals and
p.(None): the environment.
p.(None): Individuals who are harmed by their participation in research may have no means of seeking retribution or compensation
p.(None): if they cannot afford legal representation and there is no form of legal aid. For communities, a lack of awareness and
p.(None): expertise, or too much trust in the HIC researchers, may lead to the loss of intellectual property rights (IPRs) to
p.(None): local knowledge and resources. At a national and international level, researchers from HICs who choose to ignore or
p.(None): flout the research ethics and legal requirements in the host LMIC can be difficult to police. This is especially
p.(None): problem- atic in localities where there is a lack of resources and/or infrastructure to ensure ethical compliance
p.(None): through the entire research process and where the home institu- tions in HICs do not ensure that their employees comply
p.(None): with requirements.
p.(None):
p.(None):
p.(None): Respect
p.(None):
p.(None): Respect requires an acceptance of customs and cultures that may be different from one’s own, and a commitment not to
p.(None): behave in a way that causes offence. One may need to abide by decisions or ways of approaching matters with which one
p.(None): dis- agrees. This can be problematic, especially if local customs are illegal or perceived as dangerous.6 However,
p.(None): respect is important in LMIC-HIC collaborations, and there are many possible ways of showing respect that do not
p.(None): create conflicts of con- science. For instance, HIC researchers should not insist that LMIC ethics commit- tees accept
p.(None): the ethics approval submission in the HIC’s preferred format, but should rather conform with the format preferred by
p.(None): the LMIC committee. Table 5.3 shows the primary risks related to respect for persons, institutions, communities,
...
p.(None): insects, fish and animals had been ignored. Through the historical introduc- tion of Western agricultural systems
p.(None): and cash crops such as tobacco, as well as genetically engineered crops, Africa had failed to develop
p.(None): agricultural solutions adapted to local conditions. According to Dr Mharapara, a lack of financial resources meant
p.(None): that African nations had been, and still were, vulnerable to exploitation by foreign researchers. This had resulted in
p.(None): damage to ecological systems, the loss of soils, fertility, biodiversity and natural resilience, and the
p.(None): erosion of indigenous knowledge. He advocated inclusive, consultative, robust and agreed processes to establish
p.(None): equitable research partnerships (Van Niekerk et al. 2017).
p.(None):
p.(None):
p.(None): External Engagement with Research Funders
p.(None):
p.(None): Estimates for research and development expenditure in the European Union in 2016 indicate that 56.6% of all such
p.(None): expenditure comes from the business sector, 30.9% from the government sector and the remainder mostly from charitable
p.(None): foundations (Eurostat 2018). TRUST’s main consultation workshop for research funders was held in London in 2017
p.(None): and involved all three sectors: public funders, private
p.(None):
p.(None): 7 Local relevance of research … should be determined in collaboration with local partners.
p.(None): 8 Local researchers should be included, wherever possible, throughout the research process, includ- ing in study
p.(None): design, study implementation, data ownership, intellectual property and authorship of publications.
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 61
p.(None): Table 6.3 Good practice input from funders and industry with GCC output
p.(None): Good practice Relevant GCC article
p.(None):
p.(None): Ensuring double ethics review Community
p.(None): engagement
p.(None): Clear roles and responsibilities
p.(None): Article 10: Local ethics review should be sought wherever possible.
p.(None):
p.(None): Article 2: Local communities and research participants should be included throughout the research process.
p.(None): Article 20: A clear understanding should be reached among collaborators with regard to their roles, responsibilities
p.(None): and conduct throughout the research cycle.
p.(None):
p.(None): funders and charitable funders of research (see Table 6.2). The three main good practice elements9 raised by funders
p.(None): and industry to stop ethics dumping are listed in Table 6.3, with their corresponding GCC articles (Singh and Makanga
p.(None): 2017).
p.(None): As already indicated, engagement with research funders was not restricted to one meeting, but took place over
p.(None): approximately two years via the funder and industry platforms described above. Additionally, the first draft of the GCC
p.(None): was distributed to all members of the platforms nine months after the workshop. Both groups pro- vided further comments
p.(None): on the draft.
p.(None):
p.(None):
p.(None): External Engagement with Researchers
p.(None):
...
p.(None): and also contributed to the most recently launched version in 2017. At her invitation, 30 leading bioethicists from
p.(None): India came together with guests from Europe in a two-day workshop in Mumbai in 2016. This workshop, which was attended
p.(None): by many senior research ethics committee chairs and members, was an important fact-finding mission in the early stages
p.(None): of the project. Cases of exploita- tion were collated and good practice in research involving LMICs discussed
p.(None): (Chatfield et al. 2016b).
p.(None): Further in-depth consultation with ethics committee chairs formed part of a ple- nary workshop in Nairobi in 2017.
p.(None): TRUST received valuable input from three esteemed ethicists: Professor Elizabeth Bukusi (Deputy Director
p.(None): Research and Development, Kenya Medical Research Institute), Professor Anastasia Guantai (Kenyatta National
p.(None): Hospital) and Professor Kirana Bhatt (Chair of the National Bioethics Committee, University of Nairobi), who
p.(None): shared their respective experi- ences, concerns and insights. Table 6.5 summarizes some of the issues raised
p.(None): (Chatfield et al. 2016b) and their relationship to the final GCC.
p.(None):
p.(None): 66 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.5 Input from research ethics committee chairs and GCC output
p.(None): Input Relevant GCC article
p.(None):
p.(None): Intellectual property rights are often held only in the North.
p.(None):
p.(None): Attempts at gaining ethics approvals can be extremely late.
p.(None): LMIC partners’ tasks are restricted to obtaining data.
p.(None):
p.(None): Why does biological material need to be shipped abroad?
p.(None): Article 4: Local researchers should be included, wherever possible, throughout the research process, including in study
p.(None): design, study implementation, data ownership, intellectual property and authorship of publications.
p.(None): Article 11: Researchers from high-income settings should show respect to host country research ethics committees.
p.(None):
p.(None): Article 4 (see above)
p.(None): Article 20: A clear understanding should be reached among collaborators with regard to their roles, responsibilities
p.(None): and conduct throughout the research cycle.
p.(None): Article 5: Access by researchers to any … human biological materials … should be subject to the free and prior informed
p.(None): consent of the owners or custodians. Formal agreements should govern the transfer of any material or knowledge to
p.(None): researchers, on terms that are co-developed with resource custodians or knowledge holders.
p.(None):
p.(None): Analysis of Existing Guidelines
p.(None):
p.(None): We have summarized above the extensive consultation activities of the TRUST project prior to the actual
p.(None): drafting of the GCC. Aside from these valuable contribu- tions, it was also vital that the GCC should not set out to
p.(None): “reinvent the wheel”. Given the vast number of existing guidelines, and the significant expertise that went into
p.(None): drafting them, it was important for us to link the GCC to those existing guide- lines so as to produce something
p.(None): that did not replicate earlier work, but rather complemented it.
p.(None): Research ethics committees have been in operation since the 1960s (Levine 2004). The earliest codes of
...
p.(None): 3. How can the on-line approval and code adherence system that the SASC wishes to install be designed and funded, both
p.(None): for development and for maintenance?
p.(None): 4. Could the San effort be captured in a model fit to assist other communities that do not have a 25-year history of
p.(None): institution building around their rights?
p.(None): 5. As the San community wishes to assist others in developing their own codes, how can such efforts be funded?
p.(None):
p.(None):
p.(None): Legal Support
p.(None):
p.(None): Many of the important steps undertaken along the path of community empowerment require legal support or intervention.
p.(None): The formulation of constitutions, leases and basic legal documents underpinning salaried appointments, and the drafting
p.(None): of basic agreements with government, funders and other external actors all require the ser- vices of a lawyer to
p.(None): protect the San’s interests.
p.(None): WIMSA and SASI have, from the outset, retained the services of an in-house lawyer. This ensures that they receive basic
p.(None): institutional legal support, as well as strategic legal support, in their various advocacy programmes. Apart
p.(None): from basic institutional legal support, the most visible advocacy successes of the San have all relied upon close
p.(None): collaboration with a legal adviser.
p.(None):
p.(None): 80 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): San policy interventions at the United Nations, land claims and successful San claims for intellectual property
p.(None): rights related to their traditional knowledge (on Hoodia, buchu, Sceletium, rooibos etc), which raised the
p.(None): international profile of the San as indigenous peoples, all required committed legal support. This was made available
p.(None): mostly via SASI.
p.(None): The prohibitive cost of standard commercial lawyers is a well-known deterrent to obtaining legal advice and assistance.
p.(None): In addition, utilizing lawyers who are not familiar with the ethos and needs of the community can lead to expensive
p.(None): mistakes and misunderstandings. Lawyers who are willing to represent the community legally on a pro bono or
p.(None): noncommercial basis can therefore give a vulnerable com- munity a significant advantage.
p.(None): Dr Roger Chennells, SASI’s lawyer, also provided a legal editing service for the San Code of Research Ethics.
p.(None):
p.(None):
p.(None): Supportive Research Collaborations
p.(None):
p.(None): Formulating ethics codes is a time-consuming business that requires funding, in particular to support
p.(None): workshops where San traditional leaders and San community members can discuss their concerns and ways forward. Sceptics
p.(None): may point out that the same individuals always attend such workshops largely out of appreciation for the food provided,
p.(None): and leave without any tangible or lasting benefits.
p.(None): By contrast, there is much anecdotal evidence of San colleagues who reported, after attending workshops, that their
p.(None): thinking, and indeed sometimes their lives, had forever been altered by an insight gained at the workshop. The San
...
p.(None): environment.
p.(None): Excellence in research is also required, in order for it to be positive and caring for the San. Research that is not up
p.(None): to a high standard might result in bad interac- tions, which will be lacking in care for the community.
p.(None): Caring research needs to accept the San people as they are, and take note of the cultural and social requirements of
p.(None): this Code of Ethics.
p.(None): We have encountered lack of care in many instances in the past. For instance, we were spoken down to, or confused with
p.(None): complicated scientific language, or treated as ignorant. Failing to ensure that something is left behind that improves
p.(None): the lives of the San also represents lack of care.
p.(None):
p.(None):
p.(None): Process
p.(None):
p.(None): Researchers need to follow the processes that are set out in our research protocols carefully, in order for this Code
p.(None): of Ethics to work.
p.(None): The San research protocol that the San Council will manage is an important process that we have decided on,
p.(None): which will set out specific requirements through every step of the research process.
p.(None): This process starts with a research idea that is collectively designed, through to approval of the project, and
p.(None): subsequent publications.
p.(None): The San commit to engaging fairly with researchers and manage effectively all stages of the research process, as their
p.(None): resources allow. They also commit to respect- ing the various local San structures (e.g. Communal Property
p.(None): Association, CPA leaders) in their communications between San leaders and San communities.
p.(None): Andries Steenkamp, the respected San leader who contributed to this Code of Ethics until he passed away in 2016, asked
p.(None): researchers to come through the door, not the window. The door stands for the San processes. When researchers respect
p.(None): the door, the San can have research that is positive for us.
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): Key to the achievements of the San in South Africa have been: dedicated San lead- ers of integrity, supportive NGOs,
p.(None): legal support, and long-term relationships with key individuals who also assisted with fundraising (see Fig. 7.1).
p.(None):
p.(None): 86 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): Fig. 7.1 Success factors
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): The San leadership have developed an approach to outsiders, for instance researchers, that is open to forging
p.(None): authentic human relationships. Every research project meeting or benefit-sharing negotiation was regarded as an
p.(None): opportunity to meet a certain person who might prove himself or herself to be mutually open to a relationship of trust.
p.(None): In particular Andries Steenkamp of the !Khomani San and Mario Mahongo of the !Xun San, both former chairpersons of the
p.(None): SASC, formed such relationships of trust. Not only was the famous San humour seldom far from the surface, but they
...
p.(None): informed, treated fairly and empowered.
p.(None): Most protective mechanisms, including complaints procedures, are strengthened when supported by legal systems, but
p.(None): participants, communities, researchers and institutions in LMICs often have no or very limited access to legal advice
p.(None): or protec- tion. The next section introduces an online toolkit that will be helpful in such situations.
p.(None):
p.(None):
p.(None): A Fair Research Contracting Tool
p.(None):
p.(None): The need for fair research contracts is best illustrated by the situation in interna- tional collaborative health
p.(None): research. Research undertaken in LMICs can lead to sig- nificant benefits flowing into HICs. In 2009, Glickman et al.
p.(None): undertook a systematic review to examine what had led to a “dramatic shift in the location of clinical trials” and
p.(None): concluded that important factors were:
p.(None): • shortened timelines for clinical testing due to a larger pool of research participants
p.(None):
p.(None): 8 These might include internal resolution through study-specific schemes; internal resolution through research
p.(None): ethics committees; litigation through the courts; or alternative dispute resolution mechanisms such as mediation,
p.(None): adjudication and arbitration.
p.(None):
p.(None): 104 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): • lower regulatory barriers for research in LMICs
p.(None): • international harmonization of intellectual property rights protection
p.(None): To take full advantage of the benefits of conducting medical research in LMICs, research institutions in HICs have
p.(None): invested substantially in building legal and con- tracting expertise for the benefit of their own institutions and
p.(None): stakeholders. Such expertise may not be as easily available in LMIC institutions. As a result, the benefits of research
p.(None): collaborations remain heavily skewed towards the beneficiaries based in HICs (Sack et al. 2009).
p.(None): In 2011 the Council on Health Research for Development (COHRED) commit- ted itself to launching its Fair Research
p.(None): Contracting (FRC) initiative to support LMIC partners when negotiating equitable research partnerships. FRC
p.(None): aimed to identify best practices for the research contracting process that would be useful in the following three
p.(None): scenarios:
p.(None): • where there is no lawyer
p.(None): • where there may be lay personnel who could be trained
p.(None): • where there is a lawyer or legal expertise
p.(None): A basic framework was subsequently developed by COHRED and partners to assist LMIC collaborators in making
p.(None): contractual demands on HIC collaborators without requiring large legal teams of their own. This focused on the fair
p.(None): distribu- tion of post-research benefits, intellectual property rights, data and data ownerships, specimen ownership
p.(None): and usage, technology transfer and institutional capacity build- ing as key outcomes of the FRC process. Between 2015
p.(None): and 2018, and as part of the TRUST project, the existing FRC framework was enhanced and expanded to pro- vide an online
p.(None): toolkit relevant for all types of research.
p.(None): The FRC online toolkit9 now provides information, tips and case studies in six key areas:
p.(None): • Negotiation strategies: for understanding the various aspects of negotiations, whether a research partner
p.(None): is at a basic starting point or an advanced level in the development of contract negotiations
p.(None): • Research contracting: for a basic understanding of contracts and contracting so that a research partner can better
p.(None): manage responsibilities, opportunities and risks that impact the research partnership
p.(None): • Research data: providing the essential principles concerning rights and responsi- bilities, including
p.(None): accountability and access to data in collaborative research
p.(None): • Intellectual property: providing an introduction to some of the key general prin- ciples that require
p.(None): consideration before participation in collaborative research agreements
p.(None): • Research costing: providing research partners with a basic understanding of cost considerations when developing a
p.(None): full cost research budget proposal
p.(None):
p.(None):
p.(None):
p.(None): 9 The entire online toolkit is available at http://frcweb.cohred.org/
p.(None):
p.(None): Conclusion
p.(None): 105
p.(None):
p.(None): • Technology transfer and capacity: concerning the flow of knowledge, experience and materials from one partner to
p.(None): another, and the ability of people and organiza- tions to manage their affairs and reach objectives successfully.
p.(None): The development of this resource means that vulnerable groups, such as com- munities or researchers without legal
p.(None): support, have access to resources that can help develop a good understanding of research contracting for equitable
p.(None): research part- nerships and avoid exploitation in research.
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): According to Eriksson et al. (2008), a serious flaw in most new ethics guidelines is that they are produced with the
p.(None): pretension that there are no other guidelines in exis- tence, and it would be much better if they just stated what they
p.(None): added to existing guidelines. Such is the case with the GCC, which focuses solely on factors that are specific to
...
p.(None): Genetic research, 54, 74, 92
p.(None): Genetics, 2, 7, 13, 60, 62, 63, 74, 75,
p.(None): 81, 82
p.(None): Global Code of Conduct for Research in Resource-Poor Settings, 2, 5, 14, 27,
p.(None): 37, 51, 80, 89, 109, 115–117
p.(None): Good Participatory Practice, 6, 20, 63
p.(None):
p.(None):
p.(None): H
p.(None): Harm, 1, 17, 19, 28, 34, 35, 38, 43, 45–47, 54,
p.(None): 65, 73, 75, 84, 95, 98
p.(None): Health and safety, 9, 10
p.(None): HealthyXvolunteers, 63
p.(None): Helicopter research, 23, 41
p.(None): High-income countries (HICs), 2, 9, 20–23,
p.(None): 38–44, 47, 48, 56, 65, 70, 99–101, 104
p.(None): Honesty, 2, 5, 6, 10–11, 13–24, 27–31, 33, 40,
p.(None): 46–48, 68, 70, 74, 82, 83, 90, 93,
p.(None): 95–98, 102, 110–112
p.(None): Horizon 2020, 23, 52, 53
p.(None): Human participants, 65, 117
p.(None): Human rights, 22, 42, 44, 55, 75
p.(None):
p.(None):
p.(None): I
p.(None): Ideals, 3, 16, 17, 24, 32
p.(None): Illegal, 22, 43, 63, 65, 100
p.(None): Illiterate populations, 22, 47
p.(None): Incrimination, 9, 11, 68
p.(None): India, 39, 44, 56, 61, 65, 110, 111, 115, 116
p.(None): Indigenous peoples, 49, 55, 63, 73, 75,
p.(None): 80, 112
p.(None): Industry, 39, 54–58, 61, 69, 70, 117
p.(None): Inequalities, vii
p.(None): Information sheets, 24, 47, 98, 103
p.(None): Informed consent, 2, 7, 8, 24, 44–47, 63, 66,
p.(None): 74, 82, 84, 100, 105
p.(None): Integrity, 5, 23, 24, 46–48, 53, 67, 70, 74,
p.(None): 78–79, 82, 85, 86, 94, 112, 117
p.(None): Intellectual property, 6, 20, 43, 60, 66,
p.(None): 80, 104
p.(None):
p.(None): Index
p.(None): 121
p.(None):
p.(None):
p.(None): K
p.(None): Kenya, 2, 39, 40, 42, 61, 63, 65, 100, 110,
p.(None): 115, 116
p.(None): !Khomani, 74, 77, 78, 81, 86
p.(None): Khwe, 74, 77, 78, 81
p.(None): Knowledge holders, 7, 55, 66
p.(None):
p.(None):
p.(None): L
p.(None): Lawyers, 79, 80, 104
p.(None): Legal framework, 45, 55
p.(None): Legal support, 74, 79, 80, 85, 105
p.(None): Local communities, 6, 7, 9, 20, 27, 40,
p.(None): 42–45, 52, 61, 63, 64, 69, 90, 92,
p.(None): 94–98, 105
p.(None): Local relevance, 6, 17, 60–62, 68, 102, 105
p.(None): Local researchers, 6, 7, 10, 20, 27, 40, 48, 60,
p.(None): 64, 66, 94, 96, 101
p.(None): Low- and middle-income countries (LMICs), 2, 20–22, 37–44, 46–48, 55, 56, 58, 61,
p.(None): 62, 65, 66, 69, 70, 99–105
p.(None):
p.(None):
p.(None): M
p.(None): Majengo, 63
p.(None): Medical research, 22, 23, 41, 45, 57, 65, 66,
p.(None): 104, 111, 116, 117
p.(None): Metaethical relativism, 30–32
p.(None): Misconduct, 8, 47, 105
p.(None):
p.(None):
p.(None): N
p.(None): Non-compliance, 1
p.(None): Non-governmental organisations (NGOs), 54, 63, 75–78, 85
p.(None): Non-human primates, 2, 44, 65
p.(None): Normative relativism, 30, 31
p.(None):
p.(None):
p.(None): O
p.(None): Open communication, 24, 94
p.(None):
p.(None):
p.(None): P
p.(None): Peer educators, 40
p.(None): Personal risk, 9, 41, 42, 44–47, 68
p.(None): Placebo, 38, 41
p.(None): Policymakers, 39, 54, 55, 58, 60, 70
p.(None): Poverty, 2, 3, 48, 55, 82
p.(None): Power, 2, 5, 7, 17–19, 29, 43, 44, 48, 49, 62,
p.(None): 70, 75, 100, 102
p.(None): Principles, 3, 16–18, 23, 24, 28, 29, 32–35, 39,
p.(None): 60, 75, 77, 82, 98, 104, 117
...
Social / Racial Minority
Searching for indicator minority:
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p.(None): high- income country (HIC). A concerted effort is therefore required to understand local needs and preferences so that
p.(None): a complaints mechanism can be implemented that is both user-friendly and fit for purpose.
p.(None):
p.(None):
p.(None): Factors Affecting Accessibility
p.(None):
p.(None): It is known from studies in the field of dispute resolution that people often feel reluctant to make
p.(None): complaints and that this can be related to a variety of complex factors. In 2009 the Health Professions
p.(None): Council in the UK published a
p.(None):
p.(None): 100 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): comprehensive scoping review of existing mechanisms for complaints about health professionals (HPC 2009). In this
p.(None): report, the HPC describes a range of factors that can act as barriers to making a specific complaint. As there are no
p.(None): equivalent publi- cations about complaints procedures in LMICs, we summarize here the factors that are relevant to
p.(None): research in LMICs.
p.(None): Readiness to complain in any environment can be influenced by gender, ethnic- ity, age, education, income,
p.(None): accessibility of information and the perceived “serious- ness” of the problem (Pleasence et al. 2006).
p.(None): Specifically, ethnic minority communities are less likely to use systems that they perceive as being culturally
p.(None): insensitive and are more fearful of the consequences of taking action when they feel those systems have failed them.
p.(None): Difficulties with access to information are highlighted as a barrier to making a complaint (Henwood et al. 2003),
p.(None): especially where there is “information illiteracy”; some people possess the relevant skills and confidence to seek out
p.(None): information, but many do not. In situations where levels of education and literacy are not high, this is likely to be
p.(None): exacerbated.
p.(None): The relationship between the person who brings the complaint and the bureau- cracies to which they must direct
p.(None): their complaint can be a factor (Cowan and Halliday 2003). This relationship can either encourage or
p.(None): discourage a potential complainant’s trust in complaints mechanisms. The power imbalance between par- ties in such
p.(None): relationships can be substantial. For example, when working with impoverished communities, HIC researchers
p.(None): should be aware that participation in a clinical study may provide a participant’s only access to health care or other
p.(None): much- needed benefits. Fear of retribution is often cited as a barrier to making a complaint, particularly in
p.(None): circumstances where the complainant has an ongoing relationship with the complainee (HPC 2009). In situations where
p.(None): there is a power imbalance, people may not have the confidence to complain; they may be reluctant to seem ungrateful,
...
Searching for indicator race:
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p.(None): fact that the San generally lived in small groups in remote locations added to their isolation, and contributed towards
p.(None): their vulnerability to exploitation by others.
p.(None): Generally impoverished, marginalized and cut off from the modern world, they received minimal support from their
p.(None): respective governments. Almost no communi- cation took place between the leaders of these far-flung communities, with
p.(None): the result that their ability to share information and empower their peoples remained structur- ally constrained.
p.(None):
p.(None):
p.(None):
p.(None): 2 The following are the most common major San languages currently spoken in the region. Botswana hosts
p.(None): Nharo, Gwi, G/anna and Khwe; Namibia hosts Ju/huasi, Hei//om, Kung, !Xun and Khwe; South Africa hosts the !Khomani, the
p.(None): !Xun and the Khwe; Zimbabwe hosts the Tyua.
p.(None):
p.(None): Institution Building and Supportive NGOs
p.(None): 75
p.(None):
p.(None): The fate suffered by the San peoples in Africa is similar to that of many indige- nous peoples in other parts of the
p.(None): world. Expansion and conquest, firstly by asser- tive local pastoralist and agriculturalist communities, followed later
p.(None): and with similar devastation by colonial powers, all but obliterated their former existence. The San history over the
p.(None): centuries has been one of dispossession, enslavement, cultural extinction and recorded patterns of officially
p.(None): sanctioned genocide (Penn 2013).
p.(None): For many reasons, including their lifestyle until recent times as hunter-gatherer peoples, and their unique genetic
p.(None): properties as descendants of possibly the earliest members of the human race, the San have found themselves
p.(None): in high demand as research populations.
p.(None): Modern San leaders faced with increasing societal challenges had no means of communicating their problems with other
p.(None): leaders, of learning about their human rights, or of discussing ways in which they might legitimately
p.(None): challenge the unwanted interventions of researchers and other outsiders such as media practitioners.
p.(None): In addition, the San world view is generally one of seeking harmony, and avoid- ing all forms of conflict. Several
p.(None): scholars of conflict resolution have based their principles of good practice on ancient San systems, in which the
p.(None): prevention of dis- putes and the reconciliation of interests are deeply ingrained (Ury 1995).
p.(None): The outside world regarded the San as a classic example of a “vulnerable popula- tion”, lacking the means to organize a
p.(None): collective expression of their common inter- ests and concerns (Chennells 2009). Prior to the year 2000, virtually all
p.(None): research was externally conceived, and was perceived by the San as being disruptive and on occasion harmful to the
p.(None): research populations (Chennells and Steenkamp 2018).
p.(None): Internet searches of the words San, Khoisan3 and Bushmen throw up thousands of papers, books and research theses,
p.(None): supporting the assertion that they are among the most researched peoples in the world. Until they formed their own
p.(None): representa- tive organizations, they did not have a unified voice and thus remained powerless to resist unwanted
p.(None): attention from outsiders.
p.(None):
p.(None):
p.(None): Institution Building and Supportive NGOs
p.(None):
...
Social / Religion
Searching for indicator belief:
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p.(None): actually able to offer, why and how often my friend has problems of this kind, and so on.
p.(None): For all those who are still developing their virtues, a code such as the GCC can help to guide action. As noted at the
p.(None): outset, people are much more contented and productive when their own values are aligned with company or institutional
p.(None): values and rules. It therefore made sense to align the articles of the GCC with those values that are necessary for
p.(None): ethical research and to which researchers must aspire. The values of fairness, respect, care and honesty provide the
p.(None): ethos, the motivation and the goals for ethical research. The 23 articles making up the GCC therefore enable
p.(None): operationalization of the values.
p.(None): This leaves the task of outlining what is meant by each of the four values of fair- ness, respect, care and honesty,
p.(None): keeping in mind the following important points. First, precise specifications of values might be affected by customs
p.(None): and preferences, so that different cultures have different views on the exact content of the values. Second, the
p.(None): importance of process cannot be underestimated. The reason why articles 25 and 46 of the GCC emphasize inclusion is
p.(None): that the specification of what each value requires in a given setting needs to be determined collaboratively. As a
p.(None): result, this sketch of the content of the four values is brief and leaves room for regional variations.
p.(None):
p.(None):
p.(None): The Four Values
p.(None): Fairness
p.(None):
p.(None): The terms “fairness”, “justice” and “equity” are often used interchangeably. The TRUST consortium chose the term
p.(None): “fairness” in the belief that it would be the most widely understood globally. Philosophers commonly distinguish
p.(None): between four types of fairness (Pogge 2006) (see Fig. 3.2).
p.(None): The most relevant fairness concepts in global research ethics are fairness in exchange and corrective
p.(None): fairness. In global collaborations, at least two parties are involved in a range of transactions. Typical fairness
p.(None): issues between partners from high-income countries (HICs) and those from low- and middle-income countries (LMICs) are:
p.(None): • Is the research relevant to local research needs?
p.(None): • Will benefit sharing take place?
p.(None): • Are authors from LMICs involved in publications?
p.(None):
p.(None): 5 Local communities and research participants should be included throughout the research process, wherever possible,
p.(None): from planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly represented.
p.(None): This approach represents Good Participatory Practice.
p.(None): 6 Local researchers should be included, wherever possible, throughout the research process, includ- ing in study
p.(None): design, study implementation, data ownership, intellectual property and authorship of publications.
p.(None):
p.(None): The Four Values
p.(None): 21
p.(None):
p.(None): Fairness in
p.(None): exchange
p.(None): • establishes the equity of transactions between at least two parties.
p.(None):
p.(None): Distributive fairness
p.(None): • deals with the division of existing, scarce resources among qualifying recipients.
p.(None):
p.(None): Corrective fairness
p.(None): • rights a wrong that one has brought upon another, often through a court.
p.(None):
p.(None): Retributive fairness
p.(None): Fig. 3.2 Types of fairness
...
p.(None): and criminal law, and if they do, it is indeed crimi- nal law that should be used to deal with a fairness violation.
p.(None):
p.(None): 22 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Respect
p.(None):
p.(None): The term “respect” is used in many ethics frameworks. For instance, the Declaration of Helsinki (WMA 2013) notes in
p.(None): article 7:
p.(None): Medical research is subject to ethical standards that promote and ensure respect for all human subjects
p.(None): and protect their health and rights. (emphasis added)
p.(None): Its ubiquitous use does not, however, mean that “respect” is a clear term. In everyday life, it is used in
p.(None): the sense of deep admiration. For instance, somebody could say, “I respect the achievements of Nelson Mandela”.
p.(None): However, that is not what is meant by respect in research ethics. The statement from the Declaration of Helsinki does
p.(None): not mean that research participants must be admired. To be respected in research ethics is almost the opposite. It
p.(None): means that one must accept a decision or a way of approaching a matter, even if one disagrees strongly. A case in point
p.(None): would be respecting the decision of a competent adult Jehovah’s Witness to refuse a blood transfusion for reasons of
p.(None): religious belief, even if this means certain death.
p.(None): Respect is therefore a difficult value, as there will be cases where one cannot accept another’s decision. For
p.(None): instance, if a researcher learns about female genital mutilation being used as a “cure” for diarrhoea in female babies
p.(None): (Luc and Altare 2018), respecting this approach to health care is likely to be the wrong decision – particularly as the
p.(None): practice is probably illegal. But the fact that respect may be dif- ficult to operationalize in global research
p.(None): collaborations does not mean that it is a value one can dispense with.
p.(None): There are many possible ways of showing respect that do not create conflicts of conscience. For instance, illiterate
p.(None): San community members should not be enrolled in research studies unless San leaders have been contacted first, in
p.(None): accordance with com- munity systems. And researchers from HICs should not insist that LMIC ethics com- mittees accept
p.(None): the format of the researchers’ preferred ethics approval submission; instead the HIC researchers should submit the
p.(None): study for approval in the format required by the LMIC committee. This shows respect in international collaborative
p.(None): research.
p.(None): While it may be difficult to imagine a situation where an HIC researcher is accused of being too fair, too
p.(None): honest or too caring, it is possible to be accused of being “too respectful” – for instance, if one tolerates major
p.(None): violations of human rights. It is indeed sometimes difficult to strike a balance between dogmatically
...
p.(None): participants and local researchers to avoid violating customary practices. Research is a
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 27
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_4
p.(None):
p.(None): 28 4 Respect and a Global Code of
p.(None): Conduct?
p.(None):
p.(None): values the code recommends are globally applicable. How do we reconcile this ten- sion? That is, how do we demonstrate
p.(None): that, in making use of the four values, one group is not illegitimately imposing its values on others, in ways that the
p.(None): GCC itself would deem unacceptable?
p.(None): The surest way of doing this is to defend the claim that the four values, which we believe have particular application
p.(None): in research in resource-poor settings, could be global or universal values. Let us call this claim “the global
p.(None): applicability thesis”. We need somehow, then, to be able to maintain the global applicability thesis alongside the
p.(None): recognition of significant variation in norms across cultures. We will look in turn, in the sections that follow, at a
p.(None): number of suggestions about how this may be achieved.
p.(None): First we will consider the possibility that the requirement to proceed with fair- ness, respect, care and honesty leads
p.(None): to an acceptance of a thoroughgoing moral relativism – that is, a robust and unflinching commitment to the belief that
p.(None): all values are culture-bound, and that there are no “extra-cultural” values or norms. We will argue that, for reasons
p.(None): articulated by Bernard Williams (1972) nearly half a century ago, such strict moral relativism is unsustainable.
p.(None): Then we will consider the merits of a more moderate moral relativism, of the sort argued for by the Chinese-American
p.(None): philosopher David Wong (1991, 2009). This approach combines a recognition of variation in norms across cultures with a
p.(None): certain sort of universalism. For Wong, what remains constant across disparate systems of moral norms is the purpose
p.(None): behind any such system, or the aim of morality as such. We will argue that Wong’s approach, though an improvement on a
p.(None): more extreme relativism, does not provide what we need: that is, it does not show there to be some universal norms –
p.(None): among which are our four values – in addition to some genuine cross-cultural normative variation.
p.(None): Finally we introduce an approach that has much in common with the TRUST2 approach: the “four-principles approach”
p.(None): presented by Tom Beauchamp and James Childress in successive editions of their book Principles of Biomedical
p.(None): Ethics (2013). Beauchamp and Childress maintain that there are four central values/prin- ciples3 (see the box below
p.(None): for the difference between the two) that are especially applicable to their own area of ethical interest, biomedical
p.(None): ethics. They use the term principles, and identify them as respect for autonomy, non-maleficence (do no
...
Searching for indicator religion:
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p.(None): have been developed by the community in the past and may be modified in the future (WHO 1998: 5)
p.(None): As we can infer from this definition, there are many different types of communi- ties and also communities within
p.(None): communities. For example, indigenous communi- ties, having a historical continuity with preinvasion and precolonial
p.(None): societies that developed on their territories, may consider themselves distinct from other sectors of the societies
p.(None): that now prevail on those territories, or parts of them. They generally form nondominant sectors of society and can be
p.(None): intent on preserving, developing and transmitting to future generations their ancestral territories and their
p.(None): ethnic identity, as the basis of their continued existence as peoples, in accordance with their own cultural patterns,
p.(None): social institutions and legal systems (Martínez Cobo
p.(None):
p.(None): 92 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): 2014). They often have particular relationships with advocacy groups who work to protect or represent their interests.4
p.(None): The concept of communities within communities also includes groups of people who are vulnerable because of a
p.(None): range of physical (disabilities, for example) or cultural (religion, for example) characteristics. For instance,
p.(None): sex workers, injecting drug users and men who have sex with men are often marginalized within their own broader
p.(None): communities.5 People from such groups are frequently sought for interna- tional research and yet the community at
p.(None): large or the community leaders are often unable to provide the input needed to ensure ethical management of
p.(None): research projects. Communities and their leaders may be unaware of the specific circumstances of these people and their
p.(None): lives, and they may even be openly hostile. We therefore need mechanisms for ensuring that the voice of
p.(None): marginalized and vulnerable populations is heard, and that their interests in research are represented.
p.(None): In the 1990s, community engagement assumed prominence as the new guiding light of public health efforts; research and
p.(None): health-improvement programmes that involved communities had better results than programmes led by government alone (NIH
p.(None): 2011). At the same time, the limitations of existing guidelines for the protec- tion of communities in genetic research
p.(None): was becoming increasingly apparent (Weijer et al. 1999). The benefits of community engagement in all types of research
p.(None): are now widely acknowledged, and numerous publications describe many potential benefits such as:
p.(None): • increasing community understanding and acceptance of the studies
p.(None): • enhancing researchers’ ability to understand and address community priorities
p.(None): • improving logistics and the running of studies
p.(None): • strengthening the quality of the information collected
...
Searching for indicator religious:
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p.(None): become a subject of extensive research in the social sci- ences and in psychology, particularly over the past forty
p.(None): years, with just about every area of life being examined through the lens of personal values – for example, con- sumer
p.(None): practices (Pinto et al. 2011), political voting habits (Kaufmann 2016), employee creativity (Sousa and Coelho
p.(None): 2011), healthcare decisions (Huijer and Van Leeuwen 2000), investment decisions (Pasewark and Riley 2010), and
p.(None): sexuality and disability (Wolfe 1997), to name but a few.
p.(None):
p.(None):
p.(None): 4 Local ethics review should be sought wherever possible. It is of vital importance that research projects are approved
p.(None): by a research ethics committee in the host country, wherever this exists, even if ethics approval has already been
p.(None): obtained in the high-income setting.
p.(None):
p.(None): From Values to Action
p.(None): 19
p.(None):
p.(None): Arguably the most prominent theory of the motivational power of human values was developed by social psychologist
p.(None): Shalom Schwartz, back in 1992. Schwartz’s theory of basic values is distinctive because, unlike most other theories, it
p.(None): has been tested via extensive empirical investigation. Studies undertaken since the early 1990s have generated
p.(None): large data sets from 82 countries, including highly diverse geographic, cultural, religious, age and occupational
p.(None): groups (Schwartz 2012). Findings from Schwartz’s global studies indicate that values are inextricably linked to
p.(None): affect. He claims that when values are activated, they become infused with feel- ing (Schwartz 2012). For example,
p.(None): people for whom routine and security are impor- tant values will become disturbed when their employment is threatened
p.(None): and may fall into despair if they actually lose their jobs. Correspondingly, when moral values like fairness or respect
p.(None): are important, people will react when they witness instances of unfairness or disrespect; they will feel motivated to
p.(None): respond in some way.
p.(None): Schwartz’s research investigated motivational values in general (combining our second and third meanings of “value”),
p.(None): and not just moral values. As noted earlier, people can be motivated by many different values, but interestingly, when
p.(None): asked to rank values in order of importance, the participants in Schwartz’s studies consis- tently rated those with
p.(None): explicit moral connotations as the most important values (Schwartz 2012). This suggests that people hold their
p.(None): moral values in high esteem and can be strongly influenced by them.
p.(None):
p.(None):
p.(None): From Values to Action
p.(None):
p.(None): Ethical values give us direction but are not sufficient to make us ethical researchers who avoid ethics dumping. One
p.(None): can hold the value of honesty and yet fail to be an honest person. One can hold the value of respect and yet cause harm
p.(None): when disre- specting local customs. Values can motivate and they can help to establish moral goals, but they do not
...
p.(None): included in the GCC. Likewise, retributive fairness is less relevant as few ethics violations fall under the punitive
p.(None): and criminal law, and if they do, it is indeed crimi- nal law that should be used to deal with a fairness violation.
p.(None):
p.(None): 22 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Respect
p.(None):
p.(None): The term “respect” is used in many ethics frameworks. For instance, the Declaration of Helsinki (WMA 2013) notes in
p.(None): article 7:
p.(None): Medical research is subject to ethical standards that promote and ensure respect for all human subjects
p.(None): and protect their health and rights. (emphasis added)
p.(None): Its ubiquitous use does not, however, mean that “respect” is a clear term. In everyday life, it is used in
p.(None): the sense of deep admiration. For instance, somebody could say, “I respect the achievements of Nelson Mandela”.
p.(None): However, that is not what is meant by respect in research ethics. The statement from the Declaration of Helsinki does
p.(None): not mean that research participants must be admired. To be respected in research ethics is almost the opposite. It
p.(None): means that one must accept a decision or a way of approaching a matter, even if one disagrees strongly. A case in point
p.(None): would be respecting the decision of a competent adult Jehovah’s Witness to refuse a blood transfusion for reasons of
p.(None): religious belief, even if this means certain death.
p.(None): Respect is therefore a difficult value, as there will be cases where one cannot accept another’s decision. For
p.(None): instance, if a researcher learns about female genital mutilation being used as a “cure” for diarrhoea in female babies
p.(None): (Luc and Altare 2018), respecting this approach to health care is likely to be the wrong decision – particularly as the
p.(None): practice is probably illegal. But the fact that respect may be dif- ficult to operationalize in global research
p.(None): collaborations does not mean that it is a value one can dispense with.
p.(None): There are many possible ways of showing respect that do not create conflicts of conscience. For instance, illiterate
p.(None): San community members should not be enrolled in research studies unless San leaders have been contacted first, in
p.(None): accordance with com- munity systems. And researchers from HICs should not insist that LMIC ethics com- mittees accept
p.(None): the format of the researchers’ preferred ethics approval submission; instead the HIC researchers should submit the
p.(None): study for approval in the format required by the LMIC committee. This shows respect in international collaborative
p.(None): research.
p.(None): While it may be difficult to imagine a situation where an HIC researcher is accused of being too fair, too
p.(None): honest or too caring, it is possible to be accused of being “too respectful” – for instance, if one tolerates major
...
p.(None): flout the research ethics and legal requirements in the host LMIC can be difficult to police. This is especially
p.(None): problem- atic in localities where there is a lack of resources and/or infrastructure to ensure ethical compliance
p.(None): through the entire research process and where the home institu- tions in HICs do not ensure that their employees comply
p.(None): with requirements.
p.(None):
p.(None):
p.(None): Respect
p.(None):
p.(None): Respect requires an acceptance of customs and cultures that may be different from one’s own, and a commitment not to
p.(None): behave in a way that causes offence. One may need to abide by decisions or ways of approaching matters with which one
p.(None): dis- agrees. This can be problematic, especially if local customs are illegal or perceived as dangerous.6 However,
p.(None): respect is important in LMIC-HIC collaborations, and there are many possible ways of showing respect that do not
p.(None): create conflicts of con- science. For instance, HIC researchers should not insist that LMIC ethics commit- tees accept
p.(None): the ethics approval submission in the HIC’s preferred format, but should rather conform with the format preferred by
p.(None): the LMIC committee. Table 5.3 shows the primary risks related to respect for persons, institutions, communities,
p.(None): countries, animals and the environment.
p.(None): Local LMIC customs, traditions, and religious and spiritual beliefs may be very different from those of the HIC
p.(None): researcher. For example, from an African cultural point of view, human body parts are sacred, whether they are obtained
p.(None): from living or deceased persons. Hence, the removal of blood or other body parts for research may have a profound
p.(None): impact that needs to be acknowledged and addressed in a man- ner that is sensitive to the wishes of the local
p.(None): community. A liberal interpretation of autonomy, i.e. individual autonomy, prevails in HICs but may not be
p.(None): easily transferred to LMIC settings where “community” or “group autonomy” is also highly valued. Furthermore,
p.(None): in some settings it might be deemed rude for a research participant to say “no” or to ask questions about the research.
p.(None): In other situations, people may be too afraid or unconfident to do so. Either way, the power imbalance between
p.(None): researcher and research participant can impact upon the consent process.
p.(None):
p.(None): 6 For instance, if a researcher learns that female genital mutilation is being used as a “cure” for diarrhoea in female
p.(None): babies, respecting this approach to health care is likely to be the wrong deci- sion, particularly as the practice is
p.(None): likely illegal. At the very least such a decision would leave the researcher with a serious conflict of conscience (Luc
p.(None): and Altare 2018).
p.(None):
p.(None): 44 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): Table 5.3 Primary risks for respect
p.(None): Level of risk Nature of risk
p.(None): Personal • Unequal power relations
p.(None): • Tendency to defer to authorities
p.(None): • Individual spiritual and religious priorities incompatible with or ignored by HIC partners
p.(None): • Researchers and/or ethics committees deciding “what is best”
p.(None):
p.(None): Researcher/ institutional
p.(None): • Research protocol and papers imported from HIC partners and not tailored to local needs
p.(None): • Ethical approval sought only from HIC partner
p.(None): Community • Diverse interpretations of important values
p.(None): • Local requirements for effective community engagement ignored
p.(None): • Diverse ethical priorities for matters such as:
p.(None): - gender equality
p.(None): - sexual relations
p.(None): • Particular spiritual and religious priorities incompatible with or ignored by Northern partners
p.(None): • Localized social effects from research team presence
p.(None): • Local customs that may violate laws of the country and/or human rights Country • Research protocols and
p.(None): practices which fail to take account of national
p.(None): traditions and legislation
p.(None): Animal • Variations in customs, norms and attitudes regarding animal welfare and inhumane practices
p.(None): Environmental • Variations in customs, norms and attitudes regarding the environment
p.(None):
p.(None): Animals and environments are also at risk of exploitation because of variations in customs and norms. What is
p.(None): considered “animal cruelty” or “inhumane practice” in animal experimentation varies greatly between cultures.
p.(None): Additionally, some ani- mals are awarded greater protection in certain cultures than others, for example, dogs and cats
p.(None): in the United Kingdom and cows in India. Animal experimentation on non-human primates is particularly controversial
p.(None): in most countries, but in some certain non-human primates are viewed as “pests” (Hill and Webber 2010). Different
p.(None): partners in collaborative research may have different philosophies related to the environment. Environmental
p.(None): protection is sometimes regarded as a colonial con- struct that has negative impacts on local communities in LMICs, and
p.(None): research agen- das likewise. There may therefore be a philosophical or paradigmatic difference between
p.(None): research partners that needs to be identified and addressed.
p.(None):
p.(None):
p.(None): Care
p.(None):
...
Social / Soldier
Searching for indicator army:
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p.(None): throughout the region were trained in the implementation of the contract, and it was used to deal with researchers,
p.(None): filmmakers, writers and others who entered San territory wanting to gather information.
p.(None):
p.(None):
p.(None): South African San Institute and South African San Council
p.(None):
p.(None): The San Code of Research Ethics takes a step further than the WIMSA Media and Research Contract. It outlines exactly
p.(None): what the San require from researchers. The WIMSA contract, by contrast, is more akin to an ethics approval
p.(None): form, which requires researchers to provide information about their studies before they enter San communities. One
p.(None): major difference is therefore that the San code requires collabo- ration from the start – that is, from the inception
p.(None): of the research – rather than approv- ing fully conceived studies as through the WIMSA form.
p.(None): The two NGOs most important in developing the San Code of Research Ethics were the South African San Institute (SASI)
p.(None): and the South African San Council (SASC).
p.(None): SASI was formed in 1996 and initially took the form of a dedicated San service NGO. SASI’s original mission was to
p.(None): assist the !Khomani San with their restitution land claim in the Kalahari. This was completed successfully in 1999, but
p.(None): SASI con- tinued to be active. SASI also supported the !Xun and Khwe San communities, who were relocated to South
p.(None): Africa from Namibia after the end of the “bush wars” in 1990, and settled in a temporary army camp near Kimberley,
p.(None): where SASI is based. The communities’ first needs were for assistance in relation to housing and other social problems
p.(None): arising from their exceedingly disrupted and war-torn history, hav- ing been caught in the crossfire between the
p.(None): apartheid government of South Africa and guerrilla fighters in Angola and Namibia. SASI was the partner in the TRUST
p.(None): project which represented the San peoples, and which assisted with the develop- ment of the San Code of Ethics. They
p.(None): hosted all relevant workshops and the launch of the code in Cape Town (see below).
p.(None): The SASC had existed informally since 1996, representing the interests of three South African San communities on the
p.(None): WIMSA board (!Khomani, Khwe, !Xun). It was legally constituted in 2001 so that it could negotiate officially on behalf
p.(None): of the San, and proceeded over the years to become a major success story in San institu- tion building. The SASC
p.(None): negotiated a famous benefit-sharing agreement with South Africa’s Council for Scientific and Industrial Research
p.(None): (CSIR) in relation to the San’s traditional knowledge rights to the Hoodia plant.
p.(None): The global UN Convention on Biological Diversity (CBD) of 1992 was the first instrument to provide for the principle
p.(None): that commercial users of plants with active ingredients based upon traditional knowledge needed to negotiate
p.(None): benefit-sharing agreements with the holders of the traditional knowledge, in order to ensure fair-
p.(None):
p.(None): 78 7 The San Code of
p.(None): Research Ethics
p.(None):
...
Social / Threat of Stigma
Searching for indicator stigma:
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p.(None): Chapter 7 of this book of the development of the San Code of Research Ethics. Second, Partners for Health and
p.(None): Development in Africa (PHDA) made the inclusion of sex workers from the Majengo area of Nairobi possible. At this point
p.(None): we will focus on their involvement in order to illustrate the bottom-up approach of the GCC drafting process.
p.(None): PHDA is a nonprofit organization that undertakes work in the fields of health and development in Kenya. Its mission is
p.(None): to increase access to health for disadvantaged communities in Africa by strengthening health systems, research,
p.(None): programme devel- opment and partnerships. PHDA’s programmes are implemented by a collaborative group of scientists and
p.(None): public health professionals from the University of Manitoba (Canada), the University of Nairobi and the government of
p.(None): Kenya. Its work focuses mainly on HIV prevention, treatment and care, research, capacity-building and
p.(None): training.
p.(None): The Sex Workers Outreach Programme (SWOP) is a PHDA initiative that under- takes active community engagement and
p.(None): provides clinical and preventative services to 33,000 sex workers residing in Nairobi. These sex workers would
p.(None): otherwise find access to medical services in public health facilities extremely limited due to stigma and
p.(None): discrimination. Those enrolled in the sex workers cohort for HIV prevention services are free to volunteer for
p.(None): available research studies after providing informed consent. Most studies are on the epidemiology of sexually
p.(None): transmitted diseases, and on host genetic factors that influence infectivity and disease progression.
p.(None): Given that sex work is illegal in Kenya, we cannot assign input to specific, named individuals here. Suffice to say
p.(None): that the personal contributions of courageous and admirable sex workers, both female and male, provided the TRUST team
p.(None): not only with practical advice that took shape in specific articles of the GCC, but also with inspiration. Table 6.4
p.(None): presents two examples of issues raised by the Nairobi sex workers (Chatfield et al. 2016a) that were implemented in the
p.(None): GCC.
p.(None):
p.(None): 64 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.4 Input from sex workers and GCC connection
p.(None): Issues raised by sex workers Relevant GCC Article
p.(None):
...
Searching for indicator threat:
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p.(None): Fairness, respect, care and honesty: four simple words with clear meaning to help researchers enter the house through
p.(None): the door and no longer through the win- dow.3 – Dr François Hirsch (French), former head of the Inserm (French
p.(None): National Institute of Health and Medical Research) Office for Ethics, co-author of the GCC
p.(None): Ron Iphofen [British], an adviser on research ethics to the European Commission, believes the code will have a profound
p.(None): impact on how funding proposals to the EU are designed and reviewed. “I could envisage reviewers [of EU-funded
p.(None): research proposals] now looking suspiciously at any application for funds that entailed research by wealthy
p.(None): nations on the less wealthy that did not mention the code,” he says. (Nordling 2018)
p.(None): The emphasis in the GCC on fairness, respect, care and honesty resonates with our work at UNESCO. – Dr Dafna
p.(None): Feinholz (Mexican), UNESCO’s chief of Bioethics and Ethics of Science and Technology, co-author of the GCC
p.(None):
p.(None):
p.(None):
p.(None): 2 The EU-funded consortium that developed the GCC.
p.(None): 3 This refers to Andries Steenkamp’s iconic request to researchers, namely to enter San communi- ties through the
p.(None): metaphorical “front door” – that is, the San Council – and not, like thieves, through the window.
p.(None):
p.(None): 112 9 Towards Equitable Research
p.(None): Partnership
p.(None):
p.(None): TRUST was a game changer.4
p.(None): Ethics dumping is a real threat to the quality of science and the GCC is now a mandatory reference document for EU
p.(None): framework program funding to guard against it. – Dorian Karatzas (Greek), head of Ethics and Research Integrity,
p.(None): European Commission
p.(None): Best science for the most neglected, also means best ethical standards. That’s why the GCC aims high: to protect the
p.(None): most neglected. – Dr François Bompart (French), director of Paediatric HIV/Hepatitis C Programmes at the Drugs
p.(None): for Neglected Diseases initiative (DNDi), former vice president, Access to Medicines at Sanofi, co-author of the GCC
p.(None): We get given consent forms and documents, often in a hurry. We sign because we need the money and then end up with
p.(None): regret. It feels like a form of abuse. They want something from us and they know how to get it. Because of our
p.(None): socio-economic conditions, we will always be vulnerable to those from the North. A code of ethics is needed that
p.(None): protects indigenous people.5 – Andries Steenkamp (1960–2016) (South African), former chair of the South African
p.(None): San Council, co-author of both codes
p.(None): I don’t want researchers to see us as museums who cannot speak for themselves and who don’t expect something in return.
p.(None): As humans, we need support.6 – Reverend Mario Mahongo (1952–2018) (Angolan), co-author of both codes
...
Searching for indicator stigmatization:
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p.(None):
p.(None):
p.(None): Article 11
p.(None):
p.(None): Researchers from high-income settings should show respect to host country research ethics committees.
p.(None):
p.(None):
p.(None): Care
p.(None): Article 12
p.(None):
p.(None): Informed consent procedures should be tailored to local requirements to achieve genuine understanding and well-founded
p.(None): decision-making.
p.(None):
p.(None):
p.(None): Article 13
p.(None):
p.(None): A clear procedure for feedback, complaints or allegations of misconduct must be offered that gives genuine and
p.(None): appropriate access to all research participants and local partners to express any concerns they may have with the
p.(None): research process. This procedure must be agreed with local partners at the outset of the research.
p.(None):
p.(None): Care
p.(None): 9
p.(None):
p.(None): Article 14
p.(None):
p.(None): Research that would be severely restricted or prohibited in a high-income setting should not be carried out in a
p.(None): lower-income setting. Exceptions might be permissi- ble in the context of specific local conditions (e.g. diseases not
p.(None): prevalent in high- income countries).
p.(None): If and when such exceptions are dealt with, the internationally acknowledged compliance commandment “comply or
p.(None): explain” must be used, i.e. exceptions agreed upon by the local stakeholders and researchers must be explicitly
p.(None): and trans- parently justified and made easily accessible to interested parties.
p.(None):
p.(None):
p.(None): Article 15
p.(None):
p.(None): Where research involvement could lead to stigmatization (e.g. research on sexually transmitted diseases), incrimination
p.(None): (e.g. sex work), discrimination or indetermi- nate personal risk (e.g. research on political beliefs), special measures
p.(None): to ensure the safety and wellbeing of research participants need to be agreed with local partners.
p.(None):
p.(None):
p.(None): Article 16
p.(None):
p.(None): Ahead of the research it should be determined whether local resources will be depleted to provide staff or
p.(None): other resources for the new project (e.g. nurses or labo- ratory staff). If so, the implications should be discussed in
p.(None): detail with local com- munities, partners and authorities and monitored during the study.
p.(None):
p.(None):
p.(None): Article 17
p.(None):
p.(None): In situations where animal welfare regulations are inadequate or non-existent in the local setting compared with the
p.(None): country of origin of the researcher, animal experi- mentation should always be undertaken in line with the higher
p.(None): standards of protec- tion for animals.
p.(None):
p.(None): 10 2 A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None): Article 18
p.(None):
p.(None): In situations where environmental protection and biorisk-related regulations are inadequate or non-existent in
p.(None): the local setting compared with the country of origin of the researcher, research should always be undertaken in line
...
p.(None): partners and employers.
p.(None):
p.(None):
p.(None): Honesty
p.(None): Article 20
p.(None):
p.(None): A clear understanding should be reached among collaborators with regard to their roles, responsibilities and conduct
p.(None): throughout the research cycle, from study design through to study implementation, review and dissemination.
p.(None): Capacity-building plans for local researchers should be part of these discussions.
p.(None):
p.(None):
p.(None): Article 21
p.(None):
p.(None): Lower educational standards, illiteracy or language barriers can never be an excuse for hiding information or providing
p.(None): it incompletely. Information must always be presented honestly and as clearly as possible. Plain language and a
p.(None): non-patronising style in the appropriate local languages should be adopted in communication with research participants
p.(None): who may have difficulties comprehending the research process and requirements.
p.(None):
p.(None):
p.(None): Article 22
p.(None):
p.(None): Corruption and bribery of any kind cannot be accepted or supported by researchers from any countries.
p.(None):
p.(None): Honesty
p.(None): 11
p.(None):
p.(None): Article 23
p.(None):
p.(None): Lower local data protection standards or compliance procedures can never be an excuse to tolerate the potential for
p.(None): privacy breaches. Special attention must be paid to research participants who are at risk of stigmatization,
p.(None): discrimination or incrimi- nation through the research participation.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 3
p.(None): The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract Values inspire, motivate and engage people to discharge obligations or duties. This chapter defends the
p.(None): values approach in the context of guarding against ethics dumping, the practice of exporting unethical research from
...
p.(None): commit- tees shared their experiences and opinions about the primary ethical challenges for LMIC-HIC collaborative
p.(None): research in Kenya. Findings from both events revealed multiple risks of exploitation that are characteristic of
p.(None): research in some LMIC set- tings. These included traditional requirements for appropriate community
p.(None):
p.(None): 4 This type of consultative exercise is of proven value in the development of ethical codes that are broadly
p.(None): representative and can have wide-ranging impact. For example, the principles of the “Three Rs”, which are
p.(None): globally accepted as a reasonable measure for ethical conduct in animal research, arose from a broad consultation with
p.(None): stakeholders undertaken by Russell and Burch in the 1950s. See Russell et al. (1959).
p.(None):
p.(None): 40 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): consultations and permissions, and specific cultural beliefs and customs that must be respected.
p.(None): Ongoing consultation with representatives from two vulnerable groups that have first-hand accounts of the risks
p.(None): for exploitation were undertaken. From Nairobi, Kenya, sex worker peer educators and, from South Africa, members
p.(None): of the San com- munity shared their experiences of being the subjects of exploitation and their opin- ions about how
p.(None): they want to be treated in future. Among many other insights, both groups described a lack of benefits from research
p.(None): projects (which are often highly beneficial to the researchers), as well as risks of stigmatization from the manner in
p.(None): which they were involved in the study.
p.(None): 12 months of in-depth and far-reaching investigation produced a considerable amount of data (Chapter 6). From this
p.(None): data, individual vulnerabilities and risks of exploitation were extracted, organized and tabulated on an Excel
p.(None): spreadsheet with source details and descriptions of the vulnerability or risk. Care was taken to ensure that each
p.(None): individual entry was based upon real-world experience rather than hypo- thetical suppositions. Our lists were compared
p.(None): with risks mentioned in the literature and, where necessary, additional information sought to address gaps.
p.(None): Once collated, the raw data was streamlined to group similar vulnerabilities together. For instance, there
p.(None): were many different examples of how people living in resource-poor circumstances may be unfairly enticed to participate
p.(None): in research by the prospect of payment or reward. Such examples were grouped under the label “undue inducement”.
p.(None): Further thematic analysis resulted in distinctions between the various potential subjects of exploitation, or levels of
p.(None): risk for exploitation (persons, institutions,5 local communities, countries, animals and the environment). In
p.(None): the final stage of the analysis the vulnerabilities were grouped according to the four values of fairness, respect,
p.(None): care and honesty.
p.(None):
p.(None):
p.(None): Our Findings
p.(None):
p.(None): The remainder of this chapter is devoted to presenting and explaining our findings. For each value, an exploitation
...
p.(None): At the individual level, variations in spoken language, understanding, levels of literacy and use of terminology are
p.(None): just some of the issues that can lead to exploita- tion. The number of different ways in which individuals can suffer
p.(None): harm as a result of their involvement in research is vast. At the community level, the mere presence of a research team
p.(None): can have a great impact upon a local community. Research teams require food and accommodation, purchase local goods and
p.(None): services, and form rela- tionships with local people.
p.(None): At a national and international level, the rapid emergence of high-risk applica- tions of technologies such as genome
p.(None): editing7 challenges not only safety risk assess- ments but also existing governance tools. This creates an environment
p.(None): where risky experiments might be carried out in countries with an inadequate legal framework,
p.(None):
p.(None): Table 5.4 Primary risks for care
p.(None): Level of risk Nature of risk
p.(None): Personal • In medical research: therapeutic misconception
p.(None): • Misunderstanding of research aims
p.(None): • Procedures for informed consent not tailored to individual
p.(None): • Lack of possible actions to address adverse effects of participation
p.(None): • Direct risks, such as physical side effects
p.(None): • Indirect risks, such as stigmatization
p.(None):
p.(None): Researcher/ institutional
p.(None): • No host country research ethics structures or inappropriate match with requirements
p.(None): • No capacity in existing REC
p.(None): • REC members are poorly trained and lack specialized expertise to review ALL types of research protocols
p.(None): • REC meetings are either too few or too sporadic
p.(None): • REC does not have local or national government or ministry support to conduct its activities
p.(None): Community • Localized physical effects from research team presence Country • Insufficient data
p.(None): security measures
p.(None): • Insufficient safeguarding protocols
p.(None): • Lack of risk management approaches to biosafety
p.(None): • Lack of risk management approaches to biosecurity
p.(None): Animal • Animal research centres established in countries where regulation is less stringent
p.(None): • Lack of resources for humane animal care
p.(None): Environmental • Inadequate consideration of unintended consequences for biodiversity and the environment
p.(None): • Inadequate consideration of local environmental contexts
p.(None): • Disregard for long-term effects upon local environment
p.(None): • Lack of resources for environmental protection
p.(None): • Insufficient information for assessment of environmental effects
p.(None):
p.(None):
p.(None): 7 For example, applying genome editing technologies to human embryonic stem cells.
p.(None):
p.(None): 46 5 Exploitation Risks in Collaborative International Research
...
p.(None): Built
p.(None):
p.(None): Table 6.7 GCC drafting committee
p.(None): Region of
p.(None): Drafter origin Focus Background Roles
p.(None):
p.(None): Schroeder North All engagement and
p.(None): fact-finding
p.(None): Philosophy, politics, economics
p.(None): Full first draft
p.(None):
p.(None): Chennells South Vulnerable populations
p.(None): Law Drafting articles to protect vulnerable populations
p.(None):
p.(None): Chatfield North Risks Social science, philosophy
p.(None): Redrafting to ensure all risks were covered
p.(None): Singh South Existing guidelines Public health Redrafting with a focus on
p.(None): existing guidelines
p.(None):
p.(None): Table 6.7 shows the configuration of the four-person drafting committee. The emphasis was on 50% North and 50% South
p.(None): membership, taking into account the expertise needed and relevant background.
p.(None): The four-values approach, featuring fairness, respect, care and honesty, had been adopted by the consortium at an
p.(None): earlier stage (chapter 3). Based on these values and the inputs into the GCC from consultations and fact-finding
p.(None): activities over two years (see Fig. 6.1), the lead author, Professor Doris Schroeder, drafted the first version, which
p.(None): contained 20 articles, three fewer than the final version.
p.(None): For instance, article 15 on the risks of stigmatization, incrimination, discrimina- tion and indeterminate personal
p.(None): risk was added during the peer review process by Professor Morton, the veterinary expert in the consortium.
p.(None): Professor Schroeder’s first draft was refined considerably by the social science and risk expert on the drafting
p.(None): committee, Dr Kate Chatfield. Dr Roger Chennells, the expert on involving vulnerable populations in research,
p.(None): who also provided a legal perspective, drafted his own articles on the prevention of ethics dumping. Many
p.(None): of these addressed the same issues identified by the lead author, but now illu- minated by a legal reading. For
p.(None): example, article 20 on the clear understanding of roles and responsibilities was an important addition. Finally, the
p.(None): expert on existing guidelines, Dr Michelle Singh, checked the draft code for oversights relevant to
p.(None): countering ethics dumping and also, for example, added article 7 on the importance of compensating local support
p.(None): systems.
p.(None): The first full draft agreed by the four-person committee then went through a rigorous internal peer
p.(None): review process in the consortium, including detailed discussions at a plenary meeting in Germany in
p.(None): February 2018. Each draft article was analysed in depth. Changes at this stage included:
p.(None): • A different order to demonstrate importance through emphasis: for example, the assertion that the local relevance
p.(None): of research is essential became article 1.
...
p.(None): information, but many do not. In situations where levels of education and literacy are not high, this is likely to be
p.(None): exacerbated.
p.(None): The relationship between the person who brings the complaint and the bureau- cracies to which they must direct
p.(None): their complaint can be a factor (Cowan and Halliday 2003). This relationship can either encourage or
p.(None): discourage a potential complainant’s trust in complaints mechanisms. The power imbalance between par- ties in such
p.(None): relationships can be substantial. For example, when working with impoverished communities, HIC researchers
p.(None): should be aware that participation in a clinical study may provide a participant’s only access to health care or other
p.(None): much- needed benefits. Fear of retribution is often cited as a barrier to making a complaint, particularly in
p.(None): circumstances where the complainant has an ongoing relationship with the complainee (HPC 2009). In situations where
p.(None): there is a power imbalance, people may not have the confidence to complain; they may be reluctant to seem ungrateful,
p.(None): not wish to be seen as a complainer, or fear loss. Research has shown that some people even reconstruct negative
p.(None): experiences in a positive light in order to maintain relationships (Edwards et al. 2004).
p.(None): In addition to the above, participatory engagement activities in the TRUST proj- ect (Chapter 6) have revealed the
p.(None): following factors that could also act as barriers to research participants making complaints about research activities
p.(None): in LMICs:
p.(None): • Fear of damage or stigmatization from loss of confidentiality or anonymity. In Kenya, for example, where sex work
p.(None): is illegal, sex workers may be reluctant to make any formal complaints.
p.(None): • Cultural norms that preclude complaining. In some cultures, it is not acceptable to make complaints, especially
p.(None): to or about visitors and/or those in authority. Complaining may be perceived as disrespectful, ungrateful or
p.(None): inappropriate.
p.(None): • Illiteracy of research participants and communication (language) difficulties, leading to a lack of
p.(None): understanding of reasonable rights relating to informed con- sent and to reasonable expectations of the research.
p.(None):
p.(None): Developing an Accessible Complaints Procedure 101
p.(None):
p.(None): • Inability to access the means by which to file a complaint: for example, if only an email address is provided as a
p.(None): contact and one has no access to computers or internet connections.
p.(None):
p.(None):
p.(None): The Scope of a Complaints Procedure
p.(None):
p.(None): A comprehensive complaints procedure can have a broad scope; it can be used to complain about any activities that are
p.(None): associated with a research study. These may include, for example:
p.(None): • any perceived deviation from the information provided
...
p.(None): 45–47, 51, 52, 54, 65–67, 70, 98, 103
p.(None): Research integrity, 5, 24, 46, 47, 67, 112, 117
p.(None): Research participants, 2, 6–11, 20–24, 27, 38,
p.(None): 40, 43, 44, 52, 54, 55, 57, 61–64, 70,
p.(None): 92, 96, 98–100, 103, 105, 110
p.(None): Resource custodians, 7, 66
p.(None): Resource-poor settings, 2, 5, 14, 27, 28, 37,
p.(None): 51, 52, 80, 89, 99, 109, 111, 115–117
p.(None): Respect, 2, 5–8, 13–24, 27–35, 40, 43–44, 66,
p.(None): 68–70, 74, 78, 79, 82, 83, 85, 86, 90,
p.(None): 92, 93, 95–98, 102, 103, 105, 110–112
p.(None): Responsibilities, 8, 10, 16, 47, 51, 55, 58, 61,
p.(None): 66, 68, 104, 117
p.(None): Risk mitigation measures, 23, 67
p.(None): Risks, 1, 3, 9–11, 14, 23, 44, 52, 56, 64,
p.(None): 66–68, 70, 82, 104
p.(None):
p.(None):
p.(None): S
p.(None): Safeguarding, 45, 51, 54, 97, 103
p.(None): Safety, 9, 10, 14, 45
p.(None): Samples, 2, 34, 47, 64, 82
p.(None): San, 2, 3, 18, 22, 40, 56, 63, 73–86, 109–112,
p.(None): 115–117
p.(None): San Code of Research Ethics, 2, 3, 63, 73–86,
p.(None): 109, 110, 117
p.(None): Security, 10, 15, 19, 45, 49, 116
p.(None): SexXworkers, 40, 55, 56, 63, 64, 92, 100, 112
p.(None): Social science, 2, 18, 39, 61, 68, 101
p.(None): Socio-anthropological research, 56
p.(None): South Africa, 18, 40, 61, 63, 69, 74–77, 79,
p.(None): 84–86, 110, 115, 116
p.(None): South African San Council (SASC), 18, 76–81, 86, 112, 116, 117
p.(None): Spokespersons, 93, 94, 102
p.(None): Stakeholder engagements, 3, 92
p.(None): Standards, 2, 3, 6, 9–11, 13, 16–18, 22, 24, 38,
p.(None): 41, 42, 48, 58, 62, 64, 65, 67, 70, 80,
p.(None): 85, 112
p.(None): Stigmatization, 9, 11, 40, 45, 68, 100
p.(None): Stigmatized, 42
p.(None): Sub-Saharan Africa, 55
p.(None):
p.(None): 122
p.(None):
p.(None): T
p.(None): Traditional knowledge, 7, 42, 54, 76–78, 80,
p.(None): 82, 84, 95, 97
p.(None): Training, 19, 63, 81, 95, 112, 117
p.(None): Transparency, 24, 46, 47, 84, 95
p.(None): Trust, 14, 15, 43, 47, 57, 78, 79, 84, 86, 93,
p.(None): 97, 100, 102, 116
p.(None): TRUST project, 14, 16, 17, 20, 28, 39, 49,
p.(None): 52–58, 60–66, 70, 77, 79–82, 100, 104,
p.(None): 111, 112, 117
p.(None): 2030 Agenda for Sustainable Development, 2
p.(None):
p.(None):
p.(None): U
p.(None): Undue inducement, 40, 41
p.(None): United Nations (UN), 2, 13, 21, 49, 58, 70, 77,
p.(None): 80, 116
p.(None): Universal Declaration of Human Rights, 13, 21
p.(None): Index
p.(None):
p.(None): V
p.(None): Values, 2, 3, 5–11, 13–24, 27–35, 39, 40, 43,
p.(None): 44, 46, 49, 62, 64, 68, 70, 74, 78, 82,
p.(None): 89–93, 97, 98, 102, 103, 110, 111, 116
p.(None): Values compass, 90, 91, 93
p.(None): Virtues, 3, 16, 17, 19, 20, 24
p.(None): Vulnerability, 37–40, 74
p.(None): Vulnerable, 2, 24, 29, 38, 39, 44, 52, 53, 55,
p.(None): 57, 60, 63, 64, 66, 68, 70, 75, 80, 82,
p.(None): 90, 92, 99, 103, 111, 112
p.(None): Vulnerable groups, 40, 92, 102, 105
p.(None):
p.(None):
p.(None): W
p.(None): Women, 49
p.(None):
p.(None):
p.(None): X
...
Searching for indicator stigmatized:
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p.(None): have the capacity to make culturally sensitive decisions. Table 5.2
p.(None):
p.(None):
p.(None):
p.(None): Table 5.2 Primary risks for corrective fairness
p.(None): Level of risk Nature of risk
p.(None): Personal • Difficult or no access to legal system or legal aid
p.(None): • Human rights violations not taken up by civil society
p.(None):
p.(None): Researcher/ institutional
p.(None): • Lack of protection of IPR for LMIC institutions
p.(None): • Lack of clear standards for operating systems and timelines for RECs
p.(None): • No capacity/procedures for study oversight to ensure compliance with REC decisions
p.(None): Community • Lack of protection of IPR or traditional knowledge for local communities
p.(None): • Human rights violations not taken up by civil society
p.(None): • Absence of systems for community approvals Country • No relevant legal instruments for ethics committees
p.(None): • Poor research governance frameworks to ensure adherence to ethical standards
p.(None): • No cross-border legal recourse in cases of exploitation
p.(None): • Discriminatory laws that may create stigmatized minorities Animal • Variations in regulatory standards
p.(None): for animal experimentation
p.(None): • Inadequate systems to ensure compliance with animal welfare standards
p.(None): Environmental • Variations in governance of natural resources
p.(None): • Variations in procedural rights
p.(None): • Environmental protection not well policed by civil society
p.(None):
p.(None): Our Findings
p.(None): 43
p.(None):
p.(None): shows the primary risks related to corrective fairness for persons, institutions, com- munities, countries, animals and
p.(None): the environment.
p.(None): Individuals who are harmed by their participation in research may have no means of seeking retribution or compensation
p.(None): if they cannot afford legal representation and there is no form of legal aid. For communities, a lack of awareness and
p.(None): expertise, or too much trust in the HIC researchers, may lead to the loss of intellectual property rights (IPRs) to
p.(None): local knowledge and resources. At a national and international level, researchers from HICs who choose to ignore or
p.(None): flout the research ethics and legal requirements in the host LMIC can be difficult to police. This is especially
p.(None): problem- atic in localities where there is a lack of resources and/or infrastructure to ensure ethical compliance
p.(None): through the entire research process and where the home institu- tions in HICs do not ensure that their employees comply
p.(None): with requirements.
p.(None):
p.(None):
p.(None): Respect
...
p.(None): 40, 43, 44, 52, 54, 55, 57, 61–64, 70,
p.(None): 92, 96, 98–100, 103, 105, 110
p.(None): Resource custodians, 7, 66
p.(None): Resource-poor settings, 2, 5, 14, 27, 28, 37,
p.(None): 51, 52, 80, 89, 99, 109, 111, 115–117
p.(None): Respect, 2, 5–8, 13–24, 27–35, 40, 43–44, 66,
p.(None): 68–70, 74, 78, 79, 82, 83, 85, 86, 90,
p.(None): 92, 93, 95–98, 102, 103, 105, 110–112
p.(None): Responsibilities, 8, 10, 16, 47, 51, 55, 58, 61,
p.(None): 66, 68, 104, 117
p.(None): Risk mitigation measures, 23, 67
p.(None): Risks, 1, 3, 9–11, 14, 23, 44, 52, 56, 64,
p.(None): 66–68, 70, 82, 104
p.(None):
p.(None):
p.(None): S
p.(None): Safeguarding, 45, 51, 54, 97, 103
p.(None): Safety, 9, 10, 14, 45
p.(None): Samples, 2, 34, 47, 64, 82
p.(None): San, 2, 3, 18, 22, 40, 56, 63, 73–86, 109–112,
p.(None): 115–117
p.(None): San Code of Research Ethics, 2, 3, 63, 73–86,
p.(None): 109, 110, 117
p.(None): Security, 10, 15, 19, 45, 49, 116
p.(None): SexXworkers, 40, 55, 56, 63, 64, 92, 100, 112
p.(None): Social science, 2, 18, 39, 61, 68, 101
p.(None): Socio-anthropological research, 56
p.(None): South Africa, 18, 40, 61, 63, 69, 74–77, 79,
p.(None): 84–86, 110, 115, 116
p.(None): South African San Council (SASC), 18, 76–81, 86, 112, 116, 117
p.(None): Spokespersons, 93, 94, 102
p.(None): Stakeholder engagements, 3, 92
p.(None): Standards, 2, 3, 6, 9–11, 13, 16–18, 22, 24, 38,
p.(None): 41, 42, 48, 58, 62, 64, 65, 67, 70, 80,
p.(None): 85, 112
p.(None): Stigmatization, 9, 11, 40, 45, 68, 100
p.(None): Stigmatized, 42
p.(None): Sub-Saharan Africa, 55
p.(None):
p.(None): 122
p.(None):
p.(None): T
p.(None): Traditional knowledge, 7, 42, 54, 76–78, 80,
p.(None): 82, 84, 95, 97
p.(None): Training, 19, 63, 81, 95, 112, 117
p.(None): Transparency, 24, 46, 47, 84, 95
p.(None): Trust, 14, 15, 43, 47, 57, 78, 79, 84, 86, 93,
p.(None): 97, 100, 102, 116
p.(None): TRUST project, 14, 16, 17, 20, 28, 39, 49,
p.(None): 52–58, 60–66, 70, 77, 79–82, 100, 104,
p.(None): 111, 112, 117
p.(None): 2030 Agenda for Sustainable Development, 2
p.(None):
p.(None):
p.(None): U
p.(None): Undue inducement, 40, 41
p.(None): United Nations (UN), 2, 13, 21, 49, 58, 70, 77,
p.(None): 80, 116
p.(None): Universal Declaration of Human Rights, 13, 21
p.(None): Index
p.(None):
p.(None): V
p.(None): Values, 2, 3, 5–11, 13–24, 27–35, 39, 40, 43,
p.(None): 44, 46, 49, 62, 64, 68, 70, 74, 78, 82,
p.(None): 89–93, 97, 98, 102, 103, 110, 111, 116
p.(None): Values compass, 90, 91, 93
p.(None): Virtues, 3, 16, 17, 19, 20, 24
p.(None): Vulnerability, 37–40, 74
p.(None): Vulnerable, 2, 24, 29, 38, 39, 44, 52, 53, 55,
p.(None): 57, 60, 63, 64, 66, 68, 70, 75, 80, 82,
p.(None): 90, 92, 99, 103, 111, 112
p.(None): Vulnerable groups, 40, 92, 102, 105
p.(None):
p.(None):
p.(None): W
p.(None): Women, 49
p.(None):
p.(None):
p.(None): X
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.(None): Leaving no one behind does not “only” include reducing income and wealth inequalities, and affirmative
p.(None): action in support of better opportunities for self- determined living within and among countries. It also
p.(None): implies reaching those most at risk from poverty and its impacts. This again necessitates research focused on the needs
p.(None): of the poor in a way that does not infringe their human rights.
p.(None): Research and innovation can only be sustainably successful when based on soci- etal trust. The precondition for
p.(None): societal trust and public acceptance is the perception that work is done with integrity and based on fundamental values
p.(None): shared by the global community. Trust depends not only on research work being compliant with laws and regulations, but
p.(None): also, more than ever, on its legitimacy.
p.(None): Such legitimacy can be achieved through inclusion and, importantly, the co- design of solutions with
p.(None): vulnerable populations. Leaving no one behind also means leaving no one behind throughout the research process, aiming
p.(None): for research with, not about, vulnerable populations.
p.(None):
p.(None): vii
p.(None):
p.(None): viii
p.(None): Foreword
p.(None):
p.(None): The results of the TRUST Project, whose Global Code of Conduct for Research in Resource-Poor Settings (GCC) this book
p.(None): celebrates, contribute to realizing the European Union’s ambition of a more inclusive, equal and sustainable global
p.(None): soci- ety – a profound expectation of people all over the world.
p.(None): The fact that the GCC now exists and has been welcomed by the European Commission as a precondition for
p.(None): its research grants is only a beginning.
p.(None): My hope is that enlightened stakeholders in public institutions, foundations and the private sector will now start a
p.(None): discourse and apply moral imagination to the concrete consequences of the GCC. This relates to the processes and
p.(None): content of their research endeavours as well as the selection criteria for hiring, promoting and remu- nerating the
p.(None): research workforce.
p.(None): Research excellence is no longer only defined by playing by the rules and being “successful”. The results of discourses
p.(None): about the operationalization of the TRUST values of fairness, respect, care and honesty are the new
p.(None): benchmark for excellence.
p.(None):
p.(None): Basel, Switzerland Klaus Leisinger
p.(None):
p.(None):
p.(None): Reference
p.(None):
p.(None): UN (2015) Transforming our world: the 2030 agenda for sustainable development. United Nations.
p.(None): https://www.un.org/development/desa/dspd/2015/08/transforming-our-world-the-2030- agenda-for-sustainable-development/
p.(None):
p.(None):
p.(None): Professor Klaus Leisinger, a social scientist and economist, is the President of the Global Values Alliance in Basel,
p.(None): Switzerland. He served as an adviser on corporate responsibility to UN Secretaries-General Kofi Annan and Ban Ki-moon.
p.(None): He is cur- rently a member of the Leadership Council of the UN Sustainable Development Solutions Network. In 2011, he
...
p.(None): solutions, with the specific aim of drafting the GCC. (Chapter 8 provides more general advice on community
p.(None): engagement with vulnerable populations (Chapter 8).)
p.(None):
p.(None):
p.(None): Broad Consultation
p.(None):
p.(None): Governance mechanisms such as ethics codes require evidence of legitimacy. Why should a particular ethics code be
p.(None): followed by researchers? The answer that can be given for the GCC is fourfold. First, the funder that supported the
p.(None): development of the GCC – the European Commission – requested a new code to guard against ethics dumping. Hence, instead
p.(None): of engaging in a long-term process to negotiate the addi- tion of specific sections on international collaborative
p.(None): research to existing ethics codes and governance mechanisms, a funder with an interest in the output opted for a new
p.(None): and independent code. Second, in 2015 the TRUST consortium’s bid was chosen by peer reviewers from a range of proposals
p.(None): to tackle ethics dumping. The criteria for the selection were excellence and impact, as well as the quality and effi-
p.(None): ciency of the proposed implementation (Horizon 2020 nd). Third, upon the comple- tion and launch of the GCC in 2018,
p.(None): the EC ethics and integrity sector and the EC legal department assessed the code and the decision was taken to make it
p.(None): a manda- tory reference document for European Union (EU) framework programmes (Burtscher 2018).
p.(None): However, the most important element for the GCC’s credibility may be the fourth element, the fact that the TRUST
p.(None): consortium made every possible effort to engage all relevant stakeholders across five continents in the development of
p.(None): the GCC.
p.(None):
p.(None): 54 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): In the effort to reach all relevant stakeholders, the TRUST consortium first had to agree upon who needed to be
p.(None): consulted on ethics dumping in research. The follow- ing six groups were identified:
p.(None): 1. The research process starts with research policymakers, who set the parameters for research activities. For
p.(None): instance, in the European Union, research aimed at human cloning for reproductive purposes is forbidden (European
p.(None): Commission 2013), which means it is outside the activity range of researchers.
p.(None): 2. A second highly influential stakeholder group consists of research funders. Without specific funding, most
p.(None): research is not possible. Whether research fund- ing is provided by industry, charitable foundations or state-funded
p.(None): research pro- grammes makes no significant difference. All funders are of particular importance in tackling ethics
p.(None): dumping, as they often set specific ethical rules that the researchers they fund must adhere to.
p.(None): 3. Researchers design research projects and work directly with participants and communities during
p.(None): implementation. It is normally they who are responsible for ethics dumping, whether deliberate or inadvertent.
p.(None): 4. Many studies involve human research participants who are directly affected by the research. As ethics dumping can
p.(None): also affect animals and the environment, groups working to defend them against unethical treatment could count as advo-
p.(None): cates – that is, persons who act on behalf of other entities. The same applies to nongovernmental organizations (NGOs)
p.(None): or think-tanks that promote the interests of those who cannot defend themselves against exploitation, or who struggle
p.(None): to do so. Hence, these groups are included in the list of stakeholders.
p.(None): 5. Negative impacts from unethical research conduct can extend beyond research participants and cause harm to
...
p.(None): representatives from the following national bodies:
p.(None): • The South African Department of Science and Technology
p.(None): • The South African Department of Environmental Affairs
p.(None): • The South African National Research Foundation
p.(None): • The Zimbabwean Agricultural Research Council
p.(None): To give an example of input, articles 17 and 48 of the GCC are directly linked to input from research
p.(None): policymakers. Dr Isaiah Mharapara from the Zimbabwean Agricultural Research Council argued that agricultural
p.(None): research in Africa had largely been based on foreign principles, meaning that the continent’s own crops, fruits,
p.(None): insects, fish and animals had been ignored. Through the historical introduc- tion of Western agricultural systems
p.(None): and cash crops such as tobacco, as well as genetically engineered crops, Africa had failed to develop
p.(None): agricultural solutions adapted to local conditions. According to Dr Mharapara, a lack of financial resources meant
p.(None): that African nations had been, and still were, vulnerable to exploitation by foreign researchers. This had resulted in
p.(None): damage to ecological systems, the loss of soils, fertility, biodiversity and natural resilience, and the
p.(None): erosion of indigenous knowledge. He advocated inclusive, consultative, robust and agreed processes to establish
p.(None): equitable research partnerships (Van Niekerk et al. 2017).
p.(None):
p.(None):
p.(None): External Engagement with Research Funders
p.(None):
p.(None): Estimates for research and development expenditure in the European Union in 2016 indicate that 56.6% of all such
p.(None): expenditure comes from the business sector, 30.9% from the government sector and the remainder mostly from charitable
p.(None): foundations (Eurostat 2018). TRUST’s main consultation workshop for research funders was held in London in 2017
p.(None): and involved all three sectors: public funders, private
p.(None):
p.(None): 7 Local relevance of research … should be determined in collaboration with local partners.
p.(None): 8 Local researchers should be included, wherever possible, throughout the research process, includ- ing in study
p.(None): design, study implementation, data ownership, intellectual property and authorship of publications.
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 61
p.(None): Table 6.3 Good practice input from funders and industry with GCC output
p.(None): Good practice Relevant GCC article
p.(None):
p.(None): Ensuring double ethics review Community
p.(None): engagement
p.(None): Clear roles and responsibilities
p.(None): Article 10: Local ethics review should be sought wherever possible.
p.(None):
p.(None): Article 2: Local communities and research participants should be included throughout the research process.
p.(None): Article 20: A clear understanding should be reached among collaborators with regard to their roles, responsibilities
p.(None): and conduct throughout the research cycle.
p.(None):
p.(None): funders and charitable funders of research (see Table 6.2). The three main good practice elements9 raised by funders
...
p.(None): codeofconduct.org/wp-content/uploads/2018/12/TRUSTNewsletter_2018_Issue5.pdf
p.(None): Chatfield K, Schroeder D, Kimani J (2016a) Vulnerable populations in North-South collabora- tive research: Nairobi
p.(None): plenary 2016. A report for TRUST. http://trust-project.eu/wp-content/
p.(None): uploads/2016/11/Meeting-Report-TRUST-Nairobi-Final.pdf
p.(None): Chatfield K, Schroeder D, Muthuswamy V (2016b) Mumbai case studies meeting. A report for TRUST.
p.(None): http://trust-project.eu/wp-content/uploads/2016/06/Mumbai-Case-Studies-Workshop. pdf
p.(None): Cook WK (2008) Integrating research and action: a systematic review of community-based par- ticipatory research to
p.(None): address health disparities in environmental and occupational health in the United States. Journal of Epidemiology and
p.(None): Community Health 62(8):668–676. https://doi. org/10.1136/jech.2007.067645
p.(None): Dammann J, Cavallaro F (2017) First engagement report. A report for TRUST. http://trust-project.
p.(None): eu/wp-content/uploads/2016/03/TRUST-1st-Engagement-Report_Final.pdf
p.(None): Dammann J, Schroeder D (2018) Second engagement report. A report for TRUST. http://trust-
p.(None): project.eu/wp-content/uploads/2018/12/TRUST-2nd-Engagement-Report-Final.pdf
p.(None): Davis M (2007) Eighteen rules for writing a code of professional ethics. Science and Engineering Ethics 13(2):171–189.
p.(None): Dunn A (2011) Community engagement: under the microscope. Wellcome Trust, London. https://
p.(None): wellcome.ac.uk/sites/default/files/wtvm054326_0.pdf
p.(None): European Commission (2013) Declarations of the Commission (framework programme) 2013/C 373/02. Official Journal of
p.(None): the European Union 20 December. http://ec.europa.eu/research/
p.(None): participants/data/ref/h2020/legal_basis/fp/h2020-eu-decl-fp_en.pdf
p.(None): Eurostat (2018) Intramural R&D expenditure (GERD) by source of funds. https://ec.europa.eu/
p.(None): eurostat/web/products-datasets/product?code=rd_e_gerdfund
p.(None): Gallo AM., Angst DB, Knafl KA (2009) Disclosure of genetic information within families. The American Journal of Nursing
p.(None): 109(4):65–69. http://www.ncbi.nlm.nih.gov/pubmed/19325321
p.(None): Hebert JR, Brandt HM, Armstead CA, Adams SA, Steck SE (2009) Interdisciplinary, translational, and community-based
p.(None): participatory research: finding a common language to improve can- cer research. Cancer Epidemiology, Biomarkers
p.(None): & Prevention 18(4):1213–1217. https://doi. org/10.1158/1055-9965.EPI-08-1166
p.(None): Horizon 2020 (nd) Evaluation of proposals. Research and Innovation, European Commission.
p.(None): http://ec.europa.eu/research/participants/docs/h2020-funding-guide/grants/
p.(None): from-evaluation-to-grant-signature/evaluation-of-proposals_en.htm
p.(None): Jack A (2012) Wellcome challenges science journals. Financial Times, 10 April. https://www.
p.(None): ft.com/content/81529c58-8330-11e1-ab78-00144feab49a
p.(None): Kelman A, Kang A, Crawford B (2019) Continued access to investigational medicinal products for clinical trial
p.(None): participants: an industry approach. Cambridge Quarterly of Healthcare Ethics 28(1):124–133.
p.(None): https://www.cambridge.org/core/product/identifier/S0963180118000464/ type/journal_article
p.(None): Kessel M (2014) Restoring the pharmaceutical industry’s reputation. Nature Biotechnology 32:983–990.
p.(None): https://doi.org/10.1038/nbt.3036
...
p.(None): 66, 104, 117
p.(None): Data ownership, 6, 20, 60, 66, 104
p.(None): Data protection, 11, 47
p.(None): Declaration of Helsinki, 13, 22, 23, 51,
p.(None): 61, 117
p.(None): Descriptive relativism, 30, 33
p.(None): Development, 2, 19, 37, 39, 52–55, 57, 58, 60,
p.(None): 63, 65, 70, 74, 76–80, 82, 90–92, 96,
p.(None): 102–105, 110, 115–117
p.(None): Difference principle, 17
p.(None): Discrimination, 9, 11, 63, 68
p.(None): Double standards, 2, 6, 70
p.(None):
p.(None):
p.(None): E
p.(None): Ebola, 2
p.(None): Emergency research, 39
p.(None): Environmental protection, 10, 23, 42, 44,
p.(None): 45, 67
p.(None): Equitable partnerships, 14, 60, 104, 105,
p.(None): 109–112
p.(None): Ethical guidelines, 65–67, 105, 117
p.(None): Ethical review, 8, 18, 23, 39, 51, 56, 61,
p.(None): 65–68, 110, 111, 115, 116
p.(None): Ethical values, 7, 17–19, 28, 29, 82
p.(None): Ethics approval, 2, 8, 18, 22, 43, 44, 46, 48,
p.(None): 66, 77, 98
p.(None): Ethics committee, 8, 18, 21, 22, 39, 42–44, 46,
p.(None): 51, 52, 54, 56, 58, 62, 65–67, 69, 70,
p.(None): 74, 98, 103, 110, 111, 116
p.(None): Ethics dumping, 1–3, 5–11, 14, 18, 19, 24, 27,
p.(None): 37, 52–54, 56–58, 61, 63, 66–68, 70,
p.(None): 89–98, 100–105, 109, 110, 112
p.(None): Europe, 1, 55, 65, 111
p.(None): European Code of Conduct for Research Integrity, 5, 24, 117
p.(None): European Commission (EC), 1, 2, 23, 52–54,
p.(None): 57, 70, 110–112, 117
p.(None): European Parliament, 2, 64, 70, 111, 115
p.(None): European Union (EU), 1, 14, 28, 48, 53, 54,
p.(None): 60, 64, 70, 80, 110–112, 116
p.(None): Evaluation, 6, 20, 63, 65, 93, 96, 98
p.(None): Exploitation, 2, 3, 14, 24, 37–49, 54, 58, 60,
p.(None): 62, 63, 65, 66, 74, 82, 83, 105
p.(None): Exploitative, 19, 38, 40, 41
p.(None):
p.(None):
p.(None): F
p.(None): Fairness, 2, 5–7, 13–24, 27–31, 33, 40–43, 68,
p.(None): 70, 74, 77–78, 82, 84, 90, 93, 95–98,
p.(None): 102, 110–112, 117
p.(None): Index
p.(None):
p.(None): Fair research contract (FRC), 90, 103, 104
p.(None): Farmers, 101
p.(None): Feedback, 6, 8, 20, 41, 48, 61, 63, 64, 83,
p.(None): 96, 105
p.(None): Four values framework, 13–24, 30, 102 Free and prior informed consent, 7, 66 Funders, 53–58, 60, 61, 70, 79, 116
p.(None):
p.(None):
p.(None): G
p.(None): Gender, 44, 49, 61, 100
p.(None): Genetic research, 54, 74, 92
p.(None): Genetics, 2, 7, 13, 60, 62, 63, 74, 75,
p.(None): 81, 82
p.(None): Global Code of Conduct for Research in Resource-Poor Settings, 2, 5, 14, 27,
p.(None): 37, 51, 80, 89, 109, 115–117
p.(None): Good Participatory Practice, 6, 20, 63
p.(None):
p.(None):
p.(None): H
p.(None): Harm, 1, 17, 19, 28, 34, 35, 38, 43, 45–47, 54,
p.(None): 65, 73, 75, 84, 95, 98
p.(None): Health and safety, 9, 10
p.(None): HealthyXvolunteers, 63
p.(None): Helicopter research, 23, 41
p.(None): High-income countries (HICs), 2, 9, 20–23,
p.(None): 38–44, 47, 48, 56, 65, 70, 99–101, 104
p.(None): Honesty, 2, 5, 6, 10–11, 13–24, 27–31, 33, 40,
p.(None): 46–48, 68, 70, 74, 82, 83, 90, 93,
p.(None): 95–98, 102, 110–112
p.(None): Horizon 2020, 23, 52, 53
p.(None): Human participants, 65, 117
p.(None): Human rights, 22, 42, 44, 55, 75
p.(None):
p.(None):
p.(None): I
...
Social / Victim of Abuse
Searching for indicator abuse:
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p.(None):
p.(None): Have the agreed benefits for participation been realized?
p.(None): In health research, is the agreed
p.(None): post-study access to successfully tested treatments or interventions being made available?
p.(None): How have the community been involved in the evaluation of the research findings?
p.(None): How have the community been involved in the evaluation of the research process?
p.(None): Do the community believe that they have benefited from the research?
p.(None): Have all promises to the community been fulfilled? How have complaints been managed? Are there lessons to be learned
p.(None): and shared?
p.(None): Have implications that might impact upon individuals or the community, including potential harms and benefits, been
p.(None): disclosed?
p.(None): Respect Care
p.(None):
p.(None): Are there mechanisms in place to feedback news about broader impacts of the research?
p.(None): Has the contribution of members of the
p.(None): Do the community believe that researchers paid due attention to the impact of the study and the study team upon the
p.(None): participants, their families, the local community and the environment?
p.(None): local community been fully credited? Was the resulting project of high quality and
p.(None):
p.(None): Have the community’s knowledge and its value to the research been fully credited?
p.(None): Do the community believe that local culture and tradition have been respected?
p.(None): worthwhile so that the efforts of the community were not wasted?
p.(None):
p.(None): participants7 so that it endures beyond the ethical approval process; they offer a mechanism for
p.(None): correcting mistakes and for protecting people, animals and the envi- ronment from abuse and mistreatment.
p.(None): Significantly, complaints mechanisms offer a means of revealing lapses and failures in ethical conduct, thereby
p.(None): providing oppor- tunities for enhancing ethical compliance in research (Fig. 8.2).
p.(None): Researchers, research organizations and research ethics committees (RECs) can go to great lengths to ensure that
p.(None): research protocols are scientifically rigorous and that research is conducted in accordance with the relevant
p.(None): ethical principles. However, even when the greatest care is taken, unexpected events can occur and participation can
p.(None): lead to emotional and/or physical harm. While most RECs will specify the need for an identified contact person in case
p.(None): of queries or complaints, this commonly takes the form of basic contact details on a participant information sheet,
p.(None): often in the form of an email address. Where further information is given, it
p.(None):
p.(None):
p.(None): 7 “Participation” is referred to here in its broadest sense to include experimental research animals and environments,
p.(None): as well as human research participants, local communities and researchers.
p.(None):
p.(None): Developing an Accessible Complaints Procedure
p.(None): 99
p.(None):
p.(None):
p.(None):
p.(None): Gives voice
p.(None):
p.(None):
p.(None):
p.(None): Aligns experience with expectation
p.(None):
p.(None): Reveals ethical challenges
p.(None):
p.(None): Complaints
p.(None): procedure
p.(None):
p.(None):
p.(None):
p.(None): Enhances ethical compliance
p.(None):
p.(None): Safeguards participants
p.(None):
p.(None):
p.(None): Corrects mistakes
p.(None):
p.(None):
p.(None):
...
p.(None):
p.(None):
p.(None):
p.(None): 2 The EU-funded consortium that developed the GCC.
p.(None): 3 This refers to Andries Steenkamp’s iconic request to researchers, namely to enter San communi- ties through the
p.(None): metaphorical “front door” – that is, the San Council – and not, like thieves, through the window.
p.(None):
p.(None): 112 9 Towards Equitable Research
p.(None): Partnership
p.(None):
p.(None): TRUST was a game changer.4
p.(None): Ethics dumping is a real threat to the quality of science and the GCC is now a mandatory reference document for EU
p.(None): framework program funding to guard against it. – Dorian Karatzas (Greek), head of Ethics and Research Integrity,
p.(None): European Commission
p.(None): Best science for the most neglected, also means best ethical standards. That’s why the GCC aims high: to protect the
p.(None): most neglected. – Dr François Bompart (French), director of Paediatric HIV/Hepatitis C Programmes at the Drugs
p.(None): for Neglected Diseases initiative (DNDi), former vice president, Access to Medicines at Sanofi, co-author of the GCC
p.(None): We get given consent forms and documents, often in a hurry. We sign because we need the money and then end up with
p.(None): regret. It feels like a form of abuse. They want something from us and they know how to get it. Because of our
p.(None): socio-economic conditions, we will always be vulnerable to those from the North. A code of ethics is needed that
p.(None): protects indigenous people.5 – Andries Steenkamp (1960–2016) (South African), former chair of the South African
p.(None): San Council, co-author of both codes
p.(None): I don’t want researchers to see us as museums who cannot speak for themselves and who don’t expect something in return.
p.(None): As humans, we need support.6 – Reverend Mario Mahongo (1952–2018) (Angolan), co-author of both codes
p.(None): We want to be treated by researchers with fairness, respect, care and honesty. Is that too much to ask?7 – Joyce
p.(None): Adhiambo Odhiambo (Kenyan), health activist and former sex worker, co-author of the GCC
p.(None): Indeed, is that too much to ask?
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Burtscher W (2018) TRUST Global Code of Conduct to be a reference document applied by all research projects applying
p.(None): for H2020 funding. TRUST eNewsletter Issue 5. http://www.global-
p.(None): codeofconduct.org/wp-content/uploads/2018/12/TRUSTNewsletter_2018_Issue5.pdf
p.(None): Economist (2018) Recent events highlight an unpleasant scientific practice: ethics dumping. The Economist, 31
p.(None): January. https://www.economist.com/science-and-technology/2019/02/02/
p.(None): recent-events-highlight-an-unpleasant-scientific-practice-ethics-dumping
...
Social / Women
Searching for indicator women:
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p.(None): Nations member states have never been members of the Security Council and hence have never even had voting
p.(None): rights, let alone veto power.
p.(None):
p.(None):
p.(None): Past History of Colonialism
p.(None):
p.(None): Does the history of colonialism still bear upon research today? We believe it does, as can be seen from the experience
p.(None): of indigenous peoples in research. Linda Tuhiwai Smith has powerfully shown that indigenous peoples often
p.(None): consider research a “dirty word”. She describes how “imperialism frames the indigenous experience” and how
p.(None): “indigenous peoples had to challenge, understand and have a shared lan- guage for talking about ... colonialism” (Smith
p.(None): 2012).
p.(None): We close this chapter with a comment from the TRUST gender adviser, Prof.
p.(None): Fatima Alvarez-Castillo (2016):
p.(None): A culture’s worldview, expressed in language, contains norms and values about power and relations of power. For
p.(None): example, the word “expert” imbues persons with authority and assigns higher credibility to their claims than
p.(None): those of non-experts. The public is expected to defer to their opinions on matters of their expertise. It was not until
p.(None): about the 1960s when the usual understanding of expertise was challenged by feminists, who argued that
p.(None): unschooled women have more expertise about their own situation than the experts. This ushered in a new research
p.(None): philosophy that valorizes poor women’s stories and their own versions of their realities.
p.(None):
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Alvarez-Castillo F (2016) Gender sensitivity: writing and language. In: Chatfield K, Schroeder D, Kimani J (eds)
p.(None): Nairobi plenary meeting report, TRUST Project. http://trust-project.eu/wp-
p.(None): content/uploads/2016/11/Meeting-Report-TRUST-Nairobi-Final.pdf
p.(None): Annas G, Grodin M (1998) Human rights and maternal-fetal HIV transmission prevention trials in Africa. American Journal
p.(None): of Public Health 88(4):560–563
p.(None): Bhatt K (2016) Concerns for Kenyan National Bioethics Committee when approving North-South collaborative projects. In:
p.(None): Chatfield K, Schroeder D, Kimani J (eds) Nairobi plenary meeting report, TRUST Project.
p.(None): http://trust-project.eu/wp-content/uploads/2016/11/Meeting-Report- TRUST-Nairobi-Final.pdf
p.(None): EU (2010) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of
p.(None): animals used for scientific purposes (text with EEA relevance). OJ L 276/33.
p.(None): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32010L0063
p.(None): Hill CM, Webber AD (2010) Perceptions of nonhuman primates in human–wildlife conflict sce- narios. American Journal of
p.(None): Primatology 72(10):919−924
p.(None): Hughes J (2010) European textbook on ethics in research. European Commission, Brussels
p.(None):
p.(None): 50 5 Exploitation Risks in Collaborative International Research
p.(None):
...
p.(None): Spokespersons, 93, 94, 102
p.(None): Stakeholder engagements, 3, 92
p.(None): Standards, 2, 3, 6, 9–11, 13, 16–18, 22, 24, 38,
p.(None): 41, 42, 48, 58, 62, 64, 65, 67, 70, 80,
p.(None): 85, 112
p.(None): Stigmatization, 9, 11, 40, 45, 68, 100
p.(None): Stigmatized, 42
p.(None): Sub-Saharan Africa, 55
p.(None):
p.(None): 122
p.(None):
p.(None): T
p.(None): Traditional knowledge, 7, 42, 54, 76–78, 80,
p.(None): 82, 84, 95, 97
p.(None): Training, 19, 63, 81, 95, 112, 117
p.(None): Transparency, 24, 46, 47, 84, 95
p.(None): Trust, 14, 15, 43, 47, 57, 78, 79, 84, 86, 93,
p.(None): 97, 100, 102, 116
p.(None): TRUST project, 14, 16, 17, 20, 28, 39, 49,
p.(None): 52–58, 60–66, 70, 77, 79–82, 100, 104,
p.(None): 111, 112, 117
p.(None): 2030 Agenda for Sustainable Development, 2
p.(None):
p.(None):
p.(None): U
p.(None): Undue inducement, 40, 41
p.(None): United Nations (UN), 2, 13, 21, 49, 58, 70, 77,
p.(None): 80, 116
p.(None): Universal Declaration of Human Rights, 13, 21
p.(None): Index
p.(None):
p.(None): V
p.(None): Values, 2, 3, 5–11, 13–24, 27–35, 39, 40, 43,
p.(None): 44, 46, 49, 62, 64, 68, 70, 74, 78, 82,
p.(None): 89–93, 97, 98, 102, 103, 110, 111, 116
p.(None): Values compass, 90, 91, 93
p.(None): Virtues, 3, 16, 17, 19, 20, 24
p.(None): Vulnerability, 37–40, 74
p.(None): Vulnerable, 2, 24, 29, 38, 39, 44, 52, 53, 55,
p.(None): 57, 60, 63, 64, 66, 68, 70, 75, 80, 82,
p.(None): 90, 92, 99, 103, 111, 112
p.(None): Vulnerable groups, 40, 92, 102, 105
p.(None):
p.(None):
p.(None): W
p.(None): Women, 49
p.(None):
p.(None):
p.(None): X
...
Social / Youth/Minors
Searching for indicator minor:
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p.(None): • Low self-esteem in engaging with outside individuals and agencies
p.(None): • Earlier theft of traditional knowledge leading to mistrust of researchers
p.(None): • Lack of system to combat the problems
p.(None): • Lack of institutional and financial support to the leadership who aim to improve the situation
p.(None): With these challenges in mind, the initial draft of the San Code of Research Ethics was revised and
p.(None): refined. In addition, each element of the new draft code was grouped into one of the four TRUST ethical values of
p.(None): fairness, respect, care, and honesty. These values had been agreed on previously by the TRUST group, with San input.
p.(None): The four core values were to be supported by a fifth value, which the San
p.(None):
p.(None): 7 A short video presentation about the workshop is available at https://www.youtube.com/ watch?v=HOdw3mv7JSo.
p.(None):
p.(None): The San Code of Research Ethics
p.(None): 83
p.(None):
p.(None): delegates deemed essential, namely proper process. In small groups the key points of each value were written out in
p.(None): greater detail.
p.(None): A highly important decision was that examples of past exploitation would form part of the code itself.
p.(None): The results of the third workshop were then given to colleagues who undertook further work. In December 2016, Roger
p.(None): Chennells worked on the code from a legal perspective, and in January 2017, Doris Schroeder worked on
p.(None): its ethical dimensions.
p.(None): The subsequent draft, which had been edited from both a legal and an ethical perspective, was then presented to the San
p.(None): leadership for adoption. Further minor changes were made, until the code was unanimously adopted and declared ready to
p.(None): be launched by the San leadership.
p.(None):
p.(None):
p.(None): The San Code of Research Ethics
p.(None): Respect
p.(None):
p.(None): We require respect, not only for individuals but also for the community.
p.(None): We require respect for our culture, which also includes our history. We have cer- tain sensitivities that are not known
p.(None): by others. Respect is shown when we can input into all research endeavours at all stages so that we can explain these
p.(None): sensitivities.
p.(None): Respect for our culture includes respect for our relationship with the environment.
p.(None): Respect for individuals requires the protection of our privacy at all times. Respect requires that our contribution to
p.(None): research is acknowledged at all times. Respect requires that promises made by researchers need to be met.
p.(None): Respectful researchers engage with us in advance of carrying out research. There should be no assumption that
p.(None): San will automatically approve of any research projects that are brought to us.
p.(None): We have encountered lack of respect in many instances in the past. In Genomics research, our leaders were avoided, and
p.(None): respect was not shown to them. Researchers took photographs of individuals in their homes, of breastfeeding
p.(None): mothers, or of underage children, whilst ignoring our social customs and norms. Bribes or other advantages were
p.(None): offered. Failure by researchers to meet their promises to provide feedback is an example of disrespect which is
...
Social / education
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p.(None): Additionally, some ani- mals are awarded greater protection in certain cultures than others, for example, dogs and cats
p.(None): in the United Kingdom and cows in India. Animal experimentation on non-human primates is particularly controversial
p.(None): in most countries, but in some certain non-human primates are viewed as “pests” (Hill and Webber 2010). Different
p.(None): partners in collaborative research may have different philosophies related to the environment. Environmental
p.(None): protection is sometimes regarded as a colonial con- struct that has negative impacts on local communities in LMICs, and
p.(None): research agen- das likewise. There may therefore be a philosophical or paradigmatic difference between
p.(None): research partners that needs to be identified and addressed.
p.(None):
p.(None):
p.(None): Care
p.(None):
p.(None): Researchers who take good care in their research combine two elements: they care about research participants, in the
p.(None): sense that they are important to them, and they feel responsible for the welfare of those who contribute to their
p.(None): research, or might suffer as a result of it. In work with vulnerable communities, this might, for exam- ple, entail
p.(None): the tailoring of informed consent procedures to local requirements
p.(None):
p.(None): Our Findings
p.(None): 45
p.(None):
p.(None): (language, literacy, education levels) to achieve genuine understanding. Table 5.4 shows the primary risks related to
p.(None): care for persons, institutions, communities, coun- tries, animals and the environment.
p.(None): At the individual level, variations in spoken language, understanding, levels of literacy and use of terminology are
p.(None): just some of the issues that can lead to exploita- tion. The number of different ways in which individuals can suffer
p.(None): harm as a result of their involvement in research is vast. At the community level, the mere presence of a research team
p.(None): can have a great impact upon a local community. Research teams require food and accommodation, purchase local goods and
p.(None): services, and form rela- tionships with local people.
p.(None): At a national and international level, the rapid emergence of high-risk applica- tions of technologies such as genome
p.(None): editing7 challenges not only safety risk assess- ments but also existing governance tools. This creates an environment
p.(None): where risky experiments might be carried out in countries with an inadequate legal framework,
p.(None):
p.(None): Table 5.4 Primary risks for care
p.(None): Level of risk Nature of risk
p.(None): Personal • In medical research: therapeutic misconception
p.(None): • Misunderstanding of research aims
p.(None): • Procedures for informed consent not tailored to individual
p.(None): • Lack of possible actions to address adverse effects of participation
...
p.(None): San leaders such as Kipi George and Augustino Victorino promoted the formation of a cross-border, regional
p.(None): organiza- tion to protect the rights of all San peoples in southern Africa. The topics that emerged as
p.(None): clear priorities among San communities were:
p.(None): • Access to land
p.(None): • Benefit sharing for traditional knowledge
p.(None): • Protection of heritage and culture4
p.(None): WIMSA functioned effectively as a regional organization from its inception in 1996 until approximately 2016. The
p.(None): successes of this important San organization in raising awareness and promoting advocacy among the San cannot be
p.(None): overstated.
p.(None):
p.(None): Table 7.1 San support organizations
p.(None): Start year Organization name Organization region 1981
p.(None): Nyae Nyae Development Foundation Tsumkwe, Namibia 1988 Kuru Development Trust
p.(None): Ghanzi, Botswana
p.(None): 1991 First People of the Kalahari Ghanzi, Botswana 1992
p.(None): First Regional San Conference Windhoek, Namibia
p.(None):
p.(None): 1995 Final Regional San Conference (pre-WIMSA)
p.(None): D’Kar, Botswana
p.(None): 1996 WIMSA Windhoek, Namibia 1996
p.(None): South African San Institute (SASI) Kimberley, South Africa
p.(None):
p.(None): 1999 !Khwa ttu San Culture and Education Centre
p.(None): Darling, South Africa.
p.(None): 2001` South African San Council Upington, South Africa
p.(None): 2006 Namibia San Council Windhoek, Namibia
p.(None): 2007 Khwedom Council Gaborone, Botswana.
p.(None):
p.(None):
p.(None): 4 A San organisation that is highly active and successful in protecting the San cultural heritage is
p.(None): !Khwa ttu, which was not directly involved in the development of the San Code of Research Ethics and is therefore not
p.(None): included here with its own section. Details about !Khwa ttu can be found in Chennells and Schroeder (2019).
p.(None):
p.(None): Institution Building and Supportive NGOs
p.(None): 77
p.(None):
p.(None): Importantly, in 1998 WIMSA drafted the San’s first Media and Research Contract, which was aimed at managing
p.(None): external incursions into San culture which up to that time had occurred with no San control at all. San leaders
p.(None): throughout the region were trained in the implementation of the contract, and it was used to deal with researchers,
p.(None): filmmakers, writers and others who entered San territory wanting to gather information.
p.(None):
p.(None):
p.(None): South African San Institute and South African San Council
p.(None):
p.(None): The San Code of Research Ethics takes a step further than the WIMSA Media and Research Contract. It outlines exactly
p.(None): what the San require from researchers. The WIMSA contract, by contrast, is more akin to an ethics approval
...
p.(None): For collaborative research undertaken in resource-poor settings, especially low and middle-income countries (LMICs),
p.(None): the accessibility of a complaints procedure may be affected by many factors that are unfamiliar to researchers from a
p.(None): high- income country (HIC). A concerted effort is therefore required to understand local needs and preferences so that
p.(None): a complaints mechanism can be implemented that is both user-friendly and fit for purpose.
p.(None):
p.(None):
p.(None): Factors Affecting Accessibility
p.(None):
p.(None): It is known from studies in the field of dispute resolution that people often feel reluctant to make
p.(None): complaints and that this can be related to a variety of complex factors. In 2009 the Health Professions
p.(None): Council in the UK published a
p.(None):
p.(None): 100 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): comprehensive scoping review of existing mechanisms for complaints about health professionals (HPC 2009). In this
p.(None): report, the HPC describes a range of factors that can act as barriers to making a specific complaint. As there are no
p.(None): equivalent publi- cations about complaints procedures in LMICs, we summarize here the factors that are relevant to
p.(None): research in LMICs.
p.(None): Readiness to complain in any environment can be influenced by gender, ethnic- ity, age, education, income,
p.(None): accessibility of information and the perceived “serious- ness” of the problem (Pleasence et al. 2006).
p.(None): Specifically, ethnic minority communities are less likely to use systems that they perceive as being culturally
p.(None): insensitive and are more fearful of the consequences of taking action when they feel those systems have failed them.
p.(None): Difficulties with access to information are highlighted as a barrier to making a complaint (Henwood et al. 2003),
p.(None): especially where there is “information illiteracy”; some people possess the relevant skills and confidence to seek out
p.(None): information, but many do not. In situations where levels of education and literacy are not high, this is likely to be
p.(None): exacerbated.
p.(None): The relationship between the person who brings the complaint and the bureau- cracies to which they must direct
p.(None): their complaint can be a factor (Cowan and Halliday 2003). This relationship can either encourage or
p.(None): discourage a potential complainant’s trust in complaints mechanisms. The power imbalance between par- ties in such
p.(None): relationships can be substantial. For example, when working with impoverished communities, HIC researchers
p.(None): should be aware that participation in a clinical study may provide a participant’s only access to health care or other
p.(None): much- needed benefits. Fear of retribution is often cited as a barrier to making a complaint, particularly in
p.(None): circumstances where the complainant has an ongoing relationship with the complainee (HPC 2009). In situations where
p.(None): there is a power imbalance, people may not have the confidence to complain; they may be reluctant to seem ungrateful,
p.(None): not wish to be seen as a complainer, or fear loss. Research has shown that some people even reconstruct negative
p.(None): experiences in a positive light in order to maintain relationships (Edwards et al. 2004).
p.(None): In addition to the above, participatory engagement activities in the TRUST proj- ect (Chapter 6) have revealed the
p.(None): following factors that could also act as barriers to research participants making complaints about research activities
p.(None): in LMICs:
p.(None): • Fear of damage or stigmatization from loss of confidentiality or anonymity. In Kenya, for example, where sex work
...
p.(None): should look like. This “thin approach” was used for a reason: no complaints mechanism will fit all situations. Hence,
p.(None): the emphasis is on the process, namely to agree with local partners on an approach. Codes are not enough in themselves
p.(None): to ensure ethical conduct; they need buy-in from all those involved, and such buy-in needs to be generated
p.(None): through effective engagement mechanisms.
p.(None): Researchers should therefore see community engagement as the gateway to effective implementation of the GCC.
p.(None): For example, when considering the local rel- evance of the proposed research (article 1), who better to ask than
p.(None): members of the local community? When wondering how best to seek informed consent, who better to ask than members of the
p.(None): local community? Consultation with the community offers the most direct route to addressing questions about
p.(None): implementation and to realizing the essence of the GCC: a global collaborative effort to eradicate ethics dumping.
p.(None):
p.(None): 106 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): References
p.(None):
p.(None): Ahmed SM, Palermo AGS (2010) Community engagement in research: frameworks for educa- tion and peer review. American
p.(None): Journal of Public Health 100(8):1380–1387. https://doi. org/10.2105/AJPH.2009.178137
p.(None): Anderson EE, Solomon S, Heitman E, DuBois JM, Fisher CB, Kost RG, Ross LF (2012) Research ethics education for
p.(None): community-engaged research: a review and research agenda. Journal of Empirical Research on Human Research Ethics
p.(None): 7(2):322–319
p.(None): Bassler A, Brasier K, Fogel N, Taverno R (2008) Developing effective citizen engagement: a how- to guide for community
p.(None): leaders. Center for Rural Pennsylvania, Harrisburg PA. http://www.
p.(None): rural.palegislature.us/effective_citizen_engagement.pdf
p.(None): Bowman JS (2000) Towards a professional ethos: from regulatory to reflective codes. International Review of
p.(None): Administrative Sciences 66:673–687
p.(None): Cook WK (2008) Integrating research and action: a systematic review of community-based par- ticipatory research to
p.(None): address health disparities in environmental and occupational health in the United States. Journal of Epidemiology and
p.(None): Community Health 62(8):668–676. https://doi. org/10.1136/jech.2007.067645
p.(None): Cowan D, Halliday S (2003) The appeal of internal review: law, administrative justice and the (non-) emergence of
p.(None): disputes. Hart, Oxford
p.(None): Day G (2006) Community and everyday life. Routledge, London
p.(None): Dunn A (2011) Community engagement: under the microscope. Wellcome Trust, London Edwards C, Staniszweska S, Crichton N
p.(None): (2004) Investigation of the ways in which patients’ reports
p.(None): of their satisfaction with healthcare are constructed. Sociology of Health and Illness 26(2):159 Eriksson S, Höglund
p.(None): AT, Helgesson G (2008) Do ethical guidelines give guidance? A critical examination of eight ethics
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p.(None): Thanks to Professor Jeffrey Sachs, Dr Leonardo Simão, Dr Mahnaz Vahedi and Vivienne Parry MBE for joining the TRUST
p.(None): team at the European Parliament event. Thanks to Fritz Schmuhl, the senior editor at Springer, who is still the best
p.(None): book editor I know. This is my sixth Springer book with him, which says it all. Thanks also to George Solomon, the
p.(None): project co-ordinator for this book, for dealing swiftly and efficiently with all questions and for smoothing out any
p.(None): complications in the book production process. Finally, thanks to Ramkumar Rathika for expertly guiding
p.(None): the e-proofing process.
p.(None): This is also the sixth book for which Paul Wise in South Africa has been the professional copy-editor. Copy-editing
p.(None): sounds like checking that references are in the right format, but that’s comparing a mouse to a lion. Paul does a
p.(None): lion’s work; he even found a factual mistake in an author biography – written by the author. Thanks, Paul! I hope
p.(None): you’re around for the seventh book.
p.(None): Thanks to Professor Michael Parker, the director of Ethox at Oxford University, for giving a team of us (Joshua Kimani,
p.(None): Leana Snyders, Joyce Adhiambo Odhiambo and me) the floor in his distinguished institute to introduce the GCC.
p.(None): Thanks to David Coles, Olivia Biernacki, Francesca Cavallaro, Julie Cook, Dieynaba N’Diaye, Francois Bompart,
p.(None): Jacintha Toohey, Rachel Wynberg, Jaci van Niekirk and Myriam Ait Aissa for their contributions to the work, which is
p.(None): summa- rized in Chapter 8.
p.(None): Thanks to Julie Cook for brilliant comments on earlier versions of the manu- script, and also to two anonymous peer
p.(None): reviewers for their helpful comments on the book plans.
p.(None): Thanks to Dr Francesca Cavallaro for creating the educational and fun GCC website.1
p.(None): Thanks to Amy Azra Dean for producing film clips for the GCC website.
p.(None):
p.(None): 1 globalcodeofconduct.org/
p.(None):
p.(None): Acknowledgements
p.(None): xi
p.(None):
p.(None): Thanks to Kelly Laas, host of the world’s largest collection of ethics codes,2 who has a good answer to any question on
p.(None): ethics codes.
p.(None): Thanks to Julia Dammann for productive Twitter activities on the GCC.
p.(None): Thanks to Dr Michael Makanga and the European & Developing Countries Clinical Trials Partnership for carrying
p.(None): the costs of the Portuguese translations of the GCC and the San Code of Research Ethics. Thanks to Dr Alexis Holden at
p.(None): the University of Central Lancashire (UCLan), who approved the funding of six further translations.
p.(None): Thanks to Professor Olga Kubar, Mr Albert Schröder, Dr François Hirsch, Dr Veronique Delpire, Dr Yandong Zhao, Ms Xu
p.(None): Goebel, Dr Shunzo Majima, Dr Dafna Feinholz, Dr Nandini Kumar, Dr Vasantha Muthuswamy, Dr Swapnil S Agarwal, Dr Prabhat
p.(None): K Choudhary, Dr Roli Mathur and Dr Amitabh Dutta for their contributions to the Russian, German, French,
p.(None): Mandarin, Japanese, Spanish and Hindi translations.
p.(None): Thanks to Robin Richardson, head of the School of Health Sciences at UCLan, for giving Kate Chatfield and me room to do
p.(None): as much work on the GCC as needed, despite other pressing engagements.
p.(None): Thanks to Denise Bowers, the head of Payroll at UCLan, for supporting an inter- national team at the Centre for
p.(None): Professional Ethics, despite Brexit.
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xvii
p.(None):
p.(None): Abbreviations
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ACF Action contre la Faim
p.(None): CBD UN Convention on Biological Diversity COHRED Council on Health Research for Development EC
p.(None): European Commission (EC)
p.(None): EDCTP European and Developing Countries Clinical Trials Partnership EFPIA European Federation of
p.(None): Pharmaceutical Industries and Associations FERCI Forum for Ethics Review Committees in India
p.(None): GCC Global Code of Conduct for Research in Resource-Poor Settings GVA Global Values Alliance
p.(None): HIC high-income country
p.(None): Inserm Institut national de la santé et de la recherche médicale IPR intellectual property
p.(None): rights
p.(None): LMICs low- and middle-income countries NGO nongovernmental organization
p.(None): PHDA Partners for Health and Development in Africa REC research ethics committee
p.(None): SASC South African San Council SASI South African San Institute
p.(None): SWOP Sex Workers Outreach Programme
p.(None): UNESCO United Nations Educational, Scientific and Cultural Organization WIMSA Working Group of Indigenous
p.(None): Minorities in Southern Africa
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xix
p.(None):
p.(None): Chapter 1
p.(None): Ethics Dumping and the Need for a Global Code of Conduct
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The UN’s 2030 Agenda for Sustainable Development calls for more research and innovation to end
p.(None): poverty, leaving no one behind – and yet the export of unethical practices from high-income to lower-income settings is
p.(None): still a major concern. Such ethics dumping occurs in all academic disciplines. When research is regarded, on the one
p.(None): hand, as a dirty word among vulnerable populations who face ethics dumping, and, on the other, as a solution to many of
p.(None): humanity’s problems, how can the resulting gulf be bridged? This book describes one initiative to counter ethics
p.(None): dumping: the development and promotion of the Global Code of Conduct for Research in Resource-Poor Settings.
p.(None):
...
p.(None): country of origin of the researcher, animal experi- mentation should always be undertaken in line with the higher
p.(None): standards of protec- tion for animals.
p.(None):
p.(None): 10 2 A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None): Article 18
p.(None):
p.(None): In situations where environmental protection and biorisk-related regulations are inadequate or non-existent in
p.(None): the local setting compared with the country of origin of the researcher, research should always be undertaken in line
p.(None): with the higher stan- dards of environmental protection.
p.(None):
p.(None):
p.(None): Article 19
p.(None):
p.(None): Where research may involve health, safety or security risks for researchers or expose researchers to conflicts of
p.(None): conscience, tailored risk management plans should be agreed in advance of the research between the research team, local
p.(None): partners and employers.
p.(None):
p.(None):
p.(None): Honesty
p.(None): Article 20
p.(None):
p.(None): A clear understanding should be reached among collaborators with regard to their roles, responsibilities and conduct
p.(None): throughout the research cycle, from study design through to study implementation, review and dissemination.
p.(None): Capacity-building plans for local researchers should be part of these discussions.
p.(None):
p.(None):
p.(None): Article 21
p.(None):
p.(None): Lower educational standards, illiteracy or language barriers can never be an excuse for hiding information or providing
p.(None): it incompletely. Information must always be presented honestly and as clearly as possible. Plain language and a
p.(None): non-patronising style in the appropriate local languages should be adopted in communication with research participants
p.(None): who may have difficulties comprehending the research process and requirements.
p.(None):
p.(None):
p.(None): Article 22
p.(None):
p.(None): Corruption and bribery of any kind cannot be accepted or supported by researchers from any countries.
p.(None):
p.(None): Honesty
p.(None): 11
p.(None):
p.(None): Article 23
p.(None):
p.(None): Lower local data protection standards or compliance procedures can never be an excuse to tolerate the potential for
p.(None): privacy breaches. Special attention must be paid to research participants who are at risk of stigmatization,
p.(None): discrimination or incrimi- nation through the research participation.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
...
p.(None): The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract Values inspire, motivate and engage people to discharge obligations or duties. This chapter defends the
p.(None): values approach in the context of guarding against ethics dumping, the practice of exporting unethical research from
p.(None): higher-income to lower-income settings. A number of essential questions will be answered: What are values? What is the
p.(None): meaning of the word “value”? Why does it make sense to choose values as an instrument to guide ethical action in
p.(None): preference to other possibilities? And what is meant by fairness, respect, care and honesty? It is concluded that
p.(None): values can provide excellent guidance and aspiration in the fight against ethics dumping, and are therefore a
p.(None): well-chosen structure for the Global Code of Conduct for Research in Resource-Poor Settings.
p.(None):
p.(None): Keywords Values · Virtues · Fairness · Respect · Care · Honesty
p.(None):
p.(None):
p.(None): Introduction
p.(None):
p.(None): Many celebrated documents which advocate for a better world include a preamble that mentions values. For instance,
p.(None): at the international level, the Universal Declaration of Human Rights (UN 1948) lists four values in the first
p.(None): sentence: dig- nity, freedom, justice and peace in the world. The first sentence of the Convention on Biological
p.(None): Diversity (UN 1992) refers to “the intrinsic value of biological diver- sity and of the ecological, genetic, social,
p.(None): economic, scientific, educational, cul- tural, recreational and aesthetic values of biological diversity” (emphasis
p.(None): added).
p.(None): Other national or professional codes have incorporated values prominently into individual articles. For instance, at
p.(None): the national level in the UK, the first item of The Code: Professional Standards of Practice and Behaviour for Nurses,
p.(None): Midwives and Nursing Associates, reads: “Treat people with kindness, respect and compassion” (NMC 2018).
p.(None): In some codes one has to search to find obvious references to values as they are often incorporated in a more implicit
p.(None): manner, such as in the Declaration of Helsinki
p.(None):
p.(None):
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 13
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_3
p.(None):
p.(None): 14 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): (WMA 2013), which speaks of “safety, effectiveness, efficiency, accessibility and quality” in article 6.
p.(None): When developing the Global Code of Conduct for Research in Resource-Poor Settings (GCC), a unique approach emerged
p.(None): naturally from the process employed. Its underpinning values materialized ahead of its final articles through an
p.(None): investiga- tion into the risks of exploitation in international collaborative research (Chapter 5), and from a global
p.(None): engagement and fact-finding mission (Chapter 6).
...
p.(None): those involved in research (Levine 2004: 2312).
p.(None): Figure 6.2 graphically depicts the main parties involved in research, and there- fore represents the research
p.(None): stakeholders in the fight against ethics dumping.
p.(None): There were budget-holding representatives from each of these research stake- holder groups in the TRUST project
p.(None): consortium (see Table 6.1). This meant that even before outward engagement to draft the GCC, a lot of information could
p.(None): be generated internally.
p.(None): As Table 6.1 shows, considerable expertise from different stakeholder perspec- tives was available internally. In
p.(None): addition, input was sought from external experts, who engaged through four channels, facilitated by six enablers, to
p.(None): participate in the development of a range of project outputs, one of which was the GCC. This approach is detailed in
p.(None): Figure 6.3 (Dammann and Cavallaro 2017).
p.(None):
p.(None): Meaningful Consultation with Diverse Stakeholders 55
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Fig. 6.2 Research stakeholders
p.(None):
p.(None): Table 6.1 Main research stakeholders involved as TRUST budget holders
p.(None): Stakeholder
p.(None): type TRUST partner
p.(None):
p.(None): Research policymakers
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research funders
p.(None): The United Nations Educational, Scientific and Cultural Organization (UNESCO) promotes policy frameworks for research
p.(None): through drafting internationally focused guidelines on scientific co-operation.
p.(None): The “Institut national de la santé et de la recherche médicale”® (Inserm) holds responsibility for the strategic,
p.(None): scientific and operational coordination of French biomedical research.
p.(None): The European and Developing Countries Clinical Trials Partnership (EDCTP) funds research for the prevention and
p.(None): treatment of poverty-related infectious diseases in sub-Saharan Africa.
p.(None): The Swiss-based Global Values Alliance (GVA) is a foundation that focuses on engagement with pharmaceutical industry
p.(None): partners as its main role in the TRUST project
p.(None): Researchers The Centre for Professional Ethics at the University of Central Lancashire is one of the oldest
p.(None): research-only ethics centres in Europe, with specialist expertise in global justice issues.
p.(None): The Bio-Economy Research Chair at the University of Cape Town and her team focus on engagement with communities,
p.(None): indigenous knowledge holders and policymakers to ensure environmentally sustainable poverty reduction. The Law School
p.(None): of the University of the Witwatersrand, Johannesburg, contributed specialist human rights and legal frameworks
p.(None): expertise.
p.(None):
p.(None): Research participants
p.(None):
p.(None):
...
p.(None): countries. Hence, rather than seeing the values as solely applicable when there are vast power differentials between
p.(None): researchers and research participants (as between HICs and LMICs), they were keen to use them in any research.
p.(None): A third recurring issue for researchers has been the following: “We appreciate that the code is short and accessible,
p.(None): but wouldn’t a longer, more detailed code give more support to early career researchers?” The TRUST consortium agreed
p.(None): upon a concise code because it is vital that the demands of substance for each article be clear and straightforward,
p.(None): while the process demands remain flexible. Let us take article 1 as an example:
p.(None): The substance element of article 1 is: “Local relevance of research is essential”. Further information would not be
p.(None): helpful to early career (or any other) researchers. The process element of article 1 is: “[Local relevance] should be
p.(None): determined in collaboration with local partners.” This could only be set out in more detail if there were a single
p.(None): process that would fit every situation – and that is not the case. What an equitable process for determining research
p.(None): goals should look like in an interna- tional collaborative research project is one of the things that need to be agreed
p.(None): on within the process of that project. Hence, prescriptive details would have been coun-
p.(None): terproductive to the very spirit of the article.
p.(None): Instead of attempting to formulate a range of possibilities to fill the process ele- ments with substance, we opted to
p.(None): provide educational material to support the GCC online,11 because any process requirements are best agreed
p.(None): between the relevant partners rather than imposed prescriptively by code drafters. Hence, our educational materials
p.(None): future-proof the GCC, as they can be updated in real time for use by early career (or any other) researchers, and,
p.(None): unlike the GCC itself, they are not mandatory.
p.(None):
p.(None):
p.(None): 10 Personal communication from Dr Vasantha Muthuswamy, a TRUST project team member, after a GCC presentation in Taiwan.
p.(None): 11 http://www.globalcodeofconduct.org/
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 63
p.(None):
p.(None): Engagement with Research Participants and Research Communities
p.(None):
p.(None): The inclusion of the perspectives of research participants and research communities who are vulnerable to exploitation,
p.(None): and therefore to ethics dumping, was essential to our bottom-up approach. It is also the ethical approach, as
p.(None): stipulated in article 2 of the GCC:
p.(None): Local communities and research participants should be included throughout the research process, wherever possible, from
p.(None): planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly
p.(None): represented. This approach represents Good Participatory Practice.
p.(None): Two NGO partners in the TRUST project were tasked specifically with ensuring that the voices of vulnerable populations
p.(None): were heard and acted upon. First, the South African San Institute (SASI) made the inclusion of indigenous peoples from
p.(None): South Africa possible. While San leaders and representatives were involved in all the work of the TRUST project,
...
Social / employees
Searching for indicator employees:
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p.(None): occasional income, as long as they are not bound to a nine-to-five job. If most humans around the world value a
p.(None): particular thing, it can be described as a universal value.
p.(None): Thirdly, values can refer to goals and ambitions, with a moral connotation. In business literature, for example, one
p.(None): often finds reference to value-led management or organizational values, and many institutions make a point of
p.(None): establishing, pro- moting and broadcasting their values. For instance, the stated values of the University of Central
p.(None): Lancashire (UCLan), at which several of the authors of this book are based, are: common sense, compassion,
p.(None): teamwork, attention to detail and trust (UCLan nd). These values are all morally positive and they are intended to
p.(None): guide the actions of students, staff and the institution itself. In this third sense of the word, moral values “will
p.(None): enable us to determine what is morally right or what is valuable in particular circumstances” (Raz 2001: 208). If
p.(None): most humans around the world share a particular moral value, it can be described as a universal moral value.
p.(None): There are numerous advantages to having credible moral values at the level of organizations. Such values influence the
p.(None): culture of an organization (Martins and Coetzee 2011), which in turn has a positive impact upon corporate performance
p.(None): (Ofori and Sokro 2010), and job stress and satisfaction (Mansor and Tayib 2010), as well as business performance and
p.(None): competitive advantage (Crabb 2011). Furthermore, when employees’ values are aligned with organizational values, this
p.(None): benefits both the wellbeing of individuals and the success of the organization (Posner 2010).
p.(None): There are many internet sites that offer lists of core values. One of them (Threads Culture nd) includes 500 values,
p.(None): from “above and beyond” to “work life balance”.
p.(None):
p.(None): 16 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Not all of these are moral values. For instance, this particular list includes values such as clean, exuberant,
p.(None): hygienic, neat, poised and winning (Threads Culture nd). Another site lists 50 values, including authenticity, loyalty
p.(None): and wisdom, and advises that fewer than five should be selected for leadership purposes (Clear nd).
p.(None): The GCC is structured around four moral values: fairness, respect, care and hon- esty. These four values were not
p.(None): chosen from any existing lists; they emerged through in-depth consultation efforts around the globe (chapter 6).
p.(None): But why did the TRUST team choose moral values rather than other action-guiding moral modes for the GCC?
p.(None):
p.(None):
p.(None): What Can Guide Moral Action?
p.(None):
p.(None): The GCC is based on moral values, but the code authors could have opted to frame the code and guide action in other
p.(None): ways, including the following:
p.(None): • Standards is a technical term used to achieve desired action. Standards are pre- cise and give exact
p.(None): specifications, which are in many cases measurable, as in the maximum vehicle emissions allowed for cars. Standards can
p.(None): also be used in eth- ics. For instance, a well-known voluntary standard to guide ethical action is ISO 26000 (ISO
...
p.(None): Philippa Foot P (1978) Virtues and vices. In: Virtues and vices and other essays in moral philoso- phy. Blackwell,
p.(None): Oxford, p 1–18
p.(None): Pinto DC, Nique WM, Añaña EDS, Herter MM (2011) Green consumer values: how do personal values influence
p.(None): environmentally responsible water consumption? International Journal of Consumer Studies 35(2):122–131
p.(None): Pogge T (2006) Justice. In: Borchert DM (ed) Encyclopedia of philosophy, 2nd edn (vol 4).
p.(None): Macmillan Reference, Detroit MI, p 862–870
p.(None): Posner BZ (2010) Another look at the impact of personal and organizational values congruency.
p.(None): Journal of Business Ethics 97(4):535–541
p.(None): Rawls J (1999) A theory of justice, revised edn. Oxford University Press, Oxford
p.(None): Raz J (2001) Engaging reason: On the theory of value and action. Oxford University Press, Oxford Resnik DB (2012)
p.(None): Ethical virtues in scientific research. Accountability in Research 19(6):329–343 Russell D C (2015) Aristotle on
p.(None): cultivating virtue. In: Snow, N (ed) Cultivating virtue: perspectives
p.(None): from philosophy, theology, and psychology. Oxford University Press, Oxford, p 37–38 Schwartz SH (2012) An overview
p.(None): of the Schwartz theory of basic values. Online Readings in
p.(None): Psychology and Culture 2(1):11
p.(None): Sousa CM, Coelho F (2011) From personal values to creativity: evidence from frontline service employees. European
p.(None): Journal of Marketing 45(7/8):1029–1050
p.(None): Threads Culture (nd) Core values examples. https://www.threadsculture.com/
p.(None): core-values-examples/
p.(None): UCLan (nd) The UCLan values. University of Central Lancashire. https://www.uclan.ac.uk/work/ life-at-uclan.php
p.(None): UN (1948) Universal Declaration of Human Rights. http://www.un.org/en/
p.(None): universal-declaration-human-rights/
p.(None): UN (1992) Convention on Biological Diversity. https://www.cbd.int/doc/legal/cbd-en.pdf
p.(None): Wang X, Li F, Sun Q (2018) Confucian ethics, moral foundations, and shareholder value perspec- tives: an exploratory
p.(None): study. Business Ethics: A European Review 27(3):260–271
p.(None): WMA (2013) Declaration of Helsinki. World Medical Association. https://www.wma.net/policies-
p.(None): post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human- subjects/
p.(None): Wolfe PS (1997) The influence of personal values on issues of sexuality and disability. Sexuality and disability
p.(None): 15(2):69–90
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
...
p.(None): for animal experimentation
p.(None): • Inadequate systems to ensure compliance with animal welfare standards
p.(None): Environmental • Variations in governance of natural resources
p.(None): • Variations in procedural rights
p.(None): • Environmental protection not well policed by civil society
p.(None):
p.(None): Our Findings
p.(None): 43
p.(None):
p.(None): shows the primary risks related to corrective fairness for persons, institutions, com- munities, countries, animals and
p.(None): the environment.
p.(None): Individuals who are harmed by their participation in research may have no means of seeking retribution or compensation
p.(None): if they cannot afford legal representation and there is no form of legal aid. For communities, a lack of awareness and
p.(None): expertise, or too much trust in the HIC researchers, may lead to the loss of intellectual property rights (IPRs) to
p.(None): local knowledge and resources. At a national and international level, researchers from HICs who choose to ignore or
p.(None): flout the research ethics and legal requirements in the host LMIC can be difficult to police. This is especially
p.(None): problem- atic in localities where there is a lack of resources and/or infrastructure to ensure ethical compliance
p.(None): through the entire research process and where the home institu- tions in HICs do not ensure that their employees comply
p.(None): with requirements.
p.(None):
p.(None):
p.(None): Respect
p.(None):
p.(None): Respect requires an acceptance of customs and cultures that may be different from one’s own, and a commitment not to
p.(None): behave in a way that causes offence. One may need to abide by decisions or ways of approaching matters with which one
p.(None): dis- agrees. This can be problematic, especially if local customs are illegal or perceived as dangerous.6 However,
p.(None): respect is important in LMIC-HIC collaborations, and there are many possible ways of showing respect that do not
p.(None): create conflicts of con- science. For instance, HIC researchers should not insist that LMIC ethics commit- tees accept
p.(None): the ethics approval submission in the HIC’s preferred format, but should rather conform with the format preferred by
p.(None): the LMIC committee. Table 5.3 shows the primary risks related to respect for persons, institutions, communities,
p.(None): countries, animals and the environment.
p.(None): Local LMIC customs, traditions, and religious and spiritual beliefs may be very different from those of the HIC
p.(None): researcher. For example, from an African cultural point of view, human body parts are sacred, whether they are obtained
p.(None): from living or deceased persons. Hence, the removal of blood or other body parts for research may have a profound
p.(None): impact that needs to be acknowledged and addressed in a man- ner that is sensitive to the wishes of the local
...
Social / gender
Searching for indicator gender:
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p.(None): researcher and research participant can impact upon the consent process.
p.(None):
p.(None): 6 For instance, if a researcher learns that female genital mutilation is being used as a “cure” for diarrhoea in female
p.(None): babies, respecting this approach to health care is likely to be the wrong deci- sion, particularly as the practice is
p.(None): likely illegal. At the very least such a decision would leave the researcher with a serious conflict of conscience (Luc
p.(None): and Altare 2018).
p.(None):
p.(None): 44 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): Table 5.3 Primary risks for respect
p.(None): Level of risk Nature of risk
p.(None): Personal • Unequal power relations
p.(None): • Tendency to defer to authorities
p.(None): • Individual spiritual and religious priorities incompatible with or ignored by HIC partners
p.(None): • Researchers and/or ethics committees deciding “what is best”
p.(None):
p.(None): Researcher/ institutional
p.(None): • Research protocol and papers imported from HIC partners and not tailored to local needs
p.(None): • Ethical approval sought only from HIC partner
p.(None): Community • Diverse interpretations of important values
p.(None): • Local requirements for effective community engagement ignored
p.(None): • Diverse ethical priorities for matters such as:
p.(None): - gender equality
p.(None): - sexual relations
p.(None): • Particular spiritual and religious priorities incompatible with or ignored by Northern partners
p.(None): • Localized social effects from research team presence
p.(None): • Local customs that may violate laws of the country and/or human rights Country • Research protocols and
p.(None): practices which fail to take account of national
p.(None): traditions and legislation
p.(None): Animal • Variations in customs, norms and attitudes regarding animal welfare and inhumane practices
p.(None): Environmental • Variations in customs, norms and attitudes regarding the environment
p.(None):
p.(None): Animals and environments are also at risk of exploitation because of variations in customs and norms. What is
p.(None): considered “animal cruelty” or “inhumane practice” in animal experimentation varies greatly between cultures.
p.(None): Additionally, some ani- mals are awarded greater protection in certain cultures than others, for example, dogs and cats
p.(None): in the United Kingdom and cows in India. Animal experimentation on non-human primates is particularly controversial
p.(None): in most countries, but in some certain non-human primates are viewed as “pests” (Hill and Webber 2010). Different
p.(None): partners in collaborative research may have different philosophies related to the environment. Environmental
p.(None): protection is sometimes regarded as a colonial con- struct that has negative impacts on local communities in LMICs, and
...
p.(None): play a part in
p.(None):
p.(None):
p.(None): 8 Many academic journals that publish results from animal experimentation stipulate requirements that the studies have
p.(None): been conducted in a manner that is consistent with high ethical standards such as EU Directive 2010/63 (EU 2010).
p.(None):
p.(None): References
p.(None): 49
p.(None):
p.(None): maintaining power differentials. To give one striking example, the United Nations Security Council has 15 members. Of
p.(None): these, ten are elected by the General Assembly for periods of two years while five (China, France, Russia, the United
p.(None): Kingdom and the United States) have been permanent members with “veto power” since 1946. More than 60 United
p.(None): Nations member states have never been members of the Security Council and hence have never even had voting
p.(None): rights, let alone veto power.
p.(None):
p.(None):
p.(None): Past History of Colonialism
p.(None):
p.(None): Does the history of colonialism still bear upon research today? We believe it does, as can be seen from the experience
p.(None): of indigenous peoples in research. Linda Tuhiwai Smith has powerfully shown that indigenous peoples often
p.(None): consider research a “dirty word”. She describes how “imperialism frames the indigenous experience” and how
p.(None): “indigenous peoples had to challenge, understand and have a shared lan- guage for talking about ... colonialism” (Smith
p.(None): 2012).
p.(None): We close this chapter with a comment from the TRUST gender adviser, Prof.
p.(None): Fatima Alvarez-Castillo (2016):
p.(None): A culture’s worldview, expressed in language, contains norms and values about power and relations of power. For
p.(None): example, the word “expert” imbues persons with authority and assigns higher credibility to their claims than
p.(None): those of non-experts. The public is expected to defer to their opinions on matters of their expertise. It was not until
p.(None): about the 1960s when the usual understanding of expertise was challenged by feminists, who argued that
p.(None): unschooled women have more expertise about their own situation than the experts. This ushered in a new research
p.(None): philosophy that valorizes poor women’s stories and their own versions of their realities.
p.(None):
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Alvarez-Castillo F (2016) Gender sensitivity: writing and language. In: Chatfield K, Schroeder D, Kimani J (eds)
p.(None): Nairobi plenary meeting report, TRUST Project. http://trust-project.eu/wp-
p.(None): content/uploads/2016/11/Meeting-Report-TRUST-Nairobi-Final.pdf
p.(None): Annas G, Grodin M (1998) Human rights and maternal-fetal HIV transmission prevention trials in Africa. American Journal
p.(None): of Public Health 88(4):560–563
p.(None): Bhatt K (2016) Concerns for Kenyan National Bioethics Committee when approving North-South collaborative projects. In:
p.(None): Chatfield K, Schroeder D, Kimani J (eds) Nairobi plenary meeting report, TRUST Project.
p.(None): http://trust-project.eu/wp-content/uploads/2016/11/Meeting-Report- TRUST-Nairobi-Final.pdf
p.(None): EU (2010) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of
p.(None): animals used for scientific purposes (text with EEA relevance). OJ L 276/33.
p.(None): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32010L0063
p.(None): Hill CM, Webber AD (2010) Perceptions of nonhuman primates in human–wildlife conflict sce- narios. American Journal of
p.(None): Primatology 72(10):919−924
p.(None): Hughes J (2010) European textbook on ethics in research. European Commission, Brussels
p.(None):
p.(None): 50 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): Luc G, Altare C. (2018) Social science research in a humanitarian emergency context. In: Schroeder D, Cook J, Hirsch F,
...
p.(None): Good practice Relevant GCC article
p.(None):
p.(None): Ensuring double ethics review Community
p.(None): engagement
p.(None): Clear roles and responsibilities
p.(None): Article 10: Local ethics review should be sought wherever possible.
p.(None):
p.(None): Article 2: Local communities and research participants should be included throughout the research process.
p.(None): Article 20: A clear understanding should be reached among collaborators with regard to their roles, responsibilities
p.(None): and conduct throughout the research cycle.
p.(None):
p.(None): funders and charitable funders of research (see Table 6.2). The three main good practice elements9 raised by funders
p.(None): and industry to stop ethics dumping are listed in Table 6.3, with their corresponding GCC articles (Singh and Makanga
p.(None): 2017).
p.(None): As already indicated, engagement with research funders was not restricted to one meeting, but took place over
p.(None): approximately two years via the funder and industry platforms described above. Additionally, the first draft of the GCC
p.(None): was distributed to all members of the platforms nine months after the workshop. Both groups pro- vided further comments
p.(None): on the draft.
p.(None):
p.(None):
p.(None): External Engagement with Researchers
p.(None):
p.(None): The consortium that drafted the GCC represented a wide range of academic disci- plines, namely ethics, medicine,
p.(None): economics, bioethics, law, social psychology, soci- ology, psychology, gender studies, chemistry, social sciences,
p.(None): psychiatry, biology, zoology, veterinary medicine, political science and management. The multidisci- plinary
p.(None): nature of the consortium’s expertise enabled broad engagement with the wider academic community. For example,
p.(None): academic presentations that included the GCC were delivered in Belgium, China, Congo, Cyprus, Germany, India, Kenya,
p.(None): Latvia, the Netherlands, the Philippines, Portugal, Rwanda, South Africa, Sweden, Taiwan, Uganda, Vatican City, the UK
p.(None): and the USA (Dammann and Schroeder 2018). The feedback from researchers was essentially threefold. First, researchers
p.(None): were interested in the potential “grey areas” of ethics dumping. A question in this context, asked on many occasions by
p.(None): different audiences, was: “If a particular research study has no real local relevance to LMICs, and the
p.(None): research money spent by well- intentioned researchers from HICs (who genuinely believe that they are improving the
p.(None): world) is in fact being wasted, does that count as ethics dumping?” A case in
p.(None):
p.(None):
p.(None): 9 A fourth good practice element that was emphasized at the funder and industry workshop was the provision of
p.(None): post-trial access to successfully marketed drugs. This requirement was not included in the GCC for two main reasons.
p.(None): First, the GCC was designed to be applicable to all disciplines, and hence articles with limited applicability were
p.(None): avoided. Second, post-trial access is clearly indicated in existing guidelines, in particular in the Declaration of
...
p.(None):
p.(None): frequently stipulates that all complaints must be made in writing. The requirement to complain in writing via email
p.(None): might preclude complaints from the most vulner- able research participants.
p.(None): For collaborative research undertaken in resource-poor settings, especially low and middle-income countries (LMICs),
p.(None): the accessibility of a complaints procedure may be affected by many factors that are unfamiliar to researchers from a
p.(None): high- income country (HIC). A concerted effort is therefore required to understand local needs and preferences so that
p.(None): a complaints mechanism can be implemented that is both user-friendly and fit for purpose.
p.(None):
p.(None):
p.(None): Factors Affecting Accessibility
p.(None):
p.(None): It is known from studies in the field of dispute resolution that people often feel reluctant to make
p.(None): complaints and that this can be related to a variety of complex factors. In 2009 the Health Professions
p.(None): Council in the UK published a
p.(None):
p.(None): 100 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): comprehensive scoping review of existing mechanisms for complaints about health professionals (HPC 2009). In this
p.(None): report, the HPC describes a range of factors that can act as barriers to making a specific complaint. As there are no
p.(None): equivalent publi- cations about complaints procedures in LMICs, we summarize here the factors that are relevant to
p.(None): research in LMICs.
p.(None): Readiness to complain in any environment can be influenced by gender, ethnic- ity, age, education, income,
p.(None): accessibility of information and the perceived “serious- ness” of the problem (Pleasence et al. 2006).
p.(None): Specifically, ethnic minority communities are less likely to use systems that they perceive as being culturally
p.(None): insensitive and are more fearful of the consequences of taking action when they feel those systems have failed them.
p.(None): Difficulties with access to information are highlighted as a barrier to making a complaint (Henwood et al. 2003),
p.(None): especially where there is “information illiteracy”; some people possess the relevant skills and confidence to seek out
p.(None): information, but many do not. In situations where levels of education and literacy are not high, this is likely to be
p.(None): exacerbated.
p.(None): The relationship between the person who brings the complaint and the bureau- cracies to which they must direct
p.(None): their complaint can be a factor (Cowan and Halliday 2003). This relationship can either encourage or
p.(None): discourage a potential complainant’s trust in complaints mechanisms. The power imbalance between par- ties in such
p.(None): relationships can be substantial. For example, when working with impoverished communities, HIC researchers
...
p.(None): Ethical guidelines, 65–67, 105, 117
p.(None): Ethical review, 8, 18, 23, 39, 51, 56, 61,
p.(None): 65–68, 110, 111, 115, 116
p.(None): Ethical values, 7, 17–19, 28, 29, 82
p.(None): Ethics approval, 2, 8, 18, 22, 43, 44, 46, 48,
p.(None): 66, 77, 98
p.(None): Ethics committee, 8, 18, 21, 22, 39, 42–44, 46,
p.(None): 51, 52, 54, 56, 58, 62, 65–67, 69, 70,
p.(None): 74, 98, 103, 110, 111, 116
p.(None): Ethics dumping, 1–3, 5–11, 14, 18, 19, 24, 27,
p.(None): 37, 52–54, 56–58, 61, 63, 66–68, 70,
p.(None): 89–98, 100–105, 109, 110, 112
p.(None): Europe, 1, 55, 65, 111
p.(None): European Code of Conduct for Research Integrity, 5, 24, 117
p.(None): European Commission (EC), 1, 2, 23, 52–54,
p.(None): 57, 70, 110–112, 117
p.(None): European Parliament, 2, 64, 70, 111, 115
p.(None): European Union (EU), 1, 14, 28, 48, 53, 54,
p.(None): 60, 64, 70, 80, 110–112, 116
p.(None): Evaluation, 6, 20, 63, 65, 93, 96, 98
p.(None): Exploitation, 2, 3, 14, 24, 37–49, 54, 58, 60,
p.(None): 62, 63, 65, 66, 74, 82, 83, 105
p.(None): Exploitative, 19, 38, 40, 41
p.(None):
p.(None):
p.(None): F
p.(None): Fairness, 2, 5–7, 13–24, 27–31, 33, 40–43, 68,
p.(None): 70, 74, 77–78, 82, 84, 90, 93, 95–98,
p.(None): 102, 110–112, 117
p.(None): Index
p.(None):
p.(None): Fair research contract (FRC), 90, 103, 104
p.(None): Farmers, 101
p.(None): Feedback, 6, 8, 20, 41, 48, 61, 63, 64, 83,
p.(None): 96, 105
p.(None): Four values framework, 13–24, 30, 102 Free and prior informed consent, 7, 66 Funders, 53–58, 60, 61, 70, 79, 116
p.(None):
p.(None):
p.(None): G
p.(None): Gender, 44, 49, 61, 100
p.(None): Genetic research, 54, 74, 92
p.(None): Genetics, 2, 7, 13, 60, 62, 63, 74, 75,
p.(None): 81, 82
p.(None): Global Code of Conduct for Research in Resource-Poor Settings, 2, 5, 14, 27,
p.(None): 37, 51, 80, 89, 109, 115–117
p.(None): Good Participatory Practice, 6, 20, 63
p.(None):
p.(None):
p.(None): H
p.(None): Harm, 1, 17, 19, 28, 34, 35, 38, 43, 45–47, 54,
p.(None): 65, 73, 75, 84, 95, 98
p.(None): Health and safety, 9, 10
p.(None): HealthyXvolunteers, 63
p.(None): Helicopter research, 23, 41
p.(None): High-income countries (HICs), 2, 9, 20–23,
p.(None): 38–44, 47, 48, 56, 65, 70, 99–101, 104
p.(None): Honesty, 2, 5, 6, 10–11, 13–24, 27–31, 33, 40,
p.(None): 46–48, 68, 70, 74, 82, 83, 90, 93,
p.(None): 95–98, 102, 110–112
p.(None): Horizon 2020, 23, 52, 53
p.(None): Human participants, 65, 117
p.(None): Human rights, 22, 42, 44, 55, 75
p.(None):
p.(None):
p.(None): I
p.(None): Ideals, 3, 16, 17, 24, 32
p.(None): Illegal, 22, 43, 63, 65, 100
p.(None): Illiterate populations, 22, 47
p.(None): Incrimination, 9, 11, 68
p.(None): India, 39, 44, 56, 61, 65, 110, 111, 115, 116
p.(None): Indigenous peoples, 49, 55, 63, 73, 75,
p.(None): 80, 112
p.(None): Industry, 39, 54–58, 61, 69, 70, 117
p.(None): Inequalities, vii
p.(None): Information sheets, 24, 47, 98, 103
p.(None): Informed consent, 2, 7, 8, 24, 44–47, 63, 66,
p.(None): 74, 82, 84, 100, 105
p.(None): Integrity, 5, 23, 24, 46–48, 53, 67, 70, 74,
p.(None): 78–79, 82, 85, 86, 94, 112, 117
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p.(None): • increasing community understanding and acceptance of the studies
p.(None): • enhancing researchers’ ability to understand and address community priorities
p.(None): • improving logistics and the running of studies
p.(None): • strengthening the quality of the information collected
p.(None): • ensuring culturally sensitive communications and research approaches
p.(None): • enhancing opportunities for capacity building (Hebert et al. 2009; Cook 2008; Bassler et al. 2008; Dunn 2011).
p.(None): Community engagement is an ethical imperative (a “must”) for researchers oper- ating globally. Research participants,
p.(None): their local communities and research partners in international locations should be equal stakeholders in the pursuit of
p.(None): research- related gains (Anderson et al. 2012). Ahmed and Palermo (2010) provide a salient definition of community
p.(None): engagement in research as
p.(None): a process of inclusive participation that supports mutual respect of values, strategies, and actions for authentic
p.(None): partnership of people affiliated with or self-identified by geographic proximity, special interest, or similar
p.(None): situations to address issues affecting the well-being of the community of focus.
p.(None): To be effective in international research, community engagement requires the development of partnerships with
p.(None): “local” stakeholders (for example, national,
p.(None):
p.(None): 4 Advocacy groups (also known as pressure groups, lobby groups, campaign groups, interest groups or special interest
p.(None): groups) use various forms of advocacy in order to influence public opinion and/ or policy.
p.(None): 5 Here “broader community” can refer to a village, town, ethnic group etc.
p.(None):
p.(None): Ethical Engagement with Communities
p.(None): 93
p.(None):
p.(None): regional or advocacy groups), involving them in assessing local challenges and research priorities,
p.(None): determining the value of research, planning, conducting and overseeing research, and integrating the
p.(None): results with local needs where relevant (Jones and Wells 2007). Moreover, it requires members of the
p.(None): research team to become part of the community, and members of the community to become part of the research team to
p.(None): create bespoke working environments before, during and after the research.
p.(None): Many models have been proposed for effective community engagement in research,6 and many written guides
p.(None): already exist. Rather than add an invention of our own to the numerous existing models, we show here how reference to
p.(None): the four values of fairness, respect, care and honesty can highlight the primary ethical con- siderations for
p.(None): organizations or researchers engaging with communities over the course of a research project. After all, as Dunn
p.(None): (2011: 5) points out, “Engagement is not a benchmark for ethics. Ethics does not stop when community engagement takes
p.(None): place. Engagement itself has ethical implications.”
p.(None): Our guidance for community engagement is intended to be useful; we show how application of the values compass at key
p.(None): stages of the research process can invoke particular questions for contemplation. There may be other relevant
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p.(None): The Results Phase 96
p.(None): Evaluating the Study 96
p.(None): Developing an Accessible Complaints Procedure 97
p.(None): Factors Affecting Accessibility 99
p.(None): The Scope of a Complaints Procedure 101
p.(None): A Values-Based Approach to Developing a Complaints
p.(None): Procedure 102
p.(None): A Fair Research Contracting Tool 103
p.(None): Conclusion 105
p.(None): References 106
p.(None): 9 Towards Equitable Research Partnership 109
p.(None): References 112
p.(None): Appendix
p.(None): 115
p.(None): Index
p.(None): 119
p.(None):
p.(None): About the Authors
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Doris Schroeder is director of the Centre for Professional Ethics at the University of Central Lancashire, and
p.(None): professor of moral philosophy at the School of Law, UCLan Cyprus. She is the lead author of the Global Code of Conduct
p.(None): for Research in Resource-Poor Settings.
p.(None):
p.(None): Kate Chatfield is deputy director of the Centre for Professional Ethics, University of Central Lancashire, UK. She is a
p.(None): social science researcher and ethicist special- izing in global justice, research ethics, animal ethics and responsible
p.(None): innovation.
p.(None):
p.(None): Michelle Singh is a project officer at the European & Developing Countries Clinical Trials Partnership in Cape Town,
p.(None): South Africa. She holds a medical PhD and previ- ously managed maternal and child health research studies and clinical
p.(None): trials at the South African Medical Research Council.
p.(None):
p.(None): Roger Chennells works as legal adviser to the South African San Institute and is a founder-partner in the human rights
p.(None): law practice Chennells Albertyn, Stellenbosch, established in 1981. Specializing in labour, land, environmental and
p.(None): human rights law, he has also worked for Aboriginal people in Australia.
p.(None):
p.(None): Peter Herissone-Kelly is senior lecturer in philosophy, University of Central Lancashire, UK. He is a
p.(None): specialist in Kantian ethics as well as bioethics, analytic philosophy of language and metaethics.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xvii
p.(None):
p.(None): Abbreviations
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ACF Action contre la Faim
p.(None): CBD UN Convention on Biological Diversity COHRED Council on Health Research for Development EC
p.(None): European Commission (EC)
p.(None): EDCTP European and Developing Countries Clinical Trials Partnership EFPIA European Federation of
p.(None): Pharmaceutical Industries and Associations FERCI Forum for Ethics Review Committees in India
p.(None): GCC Global Code of Conduct for Research in Resource-Poor Settings GVA Global Values Alliance
p.(None): HIC high-income country
p.(None): Inserm Institut national de la santé et de la recherche médicale IPR intellectual property
p.(None): rights
p.(None): LMICs low- and middle-income countries NGO nongovernmental organization
p.(None): PHDA Partners for Health and Development in Africa REC research ethics committee
p.(None): SASC South African San Council SASI South African San Institute
p.(None): SWOP Sex Workers Outreach Programme
...
p.(None): piety, loyalty and reciproc- ity (Wang et al. 2018). Virtues are a good way to drive ethical action, in particular
p.(None): global ethical action, but the TRUST team had good reason not to use virtues as the foundation of the GCC.
p.(None): Virtues can be regarded as embodied ethical values because they are manifested in persons. One can learn a lot by
p.(None): observing real people (such as Mother Theresa or Nelson Mandela) and following their example. This makes virtue
p.(None): approaches very useful in leadership and mentoring (Resnik 2012). But not every researcher has access to
p.(None): mentors and learning via example. Besides, early career researchers are said to benefit more from rule-based approaches
p.(None): (Resnik 2012). Hence, while vir- tues were considered as a possibility for the foundation of the GCC, they
p.(None): were excluded because of their strong reliance upon the availability of role models.
p.(None): Principles have a long-standing tradition in practical moral frameworks, espe- cially principlism, the moral
p.(None): framework relating to bioethics developed by Beauchamp and Childress (2013). As argued in Chapter 4, we
p.(None): believe that the four principles of Beauchamp and Childress – autonomy, non-maleficence (do no harm), beneficence and
p.(None): justice – should instead be called values. Principles, as we under- stand them, are more concrete than values.
p.(None): Principles can provide almost immediate and very straightforward answers to ethical questions.
p.(None): A famous principle in political philosophy is Rawls’s difference principle. The principle holds that divergence from an
p.(None): egalitarian distribution of social goods (e.g. income, wealth, power) is only allowed when this non-egalitarian
p.(None): distribution favours the least advantaged in society (Rawls 1999: 65–70). In other words, if a particularly talented
p.(None): wealth creator increases the overall wealth pie so that the least advantaged in society are better off, she can receive
p.(None): a bigger share of the pie than others. Knowing about this principle gives answers to social philosophy questions, which
p.(None): the value of fairness or justice would not. Rawls applied the value of fairness to derive the more concrete difference
p.(None): principle. Principles are therefore too con- crete and too prescriptive to form the foundation of the GCC. They would
p.(None): not leave enough room for local agreements between partners from high- and lower-income settings as envisaged by
p.(None): various GCC articles, such as article 1: “Local relevance of research … should be determined in collaboration with
p.(None): local partners.”
p.(None):
p.(None): 18 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Standards are even more specific than principles and have an even stronger action-guiding function. They
p.(None): prescribe very concrete activities in given settings. To formulate standards for ethical interaction between partners
p.(None): from different settings would certainly be too prescriptive. A standard cannot be diverged from (for exam- ple, a limit
p.(None): to vehicle emissions). For instance, if article 104 were a standard, no exception to double ethics review would be
p.(None): possible. But there may be good reason to allow such an exception in certain circumstances. For instance, if ethics
p.(None): approval has been given in a high-income setting and community approval obtained in a host setting where no ethics
p.(None): committee operates, then it may be perfectly ethical to proceed.
p.(None): The San community in South Africa, for instance, has no facility for providing ethics committee approval, but the South
...
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p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
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p.(None): case, our argumenta- tional strategy will be similar to that of Beauchamp and Childress.
p.(None): However, we want to maintain that the four GCC values, taken together, have a less contentious claim to be globally
p.(None): applicable than Beauchamp and Childress’s principles, for two reasons.
p.(None): 1. One of Beauchamp and Childress’s principles – respect for autonomy – has often, and with some
p.(None): justification, been criticized for being culturally bound rather than universal (Huxtable 2013, Kara 2007,
p.(None): Cheng-Tek Tai 2013, Kiak Min 2017)
p.(None): 2. The GCC’s four-values approach was developed collaboratively with diverse stakeholders from all continents,
p.(None): including significant representation from vul- nerable research populations (see Chapters 6 and 7).
p.(None):
p.(None): 30 4 Respect and a Global Code of
p.(None): Conduct?
p.(None):
p.(None): The Four Values and Moral Relativism
p.(None):
p.(None): Giving the value of respect high standing, as one of only four values in the GCC framework, opens the framework to
p.(None): attack for being morally relative. Unlike fair- ness, care and honesty, the value of respect centres on foreseeable
p.(None): disagreement. If I have to respect what somebody does in a country that is not my own, even though I disagree heavily
p.(None): for moral reasons, does this mean there are no globally shared values? If this were the case, it would mean that no
p.(None): global moral framework is avail- able to ground the 23 articles of the GCC.
p.(None): In philosophy, this conundrum is called the doctrine of moral relativism. Such relativism has been divided into
p.(None): three related forms with different emphases: descriptive relativism, metaethical relativism and normative
p.(None): relativism.
p.(None):
p.(None):
p.(None): Descriptive relativism
p.(None):
p.(None):
p.(None):
p.(None): Metaethical4 relativism
p.(None):
p.(None):
p.(None):
p.(None): Normative relativism
p.(None): Descriptive relativism is a sociological or anthropological, rather than philosophical, doctrine, which is based upon
p.(None): observations of disparate cultures. It holds that, as a matter of fact, moral norms show considerable variation across
p.(None): societies: courses of action deemed permissible or even obligatory in one society may be proscribed in another.
p.(None): Metaethical relativism is a philosophical doctrine that we may be tempted to adopt if we find ourselves convinced by
p.(None): the claims of the descriptive relativist. It maintains that there are no universal or extra-cultural moral truths:
p.(None): insofar as a given moral judgement can accurately be described as true or false, this position maintains that it is
p.(None): true or false only relative to a given society.
p.(None): If we subscribe to metaethical relativism, then we can only say that a particular action is wrong in our society, not
p.(None): in other societies. Our only option is to “live and let live”.
p.(None):
p.(None): A summary of these positions and how they follow from each other is shown in Figure 4.1.
p.(None): Normative relativism might seem to offer us a way to resolve the apparent ten- sion in the four-values approach, which
p.(None): might be thought to dovetail neatly with the normative relativist’s outlook. Since we have no business interfering in
p.(None): or evaluat- ing the moral codes of those from other cultures, our interactions with them, includ- ing research
p.(None): interactions, need to be as “light-touch” as possible. We need to treat each other fairly and with care, respect
p.(None): cultural differences, not impose our own values, and ensure our interactions are honest.
p.(None): The problem here, however, is that just as descriptive relativism does not entail (though it may lend support to)
p.(None): metaethical relativism, metaethical relativism also does not entail normative relativism (and provides no support for
p.(None): it at all). This point is well argued by Bernard Williams (1972: 34) in his 1972 book Morality, in
p.(None):
p.(None):
p.(None):
p.(None): 4 Metaethics is a branch of analytical philosophy which deals with higher-level questions of moral- ity. Rather than
p.(None): asking how to lead a moral life, which values are appropriate to govern it, etc., metaethics asks whether such
p.(None): questions can be answered in the first place.
p.(None):
p.(None): A More Moderate Relativism
p.(None): 31
p.(None):
p.(None): Descriptive Relativism
p.(None): Metaethical Relativism
p.(None): Normative Relativism
p.(None):
p.(None): One can observe different moral norms
p.(None): There are no universal or extra-cultural moral truths
p.(None): We have to "live and let live"
p.(None): Fig. 4.1 Different types of relativism and their relationship
p.(None):
p.(None): which he calls normative relativism “possibly the most absurd view to have been advanced even in moral philosophy”. He
p.(None): writes:
p.(None): [T]he view is clearly inconsistent, since it makes a claim … about what is right and wrong in one’s dealings with other
p.(None): societies, which uses a nonrelative sense of “right” not allowed for in [metaethical relativism].
p.(None): In other words, metaethical relativism does not lead to any position, including normative relativism, which tells us
p.(None): what we should do in interacting with those from other cultures. This is simply because metaethical relativism itself
p.(None): tells us that there is no global “should”. Every claim about what we should do has been generated and will be bound by
p.(None): our own culture. If the imperative to treat those from other cultures with fairness, respect, care and honesty is
p.(None): thought to be one that floats free of, and exists outside, any culturally bound system of values, and we want the GCC
p.(None): to apply globally, then we cannot be metaethical relativists.
p.(None):
p.(None):
p.(None): A More Moderate Relativism
p.(None):
p.(None): It may be that we can justify the four values by appealing to the more moderate form of relativism espoused by David
p.(None): Wong (2009). According to Wong, although moral norms do indeed vary across cultures, as the descriptive
p.(None): relativist assumes, and although there is no one single true morality, there is something that is universal about
p.(None): morality, and common to all particular moralities worthy of the name.
p.(None): What is common is the central aim or purpose of morality. This aim is not itself a value in any given moral system, but
p.(None): rather what determines whether any given value is fit to figure in such a system. A consequence of this, and one which
...
p.(None): rights, let alone veto power.
p.(None):
p.(None):
p.(None): Past History of Colonialism
p.(None):
p.(None): Does the history of colonialism still bear upon research today? We believe it does, as can be seen from the experience
p.(None): of indigenous peoples in research. Linda Tuhiwai Smith has powerfully shown that indigenous peoples often
p.(None): consider research a “dirty word”. She describes how “imperialism frames the indigenous experience” and how
p.(None): “indigenous peoples had to challenge, understand and have a shared lan- guage for talking about ... colonialism” (Smith
p.(None): 2012).
p.(None): We close this chapter with a comment from the TRUST gender adviser, Prof.
p.(None): Fatima Alvarez-Castillo (2016):
p.(None): A culture’s worldview, expressed in language, contains norms and values about power and relations of power. For
p.(None): example, the word “expert” imbues persons with authority and assigns higher credibility to their claims than
p.(None): those of non-experts. The public is expected to defer to their opinions on matters of their expertise. It was not until
p.(None): about the 1960s when the usual understanding of expertise was challenged by feminists, who argued that
p.(None): unschooled women have more expertise about their own situation than the experts. This ushered in a new research
p.(None): philosophy that valorizes poor women’s stories and their own versions of their realities.
p.(None):
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Alvarez-Castillo F (2016) Gender sensitivity: writing and language. In: Chatfield K, Schroeder D, Kimani J (eds)
p.(None): Nairobi plenary meeting report, TRUST Project. http://trust-project.eu/wp-
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p.(None): Chatfield K, Schroeder D, Kimani J (eds) Nairobi plenary meeting report, TRUST Project.
p.(None): http://trust-project.eu/wp-content/uploads/2016/11/Meeting-Report- TRUST-Nairobi-Final.pdf
p.(None): EU (2010) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of
p.(None): animals used for scientific purposes (text with EEA relevance). OJ L 276/33.
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p.(None): Hughes J (2010) European textbook on ethics in research. European Commission, Brussels
p.(None):
p.(None): 50 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): Luc G, Altare C. (2018) Social science research in a humanitarian emergency context. In: Schroeder D, Cook J, Hirsch F,
p.(None): Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North- South research collaborations, Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 9-14
p.(None): Macklin R (2003) Vulnerability and protection. Bioethics 17(5–6):472–486
p.(None): Pogge T (2006) Justice. In: Borchert DM (ed) Encyclopedia of philosophy, 2nd edn, vol 4.
p.(None): Macmillan Reference, Detroit, pp 862–870
p.(None): Russell WMS, Burch RL, Hume CW (1959) The principles of humane experimental technique.
p.(None): Methuen & Co, London
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p.(None): Stone CD (2010) Should trees have standing? Law, morality, and the environment, 3rd edn. Oxford University Press,
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p.(None): Smith, LT (2012) Decolonizing methodologies: research and indigenous peoples. Zed Books, London
p.(None): Universities UK (2015) The concordat to support research integrity. Universities UK, London Wood A (1995) Exploitation.
p.(None): Social Philosophy and Policy 12:150–151
p.(None):
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p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 6
p.(None): How the Global Code of Conduct Was Built
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract How can an ethics code achieve impact? The answer is twofold. First, through adoption by influential research
p.(None): funders, who then make it mandatory for their award recipients. This is the case with the Global Code of Conduct for
...
p.(None): simultaneously identifying which risks, if any, were not covered by any notable guidance. For instance, the lack
p.(None): of guidance on risk management approaches to biosafety and biosecurity was discovered in this way (Singh
p.(None): and Schroeder 2017), leading to article 1813 of the GCC.
p.(None): Once the fact-finding, consultations and analysis had been done, the drafting process began.
p.(None):
p.(None):
p.(None): Drafting Process
p.(None):
p.(None): The drafting committee of the GCC consisted of four people, following Michael Davis’s (2007) advice:
p.(None): Keep the drafting committee small. Preparing a first draft of a code is not an activity made lighter “by many hands”.
p.(None): It is more like the soup that “too many cooks” spoil.”
p.(None):
p.(None): 13 In situations where environmental protection and biorisk-related regulations are inadequate or non-existent in the
p.(None): local setting compared with the country of origin of the researcher, research should always be undertaken in line with
p.(None): the higher standards of environmental protection.
p.(None):
p.(None): 68 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.7 GCC drafting committee
p.(None): Region of
p.(None): Drafter origin Focus Background Roles
p.(None):
p.(None): Schroeder North All engagement and
p.(None): fact-finding
p.(None): Philosophy, politics, economics
p.(None): Full first draft
p.(None):
p.(None): Chennells South Vulnerable populations
p.(None): Law Drafting articles to protect vulnerable populations
p.(None):
p.(None): Chatfield North Risks Social science, philosophy
p.(None): Redrafting to ensure all risks were covered
p.(None): Singh South Existing guidelines Public health Redrafting with a focus on
p.(None): existing guidelines
p.(None):
p.(None): Table 6.7 shows the configuration of the four-person drafting committee. The emphasis was on 50% North and 50% South
p.(None): membership, taking into account the expertise needed and relevant background.
p.(None): The four-values approach, featuring fairness, respect, care and honesty, had been adopted by the consortium at an
p.(None): earlier stage (chapter 3). Based on these values and the inputs into the GCC from consultations and fact-finding
p.(None): activities over two years (see Fig. 6.1), the lead author, Professor Doris Schroeder, drafted the first version, which
p.(None): contained 20 articles, three fewer than the final version.
p.(None): For instance, article 15 on the risks of stigmatization, incrimination, discrimina- tion and indeterminate personal
p.(None): risk was added during the peer review process by Professor Morton, the veterinary expert in the consortium.
p.(None): Professor Schroeder’s first draft was refined considerably by the social science and risk expert on the drafting
p.(None): committee, Dr Kate Chatfield. Dr Roger Chennells, the expert on involving vulnerable populations in research,
p.(None): who also provided a legal perspective, drafted his own articles on the prevention of ethics dumping. Many
p.(None): of these addressed the same issues identified by the lead author, but now illu- minated by a legal reading. For
...
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p.(None):
p.(None):
p.(None): Care
p.(None): Article 12
p.(None):
p.(None): Informed consent procedures should be tailored to local requirements to achieve genuine understanding and well-founded
p.(None): decision-making.
p.(None):
p.(None):
p.(None): Article 13
p.(None):
p.(None): A clear procedure for feedback, complaints or allegations of misconduct must be offered that gives genuine and
p.(None): appropriate access to all research participants and local partners to express any concerns they may have with the
p.(None): research process. This procedure must be agreed with local partners at the outset of the research.
p.(None):
p.(None): Care
p.(None): 9
p.(None):
p.(None): Article 14
p.(None):
p.(None): Research that would be severely restricted or prohibited in a high-income setting should not be carried out in a
p.(None): lower-income setting. Exceptions might be permissi- ble in the context of specific local conditions (e.g. diseases not
p.(None): prevalent in high- income countries).
p.(None): If and when such exceptions are dealt with, the internationally acknowledged compliance commandment “comply or
p.(None): explain” must be used, i.e. exceptions agreed upon by the local stakeholders and researchers must be explicitly
p.(None): and trans- parently justified and made easily accessible to interested parties.
p.(None):
p.(None):
p.(None): Article 15
p.(None):
p.(None): Where research involvement could lead to stigmatization (e.g. research on sexually transmitted diseases), incrimination
p.(None): (e.g. sex work), discrimination or indetermi- nate personal risk (e.g. research on political beliefs), special measures
p.(None): to ensure the safety and wellbeing of research participants need to be agreed with local partners.
p.(None):
p.(None):
p.(None): Article 16
p.(None):
p.(None): Ahead of the research it should be determined whether local resources will be depleted to provide staff or
p.(None): other resources for the new project (e.g. nurses or labo- ratory staff). If so, the implications should be discussed in
p.(None): detail with local com- munities, partners and authorities and monitored during the study.
p.(None):
p.(None):
p.(None): Article 17
p.(None):
p.(None): In situations where animal welfare regulations are inadequate or non-existent in the local setting compared with the
p.(None): country of origin of the researcher, animal experi- mentation should always be undertaken in line with the higher
p.(None): standards of protec- tion for animals.
p.(None):
p.(None): 10 2 A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None): Article 18
p.(None):
p.(None): In situations where environmental protection and biorisk-related regulations are inadequate or non-existent in
p.(None): the local setting compared with the country of origin of the researcher, research should always be undertaken in line
p.(None): with the higher stan- dards of environmental protection.
p.(None):
p.(None):
p.(None): Article 19
p.(None):
...
p.(None): public health professionals from the University of Manitoba (Canada), the University of Nairobi and the government of
p.(None): Kenya. Its work focuses mainly on HIV prevention, treatment and care, research, capacity-building and
p.(None): training.
p.(None): The Sex Workers Outreach Programme (SWOP) is a PHDA initiative that under- takes active community engagement and
p.(None): provides clinical and preventative services to 33,000 sex workers residing in Nairobi. These sex workers would
p.(None): otherwise find access to medical services in public health facilities extremely limited due to stigma and
p.(None): discrimination. Those enrolled in the sex workers cohort for HIV prevention services are free to volunteer for
p.(None): available research studies after providing informed consent. Most studies are on the epidemiology of sexually
p.(None): transmitted diseases, and on host genetic factors that influence infectivity and disease progression.
p.(None): Given that sex work is illegal in Kenya, we cannot assign input to specific, named individuals here. Suffice to say
p.(None): that the personal contributions of courageous and admirable sex workers, both female and male, provided the TRUST team
p.(None): not only with practical advice that took shape in specific articles of the GCC, but also with inspiration. Table 6.4
p.(None): presents two examples of issues raised by the Nairobi sex workers (Chatfield et al. 2016a) that were implemented in the
p.(None): GCC.
p.(None):
p.(None): 64 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.4 Input from sex workers and GCC connection
p.(None): Issues raised by sex workers Relevant GCC Article
p.(None):
p.(None): “We need feedback to the community from the research in simple and non-scientific language. Some results have been
p.(None): shared with us in the past, but I did not know what they meant. Do not give us results in scientific language. It puts
p.(None): us at risk if we do not understand the results. … Come back with the results and tell us how we can make our lives
p.(None): better.”
...
p.(None): exacerbated.
p.(None): The relationship between the person who brings the complaint and the bureau- cracies to which they must direct
p.(None): their complaint can be a factor (Cowan and Halliday 2003). This relationship can either encourage or
p.(None): discourage a potential complainant’s trust in complaints mechanisms. The power imbalance between par- ties in such
p.(None): relationships can be substantial. For example, when working with impoverished communities, HIC researchers
p.(None): should be aware that participation in a clinical study may provide a participant’s only access to health care or other
p.(None): much- needed benefits. Fear of retribution is often cited as a barrier to making a complaint, particularly in
p.(None): circumstances where the complainant has an ongoing relationship with the complainee (HPC 2009). In situations where
p.(None): there is a power imbalance, people may not have the confidence to complain; they may be reluctant to seem ungrateful,
p.(None): not wish to be seen as a complainer, or fear loss. Research has shown that some people even reconstruct negative
p.(None): experiences in a positive light in order to maintain relationships (Edwards et al. 2004).
p.(None): In addition to the above, participatory engagement activities in the TRUST proj- ect (Chapter 6) have revealed the
p.(None): following factors that could also act as barriers to research participants making complaints about research activities
p.(None): in LMICs:
p.(None): • Fear of damage or stigmatization from loss of confidentiality or anonymity. In Kenya, for example, where sex work
p.(None): is illegal, sex workers may be reluctant to make any formal complaints.
p.(None): • Cultural norms that preclude complaining. In some cultures, it is not acceptable to make complaints, especially
p.(None): to or about visitors and/or those in authority. Complaining may be perceived as disrespectful, ungrateful or
p.(None): inappropriate.
p.(None): • Illiteracy of research participants and communication (language) difficulties, leading to a lack of
p.(None): understanding of reasonable rights relating to informed con- sent and to reasonable expectations of the research.
p.(None):
p.(None): Developing an Accessible Complaints Procedure 101
p.(None):
p.(None): • Inability to access the means by which to file a complaint: for example, if only an email address is provided as a
p.(None): contact and one has no access to computers or internet connections.
p.(None):
p.(None):
p.(None): The Scope of a Complaints Procedure
p.(None):
p.(None): A comprehensive complaints procedure can have a broad scope; it can be used to complain about any activities that are
p.(None): associated with a research study. These may include, for example:
p.(None): • any perceived deviation from the information provided
p.(None): • any deviation from agreed processes
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p.(None): this workshop, approximately 30 leading bioethicists from around India came together to share their experiences and
p.(None): discuss cases of exploitation in research. In Nairobi on 23 and 24 May 2016, three esteemed chairs of national ethics
p.(None): commit- tees shared their experiences and opinions about the primary ethical challenges for LMIC-HIC collaborative
p.(None): research in Kenya. Findings from both events revealed multiple risks of exploitation that are characteristic of
p.(None): research in some LMIC set- tings. These included traditional requirements for appropriate community
p.(None):
p.(None): 4 This type of consultative exercise is of proven value in the development of ethical codes that are broadly
p.(None): representative and can have wide-ranging impact. For example, the principles of the “Three Rs”, which are
p.(None): globally accepted as a reasonable measure for ethical conduct in animal research, arose from a broad consultation with
p.(None): stakeholders undertaken by Russell and Burch in the 1950s. See Russell et al. (1959).
p.(None):
p.(None): 40 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): consultations and permissions, and specific cultural beliefs and customs that must be respected.
p.(None): Ongoing consultation with representatives from two vulnerable groups that have first-hand accounts of the risks
p.(None): for exploitation were undertaken. From Nairobi, Kenya, sex worker peer educators and, from South Africa, members
p.(None): of the San com- munity shared their experiences of being the subjects of exploitation and their opin- ions about how
p.(None): they want to be treated in future. Among many other insights, both groups described a lack of benefits from research
p.(None): projects (which are often highly beneficial to the researchers), as well as risks of stigmatization from the manner in
p.(None): which they were involved in the study.
p.(None): 12 months of in-depth and far-reaching investigation produced a considerable amount of data (Chapter 6). From this
p.(None): data, individual vulnerabilities and risks of exploitation were extracted, organized and tabulated on an Excel
p.(None): spreadsheet with source details and descriptions of the vulnerability or risk. Care was taken to ensure that each
p.(None): individual entry was based upon real-world experience rather than hypo- thetical suppositions. Our lists were compared
p.(None): with risks mentioned in the literature and, where necessary, additional information sought to address gaps.
p.(None): Once collated, the raw data was streamlined to group similar vulnerabilities together. For instance, there
p.(None): were many different examples of how people living in resource-poor circumstances may be unfairly enticed to participate
p.(None): in research by the prospect of payment or reward. Such examples were grouped under the label “undue inducement”.
p.(None): Further thematic analysis resulted in distinctions between the various potential subjects of exploitation, or levels of
...
p.(None): scientific and operational coordination of French biomedical research.
p.(None): The European and Developing Countries Clinical Trials Partnership (EDCTP) funds research for the prevention and
p.(None): treatment of poverty-related infectious diseases in sub-Saharan Africa.
p.(None): The Swiss-based Global Values Alliance (GVA) is a foundation that focuses on engagement with pharmaceutical industry
p.(None): partners as its main role in the TRUST project
p.(None): Researchers The Centre for Professional Ethics at the University of Central Lancashire is one of the oldest
p.(None): research-only ethics centres in Europe, with specialist expertise in global justice issues.
p.(None): The Bio-Economy Research Chair at the University of Cape Town and her team focus on engagement with communities,
p.(None): indigenous knowledge holders and policymakers to ensure environmentally sustainable poverty reduction. The Law School
p.(None): of the University of the Witwatersrand, Johannesburg, contributed specialist human rights and legal frameworks
p.(None): expertise.
p.(None):
p.(None): Research participants
p.(None):
p.(None):
p.(None): Research advocates (support organizations)
p.(None): Many of the individuals involved in drafting the GCC have previously been research participants. Of particular
p.(None): importance in this process were the indigenous peoples and sex worker representatives who were involved through SASI
p.(None): and PHDA (see “Research communities” below).
p.(None): The Council on Health Research for Development (COHRED) helps promote the health and development of populations in low-
p.(None): and middle- income countries.
p.(None): Action Contre La Faim (ACF) is recognized as one of the leading organizations in the fight against hunger worldwide.
p.(None): ACF undertakes its own research on highly vulnerable populations.
p.(None):
p.(None): 56 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.1 (continued)
p.(None): Stakeholder
p.(None): type TRUST partner
p.(None):
p.(None): Research communities
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research ethics reviewers
p.(None): The South African San Institute (SASI) is dedicated to serving the San communities of southern Africa through legal,
p.(None): advocacy, socio- anthropological and related services.
p.(None): Partners for Health and Development in Africa (PHDA) supports female and male sex workers in the low socio-economic
p.(None): strata who reside in the informal settlements of Nairobi.
p.(None): The Forum for Ethics Review Committees in India (FERCI) promotes the effective implementation of the ethical review of
p.(None): biomedical research studies in India.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): • Advisory board
p.(None): • Engagement panel
p.(None): • Stakeholder inventory
...
p.(None): shared with us in the past, but I did not know what they meant. Do not give us results in scientific language. It puts
p.(None): us at risk if we do not understand the results. … Come back with the results and tell us how we can make our lives
p.(None): better.”
p.(None): “We know that the samples that are collected from us are sometimes sent to other countries. What happens to them? In my
p.(None): culture – if my blood is taken, it must come back to me and I bury it. … [L]ocal and cultural values should be taken
p.(None): into account.”
p.(None): Article 3: Feedback about the findings of the research must be given to local communities and research participants. It
p.(None): should be provided in a way that is meaningful, appropriate and readily comprehended.
p.(None):
p.(None):
p.(None):
p.(None): Article 8: Potential cultural sensitivities should be explored in advance of research with local communities, research
p.(None): participants and local researchers to avoid violating customary practices. … If researchers from high-income settings
p.(None): cannot agree on a way of undertaking the research that is acceptable to local stakeholders, it should not take place.
p.(None):
p.(None): The main message that the TRUST team has been promoting since the meetings with the Nairobi sex workers has been: “Let
p.(None): representatives of vulnerable popula- tions speak for themselves” (Schroeder and Tavlaki 2018). As a result, a former
p.(None): sex worker from Nairobi brought the demands of her community to the European Parliament to great acclaim
p.(None): (TRUST 2018).
p.(None):
p.(None):
p.(None): Advocate Voices for Animals
p.(None):
p.(None): A senior veterinarian, Professor David Morton, was involved throughout the TRUST project as an adviser. At a plenary
p.(None): meeting in Cape Town, he described how animals had no voice and therefore no choice about involvement in
p.(None): research. He asked: “Who consents on behalf of animals?”
p.(None): There are currently no globally agreed ethical standards for research involving animal experimentation, and regulation
p.(None): varies from country to country. In the EU, animal experiments are governed by Directive 2010/63/EU, known as the Animal
p.(None): Experiments Directive, which stipulates measures that must be taken to replace, reduce and refine (the “Three
p.(None): Rs”12) the use of animals in scientific research. Among other requirements, it lays down minimum standards for housing
p.(None): and care and regu-
p.(None):
p.(None):
p.(None):
p.(None): 12 The “Three Rs” are the underpinning requirements of most policies and regulations in animal research:
p.(None): → Replacement: Methods that avoid or replace the use of animals.
p.(None): → Reduction: Methods that minimize the number of animals used per experiment.
p.(None): → Refinement: Methods that minimize suffering and improve welfare.
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 65
p.(None):
p.(None): lates the use of animals through systematic project evaluation that requires the assessment of pain,
p.(None): suffering, distress and lasting harm caused to the animals.
...
p.(None): European Commission
p.(None): Best science for the most neglected, also means best ethical standards. That’s why the GCC aims high: to protect the
p.(None): most neglected. – Dr François Bompart (French), director of Paediatric HIV/Hepatitis C Programmes at the Drugs
p.(None): for Neglected Diseases initiative (DNDi), former vice president, Access to Medicines at Sanofi, co-author of the GCC
p.(None): We get given consent forms and documents, often in a hurry. We sign because we need the money and then end up with
p.(None): regret. It feels like a form of abuse. They want something from us and they know how to get it. Because of our
p.(None): socio-economic conditions, we will always be vulnerable to those from the North. A code of ethics is needed that
p.(None): protects indigenous people.5 – Andries Steenkamp (1960–2016) (South African), former chair of the South African
p.(None): San Council, co-author of both codes
p.(None): I don’t want researchers to see us as museums who cannot speak for themselves and who don’t expect something in return.
p.(None): As humans, we need support.6 – Reverend Mario Mahongo (1952–2018) (Angolan), co-author of both codes
p.(None): We want to be treated by researchers with fairness, respect, care and honesty. Is that too much to ask?7 – Joyce
p.(None): Adhiambo Odhiambo (Kenyan), health activist and former sex worker, co-author of the GCC
p.(None): Indeed, is that too much to ask?
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Burtscher W (2018) TRUST Global Code of Conduct to be a reference document applied by all research projects applying
p.(None): for H2020 funding. TRUST eNewsletter Issue 5. http://www.global-
p.(None): codeofconduct.org/wp-content/uploads/2018/12/TRUSTNewsletter_2018_Issue5.pdf
p.(None): Economist (2018) Recent events highlight an unpleasant scientific practice: ethics dumping. The Economist, 31
p.(None): January. https://www.economist.com/science-and-technology/2019/02/02/
p.(None): recent-events-highlight-an-unpleasant-scientific-practice-ethics-dumping
p.(None): IIT (nd) The ethics codes collection. Center for the Study of Ethics in the Professions, Illinois Institute of
p.(None): Technology, Chicago. http://ethicscodescollection.org/
p.(None):
p.(None): 4 Opening words during European Commission ethics staff training on the GCC, 3 Dec 2019, Covent Garden
p.(None): Building, Brussels.
p.(None): 5 Recorded message from Nairobi TRUST meeting, 23 May 2016.
p.(None): 6 Recorded video message from Kimberley TRUST meeting, Feb 2017.
p.(None): 7 European Parliament, TRUST event, 29 June 2018.
p.(None):
p.(None): References
p.(None): 113
p.(None):
p.(None): Nordling L (2018) Europe’s biggest research fund cracks down on “ethics dumping”. Nature 559:17–18.
p.(None): https://www.nature.com/articles/d41586-018-05616-w
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p.(None): specialist in Kantian ethics as well as bioethics, analytic philosophy of language and metaethics.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xvii
p.(None):
p.(None): Abbreviations
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ACF Action contre la Faim
p.(None): CBD UN Convention on Biological Diversity COHRED Council on Health Research for Development EC
p.(None): European Commission (EC)
p.(None): EDCTP European and Developing Countries Clinical Trials Partnership EFPIA European Federation of
p.(None): Pharmaceutical Industries and Associations FERCI Forum for Ethics Review Committees in India
p.(None): GCC Global Code of Conduct for Research in Resource-Poor Settings GVA Global Values Alliance
p.(None): HIC high-income country
p.(None): Inserm Institut national de la santé et de la recherche médicale IPR intellectual property
p.(None): rights
p.(None): LMICs low- and middle-income countries NGO nongovernmental organization
p.(None): PHDA Partners for Health and Development in Africa REC research ethics committee
p.(None): SASC South African San Council SASI South African San Institute
p.(None): SWOP Sex Workers Outreach Programme
p.(None): UNESCO United Nations Educational, Scientific and Cultural Organization WIMSA Working Group of Indigenous
p.(None): Minorities in Southern Africa
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xix
p.(None):
p.(None): Chapter 1
p.(None): Ethics Dumping and the Need for a Global Code of Conduct
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The UN’s 2030 Agenda for Sustainable Development calls for more research and innovation to end
p.(None): poverty, leaving no one behind – and yet the export of unethical practices from high-income to lower-income settings is
p.(None): still a major concern. Such ethics dumping occurs in all academic disciplines. When research is regarded, on the one
p.(None): hand, as a dirty word among vulnerable populations who face ethics dumping, and, on the other, as a solution to many of
p.(None): humanity’s problems, how can the resulting gulf be bridged? This book describes one initiative to counter ethics
p.(None): dumping: the development and promotion of the Global Code of Conduct for Research in Resource-Poor Settings.
p.(None):
...
p.(None): expertise.
p.(None):
p.(None): Research participants
p.(None):
p.(None):
p.(None): Research advocates (support organizations)
p.(None): Many of the individuals involved in drafting the GCC have previously been research participants. Of particular
p.(None): importance in this process were the indigenous peoples and sex worker representatives who were involved through SASI
p.(None): and PHDA (see “Research communities” below).
p.(None): The Council on Health Research for Development (COHRED) helps promote the health and development of populations in low-
p.(None): and middle- income countries.
p.(None): Action Contre La Faim (ACF) is recognized as one of the leading organizations in the fight against hunger worldwide.
p.(None): ACF undertakes its own research on highly vulnerable populations.
p.(None):
p.(None): 56 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.1 (continued)
p.(None): Stakeholder
p.(None): type TRUST partner
p.(None):
p.(None): Research communities
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research ethics reviewers
p.(None): The South African San Institute (SASI) is dedicated to serving the San communities of southern Africa through legal,
p.(None): advocacy, socio- anthropological and related services.
p.(None): Partners for Health and Development in Africa (PHDA) supports female and male sex workers in the low socio-economic
p.(None): strata who reside in the informal settlements of Nairobi.
p.(None): The Forum for Ethics Review Committees in India (FERCI) promotes the effective implementation of the ethical review of
p.(None): biomedical research studies in India.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): • Advisory board
p.(None): • Engagement panel
p.(None): • Stakeholder inventory
p.(None): • Project deliverables
p.(None): • Publications
p.(None): • eNewsletters
p.(None):
p.(None): • Funder platform
p.(None): • Industry platform
p.(None): • Case study competition
p.(None): Enablers
p.(None): • Project website
p.(None): • Social media
p.(None): • Brochure
p.(None): • Project conferences and consultation meetings
p.(None): • Films
p.(None): • Interviews
p.(None): • Conference presentations
p.(None): Outputs
p.(None):
p.(None):
p.(None):
p.(None): Fig. 6.3 TRUST communication and engagement strategy
p.(None):
p.(None): External engagement prior to drafting the GCC was extensive. The elements of the communication and engagement strategy
p.(None): that were specifically relevant to the drafting of the GCC are described in more detail below, namely:
p.(None): • A case study competition
p.(None): • Project conferences and consultation meetings
p.(None): • Funder and industry platforms
p.(None):
p.(None):
p.(None): The Case Study Competition
p.(None):
p.(None): As the GCC was designed to address the risks of ethics dumping, it was essential to analyse as many actual examples of
p.(None): ethics dumping as possible. To reach out to stakeholders who were not connected with existing networks, a
...
p.(None): 11 http://www.globalcodeofconduct.org/
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 63
p.(None):
p.(None): Engagement with Research Participants and Research Communities
p.(None):
p.(None): The inclusion of the perspectives of research participants and research communities who are vulnerable to exploitation,
p.(None): and therefore to ethics dumping, was essential to our bottom-up approach. It is also the ethical approach, as
p.(None): stipulated in article 2 of the GCC:
p.(None): Local communities and research participants should be included throughout the research process, wherever possible, from
p.(None): planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly
p.(None): represented. This approach represents Good Participatory Practice.
p.(None): Two NGO partners in the TRUST project were tasked specifically with ensuring that the voices of vulnerable populations
p.(None): were heard and acted upon. First, the South African San Institute (SASI) made the inclusion of indigenous peoples from
p.(None): South Africa possible. While San leaders and representatives were involved in all the work of the TRUST project,
p.(None): including the drafting of the GCC, the full impact of their contribution is best understood through the account in
p.(None): Chapter 7 of this book of the development of the San Code of Research Ethics. Second, Partners for Health and
p.(None): Development in Africa (PHDA) made the inclusion of sex workers from the Majengo area of Nairobi possible. At this point
p.(None): we will focus on their involvement in order to illustrate the bottom-up approach of the GCC drafting process.
p.(None): PHDA is a nonprofit organization that undertakes work in the fields of health and development in Kenya. Its mission is
p.(None): to increase access to health for disadvantaged communities in Africa by strengthening health systems, research,
p.(None): programme devel- opment and partnerships. PHDA’s programmes are implemented by a collaborative group of scientists and
p.(None): public health professionals from the University of Manitoba (Canada), the University of Nairobi and the government of
p.(None): Kenya. Its work focuses mainly on HIV prevention, treatment and care, research, capacity-building and
p.(None): training.
p.(None): The Sex Workers Outreach Programme (SWOP) is a PHDA initiative that under- takes active community engagement and
p.(None): provides clinical and preventative services to 33,000 sex workers residing in Nairobi. These sex workers would
p.(None): otherwise find access to medical services in public health facilities extremely limited due to stigma and
p.(None): discrimination. Those enrolled in the sex workers cohort for HIV prevention services are free to volunteer for
p.(None): available research studies after providing informed consent. Most studies are on the epidemiology of sexually
p.(None): transmitted diseases, and on host genetic factors that influence infectivity and disease progression.
p.(None): Given that sex work is illegal in Kenya, we cannot assign input to specific, named individuals here. Suffice to say
p.(None): that the personal contributions of courageous and admirable sex workers, both female and male, provided the TRUST team
p.(None): not only with practical advice that took shape in specific articles of the GCC, but also with inspiration. Table 6.4
p.(None): presents two examples of issues raised by the Nairobi sex workers (Chatfield et al. 2016a) that were implemented in the
p.(None): GCC.
p.(None):
p.(None): 64 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.4 Input from sex workers and GCC connection
p.(None): Issues raised by sex workers Relevant GCC Article
p.(None):
p.(None): “We need feedback to the community from the research in simple and non-scientific language. Some results have been
p.(None): shared with us in the past, but I did not know what they meant. Do not give us results in scientific language. It puts
p.(None): us at risk if we do not understand the results. … Come back with the results and tell us how we can make our lives
p.(None): better.”
p.(None): “We know that the samples that are collected from us are sometimes sent to other countries. What happens to them? In my
p.(None): culture – if my blood is taken, it must come back to me and I bury it. … [L]ocal and cultural values should be taken
p.(None): into account.”
p.(None): Article 3: Feedback about the findings of the research must be given to local communities and research participants. It
p.(None): should be provided in a way that is meaningful, appropriate and readily comprehended.
p.(None):
p.(None):
p.(None):
p.(None): Article 8: Potential cultural sensitivities should be explored in advance of research with local communities, research
p.(None): participants and local researchers to avoid violating customary practices. … If researchers from high-income settings
p.(None): cannot agree on a way of undertaking the research that is acceptable to local stakeholders, it should not take place.
p.(None):
p.(None): The main message that the TRUST team has been promoting since the meetings with the Nairobi sex workers has been: “Let
p.(None): representatives of vulnerable popula- tions speak for themselves” (Schroeder and Tavlaki 2018). As a result, a former
p.(None): sex worker from Nairobi brought the demands of her community to the European Parliament to great acclaim
p.(None): (TRUST 2018).
p.(None):
p.(None):
p.(None): Advocate Voices for Animals
p.(None):
p.(None): A senior veterinarian, Professor David Morton, was involved throughout the TRUST project as an adviser. At a plenary
p.(None): meeting in Cape Town, he described how animals had no voice and therefore no choice about involvement in
p.(None): research. He asked: “Who consents on behalf of animals?”
p.(None): There are currently no globally agreed ethical standards for research involving animal experimentation, and regulation
p.(None): varies from country to country. In the EU, animal experiments are governed by Directive 2010/63/EU, known as the Animal
p.(None): Experiments Directive, which stipulates measures that must be taken to replace, reduce and refine (the “Three
p.(None): Rs”12) the use of animals in scientific research. Among other requirements, it lays down minimum standards for housing
p.(None): and care and regu-
p.(None):
p.(None):
p.(None):
p.(None): 12 The “Three Rs” are the underpinning requirements of most policies and regulations in animal research:
p.(None): → Replacement: Methods that avoid or replace the use of animals.
p.(None): → Reduction: Methods that minimize the number of animals used per experiment.
p.(None): → Refinement: Methods that minimize suffering and improve welfare.
p.(None):
...
p.(None): As we can infer from this definition, there are many different types of communi- ties and also communities within
p.(None): communities. For example, indigenous communi- ties, having a historical continuity with preinvasion and precolonial
p.(None): societies that developed on their territories, may consider themselves distinct from other sectors of the societies
p.(None): that now prevail on those territories, or parts of them. They generally form nondominant sectors of society and can be
p.(None): intent on preserving, developing and transmitting to future generations their ancestral territories and their
p.(None): ethnic identity, as the basis of their continued existence as peoples, in accordance with their own cultural patterns,
p.(None): social institutions and legal systems (Martínez Cobo
p.(None):
p.(None): 92 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): 2014). They often have particular relationships with advocacy groups who work to protect or represent their interests.4
p.(None): The concept of communities within communities also includes groups of people who are vulnerable because of a
p.(None): range of physical (disabilities, for example) or cultural (religion, for example) characteristics. For instance,
p.(None): sex workers, injecting drug users and men who have sex with men are often marginalized within their own broader
p.(None): communities.5 People from such groups are frequently sought for interna- tional research and yet the community at
p.(None): large or the community leaders are often unable to provide the input needed to ensure ethical management of
p.(None): research projects. Communities and their leaders may be unaware of the specific circumstances of these people and their
p.(None): lives, and they may even be openly hostile. We therefore need mechanisms for ensuring that the voice of
p.(None): marginalized and vulnerable populations is heard, and that their interests in research are represented.
p.(None): In the 1990s, community engagement assumed prominence as the new guiding light of public health efforts; research and
p.(None): health-improvement programmes that involved communities had better results than programmes led by government alone (NIH
p.(None): 2011). At the same time, the limitations of existing guidelines for the protec- tion of communities in genetic research
p.(None): was becoming increasingly apparent (Weijer et al. 1999). The benefits of community engagement in all types of research
p.(None): are now widely acknowledged, and numerous publications describe many potential benefits such as:
p.(None): • increasing community understanding and acceptance of the studies
p.(None): • enhancing researchers’ ability to understand and address community priorities
p.(None): • improving logistics and the running of studies
p.(None): • strengthening the quality of the information collected
...
p.(None): their complaint can be a factor (Cowan and Halliday 2003). This relationship can either encourage or
p.(None): discourage a potential complainant’s trust in complaints mechanisms. The power imbalance between par- ties in such
p.(None): relationships can be substantial. For example, when working with impoverished communities, HIC researchers
p.(None): should be aware that participation in a clinical study may provide a participant’s only access to health care or other
p.(None): much- needed benefits. Fear of retribution is often cited as a barrier to making a complaint, particularly in
p.(None): circumstances where the complainant has an ongoing relationship with the complainee (HPC 2009). In situations where
p.(None): there is a power imbalance, people may not have the confidence to complain; they may be reluctant to seem ungrateful,
p.(None): not wish to be seen as a complainer, or fear loss. Research has shown that some people even reconstruct negative
p.(None): experiences in a positive light in order to maintain relationships (Edwards et al. 2004).
p.(None): In addition to the above, participatory engagement activities in the TRUST proj- ect (Chapter 6) have revealed the
p.(None): following factors that could also act as barriers to research participants making complaints about research activities
p.(None): in LMICs:
p.(None): • Fear of damage or stigmatization from loss of confidentiality or anonymity. In Kenya, for example, where sex work
p.(None): is illegal, sex workers may be reluctant to make any formal complaints.
p.(None): • Cultural norms that preclude complaining. In some cultures, it is not acceptable to make complaints, especially
p.(None): to or about visitors and/or those in authority. Complaining may be perceived as disrespectful, ungrateful or
p.(None): inappropriate.
p.(None): • Illiteracy of research participants and communication (language) difficulties, leading to a lack of
p.(None): understanding of reasonable rights relating to informed con- sent and to reasonable expectations of the research.
p.(None):
p.(None): Developing an Accessible Complaints Procedure 101
p.(None):
p.(None): • Inability to access the means by which to file a complaint: for example, if only an email address is provided as a
p.(None): contact and one has no access to computers or internet connections.
p.(None):
p.(None):
p.(None): The Scope of a Complaints Procedure
p.(None):
p.(None): A comprehensive complaints procedure can have a broad scope; it can be used to complain about any activities that are
p.(None): associated with a research study. These may include, for example:
p.(None): • any perceived deviation from the information provided
p.(None): • any deviation from agreed processes
p.(None): • treatment by members of the research team that is considered inappropriate
p.(None): • problems with the organization of the study (for example, the competence of the researchers and their ability to
p.(None): perform duties)
...
p.(None): Proxy consent, 47, 48
p.(None):
p.(None):
p.(None): R
p.(None): Recruitment, 102, 103
p.(None): Relativism, 3, 27, 28, 30–33
p.(None): Research and development (R&D), 60, 65, 111
p.(None): Research ethics, 2, 3, 8, 18, 20–24, 27, 41–43,
p.(None): 45–47, 51, 52, 54, 56, 58, 63, 65–67,
p.(None): 70, 73–86, 98, 103, 109–111, 117
p.(None): Research ethics committee (REC), 8, 18, 42,
p.(None): 45–47, 51, 52, 54, 65–67, 70, 98, 103
p.(None): Research integrity, 5, 24, 46, 47, 67, 112, 117
p.(None): Research participants, 2, 6–11, 20–24, 27, 38,
p.(None): 40, 43, 44, 52, 54, 55, 57, 61–64, 70,
p.(None): 92, 96, 98–100, 103, 105, 110
p.(None): Resource custodians, 7, 66
p.(None): Resource-poor settings, 2, 5, 14, 27, 28, 37,
p.(None): 51, 52, 80, 89, 99, 109, 111, 115–117
p.(None): Respect, 2, 5–8, 13–24, 27–35, 40, 43–44, 66,
p.(None): 68–70, 74, 78, 79, 82, 83, 85, 86, 90,
p.(None): 92, 93, 95–98, 102, 103, 105, 110–112
p.(None): Responsibilities, 8, 10, 16, 47, 51, 55, 58, 61,
p.(None): 66, 68, 104, 117
p.(None): Risk mitigation measures, 23, 67
p.(None): Risks, 1, 3, 9–11, 14, 23, 44, 52, 56, 64,
p.(None): 66–68, 70, 82, 104
p.(None):
p.(None):
p.(None): S
p.(None): Safeguarding, 45, 51, 54, 97, 103
p.(None): Safety, 9, 10, 14, 45
p.(None): Samples, 2, 34, 47, 64, 82
p.(None): San, 2, 3, 18, 22, 40, 56, 63, 73–86, 109–112,
p.(None): 115–117
p.(None): San Code of Research Ethics, 2, 3, 63, 73–86,
p.(None): 109, 110, 117
p.(None): Security, 10, 15, 19, 45, 49, 116
p.(None): SexXworkers, 40, 55, 56, 63, 64, 92, 100, 112
p.(None): Social science, 2, 18, 39, 61, 68, 101
p.(None): Socio-anthropological research, 56
p.(None): South Africa, 18, 40, 61, 63, 69, 74–77, 79,
p.(None): 84–86, 110, 115, 116
p.(None): South African San Council (SASC), 18, 76–81, 86, 112, 116, 117
p.(None): Spokespersons, 93, 94, 102
p.(None): Stakeholder engagements, 3, 92
p.(None): Standards, 2, 3, 6, 9–11, 13, 16–18, 22, 24, 38,
p.(None): 41, 42, 48, 58, 62, 64, 65, 67, 70, 80,
p.(None): 85, 112
p.(None): Stigmatization, 9, 11, 40, 45, 68, 100
p.(None): Stigmatized, 42
p.(None): Sub-Saharan Africa, 55
p.(None):
p.(None): 122
p.(None):
p.(None): T
p.(None): Traditional knowledge, 7, 42, 54, 76–78, 80,
p.(None): 82, 84, 95, 97
p.(None): Training, 19, 63, 81, 95, 112, 117
p.(None): Transparency, 24, 46, 47, 84, 95
p.(None): Trust, 14, 15, 43, 47, 57, 78, 79, 84, 86, 93,
p.(None): 97, 100, 102, 116
p.(None): TRUST project, 14, 16, 17, 20, 28, 39, 49,
p.(None): 52–58, 60–66, 70, 77, 79–82, 100, 104,
p.(None): 111, 112, 117
p.(None): 2030 Agenda for Sustainable Development, 2
p.(None):
p.(None):
p.(None): U
p.(None): Undue inducement, 40, 41
p.(None): United Nations (UN), 2, 13, 21, 49, 58, 70, 77,
p.(None): 80, 116
p.(None): Universal Declaration of Human Rights, 13, 21
p.(None): Index
p.(None):
p.(None): V
p.(None): Values, 2, 3, 5–11, 13–24, 27–35, 39, 40, 43,
p.(None): 44, 46, 49, 62, 64, 68, 70, 74, 78, 82,
p.(None): 89–93, 97, 98, 102, 103, 110, 111, 116
p.(None): Values compass, 90, 91, 93
p.(None): Virtues, 3, 16, 17, 19, 20, 24
p.(None): Vulnerability, 37–40, 74
p.(None): Vulnerable, 2, 24, 29, 38, 39, 44, 52, 53, 55,
p.(None): 57, 60, 63, 64, 66, 68, 70, 75, 80, 82,
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.(None): action for people, planet and prosperity: the 2030 Agenda for Sustainable Development. All country representatives and
p.(None): all stakehold- ers expressed their determination
p.(None): to take the bold and transformative steps which are urgently needed to shift the world on to a sustainable and
p.(None): resilient path. As we embark on this collective journey, we pledge that no one will be left behind [emphasis added].
p.(None): (UN 2015).
p.(None): To stimulate action, the heads of states and governments defined 17 sustainable development goals and 169 targets to be
p.(None): achieved by 2030. Successes in efforts to end extreme poverty, achieve food security and ensure healthy lives, as well
p.(None): as suc- cesses towards all other goals, depend not only on goal-oriented societal reforms and the mobilization of
p.(None): substantial financial and technical assistance, but also on significant technological, biomedical and other
p.(None): innovations.
p.(None): Ensuring the success of the Agenda 2030 requires massive research and develop- ment efforts as well new forms of
p.(None): research co-creation on a level playing field and with a universal professional ethos.
p.(None): Leaving no one behind does not “only” include reducing income and wealth inequalities, and affirmative
p.(None): action in support of better opportunities for self- determined living within and among countries. It also
p.(None): implies reaching those most at risk from poverty and its impacts. This again necessitates research focused on the needs
p.(None): of the poor in a way that does not infringe their human rights.
p.(None): Research and innovation can only be sustainably successful when based on soci- etal trust. The precondition for
p.(None): societal trust and public acceptance is the perception that work is done with integrity and based on fundamental values
p.(None): shared by the global community. Trust depends not only on research work being compliant with laws and regulations, but
p.(None): also, more than ever, on its legitimacy.
p.(None): Such legitimacy can be achieved through inclusion and, importantly, the co- design of solutions with
p.(None): vulnerable populations. Leaving no one behind also means leaving no one behind throughout the research process, aiming
p.(None): for research with, not about, vulnerable populations.
p.(None):
p.(None): vii
p.(None):
p.(None): viii
p.(None): Foreword
p.(None):
p.(None): The results of the TRUST Project, whose Global Code of Conduct for Research in Resource-Poor Settings (GCC) this book
p.(None): celebrates, contribute to realizing the European Union’s ambition of a more inclusive, equal and sustainable global
p.(None): soci- ety – a profound expectation of people all over the world.
p.(None): The fact that the GCC now exists and has been welcomed by the European Commission as a precondition for
p.(None): its research grants is only a beginning.
p.(None): My hope is that enlightened stakeholders in public institutions, foundations and the private sector will now start a
p.(None): discourse and apply moral imagination to the concrete consequences of the GCC. This relates to the processes and
p.(None): content of their research endeavours as well as the selection criteria for hiring, promoting and remu- nerating the
p.(None): research workforce.
p.(None): Research excellence is no longer only defined by playing by the rules and being “successful”. The results of discourses
p.(None): about the operationalization of the TRUST values of fairness, respect, care and honesty are the new
p.(None): benchmark for excellence.
p.(None):
p.(None): Basel, Switzerland Klaus Leisinger
p.(None):
p.(None):
p.(None): Reference
p.(None):
p.(None): UN (2015) Transforming our world: the 2030 agenda for sustainable development. United Nations.
p.(None): https://www.un.org/development/desa/dspd/2015/08/transforming-our-world-the-2030- agenda-for-sustainable-development/
p.(None):
p.(None):
p.(None): Professor Klaus Leisinger, a social scientist and economist, is the President of the Global Values Alliance in Basel,
p.(None): Switzerland. He served as an adviser on corporate responsibility to UN Secretaries-General Kofi Annan and Ban Ki-moon.
p.(None): He is cur- rently a member of the Leadership Council of the UN Sustainable Development Solutions Network. In 2011, he
p.(None): was awarded the first ever Outstanding Contribution to Global Health Award by South-South Awards for his successful
p.(None): work on eradicat- ing leprosy.
p.(None):
p.(None): Acknowledgements
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Writing a book is child’s play compared to writing a new ethics code – a monumental task achieved by the 56 individuals
p.(None): named in the Appendix as the proud authors of the Global Code of Conduct for Research in Resource-Poor Settings (GCC).
p.(None): Thus, by the time we started writing this book, the bulk of the work had already been done. The task of conveying the
p.(None): collective pride of these 56 authors to the world was entrusted to the Reverend Mario Mahongo, an honoured San Leader
p.(None): born in Angola. He was due to travel from the Kalahari Desert to Stockholm, Sweden, in May 2018 to launch the GCC. Just
p.(None): one day before flying to Europe, he died in a car crash. This book is dedicated to Mario. His last recorded statement
p.(None): about research ethics was: “I don’t want researchers to see us as museums who cannot speak for themselves and who don’t
p.(None): expect something in return” (Chapter 7). This statement expresses
p.(None): the fairness element of the GCC beautifully.
p.(None): The GCC was produced by the TRUST project, an initiative funded by the European Commission (EC) Horizon
p.(None): 2020 Programme, agreement number 664771. Dorian Karatzas, Roberta Monachello, Dr Louiza Kalokairinou, Edyta Sikorska,
p.(None): Yves Dumont and Wolfgang Bode formed the magnificent EC team supporting the
p.(None): TRUST project.
p.(None): Thanks to Dorian for ensuring that the GCC was brought to the attention of the highest level of decision-making on
p.(None): ethics in the EC, for suggesting TRUST as a research and development success story of Horizon 2020 (EC 2018) and for
p.(None): having the GCC checked by the EC legal department in time for our event at the European Parliament in June 2018.
p.(None): Without Dorian’s efforts, the code would not have the standing it has now, as a mandatory reference
p.(None): document for EC framework programmes.
p.(None): Thanks to Roberta for believing in our work and for being a most enthusiastic, supportive and interested project
...
p.(None): Developing an Accessible Complaints Procedure 97
p.(None): Factors Affecting Accessibility 99
p.(None): The Scope of a Complaints Procedure 101
p.(None): A Values-Based Approach to Developing a Complaints
p.(None): Procedure 102
p.(None): A Fair Research Contracting Tool 103
p.(None): Conclusion 105
p.(None): References 106
p.(None): 9 Towards Equitable Research Partnership 109
p.(None): References 112
p.(None): Appendix
p.(None): 115
p.(None): Index
p.(None): 119
p.(None):
p.(None): About the Authors
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Doris Schroeder is director of the Centre for Professional Ethics at the University of Central Lancashire, and
p.(None): professor of moral philosophy at the School of Law, UCLan Cyprus. She is the lead author of the Global Code of Conduct
p.(None): for Research in Resource-Poor Settings.
p.(None):
p.(None): Kate Chatfield is deputy director of the Centre for Professional Ethics, University of Central Lancashire, UK. She is a
p.(None): social science researcher and ethicist special- izing in global justice, research ethics, animal ethics and responsible
p.(None): innovation.
p.(None):
p.(None): Michelle Singh is a project officer at the European & Developing Countries Clinical Trials Partnership in Cape Town,
p.(None): South Africa. She holds a medical PhD and previ- ously managed maternal and child health research studies and clinical
p.(None): trials at the South African Medical Research Council.
p.(None):
p.(None): Roger Chennells works as legal adviser to the South African San Institute and is a founder-partner in the human rights
p.(None): law practice Chennells Albertyn, Stellenbosch, established in 1981. Specializing in labour, land, environmental and
p.(None): human rights law, he has also worked for Aboriginal people in Australia.
p.(None):
p.(None): Peter Herissone-Kelly is senior lecturer in philosophy, University of Central Lancashire, UK. He is a
p.(None): specialist in Kantian ethics as well as bioethics, analytic philosophy of language and metaethics.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xvii
p.(None):
p.(None): Abbreviations
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ACF Action contre la Faim
p.(None): CBD UN Convention on Biological Diversity COHRED Council on Health Research for Development EC
p.(None): European Commission (EC)
p.(None): EDCTP European and Developing Countries Clinical Trials Partnership EFPIA European Federation of
p.(None): Pharmaceutical Industries and Associations FERCI Forum for Ethics Review Committees in India
p.(None): GCC Global Code of Conduct for Research in Resource-Poor Settings GVA Global Values Alliance
p.(None): HIC high-income country
p.(None): Inserm Institut national de la santé et de la recherche médicale IPR intellectual property
p.(None): rights
p.(None): LMICs low- and middle-income countries NGO nongovernmental organization
p.(None): PHDA Partners for Health and Development in Africa REC research ethics committee
p.(None): SASC South African San Council SASI South African San Institute
p.(None): SWOP Sex Workers Outreach Programme
p.(None): UNESCO United Nations Educational, Scientific and Cultural Organization WIMSA Working Group of Indigenous
p.(None): Minorities in Southern Africa
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xix
p.(None):
p.(None): Chapter 1
p.(None): Ethics Dumping and the Need for a Global Code of Conduct
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The UN’s 2030 Agenda for Sustainable Development calls for more research and innovation to end
p.(None): poverty, leaving no one behind – and yet the export of unethical practices from high-income to lower-income settings is
p.(None): still a major concern. Such ethics dumping occurs in all academic disciplines. When research is regarded, on the one
p.(None): hand, as a dirty word among vulnerable populations who face ethics dumping, and, on the other, as a solution to many of
p.(None): humanity’s problems, how can the resulting gulf be bridged? This book describes one initiative to counter ethics
p.(None): dumping: the development and promotion of the Global Code of Conduct for Research in Resource-Poor Settings.
p.(None):
p.(None): Keywords Ethics dumping · Global research ethics · Exploitation · Vulnerability · Research governance
p.(None):
p.(None):
p.(None): Research has become a global enterprise. Individual researchers around the world are encouraged to be as mobile as
p.(None): possible (Sugimoto et al. 2017). At the same time, the activities of mobile researchers have made research “one of the
p.(None): dirtiest words in the indigenous world’s vocabulary” (Tuhiwai Smith 1999: 1). The indigenous com- munities in which
p.(None): Tuhiwai Smith, a Māori professor, grew up saw research as some- thing that “told us things already known, suggested
p.(None): things that would not work, and made careers for people who already had jobs” (Tuhiwai Smith 1999: 3).
p.(None): There is a gulf between those advocating more researcher mobility because “sci- ence is the engine of prosperity”
p.(None): (Rodrigues et al. 2016) and those who argue that research can represent harmful “visits by inquisitive and
p.(None): acquisitive strangers” (Tuhiwai Smith 1999: 3). When concerns about ethics dumping1 are added, this gulf becomes
p.(None): almost unbridgeable.
p.(None):
p.(None):
p.(None): 1 The term was introduced by the Science with and for Society Unit of the European Commission: “Due to the progressive
p.(None): globalisation of research activities, the risk is higher that research with sensitive ethical issues is conducted by
p.(None): European organisations outside the EU in a way that would not be accepted in Europe from an ethical point of view. This
p.(None): exportation of these non-compliant research practices is called ethics dumping” (European Commission nda).
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 1
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_1
p.(None):
p.(None): 2 1 Ethics Dumping and the Need for a Global Code of Conduct
p.(None):
p.(None): There are two main reasons for ethics dumping – that is, the export of unethical research practices from a high-income
p.(None): to a resource-poor setting. The first is inten- tional exploitation, where research participants and/or resources in
p.(None): low- and middle- income countries (LMICs) are exploited on purpose because the research would be prohibited in the
p.(None): high-income country (HIC). The second is exploitation based on insufficient knowledge or ethics awareness on the part
p.(None): of the mobile researcher. In both cases a lack of adequate oversight mechanisms in the host LMIC is likely to
p.(None): exacerbate the problem (Schroeder et al. 2018).
p.(None): Examples of ethics dumping in the 21st century include:
p.(None): • In clinical research, misinterpreting the standard of care, leading to the avoidable deaths of research
p.(None): participants (Srinivasan et al. 2018).
p.(None): • Research among indigenous populations that led to the publication of “private, pejorative, discriminatory and
p.(None): inappropriate” conclusions and a refusal to engage with indigenous leaders on the informed consent process
p.(None): (Chennells and Steenkamp 2018).
p.(None): • The export of valuable blood samples from a rural area in China to a US genetic bank, leading to a large amount of
p.(None): research funding for the US team (Zhao and Zhang 2018).
p.(None): • The use of wild-caught non-human primates in research by a UK researcher who undertook his experiments in Kenya,
p.(None): thus “bypassing British law” (Chatfield and Morton 2018).
p.(None): • An attempt to seek retrospective ethics approval for a highly sensitive social sci- ence study undertaken among
p.(None): vulnerable populations following a local Ebola crisis (Tegli 2018).
p.(None): How can one reconcile recent cases of ethics dumping with our generation’s highly ambitious call for more
p.(None): research and innovation? The United Nations 2030 Agenda for Sustainable Development aims “to end all forms of poverty…
p.(None): while ensuring that no one is left behind” (UN ndb). To achieve these aims, the UN encourages “fostering
p.(None): innovation” (Goal 9 of Agenda 2030), as “without innovation
p.(None): …, development will not happen” (UN nda).
p.(None): This book describes one initiative to counter ethics dumping: the development and promotion of the Global Code of
p.(None): Conduct for Research in Resource-Poor Settings (GCC) and its sister code, the San Code of Research Ethics.
p.(None): The GCC recognizes the considerable power imbalances that may be involved in international collaborative research and
p.(None): provides guidance across all disciplines. It is based on a new ethical framework that is predicated on the values of
p.(None): fairness, respect, care and honesty; values that are imperative for avoiding ethics dumping. The GCC opposes all double
p.(None): standards in research and supports long-term equitable research relationships between partners in lower-income
p.(None): and higher-income set- tings. This book introduces the GCC in the following manner:
p.(None): • Chapter 2 reproduces the GCC as launched in the European Parliament in June 2018 and adopted as a mandatory
p.(None): reference document by the European Commission (ndb).
p.(None):
p.(None): References
p.(None): 3
p.(None):
p.(None): • Chapter 3 explains why values rather than standards, principles, virtues or ideals provide the best guidance in the
p.(None): fight against ethics dumping.
p.(None): • Chapter 4 answers a philosophical question: how can the GCC can be defended against claims of moral relativism?
p.(None): • Chapter 5 details 88 risks for ethics dumping, the analytical foundation of the GCC.
p.(None): • Chapter 6 describes how the GCC was built, from extensive stakeholder engage- ments to its final translation into
p.(None): Russian, French, Spanish, German, Portuguese, Mandarin, Japanese and Hindi.
...
p.(None): Schroeder D, Cook J, Hirsch F, Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North-South research
p.(None): collaborations. Springer Briefs in Research and Innovation Governance, Berlin, p 71–80
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 2
p.(None): A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The Global Code of Conduct for Research in Resource-Poor Settings (GCC) is designed to counter
p.(None): ethics dumping, i.e. the practice of moving research from a high-income setting to a lower-income setting to circumvent
p.(None): ethical barriers. The GCC is reprinted here. It was completed in May 2018 and adopted by the European
p.(None): Commission as a mandatory reference document for Horizon 2020 in August 2018. For more information on the GCC,
p.(None): please visit: http://www.global- codeofconduct.org/
p.(None):
p.(None): Keywords Global ethics · Research ethics · International co-operation · Ethics dumping · Low- and middle-income
p.(None): countries
p.(None):
p.(None):
p.(None): Research partnerships between high-income and lower-income settings can be highly advantageous for both
p.(None): parties. Or they can lead to ethics dumping, the prac- tice of exporting unethical research practices to lower-income
p.(None): settings.
p.(None): This Global Code of Conduct for Research in Resource-Poor Settings counters ethics dumping by:
p.(None): Providing guidance across all research disciplines
p.(None): presenting clear, short statements in simple language to achieve the highest possible accessibility
p.(None): focusing on research collaborations that entail considerable imbalances of power, resources and knowledge
p.(None): using a new framework based on the values of fairness, respect, care and honesty offering a wide range of learning
p.(None): materials and affiliated information to support the
p.(None): Code, and
p.(None): complementing the European Code of Conduct for Research Integrity through a particular focus on research in
p.(None): resource-poor settings.
p.(None):
p.(None):
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 5
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_2
p.(None):
p.(None): 6 2 A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None): Those applying the Code oppose double standards in research and support long- term equitable research relationships
p.(None): between partners in lower-income and high- income settings based on fairness, respect, care and honesty.
p.(None):
p.(None):
p.(None): Fairness
p.(None): Article 1
p.(None):
p.(None): Local relevance of research is essential and should be determined in collaboration with local partners. Research that
p.(None): is not relevant in the location where it is under- taken imposes burdens without benefits.
p.(None):
p.(None):
p.(None): Article 2
p.(None):
p.(None): Local communities and research participants should be included throughout the research process, wherever
p.(None): possible, from planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly
p.(None): represented. This approach represents Good Participatory Practice.
p.(None):
p.(None):
p.(None): Article 3
p.(None):
p.(None): Feedback about the findings of the research must be given to local communities and research participants. It should be
p.(None): provided in a way that is meaningful, appropriate and readily comprehended.
p.(None):
p.(None):
p.(None): Article 4
p.(None):
p.(None): Local researchers should be included, wherever possible, throughout the research process, including in study design,
...
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 3
p.(None): The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract Values inspire, motivate and engage people to discharge obligations or duties. This chapter defends the
p.(None): values approach in the context of guarding against ethics dumping, the practice of exporting unethical research from
p.(None): higher-income to lower-income settings. A number of essential questions will be answered: What are values? What is the
p.(None): meaning of the word “value”? Why does it make sense to choose values as an instrument to guide ethical action in
p.(None): preference to other possibilities? And what is meant by fairness, respect, care and honesty? It is concluded that
p.(None): values can provide excellent guidance and aspiration in the fight against ethics dumping, and are therefore a
p.(None): well-chosen structure for the Global Code of Conduct for Research in Resource-Poor Settings.
p.(None):
p.(None): Keywords Values · Virtues · Fairness · Respect · Care · Honesty
p.(None):
p.(None):
p.(None): Introduction
p.(None):
p.(None): Many celebrated documents which advocate for a better world include a preamble that mentions values. For instance,
p.(None): at the international level, the Universal Declaration of Human Rights (UN 1948) lists four values in the first
p.(None): sentence: dig- nity, freedom, justice and peace in the world. The first sentence of the Convention on Biological
p.(None): Diversity (UN 1992) refers to “the intrinsic value of biological diver- sity and of the ecological, genetic, social,
p.(None): economic, scientific, educational, cul- tural, recreational and aesthetic values of biological diversity” (emphasis
p.(None): added).
p.(None): Other national or professional codes have incorporated values prominently into individual articles. For instance, at
p.(None): the national level in the UK, the first item of The Code: Professional Standards of Practice and Behaviour for Nurses,
p.(None): Midwives and Nursing Associates, reads: “Treat people with kindness, respect and compassion” (NMC 2018).
p.(None): In some codes one has to search to find obvious references to values as they are often incorporated in a more implicit
p.(None): manner, such as in the Declaration of Helsinki
p.(None):
p.(None):
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 13
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_3
p.(None):
p.(None): 14 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): (WMA 2013), which speaks of “safety, effectiveness, efficiency, accessibility and quality” in article 6.
p.(None): When developing the Global Code of Conduct for Research in Resource-Poor Settings (GCC), a unique approach emerged
p.(None): naturally from the process employed. Its underpinning values materialized ahead of its final articles through an
p.(None): investiga- tion into the risks of exploitation in international collaborative research (Chapter 5), and from a global
p.(None): engagement and fact-finding mission (Chapter 6).
p.(None): It soon became clear that fairness, respect, care and honesty are all lacking, or deficient, whenever ethics dumping1
p.(None): occurs, and that a loss of trust in researchers and research itself can result. What also emerged is that these values
p.(None): are shared across the range of cultures that were represented in the TRUST2 consortium. It was therefore possible to
p.(None): surmise that these shared values are vital for equitable research partnerships and to prevent ethics dumping. In other
p.(None): words, these values are neces- sary to foster an ethical culture in research, and are therefore values to which all
p.(None): researchers should aspire.
p.(None): This chapter will answer some essential questions: What are values? What is the meaning of the word “value”? Why does
p.(None): it make sense to choose values as an instru- ment to guide ethical action in preference to other possibilities? And
p.(None): finally, what is meant by “fairness”, “respect”, “care” and “honesty”?
p.(None):
p.(None):
p.(None): The Meaning of “Value”
p.(None):
p.(None): Values pervade human experience (Ogletree 2004), and references to “values” are ubiquitous. With vast numbers of
p.(None): articles, books and internet sites offering advice on matters such as values we should live by, discovering our own
p.(None): values, changing our core values and achieving success through values, it is obvious that values are important to
p.(None): people.
p.(None): The term “value” can be used in many different ways.3 With reference to the way in which people use the term,
p.(None): three primary meanings of “value” can be distin- guished (see Fig. 3.1).
p.(None): First, value can refer to measurability. Mathematics operates with values, which can, for example, be discrete or
p.(None): continuous. Artists might speak of colours having values, meaning the relative lightness or darkness of a colour. In
p.(None): music, a note value determines the duration of a musical note. Economists or art dealers might measure value in
p.(None): monetary terms; a particular company or a particular painting might be
p.(None):
p.(None):
p.(None): 1 The export of unethical research from a high-income setting to a resource-poor setting with weaker
p.(None): compliance structures or legal governance mechanisms.
p.(None): 2 TRUST was an EU-funded project which operated from 2015 to 2018 and developed the GCC, among other outputs.
p.(None): http://trust-project.eu/
p.(None): 3 This section draws on unpublished work by Professor Michael Davis, a philosopher specializing in professional ethics.
p.(None):
p.(None): The Meaning of “Value”
p.(None): 15
p.(None):
p.(None): Fig. 3.1 The meaning of value
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Value
p.(None):
p.(None):
p.(None):
p.(None): Measurement
p.(None):
p.(None):
p.(None): Worthy to agents
p.(None):
p.(None): Morally worthy to agents
p.(None):
p.(None):
p.(None): valued at a certain amount of money. Value, in this sense of the word, has no rela- tionship to values such as
p.(None): admiration, approval or motivation.
p.(None): Secondly, people can value certain features or entities. For instance, somebody might value money, fame or glory. For
p.(None): value to exist, there must be an agent (a per- son) who is doing the valuing, and the feature or entity must be worth
p.(None): something to this agent (Klein 2017). The values of one individual can be very different from those of another person.
p.(None): For instance, a regular income is worth a lot to a person who values routine and security; it can contribute to their
p.(None): wellbeing and happiness. Others, who value personal freedom more than routine and security, might be just as happy with
p.(None): occasional income, as long as they are not bound to a nine-to-five job. If most humans around the world value a
p.(None): particular thing, it can be described as a universal value.
...
p.(None):
p.(None):
p.(None): What Can Guide Moral Action?
p.(None):
p.(None): The GCC is based on moral values, but the code authors could have opted to frame the code and guide action in other
p.(None): ways, including the following:
p.(None): • Standards is a technical term used to achieve desired action. Standards are pre- cise and give exact
p.(None): specifications, which are in many cases measurable, as in the maximum vehicle emissions allowed for cars. Standards can
p.(None): also be used in eth- ics. For instance, a well-known voluntary standard to guide ethical action is ISO 26000 (ISO
p.(None): not dated), developed by the International Organization for Standardization. ISO 26000 assesses the
p.(None): social responsibility of companies. Its guidance includes prohibitions against bribery, and the requirement to
p.(None): be accountable for any environmental damage caused.
p.(None): • Principles are behavioural rules for concrete action. When you know the princi- ple, you know what to do. For
p.(None): instance, in dubio pro reo has saved many innocent people from going to jail as it gives the courts very concrete
p.(None): advice. Literally translated, it means, “when in doubt, then for the accused” (a person remains innocent until proven
p.(None): guilty). This principle goes back to both Aristotle and Roman law.
p.(None): • Virtues are beneficial character traits that human beings need to flourish (Foot 1978: 2f). One can observe
p.(None): them in real people or in fictional characters. England’s semimythical Robin Hood, for instance, is seen as
p.(None): courageous and benevolent. He fights a David-and-Goliath battle against the Sheriff of Nottingham
p.(None): (courage) so that the poor have food (benevolence). Like values, for virtues to exist, there must be an agent (a
p.(None): person) who is being virtuous; virtues focus on the moral agent rather than on the standard or principle that underlies
p.(None): a decision.
p.(None): • Ideals drive towards perfection and are highly aspirational. Some people will say “in an ideal world” to denote
p.(None): that something is unrealistic from the start. The ancient Greek philosopher Aristotle argued that we should strive
p.(None): towards perfec- tion of character and that ideals can be guiding lights in character building. “Good
p.(None): character is an ideal outside of oneself that all strive for” (Mitchell 2015).
p.(None):
p.(None): What Can Guide Moral Action?
p.(None): 17
p.(None):
p.(None): So why were values chosen as the foundation for the GCC rather than standards, principles, virtues or ideals?
p.(None): Ideals are the most aspirational of the concepts available to guide ethical action. However, hardly anybody can live up
p.(None): to all of their ideals. If one phrased an ethics code around ideals, those who should be led by the code might suggest
p.(None): that not reaching the ideals on every occasion would be acceptable. This is not the case. The 23 articles of the GCC
p.(None): (chapter 2) are not aspirational. They are mandatory.
p.(None): Virtues are found both historically and internationally in many important docu- ments of learning and wisdom. Famously,
p.(None): Aristotle (384–322 BC) linked human “happiness and wellbeing” to “leading an ethical life”, guided by the cardinal
p.(None): values of courage, justice, modesty and wisdom (Aristotle 2004). According to Confucianism, the most
...
p.(None): WMA (2013) Declaration of Helsinki. World Medical Association. https://www.wma.net/policies-
p.(None): post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human- subjects/
p.(None): Wolfe PS (1997) The influence of personal values on issues of sexuality and disability. Sexuality and disability
p.(None): 15(2):69–90
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 4
p.(None): Respect and a Global Code of Conduct?
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The Global Code of Conduct for Research in Resource-Poor Settings claims global applicability and
p.(None): promotes respect as one of its four values. Hence, the code anticipates potentially unresolvable differences
p.(None): between cultures, while maintaining it is globally valid. Examining, but discarding, several possibilities to deal
p.(None): with normative relativism, this chapter argues, with Beauchamp and Childress (2013, Principles of Biomedical Ethics,
p.(None): 7th edn. Oxford University Press, New York) that values can be internal to morality itself, allowing their global
p.(None): applicability.
p.(None):
p.(None): Keywords Values · Normative relativism · Global justice · Research ethics · Fairness · Principlism
p.(None):
p.(None):
p.(None): Introduction
p.(None):
p.(None): The Global Code of Conduct for Research in Resource-Poor Settings (GCC) is built around four values: fairness, respect,
p.(None): care and honesty. In this chapter, we tackle the moral relativism claim against values approaches. Some readers may
p.(None): feel that no such effort is necessary. It may, in their view, be obvious that fairness, respect, care and honesty are
p.(None): worthy values. They may also believe that these values have appli- cation in global research ethics and that they can
p.(None): counter ethics dumping, the prac- tice of moving unethical research from a high-income setting to a resource-poor
p.(None): setting, which – by definition – requires a global approach. For those who are more sceptical, we sketch a plausible
p.(None): response to the moral relativism objection.
p.(None): The GCC’s value of respect recognizes significant variation in cultural norms and practices (for example in article
p.(None): 81), while implicitly assuming that the four
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 1 Potential cultural sensitivities should be explored in advance of research with local communities, research
p.(None): participants and local researchers to avoid violating customary practices. Research is a
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 27
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_4
p.(None):
p.(None): 28 4 Respect and a Global Code of
p.(None): Conduct?
p.(None):
p.(None): values the code recommends are globally applicable. How do we reconcile this ten- sion? That is, how do we demonstrate
p.(None): that, in making use of the four values, one group is not illegitimately imposing its values on others, in ways that the
p.(None): GCC itself would deem unacceptable?
p.(None): The surest way of doing this is to defend the claim that the four values, which we believe have particular application
p.(None): in research in resource-poor settings, could be global or universal values. Let us call this claim “the global
p.(None): applicability thesis”. We need somehow, then, to be able to maintain the global applicability thesis alongside the
p.(None): recognition of significant variation in norms across cultures. We will look in turn, in the sections that follow, at a
p.(None): number of suggestions about how this may be achieved.
p.(None): First we will consider the possibility that the requirement to proceed with fair- ness, respect, care and honesty leads
p.(None): to an acceptance of a thoroughgoing moral relativism – that is, a robust and unflinching commitment to the belief that
p.(None): all values are culture-bound, and that there are no “extra-cultural” values or norms. We will argue that, for reasons
p.(None): articulated by Bernard Williams (1972) nearly half a century ago, such strict moral relativism is unsustainable.
p.(None): Then we will consider the merits of a more moderate moral relativism, of the sort argued for by the Chinese-American
p.(None): philosopher David Wong (1991, 2009). This approach combines a recognition of variation in norms across cultures with a
p.(None): certain sort of universalism. For Wong, what remains constant across disparate systems of moral norms is the purpose
p.(None): behind any such system, or the aim of morality as such. We will argue that Wong’s approach, though an improvement on a
p.(None): more extreme relativism, does not provide what we need: that is, it does not show there to be some universal norms –
p.(None): among which are our four values – in addition to some genuine cross-cultural normative variation.
p.(None): Finally we introduce an approach that has much in common with the TRUST2 approach: the “four-principles approach”
...
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 5
p.(None): Exploitation Risks in Collaborative International Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract Ethics dumping occurs in collaborative international research when peo- ple, communities, animals and/or
p.(None): environments are exploited by researchers. Exploitation is made possible by serious poverty and extreme power
p.(None): differentials between researchers from high-income countries and research stakeholders from low- and middle-income
p.(None): countries (LMICs). To prevent its occurrence, the risks of exploitation have to be tackled. This chapter describes 88
p.(None): risks identified for col- laborative international research, categorized according to four values: fairness,
p.(None): respect, care and honesty. The risks were identified in a broad-based consultative exercise, which included more than
p.(None): 30 members and chairs of ethics committees in LMICs, representatives from vulnerable populations in LMICs, and an open
p.(None): call for case studies of exploitation. The findings of the exercise contributed to the develop- ment of the Global Code
p.(None): of Conduct for Research in Resource-Poor Settings.
p.(None):
p.(None): Keywords Exploitation · Ethics dumping · Collaborative research · Vulnerability · Research ethics · Ethics codes
p.(None):
p.(None):
p.(None): Ethics dumping1 occurs in collaborative international research when people, com- munities, animals and/or environments
p.(None): are exploited by researchers. In order to pre- vent ethics dumping, such exploitation needs to stop. This chapter
p.(None): describes our investigation into the risks of exploitation in low- and middle-income countries (LMICs),
p.(None): uncovering what makes exploitation more likely to occur due to vulnera- bilities that can be exploited, either
p.(None): knowingly or unknowingly.
p.(None): This undertaking was vital for the development of a Global Code of Conduct for Research in Resource-Poor Settings (GCC)
p.(None): that can address real-world risks for exploitation in research. Many such risks are not well described in the
p.(None): literature, and hence there was an empirical component to our activities. Furthermore, this process was necessary to
p.(None): ensure that the GCC was more than a compilation of existing
p.(None):
p.(None):
p.(None):
p.(None): 1 The export of unethical research from a high-income setting to a resource-poor setting with weaker
p.(None): compliance structures or legal governance mechanisms.
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 37
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_5
p.(None):
p.(None): 38 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): codes, most of which had not been written with LMIC-HIC (high-income country) collaborations in mind.
p.(None):
p.(None):
p.(None): The Nature of Exploitation
p.(None):
p.(None): The potential to be exploited is part of the human condition. Exploiters take advan- tage of others’ vulnerabilities to
p.(None): promote their own interests (Hughes 2010). While there is a morally neutral sense of exploitation (the exploitation of
p.(None): natural talents to create art, for example), the term is generally used to describe a moral failing.
p.(None): Exploitation of people is very often unjust, unfair, harmful or just plain wrong. What is it, then, that
p.(None): distinguishes morally unacceptable exploitation from neutral exploitation?
p.(None): Some argue that exploitation is wrong because it is coercive (Schwartz 1995). If the only way for a woman in an LMIC to
p.(None): access antiretroviral drugs to prevent the transmission of HIV to her unborn baby is to participate in a
p.(None): placebo-controlled clinical trial,2 despite the existence of a proven standard of care,3 then one could say she has
p.(None): been coerced into enrolling (Annas and Grodin 1998). In this sense, exploi- tation occurs where one party takes
p.(None): advantage of another by making them an offer they cannot refuse; they are then coerced to accept simply because there
p.(None): is no alter- native. Others argue that exploitation is wrong because it treats human beings as means rather than ends
p.(None): (Wood 1995). In other words, exploitation instrumentalizes people. Yet others claim that exploitation is wrong
p.(None): because it disadvantages the vulnerable (Macklin 2003).
p.(None): Our investigation was concerned with the risks or vulnerabilities for exploitation, so we adopted Macklin’s definition
p.(None): of exploitation. However, it is important to bear in mind that situations that are conducive to exploitation do not
p.(None): necessarily lead to exploitation. For instance, if a pharmaceutical company is due to test new antiretro- viral drugs
p.(None): to prevent the transmission of HIV to unborn babies, and the company operates in a country where poor mothers have no
p.(None): or very limited access to health care, it does not mean that exploitation will necessarily occur. The company may
p.(None): decide not to exploit vulnerable research participants and offer the accepted stan- dard of care to those in the
p.(None): control arm, rather than a placebo.
p.(None): Exploitation usually requires a moral decision on the part of the potential exploiter, but it can also occur
p.(None): through ignorance. Whether intended or unintended, the effects of exploitation are the same for the exploited. Hence,
p.(None): ignorance is not a legitimate justification for exploitation. Uncovering the primary risks of exploitation
p.(None):
p.(None): 2 A placebo-controlled trial involves some participants being given a medicine with active ingredi- ents, for instance
p.(None): a new drug against malaria, while others, the control group, are given a substance that should have no effect (the
p.(None): placebo), so that the outcomes can be compared.
p.(None): 3 One speaks of a proven standard of care when a treatment already exists for the illness under consideration in a
...
p.(None): Ongoing consultation with representatives from two vulnerable groups that have first-hand accounts of the risks
p.(None): for exploitation were undertaken. From Nairobi, Kenya, sex worker peer educators and, from South Africa, members
p.(None): of the San com- munity shared their experiences of being the subjects of exploitation and their opin- ions about how
p.(None): they want to be treated in future. Among many other insights, both groups described a lack of benefits from research
p.(None): projects (which are often highly beneficial to the researchers), as well as risks of stigmatization from the manner in
p.(None): which they were involved in the study.
p.(None): 12 months of in-depth and far-reaching investigation produced a considerable amount of data (Chapter 6). From this
p.(None): data, individual vulnerabilities and risks of exploitation were extracted, organized and tabulated on an Excel
p.(None): spreadsheet with source details and descriptions of the vulnerability or risk. Care was taken to ensure that each
p.(None): individual entry was based upon real-world experience rather than hypo- thetical suppositions. Our lists were compared
p.(None): with risks mentioned in the literature and, where necessary, additional information sought to address gaps.
p.(None): Once collated, the raw data was streamlined to group similar vulnerabilities together. For instance, there
p.(None): were many different examples of how people living in resource-poor circumstances may be unfairly enticed to participate
p.(None): in research by the prospect of payment or reward. Such examples were grouped under the label “undue inducement”.
p.(None): Further thematic analysis resulted in distinctions between the various potential subjects of exploitation, or levels of
p.(None): risk for exploitation (persons, institutions,5 local communities, countries, animals and the environment). In
p.(None): the final stage of the analysis the vulnerabilities were grouped according to the four values of fairness, respect,
p.(None): care and honesty.
p.(None):
p.(None):
p.(None): Our Findings
p.(None):
p.(None): The remainder of this chapter is devoted to presenting and explaining our findings. For each value, an exploitation
p.(None): risk table details the main risks for persons, institu- tions, local communities, countries, animals and the
p.(None): environment. Each entry on the tables describes a vulnerability that could lead to exploitation (deliberate or unin-
p.(None): tentional) in LMIC-HIC research collaborations and all are grounded in real-world experience. Additionally, for each
p.(None): value, certain examples are described in more detail to further illustrate the risks.
p.(None): It has to be noted that some entries could have been linked to more than one value. For instance, if a research
p.(None): participant suffered from a therapeutic misconception, the researcher might not have taken enough care to explain that
p.(None): research is different from treatment because s/he was not aware that this might be problematic in some settings, or
p.(None): otherwise because s/he deliberately and dishonestly wanted to avoid explaining the difference, in which case the value
...
p.(None): varied in nature and pertain to different aspects of fairness. Philosophers commonly distinguish between different
p.(None): types of justice or fairness (Pogge 2006) (Chapter 3), but the most relevant fairness concepts for global research
p.(None): ethics are fairness in exchange and corrective fairness.
p.(None): Fairness in exchange concerns the equity of transactions that occur between par- ties. In collaborative research,
p.(None): ventures should aim to be mutually beneficial. Where the collaboration is between HIC and LMIC partners, typical
p.(None): fairness in exchange issues might include:
p.(None): The relevance of the research to local needs Whether reasonable benefit sharing is taking place
p.(None): Whether LMIC researchers are involved in meaningful ways
p.(None): Table 5.1 shows the primary risks related to fairness in exchange for persons, institutions, communities, countries and
p.(None): the environment.
p.(None):
p.(None): Table 5.1 Primary risks for fairness in exchange
p.(None): Level of risk Nature of risk
p.(None): Personal • In medical research:
p.(None): - Multiple trial enrolment
p.(None): - No post-study access to treatment
p.(None): • In all research:
p.(None): - Undue inducement
p.(None): - No access to results or benefits of research
p.(None):
p.(None): Researcher/ institutional
p.(None): • Research priorities driven by HIC partners:
p.(None): - Mismatch to local research needs
p.(None): • Poor representation of LMIC (host) partners on research teams:
p.(None): - Responsible for menial tasks only
p.(None): - Not acknowledged or represented appropriately in publications
p.(None): • “Helicopter research” by HIC partners:
p.(None): - No knowledge transfer or capacity building/strengthening
p.(None): Community • Research priorities driven by HIC partners:
p.(None): - Mismatch to local research needs
p.(None): • Little or no input from marginalized communities into research
p.(None): • Undue inducement
p.(None): • No benefit sharing or feedback
p.(None): • Support for foreign-sponsored research drains local system of staff Country • No universal access
p.(None): to health care for population:
p.(None): - Differences in standards of “usual” care
p.(None): • Placebo-controlled trials approved
p.(None): • Support for foreign-sponsored research drains local systems and resources
p.(None): • Medical science research shaped by the “para state”
p.(None): Animal
p.(None): Environmental • Study leads to reduction of natural resources
p.(None): • Lack of benefit sharing for the environment
p.(None):
p.(None): 42 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): A primary risk in the exploitation of individuals and communities is that they may not have access to the results or
p.(None): benefits of research. This occurs when the research is designed to benefit people in other countries or settings and
...
p.(None): the host country, corrective fairness is limited to the research ethics structure in the HIC country, which may not
p.(None): have the capacity to make culturally sensitive decisions. Table 5.2
p.(None):
p.(None):
p.(None):
p.(None): Table 5.2 Primary risks for corrective fairness
p.(None): Level of risk Nature of risk
p.(None): Personal • Difficult or no access to legal system or legal aid
p.(None): • Human rights violations not taken up by civil society
p.(None):
p.(None): Researcher/ institutional
p.(None): • Lack of protection of IPR for LMIC institutions
p.(None): • Lack of clear standards for operating systems and timelines for RECs
p.(None): • No capacity/procedures for study oversight to ensure compliance with REC decisions
p.(None): Community • Lack of protection of IPR or traditional knowledge for local communities
p.(None): • Human rights violations not taken up by civil society
p.(None): • Absence of systems for community approvals Country • No relevant legal instruments for ethics committees
p.(None): • Poor research governance frameworks to ensure adherence to ethical standards
p.(None): • No cross-border legal recourse in cases of exploitation
p.(None): • Discriminatory laws that may create stigmatized minorities Animal • Variations in regulatory standards
p.(None): for animal experimentation
p.(None): • Inadequate systems to ensure compliance with animal welfare standards
p.(None): Environmental • Variations in governance of natural resources
p.(None): • Variations in procedural rights
p.(None): • Environmental protection not well policed by civil society
p.(None):
p.(None): Our Findings
p.(None): 43
p.(None):
p.(None): shows the primary risks related to corrective fairness for persons, institutions, com- munities, countries, animals and
p.(None): the environment.
p.(None): Individuals who are harmed by their participation in research may have no means of seeking retribution or compensation
p.(None): if they cannot afford legal representation and there is no form of legal aid. For communities, a lack of awareness and
p.(None): expertise, or too much trust in the HIC researchers, may lead to the loss of intellectual property rights (IPRs) to
p.(None): local knowledge and resources. At a national and international level, researchers from HICs who choose to ignore or
p.(None): flout the research ethics and legal requirements in the host LMIC can be difficult to police. This is especially
p.(None): problem- atic in localities where there is a lack of resources and/or infrastructure to ensure ethical compliance
...
p.(None): • Lack of risk management approaches to biosecurity
p.(None): Animal • Animal research centres established in countries where regulation is less stringent
p.(None): • Lack of resources for humane animal care
p.(None): Environmental • Inadequate consideration of unintended consequences for biodiversity and the environment
p.(None): • Inadequate consideration of local environmental contexts
p.(None): • Disregard for long-term effects upon local environment
p.(None): • Lack of resources for environmental protection
p.(None): • Insufficient information for assessment of environmental effects
p.(None):
p.(None):
p.(None): 7 For example, applying genome editing technologies to human embryonic stem cells.
p.(None):
p.(None): 46 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): or in countries where although legal frameworks exist, their effective implementa- tion is prevented by limited
p.(None): resources.
p.(None): Most LMICs have processes in place for ethical approval of research, but they are hindered by resource issues. Even
p.(None): where research ethics committees are well established, they may have limited capacity and expertise. For effective
p.(None): governance, the wide-ranging and dynamic nature of research requires extensive and cutting- edge expertise from
p.(None): research ethics committees. This can be particularly difficult in resource-poor areas.
p.(None): Inadequate environmental information in LMICs means that research decisions and directions may be developed in a vacuum
p.(None): and result in long-term harm. For example, research programmes may introduce exotic species that deplete water
p.(None): resources, displace traditional varieties − thereby impacting upon agricultural bio- diversity or “escape” and become
p.(None): invasive, thus threatening biodiversity.
p.(None):
p.(None):
p.(None): Honesty
p.(None):
p.(None): In all cultures and nations, “do not lie” is a basic rule of ethical human interaction. However, the value of honesty
p.(None): has a broader scope in the context of global research ethics. Lying is only one possible contravention. In
p.(None): research ethics it is equally unacceptable, for instance, to omit important information from an informed consent
p.(None): process: that is, to fail to be transparent. The duties of honesty also include, most prominently, research integrity,
p.(None): which entails practices such as giving due credit for contributions and refraining from the manipulation of data and
p.(None): the misappropriation of research funds. In this section, we distinguish between these two forms of hon- esty and divide
p.(None): the risks into those that are mainly related to transparency and those that are more readily aligned with integrity.
p.(None): Table 5.5 sets out the primary risks to
p.(None):
p.(None): Table 5.5 Primary risks for honesty through transparency
p.(None): Level of risk Nature of risk
...
p.(None):
p.(None):
p.(None): Past History of Colonialism
p.(None):
p.(None): Does the history of colonialism still bear upon research today? We believe it does, as can be seen from the experience
p.(None): of indigenous peoples in research. Linda Tuhiwai Smith has powerfully shown that indigenous peoples often
p.(None): consider research a “dirty word”. She describes how “imperialism frames the indigenous experience” and how
p.(None): “indigenous peoples had to challenge, understand and have a shared lan- guage for talking about ... colonialism” (Smith
p.(None): 2012).
p.(None): We close this chapter with a comment from the TRUST gender adviser, Prof.
p.(None): Fatima Alvarez-Castillo (2016):
p.(None): A culture’s worldview, expressed in language, contains norms and values about power and relations of power. For
p.(None): example, the word “expert” imbues persons with authority and assigns higher credibility to their claims than
p.(None): those of non-experts. The public is expected to defer to their opinions on matters of their expertise. It was not until
p.(None): about the 1960s when the usual understanding of expertise was challenged by feminists, who argued that
p.(None): unschooled women have more expertise about their own situation than the experts. This ushered in a new research
p.(None): philosophy that valorizes poor women’s stories and their own versions of their realities.
p.(None):
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Alvarez-Castillo F (2016) Gender sensitivity: writing and language. In: Chatfield K, Schroeder D, Kimani J (eds)
p.(None): Nairobi plenary meeting report, TRUST Project. http://trust-project.eu/wp-
p.(None): content/uploads/2016/11/Meeting-Report-TRUST-Nairobi-Final.pdf
p.(None): Annas G, Grodin M (1998) Human rights and maternal-fetal HIV transmission prevention trials in Africa. American Journal
p.(None): of Public Health 88(4):560–563
p.(None): Bhatt K (2016) Concerns for Kenyan National Bioethics Committee when approving North-South collaborative projects. In:
p.(None): Chatfield K, Schroeder D, Kimani J (eds) Nairobi plenary meeting report, TRUST Project.
p.(None): http://trust-project.eu/wp-content/uploads/2016/11/Meeting-Report- TRUST-Nairobi-Final.pdf
p.(None): EU (2010) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of
p.(None): animals used for scientific purposes (text with EEA relevance). OJ L 276/33.
p.(None): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32010L0063
p.(None): Hill CM, Webber AD (2010) Perceptions of nonhuman primates in human–wildlife conflict sce- narios. American Journal of
p.(None): Primatology 72(10):919−924
p.(None): Hughes J (2010) European textbook on ethics in research. European Commission, Brussels
p.(None):
p.(None): 50 5 Exploitation Risks in Collaborative International Research
...
p.(None): Social Philosophy and Policy 12:150–151
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 6
p.(None): How the Global Code of Conduct Was Built
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract How can an ethics code achieve impact? The answer is twofold. First, through adoption by influential research
p.(None): funders, who then make it mandatory for their award recipients. This is the case with the Global Code of Conduct for
p.(None): Research in Resource-Poor Settings, which was adopted by both the European Commission and the European and Developing
p.(None): Countries Clinical Trials Partnership shortly after its launch in 2018. Second, an ethics code can achieve impact when
p.(None): researchers use it for guidance whether it is compulsory or not. This is most likely to happen with codes that were
p.(None): developed transparently with all research stakeholders involved. This chapter will outline how the GCC was
p.(None): developed, and in particular how exter- nal stakeholders were systematically engaged, how existing codes were carefully
p.(None): analysed and built upon, and who the early adopters were.
p.(None):
p.(None): Keywords Research ethics · Ethics dumping · Stakeholder engagement · Ethics codes
p.(None):
p.(None):
p.(None): Introduction
p.(None):
p.(None): The earliest research ethics codes were written solely for researchers:
p.(None): The Nuremberg Code (1949) and the original Declaration of Helsinki (1964) made no men- tion of committee review; these
p.(None): documents placed on the investigator all responsibility for safeguarding the rights and welfare of research subjects.
p.(None): (Levine 2004: 2312)
p.(None): In 1966, the surgeon general of the US Public Health Service issued a policy statement requesting the establishment
p.(None): of research ethics review committees or institutional review boards (Levine 2004: 2312). At this point in
p.(None): history, ethics codes would have had two main target audiences: researchers and research ethics committees.
p.(None): The Global Code of Conduct for Research in Resource-Poor Settings (GCC) was developed from the start with three
p.(None): audiences in mind: researchers, research ethics
p.(None):
p.(None):
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 51
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_6
p.(None):
p.(None): 52 6 How the Global Code of Conduct Was
p.(None): Built
p.(None): Consultation Fact-finding
p.(None):
p.(None): Vulnerable populations
p.(None): Industry Funders
p.(None): Literature Case studies
p.(None):
p.(None): Ethics committees
p.(None): Researchers Policy-
p.(None): Legal instruments
p.(None): Existing guidelines
p.(None):
p.(None): Risks and good practice ,
p.(None): Drafting
p.(None):
p.(None): Global Code of Conduct,
p.(None):
p.(None): Fig. 6.1 Input into the GCC
p.(None):
p.(None): committees and research participants (and/or their communities and support groups). To achieve a good match
p.(None): with these anticipated audiences, it was essential that all relevant stakeholders1, in particular highly
p.(None): vulnerable populations, be included at all stages of the drafting process of the GCC. This inclusion was later
p.(None): praised by the Deputy Director-General for Research and Innovation of the European Commission (EC) as “impressive” and
p.(None): a Horizon 2020 success story, [which] demonstrates that, in order to actively combat ethics dumping,2 a coordination
p.(None): of stakeholder efforts is required. Moreover, following the exam- ple of TRUST,3 such efforts should be based on a
p.(None): bottom-up approach that empowers local communities involved, as equal partners. (Burtscher 2018: 1)
p.(None): A major benefit of the bottom-up approach is that it resulted in a short, clear code that is focused on practical
p.(None): matters and accessible to nonspecialists. The develop- ment process consisted of a range of activities, which are
p.(None): summarized in Figure 6.1. Case studies were collected prior to the drafting of the GCC and published in a book
p.(None): entitled Ethics Dumping: Case Studies from North-South Research Collaborations (Schroeder et al. 2018).
p.(None): The foundation of the GCC, the risk matrix,
p.(None): has been introduced in Chapter 5 of this book.
p.(None):
p.(None): 1 “Stakeholders” is an increasingly contested term, as it may imply that all parties hold an equal stake. Some prefer
p.(None): the term “actors”, yet this brings its own complexities. While acknowledging the debate, we use the well-established
p.(None): term “stakeholders” throughout.
p.(None): 2 The export of unethical research from a high-income setting to a resource-poor setting with weaker
p.(None): compliance structures or legal governance mechanisms.
p.(None): 3 The TRUST project (http://trust-project.eu/) was funded by the European Commission from 2015 to 2018. One of its
p.(None): outputs was the GCC.
p.(None):
p.(None): Meaningful Consultation with Diverse Stakeholders 53
p.(None):
p.(None): This chapter will outline the following steps in the development of the GCC:
p.(None): • The consultations with various stakeholders over two and a half years
p.(None): • The comparative analysis of existing guidelines and relevant legal instruments
p.(None): • The drafting process.
p.(None):
p.(None):
p.(None): Meaningful Consultation with Diverse Stakeholders
p.(None):
p.(None): “They could take you out for coffee and call it consultation!” (Youdelis 2016)
p.(None): Consultation, engagement, community engagement, guided discussions, focus groups and interviews: these are all means of
p.(None): obtaining relevant input from stake- holders prior to action. When a problem affects a range of people or groups and a
p.(None): feasible and implementable solution is sought, stakeholder input and community engagement are essential (Hebert et
p.(None): al. 2009; Cook 2008; Bassler et al. 2008; Dunn 2011).
p.(None): This section shows how a wide range of stakeholders were consulted on ethics dumping concerns and potential
p.(None): solutions, with the specific aim of drafting the GCC. (Chapter 8 provides more general advice on community
p.(None): engagement with vulnerable populations (Chapter 8).)
p.(None):
p.(None):
p.(None): Broad Consultation
p.(None):
...
p.(None): which is that the constraints on research ethics committees in LMICs make them vulnerable to exploitation, often across
p.(None): the North– South global divide. Some such constraints are summarized in Table 6.6 (modified from Nyika et al. 2009).
p.(None): A new code of ethics cannot, by itself, resolve these issues, for instance the lack of resources to fund effective
p.(None): ethics review. However, it can tailor requirements to LMIC needs. To do so most effectively, the TRUST team decided
p.(None): that it would not base the drafting process on existing ethics guidelines, because, as is also noted in Chapter 4, the
p.(None): history of research ethics review is heavily built on the United States experience and context and focused on medical
p.(None): research (see also Levine 2004). To avoid any potential bias, the following approach was agreed upon. First, the
p.(None): exercise of identifying ethics dumping risks was to be carried out without reference to exist- ing ethics guidelines.
p.(None): Second, only once the risks had been identified through fact-
p.(None):
p.(None): Drafting Process
p.(None): 67
p.(None):
p.(None): Table 6.6 Constraints on African research ethics committees
p.(None): Insufficiency of resources No or poor support by the hosting institution
p.(None): Lack of or insufficient expertise on ethical review Not completely independent Pressure from researchers
p.(None): Pressure from sponsors
p.(None):
p.(None): Lack of active or consistent participation of members
p.(None): Lack of recognition of the importance of REC functions
p.(None): Unequal treatment of applicants in review
p.(None):
p.(None): finding missions and consultations would existing ethics codes be analysed for their relevance to mitigating the
p.(None): identified risks.
p.(None): After the risk research was concluded, a meticulous analysis of all identified risks for ethics dumping (chapter 5) was
p.(None): undertaken. All 88 risks were mapped onto existing ethics codes. For instance, Risk 8 was identified as “Poor
p.(None): representa- tion of Southern (host) partners on research teams, e.g. responsible for menial tasks only or
p.(None): not acknowledged or represented appropriately in publications” (Singh and Schroeder 2017). The mapping exercise
p.(None): discovered that the best match to mitigate this risk was the Montreal Statement on Research Integrity in Cross-
p.(None): Boundary Research Collaborations (Singh and Schroeder 2017), which notes:
p.(None): Collaborating partners should come to an agreement, at the outset and later as needed, on how publication and other
p.(None): dissemination decisions will be made and on standards for authorship and acknowledgement of joint research
p.(None): products. The contributions of all part- ners, especially junior partners, should receive full and appropriate
p.(None): recognition. (Montreal Statement 2013)
p.(None): Through this exercise, it was possible to arrive at guidance to counter ethics dumping, while
p.(None): simultaneously identifying which risks, if any, were not covered by any notable guidance. For instance, the lack
p.(None): of guidance on risk management approaches to biosafety and biosecurity was discovered in this way (Singh
p.(None): and Schroeder 2017), leading to article 1813 of the GCC.
p.(None): Once the fact-finding, consultations and analysis had been done, the drafting process began.
p.(None):
p.(None):
p.(None): Drafting Process
p.(None):
p.(None): The drafting committee of the GCC consisted of four people, following Michael Davis’s (2007) advice:
p.(None): Keep the drafting committee small. Preparing a first draft of a code is not an activity made lighter “by many hands”.
...
p.(None): workshops where San traditional leaders and San community members can discuss their concerns and ways forward. Sceptics
p.(None): may point out that the same individuals always attend such workshops largely out of appreciation for the food provided,
p.(None): and leave without any tangible or lasting benefits.
p.(None): By contrast, there is much anecdotal evidence of San colleagues who reported, after attending workshops, that their
p.(None): thinking, and indeed sometimes their lives, had forever been altered by an insight gained at the workshop. The San
p.(None): development programmes conducted by WIMSA, SASI and the SASC held capacity-building workshops on a range of topics. Of
p.(None): particular relevance to the San Code of Research Ethics were the workshops funded by two successive EU projects,
p.(None): ProGReSS5 and TRUST.6
p.(None): The ProGReSS project, under the leadership of Professor Doris Schroeder, ran from 2013 to 2016 with SASI as a partner
p.(None): with its own budget. The project funded two workshops to revise the WIMSA Research and Media Contract, among other
p.(None): things. By the conclusion of ProGReSS, it became clear that a new San ethics code might realize San interests more
p.(None): effectively in the future.
p.(None): The EU-funded TRUST project, also led by Professor Schroeder, catalysed a global collaborative effort to
p.(None): improve adherence to high ethical standards in research around the world. Its main product is the Global Code of
p.(None): Conduct for Research in Resource-Poor Settings, the main topic of this book. However, a second high-profile output is
p.(None): the San Code of Research Ethics.
p.(None): Both projects enabled productive workshops to be held, at which the San’s rights were further debated, and where the
p.(None): outcomes were not only used by the San in
p.(None):
p.(None): 5 http://www.progressproject.eu/
p.(None): 6 http://trust-project.eu/
p.(None):
p.(None): Drafting the San Code of Research Ethics
p.(None): 81
p.(None):
p.(None): practical cases, but also published and disseminated. The TRUST project united the efforts of many years to tackle the
p.(None): challenge of how unwanted research could be controlled. Without the collaborative support of international research
p.(None): partners, it is doubtful that the San Code of Research Ethics would have emerged.
p.(None):
p.(None):
p.(None): Drafting the San Code of Research Ethics
p.(None):
p.(None): Building on various earlier efforts, the San Code of Research Ethics was drafted over the course of three workshops and
p.(None): much intervening work during the year prior to its launch in March 2017.
p.(None): In March 2016, SASI organized a preparatory workshop at which San represen- tatives voiced their concerns and reported
p.(None): their past involvement in national and international research studies. Examples of good and bad research case studies
p.(None): were identified, in order to guide a revision of the San Media and Research Contract and the drafting of a San
...
p.(None): Case. Berlin, Springer
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 8
p.(None): Good Practice to Counter Ethics Dumping
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract An ethics code is not enough to avoid ethics dumping. Ethics codes can inspire, guide and raise awareness of
p.(None): ethical issues, but they cannot, on their own, guarantee ethical outcomes; this requires a multifaceted approach. For
p.(None): research in resource-poor settings, engagement is crucial. Such engagement has been built into the Global Code of
p.(None): Conduct for Research in Resource-Poor Settings as a require- ment, but how can it be put into practice? An
p.(None): approach for ethical community engagement is presented in this chapter, which also includes suggestions
p.(None): for an accessible complaints mechanism. At the institutional level, we tackle the question of concluding fair
p.(None): research contracts when access to legal advice is limited. Throughout, at a broader level, we show how the four
p.(None): values of fairness, respect, care and honesty can be used to help guide decision-making and the practical appli- cation
p.(None): of the code.
p.(None):
p.(None): Keywords Community engagement · Complaints procedure · Research contracts · Values compass
p.(None):
p.(None):
p.(None): Introduction
p.(None):
p.(None): The Global Code of Conduct for Research in Resource-Poor Settings (GCC) is not enough to prevent ethics dumping1.
p.(None): While codes are necessary, they are not suffi- cient in themselves to ensure good governance (Webley and Werner
p.(None): 2008). For codes to be effective, researchers must know how to use them appropriately (Giorgini et al.
p.(None): 2015), and codes can be totally ineffective when badly implemented (Bowman 2000). The use of codes, especially new
p.(None): ones, invariably raises challenges of interpretation and implementation.
p.(None): The way that the GCC has been developed helps to minimize potential chal- lenges. For instance,
p.(None): implementation problems are lessened when the needs, values
p.(None):
p.(None):
p.(None): 1 The export of unethical research from a high-income setting to a resource-poor setting with weaker
p.(None): compliance structures or legal governance mechanisms.
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 89
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_8
p.(None):
p.(None): 90 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): and interests of all stakeholders,2 particularly those who are likely to be subject to the codes (Lawton 2004), are
p.(None): taken into account during development. This helps ensure that the code is aligned with real needs and has practical
p.(None): value. Hence the bottom-up approach that was taken during development, which has facilitated an “insider” perspective,
p.(None): should help to increase effectiveness and counter the view that ethics codes are no more than a bureaucratic
p.(None): tool imposed from above. Additionally, the GCC does not replicate existing codes, nor does it seek to replace them.
p.(None): Rather, the GCC can be viewed as complementary to other codes, and this helps to avoid the confusion that can arise
p.(None): when codes seem contradictory.
p.(None): However, even the most conscientiously developed codes are open to differences in interpretation, and researchers need
p.(None): an ethical foundation for making decisions about application in particular situations (Eriksson et al. 2008).
p.(None): Furthermore, codes must form part of a wider framework that also includes mechanisms for compliance, accountability and
p.(None): addressing legal concerns.
...
p.(None): research protocols are scientifically rigorous and that research is conducted in accordance with the relevant
p.(None): ethical principles. However, even when the greatest care is taken, unexpected events can occur and participation can
p.(None): lead to emotional and/or physical harm. While most RECs will specify the need for an identified contact person in case
p.(None): of queries or complaints, this commonly takes the form of basic contact details on a participant information sheet,
p.(None): often in the form of an email address. Where further information is given, it
p.(None):
p.(None):
p.(None): 7 “Participation” is referred to here in its broadest sense to include experimental research animals and environments,
p.(None): as well as human research participants, local communities and researchers.
p.(None):
p.(None): Developing an Accessible Complaints Procedure
p.(None): 99
p.(None):
p.(None):
p.(None):
p.(None): Gives voice
p.(None):
p.(None):
p.(None):
p.(None): Aligns experience with expectation
p.(None):
p.(None): Reveals ethical challenges
p.(None):
p.(None): Complaints
p.(None): procedure
p.(None):
p.(None):
p.(None):
p.(None): Enhances ethical compliance
p.(None):
p.(None): Safeguards participants
p.(None):
p.(None):
p.(None): Corrects mistakes
p.(None):
p.(None):
p.(None):
p.(None): Fig. 8.2 The functions of an effective complaints procedure
p.(None):
p.(None): frequently stipulates that all complaints must be made in writing. The requirement to complain in writing via email
p.(None): might preclude complaints from the most vulner- able research participants.
p.(None): For collaborative research undertaken in resource-poor settings, especially low and middle-income countries (LMICs),
p.(None): the accessibility of a complaints procedure may be affected by many factors that are unfamiliar to researchers from a
p.(None): high- income country (HIC). A concerted effort is therefore required to understand local needs and preferences so that
p.(None): a complaints mechanism can be implemented that is both user-friendly and fit for purpose.
p.(None):
p.(None):
p.(None): Factors Affecting Accessibility
p.(None):
p.(None): It is known from studies in the field of dispute resolution that people often feel reluctant to make
p.(None): complaints and that this can be related to a variety of complex factors. In 2009 the Health Professions
p.(None): Council in the UK published a
p.(None):
p.(None): 100 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): comprehensive scoping review of existing mechanisms for complaints about health professionals (HPC 2009). In this
p.(None): report, the HPC describes a range of factors that can act as barriers to making a specific complaint. As there are no
p.(None): equivalent publi- cations about complaints procedures in LMICs, we summarize here the factors that are relevant to
p.(None): research in LMICs.
p.(None): Readiness to complain in any environment can be influenced by gender, ethnic- ity, age, education, income,
p.(None): accessibility of information and the perceived “serious- ness” of the problem (Pleasence et al. 2006).
...
p.(None): consideration before participation in collaborative research agreements
p.(None): • Research costing: providing research partners with a basic understanding of cost considerations when developing a
p.(None): full cost research budget proposal
p.(None):
p.(None):
p.(None):
p.(None): 9 The entire online toolkit is available at http://frcweb.cohred.org/
p.(None):
p.(None): Conclusion
p.(None): 105
p.(None):
p.(None): • Technology transfer and capacity: concerning the flow of knowledge, experience and materials from one partner to
p.(None): another, and the ability of people and organiza- tions to manage their affairs and reach objectives successfully.
p.(None): The development of this resource means that vulnerable groups, such as com- munities or researchers without legal
p.(None): support, have access to resources that can help develop a good understanding of research contracting for equitable
p.(None): research part- nerships and avoid exploitation in research.
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): According to Eriksson et al. (2008), a serious flaw in most new ethics guidelines is that they are produced with the
p.(None): pretension that there are no other guidelines in exis- tence, and it would be much better if they just stated what they
p.(None): added to existing guidelines. Such is the case with the GCC, which focuses solely on factors that are specific to
p.(None): collaborative research ventures in resource-poor (primarily LMIC) set- tings. The GCC is succinct and written in plain
p.(None): language; it is meant to be equally accessible to researchers in HICs and to their intended partners in LMICs. In these
p.(None): respects, the GCC is very straightforward, but its simplicity will inevitably generate questions about how it should be
p.(None): implemented.
p.(None): For example, article 13 of the GCC states that a clear procedure for feedback, complaints or allegations of
p.(None): misconduct must be offered that gives genuine and appropriate access to all research participants and local
p.(None): partners to express any con- cerns they may have with the research process. Aside from the injunction that the
p.(None): procedure must be agreed with local partners at the outset of the research, there is no guidance on what this procedure
p.(None): should look like. This “thin approach” was used for a reason: no complaints mechanism will fit all situations. Hence,
p.(None): the emphasis is on the process, namely to agree with local partners on an approach. Codes are not enough in themselves
p.(None): to ensure ethical conduct; they need buy-in from all those involved, and such buy-in needs to be generated
p.(None): through effective engagement mechanisms.
p.(None): Researchers should therefore see community engagement as the gateway to effective implementation of the GCC.
p.(None): For example, when considering the local rel- evance of the proposed research (article 1), who better to ask than
p.(None): members of the local community? When wondering how best to seek informed consent, who better to ask than members of the
p.(None): local community? Consultation with the community offers the most direct route to addressing questions about
...
p.(None): int/healthpromotion/about/HPR%20Glossary%201998.pdf, page 5.
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 9
p.(None): Towards Equitable Research Partnership
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The world’s largest collection of professional ethics codes already holds more than 2,500 codes. What can
p.(None): the Global Code of Conduct for Research in Resource-Poor Settings (GCC) add? This brief chapter gives
p.(None): co-authors and sup- porters of the GCC the opportunity to show why a code with the single-minded aim of eradicating
p.(None): ethics dumping is needed.
p.(None):
p.(None): Keywords Global ethics · Research ethics · International co-operation · Ethics dumping · Low- and middle-income
p.(None): countries
p.(None):
p.(None):
p.(None): The world’s largest collection of professional ethics codes holds more than 2,500 codes (IIT nd). Is another ethics
p.(None): code really needed? The evidence gathered on the 21st-century export of unethical research practices from
p.(None): high-income to lower- income settings says it is (Schroeder et al. 2018). Such ethics dumping still occurs despite a
p.(None): proliferation of ethics codes. This could be for either of two main possible reasons. First, an ethics code designed to
p.(None): guard against ethics dumping is not yet available. Second, ethics codes are not suitable for guarding against ethics
p.(None): dumping. We would agree with the first, but not the second.
p.(None): Instead of summarizing the book, this chapter concludes by giving the floor to co-authors and supporters of the Global
p.(None): Code of Conduct for Research in Resource- Poor Settings (GCC) and the San Code of Research Ethics. Their statements
p.(None): pro- vide further evidence that both codes are truly needed and that they will make a difference in the campaign
p.(None): against ethics dumping.1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 1 Quotes below without cited references are taken from personal written communications addressed to Doris Schroeder in
p.(None): early 2019.
p.(None):
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_9
p.(None): 109
p.(None):
p.(None): 110 9 Towards Equitable Research
p.(None): Partnership
p.(None):
p.(None): We found that many research stakeholders expressed a need for a simpler, more intuitive and fairer framework to
p.(None): guide research practice. – Professor Carel IJsselmuiden (South African), executive director of the COHRED Group,
p.(None): co-author of the GCC
p.(None): The San Code of Research Ethics is the voice of a community that have been exploited for so many years. The San
p.(None): community will ensure that this document will remain relevant for generations to come. – Leana Snyders (South African),
p.(None): director of the South African San Institute, co-author of both codes
p.(None): We want to know whether our global project is going well – ethically. The GCC provides a short and accessible checklist
p.(None): to prompt reflection on our stroke care research in hospitals in India. – Professor Dame Caroline Watkins (British),
...
p.(None): 111
p.(None):
p.(None): Good practices know no regional or political boundaries: research that is unethi- cal in Europe is unethical in Africa.
p.(None): That’s why the GCC is needed. – Dr Michael Makanga (Ugandan), executive director of the European & Developing Countries
p.(None): Clinical Trials Partnership, co-author of the GCC
p.(None): The world is unfair. We are talking about R&D in an unfair world ... The Code of Conduct [GCC] is exquisitely clear
p.(None): that it is unethical to do research in one place for the sake of another. (TRUST 2018) – Professor Jeffrey Sachs
p.(None): (American), speaking at the GCC launch in the European Parliament
p.(None): The new four-values system around fairness, respect, care and honesty is highly appreciated in Asia. People find it
p.(None): intuitive – in fact, most audiences loved it. – Dr Vasantha Muthuswamy (Indian), president of the Forum
p.(None): for Ethics Review Committees in India, co-author of the GCC
p.(None): Zhai Xiaomei [Chinese], the executive director of the Centre for Bioethics at the Chinese Academy of Medical Sciences,
p.(None): in Beijing, who is also deputy director of the health ministry’s ethics committee, welcomes what TRUST2 has done.
p.(None): (Economist 2018)
p.(None): To deliver our mission to end world hunger, we need to undertake research. Applying the GCC will assist us
p.(None): greatly. No previous code was designed so clearly for work with highly vulnerable populations in resource-poor
p.(None): settings. – Myriam Ait Aissa (French), head of Research and Analysis at Action contre la Faim, co-author of the GCC
p.(None): Fairness, respect, care and honesty: four simple words with clear meaning to help researchers enter the house through
p.(None): the door and no longer through the win- dow.3 – Dr François Hirsch (French), former head of the Inserm (French
p.(None): National Institute of Health and Medical Research) Office for Ethics, co-author of the GCC
p.(None): Ron Iphofen [British], an adviser on research ethics to the European Commission, believes the code will have a profound
p.(None): impact on how funding proposals to the EU are designed and reviewed. “I could envisage reviewers [of EU-funded
p.(None): research proposals] now looking suspiciously at any application for funds that entailed research by wealthy
p.(None): nations on the less wealthy that did not mention the code,” he says. (Nordling 2018)
p.(None): The emphasis in the GCC on fairness, respect, care and honesty resonates with our work at UNESCO. – Dr Dafna
p.(None): Feinholz (Mexican), UNESCO’s chief of Bioethics and Ethics of Science and Technology, co-author of the GCC
p.(None):
p.(None):
p.(None):
p.(None): 2 The EU-funded consortium that developed the GCC.
p.(None): 3 This refers to Andries Steenkamp’s iconic request to researchers, namely to enter San communi- ties through the
p.(None): metaphorical “front door” – that is, the San Council – and not, like thieves, through the window.
p.(None):
p.(None): 112 9 Towards Equitable Research
p.(None): Partnership
p.(None):
p.(None): TRUST was a game changer.4
...
p.(None): TRUST (2018) Major TRUST event successfully held at European Parliament. TRUST eNewsletter Issue
p.(None): 5. http://www.globalcodeofconduct.org/wp-content/uploads/2018/12/ TRUSTNewsletter_2018_Issue5.pdf
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Appendix
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Global Code of Conduct for Research in Resource-Poor Settings (GCC)
p.(None):
p.(None): Authors and Sources of Inspiration
p.(None): Lead Author: Doris Schroeder University of Central Lancashire, UK Authors in alphabetical order:
p.(None): • Joyce Adhiambo Partners for Health and Development, Kenya
p.(None): • Chiara Altare Action contre la Faim, France
p.(None): • Fatima Alvarez-Castillo University of the Philippines, Philippines
p.(None): • Pamela Andanda University of the Witwatersrand, South Africa
p.(None): • François Bompart Drugs for Neglected Diseases Initiative, Switzerland
p.(None): • Francesca I. Cavallaro UNESCO, France
p.(None): • Kate Chatfield University of Central Lancashire, UK
p.(None): • Roger Chennells South African San Institute, South Africa
p.(None): • David Coles University of Central Lancashire, UK
p.(None): • Julie Cook University of Central Lancashire, UK
p.(None): • Julia Dammann South African San Institute, South Africa
p.(None): • Amy Azra Dean (media) University of Central Lancashire, UK
p.(None): • Dafna Feinholz UNESCO, France
p.(None): • Solveig Fenet Institut national de la santé et de la recherche médicale, France
p.(None): • François Hirsch Institut national de la santé et de la recherche médicale, France
p.(None): • Carel IJsselmuiden Council on Health Research for Development, Switzerland
p.(None): • Sandhya Kamat Forum for Ethics Review Committees in India, India
p.(None): • Rosemary Kasiba Partners for Health and Development, Kenya
p.(None): • John Kiai Partners for Health and Development, Kenya
p.(None): • Joshua Kimani Partners for Health and Development, Kenya
p.(None): • Mihalis Kritikos Scientific Foresight Unit, European Parliament, Belgium
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019
...
p.(None): 66, 77, 98
p.(None): Ethics committee, 8, 18, 21, 22, 39, 42–44, 46,
p.(None): 51, 52, 54, 56, 58, 62, 65–67, 69, 70,
p.(None): 74, 98, 103, 110, 111, 116
p.(None): Ethics dumping, 1–3, 5–11, 14, 18, 19, 24, 27,
p.(None): 37, 52–54, 56–58, 61, 63, 66–68, 70,
p.(None): 89–98, 100–105, 109, 110, 112
p.(None): Europe, 1, 55, 65, 111
p.(None): European Code of Conduct for Research Integrity, 5, 24, 117
p.(None): European Commission (EC), 1, 2, 23, 52–54,
p.(None): 57, 70, 110–112, 117
p.(None): European Parliament, 2, 64, 70, 111, 115
p.(None): European Union (EU), 1, 14, 28, 48, 53, 54,
p.(None): 60, 64, 70, 80, 110–112, 116
p.(None): Evaluation, 6, 20, 63, 65, 93, 96, 98
p.(None): Exploitation, 2, 3, 14, 24, 37–49, 54, 58, 60,
p.(None): 62, 63, 65, 66, 74, 82, 83, 105
p.(None): Exploitative, 19, 38, 40, 41
p.(None):
p.(None):
p.(None): F
p.(None): Fairness, 2, 5–7, 13–24, 27–31, 33, 40–43, 68,
p.(None): 70, 74, 77–78, 82, 84, 90, 93, 95–98,
p.(None): 102, 110–112, 117
p.(None): Index
p.(None):
p.(None): Fair research contract (FRC), 90, 103, 104
p.(None): Farmers, 101
p.(None): Feedback, 6, 8, 20, 41, 48, 61, 63, 64, 83,
p.(None): 96, 105
p.(None): Four values framework, 13–24, 30, 102 Free and prior informed consent, 7, 66 Funders, 53–58, 60, 61, 70, 79, 116
p.(None):
p.(None):
p.(None): G
p.(None): Gender, 44, 49, 61, 100
p.(None): Genetic research, 54, 74, 92
p.(None): Genetics, 2, 7, 13, 60, 62, 63, 74, 75,
p.(None): 81, 82
p.(None): Global Code of Conduct for Research in Resource-Poor Settings, 2, 5, 14, 27,
p.(None): 37, 51, 80, 89, 109, 115–117
p.(None): Good Participatory Practice, 6, 20, 63
p.(None):
p.(None):
p.(None): H
p.(None): Harm, 1, 17, 19, 28, 34, 35, 38, 43, 45–47, 54,
p.(None): 65, 73, 75, 84, 95, 98
p.(None): Health and safety, 9, 10
p.(None): HealthyXvolunteers, 63
p.(None): Helicopter research, 23, 41
p.(None): High-income countries (HICs), 2, 9, 20–23,
p.(None): 38–44, 47, 48, 56, 65, 70, 99–101, 104
p.(None): Honesty, 2, 5, 6, 10–11, 13–24, 27–31, 33, 40,
p.(None): 46–48, 68, 70, 74, 82, 83, 90, 93,
p.(None): 95–98, 102, 110–112
p.(None): Horizon 2020, 23, 52, 53
p.(None): Human participants, 65, 117
p.(None): Human rights, 22, 42, 44, 55, 75
p.(None):
p.(None):
p.(None): I
p.(None): Ideals, 3, 16, 17, 24, 32
p.(None): Illegal, 22, 43, 63, 65, 100
p.(None): Illiterate populations, 22, 47
p.(None): Incrimination, 9, 11, 68
p.(None): India, 39, 44, 56, 61, 65, 110, 111, 115, 116
p.(None): Indigenous peoples, 49, 55, 63, 73, 75,
p.(None): 80, 112
p.(None): Industry, 39, 54–58, 61, 69, 70, 117
p.(None): Inequalities, vii
p.(None): Information sheets, 24, 47, 98, 103
p.(None): Informed consent, 2, 7, 8, 24, 44–47, 63, 66,
p.(None): 74, 82, 84, 100, 105
p.(None): Integrity, 5, 23, 24, 46–48, 53, 67, 70, 74,
p.(None): 78–79, 82, 85, 86, 94, 112, 117
p.(None): Intellectual property, 6, 20, 43, 60, 66,
p.(None): 80, 104
p.(None):
p.(None): Index
p.(None): 121
p.(None):
p.(None):
p.(None): K
p.(None): Kenya, 2, 39, 40, 42, 61, 63, 65, 100, 110,
p.(None): 115, 116
p.(None): !Khomani, 74, 77, 78, 81, 86
...
p.(None):
p.(None):
p.(None): N
p.(None): Non-compliance, 1
p.(None): Non-governmental organisations (NGOs), 54, 63, 75–78, 85
p.(None): Non-human primates, 2, 44, 65
p.(None): Normative relativism, 30, 31
p.(None):
p.(None):
p.(None): O
p.(None): Open communication, 24, 94
p.(None):
p.(None):
p.(None): P
p.(None): Peer educators, 40
p.(None): Personal risk, 9, 41, 42, 44–47, 68
p.(None): Placebo, 38, 41
p.(None): Policymakers, 39, 54, 55, 58, 60, 70
p.(None): Poverty, 2, 3, 48, 55, 82
p.(None): Power, 2, 5, 7, 17–19, 29, 43, 44, 48, 49, 62,
p.(None): 70, 75, 100, 102
p.(None): Principles, 3, 16–18, 23, 24, 28, 29, 32–35, 39,
p.(None): 60, 75, 77, 82, 98, 104, 117
p.(None): Principlism, 17
p.(None):
p.(None): Privacy, 11, 47, 83, 96, 97, 102
p.(None): Proxy consent, 47, 48
p.(None):
p.(None):
p.(None): R
p.(None): Recruitment, 102, 103
p.(None): Relativism, 3, 27, 28, 30–33
p.(None): Research and development (R&D), 60, 65, 111
p.(None): Research ethics, 2, 3, 8, 18, 20–24, 27, 41–43,
p.(None): 45–47, 51, 52, 54, 56, 58, 63, 65–67,
p.(None): 70, 73–86, 98, 103, 109–111, 117
p.(None): Research ethics committee (REC), 8, 18, 42,
p.(None): 45–47, 51, 52, 54, 65–67, 70, 98, 103
p.(None): Research integrity, 5, 24, 46, 47, 67, 112, 117
p.(None): Research participants, 2, 6–11, 20–24, 27, 38,
p.(None): 40, 43, 44, 52, 54, 55, 57, 61–64, 70,
p.(None): 92, 96, 98–100, 103, 105, 110
p.(None): Resource custodians, 7, 66
p.(None): Resource-poor settings, 2, 5, 14, 27, 28, 37,
p.(None): 51, 52, 80, 89, 99, 109, 111, 115–117
p.(None): Respect, 2, 5–8, 13–24, 27–35, 40, 43–44, 66,
p.(None): 68–70, 74, 78, 79, 82, 83, 85, 86, 90,
p.(None): 92, 93, 95–98, 102, 103, 105, 110–112
p.(None): Responsibilities, 8, 10, 16, 47, 51, 55, 58, 61,
p.(None): 66, 68, 104, 117
p.(None): Risk mitigation measures, 23, 67
p.(None): Risks, 1, 3, 9–11, 14, 23, 44, 52, 56, 64,
p.(None): 66–68, 70, 82, 104
p.(None):
p.(None):
p.(None): S
p.(None): Safeguarding, 45, 51, 54, 97, 103
p.(None): Safety, 9, 10, 14, 45
p.(None): Samples, 2, 34, 47, 64, 82
p.(None): San, 2, 3, 18, 22, 40, 56, 63, 73–86, 109–112,
p.(None): 115–117
p.(None): San Code of Research Ethics, 2, 3, 63, 73–86,
p.(None): 109, 110, 117
p.(None): Security, 10, 15, 19, 45, 49, 116
p.(None): SexXworkers, 40, 55, 56, 63, 64, 92, 100, 112
p.(None): Social science, 2, 18, 39, 61, 68, 101
p.(None): Socio-anthropological research, 56
p.(None): South Africa, 18, 40, 61, 63, 69, 74–77, 79,
p.(None): 84–86, 110, 115, 116
p.(None): South African San Council (SASC), 18, 76–81, 86, 112, 116, 117
p.(None): Spokespersons, 93, 94, 102
p.(None): Stakeholder engagements, 3, 92
p.(None): Standards, 2, 3, 6, 9–11, 13, 16–18, 22, 24, 38,
p.(None): 41, 42, 48, 58, 62, 64, 65, 67, 70, 80,
p.(None): 85, 112
p.(None): Stigmatization, 9, 11, 40, 45, 68, 100
p.(None): Stigmatized, 42
p.(None): Sub-Saharan Africa, 55
p.(None):
p.(None): 122
p.(None):
p.(None): T
p.(None): Traditional knowledge, 7, 42, 54, 76–78, 80,
p.(None): 82, 84, 95, 97
p.(None): Training, 19, 63, 81, 95, 112, 117
p.(None): Transparency, 24, 46, 47, 84, 95
...
Searching for indicator poverty:
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p.(None): The publisher, the authors, and the editors are safe to assume that the advice and information in this book are
p.(None): believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give
p.(None): a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may
p.(None): have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional
p.(None): affiliations.
p.(None):
p.(None): This Springer imprint is published by the registered company Springer Nature Switzerland AG. The registered company
p.(None): address is: Gewerbestrasse 11, 6330 Cham, Switzerland
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): To Reverend Mario Mahongo (1952–2018)
p.(None):
p.(None): Foreword
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): In September 2015, after intensive public consultation, the international community went on record with a plan of
p.(None): action for people, planet and prosperity: the 2030 Agenda for Sustainable Development. All country representatives and
p.(None): all stakehold- ers expressed their determination
p.(None): to take the bold and transformative steps which are urgently needed to shift the world on to a sustainable and
p.(None): resilient path. As we embark on this collective journey, we pledge that no one will be left behind [emphasis added].
p.(None): (UN 2015).
p.(None): To stimulate action, the heads of states and governments defined 17 sustainable development goals and 169 targets to be
p.(None): achieved by 2030. Successes in efforts to end extreme poverty, achieve food security and ensure healthy lives, as well
p.(None): as suc- cesses towards all other goals, depend not only on goal-oriented societal reforms and the mobilization of
p.(None): substantial financial and technical assistance, but also on significant technological, biomedical and other
p.(None): innovations.
p.(None): Ensuring the success of the Agenda 2030 requires massive research and develop- ment efforts as well new forms of
p.(None): research co-creation on a level playing field and with a universal professional ethos.
p.(None): Leaving no one behind does not “only” include reducing income and wealth inequalities, and affirmative
p.(None): action in support of better opportunities for self- determined living within and among countries. It also
p.(None): implies reaching those most at risk from poverty and its impacts. This again necessitates research focused on the needs
p.(None): of the poor in a way that does not infringe their human rights.
p.(None): Research and innovation can only be sustainably successful when based on soci- etal trust. The precondition for
p.(None): societal trust and public acceptance is the perception that work is done with integrity and based on fundamental values
p.(None): shared by the global community. Trust depends not only on research work being compliant with laws and regulations, but
p.(None): also, more than ever, on its legitimacy.
p.(None): Such legitimacy can be achieved through inclusion and, importantly, the co- design of solutions with
p.(None): vulnerable populations. Leaving no one behind also means leaving no one behind throughout the research process, aiming
p.(None): for research with, not about, vulnerable populations.
p.(None):
p.(None): vii
p.(None):
p.(None): viii
p.(None): Foreword
p.(None):
p.(None): The results of the TRUST Project, whose Global Code of Conduct for Research in Resource-Poor Settings (GCC) this book
p.(None): celebrates, contribute to realizing the European Union’s ambition of a more inclusive, equal and sustainable global
p.(None): soci- ety – a profound expectation of people all over the world.
p.(None): The fact that the GCC now exists and has been welcomed by the European Commission as a precondition for
p.(None): its research grants is only a beginning.
...
p.(None): The Four Values and Moral Relativism 30
p.(None): A More Moderate Relativism 31
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xiii
p.(None):
p.(None): xiv
p.(None): Contents
p.(None):
p.(None): Grounding the Global Applicability Thesis of the GCC
p.(None): in a Common Morality 32
p.(None): Conclusion 35
p.(None): References 36
p.(None): 5 Exploitation Risks in Collaborative International Research 37
p.(None): The Nature of Exploitation 38
p.(None): Our Method 39
p.(None): Our Findings 40
p.(None): Fairness 41
p.(None): Respect 43
p.(None): Care 44
p.(None): Honesty 46
p.(None): Conclusion 48
p.(None): Serious Poverty 48
p.(None): Extreme Differentials in Power 48
p.(None): Past History of Colonialism 49
p.(None): References 49
p.(None): 6 How the Global Code of Conduct Was Built 51
p.(None): Introduction 51
p.(None): Meaningful Consultation with Diverse Stakeholders 53
p.(None): Broad Consultation 53
p.(None): The Case Study Competition 56
p.(None): Meetings and Platforms: Reaching the Right Delegates 57
p.(None): External Engagement with Research Policymakers 60
p.(None): External Engagement with Research Funders 60
p.(None): External Engagement with Researchers 61
p.(None): Engagement with Research Participants and Research
p.(None): Communities 63
p.(None): Advocate Voices for Animals 64
p.(None): External Engagement with Research Ethics Committees 65
p.(None): Analysis of Existing Guidelines 66
...
p.(None): GCC Global Code of Conduct for Research in Resource-Poor Settings GVA Global Values Alliance
p.(None): HIC high-income country
p.(None): Inserm Institut national de la santé et de la recherche médicale IPR intellectual property
p.(None): rights
p.(None): LMICs low- and middle-income countries NGO nongovernmental organization
p.(None): PHDA Partners for Health and Development in Africa REC research ethics committee
p.(None): SASC South African San Council SASI South African San Institute
p.(None): SWOP Sex Workers Outreach Programme
p.(None): UNESCO United Nations Educational, Scientific and Cultural Organization WIMSA Working Group of Indigenous
p.(None): Minorities in Southern Africa
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xix
p.(None):
p.(None): Chapter 1
p.(None): Ethics Dumping and the Need for a Global Code of Conduct
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The UN’s 2030 Agenda for Sustainable Development calls for more research and innovation to end
p.(None): poverty, leaving no one behind – and yet the export of unethical practices from high-income to lower-income settings is
p.(None): still a major concern. Such ethics dumping occurs in all academic disciplines. When research is regarded, on the one
p.(None): hand, as a dirty word among vulnerable populations who face ethics dumping, and, on the other, as a solution to many of
p.(None): humanity’s problems, how can the resulting gulf be bridged? This book describes one initiative to counter ethics
p.(None): dumping: the development and promotion of the Global Code of Conduct for Research in Resource-Poor Settings.
p.(None):
p.(None): Keywords Ethics dumping · Global research ethics · Exploitation · Vulnerability · Research governance
p.(None):
p.(None):
p.(None): Research has become a global enterprise. Individual researchers around the world are encouraged to be as mobile as
p.(None): possible (Sugimoto et al. 2017). At the same time, the activities of mobile researchers have made research “one of the
p.(None): dirtiest words in the indigenous world’s vocabulary” (Tuhiwai Smith 1999: 1). The indigenous com- munities in which
p.(None): Tuhiwai Smith, a Māori professor, grew up saw research as some- thing that “told us things already known, suggested
...
p.(None): Examples of ethics dumping in the 21st century include:
p.(None): • In clinical research, misinterpreting the standard of care, leading to the avoidable deaths of research
p.(None): participants (Srinivasan et al. 2018).
p.(None): • Research among indigenous populations that led to the publication of “private, pejorative, discriminatory and
p.(None): inappropriate” conclusions and a refusal to engage with indigenous leaders on the informed consent process
p.(None): (Chennells and Steenkamp 2018).
p.(None): • The export of valuable blood samples from a rural area in China to a US genetic bank, leading to a large amount of
p.(None): research funding for the US team (Zhao and Zhang 2018).
p.(None): • The use of wild-caught non-human primates in research by a UK researcher who undertook his experiments in Kenya,
p.(None): thus “bypassing British law” (Chatfield and Morton 2018).
p.(None): • An attempt to seek retrospective ethics approval for a highly sensitive social sci- ence study undertaken among
p.(None): vulnerable populations following a local Ebola crisis (Tegli 2018).
p.(None): How can one reconcile recent cases of ethics dumping with our generation’s highly ambitious call for more
p.(None): research and innovation? The United Nations 2030 Agenda for Sustainable Development aims “to end all forms of poverty…
p.(None): while ensuring that no one is left behind” (UN ndb). To achieve these aims, the UN encourages “fostering
p.(None): innovation” (Goal 9 of Agenda 2030), as “without innovation
p.(None): …, development will not happen” (UN nda).
p.(None): This book describes one initiative to counter ethics dumping: the development and promotion of the Global Code of
p.(None): Conduct for Research in Resource-Poor Settings (GCC) and its sister code, the San Code of Research Ethics.
p.(None): The GCC recognizes the considerable power imbalances that may be involved in international collaborative research and
p.(None): provides guidance across all disciplines. It is based on a new ethical framework that is predicated on the values of
p.(None): fairness, respect, care and honesty; values that are imperative for avoiding ethics dumping. The GCC opposes all double
p.(None): standards in research and supports long-term equitable research relationships between partners in lower-income
p.(None): and higher-income set- tings. This book introduces the GCC in the following manner:
p.(None): • Chapter 2 reproduces the GCC as launched in the European Parliament in June 2018 and adopted as a mandatory
p.(None): reference document by the European Commission (ndb).
p.(None):
p.(None): References
p.(None): 3
p.(None):
p.(None): • Chapter 3 explains why values rather than standards, principles, virtues or ideals provide the best guidance in the
p.(None): fight against ethics dumping.
p.(None): • Chapter 4 answers a philosophical question: how can the GCC can be defended against claims of moral relativism?
p.(None): • Chapter 5 details 88 risks for ethics dumping, the analytical foundation of the GCC.
p.(None): • Chapter 6 describes how the GCC was built, from extensive stakeholder engage- ments to its final translation into
p.(None): Russian, French, Spanish, German, Portuguese, Mandarin, Japanese and Hindi.
p.(None): • Chapter 7 recounts the history of the San Code of Research Ethics, sister code of the GCC and the first ethics code
p.(None): launched by an indigenous group on the African continent.
p.(None): • Acknowledging that an ethics code is not enough on its own to counter ethics dumping, Chapter 8 offers advice on
p.(None): community engagement, workable com- plaints procedures and negotiating fair contracts.
p.(None): • Chapter 9 presents a brief conclusion.
p.(None): • The names of the 56 authors of the GCC are set out in the Appendix.
p.(None): Can an ethics code overcome ethics dumping and bridge the gulf between those for whom international collaborative
p.(None): research is exploitation by strangers, and those who believe it is essential to end all poverty? That is the hope of
p.(None): the authors of the GCC.
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Chatfield K, Morton D (2018) The use of non-human primates in research. In: Schroeder D, Cook J, Hirsch F, Fenet S,
p.(None): Muthuswamy V (eds) Ethics dumping: case studies from North-South research collaborations, Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 81–90
p.(None): Chennells R, Steenkamp A. (2018) International genomics research involving the San people. In: Schroeder D, Cook J,
p.(None): Hirsch F, Fenet S, Muthuswamy V (eds) Ethics dumping: case stud- ies from North-South research collaborations,
p.(None): Springer Briefs in Research and Innovation Governance, Berlin, p 15–22
p.(None): European Commission (nda) Horizon 2020: ethics. https://ec.europa.eu/programmes/horizon2020/ en/h2020-section/ethics
p.(None): European Commission (ndb) Participant portal H2020 manual: ethics. http://ec.europa.eu/research/
p.(None): participants/docs/h2020-funding-guide/cross-cutting-issues/ethics_en.htm
p.(None): Rodrigues ML, Nimrichter L, Cordero RJB (2016) The benefits of scientific mobility and interna- tional collaboration.
p.(None): FEMS Microbiology Letters 363(21):fnw247. https://academic.oup.com/ femsle/article-lookup/doi/10.1093/femsle/fnw247
p.(None): Schroeder D, Cook J, Hirsch F, Fenet S, Muthuswamy V (eds) (2018) Ethics dumping: case stud- ies from North-South
p.(None): research collaborations. Springer Briefs in Research and Innovation Governance, Berlin
...
p.(None): In: Singer P (ed) A companion to ethics. Blackwell, Oxford, p 442–450 Wong D (2009) Natural moralities: a defense of
p.(None): pluralistic relativism. Oxford University Press,
p.(None): New York
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 5
p.(None): Exploitation Risks in Collaborative International Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract Ethics dumping occurs in collaborative international research when peo- ple, communities, animals and/or
p.(None): environments are exploited by researchers. Exploitation is made possible by serious poverty and extreme power
p.(None): differentials between researchers from high-income countries and research stakeholders from low- and middle-income
p.(None): countries (LMICs). To prevent its occurrence, the risks of exploitation have to be tackled. This chapter describes 88
p.(None): risks identified for col- laborative international research, categorized according to four values: fairness,
p.(None): respect, care and honesty. The risks were identified in a broad-based consultative exercise, which included more than
p.(None): 30 members and chairs of ethics committees in LMICs, representatives from vulnerable populations in LMICs, and an open
p.(None): call for case studies of exploitation. The findings of the exercise contributed to the develop- ment of the Global Code
p.(None): of Conduct for Research in Resource-Poor Settings.
p.(None):
p.(None): Keywords Exploitation · Ethics dumping · Collaborative research · Vulnerability · Research ethics · Ethics codes
p.(None):
p.(None):
p.(None): Ethics dumping1 occurs in collaborative international research when people, com- munities, animals and/or environments
p.(None): are exploited by researchers. In order to pre- vent ethics dumping, such exploitation needs to stop. This chapter
p.(None): describes our investigation into the risks of exploitation in low- and middle-income countries (LMICs),
...
p.(None): Community • Dishonoured commitments
p.(None): Country • Data sharing without consent because of lack of strict privacy arrangements Animal •
p.(None): Deliberate obfuscation of experimental conditions
p.(None): Environmental • Results from HIC research inappropriately applied in LMIC context
p.(None):
p.(None): 48 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): data are sold for profit without the knowledge or consent of the participants. In some institutions, certain unethical
p.(None): practices may become the norm, and even those work- ers who object may feel pressurized to comply. Additionally,
p.(None): researchers may break promises routinely; where, for example, the researchers have promised to return with feedback
p.(None): about the research and then fail to do so. A lack of integrity can also threaten animal welfare. Where standards of
p.(None): animal housing and care are not high, obfuscation about the conditions in which the animals are kept may occur for two
p.(None): main reasons: first, to ease the process of gaining ethical approval from the HIC partner, and secondly, so as not
p.(None): to jeopardize publication of the experimental results.8
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): Our findings revealed 88 separate risks for exploitation but in this conclusion, we draw attention to three factors
p.(None): that underpin many of the individual risks, namely:
p.(None): Extreme differentials in available income, i.e. serious poverty Extreme differentials in power
p.(None): Past history of colonialism
p.(None):
p.(None):
p.(None): Serious Poverty
p.(None):
p.(None): The most obvious risk of exploitation in LMIC-HIC collaborative research is the extreme divergence in levels of
p.(None): affluence across the world. Many of the individual points in the risk table have their origins in extreme poverty.
p.(None): Researchers cannot solve this problem, but they can show heightened awareness of it and try their best to promote local
p.(None): improvements, for example by equitably involving local research- ers, by focusing their research on local research
p.(None): needs and by obtaining input from local populations.
p.(None):
p.(None):
p.(None): Extreme Differentials in Power
p.(None):
p.(None): The relationship between wealth and power, and the differentials in power between those who are wealthy and those who
p.(None): live in poverty, is a topic that has filled books, halls and television programmes. However, other factors also
p.(None): play a part in
p.(None):
p.(None):
p.(None): 8 Many academic journals that publish results from animal experimentation stipulate requirements that the studies have
p.(None): been conducted in a manner that is consistent with high ethical standards such as EU Directive 2010/63 (EU 2010).
p.(None):
p.(None): References
p.(None): 49
p.(None):
p.(None): maintaining power differentials. To give one striking example, the United Nations Security Council has 15 members. Of
p.(None): these, ten are elected by the General Assembly for periods of two years while five (China, France, Russia, the United
p.(None): Kingdom and the United States) have been permanent members with “veto power” since 1946. More than 60 United
p.(None): Nations member states have never been members of the Security Council and hence have never even had voting
p.(None): rights, let alone veto power.
p.(None):
p.(None):
p.(None): Past History of Colonialism
p.(None):
p.(None): Does the history of colonialism still bear upon research today? We believe it does, as can be seen from the experience
p.(None): of indigenous peoples in research. Linda Tuhiwai Smith has powerfully shown that indigenous peoples often
p.(None): consider research a “dirty word”. She describes how “imperialism frames the indigenous experience” and how
p.(None): “indigenous peoples had to challenge, understand and have a shared lan- guage for talking about ... colonialism” (Smith
p.(None): 2012).
...
p.(None): be generated internally.
p.(None): As Table 6.1 shows, considerable expertise from different stakeholder perspec- tives was available internally. In
p.(None): addition, input was sought from external experts, who engaged through four channels, facilitated by six enablers, to
p.(None): participate in the development of a range of project outputs, one of which was the GCC. This approach is detailed in
p.(None): Figure 6.3 (Dammann and Cavallaro 2017).
p.(None):
p.(None): Meaningful Consultation with Diverse Stakeholders 55
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Fig. 6.2 Research stakeholders
p.(None):
p.(None): Table 6.1 Main research stakeholders involved as TRUST budget holders
p.(None): Stakeholder
p.(None): type TRUST partner
p.(None):
p.(None): Research policymakers
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research funders
p.(None): The United Nations Educational, Scientific and Cultural Organization (UNESCO) promotes policy frameworks for research
p.(None): through drafting internationally focused guidelines on scientific co-operation.
p.(None): The “Institut national de la santé et de la recherche médicale”® (Inserm) holds responsibility for the strategic,
p.(None): scientific and operational coordination of French biomedical research.
p.(None): The European and Developing Countries Clinical Trials Partnership (EDCTP) funds research for the prevention and
p.(None): treatment of poverty-related infectious diseases in sub-Saharan Africa.
p.(None): The Swiss-based Global Values Alliance (GVA) is a foundation that focuses on engagement with pharmaceutical industry
p.(None): partners as its main role in the TRUST project
p.(None): Researchers The Centre for Professional Ethics at the University of Central Lancashire is one of the oldest
p.(None): research-only ethics centres in Europe, with specialist expertise in global justice issues.
p.(None): The Bio-Economy Research Chair at the University of Cape Town and her team focus on engagement with communities,
p.(None): indigenous knowledge holders and policymakers to ensure environmentally sustainable poverty reduction. The Law School
p.(None): of the University of the Witwatersrand, Johannesburg, contributed specialist human rights and legal frameworks
p.(None): expertise.
p.(None):
p.(None): Research participants
p.(None):
p.(None):
p.(None): Research advocates (support organizations)
p.(None): Many of the individuals involved in drafting the GCC have previously been research participants. Of particular
p.(None): importance in this process were the indigenous peoples and sex worker representatives who were involved through SASI
p.(None): and PHDA (see “Research communities” below).
p.(None): The Council on Health Research for Development (COHRED) helps promote the health and development of populations in low-
p.(None): and middle- income countries.
p.(None): Action Contre La Faim (ACF) is recognized as one of the leading organizations in the fight against hunger worldwide.
p.(None): ACF undertakes its own research on highly vulnerable populations.
p.(None):
p.(None): 56 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.1 (continued)
p.(None): Stakeholder
p.(None): type TRUST partner
p.(None):
p.(None): Research communities
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research ethics reviewers
p.(None): The South African San Institute (SASI) is dedicated to serving the San communities of southern Africa through legal,
p.(None): advocacy, socio- anthropological and related services.
...
p.(None): During this important workshop, the San developed a range of general principles that applied to their own community.
p.(None): These principles were as follows and were used for a first draft of the San Code of Research Ethics:
p.(None): • The San require respect to the environment, to San leaders and individuals, and to cultural values.
p.(None): • Honesty, integrity and honour are important between all partners.
p.(None): • Cultural and spiritual values must be fully honoured and respected in all research and media projects.
p.(None): • The right formal process should be followed to protect communities in research.
p.(None): • Informed consent is central to all research.
p.(None): • Genetics samples should only be used for the purpose stated in the research contract.
p.(None): • Researchers should not enter a community without being guided and led by members of the community
p.(None): itself.
p.(None): • Both researcher and community should benefit from the interaction.
p.(None): In November 2016, SASI organized a third workshop with the same delegates and some of the earlier external contributors
p.(None): to finalize the content of the San Code of Research Ethics. The overall goal was to achieve fair research partnerships.
p.(None): The following threats and weaknesses were discussed.
p.(None): • Vulnerable and far-flung populations and serious poverty
p.(None): • Undue influence by researchers, due to poverty
p.(None): • “Free riders” who do not support San community concerns when taking part in research for cash
p.(None): • Exploitation possibilities due to illiteracy
p.(None): • Lack of knowledge of research, what it means and what its risks are
p.(None): • Lack of knowledge about the San leadership’s approach to research
p.(None): • Lack of assistance from the government
p.(None): • Low self-esteem in engaging with outside individuals and agencies
p.(None): • Earlier theft of traditional knowledge leading to mistrust of researchers
p.(None): • Lack of system to combat the problems
p.(None): • Lack of institutional and financial support to the leadership who aim to improve the situation
p.(None): With these challenges in mind, the initial draft of the San Code of Research Ethics was revised and
p.(None): refined. In addition, each element of the new draft code was grouped into one of the four TRUST ethical values of
p.(None): fairness, respect, care, and honesty. These values had been agreed on previously by the TRUST group, with San input.
p.(None): The four core values were to be supported by a fifth value, which the San
p.(None):
p.(None): 7 A short video presentation about the workshop is available at https://www.youtube.com/ watch?v=HOdw3mv7JSo.
p.(None):
p.(None): The San Code of Research Ethics
p.(None): 83
p.(None):
p.(None): delegates deemed essential, namely proper process. In small groups the key points of each value were written out in
p.(None): greater detail.
p.(None): A highly important decision was that examples of past exploitation would form part of the code itself.
p.(None): The results of the third workshop were then given to colleagues who undertook further work. In December 2016, Roger
...
p.(None): 74, 82, 84, 100, 105
p.(None): Integrity, 5, 23, 24, 46–48, 53, 67, 70, 74,
p.(None): 78–79, 82, 85, 86, 94, 112, 117
p.(None): Intellectual property, 6, 20, 43, 60, 66,
p.(None): 80, 104
p.(None):
p.(None): Index
p.(None): 121
p.(None):
p.(None):
p.(None): K
p.(None): Kenya, 2, 39, 40, 42, 61, 63, 65, 100, 110,
p.(None): 115, 116
p.(None): !Khomani, 74, 77, 78, 81, 86
p.(None): Khwe, 74, 77, 78, 81
p.(None): Knowledge holders, 7, 55, 66
p.(None):
p.(None):
p.(None): L
p.(None): Lawyers, 79, 80, 104
p.(None): Legal framework, 45, 55
p.(None): Legal support, 74, 79, 80, 85, 105
p.(None): Local communities, 6, 7, 9, 20, 27, 40,
p.(None): 42–45, 52, 61, 63, 64, 69, 90, 92,
p.(None): 94–98, 105
p.(None): Local relevance, 6, 17, 60–62, 68, 102, 105
p.(None): Local researchers, 6, 7, 10, 20, 27, 40, 48, 60,
p.(None): 64, 66, 94, 96, 101
p.(None): Low- and middle-income countries (LMICs), 2, 20–22, 37–44, 46–48, 55, 56, 58, 61,
p.(None): 62, 65, 66, 69, 70, 99–105
p.(None):
p.(None):
p.(None): M
p.(None): Majengo, 63
p.(None): Medical research, 22, 23, 41, 45, 57, 65, 66,
p.(None): 104, 111, 116, 117
p.(None): Metaethical relativism, 30–32
p.(None): Misconduct, 8, 47, 105
p.(None):
p.(None):
p.(None): N
p.(None): Non-compliance, 1
p.(None): Non-governmental organisations (NGOs), 54, 63, 75–78, 85
p.(None): Non-human primates, 2, 44, 65
p.(None): Normative relativism, 30, 31
p.(None):
p.(None):
p.(None): O
p.(None): Open communication, 24, 94
p.(None):
p.(None):
p.(None): P
p.(None): Peer educators, 40
p.(None): Personal risk, 9, 41, 42, 44–47, 68
p.(None): Placebo, 38, 41
p.(None): Policymakers, 39, 54, 55, 58, 60, 70
p.(None): Poverty, 2, 3, 48, 55, 82
p.(None): Power, 2, 5, 7, 17–19, 29, 43, 44, 48, 49, 62,
p.(None): 70, 75, 100, 102
p.(None): Principles, 3, 16–18, 23, 24, 28, 29, 32–35, 39,
p.(None): 60, 75, 77, 82, 98, 104, 117
p.(None): Principlism, 17
p.(None):
p.(None): Privacy, 11, 47, 83, 96, 97, 102
p.(None): Proxy consent, 47, 48
p.(None):
p.(None):
p.(None): R
p.(None): Recruitment, 102, 103
p.(None): Relativism, 3, 27, 28, 30–33
p.(None): Research and development (R&D), 60, 65, 111
p.(None): Research ethics, 2, 3, 8, 18, 20–24, 27, 41–43,
p.(None): 45–47, 51, 52, 54, 56, 58, 63, 65–67,
p.(None): 70, 73–86, 98, 103, 109–111, 117
p.(None): Research ethics committee (REC), 8, 18, 42,
p.(None): 45–47, 51, 52, 54, 65–67, 70, 98, 103
p.(None): Research integrity, 5, 24, 46, 47, 67, 112, 117
p.(None): Research participants, 2, 6–11, 20–24, 27, 38,
p.(None): 40, 43, 44, 52, 54, 55, 57, 61–64, 70,
p.(None): 92, 96, 98–100, 103, 105, 110
p.(None): Resource custodians, 7, 66
p.(None): Resource-poor settings, 2, 5, 14, 27, 28, 37,
p.(None): 51, 52, 80, 89, 99, 109, 111, 115–117
p.(None): Respect, 2, 5–8, 13–24, 27–35, 40, 43–44, 66,
p.(None): 68–70, 74, 78, 79, 82, 83, 85, 86, 90,
p.(None): 92, 93, 95–98, 102, 103, 105, 110–112
p.(None): Responsibilities, 8, 10, 16, 47, 51, 55, 58, 61,
p.(None): 66, 68, 104, 117
p.(None): Risk mitigation measures, 23, 67
p.(None): Risks, 1, 3, 9–11, 14, 23, 44, 52, 56, 64,
p.(None): 66–68, 70, 82, 104
p.(None):
p.(None):
p.(None): S
p.(None): Safeguarding, 45, 51, 54, 97, 103
p.(None): Safety, 9, 10, 14, 45
p.(None): Samples, 2, 34, 47, 64, 82
...
Economic / Food Insecurity
Searching for indicator hunger:
(return to top)
p.(None): partners as its main role in the TRUST project
p.(None): Researchers The Centre for Professional Ethics at the University of Central Lancashire is one of the oldest
p.(None): research-only ethics centres in Europe, with specialist expertise in global justice issues.
p.(None): The Bio-Economy Research Chair at the University of Cape Town and her team focus on engagement with communities,
p.(None): indigenous knowledge holders and policymakers to ensure environmentally sustainable poverty reduction. The Law School
p.(None): of the University of the Witwatersrand, Johannesburg, contributed specialist human rights and legal frameworks
p.(None): expertise.
p.(None):
p.(None): Research participants
p.(None):
p.(None):
p.(None): Research advocates (support organizations)
p.(None): Many of the individuals involved in drafting the GCC have previously been research participants. Of particular
p.(None): importance in this process were the indigenous peoples and sex worker representatives who were involved through SASI
p.(None): and PHDA (see “Research communities” below).
p.(None): The Council on Health Research for Development (COHRED) helps promote the health and development of populations in low-
p.(None): and middle- income countries.
p.(None): Action Contre La Faim (ACF) is recognized as one of the leading organizations in the fight against hunger worldwide.
p.(None): ACF undertakes its own research on highly vulnerable populations.
p.(None):
p.(None): 56 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.1 (continued)
p.(None): Stakeholder
p.(None): type TRUST partner
p.(None):
p.(None): Research communities
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research ethics reviewers
p.(None): The South African San Institute (SASI) is dedicated to serving the San communities of southern Africa through legal,
p.(None): advocacy, socio- anthropological and related services.
p.(None): Partners for Health and Development in Africa (PHDA) supports female and male sex workers in the low socio-economic
p.(None): strata who reside in the informal settlements of Nairobi.
p.(None): The Forum for Ethics Review Committees in India (FERCI) promotes the effective implementation of the ethical review of
p.(None): biomedical research studies in India.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): • Advisory board
p.(None): • Engagement panel
p.(None): • Stakeholder inventory
p.(None): • Project deliverables
p.(None): • Publications
p.(None): • eNewsletters
p.(None):
p.(None): • Funder platform
p.(None): • Industry platform
p.(None): • Case study competition
p.(None): Enablers
p.(None): • Project website
p.(None): • Social media
p.(None): • Brochure
p.(None): • Project conferences and consultation meetings
p.(None): • Films
p.(None): • Interviews
p.(None): • Conference presentations
p.(None): Outputs
p.(None):
p.(None):
p.(None):
...
p.(None): ethics jargon and is concise and clear. – Elena Tavlaki (Greek), director of Signosis Sprl, co-author of the GCC
p.(None):
p.(None): 9 Towards Equitable Research Partnership
p.(None): 111
p.(None):
p.(None): Good practices know no regional or political boundaries: research that is unethi- cal in Europe is unethical in Africa.
p.(None): That’s why the GCC is needed. – Dr Michael Makanga (Ugandan), executive director of the European & Developing Countries
p.(None): Clinical Trials Partnership, co-author of the GCC
p.(None): The world is unfair. We are talking about R&D in an unfair world ... The Code of Conduct [GCC] is exquisitely clear
p.(None): that it is unethical to do research in one place for the sake of another. (TRUST 2018) – Professor Jeffrey Sachs
p.(None): (American), speaking at the GCC launch in the European Parliament
p.(None): The new four-values system around fairness, respect, care and honesty is highly appreciated in Asia. People find it
p.(None): intuitive – in fact, most audiences loved it. – Dr Vasantha Muthuswamy (Indian), president of the Forum
p.(None): for Ethics Review Committees in India, co-author of the GCC
p.(None): Zhai Xiaomei [Chinese], the executive director of the Centre for Bioethics at the Chinese Academy of Medical Sciences,
p.(None): in Beijing, who is also deputy director of the health ministry’s ethics committee, welcomes what TRUST2 has done.
p.(None): (Economist 2018)
p.(None): To deliver our mission to end world hunger, we need to undertake research. Applying the GCC will assist us
p.(None): greatly. No previous code was designed so clearly for work with highly vulnerable populations in resource-poor
p.(None): settings. – Myriam Ait Aissa (French), head of Research and Analysis at Action contre la Faim, co-author of the GCC
p.(None): Fairness, respect, care and honesty: four simple words with clear meaning to help researchers enter the house through
p.(None): the door and no longer through the win- dow.3 – Dr François Hirsch (French), former head of the Inserm (French
p.(None): National Institute of Health and Medical Research) Office for Ethics, co-author of the GCC
p.(None): Ron Iphofen [British], an adviser on research ethics to the European Commission, believes the code will have a profound
p.(None): impact on how funding proposals to the EU are designed and reviewed. “I could envisage reviewers [of EU-funded
p.(None): research proposals] now looking suspiciously at any application for funds that entailed research by wealthy
p.(None): nations on the less wealthy that did not mention the code,” he says. (Nordling 2018)
p.(None): The emphasis in the GCC on fairness, respect, care and honesty resonates with our work at UNESCO. – Dr Dafna
p.(None): Feinholz (Mexican), UNESCO’s chief of Bioethics and Ethics of Science and Technology, co-author of the GCC
p.(None):
p.(None):
p.(None):
p.(None): 2 The EU-funded consortium that developed the GCC.
p.(None): 3 This refers to Andries Steenkamp’s iconic request to researchers, namely to enter San communi- ties through the
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
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p.(None): Aristotle (384–322 BC) linked human “happiness and wellbeing” to “leading an ethical life”, guided by the cardinal
p.(None): values of courage, justice, modesty and wisdom (Aristotle 2004). According to Confucianism, the most
p.(None): important traditional virtues are said to be benevolence, righteousness, propriety, wisdom, trustworthiness, filial
p.(None): piety, loyalty and reciproc- ity (Wang et al. 2018). Virtues are a good way to drive ethical action, in particular
p.(None): global ethical action, but the TRUST team had good reason not to use virtues as the foundation of the GCC.
p.(None): Virtues can be regarded as embodied ethical values because they are manifested in persons. One can learn a lot by
p.(None): observing real people (such as Mother Theresa or Nelson Mandela) and following their example. This makes virtue
p.(None): approaches very useful in leadership and mentoring (Resnik 2012). But not every researcher has access to
p.(None): mentors and learning via example. Besides, early career researchers are said to benefit more from rule-based approaches
p.(None): (Resnik 2012). Hence, while vir- tues were considered as a possibility for the foundation of the GCC, they
p.(None): were excluded because of their strong reliance upon the availability of role models.
p.(None): Principles have a long-standing tradition in practical moral frameworks, espe- cially principlism, the moral
p.(None): framework relating to bioethics developed by Beauchamp and Childress (2013). As argued in Chapter 4, we
p.(None): believe that the four principles of Beauchamp and Childress – autonomy, non-maleficence (do no harm), beneficence and
p.(None): justice – should instead be called values. Principles, as we under- stand them, are more concrete than values.
p.(None): Principles can provide almost immediate and very straightforward answers to ethical questions.
p.(None): A famous principle in political philosophy is Rawls’s difference principle. The principle holds that divergence from an
p.(None): egalitarian distribution of social goods (e.g. income, wealth, power) is only allowed when this non-egalitarian
p.(None): distribution favours the least advantaged in society (Rawls 1999: 65–70). In other words, if a particularly talented
p.(None): wealth creator increases the overall wealth pie so that the least advantaged in society are better off, she can receive
p.(None): a bigger share of the pie than others. Knowing about this principle gives answers to social philosophy questions, which
p.(None): the value of fairness or justice would not. Rawls applied the value of fairness to derive the more concrete difference
p.(None): principle. Principles are therefore too con- crete and too prescriptive to form the foundation of the GCC. They would
p.(None): not leave enough room for local agreements between partners from high- and lower-income settings as envisaged by
p.(None): various GCC articles, such as article 1: “Local relevance of research … should be determined in collaboration with
p.(None): local partners.”
p.(None):
...
p.(None): all values are culture-bound, and that there are no “extra-cultural” values or norms. We will argue that, for reasons
p.(None): articulated by Bernard Williams (1972) nearly half a century ago, such strict moral relativism is unsustainable.
p.(None): Then we will consider the merits of a more moderate moral relativism, of the sort argued for by the Chinese-American
p.(None): philosopher David Wong (1991, 2009). This approach combines a recognition of variation in norms across cultures with a
p.(None): certain sort of universalism. For Wong, what remains constant across disparate systems of moral norms is the purpose
p.(None): behind any such system, or the aim of morality as such. We will argue that Wong’s approach, though an improvement on a
p.(None): more extreme relativism, does not provide what we need: that is, it does not show there to be some universal norms –
p.(None): among which are our four values – in addition to some genuine cross-cultural normative variation.
p.(None): Finally we introduce an approach that has much in common with the TRUST2 approach: the “four-principles approach”
p.(None): presented by Tom Beauchamp and James Childress in successive editions of their book Principles of Biomedical
p.(None): Ethics (2013). Beauchamp and Childress maintain that there are four central values/prin- ciples3 (see the box below
p.(None): for the difference between the two) that are especially applicable to their own area of ethical interest, biomedical
p.(None): ethics. They use the term principles, and identify them as respect for autonomy, non-maleficence (do no
p.(None): harm), beneficence and justice (Beauchamp and Childress 2013).
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): voluntary exercise for research participants. It is not a mission-driven exercise to impose different ethical values.
p.(None): If researchers from high-income settings cannot agree on a way of undertaking the research that is acceptable to local
p.(None): stakeholders, it should not take place.
p.(None): 2 EU-funded research project, which developed the GCC from 2015 to 2018.
p.(None): 3 According to the definition of values in the box (and in Chapter 3 of this book), the four-principles approach should
p.(None): be called the four-values approach, but this makes no difference in substance.
p.(None):
p.(None): Introduction
p.(None): 29
p.(None):
p.(None):
p.(None): Values and Principles
p.(None): The words “values” and “principles” are often used interchangeably. We will distinguish them as below.
p.(None): If people value something, they hold it dear, and they believe it is of high importance. This could be power, money or
p.(None): kindness; values are not necessar- ily morally positive. Ethical values, on the other hand, are guides on the route to
p.(None): doing the right thing or developing a moral character. They are by definition morally positive. For example, greed is
p.(None): not an ethical value, but generosity is. A principle is a behavioural rule for concrete action. When you know the
p.(None): principle, you know what to do. For instance, the principle in dubio pro reo has saved many innocent people from going
p.(None): to jail as it gives courts very con- crete advice. It means, “When in doubt, then favour the accused,” (in other words,
p.(None): “innocent until proven guilty”) and goes back to both Aristotle and
p.(None): Roman law.
p.(None):
p.(None): Beauchamp and Childress maintain that their four principles are globally appli- cable – that is to say, they are
p.(None): universally relevant to the sorts of ethical questions that arise in biomedicine; they are every bit as integral to the
p.(None): understanding and resolution of medical ethics problems in Bangkok as they are in Boston, equally pertinent in both
p.(None): Cape Town and Copenhagen. Their status as globally applicable is, according to Beauchamp and Childress, underwritten by
p.(None): their forming part of what they call “the common morality”, understood as a system of general norms that will be
p.(None): specified differently in different cultures, but to which all morally committed persons everywhere will subscribe.
p.(None): We want to argue that the four values – fairness, respect, care and honesty – are rooted in a globally applicable
p.(None): common morality, the norms of which can be speci- fied in various ways in disparate cultures. Insofar as this is the
p.(None): case, our argumenta- tional strategy will be similar to that of Beauchamp and Childress.
p.(None): However, we want to maintain that the four GCC values, taken together, have a less contentious claim to be globally
p.(None): applicable than Beauchamp and Childress’s principles, for two reasons.
p.(None): 1. One of Beauchamp and Childress’s principles – respect for autonomy – has often, and with some
p.(None): justification, been criticized for being culturally bound rather than universal (Huxtable 2013, Kara 2007,
p.(None): Cheng-Tek Tai 2013, Kiak Min 2017)
p.(None): 2. The GCC’s four-values approach was developed collaboratively with diverse stakeholders from all continents,
p.(None): including significant representation from vul- nerable research populations (see Chapters 6 and 7).
p.(None):
p.(None): 30 4 Respect and a Global Code of
p.(None): Conduct?
p.(None):
p.(None): The Four Values and Moral Relativism
p.(None):
p.(None): Giving the value of respect high standing, as one of only four values in the GCC framework, opens the framework to
p.(None): attack for being morally relative. Unlike fair- ness, care and honesty, the value of respect centres on foreseeable
p.(None): disagreement. If I have to respect what somebody does in a country that is not my own, even though I disagree heavily
p.(None): for moral reasons, does this mean there are no globally shared values? If this were the case, it would mean that no
p.(None): global moral framework is avail- able to ground the 23 articles of the GCC.
p.(None): In philosophy, this conundrum is called the doctrine of moral relativism. Such relativism has been divided into
p.(None): three related forms with different emphases: descriptive relativism, metaethical relativism and normative
p.(None): relativism.
p.(None):
p.(None):
p.(None): Descriptive relativism
p.(None):
p.(None):
p.(None):
p.(None): Metaethical4 relativism
p.(None):
p.(None):
p.(None):
p.(None): Normative relativism
...
p.(None): contribution to community. It would be surprising, the argument goes, if there were just one justifiable way of setting
p.(None): a priority with respect to the two goods. It should not be surprising, after all, if the range of human goods is simply
p.(None): too rich and diverse to be reconciled in just a single moral ideal.
p.(None): Wong’s approach may be more acceptable than an extreme, uncompromising metaethical relativism (and potentially
p.(None): more serviceable as a means of grounding the four GCC values), but it is not without its problems. For
p.(None): example, Michael Huemer (2005) points out a dilemma for any such relativism. That dilemma is revealed
p.(None): when we ask whether the regulation of interpersonal and intrapersonal conflicts is itself something that we
p.(None): should regard as good. If it is, then the regulation of such conflicts represents a value that transcends cultures,
p.(None): grounding any accept- able morality in any society and/or time. Hence, we would have at least one univer- sal value
p.(None): rather than a form of relativism.
p.(None): As a result, Wong’s approach still does not give us any definite universal values (at a minimum, the four values that
p.(None): feature in the GCC).
p.(None):
p.(None):
p.(None): Grounding the Global Applicability Thesis of the GCC in a Common Morality
p.(None):
p.(None): In their celebrated book Principles of Biomedical Ethics, Tom Beauchamp and James Childress have, over the
p.(None): course of 34 years and seven editions, maintained that there are four principles that are particularly applicable to
p.(None): problems in biomedical ethics: respect for autonomy, beneficence, non-maleficence and justice. As explained above,
p.(None): their claim is that these principles are globally applicable because they are part of what Beauchamp and Childress call
p.(None): “the common morality”, which is to be understood as a set of principles subscribed to by all morally committed people,
p.(None): whatever their culture, and whatever the time in which they live. The principles of
p.(None):
p.(None): Grounding the Global Applicability Thesis of the GCC in a Common Morality 33
p.(None):
p.(None): the common morality, then, are globally applicable, in just the way that the authors of the GCC want the four values of
p.(None): fairness, respect, care and honesty to be.
p.(None): To the rather obvious objection that no set of values/principles seems to possess the universality they ascribe to
p.(None): the common morality, given the observations of descriptive relativism, Beauchamp and Childress have two
p.(None): responses.
p.(None): 1. It is not the case that every principle that exists finds a home in the common morality: some principles are purely
p.(None): local.
p.(None): 2. More importantly, the principles of the common morality may be variously spec- ified in different cultures.
p.(None): The great benefit of the common-morality theory is that it allows an optimum balance of universality on the one hand,
p.(None): and variation across cultural settings on the other. There is a set of high-level values/principles that are internal
p.(None): to morality, but these are expressed in differing ways in particular moralities associated with par- ticular
p.(None): communities.
...
p.(None): Armed with the knowledge that non-maleficence is a foundational principle, and so a principle to which the
p.(None): morally committed will pay heed, Beauchamp and Childress (2009) go on to suggest that we can first identify a
p.(None): large sample of agents who adhere to that norm, and then determine what other general, non-specified
p.(None): principles they all hold in common. Those further general principles will be the remaining constituents of the common
p.(None): morality.
p.(None): In this scenario, partial analysis of the concept of morality reveals that one of its internal principles is
p.(None): non-maleficence. Morally committed persons can then be identified by their subscription to this principle (and
p.(None): not by their adhering to some principle that we just happen to like to think of as very important).
p.(None): The next stage in this method would involve determining what other principles all those morally committed persons
p.(None): champion. In this way, one could discern the
p.(None):
p.(None):
p.(None): 5 “Do no harm” is phrased as a principle, not as a value. Care is a value that includes “do no harm”.
p.(None):
p.(None): Conclusion
p.(None): 35
p.(None):
p.(None): constituents of the common morality without undertaking the rather forbidding chore of a full-blown,
p.(None): exhaustive analysis of the concept of morality itself.
p.(None): Beyond this thought experiment, however, we would still have to account for what appear to be counter-examples to
p.(None): Beauchamp and Childress’s claim that their four principles are globally applicable. Such counter-examples have been
p.(None): produced, especially against the principle of respect for autonomy, which is regarded as bound to Western cultures
p.(None): (Huxtable 2013; Kara 2007, Cheng-Tek Tai 2013, Kiak Min 2017). We want to examine one such counter-example.
p.(None): R.E. Florida (1996), in an article entitled “Buddhism and the Four Principles”, insists that no principle of respect
p.(None): for autonomy is to be found in Buddhist cultures at all, due to Buddhism’s metaphysic of “co-conditioned causality”.
p.(None): The thought seems to be that autonomy is not going to show up as a value, and so as something especially worthy of
p.(None): respect, in a culture that holds to a conceptual scheme in which there is no genuine separation between what those
p.(None): outside that culture call “indi- viduals” (any apparent separation being at best an illusion).
p.(None): The interesting thing about the Buddhist example is that it would be very difficult to argue that Buddhist culture is
p.(None): not fundamentally committed to non-maleficence. The notion looms exceptionally large in Buddhist ethics, in the shape
p.(None): of the norm of ahimsa, or non-harm. Those who are committed to Buddhist ethics, then, are, by Beauchamp and Childress’s
p.(None): vision, morally committed. And yet, if Florida is right, subscription to the principle of non-maleficence is not
p.(None): universally accompanied by subscription to the principle of respect for autonomy. Hence, at least one element of the
p.(None): group of four principles chosen by Beauchamp and Childress, namely respect for autonomy, does not seem to belong to the
p.(None): common morality.
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): The most promising approach based on values/principles to claim global applicabil- ity for its framework has a hole. As
p.(None): the example of Buddhist ethics shows, respect for individual autonomy cannot be regarded as a globally applicable
p.(None): value/principle that all morally committed people would subscribe to. Respect for autonomy, with the focus on
p.(None): individual autonomy, as understood by Beauchamp and Childress (2013: Chapter 4) does not seem to qualify for
p.(None): global applicability, as the Buddhist counter-example is solid. But that does not mean other values systems must fail.
p.(None): If key values are, as argued above, internal to morality, the four-values approach developed for the GCC is valid until
p.(None): falsified with rigorous counter-examples, such as the Florida example against respect for autonomy.
p.(None):
p.(None): 36 4 Respect and a Global Code of
p.(None): Conduct?
p.(None):
p.(None): References
p.(None):
p.(None): Beauchamp TL, Childress JF (2009) Principles of biomedical ethics, 6th edn. Oxford University Press, New York
p.(None): Beauchamp TL, Childress JF (2013) Principles of biomedical ethics, 7th edn. Oxford University Press, New York
p.(None): Cheng-Tek Tai M (2013) Western or Eastern principles in globalized bioethics? An Asian perspec- tive view. Tzu Chi
p.(None): Medical Journal 25(1):64–67
p.(None): Florida RE (1996) Buddhism and the four principles. In: Gillon R (ed) Principles of healthcare ethics. John Wiley and
p.(None): Sons, Chichester, p 105–116
p.(None): Foot P (2002) Moral dilemmas. Oxford University Press, Oxford
p.(None): Herissone-Kelly P (2003) The principlist approach to bioethics, and its stormy journey overseas. In: Häyry M, Takala
p.(None): T (eds) Scratching the surface of bioethics. Rodopi, Amsterdam and New York, p 65–77
p.(None): Huemer M (2005) Ethical intuitionism. Palgrave Macmillan, New York
p.(None): Huxtable R (2013) For and against the four principles of biomedical ethics. Clinical Ethics 8(2–3):39–43
p.(None): Kara M A (2007) Applicability of the principle of respect for autonomy: the perspective of Turkey.
p.(None): Journal of Medical Ethics 33(11):627–630
p.(None): Kiak Min MT (2017) Beyond a Western bioethics in Asia and its implication on autonomy. The New Bioethics 23(2):154–164
p.(None): Williams B (1972) Morality: an introduction to ethics. Cambridge University Press, Cambridge Wong D (1991) Relativism.
p.(None): In: Singer P (ed) A companion to ethics. Blackwell, Oxford, p 442–450 Wong D (2009) Natural moralities: a defense of
p.(None): pluralistic relativism. Oxford University Press,
p.(None): New York
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 5
p.(None): Exploitation Risks in Collaborative International Research
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None):
p.(None):
p.(None): Respect
p.(None):
p.(None): Respect requires an acceptance of customs and cultures that may be different from one’s own, and a commitment not to
p.(None): behave in a way that causes offence. One may need to abide by decisions or ways of approaching matters with which one
p.(None): dis- agrees. This can be problematic, especially if local customs are illegal or perceived as dangerous.6 However,
p.(None): respect is important in LMIC-HIC collaborations, and there are many possible ways of showing respect that do not
p.(None): create conflicts of con- science. For instance, HIC researchers should not insist that LMIC ethics commit- tees accept
p.(None): the ethics approval submission in the HIC’s preferred format, but should rather conform with the format preferred by
p.(None): the LMIC committee. Table 5.3 shows the primary risks related to respect for persons, institutions, communities,
p.(None): countries, animals and the environment.
p.(None): Local LMIC customs, traditions, and religious and spiritual beliefs may be very different from those of the HIC
p.(None): researcher. For example, from an African cultural point of view, human body parts are sacred, whether they are obtained
p.(None): from living or deceased persons. Hence, the removal of blood or other body parts for research may have a profound
p.(None): impact that needs to be acknowledged and addressed in a man- ner that is sensitive to the wishes of the local
p.(None): community. A liberal interpretation of autonomy, i.e. individual autonomy, prevails in HICs but may not be
p.(None): easily transferred to LMIC settings where “community” or “group autonomy” is also highly valued. Furthermore,
p.(None): in some settings it might be deemed rude for a research participant to say “no” or to ask questions about the research.
p.(None): In other situations, people may be too afraid or unconfident to do so. Either way, the power imbalance between
p.(None): researcher and research participant can impact upon the consent process.
p.(None):
p.(None): 6 For instance, if a researcher learns that female genital mutilation is being used as a “cure” for diarrhoea in female
p.(None): babies, respecting this approach to health care is likely to be the wrong deci- sion, particularly as the practice is
p.(None): likely illegal. At the very least such a decision would leave the researcher with a serious conflict of conscience (Luc
p.(None): and Altare 2018).
p.(None):
p.(None): 44 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): Table 5.3 Primary risks for respect
p.(None): Level of risk Nature of risk
p.(None): Personal • Unequal power relations
p.(None): • Tendency to defer to authorities
p.(None): • Individual spiritual and religious priorities incompatible with or ignored by HIC partners
p.(None): • Researchers and/or ethics committees deciding “what is best”
p.(None):
p.(None): Researcher/ institutional
p.(None): • Research protocol and papers imported from HIC partners and not tailored to local needs
p.(None): • Ethical approval sought only from HIC partner
p.(None): Community • Diverse interpretations of important values
...
General/Other / Manipulable
Searching for indicator manipulate:
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p.(None): Telling lies is only one possible wrongdoing in the context of a broad understanding of honesty. For instance, in
p.(None): research ethics it is equally unacceptable to leave out salient features from an informed consent process. While this
p.(None): might, strictly speaking, not involve a lie, concealing important informa- tion that might make a difference to
p.(None): someone’s consent violates the value of honesty as much as lying. For this reason, research ethicists often use the
p.(None): terms “transpar- ency” and “open communication” to ensure that all relevant information is provided so that research
p.(None): participants can make an informed choice about whether to partici- pate or not.
p.(None): In addition to lying and withholding information, there are other ways of being dishonest, in the sense of not
p.(None): communicating openly and transparently. For instance, in a vulnerable population with high levels of illiteracy, it can
p.(None): be predicted that a printed information sheet about research will not achieve informed consent. The same can be said
p.(None): for a conscious failure to overcome language barriers in a mean- ingful way: leaving highly technical English
p.(None): terms untranslated in information sheets can easily lead to misunderstandings.
p.(None): Honesty is also related to research conduct other than interaction with research participants. Most prominently, the
p.(None): duties of honesty are described in research integrity frameworks: do not manipulate your data, do not put your
p.(None): name onto pub- lications to which you have not contributed, do not waste research funds, to give only three examples.
p.(None): However, while the latter prescriptions for conduct with integ- rity in research are important, they are not directly
p.(None): linked to exploitation in global research collaboration and are not covered in the GCC. In this context, the European
p.(None): Code of Conduct for Research Integrity (ALLEA, 2017) is very helpful.
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): Standards, principles, values, virtues and ideals can guide moral action. At the foun- dation of the GCC are values.
p.(None): Why? For three main reasons:
p.(None): 1. Values inspire action; they motivate people to do things. For instance, when the value of fairness is threatened,
p.(None): people normally respond with action.
p.(None): 2. Values provide the golden middle way between being overly prescriptive and overly aspirational. Standards and
p.(None): principles require too much precision in their formulation and are too prescriptive in international collaborative
p.(None): research, while virtues and ideals are too aspirational in their demands of researchers.
p.(None): 3. Values emerged naturally from the major engagement activities undertaken prior to developing the GCC.
p.(None): The eradication of ethics dumping requires not only moral guidance but also moral action to counter violations of
p.(None): fairness, respect, care and honesty. The 23 short, accessible articles of the GCC are intended to both guide and
p.(None): inspire research- ers to act with fairness, respect, care and honesty.
p.(None):
p.(None): References
p.(None): 25
p.(None):
p.(None): References
p.(None):
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.(None): Crabb S (2011) The use of coaching principles to foster employee engagement. The Coaching Psychologist 7(1):27–34
p.(None): Directorate General for Research (2019) Horizon 2020 Programme: guidance – how to complete your ethics self-assessment,
p.(None): version 6.1. European Commission. http://ec.europa.eu/research/
p.(None): participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-self-assess_en.pdf
p.(None): Google (nd) Honesty: synonyms. https://www.google.com/search?q=honesty&ie=&oe= Google (2018) Google search for
p.(None): “Honesty” conducted on 24 November 2018.
p.(None): Huijer M, van Leeuwen E (2000) Personal values and cancer treatment refusal. Journal of Medical Ethics 26(5):358–362
p.(None): ISO (nd) ISO 26000: social responsibility. International Organization for Standardization. https://
p.(None): www.iso.org/iso-26000-social-responsibility.html
p.(None): Kaufmann E (2016) It’s NOT the economy, stupid: Brexit as a story of personal values. British Politics and Policy.
p.(None): London School of Economics and Political Science. http://blogs.lse.ac.uk/
p.(None): politicsandpolicy/personal-values-brexit-vote/
p.(None): Klein LA (2017) A free press is necessary for a strong democracy. ABA Journal. http://www.aba-
p.(None): journal.com/magazine/article/free_press_linda_klein?icn=most_read
p.(None): Locke EA (1991) The motivation sequence, the motivation hub, and the motivation core.
p.(None): Organizational Behavior and Human Decision Processes 50(2):288–299
p.(None): Luc G, Altare C (2018) Social science research in a humanitarian emergency context. In: Schroeder D, Cook J, Hirsch F,
p.(None): Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North- South research collaborations. Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 9–14. https://link.springer.com/book/10.1007%2F978-3-319-64731-9
p.(None): Mansor M, Tayib D (2010). An empirical examination of organisational culture, job stress and job satisfaction within
p.(None): the indirect tax administration in Malaysia. International Journal of Business and Social Science 1(1):81–95
p.(None): Marcum JA (2008). Medical axiology and values. In: An introductory philosophy of medicine: humanizing modern medicine.
p.(None): Philosophy and Medicine 99. Springer Science and Business Media, p 189–205
p.(None): Martins N, Coetzee M (2011) Staff perceptions of organisational values in a large South African manufacturing company:
p.(None): exploring socio-demographic differences. SA Journal of Industrial Psychology 37(1):1–11
p.(None): Mitchell LA (2015) Integrity and virtue: the forming of good character. The Linacre Quarterly 82(2):149–169
p.(None): NMC (2018) The code: professional standards of practice and behaviour for nurses, midwives and nursing associates.
p.(None): Nursing & Midwifery Council. https://www.nmc.org.uk/standards/code/ Ofori DF, Sokro E (2010). Examining the impact of
p.(None): organisational values on corporate perfor-
p.(None): mance in selected Ghanaian companies. Global Management Journal 2(1)
p.(None): Ogletree TW (2004) Value and valuation. In: Post SG (ed) Encyclopedia of bioethics, 3rd edn.
p.(None): MacMillan Reference USA, New York, p 2539–2545
...
p.(None): placebo), so that the outcomes can be compared.
p.(None): 3 One speaks of a proven standard of care when a treatment already exists for the illness under consideration in a
p.(None): trial. Hence, the ethical demand of testing any new drug against an existing one rather than a placebo is known as the
p.(None): “standard of care” debate.
p.(None):
p.(None): Our Method
p.(None): 39
p.(None):
p.(None): can help to increase awareness but, in our case, it also ensures that the GCC is designed in such a way
p.(None): that researchers are compelled to consider these factors. It is a unique facet of the GCC that it focuses the attention
p.(None): of researchers directly upon the primary risks of exploitation in collaborative HIC-LMIC research. This could only be
p.(None): achieved via thorough exploration of the risks from many perspectives, both top-down and bottom-up.
p.(None):
p.(None):
p.(None): Our Method
p.(None):
p.(None): The aim of this investigation was to identify the critical vulnerabilities that engender susceptibility to exploitation
p.(None): in LMIC-HIC collaborative research. Investigation of this vast subject would be impossible from a traditional
p.(None): literature-based approach, or through investigation in a single geographical region. Many of these vulnerabili- ties
p.(None): are poorly represented in the literature, and they can differ between countries, cultures and types of research. For
p.(None): example, clinical trials, social science, animal experiments, environmental science and research in emergency settings
p.(None): may pose a diverse array of risks that are largely determined by the local context. Consequently, a creative approach
p.(None): to data collection was needed to capture as many risks and vul- nerabilities as possible.
p.(None): In this regard it was very helpful that the interdisciplinary TRUST project con- sortium comprised multilevel ethics
p.(None): bodies, policy advisers and policymakers, civil society organizations, funding organizations, industry and academic
p.(None): scholars from a range of disciplines. With input from each of these perspectives, a broad-based consultative exercise4
p.(None): was possible which included input from these collaborators as well as more than 30 members and chairs of ethics
p.(None): committees in LMICs, represen- tatives from vulnerable populations in LMICs, and an open call for case studies of
p.(None): exploitation in research in LMICs (Chapter 6).
p.(None): For example, extensive input from members and chairs of ethics committees was sought in both India and Kenya. In India,
p.(None): the Forum for Ethics Review Committees in India (FERCI) hosted a two-day workshop in Mumbai on 11 and 12 March 2016. At
p.(None): this workshop, approximately 30 leading bioethicists from around India came together to share their experiences and
p.(None): discuss cases of exploitation in research. In Nairobi on 23 and 24 May 2016, three esteemed chairs of national ethics
p.(None): commit- tees shared their experiences and opinions about the primary ethical challenges for LMIC-HIC collaborative
...
p.(None): References
p.(None):
p.(None): Alvarez-Castillo F (2016) Gender sensitivity: writing and language. In: Chatfield K, Schroeder D, Kimani J (eds)
p.(None): Nairobi plenary meeting report, TRUST Project. http://trust-project.eu/wp-
p.(None): content/uploads/2016/11/Meeting-Report-TRUST-Nairobi-Final.pdf
p.(None): Annas G, Grodin M (1998) Human rights and maternal-fetal HIV transmission prevention trials in Africa. American Journal
p.(None): of Public Health 88(4):560–563
p.(None): Bhatt K (2016) Concerns for Kenyan National Bioethics Committee when approving North-South collaborative projects. In:
p.(None): Chatfield K, Schroeder D, Kimani J (eds) Nairobi plenary meeting report, TRUST Project.
p.(None): http://trust-project.eu/wp-content/uploads/2016/11/Meeting-Report- TRUST-Nairobi-Final.pdf
p.(None): EU (2010) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of
p.(None): animals used for scientific purposes (text with EEA relevance). OJ L 276/33.
p.(None): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32010L0063
p.(None): Hill CM, Webber AD (2010) Perceptions of nonhuman primates in human–wildlife conflict sce- narios. American Journal of
p.(None): Primatology 72(10):919−924
p.(None): Hughes J (2010) European textbook on ethics in research. European Commission, Brussels
p.(None):
p.(None): 50 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): Luc G, Altare C. (2018) Social science research in a humanitarian emergency context. In: Schroeder D, Cook J, Hirsch F,
p.(None): Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North- South research collaborations, Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 9-14
p.(None): Macklin R (2003) Vulnerability and protection. Bioethics 17(5–6):472–486
p.(None): Pogge T (2006) Justice. In: Borchert DM (ed) Encyclopedia of philosophy, 2nd edn, vol 4.
p.(None): Macmillan Reference, Detroit, pp 862–870
p.(None): Russell WMS, Burch RL, Hume CW (1959) The principles of humane experimental technique.
p.(None): Methuen & Co, London
p.(None): Schwartz J (1995) What’s wrong with exploitation? Nous 29:158–164
p.(None): Stone CD (2010) Should trees have standing? Law, morality, and the environment, 3rd edn. Oxford University Press,
p.(None): Oxford
p.(None): Smith, LT (2012) Decolonizing methodologies: research and indigenous peoples. Zed Books, London
p.(None): Universities UK (2015) The concordat to support research integrity. Universities UK, London Wood A (1995) Exploitation.
p.(None): Social Philosophy and Policy 12:150–151
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
p.(None): 105, 110
p.(None): Compensation, 43
p.(None): Complaints, 3, 8, 21, 42, 90, 91,
p.(None): 95–103, 105
p.(None): Complaints procedure, 3, 21, 42, 90, 91,
p.(None): 97–103
p.(None): Compliance, 9, 11, 14, 37, 42, 43, 47, 52, 81,
p.(None): 84, 89, 90, 96, 98
p.(None): Confidentiality, 96, 97, 100, 102 Conflicts of interest, 32
p.(None): Consent, 2, 7, 8, 24, 43–48, 63, 64, 66, 74, 82,
p.(None): 84, 96, 100, 105, 112
p.(None): Convention on Biological Diversity (CBD), 13, 77, 78, 117
p.(None): Corruption, 10
p.(None): Cultural sensitivities, 7, 27, 64
p.(None): Cultures, 14, 15, 18, 20, 23, 28–33, 35, 39, 43,
p.(None): 44, 46, 47, 49, 64, 76–78, 83, 91,
p.(None): 94–98, 100, 102, 103
p.(None): Customs, 19, 20, 40, 43, 44, 47, 83
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6
p.(None): 119
p.(None):
p.(None): 120
p.(None):
p.(None): D
p.(None): Data, 6, 7, 11, 19, 20, 24, 39–42, 45–47, 60,
p.(None): 66, 104, 117
p.(None): Data ownership, 6, 20, 60, 66, 104
p.(None): Data protection, 11, 47
p.(None): Declaration of Helsinki, 13, 22, 23, 51,
p.(None): 61, 117
p.(None): Descriptive relativism, 30, 33
p.(None): Development, 2, 19, 37, 39, 52–55, 57, 58, 60,
p.(None): 63, 65, 70, 74, 76–80, 82, 90–92, 96,
p.(None): 102–105, 110, 115–117
p.(None): Difference principle, 17
p.(None): Discrimination, 9, 11, 63, 68
p.(None): Double standards, 2, 6, 70
p.(None):
p.(None):
p.(None): E
p.(None): Ebola, 2
p.(None): Emergency research, 39
p.(None): Environmental protection, 10, 23, 42, 44,
p.(None): 45, 67
p.(None): Equitable partnerships, 14, 60, 104, 105,
p.(None): 109–112
p.(None): Ethical guidelines, 65–67, 105, 117
p.(None): Ethical review, 8, 18, 23, 39, 51, 56, 61,
p.(None): 65–68, 110, 111, 115, 116
p.(None): Ethical values, 7, 17–19, 28, 29, 82
p.(None): Ethics approval, 2, 8, 18, 22, 43, 44, 46, 48,
p.(None): 66, 77, 98
p.(None): Ethics committee, 8, 18, 21, 22, 39, 42–44, 46,
p.(None): 51, 52, 54, 56, 58, 62, 65–67, 69, 70,
p.(None): 74, 98, 103, 110, 111, 116
p.(None): Ethics dumping, 1–3, 5–11, 14, 18, 19, 24, 27,
p.(None): 37, 52–54, 56–58, 61, 63, 66–68, 70,
p.(None): 89–98, 100–105, 109, 110, 112
p.(None): Europe, 1, 55, 65, 111
p.(None): European Code of Conduct for Research Integrity, 5, 24, 117
p.(None): European Commission (EC), 1, 2, 23, 52–54,
p.(None): 57, 70, 110–112, 117
p.(None): European Parliament, 2, 64, 70, 111, 115
p.(None): European Union (EU), 1, 14, 28, 48, 53, 54,
p.(None): 60, 64, 70, 80, 110–112, 116
p.(None): Evaluation, 6, 20, 63, 65, 93, 96, 98
p.(None): Exploitation, 2, 3, 14, 24, 37–49, 54, 58, 60,
p.(None): 62, 63, 65, 66, 74, 82, 83, 105
p.(None): Exploitative, 19, 38, 40, 41
p.(None):
p.(None):
p.(None): F
p.(None): Fairness, 2, 5–7, 13–24, 27–31, 33, 40–43, 68,
p.(None): 70, 74, 77–78, 82, 84, 90, 93, 95–98,
p.(None): 102, 110–112, 117
p.(None): Index
p.(None):
p.(None): Fair research contract (FRC), 90, 103, 104
p.(None): Farmers, 101
p.(None): Feedback, 6, 8, 20, 41, 48, 61, 63, 64, 83,
p.(None): 96, 105
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None):
p.(None): References
p.(None): 49
p.(None):
p.(None): maintaining power differentials. To give one striking example, the United Nations Security Council has 15 members. Of
p.(None): these, ten are elected by the General Assembly for periods of two years while five (China, France, Russia, the United
p.(None): Kingdom and the United States) have been permanent members with “veto power” since 1946. More than 60 United
p.(None): Nations member states have never been members of the Security Council and hence have never even had voting
p.(None): rights, let alone veto power.
p.(None):
p.(None):
p.(None): Past History of Colonialism
p.(None):
p.(None): Does the history of colonialism still bear upon research today? We believe it does, as can be seen from the experience
p.(None): of indigenous peoples in research. Linda Tuhiwai Smith has powerfully shown that indigenous peoples often
p.(None): consider research a “dirty word”. She describes how “imperialism frames the indigenous experience” and how
p.(None): “indigenous peoples had to challenge, understand and have a shared lan- guage for talking about ... colonialism” (Smith
p.(None): 2012).
p.(None): We close this chapter with a comment from the TRUST gender adviser, Prof.
p.(None): Fatima Alvarez-Castillo (2016):
p.(None): A culture’s worldview, expressed in language, contains norms and values about power and relations of power. For
p.(None): example, the word “expert” imbues persons with authority and assigns higher credibility to their claims than
p.(None): those of non-experts. The public is expected to defer to their opinions on matters of their expertise. It was not until
p.(None): about the 1960s when the usual understanding of expertise was challenged by feminists, who argued that
p.(None): unschooled women have more expertise about their own situation than the experts. This ushered in a new research
p.(None): philosophy that valorizes poor women’s stories and their own versions of their realities.
p.(None):
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Alvarez-Castillo F (2016) Gender sensitivity: writing and language. In: Chatfield K, Schroeder D, Kimani J (eds)
p.(None): Nairobi plenary meeting report, TRUST Project. http://trust-project.eu/wp-
p.(None): content/uploads/2016/11/Meeting-Report-TRUST-Nairobi-Final.pdf
p.(None): Annas G, Grodin M (1998) Human rights and maternal-fetal HIV transmission prevention trials in Africa. American Journal
p.(None): of Public Health 88(4):560–563
p.(None): Bhatt K (2016) Concerns for Kenyan National Bioethics Committee when approving North-South collaborative projects. In:
p.(None): Chatfield K, Schroeder D, Kimani J (eds) Nairobi plenary meeting report, TRUST Project.
p.(None): http://trust-project.eu/wp-content/uploads/2016/11/Meeting-Report- TRUST-Nairobi-Final.pdf
...
p.(None): relationships can be substantial. For example, when working with impoverished communities, HIC researchers
p.(None): should be aware that participation in a clinical study may provide a participant’s only access to health care or other
p.(None): much- needed benefits. Fear of retribution is often cited as a barrier to making a complaint, particularly in
p.(None): circumstances where the complainant has an ongoing relationship with the complainee (HPC 2009). In situations where
p.(None): there is a power imbalance, people may not have the confidence to complain; they may be reluctant to seem ungrateful,
p.(None): not wish to be seen as a complainer, or fear loss. Research has shown that some people even reconstruct negative
p.(None): experiences in a positive light in order to maintain relationships (Edwards et al. 2004).
p.(None): In addition to the above, participatory engagement activities in the TRUST proj- ect (Chapter 6) have revealed the
p.(None): following factors that could also act as barriers to research participants making complaints about research activities
p.(None): in LMICs:
p.(None): • Fear of damage or stigmatization from loss of confidentiality or anonymity. In Kenya, for example, where sex work
p.(None): is illegal, sex workers may be reluctant to make any formal complaints.
p.(None): • Cultural norms that preclude complaining. In some cultures, it is not acceptable to make complaints, especially
p.(None): to or about visitors and/or those in authority. Complaining may be perceived as disrespectful, ungrateful or
p.(None): inappropriate.
p.(None): • Illiteracy of research participants and communication (language) difficulties, leading to a lack of
p.(None): understanding of reasonable rights relating to informed con- sent and to reasonable expectations of the research.
p.(None):
p.(None): Developing an Accessible Complaints Procedure 101
p.(None):
p.(None): • Inability to access the means by which to file a complaint: for example, if only an email address is provided as a
p.(None): contact and one has no access to computers or internet connections.
p.(None):
p.(None):
p.(None): The Scope of a Complaints Procedure
p.(None):
p.(None): A comprehensive complaints procedure can have a broad scope; it can be used to complain about any activities that are
p.(None): associated with a research study. These may include, for example:
p.(None): • any perceived deviation from the information provided
p.(None): • any deviation from agreed processes
p.(None): • treatment by members of the research team that is considered inappropriate
p.(None): • problems with the organization of the study (for example, the competence of the researchers and their ability to
p.(None): perform duties)
p.(None): • the (mis)handling of personal or sensitive information
p.(None): • concerns about any unethical behaviour or practices by the research team
p.(None): The scope of a complaints procedure will also depend upon the intended users. Many complaints procedures are intended
...
General/Other / Undue Influence
Searching for indicator undueXinfluence:
(return to top)
p.(None): During this important workshop, the San developed a range of general principles that applied to their own community.
p.(None): These principles were as follows and were used for a first draft of the San Code of Research Ethics:
p.(None): • The San require respect to the environment, to San leaders and individuals, and to cultural values.
p.(None): • Honesty, integrity and honour are important between all partners.
p.(None): • Cultural and spiritual values must be fully honoured and respected in all research and media projects.
p.(None): • The right formal process should be followed to protect communities in research.
p.(None): • Informed consent is central to all research.
p.(None): • Genetics samples should only be used for the purpose stated in the research contract.
p.(None): • Researchers should not enter a community without being guided and led by members of the community
p.(None): itself.
p.(None): • Both researcher and community should benefit from the interaction.
p.(None): In November 2016, SASI organized a third workshop with the same delegates and some of the earlier external contributors
p.(None): to finalize the content of the San Code of Research Ethics. The overall goal was to achieve fair research partnerships.
p.(None): The following threats and weaknesses were discussed.
p.(None): • Vulnerable and far-flung populations and serious poverty
p.(None): • Undue influence by researchers, due to poverty
p.(None): • “Free riders” who do not support San community concerns when taking part in research for cash
p.(None): • Exploitation possibilities due to illiteracy
p.(None): • Lack of knowledge of research, what it means and what its risks are
p.(None): • Lack of knowledge about the San leadership’s approach to research
p.(None): • Lack of assistance from the government
p.(None): • Low self-esteem in engaging with outside individuals and agencies
p.(None): • Earlier theft of traditional knowledge leading to mistrust of researchers
p.(None): • Lack of system to combat the problems
p.(None): • Lack of institutional and financial support to the leadership who aim to improve the situation
p.(None): With these challenges in mind, the initial draft of the San Code of Research Ethics was revised and
p.(None): refined. In addition, each element of the new draft code was grouped into one of the four TRUST ethical values of
p.(None): fairness, respect, care, and honesty. These values had been agreed on previously by the TRUST group, with San input.
p.(None): The four core values were to be supported by a fifth value, which the San
p.(None):
p.(None): 7 A short video presentation about the workshop is available at https://www.youtube.com/ watch?v=HOdw3mv7JSo.
p.(None):
p.(None): The San Code of Research Ethics
p.(None): 83
p.(None):
p.(None): delegates deemed essential, namely proper process. In small groups the key points of each value were written out in
p.(None): greater detail.
p.(None): A highly important decision was that examples of past exploitation would form part of the code itself.
...
General/Other / cultural difference
Searching for indicator culturally:
(return to top)
p.(None): possible, from planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly
p.(None): represented. This approach represents Good Participatory Practice.
p.(None):
p.(None):
p.(None): Article 3
p.(None):
p.(None): Feedback about the findings of the research must be given to local communities and research participants. It should be
p.(None): provided in a way that is meaningful, appropriate and readily comprehended.
p.(None):
p.(None):
p.(None): Article 4
p.(None):
p.(None): Local researchers should be included, wherever possible, throughout the research process, including in study design,
p.(None): study implementation, data ownership, intellec- tual property and authorship of publications.
p.(None):
p.(None): Respect
p.(None): 7
p.(None):
p.(None): Article 5
p.(None):
p.(None): Access by researchers to any biological or agricultural resources, human biological materials, traditional knowledge,
p.(None): cultural artefacts or non-renewable resources such as minerals should be subject to the free and prior informed consent
p.(None): of the owners or custodians. Formal agreements should govern the transfer of any material or knowledge to
p.(None): researchers, on terms that are co-developed with resource custodians or knowledge holders.
p.(None):
p.(None):
p.(None): Article 6
p.(None):
p.(None): Any research that uses biological materials and associated information such as tra- ditional knowledge or genetic
p.(None): sequence data should clarify to participants the poten- tial monetary and non-monetary benefits that might arise. A
p.(None): culturally appropriate plan to share benefits should be agreed to by all relevant stakeholders, and reviewed regularly
p.(None): as the research evolves. Researchers from high-income settings need to be aware of the power and resource differentials
p.(None): in benefit-sharing discussions, with sustained efforts to bring lower-capacity parties into the dialogue.
p.(None):
p.(None):
p.(None): Article 7
p.(None):
p.(None): It is essential to compensate local research support systems, for instance translators, interpreters or local
p.(None): coordinators, fairly for their contribution to research projects.
p.(None):
p.(None):
p.(None): Respect
p.(None): Article 8
p.(None):
p.(None): Potential cultural sensitivities should be explored in advance of research with local communities, research
p.(None): participants and local researchers to avoid violating custom- ary practices. Research is a voluntary exercise for
p.(None): research participants. It is not a mission-driven exercise to impose different ethical values. If researchers from
p.(None): high- income settings cannot agree on a way of undertaking the research that is acceptable to local stakeholders, it
p.(None): should not take place.
p.(None):
p.(None): 8 2 A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None): Article 9
p.(None):
p.(None): Community assent should be obtained through recognized local structures, if required locally. While individual
p.(None): consent must not be compromised, assent from the community may be an ethical prerequisite and a sign of respect for the
...
p.(None): “innocent until proven guilty”) and goes back to both Aristotle and
p.(None): Roman law.
p.(None):
p.(None): Beauchamp and Childress maintain that their four principles are globally appli- cable – that is to say, they are
p.(None): universally relevant to the sorts of ethical questions that arise in biomedicine; they are every bit as integral to the
p.(None): understanding and resolution of medical ethics problems in Bangkok as they are in Boston, equally pertinent in both
p.(None): Cape Town and Copenhagen. Their status as globally applicable is, according to Beauchamp and Childress, underwritten by
p.(None): their forming part of what they call “the common morality”, understood as a system of general norms that will be
p.(None): specified differently in different cultures, but to which all morally committed persons everywhere will subscribe.
p.(None): We want to argue that the four values – fairness, respect, care and honesty – are rooted in a globally applicable
p.(None): common morality, the norms of which can be speci- fied in various ways in disparate cultures. Insofar as this is the
p.(None): case, our argumenta- tional strategy will be similar to that of Beauchamp and Childress.
p.(None): However, we want to maintain that the four GCC values, taken together, have a less contentious claim to be globally
p.(None): applicable than Beauchamp and Childress’s principles, for two reasons.
p.(None): 1. One of Beauchamp and Childress’s principles – respect for autonomy – has often, and with some
p.(None): justification, been criticized for being culturally bound rather than universal (Huxtable 2013, Kara 2007,
p.(None): Cheng-Tek Tai 2013, Kiak Min 2017)
p.(None): 2. The GCC’s four-values approach was developed collaboratively with diverse stakeholders from all continents,
p.(None): including significant representation from vul- nerable research populations (see Chapters 6 and 7).
p.(None):
p.(None): 30 4 Respect and a Global Code of
p.(None): Conduct?
p.(None):
p.(None): The Four Values and Moral Relativism
p.(None):
p.(None): Giving the value of respect high standing, as one of only four values in the GCC framework, opens the framework to
p.(None): attack for being morally relative. Unlike fair- ness, care and honesty, the value of respect centres on foreseeable
p.(None): disagreement. If I have to respect what somebody does in a country that is not my own, even though I disagree heavily
p.(None): for moral reasons, does this mean there are no globally shared values? If this were the case, it would mean that no
p.(None): global moral framework is avail- able to ground the 23 articles of the GCC.
p.(None): In philosophy, this conundrum is called the doctrine of moral relativism. Such relativism has been divided into
p.(None): three related forms with different emphases: descriptive relativism, metaethical relativism and normative
p.(None): relativism.
p.(None):
p.(None):
p.(None): Descriptive relativism
p.(None):
p.(None):
p.(None):
p.(None): Metaethical4 relativism
p.(None):
p.(None):
p.(None):
p.(None): Normative relativism
p.(None): Descriptive relativism is a sociological or anthropological, rather than philosophical, doctrine, which is based upon
p.(None): observations of disparate cultures. It holds that, as a matter of fact, moral norms show considerable variation across
...
p.(None):
p.(None):
p.(None): 4 Metaethics is a branch of analytical philosophy which deals with higher-level questions of moral- ity. Rather than
p.(None): asking how to lead a moral life, which values are appropriate to govern it, etc., metaethics asks whether such
p.(None): questions can be answered in the first place.
p.(None):
p.(None): A More Moderate Relativism
p.(None): 31
p.(None):
p.(None): Descriptive Relativism
p.(None): Metaethical Relativism
p.(None): Normative Relativism
p.(None):
p.(None): One can observe different moral norms
p.(None): There are no universal or extra-cultural moral truths
p.(None): We have to "live and let live"
p.(None): Fig. 4.1 Different types of relativism and their relationship
p.(None):
p.(None): which he calls normative relativism “possibly the most absurd view to have been advanced even in moral philosophy”. He
p.(None): writes:
p.(None): [T]he view is clearly inconsistent, since it makes a claim … about what is right and wrong in one’s dealings with other
p.(None): societies, which uses a nonrelative sense of “right” not allowed for in [metaethical relativism].
p.(None): In other words, metaethical relativism does not lead to any position, including normative relativism, which tells us
p.(None): what we should do in interacting with those from other cultures. This is simply because metaethical relativism itself
p.(None): tells us that there is no global “should”. Every claim about what we should do has been generated and will be bound by
p.(None): our own culture. If the imperative to treat those from other cultures with fairness, respect, care and honesty is
p.(None): thought to be one that floats free of, and exists outside, any culturally bound system of values, and we want the GCC
p.(None): to apply globally, then we cannot be metaethical relativists.
p.(None):
p.(None):
p.(None): A More Moderate Relativism
p.(None):
p.(None): It may be that we can justify the four values by appealing to the more moderate form of relativism espoused by David
p.(None): Wong (2009). According to Wong, although moral norms do indeed vary across cultures, as the descriptive
p.(None): relativist assumes, and although there is no one single true morality, there is something that is universal about
p.(None): morality, and common to all particular moralities worthy of the name.
p.(None): What is common is the central aim or purpose of morality. This aim is not itself a value in any given moral system, but
p.(None): rather what determines whether any given value is fit to figure in such a system. A consequence of this, and one which
p.(None): renders Wong’s relativism more palatable for many than more extreme versions, is that although there is no
p.(None): single true morality, some moral systems are better than others.
p.(None):
p.(None): 32 4 Respect and a Global Code of
p.(None): Conduct?
p.(None):
p.(None): Why? Because moral systems regulate interpersonal and intrapersonal conflicts. More precisely (Wong 2009: xii):
p.(None): Morality … comprises an idealized set of norms in imperatival form (“A is to do X under conditions C”) abstracted from
p.(None): the practices and institutions of a society that serves to regu- late conflicts of interest, both between persons and
p.(None): within the psychological economy of a single person.
...
p.(None): study of the hepatitis B vaccine in Kenya. Although the research was undertaken in Kenya, for many years afterwards
p.(None): people in Kenya could not afford to purchase the vaccine and therefore could not benefit (Bhatt 2016). When research
p.(None): aims are driven by, and in the interests of, high-income researchers or institutions with no real benefit to the local
p.(None): community or participants, we must ask why it is being conducted there.
p.(None): Local LMIC researchers are exploited when used only for tasks such as data col- lection, or when, having participated
p.(None): in a research project, they are then not properly represented, or not represented at all, in subsequent publications.
p.(None): Local environ- ments are exploited when environmental studies fail to benefit them. Research agreements
p.(None): focused on the use of biodiversity and traditional knowledge typically ignore the environmental component, and the
p.(None): common approaches to benefit shar- ing from research activities include only humans (Stone 2010).
p.(None): Corrective fairness presupposes the availability of legal instruments and access to mechanisms for righting wrongs
p.(None): (e.g. a complaints procedure, a court or an ethics committee). For instance, if no research ethics structure exists in
p.(None): the host country, corrective fairness is limited to the research ethics structure in the HIC country, which may not
p.(None): have the capacity to make culturally sensitive decisions. Table 5.2
p.(None):
p.(None):
p.(None):
p.(None): Table 5.2 Primary risks for corrective fairness
p.(None): Level of risk Nature of risk
p.(None): Personal • Difficult or no access to legal system or legal aid
p.(None): • Human rights violations not taken up by civil society
p.(None):
p.(None): Researcher/ institutional
p.(None): • Lack of protection of IPR for LMIC institutions
p.(None): • Lack of clear standards for operating systems and timelines for RECs
p.(None): • No capacity/procedures for study oversight to ensure compliance with REC decisions
p.(None): Community • Lack of protection of IPR or traditional knowledge for local communities
p.(None): • Human rights violations not taken up by civil society
p.(None): • Absence of systems for community approvals Country • No relevant legal instruments for ethics committees
p.(None): • Poor research governance frameworks to ensure adherence to ethical standards
p.(None): • No cross-border legal recourse in cases of exploitation
p.(None): • Discriminatory laws that may create stigmatized minorities Animal • Variations in regulatory standards
p.(None): for animal experimentation
p.(None): • Inadequate systems to ensure compliance with animal welfare standards
...
p.(None): sex workers, injecting drug users and men who have sex with men are often marginalized within their own broader
p.(None): communities.5 People from such groups are frequently sought for interna- tional research and yet the community at
p.(None): large or the community leaders are often unable to provide the input needed to ensure ethical management of
p.(None): research projects. Communities and their leaders may be unaware of the specific circumstances of these people and their
p.(None): lives, and they may even be openly hostile. We therefore need mechanisms for ensuring that the voice of
p.(None): marginalized and vulnerable populations is heard, and that their interests in research are represented.
p.(None): In the 1990s, community engagement assumed prominence as the new guiding light of public health efforts; research and
p.(None): health-improvement programmes that involved communities had better results than programmes led by government alone (NIH
p.(None): 2011). At the same time, the limitations of existing guidelines for the protec- tion of communities in genetic research
p.(None): was becoming increasingly apparent (Weijer et al. 1999). The benefits of community engagement in all types of research
p.(None): are now widely acknowledged, and numerous publications describe many potential benefits such as:
p.(None): • increasing community understanding and acceptance of the studies
p.(None): • enhancing researchers’ ability to understand and address community priorities
p.(None): • improving logistics and the running of studies
p.(None): • strengthening the quality of the information collected
p.(None): • ensuring culturally sensitive communications and research approaches
p.(None): • enhancing opportunities for capacity building (Hebert et al. 2009; Cook 2008; Bassler et al. 2008; Dunn 2011).
p.(None): Community engagement is an ethical imperative (a “must”) for researchers oper- ating globally. Research participants,
p.(None): their local communities and research partners in international locations should be equal stakeholders in the pursuit of
p.(None): research- related gains (Anderson et al. 2012). Ahmed and Palermo (2010) provide a salient definition of community
p.(None): engagement in research as
p.(None): a process of inclusive participation that supports mutual respect of values, strategies, and actions for authentic
p.(None): partnership of people affiliated with or self-identified by geographic proximity, special interest, or similar
p.(None): situations to address issues affecting the well-being of the community of focus.
p.(None): To be effective in international research, community engagement requires the development of partnerships with
p.(None): “local” stakeholders (for example, national,
p.(None):
p.(None): 4 Advocacy groups (also known as pressure groups, lobby groups, campaign groups, interest groups or special interest
p.(None): groups) use various forms of advocacy in order to influence public opinion and/ or policy.
p.(None): 5 Here “broader community” can refer to a village, town, ethnic group etc.
p.(None):
p.(None): Ethical Engagement with Communities
p.(None): 93
p.(None):
p.(None): regional or advocacy groups), involving them in assessing local challenges and research priorities,
...
p.(None): a complaints mechanism can be implemented that is both user-friendly and fit for purpose.
p.(None):
p.(None):
p.(None): Factors Affecting Accessibility
p.(None):
p.(None): It is known from studies in the field of dispute resolution that people often feel reluctant to make
p.(None): complaints and that this can be related to a variety of complex factors. In 2009 the Health Professions
p.(None): Council in the UK published a
p.(None):
p.(None): 100 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): comprehensive scoping review of existing mechanisms for complaints about health professionals (HPC 2009). In this
p.(None): report, the HPC describes a range of factors that can act as barriers to making a specific complaint. As there are no
p.(None): equivalent publi- cations about complaints procedures in LMICs, we summarize here the factors that are relevant to
p.(None): research in LMICs.
p.(None): Readiness to complain in any environment can be influenced by gender, ethnic- ity, age, education, income,
p.(None): accessibility of information and the perceived “serious- ness” of the problem (Pleasence et al. 2006).
p.(None): Specifically, ethnic minority communities are less likely to use systems that they perceive as being culturally
p.(None): insensitive and are more fearful of the consequences of taking action when they feel those systems have failed them.
p.(None): Difficulties with access to information are highlighted as a barrier to making a complaint (Henwood et al. 2003),
p.(None): especially where there is “information illiteracy”; some people possess the relevant skills and confidence to seek out
p.(None): information, but many do not. In situations where levels of education and literacy are not high, this is likely to be
p.(None): exacerbated.
p.(None): The relationship between the person who brings the complaint and the bureau- cracies to which they must direct
p.(None): their complaint can be a factor (Cowan and Halliday 2003). This relationship can either encourage or
p.(None): discourage a potential complainant’s trust in complaints mechanisms. The power imbalance between par- ties in such
p.(None): relationships can be substantial. For example, when working with impoverished communities, HIC researchers
p.(None): should be aware that participation in a clinical study may provide a participant’s only access to health care or other
p.(None): much- needed benefits. Fear of retribution is often cited as a barrier to making a complaint, particularly in
p.(None): circumstances where the complainant has an ongoing relationship with the complainee (HPC 2009). In situations where
p.(None): there is a power imbalance, people may not have the confidence to complain; they may be reluctant to seem ungrateful,
p.(None): not wish to be seen as a complainer, or fear loss. Research has shown that some people even reconstruct negative
...
General/Other / participants in a control group
Searching for indicator control group:
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p.(None): of exploitation. However, it is important to bear in mind that situations that are conducive to exploitation do not
p.(None): necessarily lead to exploitation. For instance, if a pharmaceutical company is due to test new antiretro- viral drugs
p.(None): to prevent the transmission of HIV to unborn babies, and the company operates in a country where poor mothers have no
p.(None): or very limited access to health care, it does not mean that exploitation will necessarily occur. The company may
p.(None): decide not to exploit vulnerable research participants and offer the accepted stan- dard of care to those in the
p.(None): control arm, rather than a placebo.
p.(None): Exploitation usually requires a moral decision on the part of the potential exploiter, but it can also occur
p.(None): through ignorance. Whether intended or unintended, the effects of exploitation are the same for the exploited. Hence,
p.(None): ignorance is not a legitimate justification for exploitation. Uncovering the primary risks of exploitation
p.(None):
p.(None): 2 A placebo-controlled trial involves some participants being given a medicine with active ingredi- ents, for instance
p.(None): a new drug against malaria, while others, the control group, are given a substance that should have no effect (the
p.(None): placebo), so that the outcomes can be compared.
p.(None): 3 One speaks of a proven standard of care when a treatment already exists for the illness under consideration in a
p.(None): trial. Hence, the ethical demand of testing any new drug against an existing one rather than a placebo is known as the
p.(None): “standard of care” debate.
p.(None):
p.(None): Our Method
p.(None): 39
p.(None):
p.(None): can help to increase awareness but, in our case, it also ensures that the GCC is designed in such a way
p.(None): that researchers are compelled to consider these factors. It is a unique facet of the GCC that it focuses the attention
p.(None): of researchers directly upon the primary risks of exploitation in collaborative HIC-LMIC research. This could only be
p.(None): achieved via thorough exploration of the risks from many perspectives, both top-down and bottom-up.
p.(None):
p.(None):
p.(None): Our Method
p.(None):
p.(None): The aim of this investigation was to identify the critical vulnerabilities that engender susceptibility to exploitation
p.(None): in LMIC-HIC collaborative research. Investigation of this vast subject would be impossible from a traditional
p.(None): literature-based approach, or through investigation in a single geographical region. Many of these vulnerabili- ties
...
Searching for indicator placebo:
(return to top)
p.(None):
p.(None):
p.(None):
p.(None): 1 The export of unethical research from a high-income setting to a resource-poor setting with weaker
p.(None): compliance structures or legal governance mechanisms.
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 37
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_5
p.(None):
p.(None): 38 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): codes, most of which had not been written with LMIC-HIC (high-income country) collaborations in mind.
p.(None):
p.(None):
p.(None): The Nature of Exploitation
p.(None):
p.(None): The potential to be exploited is part of the human condition. Exploiters take advan- tage of others’ vulnerabilities to
p.(None): promote their own interests (Hughes 2010). While there is a morally neutral sense of exploitation (the exploitation of
p.(None): natural talents to create art, for example), the term is generally used to describe a moral failing.
p.(None): Exploitation of people is very often unjust, unfair, harmful or just plain wrong. What is it, then, that
p.(None): distinguishes morally unacceptable exploitation from neutral exploitation?
p.(None): Some argue that exploitation is wrong because it is coercive (Schwartz 1995). If the only way for a woman in an LMIC to
p.(None): access antiretroviral drugs to prevent the transmission of HIV to her unborn baby is to participate in a
p.(None): placebo-controlled clinical trial,2 despite the existence of a proven standard of care,3 then one could say she has
p.(None): been coerced into enrolling (Annas and Grodin 1998). In this sense, exploi- tation occurs where one party takes
p.(None): advantage of another by making them an offer they cannot refuse; they are then coerced to accept simply because there
p.(None): is no alter- native. Others argue that exploitation is wrong because it treats human beings as means rather than ends
p.(None): (Wood 1995). In other words, exploitation instrumentalizes people. Yet others claim that exploitation is wrong
p.(None): because it disadvantages the vulnerable (Macklin 2003).
p.(None): Our investigation was concerned with the risks or vulnerabilities for exploitation, so we adopted Macklin’s definition
p.(None): of exploitation. However, it is important to bear in mind that situations that are conducive to exploitation do not
p.(None): necessarily lead to exploitation. For instance, if a pharmaceutical company is due to test new antiretro- viral drugs
p.(None): to prevent the transmission of HIV to unborn babies, and the company operates in a country where poor mothers have no
p.(None): or very limited access to health care, it does not mean that exploitation will necessarily occur. The company may
p.(None): decide not to exploit vulnerable research participants and offer the accepted stan- dard of care to those in the
p.(None): control arm, rather than a placebo.
p.(None): Exploitation usually requires a moral decision on the part of the potential exploiter, but it can also occur
p.(None): through ignorance. Whether intended or unintended, the effects of exploitation are the same for the exploited. Hence,
p.(None): ignorance is not a legitimate justification for exploitation. Uncovering the primary risks of exploitation
p.(None):
p.(None): 2 A placebo-controlled trial involves some participants being given a medicine with active ingredi- ents, for instance
p.(None): a new drug against malaria, while others, the control group, are given a substance that should have no effect (the
p.(None): placebo), so that the outcomes can be compared.
p.(None): 3 One speaks of a proven standard of care when a treatment already exists for the illness under consideration in a
p.(None): trial. Hence, the ethical demand of testing any new drug against an existing one rather than a placebo is known as the
p.(None): “standard of care” debate.
p.(None):
p.(None): Our Method
p.(None): 39
p.(None):
p.(None): can help to increase awareness but, in our case, it also ensures that the GCC is designed in such a way
p.(None): that researchers are compelled to consider these factors. It is a unique facet of the GCC that it focuses the attention
p.(None): of researchers directly upon the primary risks of exploitation in collaborative HIC-LMIC research. This could only be
p.(None): achieved via thorough exploration of the risks from many perspectives, both top-down and bottom-up.
p.(None):
p.(None):
p.(None): Our Method
p.(None):
p.(None): The aim of this investigation was to identify the critical vulnerabilities that engender susceptibility to exploitation
p.(None): in LMIC-HIC collaborative research. Investigation of this vast subject would be impossible from a traditional
p.(None): literature-based approach, or through investigation in a single geographical region. Many of these vulnerabili- ties
p.(None): are poorly represented in the literature, and they can differ between countries, cultures and types of research. For
p.(None): example, clinical trials, social science, animal experiments, environmental science and research in emergency settings
p.(None): may pose a diverse array of risks that are largely determined by the local context. Consequently, a creative approach
p.(None): to data collection was needed to capture as many risks and vul- nerabilities as possible.
p.(None): In this regard it was very helpful that the interdisciplinary TRUST project con- sortium comprised multilevel ethics
p.(None): bodies, policy advisers and policymakers, civil society organizations, funding organizations, industry and academic
...
p.(None): the environment.
p.(None):
p.(None): Table 5.1 Primary risks for fairness in exchange
p.(None): Level of risk Nature of risk
p.(None): Personal • In medical research:
p.(None): - Multiple trial enrolment
p.(None): - No post-study access to treatment
p.(None): • In all research:
p.(None): - Undue inducement
p.(None): - No access to results or benefits of research
p.(None):
p.(None): Researcher/ institutional
p.(None): • Research priorities driven by HIC partners:
p.(None): - Mismatch to local research needs
p.(None): • Poor representation of LMIC (host) partners on research teams:
p.(None): - Responsible for menial tasks only
p.(None): - Not acknowledged or represented appropriately in publications
p.(None): • “Helicopter research” by HIC partners:
p.(None): - No knowledge transfer or capacity building/strengthening
p.(None): Community • Research priorities driven by HIC partners:
p.(None): - Mismatch to local research needs
p.(None): • Little or no input from marginalized communities into research
p.(None): • Undue inducement
p.(None): • No benefit sharing or feedback
p.(None): • Support for foreign-sponsored research drains local system of staff Country • No universal access
p.(None): to health care for population:
p.(None): - Differences in standards of “usual” care
p.(None): • Placebo-controlled trials approved
p.(None): • Support for foreign-sponsored research drains local systems and resources
p.(None): • Medical science research shaped by the “para state”
p.(None): Animal
p.(None): Environmental • Study leads to reduction of natural resources
p.(None): • Lack of benefit sharing for the environment
p.(None):
p.(None): 42 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): A primary risk in the exploitation of individuals and communities is that they may not have access to the results or
p.(None): benefits of research. This occurs when the research is designed to benefit people in other countries or settings and
p.(None): the individu- als who contributed to the study never get a chance to benefit from it. This happened with a clinical
p.(None): study of the hepatitis B vaccine in Kenya. Although the research was undertaken in Kenya, for many years afterwards
p.(None): people in Kenya could not afford to purchase the vaccine and therefore could not benefit (Bhatt 2016). When research
p.(None): aims are driven by, and in the interests of, high-income researchers or institutions with no real benefit to the local
p.(None): community or participants, we must ask why it is being conducted there.
p.(None): Local LMIC researchers are exploited when used only for tasks such as data col- lection, or when, having participated
p.(None): in a research project, they are then not properly represented, or not represented at all, in subsequent publications.
p.(None): Local environ- ments are exploited when environmental studies fail to benefit them. Research agreements
p.(None): focused on the use of biodiversity and traditional knowledge typically ignore the environmental component, and the
...
p.(None): Informed consent, 2, 7, 8, 24, 44–47, 63, 66,
p.(None): 74, 82, 84, 100, 105
p.(None): Integrity, 5, 23, 24, 46–48, 53, 67, 70, 74,
p.(None): 78–79, 82, 85, 86, 94, 112, 117
p.(None): Intellectual property, 6, 20, 43, 60, 66,
p.(None): 80, 104
p.(None):
p.(None): Index
p.(None): 121
p.(None):
p.(None):
p.(None): K
p.(None): Kenya, 2, 39, 40, 42, 61, 63, 65, 100, 110,
p.(None): 115, 116
p.(None): !Khomani, 74, 77, 78, 81, 86
p.(None): Khwe, 74, 77, 78, 81
p.(None): Knowledge holders, 7, 55, 66
p.(None):
p.(None):
p.(None): L
p.(None): Lawyers, 79, 80, 104
p.(None): Legal framework, 45, 55
p.(None): Legal support, 74, 79, 80, 85, 105
p.(None): Local communities, 6, 7, 9, 20, 27, 40,
p.(None): 42–45, 52, 61, 63, 64, 69, 90, 92,
p.(None): 94–98, 105
p.(None): Local relevance, 6, 17, 60–62, 68, 102, 105
p.(None): Local researchers, 6, 7, 10, 20, 27, 40, 48, 60,
p.(None): 64, 66, 94, 96, 101
p.(None): Low- and middle-income countries (LMICs), 2, 20–22, 37–44, 46–48, 55, 56, 58, 61,
p.(None): 62, 65, 66, 69, 70, 99–105
p.(None):
p.(None):
p.(None): M
p.(None): Majengo, 63
p.(None): Medical research, 22, 23, 41, 45, 57, 65, 66,
p.(None): 104, 111, 116, 117
p.(None): Metaethical relativism, 30–32
p.(None): Misconduct, 8, 47, 105
p.(None):
p.(None):
p.(None): N
p.(None): Non-compliance, 1
p.(None): Non-governmental organisations (NGOs), 54, 63, 75–78, 85
p.(None): Non-human primates, 2, 44, 65
p.(None): Normative relativism, 30, 31
p.(None):
p.(None):
p.(None): O
p.(None): Open communication, 24, 94
p.(None):
p.(None):
p.(None): P
p.(None): Peer educators, 40
p.(None): Personal risk, 9, 41, 42, 44–47, 68
p.(None): Placebo, 38, 41
p.(None): Policymakers, 39, 54, 55, 58, 60, 70
p.(None): Poverty, 2, 3, 48, 55, 82
p.(None): Power, 2, 5, 7, 17–19, 29, 43, 44, 48, 49, 62,
p.(None): 70, 75, 100, 102
p.(None): Principles, 3, 16–18, 23, 24, 28, 29, 32–35, 39,
p.(None): 60, 75, 77, 82, 98, 104, 117
p.(None): Principlism, 17
p.(None):
p.(None): Privacy, 11, 47, 83, 96, 97, 102
p.(None): Proxy consent, 47, 48
p.(None):
p.(None):
p.(None): R
p.(None): Recruitment, 102, 103
p.(None): Relativism, 3, 27, 28, 30–33
p.(None): Research and development (R&D), 60, 65, 111
p.(None): Research ethics, 2, 3, 8, 18, 20–24, 27, 41–43,
p.(None): 45–47, 51, 52, 54, 56, 58, 63, 65–67,
p.(None): 70, 73–86, 98, 103, 109–111, 117
p.(None): Research ethics committee (REC), 8, 18, 42,
p.(None): 45–47, 51, 52, 54, 65–67, 70, 98, 103
p.(None): Research integrity, 5, 24, 46, 47, 67, 112, 117
p.(None): Research participants, 2, 6–11, 20–24, 27, 38,
p.(None): 40, 43, 44, 52, 54, 55, 57, 61–64, 70,
p.(None): 92, 96, 98–100, 103, 105, 110
p.(None): Resource custodians, 7, 66
p.(None): Resource-poor settings, 2, 5, 14, 27, 28, 37,
p.(None): 51, 52, 80, 89, 99, 109, 111, 115–117
p.(None): Respect, 2, 5–8, 13–24, 27–35, 40, 43–44, 66,
p.(None): 68–70, 74, 78, 79, 82, 83, 85, 86, 90,
p.(None): 92, 93, 95–98, 102, 103, 105, 110–112
p.(None): Responsibilities, 8, 10, 16, 47, 51, 55, 58, 61,
p.(None): 66, 68, 104, 117
p.(None): Risk mitigation measures, 23, 67
p.(None): Risks, 1, 3, 9–11, 14, 23, 44, 52, 56, 64,
p.(None): 66–68, 70, 82, 104
p.(None):
p.(None):
p.(None): S
p.(None): Safeguarding, 45, 51, 54, 97, 103
...
General/Other / people living in remote/rural area
Searching for indicator rural area:
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p.(None):
p.(None): 2 1 Ethics Dumping and the Need for a Global Code of Conduct
p.(None):
p.(None): There are two main reasons for ethics dumping – that is, the export of unethical research practices from a high-income
p.(None): to a resource-poor setting. The first is inten- tional exploitation, where research participants and/or resources in
p.(None): low- and middle- income countries (LMICs) are exploited on purpose because the research would be prohibited in the
p.(None): high-income country (HIC). The second is exploitation based on insufficient knowledge or ethics awareness on the part
p.(None): of the mobile researcher. In both cases a lack of adequate oversight mechanisms in the host LMIC is likely to
p.(None): exacerbate the problem (Schroeder et al. 2018).
p.(None): Examples of ethics dumping in the 21st century include:
p.(None): • In clinical research, misinterpreting the standard of care, leading to the avoidable deaths of research
p.(None): participants (Srinivasan et al. 2018).
p.(None): • Research among indigenous populations that led to the publication of “private, pejorative, discriminatory and
p.(None): inappropriate” conclusions and a refusal to engage with indigenous leaders on the informed consent process
p.(None): (Chennells and Steenkamp 2018).
p.(None): • The export of valuable blood samples from a rural area in China to a US genetic bank, leading to a large amount of
p.(None): research funding for the US team (Zhao and Zhang 2018).
p.(None): • The use of wild-caught non-human primates in research by a UK researcher who undertook his experiments in Kenya,
p.(None): thus “bypassing British law” (Chatfield and Morton 2018).
p.(None): • An attempt to seek retrospective ethics approval for a highly sensitive social sci- ence study undertaken among
p.(None): vulnerable populations following a local Ebola crisis (Tegli 2018).
p.(None): How can one reconcile recent cases of ethics dumping with our generation’s highly ambitious call for more
p.(None): research and innovation? The United Nations 2030 Agenda for Sustainable Development aims “to end all forms of poverty…
p.(None): while ensuring that no one is left behind” (UN ndb). To achieve these aims, the UN encourages “fostering
p.(None): innovation” (Goal 9 of Agenda 2030), as “without innovation
p.(None): …, development will not happen” (UN nda).
p.(None): This book describes one initiative to counter ethics dumping: the development and promotion of the Global Code of
p.(None): Conduct for Research in Resource-Poor Settings (GCC) and its sister code, the San Code of Research Ethics.
p.(None): The GCC recognizes the considerable power imbalances that may be involved in international collaborative research and
...
Orphaned Trigger Words
p.(None):
p.(None):
p.(None):
p.(None): Foreword by Klaus Leisinger
p.(None):
p.(None): Doris Schroeder
p.(None): Centre for Professional Ethics University of Central Lancashire Preston, Lancashire, UK
p.(None):
p.(None): Michelle Singh Africa Office
p.(None): European & Developing Countries Clinical Trials Partnership
p.(None): Cape Town, South Africa
p.(None):
p.(None): Peter Herissone-Kelly
p.(None): School of Humanities and Social Sciences University of Central Lancashire
p.(None): Preston, Lancashire, UK
p.(None): Kate Chatfield
p.(None): Centre for Professional Ethics University of Central Lancashire Preston, Lancashire, UK
p.(None):
p.(None): Roger Chennells
p.(None): Chennells Albertyn Attorneys Stellenbosch, South Africa
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ISSN 2452-0519 ISSN 2452-0527 (electronic)
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p.(None):
p.(None): This Springer imprint is published by the registered company Springer Nature Switzerland AG. The registered company
p.(None): address is: Gewerbestrasse 11, 6330 Cham, Switzerland
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): To Reverend Mario Mahongo (1952–2018)
p.(None):
p.(None): Foreword
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): In September 2015, after intensive public consultation, the international community went on record with a plan of
p.(None): action for people, planet and prosperity: the 2030 Agenda for Sustainable Development. All country representatives and
p.(None): all stakehold- ers expressed their determination
p.(None): to take the bold and transformative steps which are urgently needed to shift the world on to a sustainable and
p.(None): resilient path. As we embark on this collective journey, we pledge that no one will be left behind [emphasis added].
p.(None): (UN 2015).
p.(None): To stimulate action, the heads of states and governments defined 17 sustainable development goals and 169 targets to be
p.(None): achieved by 2030. Successes in efforts to end extreme poverty, achieve food security and ensure healthy lives, as well
p.(None): as suc- cesses towards all other goals, depend not only on goal-oriented societal reforms and the mobilization of
p.(None): substantial financial and technical assistance, but also on significant technological, biomedical and other
p.(None): innovations.
p.(None): Ensuring the success of the Agenda 2030 requires massive research and develop- ment efforts as well new forms of
p.(None): research co-creation on a level playing field and with a universal professional ethos.
p.(None): Leaving no one behind does not “only” include reducing income and wealth inequalities, and affirmative
p.(None): action in support of better opportunities for self- determined living within and among countries. It also
p.(None): implies reaching those most at risk from poverty and its impacts. This again necessitates research focused on the needs
p.(None): of the poor in a way that does not infringe their human rights.
p.(None): Research and innovation can only be sustainably successful when based on soci- etal trust. The precondition for
p.(None): societal trust and public acceptance is the perception that work is done with integrity and based on fundamental values
p.(None): shared by the global community. Trust depends not only on research work being compliant with laws and regulations, but
p.(None): also, more than ever, on its legitimacy.
p.(None): Such legitimacy can be achieved through inclusion and, importantly, the co- design of solutions with
p.(None): vulnerable populations. Leaving no one behind also means leaving no one behind throughout the research process, aiming
p.(None): for research with, not about, vulnerable populations.
p.(None):
p.(None): vii
p.(None):
p.(None): viii
p.(None): Foreword
p.(None):
p.(None): The results of the TRUST Project, whose Global Code of Conduct for Research in Resource-Poor Settings (GCC) this book
p.(None): celebrates, contribute to realizing the European Union’s ambition of a more inclusive, equal and sustainable global
p.(None): soci- ety – a profound expectation of people all over the world.
p.(None): The fact that the GCC now exists and has been welcomed by the European Commission as a precondition for
p.(None): its research grants is only a beginning.
p.(None): My hope is that enlightened stakeholders in public institutions, foundations and the private sector will now start a
p.(None): discourse and apply moral imagination to the concrete consequences of the GCC. This relates to the processes and
p.(None): content of their research endeavours as well as the selection criteria for hiring, promoting and remu- nerating the
p.(None): research workforce.
p.(None): Research excellence is no longer only defined by playing by the rules and being “successful”. The results of discourses
p.(None): about the operationalization of the TRUST values of fairness, respect, care and honesty are the new
p.(None): benchmark for excellence.
p.(None):
p.(None): Basel, Switzerland Klaus Leisinger
p.(None):
p.(None):
p.(None): Reference
p.(None):
p.(None): UN (2015) Transforming our world: the 2030 agenda for sustainable development. United Nations.
p.(None): https://www.un.org/development/desa/dspd/2015/08/transforming-our-world-the-2030- agenda-for-sustainable-development/
p.(None):
p.(None):
p.(None): Professor Klaus Leisinger, a social scientist and economist, is the President of the Global Values Alliance in Basel,
p.(None): Switzerland. He served as an adviser on corporate responsibility to UN Secretaries-General Kofi Annan and Ban Ki-moon.
p.(None): He is cur- rently a member of the Leadership Council of the UN Sustainable Development Solutions Network. In 2011, he
p.(None): was awarded the first ever Outstanding Contribution to Global Health Award by South-South Awards for his successful
p.(None): work on eradicat- ing leprosy.
p.(None):
p.(None): Acknowledgements
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Writing a book is child’s play compared to writing a new ethics code – a monumental task achieved by the 56 individuals
p.(None): named in the Appendix as the proud authors of the Global Code of Conduct for Research in Resource-Poor Settings (GCC).
p.(None): Thus, by the time we started writing this book, the bulk of the work had already been done. The task of conveying the
p.(None): collective pride of these 56 authors to the world was entrusted to the Reverend Mario Mahongo, an honoured San Leader
p.(None): born in Angola. He was due to travel from the Kalahari Desert to Stockholm, Sweden, in May 2018 to launch the GCC. Just
p.(None): one day before flying to Europe, he died in a car crash. This book is dedicated to Mario. His last recorded statement
p.(None): about research ethics was: “I don’t want researchers to see us as museums who cannot speak for themselves and who don’t
p.(None): expect something in return” (Chapter 7). This statement expresses
p.(None): the fairness element of the GCC beautifully.
p.(None): The GCC was produced by the TRUST project, an initiative funded by the European Commission (EC) Horizon
p.(None): 2020 Programme, agreement number 664771. Dorian Karatzas, Roberta Monachello, Dr Louiza Kalokairinou, Edyta Sikorska,
p.(None): Yves Dumont and Wolfgang Bode formed the magnificent EC team supporting the
p.(None): TRUST project.
p.(None): Thanks to Dorian for ensuring that the GCC was brought to the attention of the highest level of decision-making on
p.(None): ethics in the EC, for suggesting TRUST as a research and development success story of Horizon 2020 (EC 2018) and for
p.(None): having the GCC checked by the EC legal department in time for our event at the European Parliament in June 2018.
p.(None): Without Dorian’s efforts, the code would not have the standing it has now, as a mandatory reference
p.(None): document for EC framework programmes.
p.(None): Thanks to Roberta for believing in our work and for being a most enthusiastic, supportive and interested project
p.(None): officer, despite several amendments. Thanks to Wolfgang for facilitating one of those amendments very
p.(None): professionally and in record time during a summer break.
p.(None): Thanks to Louiza for providing insightful funder input during the GCC develop- ment phase. Thanks to Edyta for
p.(None): organizing a very stimulating training event for EC staff on the GCC. Thanks to Yves Dumont for inventing the term
p.(None): “ethics dumping” in 2013.
p.(None): ix
p.(None):
p.(None): x
p.(None): Acknowledgements
p.(None):
p.(None): Thanks to Stelios Kouloglou, MEP, and Dr Mihalis Kritikos for giving us the opportunity to present the GCC at a
p.(None): European Parliament event.
p.(None): Thanks to Dr Wolfgang Burtscher, the EC’s deputy director-general for Research and Innovation, for announcing in person
p.(None): at the European Parliament event that the GCC would henceforth be a mandatory reference document for EC
p.(None): framework programmes.
p.(None): Thanks to the University of Cape Town for being the first university to adopt the GCC in April 2019. This is owed to
p.(None): Prof. Rachel Wynberg’s long-term commitment to equitable research partnerships and the protection of vulnerable
p.(None): populations in research.
p.(None): Thanks to Joyce Adhiambo Odhiambo and her colleagues in Nairobi for prepar- ing the excellent speech on the four values
p.(None): of the GCC – fairness, respect, care and honesty – that she presented at the European Parliament (TRUST 2018).
p.(None): Thanks to Leana Snyders, the director of the South African San Council, for tak- ing the place of Reverend Mario
p.(None): Mahongo at the Stockholm GCC launch event and for doing so brilliantly, despite the shock of his tragic death. Thanks
p.(None): also for her speech at the European Parliament event.
p.(None): Thanks to Professor Jeffrey Sachs, Dr Leonardo Simão, Dr Mahnaz Vahedi and Vivienne Parry MBE for joining the TRUST
p.(None): team at the European Parliament event. Thanks to Fritz Schmuhl, the senior editor at Springer, who is still the best
p.(None): book editor I know. This is my sixth Springer book with him, which says it all. Thanks also to George Solomon, the
p.(None): project co-ordinator for this book, for dealing swiftly and efficiently with all questions and for smoothing out any
p.(None): complications in the book production process. Finally, thanks to Ramkumar Rathika for expertly guiding
p.(None): the e-proofing process.
p.(None): This is also the sixth book for which Paul Wise in South Africa has been the professional copy-editor. Copy-editing
p.(None): sounds like checking that references are in the right format, but that’s comparing a mouse to a lion. Paul does a
p.(None): lion’s work; he even found a factual mistake in an author biography – written by the author. Thanks, Paul! I hope
p.(None): you’re around for the seventh book.
p.(None): Thanks to Professor Michael Parker, the director of Ethox at Oxford University, for giving a team of us (Joshua Kimani,
p.(None): Leana Snyders, Joyce Adhiambo Odhiambo and me) the floor in his distinguished institute to introduce the GCC.
p.(None): Thanks to David Coles, Olivia Biernacki, Francesca Cavallaro, Julie Cook, Dieynaba N’Diaye, Francois Bompart,
p.(None): Jacintha Toohey, Rachel Wynberg, Jaci van Niekirk and Myriam Ait Aissa for their contributions to the work, which is
p.(None): summa- rized in Chapter 8.
p.(None): Thanks to Julie Cook for brilliant comments on earlier versions of the manu- script, and also to two anonymous peer
p.(None): reviewers for their helpful comments on the book plans.
p.(None): Thanks to Dr Francesca Cavallaro for creating the educational and fun GCC website.1
p.(None): Thanks to Amy Azra Dean for producing film clips for the GCC website.
p.(None):
p.(None): 1 globalcodeofconduct.org/
p.(None):
p.(None): Acknowledgements
p.(None): xi
p.(None):
...
p.(None): Conclusion 24
p.(None): References 25
p.(None): 4 Respect and a Global Code of Conduct? 27
p.(None): Introduction 27
p.(None): The Four Values and Moral Relativism 30
p.(None): A More Moderate Relativism 31
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xiii
p.(None):
p.(None): xiv
p.(None): Contents
p.(None):
p.(None): Grounding the Global Applicability Thesis of the GCC
p.(None): in a Common Morality 32
p.(None): Conclusion 35
p.(None): References 36
p.(None): 5 Exploitation Risks in Collaborative International Research 37
p.(None): The Nature of Exploitation 38
p.(None): Our Method 39
p.(None): Our Findings 40
p.(None): Fairness 41
p.(None): Respect 43
p.(None): Care 44
p.(None): Honesty 46
p.(None): Conclusion 48
p.(None): Serious Poverty 48
p.(None): Extreme Differentials in Power 48
p.(None): Past History of Colonialism 49
...
p.(None):
p.(None): Doris Schroeder is director of the Centre for Professional Ethics at the University of Central Lancashire, and
p.(None): professor of moral philosophy at the School of Law, UCLan Cyprus. She is the lead author of the Global Code of Conduct
p.(None): for Research in Resource-Poor Settings.
p.(None):
p.(None): Kate Chatfield is deputy director of the Centre for Professional Ethics, University of Central Lancashire, UK. She is a
p.(None): social science researcher and ethicist special- izing in global justice, research ethics, animal ethics and responsible
p.(None): innovation.
p.(None):
p.(None): Michelle Singh is a project officer at the European & Developing Countries Clinical Trials Partnership in Cape Town,
p.(None): South Africa. She holds a medical PhD and previ- ously managed maternal and child health research studies and clinical
p.(None): trials at the South African Medical Research Council.
p.(None):
p.(None): Roger Chennells works as legal adviser to the South African San Institute and is a founder-partner in the human rights
p.(None): law practice Chennells Albertyn, Stellenbosch, established in 1981. Specializing in labour, land, environmental and
p.(None): human rights law, he has also worked for Aboriginal people in Australia.
p.(None):
p.(None): Peter Herissone-Kelly is senior lecturer in philosophy, University of Central Lancashire, UK. He is a
p.(None): specialist in Kantian ethics as well as bioethics, analytic philosophy of language and metaethics.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xvii
p.(None):
p.(None): Abbreviations
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ACF Action contre la Faim
p.(None): CBD UN Convention on Biological Diversity COHRED Council on Health Research for Development EC
p.(None): European Commission (EC)
p.(None): EDCTP European and Developing Countries Clinical Trials Partnership EFPIA European Federation of
p.(None): Pharmaceutical Industries and Associations FERCI Forum for Ethics Review Committees in India
p.(None): GCC Global Code of Conduct for Research in Resource-Poor Settings GVA Global Values Alliance
p.(None): HIC high-income country
p.(None): Inserm Institut national de la santé et de la recherche médicale IPR intellectual property
p.(None): rights
p.(None): LMICs low- and middle-income countries NGO nongovernmental organization
p.(None): PHDA Partners for Health and Development in Africa REC research ethics committee
p.(None): SASC South African San Council SASI South African San Institute
p.(None): SWOP SexXWorkers Outreach Programme
p.(None): UNESCO United Nations Educational, Scientific and Cultural Organization WIMSA Working Group of Indigenous
p.(None): Minorities in Southern Africa
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): xix
p.(None):
p.(None): Chapter 1
p.(None): Ethics Dumping and the Need for a Global Code of Conduct
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The UN’s 2030 Agenda for Sustainable Development calls for more research and innovation to end
p.(None): poverty, leaving no one behind – and yet the export of unethical practices from high-income to lower-income settings is
p.(None): still a major concern. Such ethics dumping occurs in all academic disciplines. When research is regarded, on the one
p.(None): hand, as a dirty word among vulnerable populations who face ethics dumping, and, on the other, as a solution to many of
p.(None): humanity’s problems, how can the resulting gulf be bridged? This book describes one initiative to counter ethics
p.(None): dumping: the development and promotion of the Global Code of Conduct for Research in Resource-Poor Settings.
p.(None):
p.(None): Keywords Ethics dumping · Global research ethics · Exploitation · Vulnerability · Research governance
p.(None):
p.(None):
p.(None): Research has become a global enterprise. Individual researchers around the world are encouraged to be as mobile as
p.(None): possible (Sugimoto et al. 2017). At the same time, the activities of mobile researchers have made research “one of the
p.(None): dirtiest words in the indigenous world’s vocabulary” (Tuhiwai Smith 1999: 1). The indigenous com- munities in which
p.(None): Tuhiwai Smith, a Māori professor, grew up saw research as some- thing that “told us things already known, suggested
p.(None): things that would not work, and made careers for people who already had jobs” (Tuhiwai Smith 1999: 3).
p.(None): There is a gulf between those advocating more researcher mobility because “sci- ence is the engine of prosperity”
p.(None): (Rodrigues et al. 2016) and those who argue that research can represent harmful “visits by inquisitive and
p.(None): acquisitive strangers” (Tuhiwai Smith 1999: 3). When concerns about ethics dumping1 are added, this gulf becomes
p.(None): almost unbridgeable.
p.(None):
p.(None):
p.(None): 1 The term was introduced by the Science with and for Society Unit of the European Commission: “Due to the progressive
p.(None): globalisation of research activities, the risk is higher that research with sensitive ethical issues is conducted by
p.(None): European organisations outside the EU in a way that would not be accepted in Europe from an ethical point of view. This
p.(None): exportation of these non-compliant research practices is called ethics dumping” (European Commission nda).
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 1
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_1
p.(None):
p.(None): 2 1 Ethics Dumping and the Need for a Global Code of Conduct
p.(None):
p.(None): There are two main reasons for ethics dumping – that is, the export of unethical research practices from a high-income
p.(None): to a resource-poor setting. The first is inten- tional exploitation, where research participants and/or resources in
p.(None): low- and middle- income countries (LMICs) are exploited on purpose because the research would be prohibited in the
p.(None): high-income country (HIC). The second is exploitation based on insufficient knowledge or ethics awareness on the part
p.(None): of the mobile researcher. In both cases a lack of adequate oversight mechanisms in the host LMIC is likely to
p.(None): exacerbate the problem (Schroeder et al. 2018).
p.(None): Examples of ethics dumping in the 21st century include:
p.(None): • In clinical research, misinterpreting the standard of care, leading to the avoidable deaths of research
p.(None): participants (Srinivasan et al. 2018).
p.(None): • Research among indigenous populations that led to the publication of “private, pejorative, discriminatory and
p.(None): inappropriate” conclusions and a refusal to engage with indigenous leaders on the informed consent process
p.(None): (Chennells and Steenkamp 2018).
p.(None): • The export of valuable blood samples from a ruralXarea in China to a US genetic bank, leading to a large amount of
p.(None): research funding for the US team (Zhao and Zhang 2018).
p.(None): • The use of wild-caught non-human primates in research by a UK researcher who undertook his experiments in Kenya,
p.(None): thus “bypassing British law” (Chatfield and Morton 2018).
p.(None): • An attempt to seek retrospective ethics approval for a highly sensitive social sci- ence study undertaken among
p.(None): vulnerable populations following a local Ebola crisis (Tegli 2018).
p.(None): How can one reconcile recent cases of ethics dumping with our generation’s highly ambitious call for more
p.(None): research and innovation? The United Nations 2030 Agenda for Sustainable Development aims “to end all forms of poverty…
p.(None): while ensuring that no one is left behind” (UN ndb). To achieve these aims, the UN encourages “fostering
p.(None): innovation” (Goal 9 of Agenda 2030), as “without innovation
p.(None): …, development will not happen” (UN nda).
p.(None): This book describes one initiative to counter ethics dumping: the development and promotion of the Global Code of
p.(None): Conduct for Research in Resource-Poor Settings (GCC) and its sister code, the San Code of Research Ethics.
p.(None): The GCC recognizes the considerable power imbalances that may be involved in international collaborative research and
p.(None): provides guidance across all disciplines. It is based on a new ethical framework that is predicated on the values of
p.(None): fairness, respect, care and honesty; values that are imperative for avoiding ethics dumping. The GCC opposes all double
p.(None): standards in research and supports long-term equitable research relationships between partners in lower-income
p.(None): and higher-income set- tings. This book introduces the GCC in the following manner:
p.(None): • Chapter 2 reproduces the GCC as launched in the European Parliament in June 2018 and adopted as a mandatory
p.(None): reference document by the European Commission (ndb).
p.(None):
p.(None): References
p.(None): 3
p.(None):
p.(None): • Chapter 3 explains why values rather than standards, principles, virtues or ideals provide the best guidance in the
p.(None): fight against ethics dumping.
p.(None): • Chapter 4 answers a philosophical question: how can the GCC can be defended against claims of moral relativism?
p.(None): • Chapter 5 details 88 risks for ethics dumping, the analytical foundation of the GCC.
p.(None): • Chapter 6 describes how the GCC was built, from extensive stakeholder engage- ments to its final translation into
p.(None): Russian, French, Spanish, German, Portuguese, Mandarin, Japanese and Hindi.
p.(None): • Chapter 7 recounts the history of the San Code of Research Ethics, sister code of the GCC and the first ethics code
p.(None): launched by an indigenous group on the African continent.
p.(None): • Acknowledging that an ethics code is not enough on its own to counter ethics dumping, Chapter 8 offers advice on
p.(None): community engagement, workable com- plaints procedures and negotiating fair contracts.
p.(None): • Chapter 9 presents a brief conclusion.
p.(None): • The names of the 56 authors of the GCC are set out in the Appendix.
p.(None): Can an ethics code overcome ethics dumping and bridge the gulf between those for whom international collaborative
p.(None): research is exploitation by strangers, and those who believe it is essential to end all poverty? That is the hope of
p.(None): the authors of the GCC.
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Chatfield K, Morton D (2018) The use of non-human primates in research. In: Schroeder D, Cook J, Hirsch F, Fenet S,
p.(None): Muthuswamy V (eds) Ethics dumping: case studies from North-South research collaborations, Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 81–90
p.(None): Chennells R, Steenkamp A. (2018) International genomics research involving the San people. In: Schroeder D, Cook J,
p.(None): Hirsch F, Fenet S, Muthuswamy V (eds) Ethics dumping: case stud- ies from North-South research collaborations,
p.(None): Springer Briefs in Research and Innovation Governance, Berlin, p 15–22
p.(None): European Commission (nda) Horizon 2020: ethics. https://ec.europa.eu/programmes/horizon2020/ en/h2020-section/ethics
p.(None): European Commission (ndb) Participant portal H2020 manual: ethics. http://ec.europa.eu/research/
p.(None): participants/docs/h2020-funding-guide/cross-cutting-issues/ethics_en.htm
p.(None): Rodrigues ML, Nimrichter L, Cordero RJB (2016) The benefits of scientific mobility and interna- tional collaboration.
p.(None): FEMS Microbiology Letters 363(21):fnw247. https://academic.oup.com/ femsle/article-lookup/doi/10.1093/femsle/fnw247
p.(None): Schroeder D, Cook J, Hirsch F, Fenet S, Muthuswamy V (eds) (2018) Ethics dumping: case stud- ies from North-South
p.(None): research collaborations. Springer Briefs in Research and Innovation Governance, Berlin
p.(None): Srinivasan S, Johari V, Jesani A (2018) Cervical cancer screening in India. In: Schroeder D, Cook J, Hirsch F, Fenet S,
p.(None): Muthuswamy V (eds) Ethics dumping: case studies from North-South research collaborations. Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 33–47
p.(None):
p.(None): 4 1 Ethics Dumping and the Need for a Global Code of Conduct
p.(None):
p.(None): Sugimoto CR, Robinson-Garcia N, Murray DS, Yegros-Yegros A, Costas R and Larivière V (2017) Scientists have most impact
p.(None): when they’re free to move. Nature 550(7674):29–31
p.(None): Tegli J (2018) Seeking retrospective approval for a study in resource-constrained Liberia. In: Schroeder D,
p.(None): Cook J, Hirsch F, Fenet S, Muthuswamy V (eds) Ethics dumping: case stud- ies from North-South research
p.(None): collaborations. Springer Briefs in Research and Innovation Governance, Berlin, p 115-119
p.(None): Tuhiwai Smith, Linda (1999) Decolonizing methodologies: research and indigenous Peoples. Zed Books, London and New York
p.(None): UN (ndb) The sustainable development agenda. Sustainable Development Goals. https://www.
p.(None): un.org/sustainabledevelopment/development-agenda/
p.(None): UN (nda) Goal 9. Sustainable Development Goals. https://www.un.org/sustainabledevelopment/
p.(None): infrastructure-industrialization/
p.(None): Zhao Y, Zhang W (2018) An international collaborative genetic research project conducted in China. In:
p.(None): Schroeder D, Cook J, Hirsch F, Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North-South research
p.(None): collaborations. Springer Briefs in Research and Innovation Governance, Berlin, p 71–80
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p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 2
p.(None): A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The Global Code of Conduct for Research in Resource-Poor Settings (GCC) is designed to counter
p.(None): ethics dumping, i.e. the practice of moving research from a high-income setting to a lower-income setting to circumvent
p.(None): ethical barriers. The GCC is reprinted here. It was completed in May 2018 and adopted by the European
p.(None): Commission as a mandatory reference document for Horizon 2020 in August 2018. For more information on the GCC,
p.(None): please visit: http://www.global- codeofconduct.org/
p.(None):
p.(None): Keywords Global ethics · Research ethics · International co-operation · Ethics dumping · Low- and middle-income
p.(None): countries
p.(None):
p.(None):
p.(None): Research partnerships between high-income and lower-income settings can be highly advantageous for both
p.(None): parties. Or they can lead to ethics dumping, the prac- tice of exporting unethical research practices to lower-income
p.(None): settings.
p.(None): This Global Code of Conduct for Research in Resource-Poor Settings counters ethics dumping by:
p.(None): Providing guidance across all research disciplines
p.(None): presenting clear, short statements in simple language to achieve the highest possible accessibility
p.(None): focusing on research collaborations that entail considerable imbalances of power, resources and knowledge
p.(None): using a new framework based on the values of fairness, respect, care and honesty offering a wide range of learning
p.(None): materials and affiliated information to support the
p.(None): Code, and
p.(None): complementing the European Code of Conduct for Research Integrity through a particular focus on research in
p.(None): resource-poor settings.
p.(None):
p.(None):
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 5
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_2
p.(None):
p.(None): 6 2 A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None): Those applying the Code oppose double standards in research and support long- term equitable research relationships
p.(None): between partners in lower-income and high- income settings based on fairness, respect, care and honesty.
p.(None):
p.(None):
p.(None): Fairness
p.(None): Article 1
p.(None):
p.(None): Local relevance of research is essential and should be determined in collaboration with local partners. Research that
p.(None): is not relevant in the location where it is under- taken imposes burdens without benefits.
p.(None):
p.(None):
p.(None): Article 2
p.(None):
p.(None): Local communities and research participants should be included throughout the research process, wherever
p.(None): possible, from planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly
p.(None): represented. This approach represents Good Participatory Practice.
p.(None):
p.(None):
p.(None): Article 3
p.(None):
p.(None): Feedback about the findings of the research must be given to local communities and research participants. It should be
p.(None): provided in a way that is meaningful, appropriate and readily comprehended.
p.(None):
p.(None):
p.(None): Article 4
p.(None):
p.(None): Local researchers should be included, wherever possible, throughout the research process, including in study design,
p.(None): study implementation, data ownership, intellec- tual property and authorship of publications.
p.(None):
p.(None): Respect
p.(None): 7
p.(None):
p.(None): Article 5
p.(None):
p.(None): Access by researchers to any biological or agricultural resources, human biological materials, traditional knowledge,
p.(None): cultural artefacts or non-renewable resources such as minerals should be subject to the free and prior informed consent
p.(None): of the owners or custodians. Formal agreements should govern the transfer of any material or knowledge to
p.(None): researchers, on terms that are co-developed with resource custodians or knowledge holders.
p.(None):
p.(None):
p.(None): Article 6
p.(None):
p.(None): Any research that uses biological materials and associated information such as tra- ditional knowledge or genetic
p.(None): sequence data should clarify to participants the poten- tial monetary and non-monetary benefits that might arise. A
p.(None): culturally appropriate plan to share benefits should be agreed to by all relevant stakeholders, and reviewed regularly
p.(None): as the research evolves. Researchers from high-income settings need to be aware of the power and resource differentials
p.(None): in benefit-sharing discussions, with sustained efforts to bring lower-capacity parties into the dialogue.
p.(None):
p.(None):
p.(None): Article 7
p.(None):
p.(None): It is essential to compensate local research support systems, for instance translators, interpreters or local
p.(None): coordinators, fairly for their contribution to research projects.
p.(None):
p.(None):
p.(None): Respect
p.(None): Article 8
p.(None):
p.(None): Potential cultural sensitivities should be explored in advance of research with local communities, research
p.(None): participants and local researchers to avoid violating custom- ary practices. Research is a voluntary exercise for
p.(None): research participants. It is not a mission-driven exercise to impose different ethical values. If researchers from
p.(None): high- income settings cannot agree on a way of undertaking the research that is acceptable to local stakeholders, it
p.(None): should not take place.
p.(None):
p.(None): 8 2 A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None): Article 9
p.(None):
p.(None): Community assent should be obtained through recognized local structures, if required locally. While individual
p.(None): consent must not be compromised, assent from the community may be an ethical prerequisite and a sign of respect for the
p.(None): entire community. It is the responsibility of the researcher to find out local requirements.
p.(None):
p.(None):
p.(None): Article 10
p.(None):
p.(None): Local ethics review should be sought wherever possible. It is of vital importance that research projects are approved
p.(None): by a research ethics committee in the host coun- try, wherever this exists, even if ethics approval has already been
p.(None): obtained in the high-income setting.
p.(None):
p.(None):
p.(None): Article 11
p.(None):
p.(None): Researchers from high-income settings should show respect to host country research ethics committees.
p.(None):
p.(None):
p.(None): Care
p.(None): Article 12
p.(None):
p.(None): Informed consent procedures should be tailored to local requirements to achieve genuine understanding and well-founded
p.(None): decision-making.
p.(None):
p.(None):
p.(None): Article 13
p.(None):
p.(None): A clear procedure for feedback, complaints or allegations of misconduct must be offered that gives genuine and
p.(None): appropriate access to all research participants and local partners to express any concerns they may have with the
p.(None): research process. This procedure must be agreed with local partners at the outset of the research.
p.(None):
p.(None): Care
p.(None): 9
p.(None):
p.(None): Article 14
p.(None):
p.(None): Research that would be severely restricted or prohibited in a high-income setting should not be carried out in a
p.(None): lower-income setting. Exceptions might be permissi- ble in the context of specific local conditions (e.g. diseases not
p.(None): prevalent in high- income countries).
p.(None): If and when such exceptions are dealt with, the internationally acknowledged compliance commandment “comply or
p.(None): explain” must be used, i.e. exceptions agreed upon by the local stakeholders and researchers must be explicitly
p.(None): and trans- parently justified and made easily accessible to interested parties.
p.(None):
p.(None):
p.(None): Article 15
p.(None):
p.(None): Where research involvement could lead to stigmatization (e.g. research on sexually transmitted diseases), incrimination
p.(None): (e.g. sexXwork), discrimination or indetermi- nate personal risk (e.g. research on political beliefs), special measures
p.(None): to ensure the safety and wellbeing of research participants need to be agreed with local partners.
p.(None):
p.(None):
p.(None): Article 16
p.(None):
p.(None): Ahead of the research it should be determined whether local resources will be depleted to provide staff or
p.(None): other resources for the new project (e.g. nurses or labo- ratory staff). If so, the implications should be discussed in
p.(None): detail with local com- munities, partners and authorities and monitored during the study.
p.(None):
p.(None):
p.(None): Article 17
p.(None):
p.(None): In situations where animal welfare regulations are inadequate or non-existent in the local setting compared with the
p.(None): country of origin of the researcher, animal experi- mentation should always be undertaken in line with the higher
p.(None): standards of protec- tion for animals.
p.(None):
p.(None): 10 2 A Value-Based Global Code of Conduct to Counter Ethics Dumping
p.(None):
p.(None): Article 18
p.(None):
p.(None): In situations where environmental protection and biorisk-related regulations are inadequate or non-existent in
p.(None): the local setting compared with the country of origin of the researcher, research should always be undertaken in line
p.(None): with the higher stan- dards of environmental protection.
p.(None):
p.(None):
p.(None): Article 19
p.(None):
p.(None): Where research may involve health, safety or security risks for researchers or expose researchers to conflicts of
p.(None): conscience, tailored risk management plans should be agreed in advance of the research between the research team, local
p.(None): partners and employers.
p.(None):
p.(None):
p.(None): Honesty
p.(None): Article 20
p.(None):
p.(None): A clear understanding should be reached among collaborators with regard to their roles, responsibilities and conduct
p.(None): throughout the research cycle, from study design through to study implementation, review and dissemination.
p.(None): Capacity-building plans for local researchers should be part of these discussions.
p.(None):
p.(None):
p.(None): Article 21
p.(None):
p.(None): Lower educational standards, illiteracy or language barriers can never be an excuse for hiding information or providing
p.(None): it incompletely. Information must always be presented honestly and as clearly as possible. Plain language and a
p.(None): non-patronising style in the appropriate local languages should be adopted in communication with research participants
p.(None): who may have difficulties comprehending the research process and requirements.
p.(None):
p.(None):
p.(None): Article 22
p.(None):
p.(None): Corruption and bribery of any kind cannot be accepted or supported by researchers from any countries.
p.(None):
p.(None): Honesty
p.(None): 11
p.(None):
p.(None): Article 23
p.(None):
p.(None): Lower local data protection standards or compliance procedures can never be an excuse to tolerate the potential for
p.(None): privacy breaches. Special attention must be paid to research participants who are at risk of stigmatization,
p.(None): discrimination or incrimi- nation through the research participation.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 3
p.(None): The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract Values inspire, motivate and engage people to discharge obligations or duties. This chapter defends the
p.(None): values approach in the context of guarding against ethics dumping, the practice of exporting unethical research from
p.(None): higher-income to lower-income settings. A number of essential questions will be answered: What are values? What is the
p.(None): meaning of the word “value”? Why does it make sense to choose values as an instrument to guide ethical action in
p.(None): preference to other possibilities? And what is meant by fairness, respect, care and honesty? It is concluded that
p.(None): values can provide excellent guidance and aspiration in the fight against ethics dumping, and are therefore a
p.(None): well-chosen structure for the Global Code of Conduct for Research in Resource-Poor Settings.
p.(None):
p.(None): Keywords Values · Virtues · Fairness · Respect · Care · Honesty
p.(None):
p.(None):
p.(None): Introduction
p.(None):
p.(None): Many celebrated documents which advocate for a better world include a preamble that mentions values. For instance,
p.(None): at the international level, the Universal Declaration of Human Rights (UN 1948) lists four values in the first
p.(None): sentence: dig- nity, freedom, justice and peace in the world. The first sentence of the Convention on Biological
p.(None): Diversity (UN 1992) refers to “the intrinsic value of biological diver- sity and of the ecological, genetic, social,
p.(None): economic, scientific, educational, cul- tural, recreational and aesthetic values of biological diversity” (emphasis
p.(None): added).
p.(None): Other national or professional codes have incorporated values prominently into individual articles. For instance, at
p.(None): the national level in the UK, the first item of The Code: Professional Standards of Practice and Behaviour for Nurses,
p.(None): Midwives and Nursing Associates, reads: “Treat people with kindness, respect and compassion” (NMC 2018).
p.(None): In some codes one has to search to find obvious references to values as they are often incorporated in a more implicit
p.(None): manner, such as in the Declaration of Helsinki
p.(None):
p.(None):
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 13
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_3
p.(None):
p.(None): 14 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): (WMA 2013), which speaks of “safety, effectiveness, efficiency, accessibility and quality” in article 6.
p.(None): When developing the Global Code of Conduct for Research in Resource-Poor Settings (GCC), a unique approach emerged
p.(None): naturally from the process employed. Its underpinning values materialized ahead of its final articles through an
p.(None): investiga- tion into the risks of exploitation in international collaborative research (Chapter 5), and from a global
p.(None): engagement and fact-finding mission (Chapter 6).
p.(None): It soon became clear that fairness, respect, care and honesty are all lacking, or deficient, whenever ethics dumping1
p.(None): occurs, and that a loss of trust in researchers and research itself can result. What also emerged is that these values
p.(None): are shared across the range of cultures that were represented in the TRUST2 consortium. It was therefore possible to
p.(None): surmise that these shared values are vital for equitable research partnerships and to prevent ethics dumping. In other
p.(None): words, these values are neces- sary to foster an ethical culture in research, and are therefore values to which all
p.(None): researchers should aspire.
p.(None): This chapter will answer some essential questions: What are values? What is the meaning of the word “value”? Why does
p.(None): it make sense to choose values as an instru- ment to guide ethical action in preference to other possibilities? And
p.(None): finally, what is meant by “fairness”, “respect”, “care” and “honesty”?
p.(None):
p.(None):
p.(None): The Meaning of “Value”
p.(None):
p.(None): Values pervade human experience (Ogletree 2004), and references to “values” are ubiquitous. With vast numbers of
p.(None): articles, books and internet sites offering advice on matters such as values we should live by, discovering our own
p.(None): values, changing our core values and achieving success through values, it is obvious that values are important to
p.(None): people.
p.(None): The term “value” can be used in many different ways.3 With reference to the way in which people use the term,
p.(None): three primary meanings of “value” can be distin- guished (see Fig. 3.1).
p.(None): First, value can refer to measurability. Mathematics operates with values, which can, for example, be discrete or
p.(None): continuous. Artists might speak of colours having values, meaning the relative lightness or darkness of a colour. In
p.(None): music, a note value determines the duration of a musical note. Economists or art dealers might measure value in
p.(None): monetary terms; a particular company or a particular painting might be
p.(None):
p.(None):
p.(None): 1 The export of unethical research from a high-income setting to a resource-poor setting with weaker
p.(None): compliance structures or legal governance mechanisms.
p.(None): 2 TRUST was an EU-funded project which operated from 2015 to 2018 and developed the GCC, among other outputs.
p.(None): http://trust-project.eu/
p.(None): 3 This section draws on unpublished work by Professor Michael Davis, a philosopher specializing in professional ethics.
p.(None):
p.(None): The Meaning of “Value”
p.(None): 15
p.(None):
p.(None): Fig. 3.1 The meaning of value
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Value
p.(None):
p.(None):
p.(None):
p.(None): Measurement
p.(None):
p.(None):
p.(None): Worthy to agents
p.(None):
p.(None): Morally worthy to agents
p.(None):
p.(None):
p.(None): valued at a certain amount of money. Value, in this sense of the word, has no rela- tionship to values such as
p.(None): admiration, approval or motivation.
p.(None): Secondly, people can value certain features or entities. For instance, somebody might value money, fame or glory. For
p.(None): value to exist, there must be an agent (a per- son) who is doing the valuing, and the feature or entity must be worth
p.(None): something to this agent (Klein 2017). The values of one individual can be very different from those of another person.
p.(None): For instance, a regular income is worth a lot to a person who values routine and security; it can contribute to their
p.(None): wellbeing and happiness. Others, who value personal freedom more than routine and security, might be just as happy with
p.(None): occasional income, as long as they are not bound to a nine-to-five job. If most humans around the world value a
p.(None): particular thing, it can be described as a universal value.
p.(None): Thirdly, values can refer to goals and ambitions, with a moral connotation. In business literature, for example, one
p.(None): often finds reference to value-led management or organizational values, and many institutions make a point of
p.(None): establishing, pro- moting and broadcasting their values. For instance, the stated values of the University of Central
p.(None): Lancashire (UCLan), at which several of the authors of this book are based, are: common sense, compassion,
p.(None): teamwork, attention to detail and trust (UCLan nd). These values are all morally positive and they are intended to
p.(None): guide the actions of students, staff and the institution itself. In this third sense of the word, moral values “will
p.(None): enable us to determine what is morally right or what is valuable in particular circumstances” (Raz 2001: 208). If
p.(None): most humans around the world share a particular moral value, it can be described as a universal moral value.
p.(None): There are numerous advantages to having credible moral values at the level of organizations. Such values influence the
p.(None): culture of an organization (Martins and Coetzee 2011), which in turn has a positive impact upon corporate performance
p.(None): (Ofori and Sokro 2010), and job stress and satisfaction (Mansor and Tayib 2010), as well as business performance and
p.(None): competitive advantage (Crabb 2011). Furthermore, when employees’ values are aligned with organizational values, this
p.(None): benefits both the wellbeing of individuals and the success of the organization (Posner 2010).
p.(None): There are many internet sites that offer lists of core values. One of them (Threads Culture nd) includes 500 values,
p.(None): from “above and beyond” to “work life balance”.
p.(None):
p.(None): 16 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Not all of these are moral values. For instance, this particular list includes values such as clean, exuberant,
p.(None): hygienic, neat, poised and winning (Threads Culture nd). Another site lists 50 values, including authenticity, loyalty
p.(None): and wisdom, and advises that fewer than five should be selected for leadership purposes (Clear nd).
p.(None): The GCC is structured around four moral values: fairness, respect, care and hon- esty. These four values were not
p.(None): chosen from any existing lists; they emerged through in-depth consultation efforts around the globe (chapter 6).
p.(None): But why did the TRUST team choose moral values rather than other action-guiding moral modes for the GCC?
p.(None):
p.(None):
p.(None): What Can Guide Moral Action?
p.(None):
p.(None): The GCC is based on moral values, but the code authors could have opted to frame the code and guide action in other
p.(None): ways, including the following:
p.(None): • Standards is a technical term used to achieve desired action. Standards are pre- cise and give exact
p.(None): specifications, which are in many cases measurable, as in the maximum vehicle emissions allowed for cars. Standards can
p.(None): also be used in eth- ics. For instance, a well-known voluntary standard to guide ethical action is ISO 26000 (ISO
p.(None): not dated), developed by the International Organization for Standardization. ISO 26000 assesses the
p.(None): social responsibility of companies. Its guidance includes prohibitions against bribery, and the requirement to
p.(None): be accountable for any environmental damage caused.
p.(None): • Principles are behavioural rules for concrete action. When you know the princi- ple, you know what to do. For
p.(None): instance, in dubio pro reo has saved many innocent people from going to jail as it gives the courts very concrete
p.(None): advice. Literally translated, it means, “when in doubt, then for the accused” (a person remains innocent until proven
p.(None): guilty). This principle goes back to both Aristotle and Roman law.
p.(None): • Virtues are beneficial character traits that human beings need to flourish (Foot 1978: 2f). One can observe
p.(None): them in real people or in fictional characters. England’s semimythical Robin Hood, for instance, is seen as
p.(None): courageous and benevolent. He fights a David-and-Goliath battle against the Sheriff of Nottingham
p.(None): (courage) so that the poor have food (benevolence). Like values, for virtues to exist, there must be an agent (a
p.(None): person) who is being virtuous; virtues focus on the moral agent rather than on the standard or principle that underlies
p.(None): a decision.
p.(None): • Ideals drive towards perfection and are highly aspirational. Some people will say “in an ideal world” to denote
p.(None): that something is unrealistic from the start. The ancient Greek philosopher Aristotle argued that we should strive
p.(None): towards perfec- tion of character and that ideals can be guiding lights in character building. “Good
p.(None): character is an ideal outside of oneself that all strive for” (Mitchell 2015).
p.(None):
p.(None): What Can Guide Moral Action?
p.(None): 17
p.(None):
p.(None): So why were values chosen as the foundation for the GCC rather than standards, principles, virtues or ideals?
p.(None): Ideals are the most aspirational of the concepts available to guide ethical action. However, hardly anybody can live up
p.(None): to all of their ideals. If one phrased an ethics code around ideals, those who should be led by the code might suggest
p.(None): that not reaching the ideals on every occasion would be acceptable. This is not the case. The 23 articles of the GCC
p.(None): (chapter 2) are not aspirational. They are mandatory.
p.(None): Virtues are found both historically and internationally in many important docu- ments of learning and wisdom. Famously,
p.(None): Aristotle (384–322 BC) linked human “happiness and wellbeing” to “leading an ethical life”, guided by the cardinal
p.(None): values of courage, justice, modesty and wisdom (Aristotle 2004). According to Confucianism, the most
p.(None): important traditional virtues are said to be benevolence, righteousness, propriety, wisdom, trustworthiness, filial
p.(None): piety, loyalty and reciproc- ity (Wang et al. 2018). Virtues are a good way to drive ethical action, in particular
p.(None): global ethical action, but the TRUST team had good reason not to use virtues as the foundation of the GCC.
p.(None): Virtues can be regarded as embodied ethical values because they are manifested in persons. One can learn a lot by
p.(None): observing real people (such as Mother Theresa or Nelson Mandela) and following their example. This makes virtue
p.(None): approaches very useful in leadership and mentoring (Resnik 2012). But not every researcher has access to
p.(None): mentors and learning via example. Besides, early career researchers are said to benefit more from rule-based approaches
p.(None): (Resnik 2012). Hence, while vir- tues were considered as a possibility for the foundation of the GCC, they
p.(None): were excluded because of their strong reliance upon the availability of role models.
p.(None): Principles have a long-standing tradition in practical moral frameworks, espe- cially principlism, the moral
p.(None): framework relating to bioethics developed by Beauchamp and Childress (2013). As argued in Chapter 4, we
p.(None): believe that the four principles of Beauchamp and Childress – autonomy, non-maleficence (do no harm), beneficence and
p.(None): justice – should instead be called values. Principles, as we under- stand them, are more concrete than values.
p.(None): Principles can provide almost immediate and very straightforward answers to ethical questions.
p.(None): A famous principle in political philosophy is Rawls’s difference principle. The principle holds that divergence from an
p.(None): egalitarian distribution of socialXgoods (e.g. income, wealth, power) is only allowed when this non-egalitarian
p.(None): distribution favours the least advantaged in society (Rawls 1999: 65–70). In other words, if a particularly talented
p.(None): wealth creator increases the overall wealth pie so that the least advantaged in society are better off, she can receive
p.(None): a bigger share of the pie than others. Knowing about this principle gives answers to social philosophy questions, which
p.(None): the value of fairness or justice would not. Rawls applied the value of fairness to derive the more concrete difference
p.(None): principle. Principles are therefore too con- crete and too prescriptive to form the foundation of the GCC. They would
p.(None): not leave enough room for local agreements between partners from high- and lower-income settings as envisaged by
p.(None): various GCC articles, such as article 1: “Local relevance of research … should be determined in collaboration with
p.(None): local partners.”
p.(None):
p.(None): 18 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Standards are even more specific than principles and have an even stronger action-guiding function. They
p.(None): prescribe very concrete activities in given settings. To formulate standards for ethical interaction between partners
p.(None): from different settings would certainly be too prescriptive. A standard cannot be diverged from (for exam- ple, a limit
p.(None): to vehicle emissions). For instance, if article 104 were a standard, no exception to double ethics review would be
p.(None): possible. But there may be good reason to allow such an exception in certain circumstances. For instance, if ethics
p.(None): approval has been given in a high-income setting and community approval obtained in a host setting where no ethics
p.(None): committee operates, then it may be perfectly ethical to proceed.
p.(None): The San community in South Africa, for instance, has no facility for providing ethics committee approval, but the South
p.(None): African San Council can provide commu- nity approval for research projects in the community (Chapter 7). A standard of
p.(None): double ethics review would forbid any research in the San community until an eth- ics committee were established, which
p.(None): might even undermine the San people’s self- determined research governance structures. For this reason, it is clear
p.(None): that standards are too prescriptive to be applied to every setting, and might hinder valuable research.
p.(None): This leaves ethical values, which operate as guides on the route to doing the right thing and are not overly
p.(None): prescriptive. They do not undermine the need to develop bespoke agreements across cultures via discussions
p.(None): between research teams and communities. At the same time, there is another, positive reason to choose values as the
p.(None): foundation for the GCC. Values inspire and motivate people to take action – and that is exactly what is needed to guard
p.(None): against ethics dumping.
p.(None):
p.(None):
p.(None): Values and Their Motivating Power
p.(None):
p.(None): Research stakeholders who are guided by values will hopefully be inspired and motivated by the GCC and not
p.(None): just follow its rules reluctantly or grudgingly. Why is that? Values can serve as motivating factors in promoting or
p.(None): inhibiting human action (Marcum 2008, Locke 1991, Ogletree 2004). The influence of personal val- ues upon behaviour has
p.(None): become a subject of extensive research in the social sci- ences and in psychology, particularly over the past forty
p.(None): years, with just about every area of life being examined through the lens of personal values – for example, con- sumer
p.(None): practices (Pinto et al. 2011), political voting habits (Kaufmann 2016), employee creativity (Sousa and Coelho
p.(None): 2011), healthcare decisions (Huijer and Van Leeuwen 2000), investment decisions (Pasewark and Riley 2010), and
p.(None): sexuality and disability (Wolfe 1997), to name but a few.
p.(None):
p.(None):
p.(None): 4 Local ethics review should be sought wherever possible. It is of vital importance that research projects are approved
p.(None): by a research ethics committee in the host country, wherever this exists, even if ethics approval has already been
p.(None): obtained in the high-income setting.
p.(None):
p.(None): From Values to Action
p.(None): 19
p.(None):
p.(None): Arguably the most prominent theory of the motivational power of human values was developed by social psychologist
p.(None): Shalom Schwartz, back in 1992. Schwartz’s theory of basic values is distinctive because, unlike most other theories, it
p.(None): has been tested via extensive empirical investigation. Studies undertaken since the early 1990s have generated
p.(None): large data sets from 82 countries, including highly diverse geographic, cultural, religious, age and occupational
p.(None): groups (Schwartz 2012). Findings from Schwartz’s global studies indicate that values are inextricably linked to
p.(None): affect. He claims that when values are activated, they become infused with feel- ing (Schwartz 2012). For example,
p.(None): people for whom routine and security are impor- tant values will become disturbed when their employment is threatened
p.(None): and may fall into despair if they actually lose their jobs. Correspondingly, when moral values like fairness or respect
p.(None): are important, people will react when they witness instances of unfairness or disrespect; they will feel motivated to
p.(None): respond in some way.
p.(None): Schwartz’s research investigated motivational values in general (combining our second and third meanings of “value”),
...
p.(None): that the specification of what each value requires in a given setting needs to be determined collaboratively. As a
p.(None): result, this sketch of the content of the four values is brief and leaves room for regional variations.
p.(None):
p.(None):
p.(None): The Four Values
p.(None): Fairness
p.(None):
p.(None): The terms “fairness”, “justice” and “equity” are often used interchangeably. The TRUST consortium chose the term
p.(None): “fairness” in the belief that it would be the most widely understood globally. Philosophers commonly distinguish
p.(None): between four types of fairness (Pogge 2006) (see Fig. 3.2).
p.(None): The most relevant fairness concepts in global research ethics are fairness in exchange and corrective
p.(None): fairness. In global collaborations, at least two parties are involved in a range of transactions. Typical fairness
p.(None): issues between partners from high-income countries (HICs) and those from low- and middle-income countries (LMICs) are:
p.(None): • Is the research relevant to local research needs?
p.(None): • Will benefit sharing take place?
p.(None): • Are authors from LMICs involved in publications?
p.(None):
p.(None): 5 Local communities and research participants should be included throughout the research process, wherever possible,
p.(None): from planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly represented.
p.(None): This approach represents Good Participatory Practice.
p.(None): 6 Local researchers should be included, wherever possible, throughout the research process, includ- ing in study
p.(None): design, study implementation, data ownership, intellectual property and authorship of publications.
p.(None):
p.(None): The Four Values
p.(None): 21
p.(None):
p.(None): Fairness in
p.(None): exchange
p.(None): • establishes the equity of transactions between at least two parties.
p.(None):
p.(None): Distributive fairness
p.(None): • deals with the division of existing, scarce resources among qualifying recipients.
p.(None):
p.(None): Corrective fairness
p.(None): • rights a wrong that one has brought upon another, often through a court.
p.(None):
p.(None): Retributive fairness
p.(None): Fig. 3.2 Types of fairness
p.(None): • establishes which punishment is appropriate for any given crime.
p.(None):
p.(None): These are questions about fairness in exchange. For instance, LMIC research participants contribute to the progress of
p.(None): science, but this is only fair if the research is relevant to their own community or if other benefits are received
p.(None): where this is not possible. For instance, to carry the burden of a clinical study is only worthwhile for a community if
p.(None): the disease under investigation occurs locally and the end product will become available locally.
p.(None): Corrective fairness, which presupposes the availability of legal instruments and access to mechanisms to right a wrong
p.(None): (e.g. a complaints procedure, a court, an eth- ics committee) is also important in global research collaborations. For
p.(None): instance, if no host country research ethics structure exists, corrective fairness is limited to the research ethics
p.(None): structure in the HIC, which may not have the capacity to make cul- turally sensitive decisions.
p.(None): The broader question of what HICs owe LMICs falls under distributive fairness. One can illustrate the difference
p.(None): between fairness in exchange and distributive fair- ness using the example of post-study access to successfully tested
p.(None): drugs. In the first case (fairness in exchange) one could argue that research participants have contrib- uted to the
p.(None): marketing of a particular drug and are therefore owed post-study access to it (should they need the drug to promote
p.(None): their health and wellbeing, and should they not otherwise have access to it). In the second case (distributive
p.(None): fairness) one could provide a range of arguments, for instance being a signatory to the Universal Declaration of Human
p.(None): Rights (UN 1948), to maintain that all human beings who need the drug should have access to it, and not just the
p.(None): research participants. These wider fairness issues cannot be resolved by researchers and are therefore not directly
p.(None): included in the GCC. Likewise, retributive fairness is less relevant as few ethics violations fall under the punitive
p.(None): and criminal law, and if they do, it is indeed crimi- nal law that should be used to deal with a fairness violation.
p.(None):
p.(None): 22 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): Respect
p.(None):
p.(None): The term “respect” is used in many ethics frameworks. For instance, the Declaration of Helsinki (WMA 2013) notes in
p.(None): article 7:
p.(None): Medical research is subject to ethical standards that promote and ensure respect for all human subjects
p.(None): and protect their health and rights. (emphasis added)
p.(None): Its ubiquitous use does not, however, mean that “respect” is a clear term. In everyday life, it is used in
p.(None): the sense of deep admiration. For instance, somebody could say, “I respect the achievements of Nelson Mandela”.
p.(None): However, that is not what is meant by respect in research ethics. The statement from the Declaration of Helsinki does
p.(None): not mean that research participants must be admired. To be respected in research ethics is almost the opposite. It
p.(None): means that one must accept a decision or a way of approaching a matter, even if one disagrees strongly. A case in point
p.(None): would be respecting the decision of a competent adult Jehovah’s Witness to refuse a blood transfusion for reasons of
p.(None): religious belief, even if this means certain death.
p.(None): Respect is therefore a difficult value, as there will be cases where one cannot accept another’s decision. For
p.(None): instance, if a researcher learns about female genital mutilation being used as a “cure” for diarrhoea in female babies
p.(None): (Luc and Altare 2018), respecting this approach to health care is likely to be the wrong decision – particularly as the
p.(None): practice is probably illegal. But the fact that respect may be dif- ficult to operationalize in global research
p.(None): collaborations does not mean that it is a value one can dispense with.
p.(None): There are many possible ways of showing respect that do not create conflicts of conscience. For instance, illiterate
p.(None): San community members should not be enrolled in research studies unless San leaders have been contacted first, in
p.(None): accordance with com- munity systems. And researchers from HICs should not insist that LMIC ethics com- mittees accept
p.(None): the format of the researchers’ preferred ethics approval submission; instead the HIC researchers should submit the
p.(None): study for approval in the format required by the LMIC committee. This shows respect in international collaborative
p.(None): research.
p.(None): While it may be difficult to imagine a situation where an HIC researcher is accused of being too fair, too
p.(None): honest or too caring, it is possible to be accused of being “too respectful” – for instance, if one tolerates major
p.(None): violations of human rights. It is indeed sometimes difficult to strike a balance between dogmatically
p.(None): imposing one’s own approach and carelessly accepting human rights violations, but that is the balance researchers
p.(None): should strive for.
p.(None):
p.(None):
p.(None): Care
p.(None):
p.(None): Sometimes one word describes different concepts. This is the case with “care”. The statement, “I care for my
p.(None): grandfather,” can mean two diametrically opposed things. First, it could mean that the person is very attached to her
p.(None): grandfather even though she hardly ever sees him. Second, it could mean that she is the person who injects
p.(None):
p.(None): The Four Values
p.(None): 23
p.(None):
p.(None): her grandfather with insulin, cooks his meals, and makes sure that his needs are taken care of every day, even if there
p.(None): is antipathy between them.
p.(None): The meaning of the value of care in the context of global research ethics links more to the second use of the term; to
p.(None): look after or take care of somebody or some- thing. As a main priority, one should take care of the interests of those
p.(None): enrolled in research studies to the extent that one always prioritizes their welfare over any other goals – for
p.(None): example, accepting the decisions of those who choose to withdraw from an ongoing study, even if this impairs the
p.(None): project’s results. In line with article 8 of the Declaration of Helsinki (WMA 2013) that means:
p.(None): While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over
p.(None): the rights and interests of individual research subjects.
p.(None): This care applies across disciplines, not only in medical research, and it is not restricted to human research
p.(None): participants. Article 21 of the Declaration of Helsinki (WMA 2013) extends the care for research subjects’ welfare to
p.(None): research animals. Likewise, care for environmental protection is increasingly included in research ethics
p.(None): processes and frameworks for responsible research. For instance, the European Commission’s Horizon 2020 ethics
p.(None): review process addresses potentially negative impacts on the environment (Directorate General for Research 2019: sec-
p.(None): tion 7). Richard Owen et al. (2013) define responsible research and innovation as “a collective commitment of care for
p.(None): the future through responsive stewardship of sci- ence and innovation in the present”, a statement that has clear
p.(None): relevance to environ- mental protection.
p.(None): Researchers who take care to avoid negative impacts in their work will not “heli- copter” in and out of a research area
p.(None): they are not familiar with, but will use systems of due diligence to ensure that risks are assessed and mitigated. For
p.(None): instance, an HIC research team that strips a local area of all doctors and nurses by attracting them into their
p.(None): high-tech research facility is not acting carefully and ethically.
p.(None): Ideally, researchers who take good care will combine the two concepts men- tioned above: they care about
p.(None): research participants, in the sense that the participants are important to them, and they feel responsible for the
p.(None): welfare and interests of those who contribute to their research, or might suffer as a result of it (including animals
p.(None): and the environment).
p.(None):
p.(None):
p.(None): Honesty
p.(None):
p.(None): Honesty is a value that does not need complicated explanations or definitions. In all cultures and nations, “Do not
p.(None): lie” is a basic prerequisite for ethical human interac- tion. It is so basic a value that its synonyms are
p.(None): often broad ethics terms. For instance, according to Google (2018), synonyms for “honesty” are:
p.(None): moral correctness, uprightness, honourableness, honour, integrity, morals, morality, ethics, principle, (high)
p.(None): principles, nobility, righteousness, rectitude, right-mindedness, upstandingness
p.(None):
p.(None): 24 3 The Four Values Framework: Fairness, Respect, Care and Honesty
p.(None):
p.(None): What does need explaining, however, is the scope of the value of honesty in the context of global research ethics.
p.(None): Telling lies is only one possible wrongdoing in the context of a broad understanding of honesty. For instance, in
p.(None): research ethics it is equally unacceptable to leave out salient features from an informed consent process. While this
p.(None): might, strictly speaking, not involve a lie, concealing important informa- tion that might make a difference to
p.(None): someone’s consent violates the value of honesty as much as lying. For this reason, research ethicists often use the
p.(None): terms “transpar- ency” and “open communication” to ensure that all relevant information is provided so that research
p.(None): participants can make an informed choice about whether to partici- pate or not.
p.(None): In addition to lying and withholding information, there are other ways of being dishonest, in the sense of not
p.(None): communicating openly and transparently. For instance, in a vulnerable population with high levels of illiteracy, it can
p.(None): be predicted that a printed information sheet about research will not achieve informed consent. The same can be said
p.(None): for a conscious failure to overcome language barriers in a mean- ingful way: leaving highly technical English
p.(None): terms untranslated in information sheets can easily lead to misunderstandings.
p.(None): Honesty is also related to research conduct other than interaction with research participants. Most prominently, the
p.(None): duties of honesty are described in research integrity frameworks: do not manipulate your data, do not put your
p.(None): name onto pub- lications to which you have not contributed, do not waste research funds, to give only three examples.
p.(None): However, while the latter prescriptions for conduct with integ- rity in research are important, they are not directly
p.(None): linked to exploitation in global research collaboration and are not covered in the GCC. In this context, the European
p.(None): Code of Conduct for Research Integrity (ALLEA, 2017) is very helpful.
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): Standards, principles, values, virtues and ideals can guide moral action. At the foun- dation of the GCC are values.
p.(None): Why? For three main reasons:
p.(None): 1. Values inspire action; they motivate people to do things. For instance, when the value of fairness is threatened,
p.(None): people normally respond with action.
p.(None): 2. Values provide the golden middle way between being overly prescriptive and overly aspirational. Standards and
p.(None): principles require too much precision in their formulation and are too prescriptive in international collaborative
p.(None): research, while virtues and ideals are too aspirational in their demands of researchers.
p.(None): 3. Values emerged naturally from the major engagement activities undertaken prior to developing the GCC.
p.(None): The eradication of ethics dumping requires not only moral guidance but also moral action to counter violations of
p.(None): fairness, respect, care and honesty. The 23 short, accessible articles of the GCC are intended to both guide and
p.(None): inspire research- ers to act with fairness, respect, care and honesty.
p.(None):
p.(None): References
p.(None): 25
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 4
p.(None): Respect and a Global Code of Conduct?
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The Global Code of Conduct for Research in Resource-Poor Settings claims global applicability and
p.(None): promotes respect as one of its four values. Hence, the code anticipates potentially unresolvable differences
p.(None): between cultures, while maintaining it is globally valid. Examining, but discarding, several possibilities to deal
p.(None): with normative relativism, this chapter argues, with Beauchamp and Childress (2013, Principles of Biomedical Ethics,
p.(None): 7th edn. Oxford University Press, New York) that values can be internal to morality itself, allowing their global
p.(None): applicability.
p.(None):
p.(None): Keywords Values · Normative relativism · Global justice · Research ethics · Fairness · Principlism
p.(None):
p.(None):
p.(None): Introduction
p.(None):
p.(None): The Global Code of Conduct for Research in Resource-Poor Settings (GCC) is built around four values: fairness, respect,
p.(None): care and honesty. In this chapter, we tackle the moral relativism claim against values approaches. Some readers may
p.(None): feel that no such effort is necessary. It may, in their view, be obvious that fairness, respect, care and honesty are
p.(None): worthy values. They may also believe that these values have appli- cation in global research ethics and that they can
p.(None): counter ethics dumping, the prac- tice of moving unethical research from a high-income setting to a resource-poor
p.(None): setting, which – by definition – requires a global approach. For those who are more sceptical, we sketch a plausible
p.(None): response to the moral relativism objection.
p.(None): The GCC’s value of respect recognizes significant variation in cultural norms and practices (for example in article
p.(None): 81), while implicitly assuming that the four
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 1 Potential cultural sensitivities should be explored in advance of research with local communities, research
p.(None): participants and local researchers to avoid violating customary practices. Research is a
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 27
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_4
p.(None):
p.(None): 28 4 Respect and a Global Code of
p.(None): Conduct?
p.(None):
p.(None): values the code recommends are globally applicable. How do we reconcile this ten- sion? That is, how do we demonstrate
p.(None): that, in making use of the four values, one group is not illegitimately imposing its values on others, in ways that the
p.(None): GCC itself would deem unacceptable?
p.(None): The surest way of doing this is to defend the claim that the four values, which we believe have particular application
p.(None): in research in resource-poor settings, could be global or universal values. Let us call this claim “the global
p.(None): applicability thesis”. We need somehow, then, to be able to maintain the global applicability thesis alongside the
p.(None): recognition of significant variation in norms across cultures. We will look in turn, in the sections that follow, at a
p.(None): number of suggestions about how this may be achieved.
p.(None): First we will consider the possibility that the requirement to proceed with fair- ness, respect, care and honesty leads
p.(None): to an acceptance of a thoroughgoing moral relativism – that is, a robust and unflinching commitment to the belief that
p.(None): all values are culture-bound, and that there are no “extra-cultural” values or norms. We will argue that, for reasons
p.(None): articulated by Bernard Williams (1972) nearly half a century ago, such strict moral relativism is unsustainable.
p.(None): Then we will consider the merits of a more moderate moral relativism, of the sort argued for by the Chinese-American
p.(None): philosopher David Wong (1991, 2009). This approach combines a recognition of variation in norms across cultures with a
p.(None): certain sort of universalism. For Wong, what remains constant across disparate systems of moral norms is the purpose
p.(None): behind any such system, or the aim of morality as such. We will argue that Wong’s approach, though an improvement on a
p.(None): more extreme relativism, does not provide what we need: that is, it does not show there to be some universal norms –
p.(None): among which are our four values – in addition to some genuine cross-cultural normative variation.
p.(None): Finally we introduce an approach that has much in common with the TRUST2 approach: the “four-principles approach”
p.(None): presented by Tom Beauchamp and James Childress in successive editions of their book Principles of Biomedical
p.(None): Ethics (2013). Beauchamp and Childress maintain that there are four central values/prin- ciples3 (see the box below
p.(None): for the difference between the two) that are especially applicable to their own area of ethical interest, biomedical
p.(None): ethics. They use the term principles, and identify them as respect for autonomy, non-maleficence (do no
p.(None): harm), beneficence and justice (Beauchamp and Childress 2013).
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): voluntary exercise for research participants. It is not a mission-driven exercise to impose different ethical values.
p.(None): If researchers from high-income settings cannot agree on a way of undertaking the research that is acceptable to local
p.(None): stakeholders, it should not take place.
p.(None): 2 EU-funded research project, which developed the GCC from 2015 to 2018.
p.(None): 3 According to the definition of values in the box (and in Chapter 3 of this book), the four-principles approach should
p.(None): be called the four-values approach, but this makes no difference in substance.
p.(None):
p.(None): Introduction
p.(None): 29
p.(None):
p.(None):
p.(None): Values and Principles
p.(None): The words “values” and “principles” are often used interchangeably. We will distinguish them as below.
p.(None): If people value something, they hold it dear, and they believe it is of high importance. This could be power, money or
p.(None): kindness; values are not necessar- ily morally positive. Ethical values, on the other hand, are guides on the route to
p.(None): doing the right thing or developing a moral character. They are by definition morally positive. For example, greed is
p.(None): not an ethical value, but generosity is. A principle is a behavioural rule for concrete action. When you know the
p.(None): principle, you know what to do. For instance, the principle in dubio pro reo has saved many innocent people from going
p.(None): to jail as it gives courts very con- crete advice. It means, “When in doubt, then favour the accused,” (in other words,
p.(None): “innocent until proven guilty”) and goes back to both Aristotle and
p.(None): Roman law.
p.(None):
p.(None): Beauchamp and Childress maintain that their four principles are globally appli- cable – that is to say, they are
p.(None): universally relevant to the sorts of ethical questions that arise in biomedicine; they are every bit as integral to the
p.(None): understanding and resolution of medical ethics problems in Bangkok as they are in Boston, equally pertinent in both
p.(None): Cape Town and Copenhagen. Their status as globally applicable is, according to Beauchamp and Childress, underwritten by
p.(None): their forming part of what they call “the common morality”, understood as a system of general norms that will be
p.(None): specified differently in different cultures, but to which all morally committed persons everywhere will subscribe.
p.(None): We want to argue that the four values – fairness, respect, care and honesty – are rooted in a globally applicable
p.(None): common morality, the norms of which can be speci- fied in various ways in disparate cultures. Insofar as this is the
p.(None): case, our argumenta- tional strategy will be similar to that of Beauchamp and Childress.
p.(None): However, we want to maintain that the four GCC values, taken together, have a less contentious claim to be globally
p.(None): applicable than Beauchamp and Childress’s principles, for two reasons.
p.(None): 1. One of Beauchamp and Childress’s principles – respect for autonomy – has often, and with some
p.(None): justification, been criticized for being culturally bound rather than universal (Huxtable 2013, Kara 2007,
p.(None): Cheng-Tek Tai 2013, Kiak Min 2017)
p.(None): 2. The GCC’s four-values approach was developed collaboratively with diverse stakeholders from all continents,
p.(None): including significant representation from vul- nerable research populations (see Chapters 6 and 7).
p.(None):
p.(None): 30 4 Respect and a Global Code of
p.(None): Conduct?
p.(None):
p.(None): The Four Values and Moral Relativism
p.(None):
p.(None): Giving the value of respect high standing, as one of only four values in the GCC framework, opens the framework to
p.(None): attack for being morally relative. Unlike fair- ness, care and honesty, the value of respect centres on foreseeable
p.(None): disagreement. If I have to respect what somebody does in a country that is not my own, even though I disagree heavily
p.(None): for moral reasons, does this mean there are no globally shared values? If this were the case, it would mean that no
p.(None): global moral framework is avail- able to ground the 23 articles of the GCC.
p.(None): In philosophy, this conundrum is called the doctrine of moral relativism. Such relativism has been divided into
p.(None): three related forms with different emphases: descriptive relativism, metaethical relativism and normative
p.(None): relativism.
p.(None):
p.(None):
p.(None): Descriptive relativism
p.(None):
p.(None):
p.(None):
p.(None): Metaethical4 relativism
p.(None):
p.(None):
p.(None):
p.(None): Normative relativism
p.(None): Descriptive relativism is a sociological or anthropological, rather than philosophical, doctrine, which is based upon
p.(None): observations of disparate cultures. It holds that, as a matter of fact, moral norms show considerable variation across
p.(None): societies: courses of action deemed permissible or even obligatory in one society may be proscribed in another.
p.(None): Metaethical relativism is a philosophical doctrine that we may be tempted to adopt if we find ourselves convinced by
p.(None): the claims of the descriptive relativist. It maintains that there are no universal or extra-cultural moral truths:
p.(None): insofar as a given moral judgement can accurately be described as true or false, this position maintains that it is
p.(None): true or false only relative to a given society.
p.(None): If we subscribe to metaethical relativism, then we can only say that a particular action is wrong in our society, not
p.(None): in other societies. Our only option is to “live and let live”.
p.(None):
p.(None): A summary of these positions and how they follow from each other is shown in Figure 4.1.
p.(None): Normative relativism might seem to offer us a way to resolve the apparent ten- sion in the four-values approach, which
p.(None): might be thought to dovetail neatly with the normative relativist’s outlook. Since we have no business interfering in
p.(None): or evaluat- ing the moral codes of those from other cultures, our interactions with them, includ- ing research
p.(None): interactions, need to be as “light-touch” as possible. We need to treat each other fairly and with care, respect
p.(None): cultural differences, not impose our own values, and ensure our interactions are honest.
p.(None): The problem here, however, is that just as descriptive relativism does not entail (though it may lend support to)
p.(None): metaethical relativism, metaethical relativism also does not entail normative relativism (and provides no support for
p.(None): it at all). This point is well argued by Bernard Williams (1972: 34) in his 1972 book Morality, in
p.(None):
p.(None):
p.(None):
p.(None): 4 Metaethics is a branch of analytical philosophy which deals with higher-level questions of moral- ity. Rather than
p.(None): asking how to lead a moral life, which values are appropriate to govern it, etc., metaethics asks whether such
p.(None): questions can be answered in the first place.
p.(None):
p.(None): A More Moderate Relativism
p.(None): 31
p.(None):
p.(None): Descriptive Relativism
p.(None): Metaethical Relativism
p.(None): Normative Relativism
p.(None):
p.(None): One can observe different moral norms
p.(None): There are no universal or extra-cultural moral truths
p.(None): We have to "live and let live"
p.(None): Fig. 4.1 Different types of relativism and their relationship
p.(None):
p.(None): which he calls normative relativism “possibly the most absurd view to have been advanced even in moral philosophy”. He
p.(None): writes:
p.(None): [T]he view is clearly inconsistent, since it makes a claim … about what is right and wrong in one’s dealings with other
p.(None): societies, which uses a nonrelative sense of “right” not allowed for in [metaethical relativism].
p.(None): In other words, metaethical relativism does not lead to any position, including normative relativism, which tells us
p.(None): what we should do in interacting with those from other cultures. This is simply because metaethical relativism itself
p.(None): tells us that there is no global “should”. Every claim about what we should do has been generated and will be bound by
p.(None): our own culture. If the imperative to treat those from other cultures with fairness, respect, care and honesty is
p.(None): thought to be one that floats free of, and exists outside, any culturally bound system of values, and we want the GCC
p.(None): to apply globally, then we cannot be metaethical relativists.
p.(None):
p.(None):
p.(None): A More Moderate Relativism
p.(None):
p.(None): It may be that we can justify the four values by appealing to the more moderate form of relativism espoused by David
p.(None): Wong (2009). According to Wong, although moral norms do indeed vary across cultures, as the descriptive
p.(None): relativist assumes, and although there is no one single true morality, there is something that is universal about
p.(None): morality, and common to all particular moralities worthy of the name.
p.(None): What is common is the central aim or purpose of morality. This aim is not itself a value in any given moral system, but
p.(None): rather what determines whether any given value is fit to figure in such a system. A consequence of this, and one which
p.(None): renders Wong’s relativism more palatable for many than more extreme versions, is that although there is no
p.(None): single true morality, some moral systems are better than others.
p.(None):
p.(None): 32 4 Respect and a Global Code of
p.(None): Conduct?
p.(None):
p.(None): Why? Because moral systems regulate interpersonal and intrapersonal conflicts. More precisely (Wong 2009: xii):
p.(None): Morality … comprises an idealized set of norms in imperatival form (“A is to do X under conditions C”) abstracted from
p.(None): the practices and institutions of a society that serves to regu- late conflicts of interest, both between persons and
p.(None): within the psychological economy of a single person.
p.(None): For instance, Western liberal democracies stress individual rights, while other systems involve a commitment to
p.(None): community goods, such as those to be found in Chinese, Indian and traditional African communities (Wong 1991: 445).
p.(None): When we consider such differences, what reason could we have for pronouncing one culture right and the others wrong? A
p.(None): relativistic approach will reply, “None.” Wong tells us (1991: 446):
p.(None): The argument for a relativistic answer may start with the claim that each type focuses on a good that may reasonably
p.(None): occupy the centre of an ethical ideal for human life. On the one hand, there is the good of belonging to and
p.(None): contributing to a community; on the other, there is the good of respect for the individual apart from any potential
p.(None): contribution to community. It would be surprising, the argument goes, if there were just one justifiable way of setting
p.(None): a priority with respect to the two goods. It should not be surprising, after all, if the range of human goods is simply
p.(None): too rich and diverse to be reconciled in just a single moral ideal.
p.(None): Wong’s approach may be more acceptable than an extreme, uncompromising metaethical relativism (and potentially
p.(None): more serviceable as a means of grounding the four GCC values), but it is not without its problems. For
p.(None): example, Michael Huemer (2005) points out a dilemma for any such relativism. That dilemma is revealed
p.(None): when we ask whether the regulation of interpersonal and intrapersonal conflicts is itself something that we
p.(None): should regard as good. If it is, then the regulation of such conflicts represents a value that transcends cultures,
p.(None): grounding any accept- able morality in any society and/or time. Hence, we would have at least one univer- sal value
p.(None): rather than a form of relativism.
p.(None): As a result, Wong’s approach still does not give us any definite universal values (at a minimum, the four values that
p.(None): feature in the GCC).
p.(None):
p.(None):
p.(None): Grounding the Global Applicability Thesis of the GCC in a Common Morality
p.(None):
p.(None): In their celebrated book Principles of Biomedical Ethics, Tom Beauchamp and James Childress have, over the
p.(None): course of 34 years and seven editions, maintained that there are four principles that are particularly applicable to
p.(None): problems in biomedical ethics: respect for autonomy, beneficence, non-maleficence and justice. As explained above,
p.(None): their claim is that these principles are globally applicable because they are part of what Beauchamp and Childress call
p.(None): “the common morality”, which is to be understood as a set of principles subscribed to by all morally committed people,
p.(None): whatever their culture, and whatever the time in which they live. The principles of
p.(None):
p.(None): Grounding the Global Applicability Thesis of the GCC in a Common Morality 33
p.(None):
p.(None): the common morality, then, are globally applicable, in just the way that the authors of the GCC want the four values of
p.(None): fairness, respect, care and honesty to be.
p.(None): To the rather obvious objection that no set of values/principles seems to possess the universality they ascribe to
p.(None): the common morality, given the observations of descriptive relativism, Beauchamp and Childress have two
p.(None): responses.
p.(None): 1. It is not the case that every principle that exists finds a home in the common morality: some principles are purely
p.(None): local.
p.(None): 2. More importantly, the principles of the common morality may be variously spec- ified in different cultures.
p.(None): The great benefit of the common-morality theory is that it allows an optimum balance of universality on the one hand,
p.(None): and variation across cultural settings on the other. There is a set of high-level values/principles that are internal
p.(None): to morality, but these are expressed in differing ways in particular moralities associated with par- ticular
p.(None): communities.
p.(None): If the supposed common morality is a set of general, unspecified values to which all who are morally committed
p.(None): subscribe, how do we know which these values are? Would we not first have to identify some morally committed people,
p.(None): and then carry out an empirical investigation into the values they hold? The most general values shared by them all
p.(None): would then be those that constitute the common morality. But problems loom here; circularity threatens.
p.(None): How do we determine who is morally committed in the first place? Presumably, we do so by examining what values
p.(None): they hold. If they adhere to value1, value2, value3, and so on up to valuen, then, we might want to say, they
p.(None): are morally commit- ted. But this is an unacceptable, question-begging way of proceeding. If we want to find out what
p.(None): values the morally committed hold, and thereby find what values constitute the common morality, it is no good
...
p.(None): (Huxtable 2013; Kara 2007, Cheng-Tek Tai 2013, Kiak Min 2017). We want to examine one such counter-example.
p.(None): R.E. Florida (1996), in an article entitled “Buddhism and the Four Principles”, insists that no principle of respect
p.(None): for autonomy is to be found in Buddhist cultures at all, due to Buddhism’s metaphysic of “co-conditioned causality”.
p.(None): The thought seems to be that autonomy is not going to show up as a value, and so as something especially worthy of
p.(None): respect, in a culture that holds to a conceptual scheme in which there is no genuine separation between what those
p.(None): outside that culture call “indi- viduals” (any apparent separation being at best an illusion).
p.(None): The interesting thing about the Buddhist example is that it would be very difficult to argue that Buddhist culture is
p.(None): not fundamentally committed to non-maleficence. The notion looms exceptionally large in Buddhist ethics, in the shape
p.(None): of the norm of ahimsa, or non-harm. Those who are committed to Buddhist ethics, then, are, by Beauchamp and Childress’s
p.(None): vision, morally committed. And yet, if Florida is right, subscription to the principle of non-maleficence is not
p.(None): universally accompanied by subscription to the principle of respect for autonomy. Hence, at least one element of the
p.(None): group of four principles chosen by Beauchamp and Childress, namely respect for autonomy, does not seem to belong to the
p.(None): common morality.
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): The most promising approach based on values/principles to claim global applicabil- ity for its framework has a hole. As
p.(None): the example of Buddhist ethics shows, respect for individual autonomy cannot be regarded as a globally applicable
p.(None): value/principle that all morally committed people would subscribe to. Respect for autonomy, with the focus on
p.(None): individual autonomy, as understood by Beauchamp and Childress (2013: Chapter 4) does not seem to qualify for
p.(None): global applicability, as the Buddhist counter-example is solid. But that does not mean other values systems must fail.
p.(None): If key values are, as argued above, internal to morality, the four-values approach developed for the GCC is valid until
p.(None): falsified with rigorous counter-examples, such as the Florida example against respect for autonomy.
p.(None):
p.(None): 36 4 Respect and a Global Code of
p.(None): Conduct?
p.(None):
p.(None): References
p.(None):
p.(None): Beauchamp TL, Childress JF (2009) Principles of biomedical ethics, 6th edn. Oxford University Press, New York
p.(None): Beauchamp TL, Childress JF (2013) Principles of biomedical ethics, 7th edn. Oxford University Press, New York
p.(None): Cheng-Tek Tai M (2013) Western or Eastern principles in globalized bioethics? An Asian perspec- tive view. Tzu Chi
p.(None): Medical Journal 25(1):64–67
p.(None): Florida RE (1996) Buddhism and the four principles. In: Gillon R (ed) Principles of healthcare ethics. John Wiley and
p.(None): Sons, Chichester, p 105–116
p.(None): Foot P (2002) Moral dilemmas. Oxford University Press, Oxford
p.(None): Herissone-Kelly P (2003) The principlist approach to bioethics, and its stormy journey overseas. In: Häyry M, Takala
p.(None): T (eds) Scratching the surface of bioethics. Rodopi, Amsterdam and New York, p 65–77
p.(None): Huemer M (2005) Ethical intuitionism. Palgrave Macmillan, New York
p.(None): Huxtable R (2013) For and against the four principles of biomedical ethics. Clinical Ethics 8(2–3):39–43
p.(None): Kara M A (2007) Applicability of the principle of respect for autonomy: the perspective of Turkey.
p.(None): Journal of Medical Ethics 33(11):627–630
p.(None): Kiak Min MT (2017) Beyond a Western bioethics in Asia and its implication on autonomy. The New Bioethics 23(2):154–164
p.(None): Williams B (1972) Morality: an introduction to ethics. Cambridge University Press, Cambridge Wong D (1991) Relativism.
p.(None): In: Singer P (ed) A companion to ethics. Blackwell, Oxford, p 442–450 Wong D (2009) Natural moralities: a defense of
p.(None): pluralistic relativism. Oxford University Press,
p.(None): New York
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 5
p.(None): Exploitation Risks in Collaborative International Research
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract Ethics dumping occurs in collaborative international research when peo- ple, communities, animals and/or
p.(None): environments are exploited by researchers. Exploitation is made possible by serious poverty and extreme power
p.(None): differentials between researchers from high-income countries and research stakeholders from low- and middle-income
p.(None): countries (LMICs). To prevent its occurrence, the risks of exploitation have to be tackled. This chapter describes 88
p.(None): risks identified for col- laborative international research, categorized according to four values: fairness,
p.(None): respect, care and honesty. The risks were identified in a broad-based consultative exercise, which included more than
p.(None): 30 members and chairs of ethics committees in LMICs, representatives from vulnerable populations in LMICs, and an open
p.(None): call for case studies of exploitation. The findings of the exercise contributed to the develop- ment of the Global Code
p.(None): of Conduct for Research in Resource-Poor Settings.
p.(None):
p.(None): Keywords Exploitation · Ethics dumping · Collaborative research · Vulnerability · Research ethics · Ethics codes
p.(None):
p.(None):
p.(None): Ethics dumping1 occurs in collaborative international research when people, com- munities, animals and/or environments
p.(None): are exploited by researchers. In order to pre- vent ethics dumping, such exploitation needs to stop. This chapter
p.(None): describes our investigation into the risks of exploitation in low- and middle-income countries (LMICs),
p.(None): uncovering what makes exploitation more likely to occur due to vulnera- bilities that can be exploited, either
p.(None): knowingly or unknowingly.
p.(None): This undertaking was vital for the development of a Global Code of Conduct for Research in Resource-Poor Settings (GCC)
p.(None): that can address real-world risks for exploitation in research. Many such risks are not well described in the
p.(None): literature, and hence there was an empirical component to our activities. Furthermore, this process was necessary to
p.(None): ensure that the GCC was more than a compilation of existing
p.(None):
p.(None):
p.(None):
p.(None): 1 The export of unethical research from a high-income setting to a resource-poor setting with weaker
p.(None): compliance structures or legal governance mechanisms.
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 37
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_5
p.(None):
p.(None): 38 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): codes, most of which had not been written with LMIC-HIC (high-income country) collaborations in mind.
p.(None):
p.(None):
p.(None): The Nature of Exploitation
p.(None):
p.(None): The potential to be exploited is part of the human condition. Exploiters take advan- tage of others’ vulnerabilities to
p.(None): promote their own interests (Hughes 2010). While there is a morally neutral sense of exploitation (the exploitation of
p.(None): natural talents to create art, for example), the term is generally used to describe a moral failing.
p.(None): Exploitation of people is very often unjust, unfair, harmful or just plain wrong. What is it, then, that
p.(None): distinguishes morally unacceptable exploitation from neutral exploitation?
p.(None): Some argue that exploitation is wrong because it is coercive (Schwartz 1995). If the only way for a woman in an LMIC to
p.(None): access antiretroviral drugs to prevent the transmission of HIV to her unborn baby is to participate in a
p.(None): placebo-controlled clinical trial,2 despite the existence of a proven standard of care,3 then one could say she has
p.(None): been coerced into enrolling (Annas and Grodin 1998). In this sense, exploi- tation occurs where one party takes
p.(None): advantage of another by making them an offer they cannot refuse; they are then coerced to accept simply because there
p.(None): is no alter- native. Others argue that exploitation is wrong because it treats human beings as means rather than ends
p.(None): (Wood 1995). In other words, exploitation instrumentalizes people. Yet others claim that exploitation is wrong
p.(None): because it disadvantages the vulnerable (Macklin 2003).
p.(None): Our investigation was concerned with the risks or vulnerabilities for exploitation, so we adopted Macklin’s definition
p.(None): of exploitation. However, it is important to bear in mind that situations that are conducive to exploitation do not
p.(None): necessarily lead to exploitation. For instance, if a pharmaceutical company is due to test new antiretro- viral drugs
p.(None): to prevent the transmission of HIV to unborn babies, and the company operates in a country where poor mothers have no
p.(None): or very limited access to health care, it does not mean that exploitation will necessarily occur. The company may
p.(None): decide not to exploit vulnerable research participants and offer the accepted stan- dard of care to those in the
p.(None): control arm, rather than a placebo.
p.(None): Exploitation usually requires a moral decision on the part of the potential exploiter, but it can also occur
p.(None): through ignorance. Whether intended or unintended, the effects of exploitation are the same for the exploited. Hence,
p.(None): ignorance is not a legitimate justification for exploitation. Uncovering the primary risks of exploitation
p.(None):
p.(None): 2 A placebo-controlled trial involves some participants being given a medicine with active ingredi- ents, for instance
p.(None): a new drug against malaria, while others, the controlXgroup, are given a substance that should have no effect (the
p.(None): placebo), so that the outcomes can be compared.
p.(None): 3 One speaks of a proven standard of care when a treatment already exists for the illness under consideration in a
p.(None): trial. Hence, the ethical demand of testing any new drug against an existing one rather than a placebo is known as the
p.(None): “standard of care” debate.
p.(None):
p.(None): Our Method
p.(None): 39
p.(None):
p.(None): can help to increase awareness but, in our case, it also ensures that the GCC is designed in such a way
p.(None): that researchers are compelled to consider these factors. It is a unique facet of the GCC that it focuses the attention
p.(None): of researchers directly upon the primary risks of exploitation in collaborative HIC-LMIC research. This could only be
p.(None): achieved via thorough exploration of the risks from many perspectives, both top-down and bottom-up.
p.(None):
p.(None):
p.(None): Our Method
p.(None):
p.(None): The aim of this investigation was to identify the critical vulnerabilities that engender susceptibility to exploitation
p.(None): in LMIC-HIC collaborative research. Investigation of this vast subject would be impossible from a traditional
p.(None): literature-based approach, or through investigation in a single geographical region. Many of these vulnerabili- ties
p.(None): are poorly represented in the literature, and they can differ between countries, cultures and types of research. For
p.(None): example, clinical trials, social science, animal experiments, environmental science and research in emergency settings
p.(None): may pose a diverse array of risks that are largely determined by the local context. Consequently, a creative approach
p.(None): to data collection was needed to capture as many risks and vul- nerabilities as possible.
p.(None): In this regard it was very helpful that the interdisciplinary TRUST project con- sortium comprised multilevel ethics
p.(None): bodies, policy advisers and policymakers, civil society organizations, funding organizations, industry and academic
p.(None): scholars from a range of disciplines. With input from each of these perspectives, a broad-based consultative exercise4
p.(None): was possible which included input from these collaborators as well as more than 30 members and chairs of ethics
p.(None): committees in LMICs, represen- tatives from vulnerable populations in LMICs, and an open call for case studies of
p.(None): exploitation in research in LMICs (Chapter 6).
p.(None): For example, extensive input from members and chairs of ethics committees was sought in both India and Kenya. In India,
p.(None): the Forum for Ethics Review Committees in India (FERCI) hosted a two-day workshop in Mumbai on 11 and 12 March 2016. At
p.(None): this workshop, approximately 30 leading bioethicists from around India came together to share their experiences and
p.(None): discuss cases of exploitation in research. In Nairobi on 23 and 24 May 2016, three esteemed chairs of national ethics
p.(None): commit- tees shared their experiences and opinions about the primary ethical challenges for LMIC-HIC collaborative
p.(None): research in Kenya. Findings from both events revealed multiple risks of exploitation that are characteristic of
p.(None): research in some LMIC set- tings. These included traditional requirements for appropriate community
p.(None):
p.(None): 4 This type of consultative exercise is of proven value in the development of ethical codes that are broadly
p.(None): representative and can have wide-ranging impact. For example, the principles of the “Three Rs”, which are
p.(None): globally accepted as a reasonable measure for ethical conduct in animal research, arose from a broad consultation with
p.(None): stakeholders undertaken by Russell and Burch in the 1950s. See Russell et al. (1959).
p.(None):
p.(None): 40 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): consultations and permissions, and specific cultural beliefs and customs that must be respected.
p.(None): Ongoing consultation with representatives from two vulnerable groups that have first-hand accounts of the risks
p.(None): for exploitation were undertaken. From Nairobi, Kenya, sexXworker peer educators and, from South Africa, members
p.(None): of the San com- munity shared their experiences of being the subjects of exploitation and their opin- ions about how
p.(None): they want to be treated in future. Among many other insights, both groups described a lack of benefits from research
p.(None): projects (which are often highly beneficial to the researchers), as well as risks of stigmatization from the manner in
p.(None): which they were involved in the study.
p.(None): 12 months of in-depth and far-reaching investigation produced a considerable amount of data (Chapter 6). From this
p.(None): data, individual vulnerabilities and risks of exploitation were extracted, organized and tabulated on an Excel
p.(None): spreadsheet with source details and descriptions of the vulnerability or risk. Care was taken to ensure that each
p.(None): individual entry was based upon real-world experience rather than hypo- thetical suppositions. Our lists were compared
p.(None): with risks mentioned in the literature and, where necessary, additional information sought to address gaps.
p.(None): Once collated, the raw data was streamlined to group similar vulnerabilities together. For instance, there
p.(None): were many different examples of how people living in resource-poor circumstances may be unfairly enticed to participate
p.(None): in research by the prospect of payment or reward. Such examples were grouped under the label “undue inducement”.
p.(None): Further thematic analysis resulted in distinctions between the various potential subjects of exploitation, or levels of
p.(None): risk for exploitation (persons, institutions,5 local communities, countries, animals and the environment). In
p.(None): the final stage of the analysis the vulnerabilities were grouped according to the four values of fairness, respect,
p.(None): care and honesty.
p.(None):
p.(None):
p.(None): Our Findings
p.(None):
p.(None): The remainder of this chapter is devoted to presenting and explaining our findings. For each value, an exploitation
p.(None): risk table details the main risks for persons, institu- tions, local communities, countries, animals and the
p.(None): environment. Each entry on the tables describes a vulnerability that could lead to exploitation (deliberate or unin-
p.(None): tentional) in LMIC-HIC research collaborations and all are grounded in real-world experience. Additionally, for each
p.(None): value, certain examples are described in more detail to further illustrate the risks.
p.(None): It has to be noted that some entries could have been linked to more than one value. For instance, if a research
p.(None): participant suffered from a therapeutic misconception, the researcher might not have taken enough care to explain that
p.(None): research is different from treatment because s/he was not aware that this might be problematic in some settings, or
p.(None): otherwise because s/he deliberately and dishonestly wanted to avoid explaining the difference, in which case the value
p.(None): of honesty would have been violated. To avoid overburdening the tables, we made a decision to prioritize one value in
p.(None): each case.
p.(None):
p.(None): 5 “Institutions” includes local researchers as well as their organizations.
p.(None):
p.(None): Our Findings
p.(None): 41
p.(None):
p.(None): Fairness
p.(None):
p.(None): Our data revealed many risks for exploitation that might be categorized as issues of fairness (or unfairness) that are
p.(None): varied in nature and pertain to different aspects of fairness. Philosophers commonly distinguish between different
p.(None): types of justice or fairness (Pogge 2006) (Chapter 3), but the most relevant fairness concepts for global research
p.(None): ethics are fairness in exchange and corrective fairness.
p.(None): Fairness in exchange concerns the equity of transactions that occur between par- ties. In collaborative research,
p.(None): ventures should aim to be mutually beneficial. Where the collaboration is between HIC and LMIC partners, typical
p.(None): fairness in exchange issues might include:
p.(None): The relevance of the research to local needs Whether reasonable benefit sharing is taking place
p.(None): Whether LMIC researchers are involved in meaningful ways
p.(None): Table 5.1 shows the primary risks related to fairness in exchange for persons, institutions, communities, countries and
p.(None): the environment.
p.(None):
p.(None): Table 5.1 Primary risks for fairness in exchange
p.(None): Level of risk Nature of risk
p.(None): Personal • In medical research:
p.(None): - Multiple trial enrolment
p.(None): - No post-study access to treatment
p.(None): • In all research:
p.(None): - Undue inducement
p.(None): - No access to results or benefits of research
p.(None):
p.(None): Researcher/ institutional
p.(None): • Research priorities driven by HIC partners:
p.(None): - Mismatch to local research needs
p.(None): • Poor representation of LMIC (host) partners on research teams:
p.(None): - Responsible for menial tasks only
p.(None): - Not acknowledged or represented appropriately in publications
p.(None): • “Helicopter research” by HIC partners:
p.(None): - No knowledge transfer or capacity building/strengthening
p.(None): Community • Research priorities driven by HIC partners:
p.(None): - Mismatch to local research needs
p.(None): • Little or no input from marginalized communities into research
p.(None): • Undue inducement
p.(None): • No benefit sharing or feedback
p.(None): • Support for foreign-sponsored research drains local system of staff Country • No universal access
p.(None): to health care for population:
p.(None): - Differences in standards of “usual” care
p.(None): • Placebo-controlled trials approved
p.(None): • Support for foreign-sponsored research drains local systems and resources
p.(None): • Medical science research shaped by the “para state”
p.(None): Animal
p.(None): Environmental • Study leads to reduction of natural resources
p.(None): • Lack of benefit sharing for the environment
p.(None):
p.(None): 42 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): A primary risk in the exploitation of individuals and communities is that they may not have access to the results or
p.(None): benefits of research. This occurs when the research is designed to benefit people in other countries or settings and
p.(None): the individu- als who contributed to the study never get a chance to benefit from it. This happened with a clinical
p.(None): study of the hepatitis B vaccine in Kenya. Although the research was undertaken in Kenya, for many years afterwards
p.(None): people in Kenya could not afford to purchase the vaccine and therefore could not benefit (Bhatt 2016). When research
p.(None): aims are driven by, and in the interests of, high-income researchers or institutions with no real benefit to the local
p.(None): community or participants, we must ask why it is being conducted there.
p.(None): Local LMIC researchers are exploited when used only for tasks such as data col- lection, or when, having participated
p.(None): in a research project, they are then not properly represented, or not represented at all, in subsequent publications.
p.(None): Local environ- ments are exploited when environmental studies fail to benefit them. Research agreements
p.(None): focused on the use of biodiversity and traditional knowledge typically ignore the environmental component, and the
p.(None): common approaches to benefit shar- ing from research activities include only humans (Stone 2010).
p.(None): Corrective fairness presupposes the availability of legal instruments and access to mechanisms for righting wrongs
p.(None): (e.g. a complaints procedure, a court or an ethics committee). For instance, if no research ethics structure exists in
p.(None): the host country, corrective fairness is limited to the research ethics structure in the HIC country, which may not
p.(None): have the capacity to make culturally sensitive decisions. Table 5.2
p.(None):
p.(None):
p.(None):
p.(None): Table 5.2 Primary risks for corrective fairness
p.(None): Level of risk Nature of risk
p.(None): Personal • Difficult or no access to legal system or legal aid
p.(None): • Human rights violations not taken up by civil society
p.(None):
p.(None): Researcher/ institutional
p.(None): • Lack of protection of IPR for LMIC institutions
p.(None): • Lack of clear standards for operating systems and timelines for RECs
p.(None): • No capacity/procedures for study oversight to ensure compliance with REC decisions
p.(None): Community • Lack of protection of IPR or traditional knowledge for local communities
p.(None): • Human rights violations not taken up by civil society
p.(None): • Absence of systems for community approvals Country • No relevant legal instruments for ethics committees
p.(None): • Poor research governance frameworks to ensure adherence to ethical standards
p.(None): • No cross-border legal recourse in cases of exploitation
p.(None): • Discriminatory laws that may create stigmatized minorities Animal • Variations in regulatory standards
p.(None): for animal experimentation
p.(None): • Inadequate systems to ensure compliance with animal welfare standards
p.(None): Environmental • Variations in governance of natural resources
p.(None): • Variations in procedural rights
p.(None): • Environmental protection not well policed by civil society
p.(None):
p.(None): Our Findings
p.(None): 43
p.(None):
p.(None): shows the primary risks related to corrective fairness for persons, institutions, com- munities, countries, animals and
p.(None): the environment.
p.(None): Individuals who are harmed by their participation in research may have no means of seeking retribution or compensation
p.(None): if they cannot afford legal representation and there is no form of legal aid. For communities, a lack of awareness and
p.(None): expertise, or too much trust in the HIC researchers, may lead to the loss of intellectual property rights (IPRs) to
p.(None): local knowledge and resources. At a national and international level, researchers from HICs who choose to ignore or
p.(None): flout the research ethics and legal requirements in the host LMIC can be difficult to police. This is especially
p.(None): problem- atic in localities where there is a lack of resources and/or infrastructure to ensure ethical compliance
p.(None): through the entire research process and where the home institu- tions in HICs do not ensure that their employees comply
p.(None): with requirements.
p.(None):
p.(None):
p.(None): Respect
p.(None):
p.(None): Respect requires an acceptance of customs and cultures that may be different from one’s own, and a commitment not to
p.(None): behave in a way that causes offence. One may need to abide by decisions or ways of approaching matters with which one
p.(None): dis- agrees. This can be problematic, especially if local customs are illegal or perceived as dangerous.6 However,
p.(None): respect is important in LMIC-HIC collaborations, and there are many possible ways of showing respect that do not
p.(None): create conflicts of con- science. For instance, HIC researchers should not insist that LMIC ethics commit- tees accept
p.(None): the ethics approval submission in the HIC’s preferred format, but should rather conform with the format preferred by
p.(None): the LMIC committee. Table 5.3 shows the primary risks related to respect for persons, institutions, communities,
p.(None): countries, animals and the environment.
p.(None): Local LMIC customs, traditions, and religious and spiritual beliefs may be very different from those of the HIC
p.(None): researcher. For example, from an African cultural point of view, human body parts are sacred, whether they are obtained
p.(None): from living or deceased persons. Hence, the removal of blood or other body parts for research may have a profound
p.(None): impact that needs to be acknowledged and addressed in a man- ner that is sensitive to the wishes of the local
p.(None): community. A liberal interpretation of autonomy, i.e. individual autonomy, prevails in HICs but may not be
p.(None): easily transferred to LMIC settings where “community” or “group autonomy” is also highly valued. Furthermore,
p.(None): in some settings it might be deemed rude for a research participant to say “no” or to ask questions about the research.
p.(None): In other situations, people may be too afraid or unconfident to do so. Either way, the power imbalance between
p.(None): researcher and research participant can impact upon the consent process.
p.(None):
p.(None): 6 For instance, if a researcher learns that female genital mutilation is being used as a “cure” for diarrhoea in female
p.(None): babies, respecting this approach to health care is likely to be the wrong deci- sion, particularly as the practice is
p.(None): likely illegal. At the very least such a decision would leave the researcher with a serious conflict of conscience (Luc
p.(None): and Altare 2018).
p.(None):
p.(None): 44 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): Table 5.3 Primary risks for respect
p.(None): Level of risk Nature of risk
p.(None): Personal • Unequal power relations
p.(None): • Tendency to defer to authorities
p.(None): • Individual spiritual and religious priorities incompatible with or ignored by HIC partners
p.(None): • Researchers and/or ethics committees deciding “what is best”
p.(None):
p.(None): Researcher/ institutional
p.(None): • Research protocol and papers imported from HIC partners and not tailored to local needs
p.(None): • Ethical approval sought only from HIC partner
p.(None): Community • Diverse interpretations of important values
p.(None): • Local requirements for effective community engagement ignored
p.(None): • Diverse ethical priorities for matters such as:
p.(None): - gender equality
p.(None): - sexual relations
p.(None): • Particular spiritual and religious priorities incompatible with or ignored by Northern partners
p.(None): • Localized social effects from research team presence
p.(None): • Local customs that may violate laws of the country and/or human rights Country • Research protocols and
p.(None): practices which fail to take account of national
p.(None): traditions and legislation
p.(None): Animal • Variations in customs, norms and attitudes regarding animal welfare and inhumane practices
p.(None): Environmental • Variations in customs, norms and attitudes regarding the environment
p.(None):
p.(None): Animals and environments are also at risk of exploitation because of variations in customs and norms. What is
p.(None): considered “animal cruelty” or “inhumane practice” in animal experimentation varies greatly between cultures.
p.(None): Additionally, some ani- mals are awarded greater protection in certain cultures than others, for example, dogs and cats
p.(None): in the United Kingdom and cows in India. Animal experimentation on non-human primates is particularly controversial
p.(None): in most countries, but in some certain non-human primates are viewed as “pests” (Hill and Webber 2010). Different
p.(None): partners in collaborative research may have different philosophies related to the environment. Environmental
p.(None): protection is sometimes regarded as a colonial con- struct that has negative impacts on local communities in LMICs, and
p.(None): research agen- das likewise. There may therefore be a philosophical or paradigmatic difference between
p.(None): research partners that needs to be identified and addressed.
p.(None):
p.(None):
p.(None): Care
p.(None):
p.(None): Researchers who take good care in their research combine two elements: they care about research participants, in the
p.(None): sense that they are important to them, and they feel responsible for the welfare of those who contribute to their
p.(None): research, or might suffer as a result of it. In work with vulnerable communities, this might, for exam- ple, entail
p.(None): the tailoring of informed consent procedures to local requirements
p.(None):
p.(None): Our Findings
p.(None): 45
p.(None):
p.(None): (language, literacy, education levels) to achieve genuine understanding. Table 5.4 shows the primary risks related to
p.(None): care for persons, institutions, communities, coun- tries, animals and the environment.
p.(None): At the individual level, variations in spoken language, understanding, levels of literacy and use of terminology are
p.(None): just some of the issues that can lead to exploita- tion. The number of different ways in which individuals can suffer
p.(None): harm as a result of their involvement in research is vast. At the community level, the mere presence of a research team
p.(None): can have a great impact upon a local community. Research teams require food and accommodation, purchase local goods and
p.(None): services, and form rela- tionships with local people.
p.(None): At a national and international level, the rapid emergence of high-risk applica- tions of technologies such as genome
p.(None): editing7 challenges not only safety risk assess- ments but also existing governance tools. This creates an environment
p.(None): where risky experiments might be carried out in countries with an inadequate legal framework,
p.(None):
p.(None): Table 5.4 Primary risks for care
p.(None): Level of risk Nature of risk
p.(None): Personal • In medical research: therapeutic misconception
p.(None): • Misunderstanding of research aims
p.(None): • Procedures for informed consent not tailored to individual
p.(None): • Lack of possible actions to address adverse effects of participation
p.(None): • Direct risks, such as physical side effects
p.(None): • Indirect risks, such as stigmatization
p.(None):
p.(None): Researcher/ institutional
p.(None): • No host country research ethics structures or inappropriate match with requirements
p.(None): • No capacity in existing REC
p.(None): • REC members are poorly trained and lack specialized expertise to review ALL types of research protocols
p.(None): • REC meetings are either too few or too sporadic
p.(None): • REC does not have local or national government or ministry support to conduct its activities
p.(None): Community • Localized physical effects from research team presence Country • Insufficient data
p.(None): security measures
p.(None): • Insufficient safeguarding protocols
p.(None): • Lack of risk management approaches to biosafety
p.(None): • Lack of risk management approaches to biosecurity
p.(None): Animal • Animal research centres established in countries where regulation is less stringent
p.(None): • Lack of resources for humane animal care
p.(None): Environmental • Inadequate consideration of unintended consequences for biodiversity and the environment
p.(None): • Inadequate consideration of local environmental contexts
p.(None): • Disregard for long-term effects upon local environment
p.(None): • Lack of resources for environmental protection
p.(None): • Insufficient information for assessment of environmental effects
p.(None):
p.(None):
p.(None): 7 For example, applying genome editing technologies to human embryonic stemXcells.
p.(None):
p.(None): 46 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): or in countries where although legal frameworks exist, their effective implementa- tion is prevented by limited
p.(None): resources.
p.(None): Most LMICs have processes in place for ethical approval of research, but they are hindered by resource issues. Even
p.(None): where research ethics committees are well established, they may have limited capacity and expertise. For effective
p.(None): governance, the wide-ranging and dynamic nature of research requires extensive and cutting- edge expertise from
p.(None): research ethics committees. This can be particularly difficult in resource-poor areas.
p.(None): Inadequate environmental information in LMICs means that research decisions and directions may be developed in a vacuum
p.(None): and result in long-term harm. For example, research programmes may introduce exotic species that deplete water
p.(None): resources, displace traditional varieties − thereby impacting upon agricultural bio- diversity or “escape” and become
p.(None): invasive, thus threatening biodiversity.
p.(None):
p.(None):
p.(None): Honesty
p.(None):
p.(None): In all cultures and nations, “do not lie” is a basic rule of ethical human interaction. However, the value of honesty
p.(None): has a broader scope in the context of global research ethics. Lying is only one possible contravention. In
p.(None): research ethics it is equally unacceptable, for instance, to omit important information from an informed consent
p.(None): process: that is, to fail to be transparent. The duties of honesty also include, most prominently, research integrity,
p.(None): which entails practices such as giving due credit for contributions and refraining from the manipulation of data and
p.(None): the misappropriation of research funds. In this section, we distinguish between these two forms of hon- esty and divide
p.(None): the risks into those that are mainly related to transparency and those that are more readily aligned with integrity.
p.(None): Table 5.5 sets out the primary risks to
p.(None):
p.(None): Table 5.5 Primary risks for honesty through transparency
p.(None): Level of risk Nature of risk
p.(None): Personal • Inability of participant to provide fully informed individual consent:
p.(None): - Incomplete information provided
p.(None): - Information provided in an inappropriate format
p.(None): • Potential effects of participation not fully explained
p.(None): • Dual roles of researcher
p.(None):
p.(None): Researcher/ institutional
p.(None): • REC not fully independent
p.(None): • Cryptic research procedures
p.(None): Community Inability to provide fully informed community consent:
p.(None): - Incomplete information provided
p.(None): - Information provided in inappropriate format
p.(None): • Potential effects of participation not fully explained
p.(None): • Dual roles of researcher
p.(None): Country • Lack of data sharing Animal
p.(None): Environmental • Incomplete information about potential risks or harm to the environment
p.(None):
p.(None): Our Findings
p.(None): 47
p.(None):
p.(None): honesty through transparency for persons, institutions, communities, countries and the environment.
p.(None): There are many ways in which the informed consent process can be inadequate. For example, where there are
p.(None): omissions and/or inappropriate or misleading lan- guage for the context in which consent is being sought; when
p.(None): potential participants (some of whom may be illiterate) are not taken through any kind of suitable consent process but
...
p.(None): that underpin many of the individual risks, namely:
p.(None): Extreme differentials in available income, i.e. serious poverty Extreme differentials in power
p.(None): Past history of colonialism
p.(None):
p.(None):
p.(None): Serious Poverty
p.(None):
p.(None): The most obvious risk of exploitation in LMIC-HIC collaborative research is the extreme divergence in levels of
p.(None): affluence across the world. Many of the individual points in the risk table have their origins in extreme poverty.
p.(None): Researchers cannot solve this problem, but they can show heightened awareness of it and try their best to promote local
p.(None): improvements, for example by equitably involving local research- ers, by focusing their research on local research
p.(None): needs and by obtaining input from local populations.
p.(None):
p.(None):
p.(None): Extreme Differentials in Power
p.(None):
p.(None): The relationship between wealth and power, and the differentials in power between those who are wealthy and those who
p.(None): live in poverty, is a topic that has filled books, halls and television programmes. However, other factors also
p.(None): play a part in
p.(None):
p.(None):
p.(None): 8 Many academic journals that publish results from animal experimentation stipulate requirements that the studies have
p.(None): been conducted in a manner that is consistent with high ethical standards such as EU Directive 2010/63 (EU 2010).
p.(None):
p.(None): References
p.(None): 49
p.(None):
p.(None): maintaining power differentials. To give one striking example, the United Nations Security Council has 15 members. Of
p.(None): these, ten are elected by the General Assembly for periods of two years while five (China, France, Russia, the United
p.(None): Kingdom and the United States) have been permanent members with “veto power” since 1946. More than 60 United
p.(None): Nations member states have never been members of the Security Council and hence have never even had voting
p.(None): rights, let alone veto power.
p.(None):
p.(None):
p.(None): Past History of Colonialism
p.(None):
p.(None): Does the history of colonialism still bear upon research today? We believe it does, as can be seen from the experience
p.(None): of indigenous peoples in research. Linda Tuhiwai Smith has powerfully shown that indigenous peoples often
p.(None): consider research a “dirty word”. She describes how “imperialism frames the indigenous experience” and how
p.(None): “indigenous peoples had to challenge, understand and have a shared lan- guage for talking about ... colonialism” (Smith
p.(None): 2012).
p.(None): We close this chapter with a comment from the TRUST gender adviser, Prof.
p.(None): Fatima Alvarez-Castillo (2016):
p.(None): A culture’s worldview, expressed in language, contains norms and values about power and relations of power. For
p.(None): example, the word “expert” imbues persons with authority and assigns higher credibility to their claims than
p.(None): those of non-experts. The public is expected to defer to their opinions on matters of their expertise. It was not until
p.(None): about the 1960s when the usual understanding of expertise was challenged by feminists, who argued that
p.(None): unschooled women have more expertise about their own situation than the experts. This ushered in a new research
p.(None): philosophy that valorizes poor women’s stories and their own versions of their realities.
p.(None):
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Alvarez-Castillo F (2016) Gender sensitivity: writing and language. In: Chatfield K, Schroeder D, Kimani J (eds)
p.(None): Nairobi plenary meeting report, TRUST Project. http://trust-project.eu/wp-
p.(None): content/uploads/2016/11/Meeting-Report-TRUST-Nairobi-Final.pdf
p.(None): Annas G, Grodin M (1998) Human rights and maternal-fetal HIV transmission prevention trials in Africa. American Journal
p.(None): of Public Health 88(4):560–563
p.(None): Bhatt K (2016) Concerns for Kenyan National Bioethics Committee when approving North-South collaborative projects. In:
p.(None): Chatfield K, Schroeder D, Kimani J (eds) Nairobi plenary meeting report, TRUST Project.
p.(None): http://trust-project.eu/wp-content/uploads/2016/11/Meeting-Report- TRUST-Nairobi-Final.pdf
p.(None): EU (2010) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of
p.(None): animals used for scientific purposes (text with EEA relevance). OJ L 276/33.
p.(None): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32010L0063
p.(None): Hill CM, Webber AD (2010) Perceptions of nonhuman primates in human–wildlife conflict sce- narios. American Journal of
p.(None): Primatology 72(10):919−924
p.(None): Hughes J (2010) European textbook on ethics in research. European Commission, Brussels
p.(None):
p.(None): 50 5 Exploitation Risks in Collaborative International Research
p.(None):
p.(None): Luc G, Altare C. (2018) Social science research in a humanitarian emergency context. In: Schroeder D, Cook J, Hirsch F,
p.(None): Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North- South research collaborations, Springer Briefs in
p.(None): Research and Innovation Governance, Berlin, p 9-14
p.(None): Macklin R (2003) Vulnerability and protection. Bioethics 17(5–6):472–486
p.(None): Pogge T (2006) Justice. In: Borchert DM (ed) Encyclopedia of philosophy, 2nd edn, vol 4.
p.(None): Macmillan Reference, Detroit, pp 862–870
p.(None): Russell WMS, Burch RL, Hume CW (1959) The principles of humane experimental technique.
p.(None): Methuen & Co, London
p.(None): Schwartz J (1995) What’s wrong with exploitation? Nous 29:158–164
p.(None): Stone CD (2010) Should trees have standing? Law, morality, and the environment, 3rd edn. Oxford University Press,
p.(None): Oxford
p.(None): Smith, LT (2012) Decolonizing methodologies: research and indigenous peoples. Zed Books, London
p.(None): Universities UK (2015) The concordat to support research integrity. Universities UK, London Wood A (1995) Exploitation.
p.(None): Social Philosophy and Policy 12:150–151
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 6
p.(None): How the Global Code of Conduct Was Built
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract How can an ethics code achieve impact? The answer is twofold. First, through adoption by influential research
p.(None): funders, who then make it mandatory for their award recipients. This is the case with the Global Code of Conduct for
p.(None): Research in Resource-Poor Settings, which was adopted by both the European Commission and the European and Developing
p.(None): Countries Clinical Trials Partnership shortly after its launch in 2018. Second, an ethics code can achieve impact when
p.(None): researchers use it for guidance whether it is compulsory or not. This is most likely to happen with codes that were
p.(None): developed transparently with all research stakeholders involved. This chapter will outline how the GCC was
p.(None): developed, and in particular how exter- nal stakeholders were systematically engaged, how existing codes were carefully
p.(None): analysed and built upon, and who the early adopters were.
p.(None):
p.(None): Keywords Research ethics · Ethics dumping · Stakeholder engagement · Ethics codes
p.(None):
p.(None):
p.(None): Introduction
p.(None):
p.(None): The earliest research ethics codes were written solely for researchers:
p.(None): The Nuremberg Code (1949) and the original Declaration of Helsinki (1964) made no men- tion of committee review; these
p.(None): documents placed on the investigator all responsibility for safeguarding the rights and welfare of research subjects.
p.(None): (Levine 2004: 2312)
p.(None): In 1966, the surgeon general of the US Public Health Service issued a policy statement requesting the establishment
p.(None): of research ethics review committees or institutional review boards (Levine 2004: 2312). At this point in
p.(None): history, ethics codes would have had two main target audiences: researchers and research ethics committees.
p.(None): The Global Code of Conduct for Research in Resource-Poor Settings (GCC) was developed from the start with three
p.(None): audiences in mind: researchers, research ethics
p.(None):
p.(None):
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 51
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_6
p.(None):
p.(None): 52 6 How the Global Code of Conduct Was
p.(None): Built
p.(None): Consultation Fact-finding
p.(None):
p.(None): Vulnerable populations
p.(None): Industry Funders
p.(None): Literature Case studies
p.(None):
p.(None): Ethics committees
p.(None): Researchers Policy-
p.(None): Legal instruments
p.(None): Existing guidelines
p.(None):
p.(None): Risks and good practice ,
p.(None): Drafting
p.(None):
p.(None): Global Code of Conduct,
p.(None):
p.(None): Fig. 6.1 Input into the GCC
p.(None):
p.(None): committees and research participants (and/or their communities and support groups). To achieve a good match
p.(None): with these anticipated audiences, it was essential that all relevant stakeholders1, in particular highly
p.(None): vulnerable populations, be included at all stages of the drafting process of the GCC. This inclusion was later
p.(None): praised by the Deputy Director-General for Research and Innovation of the European Commission (EC) as “impressive” and
p.(None): a Horizon 2020 success story, [which] demonstrates that, in order to actively combat ethics dumping,2 a coordination
p.(None): of stakeholder efforts is required. Moreover, following the exam- ple of TRUST,3 such efforts should be based on a
p.(None): bottom-up approach that empowers local communities involved, as equal partners. (Burtscher 2018: 1)
p.(None): A major benefit of the bottom-up approach is that it resulted in a short, clear code that is focused on practical
p.(None): matters and accessible to nonspecialists. The develop- ment process consisted of a range of activities, which are
p.(None): summarized in Figure 6.1. Case studies were collected prior to the drafting of the GCC and published in a book
p.(None): entitled Ethics Dumping: Case Studies from North-South Research Collaborations (Schroeder et al. 2018).
p.(None): The foundation of the GCC, the risk matrix,
p.(None): has been introduced in Chapter 5 of this book.
p.(None):
p.(None): 1 “Stakeholders” is an increasingly contested term, as it may imply that all parties hold an equal stake. Some prefer
p.(None): the term “actors”, yet this brings its own complexities. While acknowledging the debate, we use the well-established
p.(None): term “stakeholders” throughout.
p.(None): 2 The export of unethical research from a high-income setting to a resource-poor setting with weaker
p.(None): compliance structures or legal governance mechanisms.
p.(None): 3 The TRUST project (http://trust-project.eu/) was funded by the European Commission from 2015 to 2018. One of its
p.(None): outputs was the GCC.
p.(None):
p.(None): Meaningful Consultation with Diverse Stakeholders 53
p.(None):
p.(None): This chapter will outline the following steps in the development of the GCC:
p.(None): • The consultations with various stakeholders over two and a half years
p.(None): • The comparative analysis of existing guidelines and relevant legal instruments
p.(None): • The drafting process.
p.(None):
p.(None):
p.(None): Meaningful Consultation with Diverse Stakeholders
p.(None):
p.(None): “They could take you out for coffee and call it consultation!” (Youdelis 2016)
p.(None): Consultation, engagement, community engagement, guided discussions, focus groups and interviews: these are all means of
p.(None): obtaining relevant input from stake- holders prior to action. When a problem affects a range of people or groups and a
p.(None): feasible and implementable solution is sought, stakeholder input and community engagement are essential (Hebert et
p.(None): al. 2009; Cook 2008; Bassler et al. 2008; Dunn 2011).
p.(None): This section shows how a wide range of stakeholders were consulted on ethics dumping concerns and potential
p.(None): solutions, with the specific aim of drafting the GCC. (Chapter 8 provides more general advice on community
p.(None): engagement with vulnerable populations (Chapter 8).)
p.(None):
p.(None):
p.(None): Broad Consultation
p.(None):
p.(None): Governance mechanisms such as ethics codes require evidence of legitimacy. Why should a particular ethics code be
p.(None): followed by researchers? The answer that can be given for the GCC is fourfold. First, the funder that supported the
p.(None): development of the GCC – the European Commission – requested a new code to guard against ethics dumping. Hence, instead
p.(None): of engaging in a long-term process to negotiate the addi- tion of specific sections on international collaborative
p.(None): research to existing ethics codes and governance mechanisms, a funder with an interest in the output opted for a new
p.(None): and independent code. Second, in 2015 the TRUST consortium’s bid was chosen by peer reviewers from a range of proposals
p.(None): to tackle ethics dumping. The criteria for the selection were excellence and impact, as well as the quality and effi-
p.(None): ciency of the proposed implementation (Horizon 2020 nd). Third, upon the comple- tion and launch of the GCC in 2018,
p.(None): the EC ethics and integrity sector and the EC legal department assessed the code and the decision was taken to make it
p.(None): a manda- tory reference document for European Union (EU) framework programmes (Burtscher 2018).
p.(None): However, the most important element for the GCC’s credibility may be the fourth element, the fact that the TRUST
p.(None): consortium made every possible effort to engage all relevant stakeholders across five continents in the development of
p.(None): the GCC.
p.(None):
p.(None): 54 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): In the effort to reach all relevant stakeholders, the TRUST consortium first had to agree upon who needed to be
p.(None): consulted on ethics dumping in research. The follow- ing six groups were identified:
p.(None): 1. The research process starts with research policymakers, who set the parameters for research activities. For
p.(None): instance, in the European Union, research aimed at human cloning for reproductive purposes is forbidden (European
p.(None): Commission 2013), which means it is outside the activity range of researchers.
p.(None): 2. A second highly influential stakeholder group consists of research funders. Without specific funding, most
p.(None): research is not possible. Whether research fund- ing is provided by industry, charitable foundations or state-funded
p.(None): research pro- grammes makes no significant difference. All funders are of particular importance in tackling ethics
p.(None): dumping, as they often set specific ethical rules that the researchers they fund must adhere to.
p.(None): 3. Researchers design research projects and work directly with participants and communities during
p.(None): implementation. It is normally they who are responsible for ethics dumping, whether deliberate or inadvertent.
p.(None): 4. Many studies involve human research participants who are directly affected by the research. As ethics dumping can
p.(None): also affect animals and the environment, groups working to defend them against unethical treatment could count as advo-
p.(None): cates – that is, persons who act on behalf of other entities. The same applies to nongovernmental organizations (NGOs)
p.(None): or think-tanks that promote the interests of those who cannot defend themselves against exploitation, or who struggle
p.(None): to do so. Hence, these groups are included in the list of stakeholders.
p.(None): 5. Negative impacts from unethical research conduct can extend beyond research participants and cause harm to
p.(None): community members. In genetic research, for instance, research results are likely to be relevant to close family
p.(None): members who were not involved in the study (Gallo et al. 2009). Similarly, a research partici- pant might divulge
p.(None): valuable traditional knowledge held by a community, which cannot be used ethically (or even, sometimes, legally) by the
p.(None): researcher unless s/he has also engaged the wider community (Wynberg et al. 2009).
p.(None): 6. The final group that can count as a major stakeholder in research consists of research ethics committees, which
p.(None): review and approve research proposals on behalf of funders or research institutions. This is especially important
p.(None): when tack- ling ethics dumping, as the role of research ethics committees is to safeguard the rights and welfare of
p.(None): those involved in research (Levine 2004: 2312).
p.(None): Figure 6.2 graphically depicts the main parties involved in research, and there- fore represents the research
p.(None): stakeholders in the fight against ethics dumping.
p.(None): There were budget-holding representatives from each of these research stake- holder groups in the TRUST project
p.(None): consortium (see Table 6.1). This meant that even before outward engagement to draft the GCC, a lot of information could
p.(None): be generated internally.
p.(None): As Table 6.1 shows, considerable expertise from different stakeholder perspec- tives was available internally. In
p.(None): addition, input was sought from external experts, who engaged through four channels, facilitated by six enablers, to
p.(None): participate in the development of a range of project outputs, one of which was the GCC. This approach is detailed in
p.(None): Figure 6.3 (Dammann and Cavallaro 2017).
p.(None):
p.(None): Meaningful Consultation with Diverse Stakeholders 55
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Fig. 6.2 Research stakeholders
p.(None):
p.(None): Table 6.1 Main research stakeholders involved as TRUST budget holders
p.(None): Stakeholder
p.(None): type TRUST partner
p.(None):
p.(None): Research policymakers
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research funders
p.(None): The United Nations Educational, Scientific and Cultural Organization (UNESCO) promotes policy frameworks for research
p.(None): through drafting internationally focused guidelines on scientific co-operation.
p.(None): The “Institut national de la santé et de la recherche médicale”® (Inserm) holds responsibility for the strategic,
p.(None): scientific and operational coordination of French biomedical research.
p.(None): The European and Developing Countries Clinical Trials Partnership (EDCTP) funds research for the prevention and
p.(None): treatment of poverty-related infectious diseases in sub-Saharan Africa.
p.(None): The Swiss-based Global Values Alliance (GVA) is a foundation that focuses on engagement with pharmaceutical industry
p.(None): partners as its main role in the TRUST project
p.(None): Researchers The Centre for Professional Ethics at the University of Central Lancashire is one of the oldest
p.(None): research-only ethics centres in Europe, with specialist expertise in global justice issues.
p.(None): The Bio-Economy Research Chair at the University of Cape Town and her team focus on engagement with communities,
p.(None): indigenous knowledge holders and policymakers to ensure environmentally sustainable poverty reduction. The Law School
p.(None): of the University of the Witwatersrand, Johannesburg, contributed specialist human rights and legal frameworks
p.(None): expertise.
p.(None):
p.(None): Research participants
p.(None):
p.(None):
p.(None): Research advocates (support organizations)
p.(None): Many of the individuals involved in drafting the GCC have previously been research participants. Of particular
p.(None): importance in this process were the indigenous peoples and sexXworker representatives who were involved through SASI
p.(None): and PHDA (see “Research communities” below).
p.(None): The Council on Health Research for Development (COHRED) helps promote the health and development of populations in low-
p.(None): and middle- income countries.
p.(None): Action Contre La Faim (ACF) is recognized as one of the leading organizations in the fight against hunger worldwide.
p.(None): ACF undertakes its own research on highly vulnerable populations.
p.(None):
p.(None): 56 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.1 (continued)
p.(None): Stakeholder
p.(None): type TRUST partner
p.(None):
p.(None): Research communities
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Research ethics reviewers
p.(None): The South African San Institute (SASI) is dedicated to serving the San communities of southern Africa through legal,
p.(None): advocacy, socio- anthropological and related services.
p.(None): Partners for Health and Development in Africa (PHDA) supports female and male sexXworkers in the low socio-economic
p.(None): strata who reside in the informal settlements of Nairobi.
p.(None): The Forum for Ethics Review Committees in India (FERCI) promotes the effective implementation of the ethical review of
p.(None): biomedical research studies in India.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): • Advisory board
p.(None): • Engagement panel
p.(None): • Stakeholder inventory
p.(None): • Project deliverables
p.(None): • Publications
p.(None): • eNewsletters
p.(None):
p.(None): • Funder platform
p.(None): • Industry platform
p.(None): • Case study competition
p.(None): Enablers
p.(None): • Project website
p.(None): • Social media
p.(None): • Brochure
p.(None): • Project conferences and consultation meetings
p.(None): • Films
p.(None): • Interviews
p.(None): • Conference presentations
p.(None): Outputs
p.(None):
p.(None):
p.(None):
p.(None): Fig. 6.3 TRUST communication and engagement strategy
p.(None):
p.(None): External engagement prior to drafting the GCC was extensive. The elements of the communication and engagement strategy
p.(None): that were specifically relevant to the drafting of the GCC are described in more detail below, namely:
p.(None): • A case study competition
p.(None): • Project conferences and consultation meetings
p.(None): • Funder and industry platforms
p.(None):
p.(None):
p.(None): The Case Study Competition
p.(None):
p.(None): As the GCC was designed to address the risks of ethics dumping, it was essential to analyse as many actual examples of
p.(None): ethics dumping as possible. To reach out to stakeholders who were not connected with existing networks, a
p.(None): competition to describe cases of ethics dumping was launched in 2016. Applicants from around the world were invited to
p.(None): submit short abstracts of ethics dumping cases, which involved research undertaken in low- and middle- income countries
p.(None): (LMICs) conducted by researchers, sponsors or funders from high-income countries (HICs). Cases could
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 57
p.(None):
p.(None): report on events related to any research field. A judging committee selected by TRUST ranked the best ten
p.(None): abstracts, and shortlisted applicants were invited to sub- mit a full case study. Rewards for the authors of the best
p.(None): five cases were €2,000 each and €1,000 each for five runners-up. Following peer review, eight full-length case studies
p.(None): were selected for inclusion in Ethics Dumping: Case Studies from North- South Research Collaborations (Schroeder et al.
p.(None): 2018) or as learning materials for the GCC website (http://www.globalcodeofconduct.org). This mechanism expanded the
p.(None): material available for the development of the risk matrix considerably.
p.(None):
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates
p.(None):
p.(None): “Around the world, millions of meetings are being held every day – most of them unproductive” (Koshy et al. 2017). In
p.(None): “Not Another Meeting!” Rogelberg et al. (2006) establish that perceived meeting effectiveness has a strong, direct
p.(None): relationship with posi- tive job attitudes and wellbeing at work. In the literature, meeting efficiency is linked to
p.(None): questions such as, “Is a meeting necessary?” (Koshy et al. 2017), or “Is a meeting the most cost-effective way of
p.(None): obtaining an outcome?” (Rogelberg et al. 2006). In addition, advice is given on how to make meetings more efficient,
p.(None): such as, “Prepare the agenda in advance,” and “Start with the most strategic items,” (Rogelberg et al. 2006).
p.(None): For the TRUST consortium, the most important question ahead of all major consul- tation meetings was: “Who are the
p.(None): external delegates?” On the one hand, are they senior and/or from influential institutions? Or, on the other hand, do
p.(None): they have first- hand experience of ethics dumping? In other words, the consortium aimed for senior decision-maker
p.(None): representation as well as vulnerable population representation. To give an example of the former, Table 6.2
p.(None): shows the funders and companies which were represented at the funder and industry consultation. The consultation with
p.(None): vulnerable populations on engagement with research participants will be described below.
p.(None): As noted above, millions of meetings are held every day around the world, and many of them affect job satisfaction and
p.(None): wellbeing negatively. How, then, could a meeting hosted on behalf of a three-year research project achieve such
...
p.(None): developing countries” (United Nations ndb).
p.(None): 5 Goal 3, Target 3.8: “Achieve universal … access to safe, effective, quality and affordable essential medicines and
p.(None): vaccines for all” (United Nations nda).
p.(None): 6 The meetings had a range of other purposes, many of which are not relevant here and are therefore not included in
p.(None): this summary.
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 59
p.(None):
p.(None): 60 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Returning to the six research stakeholder groups identified earlier, the next sec- tion details how each group was
p.(None): reached through project conferences and consulta- tion meetings.
p.(None):
p.(None):
p.(None): External Engagement with Research Policymakers
p.(None):
p.(None): National research foundations, research councils and government ministries guide the strategic direction of research.
p.(None): Representatives from all of these groups attended the TRUST plenary in Cape Town in 2017, in particular senior
p.(None): representatives from the following national bodies:
p.(None): • The South African Department of Science and Technology
p.(None): • The South African Department of Environmental Affairs
p.(None): • The South African National Research Foundation
p.(None): • The Zimbabwean Agricultural Research Council
p.(None): To give an example of input, articles 17 and 48 of the GCC are directly linked to input from research
p.(None): policymakers. Dr Isaiah Mharapara from the Zimbabwean Agricultural Research Council argued that agricultural
p.(None): research in Africa had largely been based on foreign principles, meaning that the continent’s own crops, fruits,
p.(None): insects, fish and animals had been ignored. Through the historical introduc- tion of Western agricultural systems
p.(None): and cash crops such as tobacco, as well as genetically engineered crops, Africa had failed to develop
p.(None): agricultural solutions adapted to local conditions. According to Dr Mharapara, a lack of financial resources meant
p.(None): that African nations had been, and still were, vulnerable to exploitation by foreign researchers. This had resulted in
p.(None): damage to ecological systems, the loss of soils, fertility, biodiversity and natural resilience, and the
p.(None): erosion of indigenous knowledge. He advocated inclusive, consultative, robust and agreed processes to establish
p.(None): equitable research partnerships (Van Niekerk et al. 2017).
p.(None):
p.(None):
p.(None): External Engagement with Research Funders
p.(None):
p.(None): Estimates for research and development expenditure in the European Union in 2016 indicate that 56.6% of all such
p.(None): expenditure comes from the business sector, 30.9% from the government sector and the remainder mostly from charitable
p.(None): foundations (Eurostat 2018). TRUST’s main consultation workshop for research funders was held in London in 2017
p.(None): and involved all three sectors: public funders, private
p.(None):
p.(None): 7 Local relevance of research … should be determined in collaboration with local partners.
p.(None): 8 Local researchers should be included, wherever possible, throughout the research process, includ- ing in study
p.(None): design, study implementation, data ownership, intellectual property and authorship of publications.
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 61
p.(None): Table 6.3 Good practice input from funders and industry with GCC output
p.(None): Good practice Relevant GCC article
p.(None):
p.(None): Ensuring double ethics review Community
p.(None): engagement
p.(None): Clear roles and responsibilities
p.(None): Article 10: Local ethics review should be sought wherever possible.
p.(None):
p.(None): Article 2: Local communities and research participants should be included throughout the research process.
p.(None): Article 20: A clear understanding should be reached among collaborators with regard to their roles, responsibilities
p.(None): and conduct throughout the research cycle.
p.(None):
p.(None): funders and charitable funders of research (see Table 6.2). The three main good practice elements9 raised by funders
p.(None): and industry to stop ethics dumping are listed in Table 6.3, with their corresponding GCC articles (Singh and Makanga
p.(None): 2017).
p.(None): As already indicated, engagement with research funders was not restricted to one meeting, but took place over
p.(None): approximately two years via the funder and industry platforms described above. Additionally, the first draft of the GCC
p.(None): was distributed to all members of the platforms nine months after the workshop. Both groups pro- vided further comments
p.(None): on the draft.
p.(None):
p.(None):
p.(None): External Engagement with Researchers
p.(None):
p.(None): The consortium that drafted the GCC represented a wide range of academic disci- plines, namely ethics, medicine,
p.(None): economics, bioethics, law, social psychology, soci- ology, psychology, gender studies, chemistry, social sciences,
p.(None): psychiatry, biology, zoology, veterinary medicine, political science and management. The multidisci- plinary
p.(None): nature of the consortium’s expertise enabled broad engagement with the wider academic community. For example,
p.(None): academic presentations that included the GCC were delivered in Belgium, China, Congo, Cyprus, Germany, India, Kenya,
p.(None): Latvia, the Netherlands, the Philippines, Portugal, Rwanda, South Africa, Sweden, Taiwan, Uganda, Vatican City, the UK
p.(None): and the USA (Dammann and Schroeder 2018). The feedback from researchers was essentially threefold. First, researchers
p.(None): were interested in the potential “grey areas” of ethics dumping. A question in this context, asked on many occasions by
p.(None): different audiences, was: “If a particular research study has no real local relevance to LMICs, and the
p.(None): research money spent by well- intentioned researchers from HICs (who genuinely believe that they are improving the
p.(None): world) is in fact being wasted, does that count as ethics dumping?” A case in
p.(None):
p.(None):
p.(None): 9 A fourth good practice element that was emphasized at the funder and industry workshop was the provision of
p.(None): post-trial access to successfully marketed drugs. This requirement was not included in the GCC for two main reasons.
p.(None): First, the GCC was designed to be applicable to all disciplines, and hence articles with limited applicability were
p.(None): avoided. Second, post-trial access is clearly indicated in existing guidelines, in particular in the Declaration of
p.(None): Helsinki (WMA 2013). A good practice example of post-trial access was included in a TRUST special symposium on industry
p.(None): obligations towards LMICs (see Kelman et al. 2019).
p.(None):
p.(None): 62 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): point has been described by Van Niekerk and Wynberg (2018). Northern researchers were working on a genetically modified
p.(None): banana with a purportedly enhanced vita- min content, the ultimate aim being to alleviate nutritional deficiencies in
p.(None): Uganda. However, it turned out that existing local varieties provided a higher vitamin content than the envisaged GM
p.(None): variety. The question of whether that should count as ethics dumping goes back to a long-standing dilemma for ethics
p.(None): committees: Is bad sci- ence bad ethics? (Levine 2004) Wasteful research cannot be put into the same cat- egory as the
p.(None): wilful exploitation of lower regulatory standards to exploit research populations in LMICs for individual gain. But at
p.(None): the same time, with such a pressing need for innovative solutions to LMIC problems, the violation of article 1 of the
p.(None): GCC (local relevance of research) and the avoidable waste of limited funding resources must count as
p.(None): unethical.
p.(None): A second recurring response to the GCC from researchers has been that “every- one loved our values”.10 Audiences in
p.(None): HICs – England, for instance – even asked whether they could use the four values in national research in their own
p.(None): countries. Hence, rather than seeing the values as solely applicable when there are vast power differentials between
p.(None): researchers and research participants (as between HICs and LMICs), they were keen to use them in any research.
p.(None): A third recurring issue for researchers has been the following: “We appreciate that the code is short and accessible,
p.(None): but wouldn’t a longer, more detailed code give more support to early career researchers?” The TRUST consortium agreed
p.(None): upon a concise code because it is vital that the demands of substance for each article be clear and straightforward,
p.(None): while the process demands remain flexible. Let us take article 1 as an example:
p.(None): The substance element of article 1 is: “Local relevance of research is essential”. Further information would not be
p.(None): helpful to early career (or any other) researchers. The process element of article 1 is: “[Local relevance] should be
p.(None): determined in collaboration with local partners.” This could only be set out in more detail if there were a single
p.(None): process that would fit every situation – and that is not the case. What an equitable process for determining research
p.(None): goals should look like in an interna- tional collaborative research project is one of the things that need to be agreed
p.(None): on within the process of that project. Hence, prescriptive details would have been coun-
p.(None): terproductive to the very spirit of the article.
p.(None): Instead of attempting to formulate a range of possibilities to fill the process ele- ments with substance, we opted to
p.(None): provide educational material to support the GCC online,11 because any process requirements are best agreed
p.(None): between the relevant partners rather than imposed prescriptively by code drafters. Hence, our educational materials
p.(None): future-proof the GCC, as they can be updated in real time for use by early career (or any other) researchers, and,
p.(None): unlike the GCC itself, they are not mandatory.
p.(None):
p.(None):
p.(None): 10 Personal communication from Dr Vasantha Muthuswamy, a TRUST project team member, after a GCC presentation in Taiwan.
p.(None): 11 http://www.globalcodeofconduct.org/
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 63
p.(None):
p.(None): Engagement with Research Participants and Research Communities
p.(None):
p.(None): The inclusion of the perspectives of research participants and research communities who are vulnerable to exploitation,
p.(None): and therefore to ethics dumping, was essential to our bottom-up approach. It is also the ethical approach, as
p.(None): stipulated in article 2 of the GCC:
p.(None): Local communities and research participants should be included throughout the research process, wherever possible, from
p.(None): planning through to post-study feedback and evaluation, to ensure that their perspectives are fairly
p.(None): represented. This approach represents Good Participatory Practice.
p.(None): Two NGO partners in the TRUST project were tasked specifically with ensuring that the voices of vulnerable populations
p.(None): were heard and acted upon. First, the South African San Institute (SASI) made the inclusion of indigenous peoples from
p.(None): South Africa possible. While San leaders and representatives were involved in all the work of the TRUST project,
p.(None): including the drafting of the GCC, the full impact of their contribution is best understood through the account in
p.(None): Chapter 7 of this book of the development of the San Code of Research Ethics. Second, Partners for Health and
p.(None): Development in Africa (PHDA) made the inclusion of sexXworkers from the Majengo area of Nairobi possible. At this point
p.(None): we will focus on their involvement in order to illustrate the bottom-up approach of the GCC drafting process.
p.(None): PHDA is a nonprofit organization that undertakes work in the fields of health and development in Kenya. Its mission is
p.(None): to increase access to health for disadvantaged communities in Africa by strengthening health systems, research,
p.(None): programme devel- opment and partnerships. PHDA’s programmes are implemented by a collaborative group of scientists and
p.(None): public health professionals from the University of Manitoba (Canada), the University of Nairobi and the government of
p.(None): Kenya. Its work focuses mainly on HIV prevention, treatment and care, research, capacity-building and
p.(None): training.
p.(None): The SexXWorkers Outreach Programme (SWOP) is a PHDA initiative that under- takes active community engagement and
p.(None): provides clinical and preventative services to 33,000 sexXworkers residing in Nairobi. These sexXworkers would
p.(None): otherwise find access to medical services in public health facilities extremely limited due to stigma and
p.(None): discrimination. Those enrolled in the sexXworkers cohort for HIV prevention services are free to volunteer for
p.(None): available research studies after providing informed consent. Most studies are on the epidemiology of sexually
p.(None): transmitted diseases, and on host genetic factors that influence infectivity and disease progression.
p.(None): Given that sexXwork is illegal in Kenya, we cannot assign input to specific, named individuals here. Suffice to say
p.(None): that the personal contributions of courageous and admirable sexXworkers, both female and male, provided the TRUST team
p.(None): not only with practical advice that took shape in specific articles of the GCC, but also with inspiration. Table 6.4
p.(None): presents two examples of issues raised by the Nairobi sexXworkers (Chatfield et al. 2016a) that were implemented in the
p.(None): GCC.
p.(None):
p.(None): 64 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.4 Input from sexXworkers and GCC connection
p.(None): Issues raised by sexXworkers Relevant GCC Article
p.(None):
p.(None): “We need feedback to the community from the research in simple and non-scientific language. Some results have been
p.(None): shared with us in the past, but I did not know what they meant. Do not give us results in scientific language. It puts
p.(None): us at risk if we do not understand the results. … Come back with the results and tell us how we can make our lives
p.(None): better.”
p.(None): “We know that the samples that are collected from us are sometimes sent to other countries. What happens to them? In my
p.(None): culture – if my blood is taken, it must come back to me and I bury it. … [L]ocal and cultural values should be taken
p.(None): into account.”
p.(None): Article 3: Feedback about the findings of the research must be given to local communities and research participants. It
p.(None): should be provided in a way that is meaningful, appropriate and readily comprehended.
p.(None):
p.(None):
p.(None):
p.(None): Article 8: Potential cultural sensitivities should be explored in advance of research with local communities, research
p.(None): participants and local researchers to avoid violating customary practices. … If researchers from high-income settings
p.(None): cannot agree on a way of undertaking the research that is acceptable to local stakeholders, it should not take place.
p.(None):
p.(None): The main message that the TRUST team has been promoting since the meetings with the Nairobi sexXworkers has been: “Let
p.(None): representatives of vulnerable popula- tions speak for themselves” (Schroeder and Tavlaki 2018). As a result, a former
p.(None): sexXworker from Nairobi brought the demands of her community to the European Parliament to great acclaim
p.(None): (TRUST 2018).
p.(None):
p.(None):
p.(None): Advocate Voices for Animals
p.(None):
p.(None): A senior veterinarian, Professor David Morton, was involved throughout the TRUST project as an adviser. At a plenary
p.(None): meeting in Cape Town, he described how animals had no voice and therefore no choice about involvement in
p.(None): research. He asked: “Who consents on behalf of animals?”
p.(None): There are currently no globally agreed ethical standards for research involving animal experimentation, and regulation
p.(None): varies from country to country. In the EU, animal experiments are governed by Directive 2010/63/EU, known as the Animal
p.(None): Experiments Directive, which stipulates measures that must be taken to replace, reduce and refine (the “Three
p.(None): Rs”12) the use of animals in scientific research. Among other requirements, it lays down minimum standards for housing
p.(None): and care and regu-
p.(None):
p.(None):
p.(None):
p.(None): 12 The “Three Rs” are the underpinning requirements of most policies and regulations in animal research:
p.(None): → Replacement: Methods that avoid or replace the use of animals.
p.(None): → Reduction: Methods that minimize the number of animals used per experiment.
p.(None): → Refinement: Methods that minimize suffering and improve welfare.
p.(None):
p.(None): Meetings and Platforms: Reaching the Right Delegates 65
p.(None):
p.(None): lates the use of animals through systematic project evaluation that requires the assessment of pain,
p.(None): suffering, distress and lasting harm caused to the animals.
p.(None): Some researchers knowingly exploit variations in standards and opt to conduct animal studies in LMICs because it
p.(None): is cheaper and/or because regulation is less strict than in HICs (Morton and Chatfield 2018). For example,
p.(None): researchers might conduct experiments on non-human primates in an LMIC setting that would be illegal in
p.(None): their HIC home country.
p.(None): For research collaborations between groups in different countries, partners may find that they are confronted with
p.(None): different ethical standards for animal experimen- tation. In such cases ethical standards should comply with the
p.(None): highest ethical stan- dards rather than be adjusted to the lowest common denominator. Hence the GCC states that
p.(None): standards for animal research in international collaborative research must comply with those that are more
p.(None): demanding and protective of animal welfare (article 17).
p.(None):
p.(None):
p.(None):
p.(None): External Engagement with Research Ethics Committees
p.(None):
p.(None): The main engagement meetings with research ethics reviewers and chairs of research ethics committees took
p.(None): place in India (2016) and Kenya (2017).
p.(None): The Forum for Ethics Review Committees in India is led by Dr Vasantha Muthuswamy, who was responsible
p.(None): for issuing the Indian Council of Medical Research’s Ethical Guidelines for Biomedical Research on Human Subjects
p.(None): in 2000 and the revised version, Ethical Guidelines for Biomedical Research on Human Participants, in 2006,
p.(None): and also contributed to the most recently launched version in 2017. At her invitation, 30 leading bioethicists from
p.(None): India came together with guests from Europe in a two-day workshop in Mumbai in 2016. This workshop, which was attended
p.(None): by many senior research ethics committee chairs and members, was an important fact-finding mission in the early stages
p.(None): of the project. Cases of exploita- tion were collated and good practice in research involving LMICs discussed
p.(None): (Chatfield et al. 2016b).
p.(None): Further in-depth consultation with ethics committee chairs formed part of a ple- nary workshop in Nairobi in 2017.
p.(None): TRUST received valuable input from three esteemed ethicists: Professor Elizabeth Bukusi (Deputy Director
p.(None): Research and Development, Kenya Medical Research Institute), Professor Anastasia Guantai (Kenyatta National
p.(None): Hospital) and Professor Kirana Bhatt (Chair of the National Bioethics Committee, University of Nairobi), who
p.(None): shared their respective experi- ences, concerns and insights. Table 6.5 summarizes some of the issues raised
p.(None): (Chatfield et al. 2016b) and their relationship to the final GCC.
p.(None):
p.(None): 66 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.5 Input from research ethics committee chairs and GCC output
p.(None): Input Relevant GCC article
p.(None):
p.(None): Intellectual property rights are often held only in the North.
p.(None):
p.(None): Attempts at gaining ethics approvals can be extremely late.
p.(None): LMIC partners’ tasks are restricted to obtaining data.
p.(None):
p.(None): Why does biological material need to be shipped abroad?
p.(None): Article 4: Local researchers should be included, wherever possible, throughout the research process, including in study
p.(None): design, study implementation, data ownership, intellectual property and authorship of publications.
p.(None): Article 11: Researchers from high-income settings should show respect to host country research ethics committees.
p.(None):
p.(None): Article 4 (see above)
p.(None): Article 20: A clear understanding should be reached among collaborators with regard to their roles, responsibilities
p.(None): and conduct throughout the research cycle.
p.(None): Article 5: Access by researchers to any … human biological materials … should be subject to the free and prior informed
p.(None): consent of the owners or custodians. Formal agreements should govern the transfer of any material or knowledge to
p.(None): researchers, on terms that are co-developed with resource custodians or knowledge holders.
p.(None):
p.(None): Analysis of Existing Guidelines
p.(None):
p.(None): We have summarized above the extensive consultation activities of the TRUST project prior to the actual
p.(None): drafting of the GCC. Aside from these valuable contribu- tions, it was also vital that the GCC should not set out to
p.(None): “reinvent the wheel”. Given the vast number of existing guidelines, and the significant expertise that went into
p.(None): drafting them, it was important for us to link the GCC to those existing guide- lines so as to produce something
p.(None): that did not replicate earlier work, but rather complemented it.
p.(None): Research ethics committees have been in operation since the 1960s (Levine 2004). The earliest codes of
p.(None): research ethics are even older (Levine 2004). Yet the ethics dumping cases identified as part of the
p.(None): fact-finding mission for the GCC occurred mostly in the 2010s (Schroeder et al. 2018), more than 50 years after the
p.(None): first codes and committees became operational. There are many reasons why ethics dumping in research persists, one of
p.(None): which is that the constraints on research ethics committees in LMICs make them vulnerable to exploitation, often across
p.(None): the North– South global divide. Some such constraints are summarized in Table 6.6 (modified from Nyika et al. 2009).
p.(None): A new code of ethics cannot, by itself, resolve these issues, for instance the lack of resources to fund effective
p.(None): ethics review. However, it can tailor requirements to LMIC needs. To do so most effectively, the TRUST team decided
p.(None): that it would not base the drafting process on existing ethics guidelines, because, as is also noted in Chapter 4, the
p.(None): history of research ethics review is heavily built on the United States experience and context and focused on medical
p.(None): research (see also Levine 2004). To avoid any potential bias, the following approach was agreed upon. First, the
p.(None): exercise of identifying ethics dumping risks was to be carried out without reference to exist- ing ethics guidelines.
p.(None): Second, only once the risks had been identified through fact-
p.(None):
p.(None): Drafting Process
p.(None): 67
p.(None):
p.(None): Table 6.6 Constraints on African research ethics committees
p.(None): Insufficiency of resources No or poor support by the hosting institution
p.(None): Lack of or insufficient expertise on ethical review Not completely independent Pressure from researchers
p.(None): Pressure from sponsors
p.(None):
p.(None): Lack of active or consistent participation of members
p.(None): Lack of recognition of the importance of REC functions
p.(None): Unequal treatment of applicants in review
p.(None):
p.(None): finding missions and consultations would existing ethics codes be analysed for their relevance to mitigating the
p.(None): identified risks.
p.(None): After the risk research was concluded, a meticulous analysis of all identified risks for ethics dumping (chapter 5) was
p.(None): undertaken. All 88 risks were mapped onto existing ethics codes. For instance, Risk 8 was identified as “Poor
p.(None): representa- tion of Southern (host) partners on research teams, e.g. responsible for menial tasks only or
p.(None): not acknowledged or represented appropriately in publications” (Singh and Schroeder 2017). The mapping exercise
p.(None): discovered that the best match to mitigate this risk was the Montreal Statement on Research Integrity in Cross-
p.(None): Boundary Research Collaborations (Singh and Schroeder 2017), which notes:
p.(None): Collaborating partners should come to an agreement, at the outset and later as needed, on how publication and other
p.(None): dissemination decisions will be made and on standards for authorship and acknowledgement of joint research
p.(None): products. The contributions of all part- ners, especially junior partners, should receive full and appropriate
p.(None): recognition. (Montreal Statement 2013)
p.(None): Through this exercise, it was possible to arrive at guidance to counter ethics dumping, while
p.(None): simultaneously identifying which risks, if any, were not covered by any notable guidance. For instance, the lack
p.(None): of guidance on risk management approaches to biosafety and biosecurity was discovered in this way (Singh
p.(None): and Schroeder 2017), leading to article 1813 of the GCC.
p.(None): Once the fact-finding, consultations and analysis had been done, the drafting process began.
p.(None):
p.(None):
p.(None): Drafting Process
p.(None):
p.(None): The drafting committee of the GCC consisted of four people, following Michael Davis’s (2007) advice:
p.(None): Keep the drafting committee small. Preparing a first draft of a code is not an activity made lighter “by many hands”.
p.(None): It is more like the soup that “too many cooks” spoil.”
p.(None):
p.(None): 13 In situations where environmental protection and biorisk-related regulations are inadequate or non-existent in the
p.(None): local setting compared with the country of origin of the researcher, research should always be undertaken in line with
p.(None): the higher standards of environmental protection.
p.(None):
p.(None): 68 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Table 6.7 GCC drafting committee
p.(None): Region of
p.(None): Drafter origin Focus Background Roles
p.(None):
p.(None): Schroeder North All engagement and
p.(None): fact-finding
p.(None): Philosophy, politics, economics
p.(None): Full first draft
p.(None):
p.(None): Chennells South Vulnerable populations
p.(None): Law Drafting articles to protect vulnerable populations
p.(None):
p.(None): Chatfield North Risks Social science, philosophy
p.(None): Redrafting to ensure all risks were covered
p.(None): Singh South Existing guidelines Public health Redrafting with a focus on
p.(None): existing guidelines
p.(None):
p.(None): Table 6.7 shows the configuration of the four-person drafting committee. The emphasis was on 50% North and 50% South
p.(None): membership, taking into account the expertise needed and relevant background.
p.(None): The four-values approach, featuring fairness, respect, care and honesty, had been adopted by the consortium at an
p.(None): earlier stage (chapter 3). Based on these values and the inputs into the GCC from consultations and fact-finding
p.(None): activities over two years (see Fig. 6.1), the lead author, Professor Doris Schroeder, drafted the first version, which
p.(None): contained 20 articles, three fewer than the final version.
p.(None): For instance, article 15 on the risks of stigmatization, incrimination, discrimina- tion and indeterminate personal
p.(None): risk was added during the peer review process by Professor Morton, the veterinary expert in the consortium.
p.(None): Professor Schroeder’s first draft was refined considerably by the social science and risk expert on the drafting
p.(None): committee, Dr Kate Chatfield. Dr Roger Chennells, the expert on involving vulnerable populations in research,
p.(None): who also provided a legal perspective, drafted his own articles on the prevention of ethics dumping. Many
p.(None): of these addressed the same issues identified by the lead author, but now illu- minated by a legal reading. For
p.(None): example, article 20 on the clear understanding of roles and responsibilities was an important addition. Finally, the
p.(None): expert on existing guidelines, Dr Michelle Singh, checked the draft code for oversights relevant to
p.(None): countering ethics dumping and also, for example, added article 7 on the importance of compensating local support
p.(None): systems.
p.(None): The first full draft agreed by the four-person committee then went through a rigorous internal peer
p.(None): review process in the consortium, including detailed discussions at a plenary meeting in Germany in
p.(None): February 2018. Each draft article was analysed in depth. Changes at this stage included:
p.(None): • A different order to demonstrate importance through emphasis: for example, the assertion that the local relevance
p.(None): of research is essential became article 1.
p.(None): • Different wording: for example, the word “gatekeeper’ in article 7 was replaced with “local coordinator”, and
p.(None): “community approval” in article 9 was changed to “community assent”.
p.(None): • Regrouping to connect with a different value: for example, local ethics review was moved from the “fairness”
p.(None): section to “respect”.
p.(None):
p.(None): Drafting Process
p.(None): 69
p.(None):
p.(None): • Combining articles: for example, showing respect to local ethics committees and producing documentation in line
p.(None): with local requirements were combined in the final article 11.
p.(None): Some issues could not be solved at the meeting and individual experts were tasked with presenting
p.(None): solutions. For instance, Professor Rachel Wynberg from the University of Cape Town, a world-leading expert on benefit
p.(None): sharing, was asked to ensure that the benefit-sharing articles of the GCC (articles 5 and 6) were in line with the most
p.(None): recent legal instruments and phrased as accessibly as possible.
p.(None): Article 14 was debated with particular gusto. Part of the group wanted to prevent any research that was prohibited in
p.(None): HICs from taking place in LMICs, whereas oth- ers wanted to leave room for justifiable exceptions. The final version of
p.(None): the article was agreed through consensus-building suggestions from Professors Carel IJsselmuiden and
p.(None): Klaus Leisinger, which enabled permissible exceptions with a “comply or explain” proviso.
p.(None): When an internal consensus was reached on the entire text, bearing in mind that “internal” involved 13 partner
p.(None): organizations from around the world, the agreed draft was released to the previously engaged external stakeholders, in
p.(None): line with further advice from Michael Davis (2007):
p.(None): Make the procedure as open as possible once there is a first draft. The openness … protects the drafting committee not
p.(None): only from the eccentricities of those outside the committee but from the tendency of drafting committees to forget
p.(None): practical constraints.
p.(None): All articles were accordingly submitted to a much broader peer review by those who had previously taken part in
p.(None): consultations, and their comments were obtained. Many of these comments were acted upon, including:
p.(None): • An industry representative’s suggestion to remove the following closing sen- tence from the draft article
p.(None): on community assent: “Developing personal, long- standing relationships with local communities produces the bedrock of
p.(None): respect.” This was on the basis that the statement did not apply to all international collab- orative research, and
p.(None): also that no other GCC article had such a commentary.
p.(None): • The request by several external stakeholders from various backgrounds that the qualification “wherever possible” be
p.(None): added to articles 2, 4 and 10, in order to be more realistic.
p.(None): • The proposal that “vehicle drivers” be removed from the examples of local research support systems given
p.(None): in article 7.
p.(None): After this extensive peer review, three further activities were undertaken. First, the final draft was reworked by a
p.(None): professional editor (Paul Wise in South Africa) to achieve the clearest, most precise and most accessible language.
p.(None): Second, the code was professionally designed for publication (CD Marketing Ltd, UK). Third, fund- ing was obtained
p.(None): (from the University of Central Lancashire, UK, and the EDCTP) to translate the code into Russian, French, Spanish,
p.(None): German, Portuguese, Mandarin, Japanese, and Hindi.14 Arabic and isiXhosa translations are in progress as this book goes
p.(None): to press.
p.(None):
p.(None): 14 The translations can be found at http://www.globalcodeofconduct.org/open-to-the-world/
p.(None):
p.(None): 70 6 How the Global Code of Conduct Was
p.(None): Built
p.(None):
p.(None): Early Adopters and Conclusion
p.(None):
p.(None): After an intensive and scrupulous development process, the GCC was launched at two high-profile events. First, at
p.(None): a meeting of the UN Leadership Council for Sustainable Development in Stockholm, Sweden, in May 2018,
p.(None): and then at the European Parliament in June 2018. The GCC had been under examination by the ethics and integrity
p.(None): sector and the legal services of the EC since March 2018. This allowed Dr Wolfgang Burtscher, Deputy
p.(None): Director-General for Research and Innovation of the EC, to announce the big news at the European Parliament event:
p.(None): the GCC would be a mandatory reference document for the framework programmes that fund European research. What this
p.(None): means was expressed succinctly in a Nature article.
p.(None): Ron Iphofen, an adviser on research ethics to the European Commission, believes the code will have a profound impact on
p.(None): how funding proposals to the EU are designed and reviewed. “I could envisage reviewers now looking suspiciously
p.(None): at any application for funds that entailed research by wealthy nations on the less wealthy that did not mention
p.(None): the code,” he says. (Nordling 2018)
p.(None): Two months later, in August 2018, the EDCTP announced that henceforth its applicants would be required to comply with
p.(None): the GCC. In April 2019, the Senate of the University of Cape Town (UCT) adopted the GCC as the first university
p.(None): globally to ensure that UCT researchers maintain the highest ethical standards.
p.(None): The groundwork for developing the GCC included a broad collation of ethics dumping case studies, as well as good
p.(None): practice examples from international collab- orative research, and extensive consultation with representatives from a
p.(None): range of stakeholder groups: research policymakers, research funders including private industry, researchers,
p.(None): research communities, research ethics committees and, most importantly, vulnerable research participants and those who
p.(None): support them. Building on 88 generic risks identified in the fact-finding and consultation phases of the
p.(None): TRUST project, and taking existing guidelines into account, a code was built which will provide guidance across all
p.(None): research disciplines. It focuses on research collabo- rations between LMIC and HIC partners, which often involve
p.(None): considerable imbal- ances of power, resources and knowledge. The GCC is presented in 23 clear, short statements in
p.(None): order to achieve the highest possible cross-cultural accessibility for researchers, funders and vulnerable populations
p.(None): alike.
p.(None): Those who apply the GCC are demonstrating that they oppose double standards in research and support long-term equitable
p.(None): research relationships between partners from LMIC and HIC settings, based upon the values of fairness, respect, care
p.(None): and honesty.
p.(None):
p.(None):
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p.(None): for H2020 funding. TRUST eNewsletter Issue 5. http://www.global-
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p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 7
p.(None): The San Code of Research Ethics
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The San peoples of southern Africa have been the object of much aca- demic research over centuries. In recent
p.(None): years, San leaders have become increas- ingly convinced that most academic research on their communities has been
p.(None): neither requested, nor useful, nor protected in any meaningful way. In many cases dissatis- faction, if not actual
p.(None): harm, has been the result. In 2017, the South African San finally published the San Code of Research Ethics,
p.(None): which requires all researchers intending to engage with San communities to commit to four central values, namely
p.(None): fairness, respect, care and honesty, as well as to comply with a simple process of community approval. The code is the
p.(None): first ethics code developed and launched by an indigenous population in Africa. Key to this achievement were: dedicated
p.(None): San lead- ers of integrity, supportive NGOs, legal assistance and long-term research collabo- rations with key
p.(None): individuals who undertook fund-raising and provided strategic support.
p.(None):
p.(None): Keywords San Peoples · Global ethics · Research ethics · Indigenous peoples · Low-and middle-income countries · Ethics
p.(None): dumping
p.(None):
p.(None):
p.(None): Introduction1
p.(None):
p.(None): The San peoples, widely known as “first” or “indigenous” peoples of southern Africa, have been the object of
p.(None): much academic research over centuries.
p.(None): In recent years San leaders have become increasingly convinced that most aca- demic research on their communities has
p.(None): been neither requested, nor useful, nor protected in any meaningful way. In many cases dissatisfaction, if not actual
p.(None): harm, has been the result. For instance, a genomics study published in 2010, based on the DNA of four San individuals,
p.(None): included conclusions which San community leaders found “private, pejorative, discriminatory and
p.(None): inappropriate” (Chennells and
p.(None):
p.(None):
p.(None):
p.(None): 1 This chapter is based on a longer, illustrated report (Chennells and Schroeder 2019).
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 73
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_7
p.(None):
p.(None): 74 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): Steenkamp 2018). Authors of the paper “refused to provide details about the informed consent process ….
p.(None): [and] defended their denial of the right of the San leadership to further information on the grounds that the research
p.(None): project had been fully approved by ethics committees/institutional review boards” (Chennells and Steenkamp
p.(None): 2018).
p.(None): In March 2017, the South African San launched the San Code of Research Ethics, the first ethics code developed and
p.(None): published by an indigenous community in Africa (Callaway 2017). The code requires all researchers intending to engage
p.(None): with San communities to commit to four central values, namely fairness, respect, care and honesty, as well as to comply
p.(None): with a simple process of community approval.
p.(None): This chapter introduces the San of southern Africa and the main San support institutions involved in producing the San
p.(None): Code of Research Ethics. It goes on to describe key elements in the development and the launch of the code, namely
p.(None): lead- ers of integrity, legal support, supportive research collaborations and the process of drafting. Finally, the
p.(None): code is reproduced in full.
p.(None):
p.(None):
p.(None): The San of Southern Africa
p.(None):
p.(None): The San peoples of Africa are iconic, widely known as the quintessential hunter- gatherers of Africa and said to be the
p.(None): oldest genetic ancestors of modern humans (Knight et al. 2003). Once ranging over the whole of southern Africa, their
p.(None): numbers have now dwindled to approximately 100,000 San living primarily in Botswana, Namibia and South Africa, with
p.(None): small remnant populations in Angola, Zimbabwe and Zambia (Hitchcock et al. 2006). Although they speak at least
p.(None): seven distinct languages2 with numerous subdialects, they nevertheless recognize a common cul- tural identity which
p.(None): is readily identified as a hunter-gatherer heritage, with a shared ancestry also confirmed by genetic research
p.(None): (Soodyall 2006).
p.(None): Prior to 1990, the San peoples lived typically in extended families and small clans in the remote reaches
p.(None): of South Africa, Botswana and Namibia, as well as in smaller scattered populations in Zimbabwe, Zambia and Angola. The
p.(None): fact that the San generally lived in small groups in remote locations added to their isolation, and contributed towards
p.(None): their vulnerability to exploitation by others.
p.(None): Generally impoverished, marginalized and cut off from the modern world, they received minimal support from their
p.(None): respective governments. Almost no communi- cation took place between the leaders of these far-flung communities, with
p.(None): the result that their ability to share information and empower their peoples remained structur- ally constrained.
p.(None):
p.(None):
p.(None):
p.(None): 2 The following are the most common major San languages currently spoken in the region. Botswana hosts
p.(None): Nharo, Gwi, G/anna and Khwe; Namibia hosts Ju/huasi, Hei//om, Kung, !Xun and Khwe; South Africa hosts the !Khomani, the
p.(None): !Xun and the Khwe; Zimbabwe hosts the Tyua.
p.(None):
p.(None): Institution Building and Supportive NGOs
p.(None): 75
p.(None):
p.(None): The fate suffered by the San peoples in Africa is similar to that of many indige- nous peoples in other parts of the
p.(None): world. Expansion and conquest, firstly by asser- tive local pastoralist and agriculturalist communities, followed later
p.(None): and with similar devastation by colonial powers, all but obliterated their former existence. The San history over the
p.(None): centuries has been one of dispossession, enslavement, cultural extinction and recorded patterns of officially
p.(None): sanctioned genocide (Penn 2013).
p.(None): For many reasons, including their lifestyle until recent times as hunter-gatherer peoples, and their unique genetic
p.(None): properties as descendants of possibly the earliest members of the human race, the San have found themselves
p.(None): in high demand as research populations.
p.(None): Modern San leaders faced with increasing societal challenges had no means of communicating their problems with other
p.(None): leaders, of learning about their human rights, or of discussing ways in which they might legitimately
p.(None): challenge the unwanted interventions of researchers and other outsiders such as media practitioners.
p.(None): In addition, the San world view is generally one of seeking harmony, and avoid- ing all forms of conflict. Several
p.(None): scholars of conflict resolution have based their principles of good practice on ancient San systems, in which the
p.(None): prevention of dis- putes and the reconciliation of interests are deeply ingrained (Ury 1995).
p.(None): The outside world regarded the San as a classic example of a “vulnerable popula- tion”, lacking the means to organize a
p.(None): collective expression of their common inter- ests and concerns (Chennells 2009). Prior to the year 2000, virtually all
p.(None): research was externally conceived, and was perceived by the San as being disruptive and on occasion harmful to the
p.(None): research populations (Chennells and Steenkamp 2018).
p.(None): Internet searches of the words San, Khoisan3 and Bushmen throw up thousands of papers, books and research theses,
p.(None): supporting the assertion that they are among the most researched peoples in the world. Until they formed their own
p.(None): representa- tive organizations, they did not have a unified voice and thus remained powerless to resist unwanted
p.(None): attention from outsiders.
p.(None):
p.(None):
p.(None): Institution Building and Supportive NGOs
p.(None):
p.(None): The most important step towards the San Code of Research Ethics was local institution-building, an
p.(None): initiative that made all further successes possible.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 3 While the term “Khoisan” is frequently used in general discourse as a collective name for two distinct groupings in
p.(None): southern Africa, namely the Khoi, or KhoiKhoi, and the San, this umbrella term is not relevant to a discussion of the
p.(None): San peoples. The Khoi or KhoiKhoi, formerly known in South Africa as Hottentots, are regarded as pastoral, and of more
p.(None): recent origin (Barnard 1992).
p.(None):
p.(None): 76 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): WIMSA: The Catalyst Institution
p.(None):
p.(None): WIMSA (the Working Group of Indigenous Minorities in Southern Africa) has arguably been the most important of
p.(None): a number of San support organizations operat- ing in southern Africa over the past 25 years. Reverend Mario Mahongo,
p.(None): one of the San leaders whose work on the San Code of Research Ethics was crucial, noted of a 1996 workshop: “For the
p.(None): first time we were meeting San leaders from the whole region, and we realised that this new organisation WIMSA could
p.(None): really help our people” (Chennells and Schroeder 2019).
p.(None): Table 7.1 lists the main non-governmental organizations (NGOs) that have pro- vided services to the San in South
p.(None): Africa, Botswana and Namibia.
p.(None): Supported through seed funding from Swedish and Dutch charities, German development worker Axel Thoma and
p.(None): San leaders such as Kipi George and Augustino Victorino promoted the formation of a cross-border, regional
p.(None): organiza- tion to protect the rights of all San peoples in southern Africa. The topics that emerged as
p.(None): clear priorities among San communities were:
p.(None): • Access to land
p.(None): • Benefit sharing for traditional knowledge
p.(None): • Protection of heritage and culture4
p.(None): WIMSA functioned effectively as a regional organization from its inception in 1996 until approximately 2016. The
p.(None): successes of this important San organization in raising awareness and promoting advocacy among the San cannot be
p.(None): overstated.
p.(None):
p.(None): Table 7.1 San support organizations
p.(None): Start year Organization name Organization region 1981
p.(None): Nyae Nyae Development Foundation Tsumkwe, Namibia 1988 Kuru Development Trust
p.(None): Ghanzi, Botswana
p.(None): 1991 First People of the Kalahari Ghanzi, Botswana 1992
p.(None): First Regional San Conference Windhoek, Namibia
p.(None):
p.(None): 1995 Final Regional San Conference (pre-WIMSA)
p.(None): D’Kar, Botswana
p.(None): 1996 WIMSA Windhoek, Namibia 1996
p.(None): South African San Institute (SASI) Kimberley, South Africa
p.(None):
p.(None): 1999 !Khwa ttu San Culture and Education Centre
p.(None): Darling, South Africa.
p.(None): 2001` South African San Council Upington, South Africa
p.(None): 2006 Namibia San Council Windhoek, Namibia
p.(None): 2007 Khwedom Council Gaborone, Botswana.
p.(None):
p.(None):
p.(None): 4 A San organisation that is highly active and successful in protecting the San cultural heritage is
p.(None): !Khwa ttu, which was not directly involved in the development of the San Code of Research Ethics and is therefore not
p.(None): included here with its own section. Details about !Khwa ttu can be found in Chennells and Schroeder (2019).
p.(None):
p.(None): Institution Building and Supportive NGOs
p.(None): 77
p.(None):
p.(None): Importantly, in 1998 WIMSA drafted the San’s first Media and Research Contract, which was aimed at managing
p.(None): external incursions into San culture which up to that time had occurred with no San control at all. San leaders
p.(None): throughout the region were trained in the implementation of the contract, and it was used to deal with researchers,
p.(None): filmmakers, writers and others who entered San territory wanting to gather information.
p.(None):
p.(None):
p.(None): South African San Institute and South African San Council
p.(None):
p.(None): The San Code of Research Ethics takes a step further than the WIMSA Media and Research Contract. It outlines exactly
p.(None): what the San require from researchers. The WIMSA contract, by contrast, is more akin to an ethics approval
p.(None): form, which requires researchers to provide information about their studies before they enter San communities. One
p.(None): major difference is therefore that the San code requires collabo- ration from the start – that is, from the inception
p.(None): of the research – rather than approv- ing fully conceived studies as through the WIMSA form.
p.(None): The two NGOs most important in developing the San Code of Research Ethics were the South African San Institute (SASI)
p.(None): and the South African San Council (SASC).
p.(None): SASI was formed in 1996 and initially took the form of a dedicated San service NGO. SASI’s original mission was to
p.(None): assist the !Khomani San with their restitution land claim in the Kalahari. This was completed successfully in 1999, but
p.(None): SASI con- tinued to be active. SASI also supported the !Xun and Khwe San communities, who were relocated to South
p.(None): Africa from Namibia after the end of the “bush wars” in 1990, and settled in a temporary army camp near Kimberley,
p.(None): where SASI is based. The communities’ first needs were for assistance in relation to housing and other social problems
p.(None): arising from their exceedingly disrupted and war-torn history, hav- ing been caught in the crossfire between the
p.(None): apartheid government of South Africa and guerrilla fighters in Angola and Namibia. SASI was the partner in the TRUST
p.(None): project which represented the San peoples, and which assisted with the develop- ment of the San Code of Ethics. They
p.(None): hosted all relevant workshops and the launch of the code in Cape Town (see below).
p.(None): The SASC had existed informally since 1996, representing the interests of three South African San communities on the
p.(None): WIMSA board (!Khomani, Khwe, !Xun). It was legally constituted in 2001 so that it could negotiate officially on behalf
p.(None): of the San, and proceeded over the years to become a major success story in San institu- tion building. The SASC
p.(None): negotiated a famous benefit-sharing agreement with South Africa’s Council for Scientific and Industrial Research
p.(None): (CSIR) in relation to the San’s traditional knowledge rights to the Hoodia plant.
p.(None): The global UN Convention on Biological Diversity (CBD) of 1992 was the first instrument to provide for the principle
p.(None): that commercial users of plants with active ingredients based upon traditional knowledge needed to negotiate
p.(None): benefit-sharing agreements with the holders of the traditional knowledge, in order to ensure fair-
p.(None):
p.(None): 78 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): ness. With this development, the San rediscovered the value of their culture and heritage in the form of their
p.(None): traditional knowledge of a wide range of medicinal and other useful indigenous plants. In 2003 the first
p.(None): benefit-sharing agreement was con- cluded with the CSIR.
p.(None): The Hoodia benefit-sharing case achieved seminal status in the CBD world (Wynberg et al. 2009) and can
p.(None): be seen as the first major step taken by the San towards achieving fairness in research. The strong demand
p.(None): for benefit sharing in research is also the reason why fairness is an important, separate value in the San Code of
p.(None): Research Ethics.
p.(None): The importance of the collaboration of SASI (support NGO) and the SASC (rep- resenting San issues directly through
p.(None): San leaders) has been emphasized by the SASC’s director, Leana Snyders:
p.(None): Our relationship with SASI has helped increase our capacity to understand the law, and also to represent our people.
p.(None): With the legal knowledge gained from negotiating benefit sharing agreements resulting from our traditional knowledge,
p.(None): the San have become acknowledged leaders in this field. (Chennells and Schroeder 2019)
p.(None):
p.(None):
p.(None):
p.(None): Leaders of Integrity
p.(None):
p.(None): It is perhaps a truism that collective progress is impossible without leaders of vision and integrity. When the San
p.(None): began their process of institutional development in 1996, they were fortunate to have a group of pioneering
p.(None): leaders who drove and sup- ported the vision to end the isolation of the past and to enter the
p.(None): organizational modern world. The San were blessed during this period with strong leaders, some of whom are still
p.(None): active, who had the wisdom to support change and the ability to engender consensus among sometimes differing opinions
p.(None): while retaining the confi- dence and trust of their people.
p.(None): One can be forgiven, however, for singling out the following leaders, who died prematurely while dedicated to the
p.(None): process of empowering their people: Kipi George (Khwe), /Xau Moses (Ju//Huansi), Augustino Victorino
p.(None): (!Xun), Robert Derenge (Khwe), Dawid Kruiper (!Khomani), Andries Steenkamp (!Khomani), and Mario Mahongo (!Xun).
p.(None): These leaders rose above their peers for many reasons, including the following, which are drawn from the many eulogies
p.(None): delivered upon their passing: they were strong and able to take difficult decisions, without losing an element of
p.(None): softness and humanity; each was regarded as honest and dedicated to his people, rather than to his immediate family and
p.(None): clan; they were respected both by their own communities and by outsiders for their intelligence, integrity and wisdom.
p.(None): These factors alone made them unique, and, like Nelson Mandela, they are constantly invoked as icons of leadership.
...
p.(None): rights related to their traditional knowledge (on Hoodia, buchu, Sceletium, rooibos etc), which raised the
p.(None): international profile of the San as indigenous peoples, all required committed legal support. This was made available
p.(None): mostly via SASI.
p.(None): The prohibitive cost of standard commercial lawyers is a well-known deterrent to obtaining legal advice and assistance.
p.(None): In addition, utilizing lawyers who are not familiar with the ethos and needs of the community can lead to expensive
p.(None): mistakes and misunderstandings. Lawyers who are willing to represent the community legally on a pro bono or
p.(None): noncommercial basis can therefore give a vulnerable com- munity a significant advantage.
p.(None): Dr Roger Chennells, SASI’s lawyer, also provided a legal editing service for the San Code of Research Ethics.
p.(None):
p.(None):
p.(None): Supportive Research Collaborations
p.(None):
p.(None): Formulating ethics codes is a time-consuming business that requires funding, in particular to support
p.(None): workshops where San traditional leaders and San community members can discuss their concerns and ways forward. Sceptics
p.(None): may point out that the same individuals always attend such workshops largely out of appreciation for the food provided,
p.(None): and leave without any tangible or lasting benefits.
p.(None): By contrast, there is much anecdotal evidence of San colleagues who reported, after attending workshops, that their
p.(None): thinking, and indeed sometimes their lives, had forever been altered by an insight gained at the workshop. The San
p.(None): development programmes conducted by WIMSA, SASI and the SASC held capacity-building workshops on a range of topics. Of
p.(None): particular relevance to the San Code of Research Ethics were the workshops funded by two successive EU projects,
p.(None): ProGReSS5 and TRUST.6
p.(None): The ProGReSS project, under the leadership of Professor Doris Schroeder, ran from 2013 to 2016 with SASI as a partner
p.(None): with its own budget. The project funded two workshops to revise the WIMSA Research and Media Contract, among other
p.(None): things. By the conclusion of ProGReSS, it became clear that a new San ethics code might realize San interests more
p.(None): effectively in the future.
p.(None): The EU-funded TRUST project, also led by Professor Schroeder, catalysed a global collaborative effort to
p.(None): improve adherence to high ethical standards in research around the world. Its main product is the Global Code of
p.(None): Conduct for Research in Resource-Poor Settings, the main topic of this book. However, a second high-profile output is
p.(None): the San Code of Research Ethics.
p.(None): Both projects enabled productive workshops to be held, at which the San’s rights were further debated, and where the
p.(None): outcomes were not only used by the San in
p.(None):
p.(None): 5 http://www.progressproject.eu/
p.(None): 6 http://trust-project.eu/
p.(None):
p.(None): Drafting the San Code of Research Ethics
p.(None): 81
p.(None):
p.(None): practical cases, but also published and disseminated. The TRUST project united the efforts of many years to tackle the
p.(None): challenge of how unwanted research could be controlled. Without the collaborative support of international research
p.(None): partners, it is doubtful that the San Code of Research Ethics would have emerged.
p.(None):
p.(None):
p.(None): Drafting the San Code of Research Ethics
p.(None):
p.(None): Building on various earlier efforts, the San Code of Research Ethics was drafted over the course of three workshops and
p.(None): much intervening work during the year prior to its launch in March 2017.
p.(None): In March 2016, SASI organized a preparatory workshop at which San represen- tatives voiced their concerns and reported
p.(None): their past involvement in national and international research studies. Examples of good and bad research case studies
p.(None): were identified, in order to guide a revision of the San Media and Research Contract and the drafting of a San
p.(None): Code of Research Ethics. The aim was to help the South African San manage their involvement in research and
p.(None): heritage studies. Delegates included SASC members plus leaders from the !Xun, the Khwe and the !Khomani, together with
p.(None): selected invited experts from the fields of genetics, sociology, ethnol- ogy, research ethics and law. During this
p.(None): workshop the participants received back- ground information on research in the different fields, delivered by
p.(None): the experts attending the workshop.
p.(None): Based on this input, initial ideas to improve research engagement were devel- oped. The following ideas were voiced:
p.(None): • A single central body needs to be created with clear external and internal author- ity, and the capacity to manage
p.(None): research and media issues.
p.(None): • A code of ethics needs to be established, whereby researchers are able to under- stand the “dos and don’ts” of
p.(None): engaging with the San.
p.(None): • Training needs to take place, both of the leaders or local coordinators of research and among the communities and
p.(None): individuals who are required to participate.
p.(None): • Research and media contracts need to be drawn up in such a way that research is not discouraged, but is managed
p.(None): for the benefit of the community. Research which is not felt to be useful should be refused.
p.(None): • Noncommercial research or engagement should be managed with basic con- tracts. More in-depth research
p.(None): should be managed with more complex contracts as appropriate.
p.(None): • There should be consequences and penalties for failure to comply with the terms of such contracts.
p.(None): • Funds should be raised in order to establish a research monitoring and compli- ance body with the SASC.
p.(None): In May 2016, SASI organized a full workshop with 22 San representatives and a further eight external contributors,
p.(None): again from the fields of genetics, sociology, eth- nology, research ethics and law. On this occasion, work was
p.(None): undertaken to ensure
p.(None):
p.(None): 82 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): that the San could protect themselves from exploitation in research through the redrafting of their original
p.(None): research contract, and by the development of what was to become the San Code of Research Ethics.7
p.(None): During this important workshop, the San developed a range of general principles that applied to their own community.
p.(None): These principles were as follows and were used for a first draft of the San Code of Research Ethics:
p.(None): • The San require respect to the environment, to San leaders and individuals, and to cultural values.
p.(None): • Honesty, integrity and honour are important between all partners.
p.(None): • Cultural and spiritual values must be fully honoured and respected in all research and media projects.
p.(None): • The right formal process should be followed to protect communities in research.
p.(None): • Informed consent is central to all research.
p.(None): • Genetics samples should only be used for the purpose stated in the research contract.
p.(None): • Researchers should not enter a community without being guided and led by members of the community
p.(None): itself.
p.(None): • Both researcher and community should benefit from the interaction.
p.(None): In November 2016, SASI organized a third workshop with the same delegates and some of the earlier external contributors
p.(None): to finalize the content of the San Code of Research Ethics. The overall goal was to achieve fair research partnerships.
p.(None): The following threats and weaknesses were discussed.
p.(None): • Vulnerable and far-flung populations and serious poverty
p.(None): • UndueXinfluence by researchers, due to poverty
p.(None): • “Free riders” who do not support San community concerns when taking part in research for cash
p.(None): • Exploitation possibilities due to illiteracy
p.(None): • Lack of knowledge of research, what it means and what its risks are
p.(None): • Lack of knowledge about the San leadership’s approach to research
p.(None): • Lack of assistance from the government
p.(None): • Low self-esteem in engaging with outside individuals and agencies
p.(None): • Earlier theft of traditional knowledge leading to mistrust of researchers
p.(None): • Lack of system to combat the problems
p.(None): • Lack of institutional and financial support to the leadership who aim to improve the situation
p.(None): With these challenges in mind, the initial draft of the San Code of Research Ethics was revised and
p.(None): refined. In addition, each element of the new draft code was grouped into one of the four TRUST ethical values of
p.(None): fairness, respect, care, and honesty. These values had been agreed on previously by the TRUST group, with San input.
p.(None): The four core values were to be supported by a fifth value, which the San
p.(None):
p.(None): 7 A short video presentation about the workshop is available at https://www.youtube.com/ watch?v=HOdw3mv7JSo.
p.(None):
p.(None): The San Code of Research Ethics
p.(None): 83
p.(None):
p.(None): delegates deemed essential, namely proper process. In small groups the key points of each value were written out in
p.(None): greater detail.
p.(None): A highly important decision was that examples of past exploitation would form part of the code itself.
p.(None): The results of the third workshop were then given to colleagues who undertook further work. In December 2016, Roger
p.(None): Chennells worked on the code from a legal perspective, and in January 2017, Doris Schroeder worked on
p.(None): its ethical dimensions.
p.(None): The subsequent draft, which had been edited from both a legal and an ethical perspective, was then presented to the San
p.(None): leadership for adoption. Further minor changes were made, until the code was unanimously adopted and declared ready to
p.(None): be launched by the San leadership.
p.(None):
p.(None):
p.(None): The San Code of Research Ethics
p.(None): Respect
p.(None):
p.(None): We require respect, not only for individuals but also for the community.
p.(None): We require respect for our culture, which also includes our history. We have cer- tain sensitivities that are not known
p.(None): by others. Respect is shown when we can input into all research endeavours at all stages so that we can explain these
p.(None): sensitivities.
p.(None): Respect for our culture includes respect for our relationship with the environment.
p.(None): Respect for individuals requires the protection of our privacy at all times. Respect requires that our contribution to
p.(None): research is acknowledged at all times. Respect requires that promises made by researchers need to be met.
p.(None): Respectful researchers engage with us in advance of carrying out research. There should be no assumption that
p.(None): San will automatically approve of any research projects that are brought to us.
p.(None): We have encountered lack of respect in many instances in the past. In Genomics research, our leaders were avoided, and
p.(None): respect was not shown to them. Researchers took photographs of individuals in their homes, of breastfeeding
p.(None): mothers, or of underage children, whilst ignoring our social customs and norms. Bribes or other advantages were
p.(None): offered. Failure by researchers to meet their promises to provide feedback is an example of disrespect which is
p.(None): encountered frequently.
p.(None):
p.(None):
p.(None): Honesty
p.(None):
p.(None): We require honesty from all those who come to us with research proposals.
p.(None): We require an open and clear exchange between the researchers and our leaders. The language must be clear, not
p.(None): academic. Complex issues must be carefully and
p.(None):
p.(None): 84 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): correctly described, not simply assuming the San cannot understand. There must be a totally honest sharing of
p.(None): information.
p.(None): Open exchange should not patronise the San. Open exchanges implies that an assessment was made of possible harms or
p.(None): problems for the San resulting from the research and that these possible harms are honestly communicated.
p.(None): Prior informed consent can only be based on honesty in the communications, which needs to be carefully documented.
p.(None): Honesty also means absolute transparency in all aspects of the engagement, including the funding situation, the purpose
p.(None): of the research, and any changes that might occur during the process.
p.(None): Honesty requires an open and continuous mode of communication between the San and researchers.
p.(None): We have encountered lack of honesty in many instances in the past. Researchers have deviated from the stated purpose of
p.(None): research, failed to honour a promise to show the San the research prior to publication, and published a biased paper
p.(None): based upon leading questions given to young San trainees. This lack of honesty caused much damage among the public, and
p.(None): harmed the trust between the collaborating organisation and the San. Another common lack of honesty is exaggerated
p.(None): claims of the researcher’s lack of resources, and thus the researchers’ inability to provide any benefits at all.
p.(None):
p.(None):
p.(None): Justice and Fairness
p.(None):
p.(None): We require justice and fairness in research.
p.(None): It is important that the San be meaningfully involved in the proposed studies, which includes learning about the
p.(None): benefits that the participants and the community might expect. These might be largely non-monetary but include
p.(None): co-research oppor- tunities, sharing of skills and research capacity, and roles for translators and research
p.(None): assistants, to give some examples.
p.(None): Any possible benefits should be discussed with the San, in order to ensure that these benefits do actually return to
p.(None): the community.
p.(None): As part of justice and fairness the San will try to enforce compliance with any breach of the Code, including through
p.(None): the use of dispute resolution mechanisms.
p.(None): In extreme cases the listing and publication of unethical researchers in a “black book” might be considered.
p.(None): An institution whose researchers fail to comply with the Code can be refused col- laboration in future research. Hence,
p.(None): there will be “consequences” for researchers who fail to comply with the Code.
p.(None): We have encountered lack of justice and fairness in many instances in the past. These include theft of San traditional
p.(None): knowledge by researchers. At the same time, many companies in South Africa and globally are benefitting from our
p.(None): traditional knowledge in sales of indigenous plant varieties without benefit sharing agree- ments, proving
p.(None): the need for further compliance measures to ensure fairness.
p.(None):
p.(None): Conclusion
p.(None): 85
p.(None):
p.(None): Care
p.(None):
p.(None): Research should be aligned to local needs and improve the lives of San. This means that the research process must be
p.(None): carried out with care for all involved, especially the San community.
p.(None): The caring part of research must extend to the families of those involved, as well as to the social and physical
p.(None): environment.
p.(None): Excellence in research is also required, in order for it to be positive and caring for the San. Research that is not up
p.(None): to a high standard might result in bad interac- tions, which will be lacking in care for the community.
p.(None): Caring research needs to accept the San people as they are, and take note of the cultural and social requirements of
p.(None): this Code of Ethics.
p.(None): We have encountered lack of care in many instances in the past. For instance, we were spoken down to, or confused with
p.(None): complicated scientific language, or treated as ignorant. Failing to ensure that something is left behind that improves
p.(None): the lives of the San also represents lack of care.
p.(None):
p.(None):
p.(None): Process
p.(None):
p.(None): Researchers need to follow the processes that are set out in our research protocols carefully, in order for this Code
p.(None): of Ethics to work.
p.(None): The San research protocol that the San Council will manage is an important process that we have decided on,
p.(None): which will set out specific requirements through every step of the research process.
p.(None): This process starts with a research idea that is collectively designed, through to approval of the project, and
p.(None): subsequent publications.
p.(None): The San commit to engaging fairly with researchers and manage effectively all stages of the research process, as their
p.(None): resources allow. They also commit to respect- ing the various local San structures (e.g. Communal Property
p.(None): Association, CPA leaders) in their communications between San leaders and San communities.
p.(None): Andries Steenkamp, the respected San leader who contributed to this Code of Ethics until he passed away in 2016, asked
p.(None): researchers to come through the door, not the window. The door stands for the San processes. When researchers respect
p.(None): the door, the San can have research that is positive for us.
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): Key to the achievements of the San in South Africa have been: dedicated San lead- ers of integrity, supportive NGOs,
p.(None): legal support, and long-term relationships with key individuals who also assisted with fundraising (see Fig. 7.1).
p.(None):
p.(None): 86 7 The San Code of
p.(None): Research Ethics
p.(None):
p.(None): Fig. 7.1 Success factors
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): The San leadership have developed an approach to outsiders, for instance researchers, that is open to forging
p.(None): authentic human relationships. Every research project meeting or benefit-sharing negotiation was regarded as an
p.(None): opportunity to meet a certain person who might prove himself or herself to be mutually open to a relationship of trust.
p.(None): In particular Andries Steenkamp of the !Khomani San and Mario Mahongo of the !Xun San, both former chairpersons of the
p.(None): SASC, formed such relationships of trust. Not only was the famous San humour seldom far from the surface, but they
p.(None): exuded an air of confidence and open curiosity, quick to understand and appreciate the persons across the table, and
p.(None): slow to take personal offence. Their personal integ- rity shone through, and the trust that they generated in others
p.(None): translated into untold benefits for the San.
p.(None): This approach ensured that the San Council is highly respected in South Africa. In addition, relationships of trust
p.(None): developed with international researchers, generat- ing funding for research and policy projects. One of the many
p.(None): results of the open- ness of San leaders to collaboration with the world is the San Code of Research Ethics, which, it
p.(None): is hoped, will put all future relationships with outsiders onto an equitable basis. As Leana Snyders put it:
p.(None): The San Code of Research Ethics is the voice of a community that have been exploited for so many years. This code
p.(None): manages to bridge the gap between the research community and the San Community through dialogue. By taking ownership of
p.(None): the code, the San Community will ensure that this document will remain relevant for generations to come. (Chennells and
p.(None): Schroeder 2019)
p.(None):
p.(None): References
p.(None): 87
p.(None):
p.(None): References
p.(None):
p.(None): Barnard A (1992) Hunters and herders of southern Africa: a comparative ethnography of the Khoisan peoples.
p.(None): Cambridge University Press, New York and Cambridge
p.(None): CallawayE(2017)SouthAfrica’sSanpeopleissueethicscodetoscientists.Nature543:475–476.https://
p.(None): www.nature.com/news/south-africa-s-san-people-issue-ethics-code-to-scientists-1.21684
p.(None): Chennells R (2009) Vulnerability and indigenous communities: are the San of South Africa a vul- nerable people?
p.(None): Cambridge Quarterly of Healthcare Ethics 8(2):147–154
p.(None): Chennells R, Steenkamp A (2018) International genomics research involving the San people. In: Schroeder D, Cook J,
p.(None): Hirsch F, Fenet S, Muthuswamy V (eds) Ethics dumping: case studies from North–South research collaborations. Springer,
p.(None): Berlin, p 15–22
p.(None): Chennells R, Schroeder D (2019) The San Code of Research Ethics: its origins and history, a report for TRUST.
p.(None): http://www.globalcodeofconduct.org/affiliated-codes/
p.(None): Hitchcock RK, Ikeya K, Biesele M, Lee RB (2006) Introduction. In: Hitchcock RK, Ikeya K, Biesele M, Lee
p.(None): RB (eds) Updating the San: image and reality of an African people in the 21st century. Senri Technological Studies 70.
p.(None): National Museum of Ethnology, Osaka, p 4
p.(None): Knight A, Underhill PA, Mortensen HM, Zhivotovsky, LA, Lin AA, Henn BM, Louis D, Ruhlen M, Mountain JL (2003). African
p.(None): Y chromosome and mtDNA divergence provides insight into the history of click languages. Current Biology 13(6):464–473
p.(None): Penn N (2013) The British and the ‘Bushmen’: the massacre of the Cape San, 1795 to 1828. Journal of
p.(None): Genocide Research 15(2):183–200 https://doi.org/10.1080/14623528.2013.793081 TRUST Project Global Research Ethics.
p.(None): (2018a) Andries Steenkamp and Petrus Vaalbooi inter-
p.(None): views – TRUST Project. https://www.youtube.com/watch?v=A4_Mvdwl_Gc
p.(None): TRUST Project Global Research Ethics. (2018b) Reverend Mario Mahongo – TRUST Project.
p.(None): https://www.youtube.com/watch?v=jMhCUNw9eAo
p.(None): Soodyall H (2006) A prehistory of Africa. Jonathan Ball Publishers, Jeppetown, South Africa Ury W (1995) Conflict
p.(None): resolution amongst the Bushmen: lessons in dispute systems design.
p.(None): Harvard Negotiation Journal 11(4): 379–389
p.(None): Wynberg R. Schroeder D, Chennells R (2009) Indigenous peoples, consent and benefit sharing: lessons from the San-Hoodia
p.(None): Case. Berlin, Springer
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 8
p.(None): Good Practice to Counter Ethics Dumping
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract An ethics code is not enough to avoid ethics dumping. Ethics codes can inspire, guide and raise awareness of
p.(None): ethical issues, but they cannot, on their own, guarantee ethical outcomes; this requires a multifaceted approach. For
p.(None): research in resource-poor settings, engagement is crucial. Such engagement has been built into the Global Code of
p.(None): Conduct for Research in Resource-Poor Settings as a require- ment, but how can it be put into practice? An
p.(None): approach for ethical community engagement is presented in this chapter, which also includes suggestions
p.(None): for an accessible complaints mechanism. At the institutional level, we tackle the question of concluding fair
p.(None): research contracts when access to legal advice is limited. Throughout, at a broader level, we show how the four
p.(None): values of fairness, respect, care and honesty can be used to help guide decision-making and the practical appli- cation
p.(None): of the code.
p.(None):
p.(None): Keywords Community engagement · Complaints procedure · Research contracts · Values compass
p.(None):
p.(None):
p.(None): Introduction
p.(None):
p.(None): The Global Code of Conduct for Research in Resource-Poor Settings (GCC) is not enough to prevent ethics dumping1.
p.(None): While codes are necessary, they are not suffi- cient in themselves to ensure good governance (Webley and Werner
p.(None): 2008). For codes to be effective, researchers must know how to use them appropriately (Giorgini et al.
p.(None): 2015), and codes can be totally ineffective when badly implemented (Bowman 2000). The use of codes, especially new
p.(None): ones, invariably raises challenges of interpretation and implementation.
p.(None): The way that the GCC has been developed helps to minimize potential chal- lenges. For instance,
p.(None): implementation problems are lessened when the needs, values
p.(None):
p.(None):
p.(None): 1 The export of unethical research from a high-income setting to a resource-poor setting with weaker
p.(None): compliance structures or legal governance mechanisms.
p.(None):
p.(None): © The Author(s), under exclusive license to Springer Nature Switzerland AG 2019 89
p.(None): D. Schroeder et al., Equitable Research Partnerships, SpringerBriefs in Research and Innovation Governance,
p.(None): https://doi.org/10.1007/978-3-030-15745-6_8
p.(None):
p.(None): 90 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): and interests of all stakeholders,2 particularly those who are likely to be subject to the codes (Lawton 2004), are
p.(None): taken into account during development. This helps ensure that the code is aligned with real needs and has practical
p.(None): value. Hence the bottom-up approach that was taken during development, which has facilitated an “insider” perspective,
p.(None): should help to increase effectiveness and counter the view that ethics codes are no more than a bureaucratic
p.(None): tool imposed from above. Additionally, the GCC does not replicate existing codes, nor does it seek to replace them.
p.(None): Rather, the GCC can be viewed as complementary to other codes, and this helps to avoid the confusion that can arise
p.(None): when codes seem contradictory.
p.(None): However, even the most conscientiously developed codes are open to differences in interpretation, and researchers need
p.(None): an ethical foundation for making decisions about application in particular situations (Eriksson et al. 2008).
p.(None): Furthermore, codes must form part of a wider framework that also includes mechanisms for compliance, accountability and
p.(None): addressing legal concerns.
p.(None): This chapter seeks to address these issues with practical guidance for implemen- tation. We show how the four values of
p.(None): fairness, respect, care and honesty can serve as an ethical foundation for decision-making. Specifically, we highlight
p.(None): the impor- tance of ethical techniques for engagement with local communities and a complaints procedure which is
p.(None): accessible to highly vulnerable populations, and finally we sum- marize a resource built in parallel to the code: a
p.(None): fair research contracting tool.
p.(None):
p.(None):
p.(None): The Values as an Ethical Foundation
p.(None):
p.(None): The four values constitute the foundation for ethical research collaborations and can be applied in virtually any
p.(None): situation to guide decision-making. When researchers keep the values at the heart of their activities, they can
p.(None): recognize and respond to ethical challenges more effectively. This requires reflexivity3 on the part of the
p.(None): researchers such that they consciously and regularly “stand back” from their activi- ties to ask whether their
p.(None): activities are aligned with the values. At any stage research- ers must ask themselves: Am I behaving with fairness,
p.(None): respect, care and honesty? We call this practical application of the values the “values compass” (see Fig. 8.1). The
p.(None): compass can be used continually as a tool for ethical reflection, but is par- ticularly helpful at key stages of the
p.(None): research process when important decisions are
p.(None): made.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 2 As noted earlier, “stakeholders” is an increasingly contested term, as it may imply that all parties hold an equal
p.(None): stake. Some prefer the term “actors”, yet this brings its own complexities. While acknowledging the debate, we use the
p.(None): well-established term “stakeholders” throughout.
p.(None): 3 “Reflexivity” can be thought of as a researcher’s ongoing critical reflection upon his or her own biases and
p.(None): assumptions and how these impact upon their relationship to the research, the course of the research and knowledge
p.(None): production.
p.(None):
p.(None): Ethical Engagement with Communities
p.(None): 91
p.(None):
p.(None): Fig. 8.1 The values compass
p.(None): FAIRNESS
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): HONESTY
p.(None):
p.(None):
p.(None):
p.(None): Values compass
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): CARE
p.(None):
p.(None):
p.(None):
p.(None): RESPECT
p.(None):
p.(None):
p.(None): In the following sections we show how the practical application of the values can help guide two important activities
p.(None): in collaborative research: community engage- ment and the development of an accessible complaints procedure.
p.(None):
p.(None):
p.(None): Ethical Engagement with Communities
p.(None):
p.(None): The term “community” is contentious and contextual, and can be difficult to define (Day 2006). For the purposes of this
p.(None): chapter, we use an early definition from the World Health Organization which describes a community as:
p.(None): A specific group of people, often living in a defined geographical area, who share a com- mon culture, values and
p.(None): norms, are arranged in a social structure according to relationships which the community has developed over a period of
p.(None): time. Members of a community gain their personal and social identity by sharing common beliefs, values and norms which
p.(None): have been developed by the community in the past and may be modified in the future (WHO 1998: 5)
p.(None): As we can infer from this definition, there are many different types of communi- ties and also communities within
p.(None): communities. For example, indigenous communi- ties, having a historical continuity with preinvasion and precolonial
p.(None): societies that developed on their territories, may consider themselves distinct from other sectors of the societies
p.(None): that now prevail on those territories, or parts of them. They generally form nondominant sectors of society and can be
p.(None): intent on preserving, developing and transmitting to future generations their ancestral territories and their
p.(None): ethnic identity, as the basis of their continued existence as peoples, in accordance with their own cultural patterns,
p.(None): social institutions and legal systems (Martínez Cobo
p.(None):
p.(None): 92 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): 2014). They often have particular relationships with advocacy groups who work to protect or represent their interests.4
p.(None): The concept of communities within communities also includes groups of people who are vulnerable because of a
p.(None): range of physical (disabilities, for example) or cultural (religion, for example) characteristics. For instance,
p.(None): sexXworkers, injecting drug users and men who have sex with men are often marginalized within their own broader
p.(None): communities.5 People from such groups are frequently sought for interna- tional research and yet the community at
p.(None): large or the community leaders are often unable to provide the input needed to ensure ethical management of
p.(None): research projects. Communities and their leaders may be unaware of the specific circumstances of these people and their
p.(None): lives, and they may even be openly hostile. We therefore need mechanisms for ensuring that the voice of
p.(None): marginalized and vulnerable populations is heard, and that their interests in research are represented.
p.(None): In the 1990s, community engagement assumed prominence as the new guiding light of public health efforts; research and
p.(None): health-improvement programmes that involved communities had better results than programmes led by government alone (NIH
p.(None): 2011). At the same time, the limitations of existing guidelines for the protec- tion of communities in genetic research
p.(None): was becoming increasingly apparent (Weijer et al. 1999). The benefits of community engagement in all types of research
p.(None): are now widely acknowledged, and numerous publications describe many potential benefits such as:
p.(None): • increasing community understanding and acceptance of the studies
p.(None): • enhancing researchers’ ability to understand and address community priorities
p.(None): • improving logistics and the running of studies
p.(None): • strengthening the quality of the information collected
p.(None): • ensuring culturally sensitive communications and research approaches
p.(None): • enhancing opportunities for capacity building (Hebert et al. 2009; Cook 2008; Bassler et al. 2008; Dunn 2011).
p.(None): Community engagement is an ethical imperative (a “must”) for researchers oper- ating globally. Research participants,
p.(None): their local communities and research partners in international locations should be equal stakeholders in the pursuit of
p.(None): research- related gains (Anderson et al. 2012). Ahmed and Palermo (2010) provide a salient definition of community
p.(None): engagement in research as
p.(None): a process of inclusive participation that supports mutual respect of values, strategies, and actions for authentic
p.(None): partnership of people affiliated with or self-identified by geographic proximity, special interest, or similar
p.(None): situations to address issues affecting the well-being of the community of focus.
p.(None): To be effective in international research, community engagement requires the development of partnerships with
p.(None): “local” stakeholders (for example, national,
p.(None):
p.(None): 4 Advocacy groups (also known as pressure groups, lobby groups, campaign groups, interest groups or special interest
p.(None): groups) use various forms of advocacy in order to influence public opinion and/ or policy.
...
p.(None): In health research, has post-study access to successfully tested treatments or interventions been agreed?
p.(None): Where relevant, have means for recognizing and protecting traditional knowledge been agreed?
p.(None): How is full transparency in all aspects of the engagement and planning being ensured?
p.(None): Are procedures for open, two-way communication in place?
p.(None): Have all details that might impact upon individuals or the community been disclosed?
p.(None): Have requirements for an accessible and user-friendly complaints mechanism been discussed and agreed? What promises are
p.(None): being made to the local community
p.(None): in the design of the study and are they likely to be
p.(None): fulfilled?
p.(None): Respect Care
p.(None):
p.(None): Are the research team complying with local/community ethics codes?
p.(None): How is community knowledge being
p.(None): How are local needs being taken into account in the design of the study?
p.(None): Is due attention being paid to the impact of the study
p.(None): respected and integrated into the design? and the study team upon the participants, their
p.(None): families, the local community and the environment?
p.(None):
p.(None): Are the relevant members of the community, as identified by the community itself, involved in the design?
p.(None): How is community culture and tradition being respected in the design of the study?
p.(None): Have the relevant persons in the community given permission/approval for the study design?
p.(None): What measures have been taken to ensure understanding (such as translators and the use of clear, non-technical
p.(None): language)
p.(None):
p.(None): Have the resource implications of this design for the local community been identified?
p.(None):
p.(None): What measures are in place to ensure that the research is high quality and worthwhile so that the efforts of the
p.(None): community are not wasted?
...
p.(None): Are appropriate steps being taken to recognize and protect traditional knowledge contributions?
p.(None): Have promises that were made about access to the results been fulfilled?
p.(None): Have all findings been disclosed in an honest manner?
p.(None): Respect Care
p.(None):
p.(None): Have the community been given an opportunity to review the results and implications of the study prior to publication?
p.(None): Have the community’s knowledge and contribution been fully acknowledged in the results?
p.(None): Have community culture and tradition been taken into consideration in the interpretation of the results?
p.(None): Have rights to privacy, anonymity and confidentiality in reporting been respected?
p.(None): What measures are in place to ensure that the findings and implications of the study are accessible to and fully
p.(None): understood by participants and the community?
p.(None):
p.(None): study and, in particular in the context of this report, of the community involvement elements. Table 8.5 lists
p.(None): important questions for the evaluation phase.
p.(None): When researchers apply the values of fairness, respect, care and honesty over the course of a research project, this
p.(None): creates a relationship of trust with the community. Our main advice for ethical community engagement is to build
p.(None): long-term, mutually beneficial relationships based on the four values, applied before, during and after research
p.(None): studies.
p.(None): In addition, for a relationship of trust to develop between researchers and local communities, it is important to have
p.(None): a well-functioning complaints procedure
p.(None):
p.(None):
p.(None): Developing an Accessible Complaints Procedure
p.(None):
p.(None): The routine use of accessible complaints procedures in research forms part of the overarching strategy for reducing
p.(None): ethics dumping, because such procedures can help to ensure that experience and practice correspond with
p.(None): expectations. An effec- tive complaints procedure can give voice to those who participate in research, offer- ing a
p.(None): channel for raising concerns that might otherwise remain unheard, both during and after a study. Complaints
p.(None): procedures can contribute to the safeguarding of
p.(None):
p.(None): 98 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): Table 8.5 Questions for reflection during the evaluation of a study
p.(None): Fairness Honesty
p.(None):
p.(None): Have the agreed benefits for participation been realized?
p.(None): In health research, is the agreed
p.(None): post-study access to successfully tested treatments or interventions being made available?
p.(None): How have the community been involved in the evaluation of the research findings?
p.(None): How have the community been involved in the evaluation of the research process?
p.(None): Do the community believe that they have benefited from the research?
p.(None): Have all promises to the community been fulfilled? How have complaints been managed? Are there lessons to be learned
p.(None): and shared?
p.(None): Have implications that might impact upon individuals or the community, including potential harms and benefits, been
p.(None): disclosed?
p.(None): Respect Care
p.(None):
p.(None): Are there mechanisms in place to feedback news about broader impacts of the research?
p.(None): Has the contribution of members of the
p.(None): Do the community believe that researchers paid due attention to the impact of the study and the study team upon the
p.(None): participants, their families, the local community and the environment?
p.(None): local community been fully credited? Was the resulting project of high quality and
p.(None):
p.(None): Have the community’s knowledge and its value to the research been fully credited?
p.(None): Do the community believe that local culture and tradition have been respected?
p.(None): worthwhile so that the efforts of the community were not wasted?
p.(None):
p.(None): participants7 so that it endures beyond the ethical approval process; they offer a mechanism for
p.(None): correcting mistakes and for protecting people, animals and the envi- ronment from abuse and mistreatment.
p.(None): Significantly, complaints mechanisms offer a means of revealing lapses and failures in ethical conduct, thereby
p.(None): providing oppor- tunities for enhancing ethical compliance in research (Fig. 8.2).
p.(None): Researchers, research organizations and research ethics committees (RECs) can go to great lengths to ensure that
p.(None): research protocols are scientifically rigorous and that research is conducted in accordance with the relevant
p.(None): ethical principles. However, even when the greatest care is taken, unexpected events can occur and participation can
p.(None): lead to emotional and/or physical harm. While most RECs will specify the need for an identified contact person in case
p.(None): of queries or complaints, this commonly takes the form of basic contact details on a participant information sheet,
p.(None): often in the form of an email address. Where further information is given, it
p.(None):
p.(None):
p.(None): 7 “Participation” is referred to here in its broadest sense to include experimental research animals and environments,
p.(None): as well as human research participants, local communities and researchers.
p.(None):
p.(None): Developing an Accessible Complaints Procedure
p.(None): 99
p.(None):
p.(None):
p.(None):
p.(None): Gives voice
p.(None):
p.(None):
p.(None):
p.(None): Aligns experience with expectation
p.(None):
p.(None): Reveals ethical challenges
p.(None):
p.(None): Complaints
p.(None): procedure
p.(None):
p.(None):
p.(None):
p.(None): Enhances ethical compliance
p.(None):
p.(None): Safeguards participants
p.(None):
p.(None):
p.(None): Corrects mistakes
p.(None):
p.(None):
p.(None):
p.(None): Fig. 8.2 The functions of an effective complaints procedure
p.(None):
p.(None): frequently stipulates that all complaints must be made in writing. The requirement to complain in writing via email
p.(None): might preclude complaints from the most vulner- able research participants.
p.(None): For collaborative research undertaken in resource-poor settings, especially low and middle-income countries (LMICs),
p.(None): the accessibility of a complaints procedure may be affected by many factors that are unfamiliar to researchers from a
p.(None): high- income country (HIC). A concerted effort is therefore required to understand local needs and preferences so that
p.(None): a complaints mechanism can be implemented that is both user-friendly and fit for purpose.
p.(None):
p.(None):
p.(None): Factors Affecting Accessibility
p.(None):
p.(None): It is known from studies in the field of dispute resolution that people often feel reluctant to make
p.(None): complaints and that this can be related to a variety of complex factors. In 2009 the Health Professions
p.(None): Council in the UK published a
p.(None):
p.(None): 100 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): comprehensive scoping review of existing mechanisms for complaints about health professionals (HPC 2009). In this
p.(None): report, the HPC describes a range of factors that can act as barriers to making a specific complaint. As there are no
p.(None): equivalent publi- cations about complaints procedures in LMICs, we summarize here the factors that are relevant to
p.(None): research in LMICs.
p.(None): Readiness to complain in any environment can be influenced by gender, ethnic- ity, age, education, income,
p.(None): accessibility of information and the perceived “serious- ness” of the problem (Pleasence et al. 2006).
p.(None): Specifically, ethnic minority communities are less likely to use systems that they perceive as being culturally
p.(None): insensitive and are more fearful of the consequences of taking action when they feel those systems have failed them.
p.(None): Difficulties with accessXtoXinformation are highlighted as a barrier to making a complaint (Henwood et al. 2003),
p.(None): especially where there is “information illiteracy”; some people possess the relevant skills and confidence to seek out
p.(None): information, but many do not. In situations where levels of education and literacy are not high, this is likely to be
p.(None): exacerbated.
p.(None): The relationship between the person who brings the complaint and the bureau- cracies to which they must direct
p.(None): their complaint can be a factor (Cowan and Halliday 2003). This relationship can either encourage or
p.(None): discourage a potential complainant’s trust in complaints mechanisms. The power imbalance between par- ties in such
p.(None): relationships can be substantial. For example, when working with impoverished communities, HIC researchers
p.(None): should be aware that participation in a clinical study may provide a participant’s only access to health care or other
p.(None): much- needed benefits. Fear of retribution is often cited as a barrier to making a complaint, particularly in
p.(None): circumstances where the complainant has an ongoing relationship with the complainee (HPC 2009). In situations where
p.(None): there is a power imbalance, people may not have the confidence to complain; they may be reluctant to seem ungrateful,
p.(None): not wish to be seen as a complainer, or fear loss. Research has shown that some people even reconstruct negative
p.(None): experiences in a positive light in order to maintain relationships (Edwards et al. 2004).
p.(None): In addition to the above, participatory engagement activities in the TRUST proj- ect (Chapter 6) have revealed the
p.(None): following factors that could also act as barriers to research participants making complaints about research activities
p.(None): in LMICs:
p.(None): • Fear of damage or stigmatization from loss of confidentiality or anonymity. In Kenya, for example, where sexXwork
p.(None): is illegal, sexXworkers may be reluctant to make any formal complaints.
p.(None): • Cultural norms that preclude complaining. In some cultures, it is not acceptable to make complaints, especially
p.(None): to or about visitors and/or those in authority. Complaining may be perceived as disrespectful, ungrateful or
p.(None): inappropriate.
p.(None): • Illiteracy of research participants and communication (language) difficulties, leading to a lack of
p.(None): understanding of reasonable rights relating to informed con- sent and to reasonable expectations of the research.
p.(None):
p.(None): Developing an Accessible Complaints Procedure 101
p.(None):
p.(None): • Inability to access the means by which to file a complaint: for example, if only an email address is provided as a
p.(None): contact and one has no access to computers or internet connections.
p.(None):
p.(None):
p.(None): The Scope of a Complaints Procedure
p.(None):
p.(None): A comprehensive complaints procedure can have a broad scope; it can be used to complain about any activities that are
p.(None): associated with a research study. These may include, for example:
p.(None): • any perceived deviation from the information provided
p.(None): • any deviation from agreed processes
p.(None): • treatment by members of the research team that is considered inappropriate
p.(None): • problems with the organization of the study (for example, the competence of the researchers and their ability to
p.(None): perform duties)
p.(None): • the (mis)handling of personal or sensitive information
p.(None): • concerns about any unethical behaviour or practices by the research team
p.(None): The scope of a complaints procedure will also depend upon the intended users. Many complaints procedures are intended
p.(None): for use purely by participants in a research study. However, in collaborative ventures in LMICs, there may be a wide
p.(None): range of potential users, because HIC-LMIC collaborative research is especially prone to ethics dumping, with
p.(None): the potential for damage to entire communities.
p.(None): Table 8.6 gives examples of the potential range of users of complaints procedures for different types of research
p.(None): studies.
p.(None): While a complaints procedure can have broad scope, it is vital that there be clar- ity about its purpose and who can
p.(None): use it, as well as about what can and cannot be dealt with through this mechanism. A lack of common understanding of
p.(None): any proce- dure’s purpose can be a source of great dissatisfaction and cause wider distrust in the process.
p.(None):
p.(None):
p.(None): Table 8.6 Potential users of complaints procedures in different types of research
p.(None): Agricultural
p.(None): Social science Clinical trials Animal experimentation research
p.(None): Research participants Research participants Local community Local farmers Local community
p.(None): Local community Local researchers Broader local
p.(None): community
p.(None): Local researchers Local researchers Local animal handlers Local researchers
p.(None):
p.(None): Local research organizations
p.(None): Local research organizations
p.(None): Local animal research centres
p.(None):
p.(None): 102 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): A Values-Based Approach to Developing a Complaints Procedure
p.(None):
p.(None): A complaints procedure that works perfectly well in one location and for one pur- pose cannot simply be transposed to a
p.(None): different situation without due consideration of its applicability. Local relevance and accessibility are vital keys in
p.(None): the design of an effective complaints procedure. Rather than a formally laid-down set of “rules” for complaints
p.(None): procedures, a strategic values-based approach needs to be imple- mented to deal with different levels and types of
p.(None): complaints, so that individuals and communities feel respected, cared for, fairly treated, fully informed and empow-
p.(None): ered. The four values can provide a framework for the development of an appropri- ate procedure, as shown in Table 8.7.
p.(None): Any complaints procedure for a research study involving LMIC populations, especially vulnerable groups or
p.(None): communities, must first consider the circumstances, situation and culture of such communities and the individuals to be
p.(None): recruited to the study. A critical step in this process is engagement with the community that will be
p.(None):
p.(None):
p.(None):
p.(None): Table 8.7 Values-based considerations for the development of a complaints procedure
p.(None): Fairness Respect
p.(None): Responses to complaints should be timely The procedure for complaints should be respectful
p.(None):
p.(None): All complaints should be taken seriously
p.(None): of local needs and preferences
p.(None): and investigated fully Appropriate levels of confidentiality and privacy
p.(None):
p.(None): Records of complaints and responses should be maintained to enable reporting and monitoring of complaints
p.(None): The nature and types of redress should be acceptable to the local community
p.(None): The lodging of honest complaints should be encouraged, and even facilitated, in order to overcome power imbalances.
p.(None): should be maintained throughout the procedure (including for all documentation, investigations, discussions and
p.(None): hearings)
p.(None): Researchers and/or appropriate staff should be fully equipped and trained for implementation of the complaints
p.(None): procedure.
p.(None): Honesty Care
p.(None):
p.(None): The purpose and limitations of the complaints procedure should be clearly communicated to all involved in the research
p.(None): The process for making a complaint should be clearly communicated to all involved in the research
p.(None): This process should be as simple and straightforward as possible
p.(None): The local community should be involved at an early stage in the development of the complaints procedure
p.(None):
p.(None): Advice should be taken from the local community about the accessibility and viability of the complaints procedure. This
p.(None): may mean offering a range of methods for information sharing and complaint acceptance – verbal, written, and through
p.(None): trusted spokespersons and community groups etc.
p.(None):
p.(None): A Fair Research Contracting Tool
p.(None): 103
p.(None):
p.(None): involved with or affected by the research so that they can help guide the develop- ment of appropriate procedures.
p.(None): Additionally, strategies8 will need to be developed for dealing with different types of complaints. It is
p.(None): important to try to avoid complex and overly burdensome strategies which all too easily become legalistic and
p.(None): formalized. In practice this can mean that nothing is set up at all, or that what is established becomes little more
p.(None): than an ineffective bureaucratic exercise. While more formal approaches and struc- tures may work in “Western”
p.(None): settings, these are unlikely to be effective in the kinds of vulnerable communities where care is needed to safeguard
p.(None): and empower; they may even have the opposite effect, and discourage any engagement at all on com- plaints issues.
p.(None): Equally, the challenges in establishing an effective strategy should not act as an excuse for researchers to adopt an
p.(None): oversimplified model (such as a contact name on the information sheet) that is of little or no benefit to anyone. For
p.(None): each unique situ- ation, researchers should work with communities to cocreate effective strategies that take
p.(None): into account the circumstances, situation and culture of that community and the individuals to be recruited to the
p.(None): study.
p.(None): While it is not possible for us to specify a single “model” complaints procedure, we have shown how the values can
p.(None): provide the basis of any complaints procedure. With these values embedded in the thinking of the research community,
p.(None): they can then seek to work with whatever procedures and structures are available, adapting, improving and tailoring
p.(None): them for application in the real world. The individuals and groups involved should feel respected, cared for, fully
p.(None): informed, treated fairly and empowered.
p.(None): Most protective mechanisms, including complaints procedures, are strengthened when supported by legal systems, but
p.(None): participants, communities, researchers and institutions in LMICs often have no or very limited access to legal advice
p.(None): or protec- tion. The next section introduces an online toolkit that will be helpful in such situations.
p.(None):
p.(None):
p.(None): A Fair Research Contracting Tool
p.(None):
p.(None): The need for fair research contracts is best illustrated by the situation in interna- tional collaborative health
p.(None): research. Research undertaken in LMICs can lead to sig- nificant benefits flowing into HICs. In 2009, Glickman et al.
p.(None): undertook a systematic review to examine what had led to a “dramatic shift in the location of clinical trials” and
p.(None): concluded that important factors were:
p.(None): • shortened timelines for clinical testing due to a larger pool of research participants
p.(None):
p.(None): 8 These might include internal resolution through study-specific schemes; internal resolution through research
p.(None): ethics committees; litigation through the courts; or alternative dispute resolution mechanisms such as mediation,
p.(None): adjudication and arbitration.
p.(None):
p.(None): 104 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): • lower regulatory barriers for research in LMICs
p.(None): • international harmonization of intellectual property rights protection
p.(None): To take full advantage of the benefits of conducting medical research in LMICs, research institutions in HICs have
p.(None): invested substantially in building legal and con- tracting expertise for the benefit of their own institutions and
p.(None): stakeholders. Such expertise may not be as easily available in LMIC institutions. As a result, the benefits of research
p.(None): collaborations remain heavily skewed towards the beneficiaries based in HICs (Sack et al. 2009).
p.(None): In 2011 the Council on Health Research for Development (COHRED) commit- ted itself to launching its Fair Research
p.(None): Contracting (FRC) initiative to support LMIC partners when negotiating equitable research partnerships. FRC
p.(None): aimed to identify best practices for the research contracting process that would be useful in the following three
p.(None): scenarios:
p.(None): • where there is no lawyer
p.(None): • where there may be lay personnel who could be trained
p.(None): • where there is a lawyer or legal expertise
p.(None): A basic framework was subsequently developed by COHRED and partners to assist LMIC collaborators in making
p.(None): contractual demands on HIC collaborators without requiring large legal teams of their own. This focused on the fair
p.(None): distribu- tion of post-research benefits, intellectual property rights, data and data ownerships, specimen ownership
p.(None): and usage, technology transfer and institutional capacity build- ing as key outcomes of the FRC process. Between 2015
p.(None): and 2018, and as part of the TRUST project, the existing FRC framework was enhanced and expanded to pro- vide an online
p.(None): toolkit relevant for all types of research.
p.(None): The FRC online toolkit9 now provides information, tips and case studies in six key areas:
p.(None): • Negotiation strategies: for understanding the various aspects of negotiations, whether a research partner
p.(None): is at a basic starting point or an advanced level in the development of contract negotiations
p.(None): • Research contracting: for a basic understanding of contracts and contracting so that a research partner can better
p.(None): manage responsibilities, opportunities and risks that impact the research partnership
p.(None): • Research data: providing the essential principles concerning rights and responsi- bilities, including
p.(None): accountability and access to data in collaborative research
p.(None): • Intellectual property: providing an introduction to some of the key general prin- ciples that require
p.(None): consideration before participation in collaborative research agreements
p.(None): • Research costing: providing research partners with a basic understanding of cost considerations when developing a
p.(None): full cost research budget proposal
p.(None):
p.(None):
p.(None):
p.(None): 9 The entire online toolkit is available at http://frcweb.cohred.org/
p.(None):
p.(None): Conclusion
p.(None): 105
p.(None):
p.(None): • Technology transfer and capacity: concerning the flow of knowledge, experience and materials from one partner to
p.(None): another, and the ability of people and organiza- tions to manage their affairs and reach objectives successfully.
p.(None): The development of this resource means that vulnerable groups, such as com- munities or researchers without legal
p.(None): support, have access to resources that can help develop a good understanding of research contracting for equitable
p.(None): research part- nerships and avoid exploitation in research.
p.(None):
p.(None):
p.(None): Conclusion
p.(None):
p.(None): According to Eriksson et al. (2008), a serious flaw in most new ethics guidelines is that they are produced with the
p.(None): pretension that there are no other guidelines in exis- tence, and it would be much better if they just stated what they
p.(None): added to existing guidelines. Such is the case with the GCC, which focuses solely on factors that are specific to
p.(None): collaborative research ventures in resource-poor (primarily LMIC) set- tings. The GCC is succinct and written in plain
p.(None): language; it is meant to be equally accessible to researchers in HICs and to their intended partners in LMICs. In these
p.(None): respects, the GCC is very straightforward, but its simplicity will inevitably generate questions about how it should be
p.(None): implemented.
p.(None): For example, article 13 of the GCC states that a clear procedure for feedback, complaints or allegations of
p.(None): misconduct must be offered that gives genuine and appropriate access to all research participants and local
p.(None): partners to express any con- cerns they may have with the research process. Aside from the injunction that the
p.(None): procedure must be agreed with local partners at the outset of the research, there is no guidance on what this procedure
p.(None): should look like. This “thin approach” was used for a reason: no complaints mechanism will fit all situations. Hence,
p.(None): the emphasis is on the process, namely to agree with local partners on an approach. Codes are not enough in themselves
p.(None): to ensure ethical conduct; they need buy-in from all those involved, and such buy-in needs to be generated
p.(None): through effective engagement mechanisms.
p.(None): Researchers should therefore see community engagement as the gateway to effective implementation of the GCC.
p.(None): For example, when considering the local rel- evance of the proposed research (article 1), who better to ask than
p.(None): members of the local community? When wondering how best to seek informed consent, who better to ask than members of the
p.(None): local community? Consultation with the community offers the most direct route to addressing questions about
p.(None): implementation and to realizing the essence of the GCC: a global collaborative effort to eradicate ethics dumping.
p.(None):
p.(None): 106 8 Good Practice to Counter Ethics
p.(None): Dumping
p.(None):
p.(None): References
p.(None):
p.(None): Ahmed SM, Palermo AGS (2010) Community engagement in research: frameworks for educa- tion and peer review. American
p.(None): Journal of Public Health 100(8):1380–1387. https://doi. org/10.2105/AJPH.2009.178137
p.(None): Anderson EE, Solomon S, Heitman E, DuBois JM, Fisher CB, Kost RG, Ross LF (2012) Research ethics education for
p.(None): community-engaged research: a review and research agenda. Journal of Empirical Research on Human Research Ethics
p.(None): 7(2):322–319
p.(None): Bassler A, Brasier K, Fogel N, Taverno R (2008) Developing effective citizen engagement: a how- to guide for community
p.(None): leaders. Center for Rural Pennsylvania, Harrisburg PA. http://www.
p.(None): rural.palegislature.us/effective_citizen_engagement.pdf
p.(None): Bowman JS (2000) Towards a professional ethos: from regulatory to reflective codes. International Review of
p.(None): Administrative Sciences 66:673–687
p.(None): Cook WK (2008) Integrating research and action: a systematic review of community-based par- ticipatory research to
p.(None): address health disparities in environmental and occupational health in the United States. Journal of Epidemiology and
p.(None): Community Health 62(8):668–676. https://doi. org/10.1136/jech.2007.067645
p.(None): Cowan D, Halliday S (2003) The appeal of internal review: law, administrative justice and the (non-) emergence of
p.(None): disputes. Hart, Oxford
p.(None): Day G (2006) Community and everyday life. Routledge, London
p.(None): Dunn A (2011) Community engagement: under the microscope. Wellcome Trust, London Edwards C, Staniszweska S, Crichton N
p.(None): (2004) Investigation of the ways in which patients’ reports
p.(None): of their satisfaction with healthcare are constructed. Sociology of Health and Illness 26(2):159 Eriksson S, Höglund
p.(None): AT, Helgesson G (2008) Do ethical guidelines give guidance? A critical examination of eight ethics
p.(None): regulations. Cambridge Quarterly of Healthcare Ethics 17(1):15–29 Giorgini V, Mecca JT, Gibson C, Medeiros K, Mumford
p.(None): MD, Connelly S, Devenport LD (2015) Researcher perceptions of ethical guidelines and codes of conduct. Accountability
p.(None): in Research
p.(None): 22(3):123–138
p.(None): Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, Schulman KA (2009) Ethical and
p.(None): scientific implications of the globalization of clinical research. New England Journal of Medicine 360:816–823.
p.(None): https://doi.org/10.1056/NEJMsb0803929
p.(None): Hebert JR, Brandt HM, Armstead CA, Adams SA, Steck SE (2009) Interdisciplinary, translational, and community-based
p.(None): participatory research: finding a common language to improve can- cer research. Cancer Epidemiology, Biomarkers
p.(None): & Prevention 18(4):1213–1217. https://doi. org/10.1158/1055-9965.EPI-08-1166
p.(None): Henwood F, Wyatt S, Hart A, Smith, J (2003) Ignorance is bliss sometimes: constraints on the emergence of the
p.(None): “informed patient” in the changing landscapes of health information. Sociology of Health and Illness
p.(None): 25(6):589–607
p.(None): HPC (2009) Scoping report on existing research on complaints mechanisms. Health
p.(None): Professions Council. https://www.hcpc-uk.org/resources/reports/2009/
p.(None): scoping-report-on-existing-research-on-complaints-mechanisms/
p.(None): Jones L, Wells K (2007) Strategies for academic and clinician engagement in community- participatory
p.(None): partnered research. Journal of the American Medical Association 297(4):407–410 Lawton A (2004) Developing and
p.(None): implementing codes of ethics. Viešoji politika ir administravi-
p.(None): mas 7:94–101
p.(None): Martínez Cobo M (2014) Study on the problem of discrimination against indigenous populations. United Nations Department
p.(None): of Economic and Social Affairs. https://www.un.org/development/
p.(None): desa/indigenouspeoples/publications/2014/09/martinez-cobo-study/
p.(None): NIH (2011) Principles of community engagement. Washington, DC: CTSA Community Engagement Key
p.(None): Function Committee Task Force on the Principles of Community Engagement, National Institutes of Health.
p.(None): https://www.atsdr.cdc.gov/communityengagement/ pdf/PCE_Report_508_FINAL.pdf
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p.(None): References
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p.(None): Stationery Office, Norwich
p.(None): Sack DA, Brooks V, Behan M, Cravioto A, Kennedy A, IJsselmuiden C, Sewankambo N (2009) Improving international research
p.(None): contracting. WHO Bulletin 87:487–488
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p.(None): Weijer C, Goldsand G, Emanuel EJ (1999) Protecting communities in research: current guidelines and limits of
p.(None): extrapolation. Nature Genetics 23(3):275
p.(None): WHO (1998) Health promotion glossary. World Health Organization, Geneva. http://www.who.
p.(None): int/healthpromotion/about/HPR%20Glossary%201998.pdf, page 5.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Chapter 9
p.(None): Towards Equitable Research Partnership
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Abstract The world’s largest collection of professional ethics codes already holds more than 2,500 codes. What can
p.(None): the Global Code of Conduct for Research in Resource-Poor Settings (GCC) add? This brief chapter gives
p.(None): co-authors and sup- porters of the GCC the opportunity to show why a code with the single-minded aim of eradicating
p.(None): ethics dumping is needed.
p.(None):
p.(None): Keywords Global ethics · Research ethics · International co-operation · Ethics dumping · Low- and middle-income
p.(None): countries
p.(None):
p.(None):
p.(None): The world’s largest collection of professional ethics codes holds more than 2,500 codes (IIT nd). Is another ethics
p.(None): code really needed? The evidence gathered on the 21st-century export of unethical research practices from
p.(None): high-income to lower- income settings says it is (Schroeder et al. 2018). Such ethics dumping still occurs despite a
p.(None): proliferation of ethics codes. This could be for either of two main possible reasons. First, an ethics code designed to
p.(None): guard against ethics dumping is not yet available. Second, ethics codes are not suitable for guarding against ethics
p.(None): dumping. We would agree with the first, but not the second.
p.(None): Instead of summarizing the book, this chapter concludes by giving the floor to co-authors and supporters of the Global
p.(None): Code of Conduct for Research in Resource- Poor Settings (GCC) and the San Code of Research Ethics. Their statements
...
p.(None):
p.(None): 9 Towards Equitable Research Partnership
p.(None): 111
p.(None):
p.(None): Good practices know no regional or political boundaries: research that is unethi- cal in Europe is unethical in Africa.
p.(None): That’s why the GCC is needed. – Dr Michael Makanga (Ugandan), executive director of the European & Developing Countries
p.(None): Clinical Trials Partnership, co-author of the GCC
p.(None): The world is unfair. We are talking about R&D in an unfair world ... The Code of Conduct [GCC] is exquisitely clear
p.(None): that it is unethical to do research in one place for the sake of another. (TRUST 2018) – Professor Jeffrey Sachs
p.(None): (American), speaking at the GCC launch in the European Parliament
p.(None): The new four-values system around fairness, respect, care and honesty is highly appreciated in Asia. People find it
p.(None): intuitive – in fact, most audiences loved it. – Dr Vasantha Muthuswamy (Indian), president of the Forum
p.(None): for Ethics Review Committees in India, co-author of the GCC
p.(None): Zhai Xiaomei [Chinese], the executive director of the Centre for Bioethics at the Chinese Academy of Medical Sciences,
p.(None): in Beijing, who is also deputy director of the health ministry’s ethics committee, welcomes what TRUST2 has done.
p.(None): (Economist 2018)
p.(None): To deliver our mission to end world hunger, we need to undertake research. Applying the GCC will assist us
p.(None): greatly. No previous code was designed so clearly for work with highly vulnerable populations in resource-poor
p.(None): settings. – Myriam Ait Aissa (French), head of Research and Analysis at Action contre la Faim, co-author of the GCC
p.(None): Fairness, respect, care and honesty: four simple words with clear meaning to help researchers enter the house through
p.(None): the door and no longer through the win- dow.3 – Dr François Hirsch (French), former head of the Inserm (French
p.(None): National Institute of Health and Medical Research) Office for Ethics, co-author of the GCC
p.(None): Ron Iphofen [British], an adviser on research ethics to the European Commission, believes the code will have a profound
p.(None): impact on how funding proposals to the EU are designed and reviewed. “I could envisage reviewers [of EU-funded
p.(None): research proposals] now looking suspiciously at any application for funds that entailed research by wealthy
p.(None): nations on the less wealthy that did not mention the code,” he says. (Nordling 2018)
p.(None): The emphasis in the GCC on fairness, respect, care and honesty resonates with our work at UNESCO. – Dr Dafna
p.(None): Feinholz (Mexican), UNESCO’s chief of Bioethics and Ethics of Science and Technology, co-author of the GCC
p.(None):
p.(None):
p.(None):
p.(None): 2 The EU-funded consortium that developed the GCC.
p.(None): 3 This refers to Andries Steenkamp’s iconic request to researchers, namely to enter San communi- ties through the
p.(None): metaphorical “front door” – that is, the San Council – and not, like thieves, through the window.
p.(None):
p.(None): 112 9 Towards Equitable Research
p.(None): Partnership
p.(None):
p.(None): TRUST was a game changer.4
p.(None): Ethics dumping is a real threat to the quality of science and the GCC is now a mandatory reference document for EU
p.(None): framework program funding to guard against it. – Dorian Karatzas (Greek), head of Ethics and Research Integrity,
p.(None): European Commission
p.(None): Best science for the most neglected, also means best ethical standards. That’s why the GCC aims high: to protect the
p.(None): most neglected. – Dr François Bompart (French), director of Paediatric HIV/Hepatitis C Programmes at the Drugs
p.(None): for Neglected Diseases initiative (DNDi), former vice president, Access to Medicines at Sanofi, co-author of the GCC
p.(None): We get given consent forms and documents, often in a hurry. We sign because we need the money and then end up with
p.(None): regret. It feels like a form of abuse. They want something from us and they know how to get it. Because of our
p.(None): socio-economic conditions, we will always be vulnerable to those from the North. A code of ethics is needed that
p.(None): protects indigenous people.5 – Andries Steenkamp (1960–2016) (South African), former chair of the South African
p.(None): San Council, co-author of both codes
p.(None): I don’t want researchers to see us as museums who cannot speak for themselves and who don’t expect something in return.
p.(None): As humans, we need support.6 – Reverend Mario Mahongo (1952–2018) (Angolan), co-author of both codes
p.(None): We want to be treated by researchers with fairness, respect, care and honesty. Is that too much to ask?7 – Joyce
p.(None): Adhiambo Odhiambo (Kenyan), health activist and former sexXworker, co-author of the GCC
p.(None): Indeed, is that too much to ask?
p.(None):
p.(None):
p.(None): References
p.(None):
p.(None): Burtscher W (2018) TRUST Global Code of Conduct to be a reference document applied by all research projects applying
p.(None): for H2020 funding. TRUST eNewsletter Issue 5. http://www.global-
p.(None): codeofconduct.org/wp-content/uploads/2018/12/TRUSTNewsletter_2018_Issue5.pdf
p.(None): Economist (2018) Recent events highlight an unpleasant scientific practice: ethics dumping. The Economist, 31
p.(None): January. https://www.economist.com/science-and-technology/2019/02/02/
p.(None): recent-events-highlight-an-unpleasant-scientific-practice-ethics-dumping
p.(None): IIT (nd) The ethics codes collection. Center for the Study of Ethics in the Professions, Illinois Institute of
p.(None): Technology, Chicago. http://ethicscodescollection.org/
p.(None):
p.(None): 4 Opening words during European Commission ethics staff training on the GCC, 3 Dec 2019, Covent Garden
p.(None): Building, Brussels.
p.(None): 5 Recorded message from Nairobi TRUST meeting, 23 May 2016.
p.(None): 6 Recorded video message from Kimberley TRUST meeting, Feb 2017.
p.(None): 7 European Parliament, TRUST event, 29 June 2018.
p.(None):
p.(None): References
p.(None): 113
p.(None):
p.(None): Nordling L (2018) Europe’s biggest research fund cracks down on “ethics dumping”. Nature 559:17–18.
p.(None): https://www.nature.com/articles/d41586-018-05616-w
p.(None): Schroeder D, Cook J, Hirsch F, Fenet S, Muthuswamy V (eds) (2018) Ethics dumping: case stud- ies from North-South
p.(None): research collaborations. Springer Briefs in Research and Innovation Governance, Berlin
p.(None): TRUST (2018) Major TRUST event successfully held at European Parliament. TRUST eNewsletter Issue
p.(None): 5. http://www.globalcodeofconduct.org/wp-content/uploads/2018/12/ TRUSTNewsletter_2018_Issue5.pdf
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
p.(None): (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
p.(None): any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link
p.(None): to the Creative Commons licence and indicate if changes were made.
p.(None): The images or other third party material in this chapter are included in the chapter’s Creative Commons licence, unless
p.(None): indicated otherwise in a credit line to the material. If material is not included in the chapter’s Creative Commons
p.(None): licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
p.(None): obtain permission directly from the copyright holder.
p.(None):
p.(None): Appendix
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Global Code of Conduct for Research in Resource-Poor Settings (GCC)
p.(None):
p.(None): Authors and Sources of Inspiration
p.(None): Lead Author: Doris Schroeder University of Central Lancashire, UK Authors in alphabetical order:
p.(None): • Joyce Adhiambo Partners for Health and Development, Kenya
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| access to information | Access to information |
| age | Age |
| army | Soldier |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| belief | Religion |
| breastfeeding | breastfeeding |
| child | Child |
| children | Child |
| coerced | Presence of Coercion |
| control group | participants in a control group |
| crime | Illegal Activity |
| criminal | criminal |
| culturally | cultural difference |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| emergency | Public Emergency |
| employees | employees |
| ethnic | Ethnicity |
| family | Motherhood/Family |
| gender | gender |
| home | Property Ownership |
| hunger | Food Insecurity |
| illegal | Illegal Activity |
| illiterate | Literacy |
| illness | Physically Disabled |
| indigenous | Indigenous |
| influence | Drug Usage |
| jail | Incarcerated |
| job | Occupation |
| language | Linguistic Proficiency |
| literacy | Literacy |
| manipulate | Manipulable |
| minor | Youth/Minors |
| minority | Racial Minority |
| mothers | Mothers |
| nation | stateless persons |
| native | Indigenous |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| philosophy | philosophical differences/differences of opinion |
| placebo | participants in a control group |
| police | Police Officer |
| political | political affiliation |
| poor | Economic/Poverty |
| poverty | Economic/Poverty |
| property | Property Ownership |
| race | Racial Minority |
| religion | Religion |
| religious | Religion |
| restricted | Incarcerated |
| rural area | people living in remote/rural area |
| sex work | sex worker |
| sex worker | sex worker |
| sex workers | sex worker |
| single | Marital Status |
| social goods | Access to Social Goods |
| stem cells | stem cells |
| stigma | Threat of Stigma |
| stigmatization | Threat of Stigma |
| stigmatized | Threat of Stigma |
| substance | Drug Usage |
| threat | Threat of Stigma |
| undueXinfluence | Undue Influence |
| union | Trade Union Membership |
| usage | Drug Usage |
| volunteers | Healthy People |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| access | ['socialXgoods'] |
| belief | ['religion', 'religious'] |
| child | ['children'] |
| children | ['child'] |
| control group | ['placebo'] |
| crime | ['illegal'] |
| drug | ['influence', 'substance', 'usage'] |
| education | ['educational'] |
| educational | ['education'] |
| home | ['property'] |
| illegal | ['crime'] |
| illiterate | ['literacy'] |
| indigenous | ['native'] |
| influence | ['drug', 'substance', 'usage'] |
| jail | ['restricted'] |
| literacy | ['illiterate'] |
| minority | ['race'] |
| native | ['indigenous'] |
| officer | ['police'] |
| opinion | ['philosophy'] |
| party | ['political'] |
| philosophy | ['opinion'] |
| placebo | ['controlXgroup'] |
| police | ['officer'] |
| political | ['party'] |
| poor | ['poverty'] |
| poverty | ['poor'] |
| property | ['home'] |
| race | ['minority'] |
| religion | ['belief', 'religious'] |
| religious | ['belief', 'religion'] |
| restricted | ['jail'] |
| sex work | ['sexXworker', 'sexXworkers'] |
| sex worker | ['sexXwork', 'sexXworkers'] |
| sex workers | ['sexXwork', 'sexXworker'] |
| social goods | ['access'] |
| stigma | ['threat', 'stigmatization', 'stigmatized'] |
| stigmatization | ['stigma', 'threat', 'stigmatized'] |
| stigmatized | ['stigma', 'threat', 'stigmatization'] |
| substance | ['drug', 'influence', 'usage'] |
| threat | ['stigma', 'stigmatization', 'stigmatized'] |
| usage | ['drug', 'influence', 'substance'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
capacity
consent
cultural
developing
ethics
exploit
harm
justice
protect
protection
risk
sensitive
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input