0A4F4F9BD490A749D5437F821CF06DF1

GCC Book

https://link.springer.com/content/pdf/10.1007%2F978-3-030-15745-6.pdf

http://leaux.net/URLS/ConvertAPI Text Files/E00CE6F53C9625581C9CAEBAD452B608.en.txt

Examining the file media/Synopses/E00CE6F53C9625581C9CAEBAD452B608.html:

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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

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalIllegal Activitycrime1
PoliticalIllegal Activityillegal7
PoliticalIndigenousindigenous32
PoliticalIndigenousnative1
Politicalcriminalcriminal1
Politicalpolitical affiliationparty11
Politicalpolitical affiliationpolitical6
Politicalstateless personsnation1
Politicalvulnerablevulnerable43
Politicalvulnerablevulnerability8
HealthDrug Usagedrug6
HealthDrug Usageinfluence6
HealthDrug Usagesubstance5
HealthDrug Usageusage1
HealthHIV/AIDSHIV6
HealthHealthy Peoplevolunteers0
HealthMentally Disableddisability3
HealthMotherhood/Familyfamily2
HealthPhysically Disabledillness3
Healthbreastfeedingbreastfeeding1
Healthstem cellsstem cells1
SocialAccess to Social Goodssocial goods1
SocialAccess to Social Goodsaccess50
SocialAccess to informationaccess to information1
SocialAgeage2
SocialChildchild2
SocialChildchildren2
SocialEthnicityethnic4
SocialIncarceratedjail2
SocialIncarceratedrestricted4
SocialLinguistic Proficiencylanguage19
SocialLiteracyilliterate3
SocialLiteracyliteracy3
SocialMarital Statussingle9
SocialMothersmothers2
SocialOccupationjob6
SocialPolice Officerofficer2
SocialPolice Officerpolice1
SocialPresence of Coercioncoerced2
SocialProperty Ownershiphome4
SocialProperty Ownershipproperty13
SocialRacial Minorityminority1
SocialRacial Minorityrace1
SocialReligionbelief3
SocialReligionreligion1
SocialReligionreligious5
SocialSoldierarmy1
SocialThreat of Stigmastigma1
SocialThreat of Stigmathreat1
SocialThreat of Stigmastigmatization7
SocialThreat of Stigmastigmatized2
SocialTrade Union Membershipunion6
SocialVictim of Abuseabuse2
SocialWomenwomen3
SocialYouth/Minorsminor1
Socialeducationeducation5
Socialeducationeducational7
Socialemployeesemployees3
Socialgendergender6
Socialphilosophical differences/differences of opinionopinion1
Socialphilosophical differences/differences of opinionphilosophy17
Socialsex workersex work3
Socialsex workersex worker4
Socialsex workersex workers15
EconomicEconomic/Povertypoor46
EconomicEconomic/Povertypoverty16
EconomicFood Insecurityhunger2
General/OtherImpaired Autonomyautonomy18
General/OtherManipulablemanipulate1
General/OtherPublic Emergencyemergency4
General/OtherRelationship to Authorityauthority2
General/OtherUndue InfluenceundueXinfluence1
General/Othercultural differenceculturally6
General/Otherparticipants in a control groupcontrol group1
General/Otherparticipants in a control groupplacebo7
General/Otherpeople living in remote/rural arearural area1

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
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
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):
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p.(None):
p.(None):
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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
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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): 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): 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
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): 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):
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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):
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.
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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
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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.
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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:

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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:
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Health / Physically Disabled

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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
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Health / 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

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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
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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
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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
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
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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): 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):
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
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): 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
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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
...

Social / Access to information

Searching for indicator access to information:

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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

Searching for indicator 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
...

Social / Child

Searching for indicator child:

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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
...

Searching for indicator children:

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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
...

Social / Ethnicity

Searching for indicator ethnic:

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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
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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
...

Social / Mothers

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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
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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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Social / Police Officer

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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):
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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):
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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
...

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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
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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

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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-<