0A4F4F9BD490A749D5437F821CF06DF1
Ethics in Health Research
https://www.commerce.uct.ac.za/Downloads/Ethics%20in%20Health%20Research%20Final%20A%20used.pdf
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This file was generated: 2020-07-15 06:30:22
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000020: 3.1.4 Recruitment & enrolment
p.000020: 20
p.000020: 3.1.5 Research procedures
p.000021: 21
p.000021: 3.1.6 Risks of harm & likelihood of benefit 21
p.000021: 3.1.7 Reimbursements, inducements & costs for participants 22
p.000021: 3.1.8 Participants’ privacy & confidentiality interests 22
p.000021: 3.1.9 Obtaining informed consent 24
p.000021: 3.2 Vulnerability & incapacity
p.000026: 26
p.000026: 3.2.1 Contextual circumstances
p.000026: 26
p.000026: 3.2.2 Minors (children & adolescents) 27
p.000026: 3.2.3 Women
p.000035: 35
p.000035: 3.2.4 Adults with factual incapacity
p.000036: 36
p.000036: 3.2.5 Persons in dependent relationships 38
p.000036: 3.2.6 Patients highly dependent on medical care 38
p.000036: 3.2.7 Persons with physical disabilities
p.000038: 38
p.000038: 3.2.8 Prisoners
p.000039: 39
p.000039: 3.2.9 Collectivities
p.000040: 40
p.000040: 3.3 Data & biological material for research purposes 40
p.000040: 3.3.1 Introduction
p.000040: 40
p.000040: 3.3.2 Permitted usage of biological material 41
p.000040: 3.3.3 Identifiability of biological materials and data 41
p.000040: 3.3.4 Collection of biological materials and data 42
p.000040: 3.3.5 Restrictions on collection of biological material 42
p.000040: 3.3.6 Informed consent
p.000042: 42
p.000042: 3.3.7 Secondary use of material or data 43
p.000042: 3.3.8 Genetic research
p.000044: 44
p.000044: 3.3.9 Genomics research
p.000044: 44
p.000044: 3.3.10 Commercially available cell lines
p.000045: 45
p.000045: 3.4 Considerations specific to research methods or contexts 45
p.000045: 3.4.1 Major incidents & research
p.000045: 45
p.000045: 3.4.2 Intensive care research
p.000046: 46
p.000046: 3.4.3 Terminal care research
p.000047: 47
p.000047: 3.4.4 Traditional medicine research
p.000047: 47
p.000047: 3.4.5 Research involving deception or withholding information 48
p.000047:
p.000047: Ethics in Health Research 2nd edition
p.000019: 19
...
p.000027: imposed. Other measures may also be appropriate.
p.000027: Note that the decision to impose additional measures should flow from an assessment of the nature of the research and
p.000027: the circumstances of the potential participants. In other words, additional protective measures should not be automatic
p.000027: just because a vulnerable group will be recruited; rather, the decision should be based on the particular
p.000027: circumstances of the proposal before the REC. For example, an automatic assumption that impoverished people cannot
p.000027: choose responsibly whether to participate in research is disrespectful because it denies their autonomy.
p.000027: If compliance with the additional measures is poor and participants’ welfare is negatively affected,
p.000027: approval for the study may be withdrawn, temporarily or permanently, as the case may be.
p.000027: Groups of participants discussed here include
p.000027: • minors (children and adolescents)
p.000027: • women
p.000027: • adults with incapacity to provide informed consent
p.000027: • persons in dependent relationships
p.000027: • persons highly dependent on medical care
p.000027: • persons with physical disabilities
p.000027: • prisoners
p.000027: • collectivities
p.000027:
p.000027: Note this list is not exhaustive but provides an indication of the types of consideration to be applied
p.000027: 3.2.2 Minors (children and adolescents)
p.000027:
p.000027: Below the age of majority, the law protects young people from their own emotional, cognitive and physical immaturity
p.000027: and limited life experience through the legal status of minority. In other words, minors, i.e. persons under 18 years
p.000027: of age,22 are legally incapable of performing legal transactions without assistance from a parent or guardian. In the
p.000027: research context, this means that, in principle, anyone under the age of 18 years may not choose independently whether
p.000027: to participate in research; a parent or guardian must give permission for the minor
p.000027:
p.000027: 21 Note that this requirement does not mean that a REC may not approve a waiver of personal informed consent for types
p.000027: of research into e.g. record reviews or such like.
p.000027: 22 Section 28 of the Constitution; and s 17 of the Children’s Act 38 of 2005.
p.000027:
...
p.000039: benefit than that offered by standard care; and
p.000039: • participation is not contrary to the medical interests of the patient; and
p.000039: • the research interventions pose no more risk of harm than that inherent in the patient’s condition
p.000039: or alternative methods of treatment; and
p.000039: • the research is based on valid scientific hypotheses that support a reasonable possibility of more
p.000039: benefit than that offered by standard care; and
p.000039: • as soon as reasonably possible, the participant and her relatives or legal representatives
p.000039: will be informed of the participant’s inclusion in the research; be requested to give delayed consent;, and
p.000039: advised of the right to withdraw from the research without any reduction in quality of care.
p.000039: 3.2.7 Persons with physical disabilities
p.000039:
p.000039: Recruitment strategies for research participation in general should be sensitive to the possibility that
p.000039: persons with physical disabilities may wish to volunteer and therefore should ensure that there are no unintended
p.000039: barriers to such participation; e.g. the absence of ramps or a lift for wheelchair-bound potential participants.
p.000039: Research involving participants with physical disabilities should anticipate possible barriers and include
p.000039: measures to minimise them.
p.000039: 3.2.8 Prisoners
p.000039:
p.000039: The chief reason to consider prisoners as a vulnerable class of persons is the potential effect of incarceration on
p.000039: the voluntariness of the decision to participate in research. Neither coercion (direct threat of negative
p.000039: sanction) nor undue influence is acceptable in the informed consent process. Researchers should pay
p.000039: attention to whether their intended participants are awaiting trial prisoners or convicted prisoners. Quite
p.000039: obviously, different ethical issues arise for the former group who remain innocent until proven
p.000039: guilty, notwithstanding being incarcerated. The recruitment strategy design must pay careful attention to
p.000039: how coercion and undue influence will be avoided. Similarly, persons administering questionnaires
p.000039: or conducting interviews must be conscious of environmental factors that may influence voluntariness.
p.000039: The REC should include, at least on an ad hoc basis, a member with experience and knowledge of working
p.000039: with prisoners when deliberating on the protocol. The researchers must comply also with the requirements of
p.000039: the Department of Correctional Services as listed at http://www.dcs.gov.za/services/Research.aspx.
p.000039:
p.000039: 40 Ethics in Health Research 2nd edition
p.000039:
p.000039:
p.000039: Research should be conducted amongst prisoners only if
p.000039: • their participation is indispensable to the research
p.000039: • the research cannot be conducted with non-prisoners
p.000039: • the research concerns a problem of relevance to prisoners
p.000039: • sound informed consent processes can be ensured
p.000039: • engagement with relevant role players about the proposed research has occurred.
p.000039: In the case of minor prisoners, the limitations and restrictions on independent consent must be remembered. In general
p.000039: terms, it is unlikely that independent consent by the minors will be justifiable.
p.000039: 3.2.9 Collectivities i.e. persons participating in research as groups
p.000039:
p.000039: ‘Collectivity’ is a term used to distinguish some distinct groups from informal communities, commercial or social
p.000039: groups. Collectivities are groups distinguished by
p.000039: • common beliefs, values, social structures and other features that identify them as a separate group
p.000039: • customary collective decision-making according to tradition and beliefs
p.000039: • the custom that leaders express a collective view
p.000039: • members of the collectivity being aware of common activities and common interests. Research involves a
p.000039: collectivity when
p.000039: • property or information private to the group as a whole is studied or used
p.000039: • permission of people occupying positions of authority, whether formal or informal, is required
p.000039: • participation of members acknowledged as representatives is involved. Research involving collectivities should
p.000039: include measures to ensure
p.000039: • dispute resolution mechanisms for anticipated or actual disagreements between the researcher and the collectivity
p.000039: • respectful negotiation with the collectivity or its leaders
p.000039: • permission is sought from appropriate representatives of the collectivity to approach individual participants
p.000039: • an informed consent process for individual participants
...
Political / Illegal Activity
Searching for indicator crime:
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p.000033: REC approval of a waiver of the parental (or substitute) permission requirement. Engagement could include
p.000033: outreach to relevant role players such as canvassing the opinion of a representative body of parents e.g. via schools.
p.000033: • Factual evidence of such engagement must form part of the PI’s justification in the protocol. Factual evidence
p.000033: may be in the form of a letter from a relevant role player (like a community leader, school principal or a CAB)
p.000033: that confirms the view that independent consent is acceptable to the parents.
p.000033: • If the REC accepts the ethical justification and the factual evidence of parental support for
p.000033: independent choice by their minor children, then the REC may grant a waiver of the requirement of written
p.000033: parental permission and must document the process carefully.
p.000033:
p.000033:
p.000033: 28Note a caregiver, a foster parent and a schoolteacher or principal are not guardians.
p.000033:
p.000033: 34 Ethics in Health Research 2nd edition
p.000033:
p.000033:
p.000033: 3.2.2.5 Mandatory reporting obligations
p.000033: There is no general obligation to report either the commission of or the intention to commit a crime. However, if a
p.000033: researcher has information indicating that direct harm to another person may occur as a result of the intention to
p.000033: commit harm (e.g. a participant says ‘I’m going to kill her…’), then there may be an obligation, especially when the
p.000033: third person is known to the researcher. For specifically designated persons, there are statutory reporting
p.000033: obligations. (See Appendix 3 for SOP Template.)
p.000033: i. Reporting obligations for abuse and neglect
p.000033: The Children’s Act requires anyone who reasonably believes a child to be suffering physical abuse causing injury,
p.000033: deliberate neglect and sexual abuse to report this to a child protection agency, the provincial social development
p.000033: department, or to a police official.
p.000033: ii. Reporting obligations for under-age sexual activity
p.000033: The age at which minors can lawfully consent to sexual activity is 16 years, in terms of the Criminal Law (Sexual
p.000033: Offences and Related Matters) Amendment Act 32 of 2007 (Sexual Offences Act). Anyone with knowledge of a
p.000033: sexual offence against a minor is required to report this to a police official. In effect, any adult or person >16
p.000033: years who engages in sexual activity with a minor < 16 years commits a crime and may be prosecuted. The Act
p.000033: describes a broad range of sexual offences, including rape, sexual assault, sexual grooming, sexual
p.000033: exploitation, and use of children in pornography including photographs. This means that the range of activities
p.000033: that may constitute a sexual offence is extensive.
p.000033: The Sexual Offences Act differentiates between adolescents (12 - < 16 years) and older minors (16 and 17
p.000033: years). In the case of children younger than 12 years, sexual activity is unlawful even with consent. For adolescents,
p.000033: the situation is as follows. The Teddy Bear Clinic case 29 found criminalisation of consensual sexual acts
p.000033: between adolescents aged 12 – < 16 years to be unconstitutional, on the basis that adolescents should not be subjected
p.000033: to criminal sanctions when they exercise their entitlement to determine their personal relationships in light of their
p.000033: rights to autonomy, dignity and privacy. The Constitutional Court imposed a moratorium on action against adolescents in
p.000033: terms of ss 15 and 16 of the Sexual Offences Act. This moratorium of 18 months is to give Parliament time to revise the
p.000033: offending legislative provisions by April 2015.30
p.000033: Consensual sexual acts between adolescents aged 12 - < 16 years are not criminal and are not reportable. Sexual acts
...
Searching for indicator unlawful:
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p.000023: particular identifying information is required for the study that purports to collect data anonymously. RECs should
p.000023: assess whether notifiable activities might occur amongst participants, e.g. abuse of minors or notifiable diseases and,
p.000023: consequently, whether appropriate measures are in place and are explained in the research proposal. Furthermore, the
p.000023: REC must ensure that the required notification or reporting and its management are explained in the consent documents.
p.000023: Where focus groups are planned, RECs should check that the information for participants explains clearly
p.000023: that researchers cannot guarantee confidentiality because members of the focus group may disclose information
p.000023: outside the research setting, despite agreeing not to do so. For this reason, consent documentation should advise
p.000023: potential focus group participants not to disclose personally sensitive information, as the researcher cannot
p.000023: guarantee confidentiality, even if other participants are urged to respect confidentiality.
p.000023: The Protection of Personal Information Act 4 of 2013 was assented to on 19 November 2013. 13 This Act
p.000023: provides guidance on how the right to privacy regarding personal information is protected. It stipulates
p.000023: that the right to privacy includes ‘protection against unlawful collection, retention, dissemination and use of
p.000023: personal information’ (Preamble to Act). A tension between the right to privacy and the need for free flow of
p.000023: information in a society that seeks to make progress on economic, social, health care and educational fronts, is
p.000023: immediately evident. The Act does not appear to hold out negative implications for research activities
p.000023: that record personal information about research participants. However, special attention should be given to
p.000023: ensuring that computers and electronically stored data are protected from unauthorised access, inadvertent or
p.000023: accidental dissemination and distribution in form of a ‘data dump’, etc.
p.000023: Research activities are a legitimate purpose, provided that protective measures are adhered to. Thus researchers and
p.000023: RECs should pay careful attention to measures that will protect privacy and confidentiality interests.
p.000023: In general terms, a person should know what information is being collected, why it is being collected, what
p.000023: will happen to it, how long it will be retained, whether it will identify the person, whether it will be shared with
p.000023: others and why, whether it will be sent outside South Africa and why. The person should agree to these terms.
p.000023: Some specific terms are summarised:
p.000023: • in the case of a child (person under the age of 18 years), a parent or guardian14 must give permission for the
p.000023: information to be collected (s 35(1)(a));15
...
p.000033: department, or to a police official.
p.000033: ii. Reporting obligations for under-age sexual activity
p.000033: The age at which minors can lawfully consent to sexual activity is 16 years, in terms of the Criminal Law (Sexual
p.000033: Offences and Related Matters) Amendment Act 32 of 2007 (Sexual Offences Act). Anyone with knowledge of a
p.000033: sexual offence against a minor is required to report this to a police official. In effect, any adult or person >16
p.000033: years who engages in sexual activity with a minor < 16 years commits a crime and may be prosecuted. The Act
p.000033: describes a broad range of sexual offences, including rape, sexual assault, sexual grooming, sexual
p.000033: exploitation, and use of children in pornography including photographs. This means that the range of activities
p.000033: that may constitute a sexual offence is extensive.
p.000033: The Sexual Offences Act differentiates between adolescents (12 - < 16 years) and older minors (16 and 17
p.000033: years). In the case of children younger than 12 years, sexual activity is unlawful even with consent. For adolescents,
p.000033: the situation is as follows. The Teddy Bear Clinic case 29 found criminalisation of consensual sexual acts
p.000033: between adolescents aged 12 – < 16 years to be unconstitutional, on the basis that adolescents should not be subjected
p.000033: to criminal sanctions when they exercise their entitlement to determine their personal relationships in light of their
p.000033: rights to autonomy, dignity and privacy. The Constitutional Court imposed a moratorium on action against adolescents in
p.000033: terms of ss 15 and 16 of the Sexual Offences Act. This moratorium of 18 months is to give Parliament time to revise the
p.000033: offending legislative provisions by April 2015.30
p.000033: Consensual sexual acts between adolescents aged 12 - < 16 years are not criminal and are not reportable. Sexual acts
p.000033: with adolescents aged 12 - < 16 years by an adult or a person >16 years, even if consensual, are criminal and
p.000033: reportable. Sexual acts with children < 12 years are criminal and reportable.
p.000033: iii. Sexual and reproductive health research with minors
p.000033: Research with minors that focuses on their sexuality and reproductive health is likely to encounter instances of
p.000033: abuse and underage sexual activity. The dilemma for
p.000033:
p.000033:
...
Political / Indigenous
Searching for indicator indigenous:
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p.000045: after collection or can be collected without identification of the donor.
p.000045: 3.3.10 Commercially available cell lines
p.000045: Biosafety and ethical issues may arise from use of commercially available cell lines depending on the nature of the
p.000045: planned research work. For example, if cells are to be infected, biosafety and hence also ethical issues, arise
p.000045: for researchers rather than participants. If cells will undergo genetic modification, there may also be ethical
p.000045: implications.
p.000045: Whether REC review is required, depends on whether institutions have properly functioning research review and biosafety
p.000045: infrastructures. Where these do not yet exist, RECs should be part of the process to ensure biosafety and ethical
p.000045: standards are maintained.
p.000045: Note that ‘blanket approval’ for use of commercially available cell lines is not permitted. At minimum, a researcher
p.000045: is expected to liaise with the REC about the biosafety and ethical implications of the planned work. RECs
p.000045: should draw up a SOP and query template to assist establishing the implications.
p.000045: 3.4 Considerations specific to research methods or contexts
p.000045:
p.000045: Particular types of research require careful scrutiny in case additional precautions or monitoring
p.000045: procedures are required.
p.000045: Types of research discussed include:
p.000045: • Major incidents39 and research
p.000045: • Intensive care research
p.000045: • Terminal care research
p.000045: • Innovative therapy or interventions
p.000045: • Indigenous medicines research
p.000045: • Deception, concealment or covert data collection
p.000045: Note this list is not exhaustive, merely illustrative.
p.000045:
p.000045: 3.4.1 Major incidents and research
p.000045:
p.000045: Major incidents include any sudden event that occurs where local resources are constrained, so that responding
p.000045: urgently and appropriately is difficult. Major incidents include acute disasters – natural or man-made –
p.000045: such as floods, tornados, earthquakes, outbreaks of deadly disease, or political violence and armed
p.000045: conflict with resultant injuries to humans.
p.000045:
p.000045: 38The Human Heredity and Health in Africa (H3Africa) Initiative http://h3africa.org/about/vision.
p.000045: 39 Previously known as disaster research.
p.000045:
p.000045: 46 Ethics in Health Research 2nd edition
p.000045:
p.000045:
p.000045: They may also take the form of an unusual and sudden demand on local resources or other emergency with consequent
p.000045: ethical implications for patient care. Research in these contexts is important for advancing emergency health
p.000045: care interventions and treatments, and for refining resource allocation policies. The potential benefits of major
p.000045: incident research include improved triage methods and procedures, effective treatment for life-threatening conditions
p.000045: and improving therapies for survival and quality of life.
...
p.000045: intensive care experts should be sought.
p.000045:
p.000045: Ethics in Health Research 2nd edition
p.000047: 47
p.000047:
p.000047: 3.4.3 Terminal care research
p.000047:
p.000047: Terminal care research is distinguished by the short remaining life expectancy of participants and their potential
p.000047: vulnerability to unrealistic expectations of benefits from participation in research. In principle, because of their
p.000047: extreme vulnerability, terminally ill patients should not participate in research that is more than minimally invasive
p.000047: without adequate justification.
p.000047: The prospect of any direct benefit from research participation must not be overstated or used to justify a risk of harm
p.000047: higher than that involved in current treatment. Research participation must not be used to prevent or devalue the needs
p.000047: and wishes of participants rather to spend time as they choose, particularly with family members.
p.000047: 3.4.4 Traditional medicines research
p.000047:
p.000047: In line with the constitutional guarantees for cultural and language rights, 40 indigenous cultures and
p.000047: traditional values of all communities must be respected. However, since fundamental rights do not trump
p.000047: each other without careful justification, participants in research involving traditional medical systems and
p.000047: beliefs must be accorded the same respect and protection as any other human research participant. 41 The
p.000047: context of the research activity, interaction or intervention is important for determining whether, how and when to
p.000047: incorporate traditional values and their cultural expression in research.
p.000047: In terms of the Traditional Health Practitioners Act 22 of 2007,
p.000047: 'Traditional medicine' means an object or substance used in traditional health practice for-
p.000047: (a) the diagnosis, treatment or prevention of a physical or mental illness; or
p.000047: (b) any curative or therapeutic purpose, including the maintenance or restoration of physical or mental health or
p.000047: well-being in human beings,
p.000047: but does not include a dependence-producing or dangerous substance or drug.
p.000047: 'Traditional health practice' means the performance of a function, activity, process or service based on a
p.000047: traditional philosophy that includes the utilisation of traditional medicine or traditional practice and which has as
p.000047: its object-
p.000047: (a) the maintenance or restoration of physical or mental health or function; or
p.000047: (b) the diagnosis, treatment or prevention of a physical or mental illness; or
p.000047: (c) the rehabilitation of a person to enable that person to resume normal functioning within the family or community;
p.000047: or
p.000047: (d) the physical or mental preparation of an individual for puberty, adulthood, pregnancy, childbirth and
p.000047: death,
p.000047: but excludes the professional activities of a person practising any of the professions contemplated in the
p.000047: Pharmacy Act 53 of 1974, the Health Professions Act 56 of 1974, the Nursing Act 50 of 1974, the Allied Health
p.000047: Professions Act 63 of 1982, or the Dental Technicians Act 19 of 1979, and any other activity not based on
p.000047: traditional philosophy.
p.000047:
p.000047:
p.000047:
p.000047: 40 Sections 30 and 31 of the Constitution.
p.000047: 41 In terms of s 12(2)(c) of the Constitution and s 71 of the National Health Act.
p.000047:
p.000047: 48 Ethics in Health Research 2nd edition
p.000047:
p.000047:
p.000047: 'Traditional philosophy' means indigenous African techniques, principles, theories, ideologies, beliefs, opinions and
p.000047: customs and uses of traditional medicines communicated from ancestors to descendants or from generations
p.000047: to generations, with or without written documentation, whether supported by science or not, and which are
p.000047: generally used in traditional health practice.
p.000047: RECs should pay attention to indications that intellectual property may be intended to be acquired by
p.000047: non-South Africans and should advise that appropriate advice be sought. Intellectual property in indigenous
p.000047: flora, fauna and medicines is a particularly sensitive matter currently and not easily regulated. Protection of
p.000047: intellectual property relating to South African medicinal plants is a cross-cutting issue, responsibility for which is
p.000047: spread amongst several government departments, including the Department of Health; Trade and Industry; Science &
p.000047: Technology; Environmental Affairs; Tourism; Agriculture, Forestry & Fisheries; and Rural Development & Land
p.000047: Affairs. International and domestic legislation, policies and regulatory guidelines applicable in these
p.000047: departments must be taken in account when conducting research on traditional medicinal plants and
p.000047: genetic material, to ensure compliance.
p.000047: Current legislation that governs intellectual property relating to traditional knowledge and genetic material
p.000047: includes
p.000047: • The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits,
p.000047: 42 which advances Articles 15 & 8(j) of the Convention on Biological Diversity
p.000047: • The National Environmental Management: Biodiversity Act 10 of 2004 and its Regulations
p.000047: • The Patents Act 57 of 1978
p.000047: • The Department of Trade & Industry’s policies on Intellectual Property including the Intellectual Property
p.000047: Amendment Bill 2008.43
p.000047: Prior ethics review of the proposed research is required to ensure that norms and standards for health research in
p.000047: South Africa are being upheld. Toxicology tests must be performed on substances to be used on or ingested by
p.000047: participants; and equivalent rigour must apply to such research. Researchers should furnish proof of safety of the
p.000047: substances to the REC. The practice of requiring a randomised controlled trial may not be appropriate in all
p.000047: circumstances for indigenous treatments and interventions. However, RECs must consider methodology carefully
p.000047: and make decisions on a case-by-case basis.
p.000047: 3.4.5 Research involving deception or withholding information
p.000047:
p.000047: Sometimes, to ensure validity of research, researchers withhold certain information in the consent process.
p.000047: This may take the form of withholding information about the purpose of specific procedures. In most such cases, the
p.000047: prospective participants are asked to consent to remain uninformed as to the purpose of some procedures until the
p.000047: research is completed. After conclusion of the study, participants are given the omitted information. In other cases,
p.000047:
p.000047: 42Ratified by South Africa on 11 May 2011. For further information, see http://www.cbd.int/abs/
p.000047: 43 Informed by a series of international conventions such as the Berne Convention of 1967, Universal Declaration of
p.000047: Human Rights (1948), Declaration on the Rights of Indigenous Peoples (2007) (Art. 13), International Covenant on
p.000047: Economic, Social and Cultural Rights, WIPO-
p.000047: UNESCO World Forum on Protection of Folklore, and the Marrakesh agreement of 1994
p.000047:
p.000047: Ethics in Health Research 2nd edition
p.000049: 49
p.000049:
p.000049: participants are not told that some information is being withheld until the research has been completed. The latter
p.000049: approach must receive the explicit approval of the REC.
p.000049: Active deception of participants is considerably more controversial that simply withholding certain
p.000049: information. Deception is not permitted where the deception itself would disguise the possibility of a participant
p.000049: being exposed to more than minimal risk. RECs should be satisfied that deception is indispensable; that no other
p.000049: research method would suffice; that significant advances could result from the research; and that nothing has
p.000049: been withheld that, if divulged, would cause a reasonable person to decline to participate. The REC should consider
p.000049: the consequences for the participant of being deceived, and whether and how deceived participants should
p.000049: be informed of the deception upon completion of the research. Participants who disapprove of having been
p.000049: deceived should be offered the opportunity to request that their information be excluded from the research.
p.000049: 3.5 Special topics
p.000049:
p.000049: 3.5.1 Novel, innovative and unproven therapies
p.000049: i. The context
...
Political / Prosecuted
Searching for indicator prosecuted:
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p.000033: obligations. (See Appendix 3 for SOP Template.)
p.000033: i. Reporting obligations for abuse and neglect
p.000033: The Children’s Act requires anyone who reasonably believes a child to be suffering physical abuse causing injury,
p.000033: deliberate neglect and sexual abuse to report this to a child protection agency, the provincial social development
p.000033: department, or to a police official.
p.000033: ii. Reporting obligations for under-age sexual activity
p.000033: The age at which minors can lawfully consent to sexual activity is 16 years, in terms of the Criminal Law (Sexual
p.000033: Offences and Related Matters) Amendment Act 32 of 2007 (Sexual Offences Act). Anyone with knowledge of a
p.000033: sexual offence against a minor is required to report this to a police official. In effect, any adult or person >16
p.000033: years who engages in sexual activity with a minor < 16 years commits a crime and may be prosecuted. The Act
p.000033: describes a broad range of sexual offences, including rape, sexual assault, sexual grooming, sexual
p.000033: exploitation, and use of children in pornography including photographs. This means that the range of activities
p.000033: that may constitute a sexual offence is extensive.
p.000033: The Sexual Offences Act differentiates between adolescents (12 - < 16 years) and older minors (16 and 17
p.000033: years). In the case of children younger than 12 years, sexual activity is unlawful even with consent. For adolescents,
p.000033: the situation is as follows. The Teddy Bear Clinic case 29 found criminalisation of consensual sexual acts
p.000033: between adolescents aged 12 – < 16 years to be unconstitutional, on the basis that adolescents should not be subjected
p.000033: to criminal sanctions when they exercise their entitlement to determine their personal relationships in light of their
p.000033: rights to autonomy, dignity and privacy. The Constitutional Court imposed a moratorium on action against adolescents in
p.000033: terms of ss 15 and 16 of the Sexual Offences Act. This moratorium of 18 months is to give Parliament time to revise the
p.000033: offending legislative provisions by April 2015.30
p.000033: Consensual sexual acts between adolescents aged 12 - < 16 years are not criminal and are not reportable. Sexual acts
...
Political / criminal
Searching for indicator criminal:
(return to top)
p.000009:
p.000009: 3 Available at http://www.health-e.org.za/wp-content/uploads/2014/08/SA-DoH-Strategic-Plan-2014-to-2019.pdf
p.000009:
p.000009: 10 Ethics in Health Research 2nd edition
p.000009:
p.000009:
p.000009: 1.3.4 The guidelines draw on prevailing international, foreign and national codes of conduct,
p.000009: declarations, and other documents relevant to research with humans, to strengthen processes of translational
p.000009: research collaboration, while taking into account the socioeconomic, ethnic and cultural diversity in South Africa. The
p.000009: guidelines also draw on and refer to international and national standards and guidelines for research using animals.
p.000009: 1.3.5 Researchers should be familiar with legislation and other binding instruments relevant to research including4
p.000009: • Animal Diseases Act 35 of 1984
p.000009: • Animal Health Act 7 of 2002
p.000009: • Animals Protection Act 71 of 1962
p.000009: • Basic Conditions of Employment Act 75 of 1997
p.000009: • Cartagena Protocol on Biosafety May 2000
p.000009: • Child Justice Act 75 of 2008
p.000009: • Children’s Act 38 of 2005
p.000009: • Choice on Termination of Pregnancy Act 92 of 1996
p.000009: • Constitution of the Republic of South Africa, 1996
p.000009: • Convention on Biological Diversity
p.000009: • Criminal Law (Sexual Offences and Related Matters) Amendment Act 32 of 2007
p.000009: • Domestic Violence Act 116 of 1998
p.000009: • Employment Equity Act 55 of 1998
p.000009: • Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act 36 of 1947
p.000009: • Genetically Modified Organisms Act, Act No 15 of 1997
p.000009: • Hazardous Substances Act 15 of 1973
p.000009: • Health Professions Act 56 of 1974
p.000009: • Labour Relations Act 66 of 1995
p.000009: • Medical Schemes Act 131 of 1998
p.000009: • Medicines and Related Substances Control Act 101 of 1965
p.000009: • Mental Health Care Act 17 of 2002
p.000009: • Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits,5
p.000009: • National Environmental Management: Biodiversity Act, Act 10 of 2004
p.000009: • National Health Act, Act No 61 of 2003
p.000009: • National Health Laboratory Service Act 37 of 2000
p.000009: • Patents Act 57 of 1978
p.000009: • Performing Animals Protection Act 24 of 1935
p.000009: • Promotion of Access to Information Act 2 of 2000
p.000009: • Promotion of Equality and Prevention of Unfair Discrimination Act 4 of 2000
p.000009: • Protected Disclosures Act 26 of 2000
p.000009: • Protection of Personal Information Act 4 of 2013
p.000009: • Provincial Nature Conservation Acts or Ordinances
p.000009:
p.000009:
p.000009:
p.000009: 4 Note this list is not exhaustive.
p.000009: 5Ratified by South Africa on 11 May 2011. For further information, see http://www.cbd.int/abs/
p.000009:
...
p.000031: of harm. Other research including clinical research that may involve a minor increase over minimal risk of harm
p.000031: may also be justified on the basis that it would be unjustifiable to exclude a significant segment of the
p.000031: child population from research on the basis of their legal status. Consequently, it is ethical and reasonable to
p.000031: designate parental substitutes in these circumstances.
p.000031: iii. Pragmatic parental substitutes27
p.000031: In the interest of fostering consistency as well as compliance with the spirit of the legal provisions
p.000031: that protect minors’ interests, especially the Constitution and the Children’s Act, pragmatic guidance is provided
p.000031: here to deal with situations where no biological parent or legal guardian exists. The permissible level of
p.000031: risk is limited (see 3.2.2.1).
p.000031: Note this guidance does not permit expedient substitution e.g. where a parent is temporarily unavailable.
p.000031: This guidance takes its lead from the Constitution, the Children’s Act, the National Health Act, the Criminal Law
p.000031: (Sexual Offences) Amendment Act; the South African Good Clinical Practice Guidelines (2006) available at
p.000031: www.doh.gov.za/docs/factsheets/guidelines/clinical/2006/index.html.
p.000031: The guidance is premised on three conditions, all of which must be satisfied:
p.000031: 1. The risk standards set out in 3.2.2.1 b) must be adhered to; and
p.000031: 2. It is not possible to do the research with adult participants; and
p.000031: 3. The research proposes to investigate a problem of relevance to minors.
p.000031: Note that if the proposed research holds out more than a minimal risk of harm, there must be a
p.000031: compelling justification for why orphans should be included as participants, e.g. the research focus has particular
p.000031: relevance for OVC and cannot be studied without their enrolment.
p.000031: The parental substitutes should be used in descending order, as listed.
p.000031: i. The minor chooses whether to participate and thus expresses her will AFTER
p.000031:
p.000031: 27 This pragmatic guidance is provided to temper the chilling effect of a literal interpretation of s 71 of the
p.000031: National Health Act 61 of 2003, which otherwise might prevent important ethical research.
p.000031:
p.000031: Ethics in Health Research 2nd edition
p.000033: 33
p.000033:
p.000033: ii. The parent gives assistance with understanding (so the minor makes an informed choice)
...
p.000033: There is no general obligation to report either the commission of or the intention to commit a crime. However, if a
p.000033: researcher has information indicating that direct harm to another person may occur as a result of the intention to
p.000033: commit harm (e.g. a participant says ‘I’m going to kill her…’), then there may be an obligation, especially when the
p.000033: third person is known to the researcher. For specifically designated persons, there are statutory reporting
p.000033: obligations. (See Appendix 3 for SOP Template.)
p.000033: i. Reporting obligations for abuse and neglect
p.000033: The Children’s Act requires anyone who reasonably believes a child to be suffering physical abuse causing injury,
p.000033: deliberate neglect and sexual abuse to report this to a child protection agency, the provincial social development
p.000033: department, or to a police official.
p.000033: ii. Reporting obligations for under-age sexual activity
p.000033: The age at which minors can lawfully consent to sexual activity is 16 years, in terms of the Criminal Law (Sexual
p.000033: Offences and Related Matters) Amendment Act 32 of 2007 (Sexual Offences Act). Anyone with knowledge of a
p.000033: sexual offence against a minor is required to report this to a police official. In effect, any adult or person >16
p.000033: years who engages in sexual activity with a minor < 16 years commits a crime and may be prosecuted. The Act
p.000033: describes a broad range of sexual offences, including rape, sexual assault, sexual grooming, sexual
p.000033: exploitation, and use of children in pornography including photographs. This means that the range of activities
p.000033: that may constitute a sexual offence is extensive.
p.000033: The Sexual Offences Act differentiates between adolescents (12 - < 16 years) and older minors (16 and 17
p.000033: years). In the case of children younger than 12 years, sexual activity is unlawful even with consent. For adolescents,
p.000033: the situation is as follows. The Teddy Bear Clinic case 29 found criminalisation of consensual sexual acts
p.000033: between adolescents aged 12 – < 16 years to be unconstitutional, on the basis that adolescents should not be subjected
p.000033: to criminal sanctions when they exercise their entitlement to determine their personal relationships in light of their
p.000033: rights to autonomy, dignity and privacy. The Constitutional Court imposed a moratorium on action against adolescents in
p.000033: terms of ss 15 and 16 of the Sexual Offences Act. This moratorium of 18 months is to give Parliament time to revise the
p.000033: offending legislative provisions by April 2015.30
p.000033: Consensual sexual acts between adolescents aged 12 - < 16 years are not criminal and are not reportable. Sexual acts
p.000033: with adolescents aged 12 - < 16 years by an adult or a person >16 years, even if consensual, are criminal and
p.000033: reportable. Sexual acts with children < 12 years are criminal and reportable.
p.000033: iii. Sexual and reproductive health research with minors
p.000033: Research with minors that focuses on their sexuality and reproductive health is likely to encounter instances of
p.000033: abuse and underage sexual activity. The dilemma for
p.000033:
p.000033:
p.000033: 29The Teddy Bear Clinic for Abused Children v Minister of Justice and Constitutional Development (CCT 12/13) [2013]
p.000033: ZACC 35; 2014 (2) SA 168 (CC); see also J v NDPP [2014] ZACC 13.
p.000033: 30See Draft Criminal Law (Sexual Offences & related matters) Amendment Act Amendment Bill [B-2014].
p.000033:
p.000033: Ethics in Health Research 2nd edition
p.000035: 35
p.000035:
p.000035: researchers is whether to ignore the strict letter of the law or to report as indicated in terms of the Sexual Offences
p.000035: Act and the Children’s Act. The matter is not simple.
p.000035: The clash of interests is obvious, e.g. using the law to protect the minor from abuse may have the unintended
p.000035: consequence of increased harm (physical and social) for that child. Further, thoughtless reporting may
p.000035: violate privacy and confidentiality interests of the minor e.g. in terms of the Choice on Termination of Pregnancy
p.000035: Act, the Children’s Act and the Child Justice Act. Whether a researcher, who has but a research interest
p.000035: in the life of the child, but no further right of access or duty of intervention ought to take on
p.000035: the responsibility of a social worker is unclear. Consequently, researchers should think very
...
Political / political affiliation
Searching for indicator political:
(return to top)
p.000005: 1.8 Purpose & status of these Guidelines 13
p.000005: 1.9 Structure of these Guidelines 13
p.000005:
p.000005:
p.000005: This chapter explains ethics in research and provides an overview of the South African research context,
p.000005: including the remit of this document.
p.000005:
p.000005: Introduction
p.000005:
p.000005: 1.1.1 South Africa is a democratic state in which human dignity, equality and the advancement of human
p.000005: rights are respected, promoted and protected in terms of the Constitution of the Republic of South Africa, 1996 (the
p.000005: Constitution). In particular, s 27(1) guarantees the right of access to health care services, while section 12(2) of
p.000005: the Bill of Rights in the SA Constitution, protects against research abuse by providing that
p.000005: ‘Everyone has the right to bodily and psychological integrity, which includes the right –
p.000005: (a) to make decisions concerning reproduction;
p.000005: (b) to security in and control over their body; and
p.000005: (c) not to be subjected to medical or scientific experiments 1 without their informed consent’.
p.000005:
p.000005:
p.000005:
p.000005: Note: Where ‘she’ or other version is found, ‘he’ or other version is implied and vice versa.
p.000005:
p.000005: 1 The term ‘experiments’ originates from Article 7 of the International Covenant on Civil and Political Rights - UN
p.000005: 1966 and echoes the Nuremberg Code; in the constitutional context, it is intended to mean ‘research’.
p.000005:
p.000005: Ethics in Health Research 2nd edition
p.000007: 7
p.000007:
p.000007: 1.1.2 The National Health Act 61 of 2003 (NHA) provides statutory authority for governance of ‘health research’ and
p.000007: the necessary research ethics regulatory infrastructure.
p.000007: 1.1.3 ‘Health research’ per the NHA may be understood to include but is not limited to research that
p.000007: contributes to knowledge of
p.000007: • biological, clinical, psychological, or social welfare matters including processes as regards humans
p.000007: • the causes and effects of and responses to disease
p.000007: • effects of the environment on humans
p.000007: • methods to improve health care service delivery
p.000007: • new pharmaceuticals, medicines, interventions and devices
p.000007: • new technologies to improve health and health care
p.000007: 1.1.4 In general terms, research includes a wide range of activities conducted by many different
p.000007: disciplines that may use different methodologies and explanatory frameworks. In the physical and
p.000007: biological sciences, research may be described as a systematic study or inquiry, usually using quantitative data, in
p.000007: seeking generalisable new knowledge. Health-related research is increasingly also using qualitative
p.000007: methodologies. The humanities, social and behavioural sciences use both qualitative and quantitative methods and
...
p.000007: improved understanding of the human condition in its environment or context.
p.000007: 1.1.14 This document does not deal with clinical trials which form the subject matter of the Department of Health’s
p.000007: Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa, 2nd edition
p.000007: (2006) or its successor. However, this document includes guidance on insurance against research-related bodily injury,
p.000007: including in clinical trials.
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: 2 Also known as ‘human subjects research’; a human subject is a living individual about whom a researcher obtains (i)
p.000007: data through interventions or interactions; or (ii) identifiable private information.
p.000007:
p.000007: Ethics in Health Research 2nd edition
p.000009: 9
p.000009:
p.000009:
p.000009: 1.2 The research context
p.000009:
p.000009: 1.2.1 South Africa provides a rich arena for health and health-related research because of its excellent health care
p.000009: and research infrastructure, skills, and expertise. The country is also characterised by a high burden of disease,
p.000009: including diseases associated with poverty and underdevelopment, along with non-communicable diseases, creating
p.000009: a need for a broad spectrum of health and health-related research. See the Department of Health’s Strategic Health Plan
p.000009: 2014-2019 or its successor.3
p.000009: 1.2.2 South Africa is also an attractive research site for social scientists, behavioural scientists,
p.000009: political scientists, economists, researchers engaged in social development, education, and many more disciplines,
p.000009: because of its political history and current socio-economic, educational, political and social development
p.000009: status.
p.000009: 1.2.3 To ensure that South Africa’s people are fairly and respectfully treated by researchers and that all research
p.000009: conducted in the country stands up to ethical scrutiny, South Africa’s research ethics systems and infrastructure
p.000009: are regularly upgraded and strengthened.
p.000009: 1.3 Regulatory authority
p.000009:
p.000009: 1.3.1 The National Health Research Ethics Council (NHREC) was established in 2006 in terms of s 72 of the
p.000009: National Health Act (NHA).
p.000009: 1.3.2 In terms of the NHA, the NHREC must
p.000009: a) set norms and standards for health research involving humans and animals, as well as for conducting clinical trials
p.000009: b) determine guidelines to facilitate best practice for research ethics committees
p.000009: c) register and audit research ethics committees
p.000009: d) adjudicate complaints about research ethics and Animal Research Ethics committees
p.000009: e) refer matters concerning violations of ethical or professional rules to the relevant health professions
p.000009: council;
p.000009: f) recommend disciplinary action against persons found to have violated the norms and standards set for
p.000009: the responsible and ethical conduct of health research
p.000009: g) advise the national and provincial departments of health on ethical matters concerning research.
...
p.000045: implications.
p.000045: Whether REC review is required, depends on whether institutions have properly functioning research review and biosafety
p.000045: infrastructures. Where these do not yet exist, RECs should be part of the process to ensure biosafety and ethical
p.000045: standards are maintained.
p.000045: Note that ‘blanket approval’ for use of commercially available cell lines is not permitted. At minimum, a researcher
p.000045: is expected to liaise with the REC about the biosafety and ethical implications of the planned work. RECs
p.000045: should draw up a SOP and query template to assist establishing the implications.
p.000045: 3.4 Considerations specific to research methods or contexts
p.000045:
p.000045: Particular types of research require careful scrutiny in case additional precautions or monitoring
p.000045: procedures are required.
p.000045: Types of research discussed include:
p.000045: • Major incidents39 and research
p.000045: • Intensive care research
p.000045: • Terminal care research
p.000045: • Innovative therapy or interventions
p.000045: • Indigenous medicines research
p.000045: • Deception, concealment or covert data collection
p.000045: Note this list is not exhaustive, merely illustrative.
p.000045:
p.000045: 3.4.1 Major incidents and research
p.000045:
p.000045: Major incidents include any sudden event that occurs where local resources are constrained, so that responding
p.000045: urgently and appropriately is difficult. Major incidents include acute disasters – natural or man-made –
p.000045: such as floods, tornados, earthquakes, outbreaks of deadly disease, or political violence and armed
p.000045: conflict with resultant injuries to humans.
p.000045:
p.000045: 38The Human Heredity and Health in Africa (H3Africa) Initiative http://h3africa.org/about/vision.
p.000045: 39 Previously known as disaster research.
p.000045:
p.000045: 46 Ethics in Health Research 2nd edition
p.000045:
p.000045:
p.000045: They may also take the form of an unusual and sudden demand on local resources or other emergency with consequent
p.000045: ethical implications for patient care. Research in these contexts is important for advancing emergency health
p.000045: care interventions and treatments, and for refining resource allocation policies. The potential benefits of major
p.000045: incident research include improved triage methods and procedures, effective treatment for life-threatening conditions
p.000045: and improving therapies for survival and quality of life.
p.000045: Although patients in a major incident context face extreme vulnerability, RECs should be cautious about
p.000045: being overly restrictive about the type of research that may be conducted. The development of new drugs and procedures
p.000045: to treat emergency patients safely depends on being able to conduct research, including carefully designed randomised
p.000045: controlled trials.
p.000045: In order to carry out research in such contexts, planning of the research and ethics clearance processes usually must
...
p.000075: follows should be read together with chapter 3.
p.000075: Specific ethical issues may arise with gaining access, building rapport, conducting ethnographic
p.000075: observations, in-depth interviews and focus groups, using data and reporting results. Attention should be given
p.000075: to issues of consent, confidentiality, social and psychological harms, privacy as well as the anticipated
p.000075: relationships between researchers and participants when assessing the design, review, conduct and reporting of the
p.000075: research. Some may be evident in the design phase, while others will only arise during the research, in which case the
p.000075: researcher must exercise discretion, sound judgement, consultation and flexibility in accordance with the level of risk
p.000075: of harm and possible benefits of the research. The basis for the exercise of discretion and the degree of
p.000075: flexibility should be considered at the design phase. The REC Chairperson should be consulted when doubt arises.
p.000075:
p.000075: 76 Ethics in Health Research 2nd edition
p.000075:
p.000075:
p.000075:
p.000075: APPENDIX 1
p.000075:
p.000075: Glossary
p.000075:
p.000075: Academic freedom – the collective freedom of researchers, including students, to conduct research and to disseminate
p.000075: ideas or findings without religious, political or institutional restrictions; it includes freedom of inquiry
p.000075: and freedom to challenge conventional thought. Academic freedom does not mean freedom to ignore ethical issues
p.000075: Accountability – the measure by which it can be demonstrated that responsibilities have been or are being fulfilled;
p.000075: it may involve reporting upwards in a hierarchical structure
p.000075: Adolescent – a child between 12 and 17 years of age
p.000075: Anonymous data or specimen–data or biological materials without any overt identifying information or link to a
p.000075: specific donor
p.000075: Audit– subset of research; not clinical practice but a review of clinical practice
p.000075: Autonomy – the capacity to understand information; to act on it voluntarily; to use own judgement to make decisions
p.000075: about own actions, including whether to participate in research
p.000075: Biobank – see Repository
p.000075: Human biological materials– materials including blood and blood products, DNA, RNA, blastomeres, polar bodies,
p.000075: cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors
p.000075: Broad consent– donor permits use of biological materials for future studies, subject only to further prior ethics
p.000075: review and approval
p.000075: Capacity – the ability to understand relevant information; to appreciate the consequences of decisions based on the
p.000075: information
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.000009: b) determine guidelines to facilitate best practice for research ethics committees
p.000009: c) register and audit research ethics committees
p.000009: d) adjudicate complaints about research ethics and Animal Research Ethics committees
p.000009: e) refer matters concerning violations of ethical or professional rules to the relevant health professions
p.000009: council;
p.000009: f) recommend disciplinary action against persons found to have violated the norms and standards set for
p.000009: the responsible and ethical conduct of health research
p.000009: g) advise the national and provincial departments of health on ethical matters concerning research.
p.000009: 1.3.3 The NHREC firmly supports ethical practice of health and health-related research and asserts that research
p.000009: should reflect core values of respect, scientific merit and integrity, justice and beneficence. Of highest
p.000009: priority are refinement of ethics guidelines, establishment of research ethics and animal research ethics
p.000009: committees, and strengthening of review processes, to protect the rights, safety and welfare interests of
p.000009: individuals involved in research, particularly vulnerable participants; to protect the welfare and safety
p.000009: interests of animals used in research; and to protect safety and other interests of researchers.
p.000009:
p.000009: 3 Available at http://www.health-e.org.za/wp-content/uploads/2014/08/SA-DoH-Strategic-Plan-2014-to-2019.pdf
p.000009:
p.000009: 10 Ethics in Health Research 2nd edition
p.000009:
p.000009:
p.000009: 1.3.4 The guidelines draw on prevailing international, foreign and national codes of conduct,
p.000009: declarations, and other documents relevant to research with humans, to strengthen processes of translational
p.000009: research collaboration, while taking into account the socioeconomic, ethnic and cultural diversity in South Africa. The
p.000009: guidelines also draw on and refer to international and national standards and guidelines for research using animals.
p.000009: 1.3.5 Researchers should be familiar with legislation and other binding instruments relevant to research including4
p.000009: • Animal Diseases Act 35 of 1984
p.000009: • Animal Health Act 7 of 2002
p.000009: • Animals Protection Act 71 of 1962
p.000009: • Basic Conditions of Employment Act 75 of 1997
p.000009: • Cartagena Protocol on Biosafety May 2000
p.000009: • Child Justice Act 75 of 2008
...
p.000051: plan must also be analysed. Even if scientific review has occurred, the REC must assess how the research will be
p.000051: conducted, whether the researchers are suitably qualified, that adequate monitoring and safety measures are
p.000051: in place and achievable, that the site is suitably resourced, and so forth.
p.000051: Scholarly disciplines and fields of research vary considerably in regard to their traditions for scholarly review,
p.000051: including the stage at which the review takes place. These disciplinary variations must be taken into account
p.000051: by RECs. Duplication of scholarly peer review should be avoided if possible. To this end, researchers should
p.000051: provide clear evidence of previous scholarly assessments and the outcome where appropriate. RECs
p.000051: may request full documentation of scholarly reviews.
p.000051: Note that a risk of harm is unlikely to be justifiable if the research lacks scientific or scholarly merit.
p.000051: 3.1.2 Inclusion and exclusion criteria
p.000051: The selection of participants must be appropriate for the research question. The rationale for the planned number of
p.000051: participants must be reasonable in light of the aims and objectives and proposed methodologies. Underpowered studies
p.000051: may be futile. An explanation of how the sample size is to be determined should be provided. For qualitative research,
p.000051: the method for sample selection must be clear and complete. The rationale for the inclusion and exclusion
p.000051: criteria must be clear, explicit and reasonable. If vulnerable participants are to be included, an adequate
p.000051: justification should be provided; protective safeguards and measures should be explained. Exclusion criteria
p.000051: should be based on sound reasons. Inclusion and exclusion criteria have ethical implications (e.g.
p.000051: fairness of selection) and are not just of scientific relevance.
p.000051: 3.1.3 Selection of study population and sampling
p.000051: The principle of distributive justice requires that particular groups or categories of persons should not bear more
p.000051: than a fair share of the burden of research participation. But, equally, groups or categories of persons should not be
p.000051: deprived of a fair opportunity to participate in research. In other words, all persons should be able to contribute
p.000051: to the advancement of knowledge that research aims to achieve. RECs should assess whether the selected
p.000051: study population that will bear the risks associated with participation is likely to benefit from the research, if not
p.000051: immediately, then at least in the foreseeable future or, at least, whether the group represented by the participants is
p.000051: likely to benefit from the research. In other words, the risk-benefit ratio can include that risk of harm to
p.000051: participants might be offset against likelihood of benefit to others, in some circumstances.
p.000051: 3.1.4 Recruitment and enrolment
p.000051: Recruitment strategies should be neutral, and should describe the purpose of the research, the anticipated risks of
...
p.000021: for travel costs and refreshments.
p.000021: Inducements encourage participation. They may be offered in some circumstances where
p.000021: e.g. recruitment, especially of healthy participants, is anticipated to be difficult. However, a justification for
p.000021: this tactic should be provided and the inducement should not unduly influence an informed choice about
p.000021: participation. In particular, an inducement should not undermine a potential participant’s assessment of risk of
p.000021: harm. All inducements should be clearly explained and justified to the REC. Input from community members on the REC or
p.000021: other role players may be constructive.
p.000021: 3.1.8 Participants’ privacy and confidentiality interests
p.000021: The principle of respect for persons requires careful attention to privacy and confidentiality interests. Privacy
p.000021: describes the person’s interest in controlling access to her personal information. Confidentiality is about
p.000021: whether and how research data might be disclosed
p.000021:
p.000021:
p.000021:
p.000021: 11 Available at http://nhrec.org.za – the current rate (2014) for unskilled construction workers is approximately R15
p.000021: - R25 per hour depending on the tasks (see Department of Labour’s sectoral determinations).
p.000021:
p.000021: Ethics in Health Research 2nd edition
p.000023: 23
p.000023:
p.000023: carelessly or inadvertently, thus revealing the participant’s identity or category, making him vulnerable to harm. (See
p.000023: also 2.3.7)
p.000023: The proposal should explain how data records (written, audio or visual) are to be secured, the length of time they will
p.000023: be retained12 and who will be responsible for storage and/or final disposal. The proposal should explain why
p.000023: particular identifying information is required for the study that purports to collect data anonymously. RECs should
p.000023: assess whether notifiable activities might occur amongst participants, e.g. abuse of minors or notifiable diseases and,
p.000023: consequently, whether appropriate measures are in place and are explained in the research proposal. Furthermore, the
p.000023: REC must ensure that the required notification or reporting and its management are explained in the consent documents.
p.000023: Where focus groups are planned, RECs should check that the information for participants explains clearly
p.000023: that researchers cannot guarantee confidentiality because members of the focus group may disclose information
p.000023: outside the research setting, despite agreeing not to do so. For this reason, consent documentation should advise
p.000023: potential focus group participants not to disclose personally sensitive information, as the researcher cannot
p.000023: guarantee confidentiality, even if other participants are urged to respect confidentiality.
p.000023: The Protection of Personal Information Act 4 of 2013 was assented to on 19 November 2013. 13 This Act
...
p.000025: • the information explains
p.000025: o that the person is being asked to participate in research
p.000025: o that the choice whether to participate is voluntary
p.000025: o that refusal to participate will not be penalised
p.000025: o that choosing to participate can be reversed, i.e. the person may decide to terminate participation at
p.000025: any time without explanation or prejudice
p.000025: o the purpose and nature of the research procedures and components
p.000025: o the research-related activities and procedures that the participant is being asked to consent to
p.000025: o the expected duration of participation
p.000025: o the nature of the participant’s responsibilities
p.000025: o the nature of the researcher’s responsibilities
p.000025: o the anticipated risks of harm or discomfort
p.000025: o the measures to minimise risk of harm
p.000025: o the extent to which confidentiality is possible
p.000025: o whether reimbursement for expenses is available
p.000025: o that sponsors of the research and regulatory authorities may inspect research records
p.000025: o who the researchers are and the nature of their expertise
p.000025: o the potential benefits, if any, for participants both during and after the research
p.000025: o that the research may be terminated early in particular circumstances
p.000025: o that the research has been approved by a registered REC (include identifying details)
p.000025: • a measure to probe understanding and comprehension of the information is planned and how it proposes to do so
p.000025: especially for very vulnerable potential participants
p.000025: Where a clinical trial is proposed, additional information for prospective participants is required.18
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 17The Flesch-Kinkaid readability tool should be used to assess the complexity of text. This tool is built into MS
p.000025: Word’s spelling & grammar check tool as ‘readability statistics’. No more than Grade 8 equivalency should be the target
p.000025: complexity level.
p.000025: 18See Department of Health (2006) Guidelines for Good Practice in the Conduct of Clinical Trials with Human
p.000025: Participants in South Africa
p.000025: or its successor.
p.000025:
p.000025: 26 Ethics in Health Research 2nd edition
p.000025:
p.000025:
p.000025: 3.2 Vulnerability and incapacity
p.000025:
p.000025: Vulnerability is not an absolute condition but rather occurs on a sliding scale. In South Africa, arguably, the
p.000025: majority of potential research participants are vulnerable when compared to those in North America or Europe,
p.000025: from whence much funding is sourced. 19 Whether vulnerability is present is a matter of fact and degree.
p.000025: However, certain groups of participants 20 require careful consideration to ensure that, where appropriate,
p.000025: additional precautions are put into place. For example, advanced age, very young age, personal or
p.000025: environmental factors like extreme poverty and ordinarily poor access to health care may increase
p.000025: vulnerability
p.000025: 3.2.1 Contextual circumstances
p.000025: Personal circumstances, such as mental or intellectual impairment, acute illness, advanced age, and pregnancy and
p.000025: childbirth may increase vulnerability. Persons may be factually incapable or less capable of understanding
p.000025: information and processing it to reach a decision
p.000025: e.g. about whether to participate in research. Environmental circumstances may also increase vulnerability such as very
p.000025: poor socio-economic conditions, low levels of formal education and literacy, or restricted access to health care
p.000025: services. Such persons may be more easily persuaded to agree to participate without a properly considered
p.000025: understanding of the implications.
p.000025: It is important to note the difference between legal incapacity and factual incapacity. No person may
p.000025: claim that, because a minor is factually capable, the legal incapacity should be waived. On the other hand, no adult
p.000025: may be assumed to be incapable unless incapacity is established factually. Consequently, mental incapacity must
p.000025: be established by a factual assessment of the individual’s abilities to understand and to
p.000025: communicate that understanding. Legal incapacity prevails notwithstanding the existence of factual capacity.
p.000025: South Africa is home to a number of vulnerable communities. Where factors usually associated with
p.000025: vulnerability are integral to the research, the proposal should demonstrate how vulnerability would be managed.
p.000025: Particular caution should be exercised before undertaking research involving participants in such
p.000025: communities, and RECs should ensure that
p.000025: • persons in these communities are not being involved in research merely because they are expediently accessible,
p.000025: while the research could be carried out in a less vulnerable community;
p.000025: • the research is relevant to the health needs and priorities of the community in which it is to be carried out;
p.000025: and that
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 19 UNAIDS defines ‘vulnerable community’ as having some or all of the following characteristics: limited economic
p.000025: development; inadequate protection of human rights and discrimination on the basis of the health status; inadequate
p.000025: community/cultural experience and understanding of scientific research; limited access to health care and treatment
p.000025: options; limited ability of individuals in the community to provide informed consent.
p.000025: 20 For further, more detailed, discussion on special classes of participants, see CIOMS International Ethical
p.000025: Guidelines for Biomedical
p.000025: Research Involving Human Subjects (2002) Guidelines 13-17,
p.000025: http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm; US Department of Health & Human Services,
p.000025: Office for Human Research Protections, http://www.hhs.gov/ohrp.
p.000025:
p.000025: Ethics in Health Research 2nd edition
p.000027: 27
p.000027:
p.000027: • research participants know they will take part in research; and that the research will be carried out only with
p.000027: their consent.21 Particular attention should be given to the content, language(s) and procedures used to obtain
p.000027: informed consent.
p.000027: Note, however, that RECs should avoid patronising assumptions about a community’s ability to make responsible
p.000027: decisions. Factual information is required before deciding that a community is too vulnerable to be invited to
p.000027: choose whether to participate in research.
p.000027: In order to ensure optimal protection of vulnerable participants, the REC may impose additional protective
p.000027: measures for the informed consent process; or require increased monitoring and interim reporting on
p.000027: participants’ welfare; or require post-recruitment reviews of the effectiveness of the protective measures
p.000027: imposed. Other measures may also be appropriate.
p.000027: Note that the decision to impose additional measures should flow from an assessment of the nature of the research and
p.000027: the circumstances of the potential participants. In other words, additional protective measures should not be automatic
p.000027: just because a vulnerable group will be recruited; rather, the decision should be based on the particular
p.000027: circumstances of the proposal before the REC. For example, an automatic assumption that impoverished people cannot
p.000027: choose responsibly whether to participate in research is disrespectful because it denies their autonomy.
p.000027: If compliance with the additional measures is poor and participants’ welfare is negatively affected,
p.000027: approval for the study may be withdrawn, temporarily or permanently, as the case may be.
p.000027: Groups of participants discussed here include
p.000027: • minors (children and adolescents)
p.000027: • women
p.000027: • adults with incapacity to provide informed consent
p.000027: • persons in dependent relationships
p.000027: • persons highly dependent on medical care
p.000027: • persons with physical disabilities
p.000027: • prisoners
p.000027: • collectivities
p.000027:
p.000027: Note this list is not exhaustive but provides an indication of the types of consideration to be applied
p.000027: 3.2.2 Minors (children and adolescents)
p.000027:
...
p.000031: Parental permission and minor’s decision must be consistent, i.e. if the minor decides not to participate, the parent
p.000031: may not override this decision. If the parent is reluctant for the minor to participate but the minor wants to
p.000031: do so, the matter must be managed carefully to establish what the concerns are and whether they may be
p.000031: resolved. The minor cannot choose to participate if the parent withholds permission for that minor
p.000031: to choose. Researchers are unlikely to be able to intervene where the suspicion is that the parent is
p.000031:
p.000031: 26 See 3.2.2.4.
p.000031:
p.000031: 32 Ethics in Health Research 2nd edition
p.000031:
p.000031:
p.000031: withholding permission unreasonably, since a best interest analysis in this context is irrelevant.
p.000031: 3.2.2.3 Orphans without guardians
p.000031: i. Introduction
p.000031: Many minors in South Africa do not have parents and very few have court-appointed guardians. These minors
p.000031: are often described as ‘orphans and vulnerable children’ or OVC. The absence of a legally appropriate parental
p.000031: substitute poses a problem for researchers because of the lack of clear guidance as to an acceptable substitute in
p.000031: the informed consent process for research participation. (Note that for treatment purposes, substituted
p.000031: consent occurs on the basis of necessity, which is not applicable to the research context.)
p.000031: ii. Justification
p.000031: Important research that seeks to understand and improve psychosocial, economic and educational conditions for
p.000031: orphans and vulnerable children to improve their future well being generally involves no more than minimal risk
p.000031: of harm. Other research including clinical research that may involve a minor increase over minimal risk of harm
p.000031: may also be justified on the basis that it would be unjustifiable to exclude a significant segment of the
p.000031: child population from research on the basis of their legal status. Consequently, it is ethical and reasonable to
p.000031: designate parental substitutes in these circumstances.
p.000031: iii. Pragmatic parental substitutes27
p.000031: In the interest of fostering consistency as well as compliance with the spirit of the legal provisions
p.000031: that protect minors’ interests, especially the Constitution and the Children’s Act, pragmatic guidance is provided
p.000031: here to deal with situations where no biological parent or legal guardian exists. The permissible level of
p.000031: risk is limited (see 3.2.2.1).
p.000031: Note this guidance does not permit expedient substitution e.g. where a parent is temporarily unavailable.
...
p.000039: • the research interventions pose no more risk of harm than that inherent in the patient’s condition
p.000039: or alternative methods of treatment; and
p.000039: • the research is based on valid scientific hypotheses that support a reasonable possibility of more
p.000039: benefit than that offered by standard care; and
p.000039: • as soon as reasonably possible, the participant and her relatives or legal representatives
p.000039: will be informed of the participant’s inclusion in the research; be requested to give delayed consent;, and
p.000039: advised of the right to withdraw from the research without any reduction in quality of care.
p.000039: 3.2.7 Persons with physical disabilities
p.000039:
p.000039: Recruitment strategies for research participation in general should be sensitive to the possibility that
p.000039: persons with physical disabilities may wish to volunteer and therefore should ensure that there are no unintended
p.000039: barriers to such participation; e.g. the absence of ramps or a lift for wheelchair-bound potential participants.
p.000039: Research involving participants with physical disabilities should anticipate possible barriers and include
p.000039: measures to minimise them.
p.000039: 3.2.8 Prisoners
p.000039:
p.000039: The chief reason to consider prisoners as a vulnerable class of persons is the potential effect of incarceration on
p.000039: the voluntariness of the decision to participate in research. Neither coercion (direct threat of negative
p.000039: sanction) nor undue influence is acceptable in the informed consent process. Researchers should pay
p.000039: attention to whether their intended participants are awaiting trial prisoners or convicted prisoners. Quite
p.000039: obviously, different ethical issues arise for the former group who remain innocent until proven
p.000039: guilty, notwithstanding being incarcerated. The recruitment strategy design must pay careful attention to
p.000039: how coercion and undue influence will be avoided. Similarly, persons administering questionnaires
p.000039: or conducting interviews must be conscious of environmental factors that may influence voluntariness.
p.000039: The REC should include, at least on an ad hoc basis, a member with experience and knowledge of working
p.000039: with prisoners when deliberating on the protocol. The researchers must comply also with the requirements of
p.000039: the Department of Correctional Services as listed at http://www.dcs.gov.za/services/Research.aspx.
p.000039:
...
p.000059: SOPs should cover topics including but not limited to
p.000059: • ethical and regulatory requirements for research with humans and research using animals
p.000059: • definitions as appropriate
p.000059: • institutional lines of authority and responsibility
p.000059: • REC activities and processes, including frequency of meetings, preparation of agenda and minutes (minutes should
p.000059: be detailed and include dissenting views), registers for meetings, expectations and time-lines for reviewers
p.000059:
p.000059: Ethics in Health Research 2nd edition
p.000061: 61
p.000061:
p.000061: • guidance and specification of REC procedures required for expedited and full REC review; if the REC
p.000061: reviews US federally funded research proposals, the procedures must comply with the US Common Rule (45 CFR 46)
p.000061: • quorum requirements
p.000061: • decisional analysis guidance
p.000061: • conflict of interest and of confidentiality regarding researchers
p.000061: • the protocol review process
p.000061: • continuing review and re-certification procedures
p.000061: • protocol amendment procedures
p.000061: • adverse events and unanticipated problems
p.000061: • protocol deviations and protocol violations
p.000061: • non-compliance consequences
p.000061: • suspension and termination
p.000061: • compliance checks and audits
p.000061: • informed consent
p.000061: • privacy and confidentiality regarding participants and their health care information
p.000061: • research involving minors
p.000061: • research involving vulnerable persons
p.000061: • data collection and storage
p.000061: • biological materials collection and storage
p.000061: • databases, registries and repositories
p.000061: • complaints procedures
p.000061: • whistleblower protection
p.000061:
p.000061: 4.5.1.1 Applications for ethics review
p.000061: i. Each research proposal should include a description of the ethical considerations implicated in the
p.000061: research.
p.000061: ii. The protocol should reflect adequate consideration of participants’ welfare, rights, beliefs,
p.000061: perceptions, customs and cultural heritage.
p.000061: iii. All documents and other material to be used to inform potential participants should be included in the ethics
p.000061: review application, such as information sheets, consent forms, questionnaires, advertisements, videos, dramatisations
p.000061: and letters.
p.000061: iv. Researchers should ensure that plain language adapted to anticipated literacy levels is used in the participant
p.000061: documentation. An indication of the readability level should be included (see also 3.1.9).
p.000061: v. Where research is to be conducted in community settings, evidence of consultation and plans for ongoing
p.000061: involvement should be included.
...
Searching for indicator vulnerability:
(return to top)
p.000003: role in development of these Guidelines and for their expert and technical input.
p.000003: The current NHREC comprises of Prof D du Toit (Chairperson), Prof D van Bogaert (Deputy Chairperson), Ms K Nevhutalu
p.000003: (NDoH), Ms C Slack, Adv LT Nevondwe, Prof A van Niekerk, Dr NP Sithebe, Ms ET Zwane, Ms T Sebata, Prof A
p.000003: Pope, the late Dr L Schoeman, Dr M Sekhoacha, Dr S Ncanana, Dr NJ Ramalivhana.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: MS MP. MATSOSO
p.000003: DIRECTOR-GENERAL: DEPARTMENT OF HEALTH DATE: 1 March 2015
p.000003:
p.000003: 4 Ethics in Health Research 2nd edition
p.000003:
p.000003: CONTENTS
p.000003: Chapter 1 Ethics in research p 6
p.000003:
p.000003: 1.1 Introduction
p.000003: 1.2 The research context
p.000003: 1.3 Regulatory authority
p.000003: 1.4 Research with humans
p.000003: 1.5 Research using animals
p.000003: 1.6 Ethical research review
p.000003: 1.7 Glossary and resources
p.000003: 1.8 Purpose and status of these Guidelines
p.000003: 1.9 Structure of these Guidelines
p.000003:
p.000003: Chapter 2 Guiding principles for ethical research
p.000014: 14
p.000014:
p.000014: 2.1 Ethical principles
p.000014: 2.2 Role of ethical principles
p.000014: 2.3 Key norms & standards
p.000014:
p.000014: Chapter 3 Substantive norms and operational processes 18
p.000014:
p.000014: 3.1 Ethical basis for decision-making in the review process
p.000014: 3.2 Vulnerability and incapacity
p.000014: 3.3 Data and biological materials for research purposes
p.000014: 3.4 Considerations specific to research methods or contexts
p.000014: 3.5 Special topics
p.000014:
p.000014: Chapter 4 Research Ethics Committees 56
p.000014:
p.000014: 4.1 Introduction
p.000014: 4.2 Legislative framework
p.000014: 4.3 Role of Research Ethics Committees
p.000014: 4.4 Membership
p.000014: 4.5 Standard operating procedures
p.000014: 4.6 Compliance reporting to NHREC
p.000014:
p.000014:
p.000014: Chapter 5 Health research ethics infrastructure
p.000067: 67
p.000067:
p.000067: 5.1 Introduction
p.000067: 5.2 National Health Research Ethics Council
p.000067: 5.3 Research Ethics committees
p.000067:
p.000067: Ethics in Health Research 2nd edition
p.000005: 5
p.000005: 5.4 Registration and audit of committees
p.000005: 5.5 Statutory entities relevant to research
p.000005: Chapter 6 Qualitative research 73
p.000005:
p.000005: 6.1 Introduction
p.000005: 6.2 Nature of qualitative research
p.000005: 6.3 Methodological approaches and requirements
p.000005: 6.4 Approach to ethics review of qualitative research
p.000005: 6.5 Criteria for review process
...
p.000017: or negative, in a timely, accessible, responsible and competent manner. This includes reporting back to participant
p.000017: communities where appropriate, in accordance with the norm of role player engagement and collaboration.
p.000017:
p.000017: 18 Ethics in Health Research 2nd edition
p.000017:
p.000017:
p.000017:
p.000017: Chapter 3
p.000017:
p.000017: SUBSTANTIVE NORMS AND OPERATIONAL PROCESSES FOR ETHICS REVIEW
p.000017:
p.000017: Contents
p.000017:
p.000017:
p.000017: 3.1 Ethical basis for decision making in the review process p 19
p.000017: 3.1.1 Scientific design, aims & objectives 19
p.000017: 3.1.2 Inclusion & exclusion criteria
p.000020: 20
p.000020: 3.1.3 Selection of study population & sampling 20
p.000020: 3.1.4 Recruitment & enrolment
p.000020: 20
p.000020: 3.1.5 Research procedures
p.000021: 21
p.000021: 3.1.6 Risks of harm & likelihood of benefit 21
p.000021: 3.1.7 Reimbursements, inducements & costs for participants 22
p.000021: 3.1.8 Participants’ privacy & confidentiality interests 22
p.000021: 3.1.9 Obtaining informed consent 24
p.000021: 3.2 Vulnerability & incapacity
p.000026: 26
p.000026: 3.2.1 Contextual circumstances
p.000026: 26
p.000026: 3.2.2 Minors (children & adolescents) 27
p.000026: 3.2.3 Women
p.000035: 35
p.000035: 3.2.4 Adults with factual incapacity
p.000036: 36
p.000036: 3.2.5 Persons in dependent relationships 38
p.000036: 3.2.6 Patients highly dependent on medical care 38
p.000036: 3.2.7 Persons with physical disabilities
p.000038: 38
p.000038: 3.2.8 Prisoners
p.000039: 39
p.000039: 3.2.9 Collectivities
p.000040: 40
p.000040: 3.3 Data & biological material for research purposes 40
p.000040: 3.3.1 Introduction
p.000040: 40
p.000040: 3.3.2 Permitted usage of biological material 41
p.000040: 3.3.3 Identifiability of biological materials and data 41
p.000040: 3.3.4 Collection of biological materials and data 42
p.000040: 3.3.5 Restrictions on collection of biological material 42
...
p.000025: o the extent to which confidentiality is possible
p.000025: o whether reimbursement for expenses is available
p.000025: o that sponsors of the research and regulatory authorities may inspect research records
p.000025: o who the researchers are and the nature of their expertise
p.000025: o the potential benefits, if any, for participants both during and after the research
p.000025: o that the research may be terminated early in particular circumstances
p.000025: o that the research has been approved by a registered REC (include identifying details)
p.000025: • a measure to probe understanding and comprehension of the information is planned and how it proposes to do so
p.000025: especially for very vulnerable potential participants
p.000025: Where a clinical trial is proposed, additional information for prospective participants is required.18
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 17The Flesch-Kinkaid readability tool should be used to assess the complexity of text. This tool is built into MS
p.000025: Word’s spelling & grammar check tool as ‘readability statistics’. No more than Grade 8 equivalency should be the target
p.000025: complexity level.
p.000025: 18See Department of Health (2006) Guidelines for Good Practice in the Conduct of Clinical Trials with Human
p.000025: Participants in South Africa
p.000025: or its successor.
p.000025:
p.000025: 26 Ethics in Health Research 2nd edition
p.000025:
p.000025:
p.000025: 3.2 Vulnerability and incapacity
p.000025:
p.000025: Vulnerability is not an absolute condition but rather occurs on a sliding scale. In South Africa, arguably, the
p.000025: majority of potential research participants are vulnerable when compared to those in North America or Europe,
p.000025: from whence much funding is sourced. 19 Whether vulnerability is present is a matter of fact and degree.
p.000025: However, certain groups of participants 20 require careful consideration to ensure that, where appropriate,
p.000025: additional precautions are put into place. For example, advanced age, very young age, personal or
p.000025: environmental factors like extreme poverty and ordinarily poor access to health care may increase
p.000025: vulnerability
p.000025: 3.2.1 Contextual circumstances
p.000025: Personal circumstances, such as mental or intellectual impairment, acute illness, advanced age, and pregnancy and
p.000025: childbirth may increase vulnerability. Persons may be factually incapable or less capable of understanding
p.000025: information and processing it to reach a decision
p.000025: e.g. about whether to participate in research. Environmental circumstances may also increase vulnerability such as very
p.000025: poor socio-economic conditions, low levels of formal education and literacy, or restricted access to health care
p.000025: services. Such persons may be more easily persuaded to agree to participate without a properly considered
p.000025: understanding of the implications.
p.000025: It is important to note the difference between legal incapacity and factual incapacity. No person may
p.000025: claim that, because a minor is factually capable, the legal incapacity should be waived. On the other hand, no adult
p.000025: may be assumed to be incapable unless incapacity is established factually. Consequently, mental incapacity must
p.000025: be established by a factual assessment of the individual’s abilities to understand and to
p.000025: communicate that understanding. Legal incapacity prevails notwithstanding the existence of factual capacity.
p.000025: South Africa is home to a number of vulnerable communities. Where factors usually associated with
p.000025: vulnerability are integral to the research, the proposal should demonstrate how vulnerability would be managed.
p.000025: Particular caution should be exercised before undertaking research involving participants in such
p.000025: communities, and RECs should ensure that
p.000025: • persons in these communities are not being involved in research merely because they are expediently accessible,
p.000025: while the research could be carried out in a less vulnerable community;
p.000025: • the research is relevant to the health needs and priorities of the community in which it is to be carried out;
p.000025: and that
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 19 UNAIDS defines ‘vulnerable community’ as having some or all of the following characteristics: limited economic
p.000025: development; inadequate protection of human rights and discrimination on the basis of the health status; inadequate
p.000025: community/cultural experience and understanding of scientific research; limited access to health care and treatment
p.000025: options; limited ability of individuals in the community to provide informed consent.
p.000025: 20 For further, more detailed, discussion on special classes of participants, see CIOMS International Ethical
p.000025: Guidelines for Biomedical
p.000025: Research Involving Human Subjects (2002) Guidelines 13-17,
p.000025: http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm; US Department of Health & Human Services,
...
p.000045: Note this list is not exhaustive, merely illustrative.
p.000045:
p.000045: 3.4.1 Major incidents and research
p.000045:
p.000045: Major incidents include any sudden event that occurs where local resources are constrained, so that responding
p.000045: urgently and appropriately is difficult. Major incidents include acute disasters – natural or man-made –
p.000045: such as floods, tornados, earthquakes, outbreaks of deadly disease, or political violence and armed
p.000045: conflict with resultant injuries to humans.
p.000045:
p.000045: 38The Human Heredity and Health in Africa (H3Africa) Initiative http://h3africa.org/about/vision.
p.000045: 39 Previously known as disaster research.
p.000045:
p.000045: 46 Ethics in Health Research 2nd edition
p.000045:
p.000045:
p.000045: They may also take the form of an unusual and sudden demand on local resources or other emergency with consequent
p.000045: ethical implications for patient care. Research in these contexts is important for advancing emergency health
p.000045: care interventions and treatments, and for refining resource allocation policies. The potential benefits of major
p.000045: incident research include improved triage methods and procedures, effective treatment for life-threatening conditions
p.000045: and improving therapies for survival and quality of life.
p.000045: Although patients in a major incident context face extreme vulnerability, RECs should be cautious about
p.000045: being overly restrictive about the type of research that may be conducted. The development of new drugs and procedures
p.000045: to treat emergency patients safely depends on being able to conduct research, including carefully designed randomised
p.000045: controlled trials.
p.000045: In order to carry out research in such contexts, planning of the research and ethics clearance processes usually must
p.000045: occur very rapidly. From the REC perspective, proposals for major incident research usually demand expedited
p.000045: processing, which means that the time for deliberation is curtailed.
p.000045: When research is not actually dependent on a major incident context, the proposal should be approached cautiously.
p.000045: RECs should consider carefully whether sufficient justification is presented for expedited processing. In the
p.000045: same way that research involving minors should be done only when adult participants cannot provide the necessary data,
p.000045: so major incident research should take place about matters that are unlikely to or do not occur in ‘ordinary’ contexts.
p.000045: Informed consent usually has to be obtained rapidly and at a time when vulnerability of patients and
p.000045: families is likely to be extreme. Patients may be incapacitated (i.e. unconscious or on a ventilator), which points to
p.000045: the likelihood of difficulties with the usual approach to informed consent. Consequently, RECs may consider
p.000045: alternative approaches such as proxy consent or delaying consent in particular circumstances. (See 3.2.4.3, 3.2.4.4 &
p.000045: 3.2.6.)
p.000045: 3.4.2 Intensive care research
p.000045:
p.000045: Characteristic features of intensive care research include difficulties in communicating with patients receiving
p.000045: ventilation assistance and impairment of cognition in heavily sedated individuals.
p.000045: Whenever possible, informed consent for planned intensive care research should be obtained from potential participants
p.000045: before admission to that care. See 3.2.4.3, 3.2.4.4 & 3.2.6.
p.000045: Research involving infants receiving neonatal intensive care should be conducted in strict accordance with
p.000045: the principles set out for minors (see 3.2.1 above). These principles do not permit research that is contrary to
p.000045: the child’s best interest. The small size and extreme vulnerability of some infants are unique features of this
p.000045: class of participants. This means that all but minimally intrusive interventions are likely to be contrary to the
p.000045: child’s best interest. Collection of even small blood samples for research in addition to those required
p.000045: for diagnostic purposes, or additional handling of a low birth-weight infant to make research- related observations,
p.000045: requires very careful justification and skill, especially in assessing the risk-benefit ratio. Input from neonatal
p.000045: intensive care experts should be sought.
p.000045:
p.000045: Ethics in Health Research 2nd edition
p.000047: 47
p.000047:
p.000047: 3.4.3 Terminal care research
p.000047:
p.000047: Terminal care research is distinguished by the short remaining life expectancy of participants and their potential
p.000047: vulnerability to unrealistic expectations of benefits from participation in research. In principle, because of their
p.000047: extreme vulnerability, terminally ill patients should not participate in research that is more than minimally invasive
p.000047: without adequate justification.
p.000047: The prospect of any direct benefit from research participation must not be overstated or used to justify a risk of harm
p.000047: higher than that involved in current treatment. Research participation must not be used to prevent or devalue the needs
p.000047: and wishes of participants rather to spend time as they choose, particularly with family members.
p.000047: 3.4.4 Traditional medicines research
p.000047:
p.000047: In line with the constitutional guarantees for cultural and language rights, 40 indigenous cultures and
p.000047: traditional values of all communities must be respected. However, since fundamental rights do not trump
p.000047: each other without careful justification, participants in research involving traditional medical systems and
p.000047: beliefs must be accorded the same respect and protection as any other human research participant. 41 The
p.000047: context of the research activity, interaction or intervention is important for determining whether, how and when to
p.000047: incorporate traditional values and their cultural expression in research.
p.000047: In terms of the Traditional Health Practitioners Act 22 of 2007,
...
p.000079: so on. Usually demographic and medical information about the donors is included in the repository as are
p.000079: codes that link the material to the donors
p.000079: Research – includes a range of activities conducted by many different disciplines that may use different
p.000079: methodologies and explanatory frameworks to extend knowledge through disciplined inquiry or systematic
p.000079: investigation
p.000079: Risk – function of the magnitude of harm and the probability that it will occur
p.000079: Risk of harm to likelihood of benefit ratio – analysis of whether the risk of harm implied is justifiable in light of
p.000079: the likelihood of benefit
p.000079: Therapeutic intervention –interventions directed towards direct health-related benefit for a participant (NHA Reg 135)
p.000079: Tiered consent – donor permits use of biological materials for current study; and chooses whether to permit storage
p.000079: for future use, sample and data sharing.
p.000079: Undue influence – effect of an unequal power relationship on voluntariness; may occur when recruitment of
p.000079: participants is done by authority figure
p.000079: Virtual Repository– a digitised system that manages distributed bar-coded electronic versions of material,
p.000079: data or images through shared data systems
p.000079: Vulnerability – diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000079: project; may be caused by limited capacity or limited access to social goods like rights, opportunities and power
p.000079:
p.000079: 80 Ethics in Health Research 2nd edition
p.000079:
p.000079:
p.000079:
p.000079: APPENDIX 2
p.000079:
p.000079: Resources
p.000079:
p.000079: Online training opportunities
p.000079:
p.000079: These links are to FREE online training in research ethics and some also do Responsible Conduct of Research
p.000079: 1. The AMANET (African Malaria Network Trust)
p.000079: http://webcourses.amanet-trust.org/mod/resource/view.php?inpopup=true&id=116
p.000079: The AMANET (African Malaria Network Trust) web-based health research ethics training programme aims at
p.000079: providing the basic understanding in biomedical research ethics. On the premise of scarcity of resources and
p.000079: opportunities for such training for Africans, this effort hopes to provide this service to the many African members of
p.000079: IRB’s and investigators who may wish to undertake the course at home or in their office and at their own time up to a
p.000079: maximum period of four months for each student number issued.
...
Health / Cognitive Impairment
Searching for indicator cognitive:
(return to top)
p.000027: circumstances of the proposal before the REC. For example, an automatic assumption that impoverished people cannot
p.000027: choose responsibly whether to participate in research is disrespectful because it denies their autonomy.
p.000027: If compliance with the additional measures is poor and participants’ welfare is negatively affected,
p.000027: approval for the study may be withdrawn, temporarily or permanently, as the case may be.
p.000027: Groups of participants discussed here include
p.000027: • minors (children and adolescents)
p.000027: • women
p.000027: • adults with incapacity to provide informed consent
p.000027: • persons in dependent relationships
p.000027: • persons highly dependent on medical care
p.000027: • persons with physical disabilities
p.000027: • prisoners
p.000027: • collectivities
p.000027:
p.000027: Note this list is not exhaustive but provides an indication of the types of consideration to be applied
p.000027: 3.2.2 Minors (children and adolescents)
p.000027:
p.000027: Below the age of majority, the law protects young people from their own emotional, cognitive and physical immaturity
p.000027: and limited life experience through the legal status of minority. In other words, minors, i.e. persons under 18 years
p.000027: of age,22 are legally incapable of performing legal transactions without assistance from a parent or guardian. In the
p.000027: research context, this means that, in principle, anyone under the age of 18 years may not choose independently whether
p.000027: to participate in research; a parent or guardian must give permission for the minor
p.000027:
p.000027: 21 Note that this requirement does not mean that a REC may not approve a waiver of personal informed consent for types
p.000027: of research into e.g. record reviews or such like.
p.000027: 22 Section 28 of the Constitution; and s 17 of the Children’s Act 38 of 2005.
p.000027:
p.000027: 28 Ethics in Health Research 2nd edition
p.000027:
p.000027:
p.000027: to choose. This is because young persons’ understanding of key aspects of the research initiative may be
p.000027: compromised and, consequently, they may be exposed to increased risk of harm from particular research procedures.
...
Searching for indicator impaired:
(return to top)
p.000017: research or denied the benefits of knowledge derived from it.’7 There should be a reasonable likelihood that the
p.000017:
p.000017: 7 Tri-Council Policy Statement (Canada) 2010, 10.
p.000017:
p.000017: Ethics in Health Research 2nd edition
p.000015: 15
p.000015:
p.000015: population from which participants are drawn will benefit from the research results, if not immediately, then in the
p.000015: future.
p.000015: • respect for persons (dignity and autonomy)
p.000015: This principle requires that persons capable of deliberation about their choices must be treated with
p.000015: respect and permitted to exercise self-determination. Further, persons who lack capacity or who have diminished
p.000015: capacity for deliberation about their choices must be protected against harm from irresponsible choices.
p.000015: Respect for persons recognises that dignity, well-being and safety interests of all research participants are the
p.000015: primary concern in research that involves human participants. Respect for persons includes ‘the dual moral
p.000015: obligations to respect autonomy and to protect those with developing, impaired or diminished autonomy’.8 Autonomy
p.000015: includes the ability to deliberate about a decision and to act on that decision. Interests of participants should
p.000015: usually outweigh the interests of science and society. Consequently, involvement of persons or particular
p.000015: categories of people in the research should be justified in research proposals. Respect for persons means also that
p.000015: the interests of researchers must be considered. These include welfare and safety interests, authorship and
p.000015: intellectual property interests, and collegial and professional interests.
p.000015: 2.2 Role of ethical principles
p.000015:
p.000015: Ethical principles assist RECs to identify and protect the interests of research participants in a variety of research
p.000015: contexts and to promote development of high-quality knowledge that may benefit future generations. These ethics
p.000015: principles are articulated in national and international research ethics guidelines. Persons who conduct research
p.000015: in South Africa are expected to adhere to these principles which underscore responsible and ethical research
p.000015: conduct.
p.000015: Note: Detailed discussion about how to apply these principles is in Chapter 3.
p.000015:
p.000015: 2.3 Key norms and standards
p.000015:
p.000015: The key ethical norms and standards are:
p.000015: • Relevance and value
p.000015: • Scientific integrity
...
p.000035: 3.2.4.2 Minors and decision-making incapacity
p.000035: Parents or guardians of minors with intellectual or mental impairments should give permission for their
p.000035: minor children to choose whether to participate in research. If the minor
p.000035:
p.000035: 32 Georgetown University Informed Consent and Limitations on Decision making Capacity Chapter 2
p.000035: https://bioethicsarchive.georgetown.edu/nbac/capacity/Informed.htm
p.000035:
p.000035: Ethics in Health Research 2nd edition
p.000037: 37
p.000037:
p.000037: is unable to communicate at all or lacks the capacity to choose, then the parent or guardian should choose whether
p.000037: the minor may be enrolled. In other words, the parent acts as a proxy decision maker. In the case of a
p.000037: minor who remains intellectually or mentally impaired after reaching the age of majority, the situation changes
p.000037: because the person becomes an adult with decision-making incapacity (see 3.2.4.3 below).
p.000037: 3.2.4.3 Adults incapable of giving adequate informed consent
p.000037: Proxy decision makers are not permitted for adult persons who lack capacity unless the proxy is a court-appointed
p.000037: curator. Neither the National Health Act 61 of 2003 nor the Mental Health Care Act 17 of 2002 makes
p.000037: provision for proxy decision makers for research purposes but they provide clear lists of proxy decision makers for
p.000037: treatment purposes.
p.000037: Since it would be unethical to exclude a category of persons from research participation without adequate
p.000037: justification, arguably, an ethical argument can be made for using the statutory treatment proxies to
p.000037: provide permission for participation in research that complies with the stipulations set out below. However,
p.000037: RECs must be careful not to confuse the distinction between treatment and research. In unusual circumstances,
p.000037: e.g. major incident research (see 3.4.1), it may be ethically permissible to permit proxy consent also in
p.000037: a situation where no statutory proxy is available but the risk of harm to knowledge ratio justifies it.
...
Searching for indicator impairment:
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p.000025: Participants in South Africa
p.000025: or its successor.
p.000025:
p.000025: 26 Ethics in Health Research 2nd edition
p.000025:
p.000025:
p.000025: 3.2 Vulnerability and incapacity
p.000025:
p.000025: Vulnerability is not an absolute condition but rather occurs on a sliding scale. In South Africa, arguably, the
p.000025: majority of potential research participants are vulnerable when compared to those in North America or Europe,
p.000025: from whence much funding is sourced. 19 Whether vulnerability is present is a matter of fact and degree.
p.000025: However, certain groups of participants 20 require careful consideration to ensure that, where appropriate,
p.000025: additional precautions are put into place. For example, advanced age, very young age, personal or
p.000025: environmental factors like extreme poverty and ordinarily poor access to health care may increase
p.000025: vulnerability
p.000025: 3.2.1 Contextual circumstances
p.000025: Personal circumstances, such as mental or intellectual impairment, acute illness, advanced age, and pregnancy and
p.000025: childbirth may increase vulnerability. Persons may be factually incapable or less capable of understanding
p.000025: information and processing it to reach a decision
p.000025: e.g. about whether to participate in research. Environmental circumstances may also increase vulnerability such as very
p.000025: poor socio-economic conditions, low levels of formal education and literacy, or restricted access to health care
p.000025: services. Such persons may be more easily persuaded to agree to participate without a properly considered
p.000025: understanding of the implications.
p.000025: It is important to note the difference between legal incapacity and factual incapacity. No person may
p.000025: claim that, because a minor is factually capable, the legal incapacity should be waived. On the other hand, no adult
...
p.000045: processing, which means that the time for deliberation is curtailed.
p.000045: When research is not actually dependent on a major incident context, the proposal should be approached cautiously.
p.000045: RECs should consider carefully whether sufficient justification is presented for expedited processing. In the
p.000045: same way that research involving minors should be done only when adult participants cannot provide the necessary data,
p.000045: so major incident research should take place about matters that are unlikely to or do not occur in ‘ordinary’ contexts.
p.000045: Informed consent usually has to be obtained rapidly and at a time when vulnerability of patients and
p.000045: families is likely to be extreme. Patients may be incapacitated (i.e. unconscious or on a ventilator), which points to
p.000045: the likelihood of difficulties with the usual approach to informed consent. Consequently, RECs may consider
p.000045: alternative approaches such as proxy consent or delaying consent in particular circumstances. (See 3.2.4.3, 3.2.4.4 &
p.000045: 3.2.6.)
p.000045: 3.4.2 Intensive care research
p.000045:
p.000045: Characteristic features of intensive care research include difficulties in communicating with patients receiving
p.000045: ventilation assistance and impairment of cognition in heavily sedated individuals.
p.000045: Whenever possible, informed consent for planned intensive care research should be obtained from potential participants
p.000045: before admission to that care. See 3.2.4.3, 3.2.4.4 & 3.2.6.
p.000045: Research involving infants receiving neonatal intensive care should be conducted in strict accordance with
p.000045: the principles set out for minors (see 3.2.1 above). These principles do not permit research that is contrary to
p.000045: the child’s best interest. The small size and extreme vulnerability of some infants are unique features of this
p.000045: class of participants. This means that all but minimally intrusive interventions are likely to be contrary to the
p.000045: child’s best interest. Collection of even small blood samples for research in addition to those required
p.000045: for diagnostic purposes, or additional handling of a low birth-weight infant to make research- related observations,
p.000045: requires very careful justification and skill, especially in assessing the risk-benefit ratio. Input from neonatal
p.000045: intensive care experts should be sought.
p.000045:
p.000045: Ethics in Health Research 2nd edition
p.000047: 47
p.000047:
p.000047: 3.4.3 Terminal care research
p.000047:
...
Health / Drug Dependence
Searching for indicator dependence:
(return to top)
p.000047: and wishes of participants rather to spend time as they choose, particularly with family members.
p.000047: 3.4.4 Traditional medicines research
p.000047:
p.000047: In line with the constitutional guarantees for cultural and language rights, 40 indigenous cultures and
p.000047: traditional values of all communities must be respected. However, since fundamental rights do not trump
p.000047: each other without careful justification, participants in research involving traditional medical systems and
p.000047: beliefs must be accorded the same respect and protection as any other human research participant. 41 The
p.000047: context of the research activity, interaction or intervention is important for determining whether, how and when to
p.000047: incorporate traditional values and their cultural expression in research.
p.000047: In terms of the Traditional Health Practitioners Act 22 of 2007,
p.000047: 'Traditional medicine' means an object or substance used in traditional health practice for-
p.000047: (a) the diagnosis, treatment or prevention of a physical or mental illness; or
p.000047: (b) any curative or therapeutic purpose, including the maintenance or restoration of physical or mental health or
p.000047: well-being in human beings,
p.000047: but does not include a dependence-producing or dangerous substance or drug.
p.000047: 'Traditional health practice' means the performance of a function, activity, process or service based on a
p.000047: traditional philosophy that includes the utilisation of traditional medicine or traditional practice and which has as
p.000047: its object-
p.000047: (a) the maintenance or restoration of physical or mental health or function; or
p.000047: (b) the diagnosis, treatment or prevention of a physical or mental illness; or
p.000047: (c) the rehabilitation of a person to enable that person to resume normal functioning within the family or community;
p.000047: or
p.000047: (d) the physical or mental preparation of an individual for puberty, adulthood, pregnancy, childbirth and
p.000047: death,
p.000047: but excludes the professional activities of a person practising any of the professions contemplated in the
p.000047: Pharmacy Act 53 of 1974, the Health Professions Act 56 of 1974, the Nursing Act 50 of 1974, the Allied Health
p.000047: Professions Act 63 of 1982, or the Dental Technicians Act 19 of 1979, and any other activity not based on
p.000047: traditional philosophy.
p.000047:
p.000047:
p.000047:
p.000047: 40 Sections 30 and 31 of the Constitution.
p.000047: 41 In terms of s 12(2)(c) of the Constitution and s 71 of the National Health Act.
p.000047:
p.000047: 48 Ethics in Health Research 2nd edition
p.000047:
p.000047:
...
Searching for indicator dependency:
(return to top)
p.000037: or disabilities and their care-givers; persons with life- threatening illnesses; patients and health care
p.000037: professionals; wards of state and guardians; students and teachers (including university teachers); employees and
p.000037: employers, including farm workers, members of the uniformed services and hospital staff and their
p.000037: respective employers.
p.000037: Particular attention should be given to ensuring that participants are adequately informed and can choose
p.000037: voluntarily whether to participate in research.
p.000037: 3.2.6 Patients highly dependent on medical care
p.000037:
p.000037: Patients who are highly dependent on medical care deserve special attention when considering research
p.000037: participation. The gravity of their medical condition may require invasive measures that carry increased risk of
p.000037: harm. The quality of informed consent may be compromised by the effect the medical condition has on the
p.000037: participant’s decision-making or communication abilities. A patient may be reluctant to refuse consent for fear that
p.000037: this may compromise his medical treatment. Adequate provision must be made for informing patients and their relatives
p.000037: about the research, to ensure that stress and other emotional factors do not impair their understanding. The dependency
p.000037: of patients and their relatives on caregivers should not unduly affect research participation decisions.
p.000037:
p.000037: Ethics in Health Research 2nd edition
p.000039: 39
p.000039:
p.000039: In particular circumstances, the REC may approve delayed consent.
p.000039: Note this does not mean that informed consent is waived.
p.000039: RECs should ensure that a clear and full justification for the proposed delay accompanies the research proposal. The
p.000039: individual circumstances of the patient must be carefully considered to prevent inadvertent violation of personal or
p.000039: cultural values.
p.000039: The REC may approve a delay in obtaining informed consent for research participation by patients highly dependent on
p.000039: medical care if
p.000039: • the research is based on valid scientific hypotheses that support a reasonable possibility of more
p.000039: benefit than that offered by standard care; and
p.000039: • participation is not contrary to the medical interests of the patient; and
p.000039: • the research interventions pose no more risk of harm than that inherent in the patient’s condition
p.000039: or alternative methods of treatment; and
p.000039: • the research is based on valid scientific hypotheses that support a reasonable possibility of more
p.000039: benefit than that offered by standard care; and
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000035: • appropriate studies on animals and non-pregnant individuals have been completed;31
p.000035: • the risk of harm to the fetus is minimal; and
p.000035:
p.000035: 31 Clinical trials involving pregnant women or nursing mothers should ideally involve products where the toxicology in
p.000035: adults is established and is acceptable. In the case of pregnant women, the potential risks associated with using a
p.000035: substance whose short term and long-term effects on a fetus and developing infant are unknown, should be outweighed by
p.000035: the benefits. An example of a positive risk-benefit ratio would be the use of anti-retrovirals in mother to child HIV
p.000035: transmission studies. For nursing mothers, the amount of drug passing into breast milk should be established and the
p.000035: potential impact on a breast-fed infant anticipated, and the mother so advised.
p.000035:
p.000035: 36 Ethics in Health Research 2nd edition
p.000035:
p.000035:
p.000035: • in all cases, inclusion poses the least risk of harm possible for achieving the objectives of the research.
p.000035: 3.2.4 Adults with factual incapacity to provide informed consent
p.000035:
p.000035: Adults who are factually incapable of giving informed consent should participate in research only where their
p.000035: participation is indispensable to the research; i.e. the research cannot deliver the desired outcomes if
p.000035: capable adult participants were to be used instead. Further, the research should investigate a problem of
p.000035: relevance to incapacitated adults. Where research can be undertaken with capable adults but nevertheless proposes
p.000035: also to include incapacitated adults, strong justification for their inclusion must be provided.
p.000035: The primary difficulty for informed consent in this context is whether proxy consent is permissible. The
...
p.000047: 3.4.4 Traditional medicines research
p.000047:
p.000047: In line with the constitutional guarantees for cultural and language rights, 40 indigenous cultures and
p.000047: traditional values of all communities must be respected. However, since fundamental rights do not trump
p.000047: each other without careful justification, participants in research involving traditional medical systems and
p.000047: beliefs must be accorded the same respect and protection as any other human research participant. 41 The
p.000047: context of the research activity, interaction or intervention is important for determining whether, how and when to
p.000047: incorporate traditional values and their cultural expression in research.
p.000047: In terms of the Traditional Health Practitioners Act 22 of 2007,
p.000047: 'Traditional medicine' means an object or substance used in traditional health practice for-
p.000047: (a) the diagnosis, treatment or prevention of a physical or mental illness; or
p.000047: (b) any curative or therapeutic purpose, including the maintenance or restoration of physical or mental health or
p.000047: well-being in human beings,
p.000047: but does not include a dependence-producing or dangerous substance or drug.
p.000047: 'Traditional health practice' means the performance of a function, activity, process or service based on a
p.000047: traditional philosophy that includes the utilisation of traditional medicine or traditional practice and which has as
p.000047: its object-
p.000047: (a) the maintenance or restoration of physical or mental health or function; or
p.000047: (b) the diagnosis, treatment or prevention of a physical or mental illness; or
p.000047: (c) the rehabilitation of a person to enable that person to resume normal functioning within the family or community;
p.000047: or
p.000047: (d) the physical or mental preparation of an individual for puberty, adulthood, pregnancy, childbirth and
p.000047: death,
p.000047: but excludes the professional activities of a person practising any of the professions contemplated in the
p.000047: Pharmacy Act 53 of 1974, the Health Professions Act 56 of 1974, the Nursing Act 50 of 1974, the Allied Health
p.000047: Professions Act 63 of 1982, or the Dental Technicians Act 19 of 1979, and any other activity not based on
p.000047: traditional philosophy.
p.000047:
p.000047:
p.000047:
p.000047: 40 Sections 30 and 31 of the Constitution.
p.000047: 41 In terms of s 12(2)(c) of the Constitution and s 71 of the National Health Act.
p.000047:
p.000047: 48 Ethics in Health Research 2nd edition
p.000047:
p.000047:
...
p.000069: capacity building interventions. The aim is to foster a collaborative and mutually supportive environment in the
p.000069: research ethics context. The overall goal is to achieve a system that adheres to high standards across the board so
p.000069: that South Africans can rightfully be confident that the health research ethics infrastructure conducts
p.000069: itself with integrity, according to the highest ethical standards.
p.000069: Identified resources, including Standard Operating Procedures, training materials, courses, web-based
p.000069: information, as well as query and appeal processes, are available to enable unregistered RECs to register
p.000069: and become compliant.
p.000069: 5.5 Statutory entities relevant to research
p.000069:
p.000069: Certain statutory entities and professional bodies are relevant to research insofar as gatekeeping and
p.000069: professional standards for researchers are concerned. Some of the more significant entities and bodies are
p.000069: explained below.
p.000069: 5.5.1 The Medicines Control Council
p.000069: The Medicines Control Council (MCC) is the statutory body tasked with ensuring that the pharmaceutical
p.000069: drugs available for use in South Africa are safe, are of the requisite quality, and have the required efficacy
p.000069: (effect). In order to carry out this mandate, the MCC must decide, based on sound scientific evidence and other
p.000069: relevant information, whether the decision to permit registration of a particular drug for particular uses
p.000069: is in the interest of public health.
p.000069: Additionally, the MCC must approve the use of unregistered medicinal substances for research purposes, as
p.000069: well as sanction new applications of registered substances where a dose change, method of administration, etc is
p.000069: to be tested. Consequently, all clinical trials of registered and unregistered substances or interventions are
p.000069: reviewed by the MCC. Clinical trials are conducted in accordance with these guidelines and the Guidelines for Good
p.000069: Practice
p.000069:
p.000069: Ethics in Health Research 2nd edition
p.000071: 71
p.000071:
p.000071: in the Conduct of Clinical Trials with Human Participants in South Africa. Breaches of the guidelines may
p.000071: lead to termination of the trial by the MCC. This means that the MCC and the NHREC have concurrent jurisdiction over
p.000071: clinical trial research: the MCC focuses specifically but not exclusively on the scientific aspects, while the
p.000071: NHREC focuses specifically but not exclusively on the ethical aspects.
p.000071: 5.5.2 South African National Clinical Trial Register
p.000071: Sponsors of clinical trials must register all South African-based trials on the South African National
p.000071: Clinical Trial Register (SANCTR) which is managed by the Department of Health. If the trial has no commercial sponsor,
p.000071: the Principal Investigator (PI) must register the trial. See the Guidelines for Good Practice in the Conduct of
p.000071: Clinical Trials with Human Participants in South Africa (SAGCP) for more information. Note that it is not the
p.000071: responsibility of RECs to oversee compliance with this requirement.
...
p.000085:
p.000085: < Insert hospital name >
p.000085:
p.000085: NOVEL, INNOVATIVE OR UNPROVEN TREATMENT CONSENT FORM
p.000085:
p.000085: How to use this Consent Form
p.000085: Read carefully through the whole document
p.000085: Fill in the RED areas ELECTRONICALLY (for future data collection) Make sure that all the necessary information is
p.000085: included
p.000085: The information written in BLUE is for guidance and should be removed before finalizing the document
p.000085: Print three (3) copies: one for patient’s folder, one for PTC, and one for the patient or her family
p.000085: This document is for a single patient use and a single treatment course only.
p.000085:
p.000085: This document tells you about a treatment for your (your child’s) condition that is still experimental but which your
p.000085: doctors would like to try. You are not being asked to join a research project. Important differences
p.000085: exist between experimental treatment and a research project.
p.000085: This treatment is experimental because
p.000085: < delete options that do not apply >
p.000085: It has been tested for conditions other than yours (your child’s).
p.000085: It has been tested for use with adults but not for use with children (< 18 years; < 12 years) It has not been registered
p.000085: in South Africa for use for your condition.
p.000085:
p.000085:
p.000085:
p.000085: Name of Drug Or Intervention
p.000085: Single Patient Use of < Insert Investigational Drug or Intervention Name >
p.000085:
p.000085:
p.000085: Treating Health care worker(s):
p.000085: < Insert Name >
p.000085: < Insert Address/Medical ward details >
p.000085: < Insert Phone Numbers/ Medical ward extension >
p.000085:
p.000085:
p.000085: Emergency Contact < Insert Emergency Contact Information >
p.000085: < Insert Phone Number/Pager, etc >
p.000085:
p.000085:
p.000085: < Insert name of investigational drug or other intervention > is a treatment that < insert either current approval status
p.000085: by the Medicines Control Council for another condition or provide a patient appropriate explanation of what
p.000085: the investigational drug or intervention is intended to do >.
p.000085:
p.000085: This treatment is not approved for < indicate what condition the patient has >, which means its use is experimental. We
p.000085: are not sure that this experimental treatment will cure or improve your condition. But in your circumstances, we offer
p.000085: you the opportunity to try it.
p.000085:
p.000085: Ethics in Health Research 2nd edition
p.000087: 87
p.000087:
p.000087: We must get permission from the hospital authorities before we may use this experimental treatment
p.000087: for you. The hospital authorities keep a careful watch over your welfare interests, especially that you
p.000087: should choose voluntarily. This is why you are asked to choose whether you would like to try the experimental treatment
p.000087: before we request permission to use the drug for you.
p.000087: You do not have to use the experimental treatment.
p.000087: Why is this experimental treatment being offered?
p.000087: Your doctors think this experimental treatment may offer an option for your clinical care, as < insert in plain language
p.000087: a description that describes why this treatment is the best option for the patient in the circumstances >
p.000087:
p.000087: How long will I take this experimental treatment?
p.000087: The total length of time you would receive this treatment will depend on many factors including: (i) how your medical
p.000087: condition responds to the experimental treatment, and (ii) further information about this use of the drug in
p.000087: your medical condition
p.000087: [Incorporate a specific schedule for the receipt of the investigational drug, if one is known] What does the
p.000087: experimental treatment involve?
p.000087: You will receive this experimental treatment in < location where the treatment (i.e. hospital
p.000087: (clinic/medical ward/OPD), home, private care, etc) will be given >. You will be asked to take a < insert appropriate
p.000087: dose (mg/mcg/ml) > dose < insert dosing schedule, i.e. once-off, once per day, 12 hourly, etc >
p.000087:
p.000087: [Be sure to include any other drugs that are taken in combination with the experimental treatment drug if appropriate
p.000087: Provide information pertaining to any safety or other assessments needed during the time that the patient receives the
p.000087: experimental treatment drug]
p.000087:
p.000087: What are the possible side effects or risks of harm?
p.000087: •Likely: < Provide appropriate risk listing >
p.000087: •Less Likely: < Provide appropriate risk listing >
p.000087: •Rare: < Provide appropriate risk listing >
p.000087: •Unknown Side Effects:
p.000087: There may also be other side effects, unknown at present, that could harm you while you are using this experimental
p.000087: treatment or after you have finished using it. We cannot predict what these currently unknown side effects
p.000087: may be. This is why it is very important that you must report any side effects you experience to your doctors
p.000087: immediately. We want to be able to treat any reaction quickly and appropriately.
p.000087: The possibility exists that you could have a reaction that, if not treated properly, could be life
p.000087: threatening
p.000087:
p.000087: What are the possible benefits of using this experimental treatment?
p.000087: You may or may not receive any benefit from using this treatment; in other words, your condition may not respond
p.000087: to the treatment.
p.000087:
p.000087: 88 Ethics in Health Research 2nd edition
p.000087:
p.000087:
p.000087: What if new information about the experimental treatment becomes available?
p.000087: While you are using this treatment, we may find out more information that could be important to your treatment.
p.000087: This includes information that might cause you to change your mind about taking the drug. We will tell you as
p.000087: soon as possible if such information becomes available so that you are informed at all times.
p.000087:
p.000087: What other choices do I have if I do not use this experimental treatment?
p.000087: Your doctors think that, at the moment, there are no other satisfactory alternatives available to you. You do have the
p.000087: option of deciding to refuse further treatment and only accept care for comfort. You can discuss these options with
p.000087: your doctors.
p.000087:
p.000087: What happens if I am harmed because of using the experimental treatment?
p.000087: We will give you the necessary medical care to treat the harms or injuries that result directly from using the
p.000087: experimental treatment.
p.000087:
p.000087: When will my participation be over?
p.000087: Your participation will last until < insert endpoint in appropriate language based on investigational drug
p.000087: being used >.
p.000087:
p.000087: If you decide to use this experimental treatment, you are free to stop taking it any time. Please
p.000087: inform your treating physician(S) if you choose to do this, so appropriate follow-up can occur.
p.000087:
p.000087: [Ensure that whether withdrawal is possible is clear to patient or family member]
p.000087:
p.000087: Who can see or use my information? How will my personal information be protected?
p.000087: The personal information in your medical record will be kept confidential as is usual with health
p.000087: information. However, we cannot guarantee total privacy. Your personal information may be shared with other health care
p.000087: professionals where it is in your best interest to do so and if required by law.
p.000087:
p.000087: Who can I call if I have questions, concerns or complaints?
p.000087: If you have questions, concerns or complaints, you should speak to your doctor listed on page one of this form.
p.000087:
p.000087: Who will know that I am receiving an experimental treatment?
p.000087: Your doctors and the rest of the medical team will know that you are using an experimental treatment.
p.000087: As explained above, your doctor will have obtained permission from the hospital authorities to use it.
p.000087: As is usual, your privacy interests will be respected and information about your treatment and condition will be
p.000087: confidential to the extent possible.
p.000087: Because of its experimental nature, we will want to write a report about what we learn from using this therapy for your
p.000087: treatment. This is to make the information available so that other doctors can learn more about it too. However, your
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Searching for indicator influence:
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p.000051: participants might be offset against likelihood of benefit to others, in some circumstances.
p.000051: 3.1.4 Recruitment and enrolment
p.000051: Recruitment strategies should be neutral, and should describe the purpose of the research, the anticipated risks of
p.000051: harm and potential benefit of participation and other relevant details.
p.000051:
p.000051: Ethics in Health Research 2nd edition
p.000021: 21
p.000021:
p.000021: Recruitment methods should be properly described in the proposal and the recruitment materials should be
p.000021: included with the proposal e.g. posters, flyers, and advertisements. Recruitment and enrolment processes
p.000021: should endeavour to avoid perceptions of selection bias. The location, context and timing of recruitment and
p.000021: enrolment should be appropriate for protection of privacy and confidentiality interests. If potential
p.000021: participants are in a dependent relationship with the researchers or recruiter, e.g. student/lecturer,
p.000021: patient
p.000021: /doctor, employee/employer, the proposal should explain the measures that ensure that the potential participant’s
p.000021: ability to make a voluntary choice is unrestricted. Where the researcher will recruit personally, the possibility
p.000021: of perceptions of undue influence or therapeutic misconception must be managed. The REC should enquire also
p.000021: whether the selected sample group has been or is currently involved in previously approved research so as to assess the
p.000021: possibility of excessive burden or risk exposure.
p.000021: 3.1.5 Research procedures
p.000021: The research procedures should be described in a manner that ensures the rationale and details are clear to
p.000021: the REC. Procedures that are standard of care should be differentiated from procedures necessary only for research
p.000021: purposes, to assist with weighing the risk of harm against the likelihood of benefit. The proposal should explain
p.000021: whether specific results of data collection, e.g. incidental findings, clinical test results and other
p.000021: clinically relevant findings, will be made known to participants.
p.000021: The appropriate expertise and qualifications of researchers, 9 study and project leaders to perform
p.000021: procedures should be assured, e.g. paediatric training is required for paediatric research procedures.
p.000021: Research procedures should not adversely affect routine treatment and management of patients or the functioning of
p.000021: health care facilities. In the case of research conducted in other settings, care should be exercised not to disrupt
p.000021: routine practices without the parties involved having made prior arrangements.
p.000021: 3.1.6 Risks of harm and likelihood of benefit
...
p.000021: method to determine the cost to participants for time expended, inconvenience and refreshments
p.000021: associated with research participation. This method costs expenses at the current hourly rate for unskilled
p.000021: labour in the market place, regardless of whether the participant is employed. See NHREC (2012) Payment of
p.000021: trial participants in South Africa: ethical consideration for Research Ethics Committees.11
p.000021: Researchers must submit planned payment schedules and amounts together with a justification to the REC
p.000021: when making application for ethics review. RECs should exercise caution against taking an unreasonably
p.000021: paternalistic view of the rate of reimbursement. The proposal and the informed consent documentation should indicate
p.000021: whether reimbursements are pro rata if the participant does not complete the study; i.e. whether only some of the
p.000021: offered reimbursement is available if participation is stopped before the anticipated end of the study.
p.000021: Where minors are the participants, their accompanying parent or guardian should also receive reimbursement
p.000021: for travel costs and refreshments.
p.000021: Inducements encourage participation. They may be offered in some circumstances where
p.000021: e.g. recruitment, especially of healthy participants, is anticipated to be difficult. However, a justification for
p.000021: this tactic should be provided and the inducement should not unduly influence an informed choice about
p.000021: participation. In particular, an inducement should not undermine a potential participant’s assessment of risk of
p.000021: harm. All inducements should be clearly explained and justified to the REC. Input from community members on the REC or
p.000021: other role players may be constructive.
p.000021: 3.1.8 Participants’ privacy and confidentiality interests
p.000021: The principle of respect for persons requires careful attention to privacy and confidentiality interests. Privacy
p.000021: describes the person’s interest in controlling access to her personal information. Confidentiality is about
p.000021: whether and how research data might be disclosed
p.000021:
p.000021:
p.000021:
p.000021: 11 Available at http://nhrec.org.za – the current rate (2014) for unskilled construction workers is approximately R15
p.000021: - R25 per hour depending on the tasks (see Department of Labour’s sectoral determinations).
p.000021:
p.000021: Ethics in Health Research 2nd edition
p.000023: 23
p.000023:
p.000023: carelessly or inadvertently, thus revealing the participant’s identity or category, making him vulnerable to harm. (See
p.000023: also 2.3.7)
p.000023: The proposal should explain how data records (written, audio or visual) are to be secured, the length of time they will
p.000023: be retained12 and who will be responsible for storage and/or final disposal. The proposal should explain why
...
p.000039: benefit than that offered by standard care; and
p.000039: • as soon as reasonably possible, the participant and her relatives or legal representatives
p.000039: will be informed of the participant’s inclusion in the research; be requested to give delayed consent;, and
p.000039: advised of the right to withdraw from the research without any reduction in quality of care.
p.000039: 3.2.7 Persons with physical disabilities
p.000039:
p.000039: Recruitment strategies for research participation in general should be sensitive to the possibility that
p.000039: persons with physical disabilities may wish to volunteer and therefore should ensure that there are no unintended
p.000039: barriers to such participation; e.g. the absence of ramps or a lift for wheelchair-bound potential participants.
p.000039: Research involving participants with physical disabilities should anticipate possible barriers and include
p.000039: measures to minimise them.
p.000039: 3.2.8 Prisoners
p.000039:
p.000039: The chief reason to consider prisoners as a vulnerable class of persons is the potential effect of incarceration on
p.000039: the voluntariness of the decision to participate in research. Neither coercion (direct threat of negative
p.000039: sanction) nor undue influence is acceptable in the informed consent process. Researchers should pay
p.000039: attention to whether their intended participants are awaiting trial prisoners or convicted prisoners. Quite
p.000039: obviously, different ethical issues arise for the former group who remain innocent until proven
p.000039: guilty, notwithstanding being incarcerated. The recruitment strategy design must pay careful attention to
p.000039: how coercion and undue influence will be avoided. Similarly, persons administering questionnaires
p.000039: or conducting interviews must be conscious of environmental factors that may influence voluntariness.
p.000039: The REC should include, at least on an ad hoc basis, a member with experience and knowledge of working
p.000039: with prisoners when deliberating on the protocol. The researchers must comply also with the requirements of
p.000039: the Department of Correctional Services as listed at http://www.dcs.gov.za/services/Research.aspx.
p.000039:
p.000039: 40 Ethics in Health Research 2nd edition
p.000039:
p.000039:
p.000039: Research should be conducted amongst prisoners only if
p.000039: • their participation is indispensable to the research
p.000039: • the research cannot be conducted with non-prisoners
p.000039: • the research concerns a problem of relevance to prisoners
p.000039: • sound informed consent processes can be ensured
p.000039: • engagement with relevant role players about the proposed research has occurred.
p.000039: In the case of minor prisoners, the limitations and restrictions on independent consent must be remembered. In general
p.000039: terms, it is unlikely that independent consent by the minors will be justifiable.
p.000039: 3.2.9 Collectivities i.e. persons participating in research as groups
p.000039:
...
p.000059: should have GCP training, evidenced by a certificate issued not more than 2 years previously.
p.000059: v. Institutions should indemnify committee members from personal liability and should ensure that adequate public
p.000059: liability insurance exists. The institution should take legal responsibility for the decisions and advice of the
p.000059: REC and AREC, provided that members act in good faith.
p.000059: 4.5 Standard Operating Procedures
p.000059:
p.000059: i. RECs and ARECs should have written standard operating procedures (SOPs) to ensure
p.000059: • standardised best practices for health research
p.000059: • compliance with national and international ethical and regulatory requirements
p.000059: • consistent processes about ethical issues in health research
p.000059: • declarations regarding confidentiality and conflict of interest for each meeting.
p.000059: ii. Ethical issues in research often require case-by-case deliberation. The ethics review process should not be
p.000059: mechanical. Although consistency of review outcomes for similar studies may be desirable, it is not always
p.000059: possible or appropriate in light of the details of an application.
p.000059: iii. REC members and researchers should be encouraged to
p.000059: • be mindful of the basic ethical principles that should inform planning, designing and conducting health research
p.000059: • be open-minded and not allow personal biases to cloud their application of these guidelines
p.000059: • accept that consensus about how ethical principles should be balanced is difficult to achieve and that divergence
p.000059: enriches deliberations
p.000059: • be mindful of the influence that the context (social, cultural and economic) has on how to prioritise principles
p.000059: • be deliberate, reflective and thoughtful in discussions about how to balance ethical considerations.
p.000059: iv. SOPs should be regarded as living documents, to be reviewed, revised and updated at regular intervals.
p.000059: v. REC members and researchers should ensure that they use the most recent versions of documents.
p.000059: 4.5.1 Written Standard Operating Procedures.
p.000059: SOPs should cover topics including but not limited to
p.000059: • ethical and regulatory requirements for research with humans and research using animals
p.000059: • definitions as appropriate
p.000059: • institutional lines of authority and responsibility
p.000059: • REC activities and processes, including frequency of meetings, preparation of agenda and minutes (minutes should
p.000059: be detailed and include dissenting views), registers for meetings, expectations and time-lines for reviewers
p.000059:
p.000059: Ethics in Health Research 2nd edition
p.000061: 61
p.000061:
p.000061: • guidance and specification of REC procedures required for expedited and full REC review; if the REC
p.000061: reviews US federally funded research proposals, the procedures must comply with the US Common Rule (45 CFR 46)
p.000061: • quorum requirements
p.000061: • decisional analysis guidance
p.000061: • conflict of interest and of confidentiality regarding researchers
p.000061: • the protocol review process
p.000061: • continuing review and re-certification procedures
p.000061: • protocol amendment procedures
...
p.000063: application in question.
p.000063:
p.000063: 64 Ethics in Health Research 2nd edition
p.000063:
p.000063:
p.000063: 4.5.1.8 Advocacy
p.000063: The REC should be alert to whether an advocate for special interest groups of participants proposed for particular
p.000063: research would add value to the review process for informed responsible decision making in the context.
p.000063: 4.5.1.9 Translators
p.000063: i. Where research participants do not adequately comprehend or speak the language used in the protocol,
p.000063: translation of information and consent documentation is important. Similarly, it is often desirable to
p.000063: have people who are fluent in the language of the intended participants to assist with the consent process.
p.000063: ii. The REC should be alert to the potential for poor consent processes in the absence of appropriately translated
p.000063: materials and the availability of translators.
p.000063: iii. If a translator will be used in the consent process and be present for the discussions, the information
p.000063: materials should state that privacy will be compromised to that extent.
p.000063: iv. A translator should not influence potential participants unduly during the interpretation
p.000063: process.
p.000063: 4.5.1.10 Monitoring
p.000063: i. RECs have the right to monitor the research it approves (Declaration of Helsinki 2013 par 23). Researchers should
p.000063: provide appropriate information to the REC to facilitate monitoring, including alerts and investigator brochures.
p.000063: The frequency and type of monitoring should reflect the degree and extent of risk of harm to
p.000063: participants or animals.
p.000063: ii. RECs may recommend and adopt any additional appropriate mechanism for monitoring, including
p.000063: random inspection of research sites, welfare monitoring sheets, data and signed consent forms, and records of
p.000063: interviews. Information and consent materials should indicate that such monitoring may take place.
p.000063: iii. RECs should request regular, at least annual, reports from principal investigators on matters including but not
p.000063: limited to
p.000063: • progress to date, or outcome in the case of completed research
p.000063: • current enrolment status (numbers, active or closed)
p.000063: • whether participant follow-up is still active or completed
p.000063: • information concerning maintenance and security of records
p.000063: • evidence of compliance with the approved protocol
p.000063: • evidence of compliance with any conditions of approval
p.000063: • negative reports from monitors or GCP inspectors
p.000063: • list all adverse events in the past 12 months
p.000063: • list all amendments made in the past 12 months.
...
p.000079: participation in research; directly means actual costs incurred and indirectly means losses that arise because
p.000079: of participation
p.000079: Repository– a collection, storage and distribution system for human biological materials for research purposes
p.000079: including blood, urine, faeces, bone marrow, cell aspirates, diagnostic specimens, pathology specimens and
p.000079: so on. Usually demographic and medical information about the donors is included in the repository as are
p.000079: codes that link the material to the donors
p.000079: Research – includes a range of activities conducted by many different disciplines that may use different
p.000079: methodologies and explanatory frameworks to extend knowledge through disciplined inquiry or systematic
p.000079: investigation
p.000079: Risk – function of the magnitude of harm and the probability that it will occur
p.000079: Risk of harm to likelihood of benefit ratio – analysis of whether the risk of harm implied is justifiable in light of
p.000079: the likelihood of benefit
p.000079: Therapeutic intervention –interventions directed towards direct health-related benefit for a participant (NHA Reg 135)
p.000079: Tiered consent – donor permits use of biological materials for current study; and chooses whether to permit storage
p.000079: for future use, sample and data sharing.
p.000079: Undue influence – effect of an unequal power relationship on voluntariness; may occur when recruitment of
p.000079: participants is done by authority figure
p.000079: Virtual Repository– a digitised system that manages distributed bar-coded electronic versions of material,
p.000079: data or images through shared data systems
p.000079: Vulnerability – diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000079: project; may be caused by limited capacity or limited access to social goods like rights, opportunities and power
p.000079:
p.000079: 80 Ethics in Health Research 2nd edition
p.000079:
p.000079:
p.000079:
p.000079: APPENDIX 2
p.000079:
p.000079: Resources
p.000079:
p.000079: Online training opportunities
p.000079:
p.000079: These links are to FREE online training in research ethics and some also do Responsible Conduct of Research
p.000079: 1. The AMANET (African Malaria Network Trust)
p.000079: http://webcourses.amanet-trust.org/mod/resource/view.php?inpopup=true&id=116
p.000079: The AMANET (African Malaria Network Trust) web-based health research ethics training programme aims at
p.000079: providing the basic understanding in biomedical research ethics. On the premise of scarcity of resources and
...
Searching for indicator substance:
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p.000033: the child whilst the child is in temporary safe care; d) the person at the head of a child and youth care centre where
p.000033: a child has been placed; e) the person at the head of a shelter; f) a child and youth care worker who cares
p.000033: for a child who is without appropriate family care in the community; and g) the child at the head of a child-
p.000033: headed household’)
p.000033: vi. If minor is caregiver in child-headed household and no supervisory adult (s 137 Children’s Act), then
p.000033: trusted adult nominated by minor, including but not limited to social worker, community worker or teacher.
p.000033: 3.2.2.4 Minors’ independent consent
p.000033: In particular circumstances, e.g. for reasons of sensitivity, like discussion about sexual activities,
p.000033: substance abuse etc., it may be desirable and ethically justifiable for minors (especially older minors i.e.
p.000033: 16 years and older) to choose independently i.e. without parental assistance, whether to participate in research.
p.000033: Generally, only minimal risk research is suitable for independent consent by minors. Reasons
p.000033: supporting the desirability of independent consent may include recruiting sufficient numbers of minors
p.000033: who otherwise would be unwilling to participate if they must tell their parents about the nature of the
p.000033: research in order to obtain parental permission.
p.000033: An ethical justification for independent consent by minors may be made in the following manner:
p.000033: • By prior engagement with participating community role players, the PI can request (and justify explicitly)
p.000033: REC approval of a waiver of the parental (or substitute) permission requirement. Engagement could include
p.000033: outreach to relevant role players such as canvassing the opinion of a representative body of parents e.g. via schools.
p.000033: • Factual evidence of such engagement must form part of the PI’s justification in the protocol. Factual evidence
p.000033: may be in the form of a letter from a relevant role player (like a community leader, school principal or a CAB)
...
p.000035: a) to protect the health of the fetus; and
p.000035: b) if exclusion is scientifically supportable.
p.000035: Note that the informed consent documents must explain carefully and fully what the possible effect of the research
p.000035: activities on the fetus might be.
p.000035: Usually, research involving pregnant women should be undertaken when
p.000035: • the purpose of the proposed research is to meet the health needs of the mother of the particular fetus;
p.000035: • appropriate studies on animals and non-pregnant individuals have been completed;31
p.000035: • the risk of harm to the fetus is minimal; and
p.000035:
p.000035: 31 Clinical trials involving pregnant women or nursing mothers should ideally involve products where the toxicology in
p.000035: adults is established and is acceptable. In the case of pregnant women, the potential risks associated with using a
p.000035: substance whose short term and long-term effects on a fetus and developing infant are unknown, should be outweighed by
p.000035: the benefits. An example of a positive risk-benefit ratio would be the use of anti-retrovirals in mother to child HIV
p.000035: transmission studies. For nursing mothers, the amount of drug passing into breast milk should be established and the
p.000035: potential impact on a breast-fed infant anticipated, and the mother so advised.
p.000035:
p.000035: 36 Ethics in Health Research 2nd edition
p.000035:
p.000035:
p.000035: • in all cases, inclusion poses the least risk of harm possible for achieving the objectives of the research.
p.000035: 3.2.4 Adults with factual incapacity to provide informed consent
p.000035:
p.000035: Adults who are factually incapable of giving informed consent should participate in research only where their
...
p.000047: without adequate justification.
p.000047: The prospect of any direct benefit from research participation must not be overstated or used to justify a risk of harm
p.000047: higher than that involved in current treatment. Research participation must not be used to prevent or devalue the needs
p.000047: and wishes of participants rather to spend time as they choose, particularly with family members.
p.000047: 3.4.4 Traditional medicines research
p.000047:
p.000047: In line with the constitutional guarantees for cultural and language rights, 40 indigenous cultures and
p.000047: traditional values of all communities must be respected. However, since fundamental rights do not trump
p.000047: each other without careful justification, participants in research involving traditional medical systems and
p.000047: beliefs must be accorded the same respect and protection as any other human research participant. 41 The
p.000047: context of the research activity, interaction or intervention is important for determining whether, how and when to
p.000047: incorporate traditional values and their cultural expression in research.
p.000047: In terms of the Traditional Health Practitioners Act 22 of 2007,
p.000047: 'Traditional medicine' means an object or substance used in traditional health practice for-
p.000047: (a) the diagnosis, treatment or prevention of a physical or mental illness; or
p.000047: (b) any curative or therapeutic purpose, including the maintenance or restoration of physical or mental health or
p.000047: well-being in human beings,
p.000047: but does not include a dependence-producing or dangerous substance or drug.
p.000047: 'Traditional health practice' means the performance of a function, activity, process or service based on a
p.000047: traditional philosophy that includes the utilisation of traditional medicine or traditional practice and which has as
p.000047: its object-
p.000047: (a) the maintenance or restoration of physical or mental health or function; or
p.000047: (b) the diagnosis, treatment or prevention of a physical or mental illness; or
p.000047: (c) the rehabilitation of a person to enable that person to resume normal functioning within the family or community;
p.000047: or
p.000047: (d) the physical or mental preparation of an individual for puberty, adulthood, pregnancy, childbirth and
p.000047: death,
p.000047: but excludes the professional activities of a person practising any of the professions contemplated in the
p.000047: Pharmacy Act 53 of 1974, the Health Professions Act 56 of 1974, the Nursing Act 50 of 1974, the Allied Health
p.000047: Professions Act 63 of 1982, or the Dental Technicians Act 19 of 1979, and any other activity not based on
p.000047: traditional philosophy.
p.000047:
p.000047:
p.000047:
p.000047: 40 Sections 30 and 31 of the Constitution.
p.000047: 41 In terms of s 12(2)(c) of the Constitution and s 71 of the National Health Act.
p.000047:
p.000047: 48 Ethics in Health Research 2nd edition
p.000047:
p.000047:
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p.000021: 3.1.7 Reimbursements, inducements & costs for participants 22
p.000021: 3.1.8 Participants’ privacy & confidentiality interests 22
p.000021: 3.1.9 Obtaining informed consent 24
p.000021: 3.2 Vulnerability & incapacity
p.000026: 26
p.000026: 3.2.1 Contextual circumstances
p.000026: 26
p.000026: 3.2.2 Minors (children & adolescents) 27
p.000026: 3.2.3 Women
p.000035: 35
p.000035: 3.2.4 Adults with factual incapacity
p.000036: 36
p.000036: 3.2.5 Persons in dependent relationships 38
p.000036: 3.2.6 Patients highly dependent on medical care 38
p.000036: 3.2.7 Persons with physical disabilities
p.000038: 38
p.000038: 3.2.8 Prisoners
p.000039: 39
p.000039: 3.2.9 Collectivities
p.000040: 40
p.000040: 3.3 Data & biological material for research purposes 40
p.000040: 3.3.1 Introduction
p.000040: 40
p.000040: 3.3.2 Permitted usage of biological material 41
p.000040: 3.3.3 Identifiability of biological materials and data 41
p.000040: 3.3.4 Collection of biological materials and data 42
p.000040: 3.3.5 Restrictions on collection of biological material 42
p.000040: 3.3.6 Informed consent
p.000042: 42
p.000042: 3.3.7 Secondary use of material or data 43
p.000042: 3.3.8 Genetic research
p.000044: 44
p.000044: 3.3.9 Genomics research
p.000044: 44
p.000044: 3.3.10 Commercially available cell lines
p.000045: 45
p.000045: 3.4 Considerations specific to research methods or contexts 45
p.000045: 3.4.1 Major incidents & research
p.000045: 45
p.000045: 3.4.2 Intensive care research
p.000046: 46
p.000046: 3.4.3 Terminal care research
p.000047: 47
p.000047: 3.4.4 Traditional medicine research
p.000047: 47
p.000047: 3.4.5 Research involving deception or withholding information 48
p.000047:
p.000047: Ethics in Health Research 2nd edition
p.000019: 19
p.000019: 3.5 Special topics
p.000049: 49
p.000049: 3.5.1 Novel, innovative & unproven therapies
p.000049: 49
p.000049: 3.5.2 Data bases, registries & repositories
p.000051: 51
p.000051: 3.5.3 Insurance against research-related bodily injury 53
p.000051:
...
p.000041: use of human data or biological materials; be meticulous in their deliberations, and should ensure the integrity and
p.000041: comprehensiveness of the informed consent documentation. In particular, consent documentation must distinguish clearly
p.000041: between biological materials or data collected for clinical purposes and those collected for research purposes.
p.000041: For purposes of this section
p.000041: ‘Anonymous data or specimen’ means data or material without any overt identifying information or link to a
p.000041: specific participant or donor
p.000041: ‘Biological specimen’ means material from a person including blood and blood products, DNA, RNA, blastomeres, polar
p.000041: bodies, cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors
p.000041: ‘Broad consent’ means the donor donates materials with permission to use them for a broad range of future
p.000041: studies, subject only to further prior ethics review and approval
p.000041: ‘Coded data or specimen’ means a number, a symbol or other method provides a coded substitute for identifiers; and a
p.000041: key to the code exists so that the specimen can be linked to its original source
p.000041: ‘Donor’ means the person (living or deceased) from whose body a biological specimen has been removed or withdrawn
p.000041: ‘Identifier’ means information such as a name, initials, address, folder number, or biometric identifier (e.g. finger
p.000041: print) that can identify a particular donor
p.000041: 3.3.2 Permitted usage of biological materials
p.000041: Biological material may be removed from living and deceased persons (NHA ss 55 and 62) for diagnostic, therapeutic and
p.000041: health research purposes (NHA s 64(1)).
p.000041: 3.3.3 Identifiability of biological materials and data
p.000041: RECs must assess the extent to which human biological materials or data could be used to identify a donor. Materials
p.000041: with direct identifiers can directly identify a donor. Coded materials may identify a donor if security and
p.000041: confidentiality measures are not adequate. Anonymised materials without any linkage to donors are unlikely to identify
p.000041: a donor. Materials collected
p.000041:
p.000041: 33 Tri-Council Policy Statement (Canada) 2010, 169.
p.000041: 34 Human biological materials means ‘material from a human being, including DNA, RNA, blastomeres, polar bodies,
p.000041: cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors from the same’
p.000041: (Regulation 177 GG 35099 2 March 2012);
p.000041: blood and blood products are also included (Regulation 180 GG 35099 2 March 2012).
p.000041:
p.000041: 42 Ethics in Health Research 2nd edition
p.000041:
p.000041:
p.000041: without identifiers of any kind are unlikely to identify an individual donor. Genetic markers make it possible to
p.000041: identify groups rather than individuals. RECs must pay attention to eliminating or at least minimising
p.000041: risks to privacy and autonomy as a result of re- identification.
...
p.000041: taken from mentally ill persons; biological materials that are not naturally replaceable may not be taken
p.000041: from a minor; no gametes may be taken from a minor; and no fetal biological material except for umbilical cord
p.000041: progenitor cells may be collected from anyone. These restrictions are absolute which means that research
p.000041: with the categories of person mentioned requires special permission. RECs must satisfy themselves that the
p.000041: necessary special permission has been obtained, where appropriate.
p.000041: 3.3.6 Informed consent
p.000041: Written informed consent is required prior to removal of biological material from a living donor (NHA ss
p.000041: 56 and 62).
p.000041: In the case of a deceased person, consent to removal and use of biological materials may be found in the Will of the
p.000041: person, in a written statement or in a witnessed oral statement (NHA s 62(1)(a)) or may be provided by ‘the spouse,
p.000041: partner, major child, parent, guardian, major brother or major sister of that person in the specific order mentioned’
p.000041: (NHA s 62(2))
p.000041: Because biological specimens may be collected for diagnostic, therapeutic or health research purposes, RECs should
p.000041: assess whether the nature of the planned usage is explained adequately so that the purpose for which consent
p.000041: is being requested is completely clear.
p.000041: RECs must also consider the circumstances under which re-consent from donors would be sought, bearing in mind specific
p.000041: local or national needs.
p.000041: Different forms of consent are implicated:
p.000041:
p.000041: Ethics in Health Research 2nd edition
p.000043: 43
p.000043:
p.000043: i. Narrow (restrictive) consent: the donor permits use of the biological specimen for single use only; no
p.000043: storage of leftover specimen; and no sharing of data or specimen. This form necessitates new consent if further use is
p.000043: desirable.
p.000043: ii. Tiered consent: the donor provides consent for the primary study and chooses whether to permit
p.000043: storage for future use, sample and data sharing.
p.000043: iii. Broad consent: the donor permits use of the specimen for current research, for storage and possible
p.000043: future research purposes,35 even though the precise nature of future research may be unclear at present. The nature of
p.000043: the further usage should be described as fully as possible and should stipulate that further prior ethics review of the
p.000043: new study is necessary. Permission may be sought to re-contact the person if intended future use is
p.000043: outside the scope of the current consent.36
p.000043: RECs should also bear in mind the vision of the H3Africa Initiative and its recommendation that consent should be
p.000043: ‘broad enough to allow for future and secondary uses of data, in line with the opportunities to use
p.000043: such data in advancing knowledge to improve health. The consent processes need to be appropriate for the
p.000043: cultural contexts in which the research takes place and tailored accordingly’.37
p.000043: RECs should be aware that ‘blanket’ or unrestricted consent is not recommended for the reason that it
p.000043: becomes difficult to implement and sustain fundamental ethical principles especially that of respect for
p.000043: persons. In South Africa’s multicultural society, different views prevail about the use of biological materials.
p.000043: RECs should bear in mind that careful deliberation is always necessary when considering future use of materials.
p.000043: One reason is that biological materials cannot be completely anonymised. The presence of hereditary elements implies
p.000043: that any sample can be re-identified, albeit only to a group rather than an individual. This has implications for the
p.000043: consent process insofar as participants should understand clearly what is being requested.
p.000043: 3.3.7 Secondary use of materials or data
p.000043: Secondary use means use in research of materials or data originally collected for other purposes.
p.000043: Biological materials collected for diagnostic or therapeutic purposes are usually stored for future use, e.g.
p.000043: pathology samples. Ordinarily informed consent for removal has not anticipated such use to include research purposes.
p.000043: Other researchers may have banked surplus samples in a tissue bank. The importance of stored biological material as a
p.000043: research resource cannot be overstated. The dilemma is whether unanticipated research usage necessitates
p.000043: fresh informed consent and, if so, what should be done when a donor is no longer available.
p.000043: In the absence of broad consent to future use of material or data, including images, for research
p.000043: purposes, the following is recommended
p.000043:
p.000043:
p.000043: 35See World Health Organization. Informed Consent Templates. Consent for Storage and Future Use of Unused Samples
p.000043: http://www.who.int/rpc/research_ethics/informed_consent/en/
p.000043: 36See also Human Heredity and Health in Africa (H3Africa) Guidelines for Informed Consent. August 2013.
p.000043: http://h3africa.org/ethics/17- ethics/71-informed-consent
p.000043: 37Human Heredity and Health in Africa (H3Africa) Initiative http://h3africa.org/
p.000043:
p.000043: 44 Ethics in Health Research 2nd edition
p.000043:
p.000043:
p.000043: i. Use of existing or archived material collected for clinical or diagnostic purposes, including waste
p.000043: and surplus samples, requires expedited review. The nature of the previously obtained consent should be determined to
p.000043: ascertain whether subsequent usage was envisaged and whether it falls within the scope of the current proposal. If so,
p.000043: new consent is not required.
p.000043: ii. If the scope of the current proposal is different, then new consent may be required.
p.000043: iii. If samples are anonymous and the results of research would not place any individual, family or
p.000043: community at social, psychological, legal or economic risk of harm, then new consent is not required.
p.000043: iv. If the link to identifiers exists but is not provided to the research team and the results of
p.000043: research will not place any individual, family or community at social, psychological, legal or economic risk
p.000043: of harm, then new consent is not required.
p.000043: v. The person who holds the code or link should sign an explicit written agreement not to release the identifiers
p.000043: to the research team. This agreement should accompany the submission to the REC.
p.000043: vi. If the samples can be linked to identifiers, the REC must decide on a case-by-case basis whether expedited or
p.000043: full review is necessary.
p.000043: 3.3.8 Genetic research
p.000043: Genetics refers to the study of genes (human DNA), heredity and variation as well as how they affect inheritance of
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p.000011: 1.6.9 Retrospective review and approval or clearance is not permitted.
p.000011:
p.000011: 1.7 Glossary and resources
p.000011:
p.000011: 1.7.1 A Glossary of terms used in these Guidelines appears in Appendix 1.
p.000011: 1.7.2 A list of resources appears in Appendix 2.
p.000011: 1.7.3 Templates appear in Appendix 3.
p.000011:
p.000011: 6 Wassenaar ‘Ethical issues in social science research’ in Terre Blanch, Durrheim & Painter (2006) 60-79.
p.000011:
p.000011: Ethics in Health Research 2nd edition
p.000013: 13
p.000013:
p.000013: 1.8 Purpose and status of these Guidelines
p.000013:
p.000013: 1.8.1 These Guidelines is intended to provide the minimum national benchmark of norms and standards for conducting
p.000013: responsible and ethical research.
p.000013: 1.8.2 The minimum benchmark for research that uses animals is found in the South African Bureau of Standards SANS
p.000013: 10386:2008 or later version. These Guidelines endorses the ethical principles laid down in the South African
p.000013: Bureau of Standards SANS 10386:2008 (or later version) and MRC Guidelines on Ethics for Medical Research:
p.000013: Use of Animals in Research and Training (2004).
p.000013: 1.8.3 These Guidelines further endorses the ethical principles laid down in
p.000013: • The Belmont Report: www.edu/irb/pdfs/BelmontReport.pdf
p.000013: • Declaration of Helsinki 2013: www.wma.net/e/policy/pdf/17c.pdf
p.000013: • Medical Research Council: Guidelines on Ethics for Medical Research: HIV Preventive Vaccine Research:
p.000013: www.sahealthinfo.org/ethics/ethicsbooks5.pdf
p.000013: • The Singapore Statement on Research Integrity www.singaporestatement.org
p.000013: • Human Heredity and Health in Africa (H3Africa) Initiative http://h3africa.org/
p.000013: 1.8.3 This document should be read in conjunction with other guidelines such as the DoH Guideline for Good Practice
p.000013: in the Conduct of Clinical Trials with Human Participants in South Africa (2006); the Human Sciences Research Council
p.000013: Research (HSRC) Ethics Guideline; and international guidelines such as the Declaration of Helsinki (2013); the Council
p.000013: for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical
p.000013: Research involving Human Subjects (2002); the ICH Harmonised Tripartite Guideline: Guideline for Good Clinical
p.000013: Practice E6 (R1) 1996; the ICH Harmonised Tripartite Guideline: Clinical Investigation of Medicinal Products in the
p.000013: Pediatric Population E11 2000.
p.000013: 1.9 Structure of these Guidelines
p.000013:
p.000013: 1.9.1 Chapter 2 discusses the principles that inform the procedures and decision-making processes for
p.000013: ethics review of research proposals.
p.000013: 1.9.2 Chapter 3 provides detailed explication of the process of ethics review, and focused guidance about specific
p.000013: human participants, specific types of research or specific research contexts. Discussion is provided also
p.000013: about storage and use of biological samples and related data for research purposes, human genetic
...
p.000029: and ‘non-therapeutic’ interventions or components and reviewers usually assess the proposal as a whole.
p.000029: d) The degree of risk of harm should be evaluated against the likelihood of benefit to the child-participant as
p.000029: outlined in b) above. Furthermore, registered RECs that have been granted permission in writing to exercise the
p.000029: Minister’s delegated power to approve research with children that includes non-therapeutic components must
p.000029: ensure that their deliberations on these components are properly minuted and recorded as required by the
p.000029: Regulations. RECs that review research with child participants must include members with appropriate paediatric
p.000029: research experience.
p.000029: e) Children should participate in research only where the proper written permissions have been obtained. The
p.000029: general principle is that minors cannot agree to research participation without assistance of a parent or
p.000029: guardian (exceptions to the general principle are discussed in 3.2.2.4). This principle holds notwithstanding the
p.000029: exceptions created in the Children’s Act 38 of 2005 for consent to medical treatment and surgical operations (s 129);
p.000029: consent to HIV-testing (s 130); and the exception for female minors created in the Choice on Termination of
p.000029: Pregnancy Act 92 of 1996 (s 5(2)). Consequently, in principle, the consent process for a minor’s participation in
p.000029: research requires
p.000029: • Permission in writing from parents or legal guardian for the minor to be approached and invited to
p.000029: participate (in accordance with s 10 of the Children’s Act 38 of 2005);
p.000029: • Assent from the minor in writing (i.e. agreement to participate) if he or she chooses to participate.
p.000029: Note that an unmarried minor mother may not agree to the participation of her child in research without assistance. Her
p.000029: guardian (usually her parent) is also the guardian of her child while she is a minor and must consent to the child’s
p.000029: participation. In other words, pregnancy and childbirth do not change the legal status of the minor mother. When the
...
p.000035: Usually, research involving pregnant women should be undertaken when
p.000035: • the purpose of the proposed research is to meet the health needs of the mother of the particular fetus;
p.000035: • appropriate studies on animals and non-pregnant individuals have been completed;31
p.000035: • the risk of harm to the fetus is minimal; and
p.000035:
p.000035: 31 Clinical trials involving pregnant women or nursing mothers should ideally involve products where the toxicology in
p.000035: adults is established and is acceptable. In the case of pregnant women, the potential risks associated with using a
p.000035: substance whose short term and long-term effects on a fetus and developing infant are unknown, should be outweighed by
p.000035: the benefits. An example of a positive risk-benefit ratio would be the use of anti-retrovirals in mother to child HIV
p.000035: transmission studies. For nursing mothers, the amount of drug passing into breast milk should be established and the
p.000035: potential impact on a breast-fed infant anticipated, and the mother so advised.
p.000035:
p.000035: 36 Ethics in Health Research 2nd edition
p.000035:
p.000035:
p.000035: • in all cases, inclusion poses the least risk of harm possible for achieving the objectives of the research.
p.000035: 3.2.4 Adults with factual incapacity to provide informed consent
p.000035:
p.000035: Adults who are factually incapable of giving informed consent should participate in research only where their
p.000035: participation is indispensable to the research; i.e. the research cannot deliver the desired outcomes if
p.000035: capable adult participants were to be used instead. Further, the research should investigate a problem of
p.000035: relevance to incapacitated adults. Where research can be undertaken with capable adults but nevertheless proposes
p.000035: also to include incapacitated adults, strong justification for their inclusion must be provided.
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p.000053: here too.
p.000053: 48(12285/08) [2013] WCHC 7 May 2013; and on appeal (A11/2014) 22 October 2014.
p.000053:
p.000053: 54 Ethics in Health Research 2nd edition
p.000053:
p.000053:
p.000053: The Department of Health’s ‘Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in
p.000053: South Africa’ (known as SA GCP 4.11)49requires a clinical trial sponsor to take out insurance cover. If a
p.000053: trial-related serious bodily injury of an enduring nature occurs as a result of participation in the trial, then
p.000053: the sponsor’s insurer pays the medical costs of necessary treatment to restore the participant to his previous
p.000053: position, if possible.
p.000053: This offer of payment has a moral rather than a legal basis. SA GCP follows the lead of the Association of the British
p.000053: Pharmaceutical Industry (ABPI), which recommends that sponsors adopt the morally right position of paying for treatment
p.000053: in the event of trial-related injury. This recommendation is followed in many countries. In South Africa, it is
p.000053: mandatory to have this insurance cover for clinical trials and RECs should assess whether it is in place and valid.
p.000053: Payment for medical expenses is made without acknowledgment of any liability and is thus to be understood as an ex
p.000053: gratia payment.
p.000053: ‘The MCC, ethics committees and other relevant regulatory authorities require that all participants in clinical trials
p.000053: are covered by comprehensive insurance for injury and damage. Notwithstanding the absence of legal commitment, the
p.000053: sponsor should pay compensation to patient-volunteers suffering bodily injury, including death, in
p.000053: accordance with these Guidelines.’
p.000053: 3.5.3.2 What a participant agrees to
p.000053: By choosing to participate in research, a participant agrees to the violation of bodily integrity necessitated by
p.000053: receiving investigative medication or undergoing procedures and to the possible risk of harm outlined in the
p.000053: consent documentation. This means that, in law, when one accepts the risk of harm (by consenting to the invasion of
p.000053: bodily integrity), then there is no claim for damages (compensation) if that harm materialises. This is known as
p.000053: voluntary acceptance of risk of harm.
p.000053: Thus, in the absence of an offer to pay for the necessary treatment and an acceptance of the offer by a participant, no
p.000053: claim for payment of treatment costs exists in law. This is why the SA GCP requires a clinical trial sponsor to take
p.000053: out insurance cover: it is morally right that the sponsor (responsible for causing the bodily injury) should assist the
p.000053: participant by paying for the reasonable medical expenses needed to treat the bodily injury that materialises through
p.000053: participation in the research. The possible risk of loss of income or other losses was also foreseeable and
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p.000035: should not be mistaken for a lack of capacity to decide whether to participate.32
p.000035: 3.2.4.2 Minors and decision-making incapacity
p.000035: Parents or guardians of minors with intellectual or mental impairments should give permission for their
p.000035: minor children to choose whether to participate in research. If the minor
p.000035:
p.000035: 32 Georgetown University Informed Consent and Limitations on Decision making Capacity Chapter 2
p.000035: https://bioethicsarchive.georgetown.edu/nbac/capacity/Informed.htm
p.000035:
p.000035: Ethics in Health Research 2nd edition
p.000037: 37
p.000037:
p.000037: is unable to communicate at all or lacks the capacity to choose, then the parent or guardian should choose whether
p.000037: the minor may be enrolled. In other words, the parent acts as a proxy decision maker. In the case of a
p.000037: minor who remains intellectually or mentally impaired after reaching the age of majority, the situation changes
p.000037: because the person becomes an adult with decision-making incapacity (see 3.2.4.3 below).
p.000037: 3.2.4.3 Adults incapable of giving adequate informed consent
p.000037: Proxy decision makers are not permitted for adult persons who lack capacity unless the proxy is a court-appointed
p.000037: curator. Neither the National Health Act 61 of 2003 nor the Mental Health Care Act 17 of 2002 makes
p.000037: provision for proxy decision makers for research purposes but they provide clear lists of proxy decision makers for
p.000037: treatment purposes.
p.000037: Since it would be unethical to exclude a category of persons from research participation without adequate
p.000037: justification, arguably, an ethical argument can be made for using the statutory treatment proxies to
p.000037: provide permission for participation in research that complies with the stipulations set out below. However,
p.000037: RECs must be careful not to confuse the distinction between treatment and research. In unusual circumstances,
p.000037: e.g. major incident research (see 3.4.1), it may be ethically permissible to permit proxy consent also in
p.000037: a situation where no statutory proxy is available but the risk of harm to knowledge ratio justifies it.
...
p.000041: risks to privacy and autonomy as a result of re- identification.
p.000041: RECs must also consider the implications for donor welfare of complete anonymisation: it prevents
p.000041: disclosure of material findings, an offer of benefits of research findings, and withdrawal of material from
p.000041: research use. Informed consent documentation must be carefully scrutinised to ensure that the proposed approach
p.000041: and its implications are adequately disclosed and explained.
p.000041: 3.3.4 Collection of biological materials and data
p.000041: Biological materials and data are collected in a variety of ways
p.000041: • specifically for research purposes
p.000041: • incidentally to diagnostic or therapeutic procedures
p.000041: • for a combination of purposes, including the intention of possible future research use
p.000041: Collection of materials or data specifically for research use requires prospective informed consent,
p.000041: usually from the living donor (see 3.3.6). Where a donor is unable to provide informed consent, a proxy
p.000041: may be permissible (see 3.2.4.3 above). Where materials or data from a deceased person are sought, permission from an
p.000041: authorised person is required (see 3.3.6).
p.000041: 3.3.5 Restrictions on collection of biological materials
p.000041: Certain persons are specially protected: without Ministerial permission, biological materials may not be
p.000041: taken from mentally ill persons; biological materials that are not naturally replaceable may not be taken
p.000041: from a minor; no gametes may be taken from a minor; and no fetal biological material except for umbilical cord
p.000041: progenitor cells may be collected from anyone. These restrictions are absolute which means that research
p.000041: with the categories of person mentioned requires special permission. RECs must satisfy themselves that the
p.000041: necessary special permission has been obtained, where appropriate.
p.000041: 3.3.6 Informed consent
p.000041: Written informed consent is required prior to removal of biological material from a living donor (NHA ss
p.000041: 56 and 62).
p.000041: In the case of a deceased person, consent to removal and use of biological materials may be found in the Will of the
p.000041: person, in a written statement or in a witnessed oral statement (NHA s 62(1)(a)) or may be provided by ‘the spouse,
p.000041: partner, major child, parent, guardian, major brother or major sister of that person in the specific order mentioned’
p.000041: (NHA s 62(2))
p.000041: Because biological specimens may be collected for diagnostic, therapeutic or health research purposes, RECs should
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p.002015:
p.002015:
p.002015:
p.002015: DR AARON MOTSOALEDI, MP
p.002015: MINISTER OF HEALTH DATE: 1 March 2015
p.002015:
p.002015: Ethics in Health Research 2nd edition
p.000003: 3
p.000003:
p.000003:
p.000003:
p.000003: ACKNOWLEDGEMENTS
p.000003: These guidelines ‘Ethics in Health Research: Principles, Processes and Structures – 2015’ provide an
p.000003: updated and strengthened guide to ensure that, in South Africa, research is conducted responsibly and
p.000003: ethically. Mandated by Section 72 of the National Health Act 61 of 2003, the National Health Research Ethics
p.000003: Council (NHREC) tasked its Working Group for Norms and Standards to produce a revision of the first edition of
p.000003: the Guidelines issued in 2004.
p.000003: Drawing on international and foreign national ethics codes and research ethics guidelines, in addition to the first
p.000003: edition of these Guidelines, the NHREC has endeavoured to produce a locally relevant document that fits with the
p.000003: matrix of research ethics guidelines available across borders.
p.000003: The basic expectations of the Guidelines include that:
p.000003: • Proposals to conduct research involving humans undergo independent ethics review before the research begins
p.000003: • Proposed health research promote health, contribute to prevention of communicable or non-communicable diseases or
p.000003: disability or result in cures or alleviation of suffering
p.000003: • Proposals to conduct health research stand up to scientific and ethical scrutiny appropriate to the
p.000003: disciplines concerned
p.000003: • Harm to research participants is prevented or at least minimised and balanced against the likelihood of benefit
p.000003: • The safety and welfare interests of animals used in research are promoted
p.000003: • Researchers are accountable for their research activities
p.000003: • Social and ethical values are promoted
p.000003: The Department is also grateful for the following officials who provided secretariat support to the NHREC and in
p.000003: particular the NHREC's Norms and Standards Working Group as well as Ms K Nevhutalu, Mr T Molebatsi, Mr J van
p.000003: der Westhuizen and Mr R Maluleke from the Secretariat, the NHREC and all interested parties for their
p.000003: role in development of these Guidelines and for their expert and technical input.
p.000003: The current NHREC comprises of Prof D du Toit (Chairperson), Prof D van Bogaert (Deputy Chairperson), Ms K Nevhutalu
p.000003: (NDoH), Ms C Slack, Adv LT Nevondwe, Prof A van Niekerk, Dr NP Sithebe, Ms ET Zwane, Ms T Sebata, Prof A
p.000003: Pope, the late Dr L Schoeman, Dr M Sekhoacha, Dr S Ncanana, Dr NJ Ramalivhana.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: MS MP. MATSOSO
p.000003: DIRECTOR-GENERAL: DEPARTMENT OF HEALTH DATE: 1 March 2015
p.000003:
p.000003: 4 Ethics in Health Research 2nd edition
p.000003:
p.000003: CONTENTS
...
p.000011: of Animals in Research and Training (2004) provide the minimum benchmark to ensure ethical and humane care of animals
p.000011: used for scientific purposes as well as for teaching activities, in line with the fundamental principles of
p.000011: Replace, Reduce and Refine animal use. ARECs and researchers are expected to familiarise themselves
p.000011: with the content of both documents in addition to these Guidelines, as appropriate.
p.000011: 1.5.5 International and foreign codes for animal research include the Directive 2010/63/EU of the European
p.000011: Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes
p.000011: and the Australian Code for the Care and Use of Animals for Scientific Purposes (8th Edition) 2013.
p.000011:
p.000011: 12 Ethics in Health Research 2nd edition
p.000011:
p.000011:
p.000011: 1.6 Ethical research review
p.000011:
p.000011: 1.6.1 The NHA (s 72(1))requires that proposals to conduct ‘health research’ must undergo independent ethics review
p.000011: before the research is commenced.
p.000011: 1.6.2 Ethics review of proposed ‘health research’ must be conducted by an REC or AREC that is registered with the
p.000011: NHREC (s 73(2) of the NHA).
p.000011: 1.6.3 RECs must review ‘health research’ proposals and protocols to ensure that the research will
p.000011: promote health, contribute to prevention of communicable or non- communicable diseases or disability or result
p.000011: in cures or alleviation of suffering caused by communicable or non-communicable diseases or disability (NHA s
p.000011: 73(2)(a)).
p.000011: 1.6.4 RECs must ensure that research proposals stand up to scientific and ethical scrutiny appropriate to the
p.000011: disciplines concerned.
p.000011: 1.6.5 RECs must review research proposals and protocols prospectively to ensure that they meet the accepted ethical
p.000011: norms and standards before research commences, using these Guidelines as a minimum benchmark (NHA s 73(2)(b)).
p.000011: 1.6.6 The review process entails an independent and objective assessment of the potential effect of the proposed
p.000011: research on potential participants and on the general day-to- day functioning of the infrastructure that provides the
p.000011: site or context for the research. Ethics review is not about obstructing scientific progress or innovative
p.000011: research. Promoting ethical conduct of research entails co-operation between RECs and researchers to
p.000011: ensure a comprehensive and frank assessment of the ethical implications of proposals so that
p.000011: participants (and researchers) can be protected appropriately.6
p.000011: 1.6.7 The review must ensure that ethical and scientific standards are maintained to
p.000011: • protect participants from harm by weighing the risks of harm against the likelihood of benefit by
p.000011: minimising risks of harm to the extent possible and then by balancing the risk of harm relative to the
p.000011: likelihood of benefit
...
p.000015: participants should be exposed to unacceptable risks of harm on the basis that the participants are likely to
p.000015: benefit from the research. In assessing the risk of harm, both the magnitude or seriousness of the harm and the
p.000015: probability of its occurrence should be addressed.
p.000015: Usually, participants who might face undue risk of harm should not be included in the study, even if they represent a
p.000015: category of person that may benefit from the research. On the other hand, research with such persons may
p.000015: nevertheless be approved after careful review and acceptable justification that demonstrates the anticipated
p.000015: importance and value of the research for society. In such cases, a carefully phased approach should be adopted.
p.000015: 2.3.5 Fair selection of participants
p.000015: This means recruitment, selection, exclusion and inclusion of participants for research must be just and fair,
p.000015: based on sound scientific and ethical principles. Persons should not be excluded unreasonably or unfairly
p.000015: on the basis of any of the prohibited grounds for discrimination: race, age, sex, sexual orientation,
p.000015: disability, education, religious belief, pregnancy, marital status, ethnic or social origin, conscience, belief or
p.000015: language (s 8 of the Constitution). Similarly, persons should not be unfairly targeted for research merely on the basis
p.000015: of one or other of these grounds.
p.000015: 2.3.6 Informed consent
p.000015: In general, participation in research must be voluntary and predicated on informed choices. Voluntariness and
p.000015: informed choices are evidenced by the informed consent process which must take place before the research
p.000015: commences, in principle, and be affirmed during the
p.000015:
p.000015: Ethics in Health Research 2nd edition
p.000017: 17
p.000017:
p.000017: course of the study, as part of the commitment to an ongoing consent process. In some circumstances,
p.000017: research may not require prior consent (see 3.2.5 & 3.3)
p.000017: 2.3.7 Ongoing respect for enrolled participants
p.000017: A research participant has the right to privacy and to confidentiality. This requires that a proposal
p.000017: must explain how these constitutionally protected rights will be managed and protected in the course of the
...
Health / Mentally Incapacitated
Searching for indicator incapable:
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p.000025:
p.000025: Vulnerability is not an absolute condition but rather occurs on a sliding scale. In South Africa, arguably, the
p.000025: majority of potential research participants are vulnerable when compared to those in North America or Europe,
p.000025: from whence much funding is sourced. 19 Whether vulnerability is present is a matter of fact and degree.
p.000025: However, certain groups of participants 20 require careful consideration to ensure that, where appropriate,
p.000025: additional precautions are put into place. For example, advanced age, very young age, personal or
p.000025: environmental factors like extreme poverty and ordinarily poor access to health care may increase
p.000025: vulnerability
p.000025: 3.2.1 Contextual circumstances
p.000025: Personal circumstances, such as mental or intellectual impairment, acute illness, advanced age, and pregnancy and
p.000025: childbirth may increase vulnerability. Persons may be factually incapable or less capable of understanding
p.000025: information and processing it to reach a decision
p.000025: e.g. about whether to participate in research. Environmental circumstances may also increase vulnerability such as very
p.000025: poor socio-economic conditions, low levels of formal education and literacy, or restricted access to health care
p.000025: services. Such persons may be more easily persuaded to agree to participate without a properly considered
p.000025: understanding of the implications.
p.000025: It is important to note the difference between legal incapacity and factual incapacity. No person may
p.000025: claim that, because a minor is factually capable, the legal incapacity should be waived. On the other hand, no adult
p.000025: may be assumed to be incapable unless incapacity is established factually. Consequently, mental incapacity must
p.000025: be established by a factual assessment of the individual’s abilities to understand and to
p.000025: communicate that understanding. Legal incapacity prevails notwithstanding the existence of factual capacity.
p.000025: South Africa is home to a number of vulnerable communities. Where factors usually associated with
p.000025: vulnerability are integral to the research, the proposal should demonstrate how vulnerability would be managed.
p.000025: Particular caution should be exercised before undertaking research involving participants in such
p.000025: communities, and RECs should ensure that
p.000025: • persons in these communities are not being involved in research merely because they are expediently accessible,
p.000025: while the research could be carried out in a less vulnerable community;
p.000025: • the research is relevant to the health needs and priorities of the community in which it is to be carried out;
p.000025: and that
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 19 UNAIDS defines ‘vulnerable community’ as having some or all of the following characteristics: limited economic
...
p.000027: approval for the study may be withdrawn, temporarily or permanently, as the case may be.
p.000027: Groups of participants discussed here include
p.000027: • minors (children and adolescents)
p.000027: • women
p.000027: • adults with incapacity to provide informed consent
p.000027: • persons in dependent relationships
p.000027: • persons highly dependent on medical care
p.000027: • persons with physical disabilities
p.000027: • prisoners
p.000027: • collectivities
p.000027:
p.000027: Note this list is not exhaustive but provides an indication of the types of consideration to be applied
p.000027: 3.2.2 Minors (children and adolescents)
p.000027:
p.000027: Below the age of majority, the law protects young people from their own emotional, cognitive and physical immaturity
p.000027: and limited life experience through the legal status of minority. In other words, minors, i.e. persons under 18 years
p.000027: of age,22 are legally incapable of performing legal transactions without assistance from a parent or guardian. In the
p.000027: research context, this means that, in principle, anyone under the age of 18 years may not choose independently whether
p.000027: to participate in research; a parent or guardian must give permission for the minor
p.000027:
p.000027: 21 Note that this requirement does not mean that a REC may not approve a waiver of personal informed consent for types
p.000027: of research into e.g. record reviews or such like.
p.000027: 22 Section 28 of the Constitution; and s 17 of the Children’s Act 38 of 2005.
p.000027:
p.000027: 28 Ethics in Health Research 2nd edition
p.000027:
p.000027:
p.000027: to choose. This is because young persons’ understanding of key aspects of the research initiative may be
p.000027: compromised and, consequently, they may be exposed to increased risk of harm from particular research procedures.
p.000027: Exceptions to the requirement for parental permission are discussed at 3.2.2.4.
p.000027: Tension exists between the views that, in general, children and adolescents should not bear the burden of research
p.000027: unnecessarily, on the one hand, and that children and adolescents are entitled to improved health care based on
p.000027: findings drawn from rigorous research conducted in the child population of South Africa, on the other.
p.000027: The solution lies in the approach that minors should participate in research only where their
p.000027: participation is indispensable to the research; i.e. the research cannot deliver the desired outcomes if adult
p.000027: participants were to be used instead.
p.000027: Because of their status of legal incapacity, in principle, minors may not choose independently whether to participate
p.000027: in research. A parent or guardian must give permission for the minor to choose. It should be noted that the parent or
p.000027: guardian does not choose for the minor who is capable of choosing;23 rather, the parent or guardian gives
p.000027: permission for the minor to choose. Where a minor is very young or is factually incapable of exercising a choice,
p.000027: then the parent or guardian chooses whether the minor should participate.
p.000027: The best interest of a child should be paramount in decisions that affect the child. 24 This principle is
p.000027: difficult to apply in the research context because research participation is unlikely to be in the best interest of a
p.000027: minor. Good research design does not accommodate a best interest analysis easily. Rather, the design draws on
p.000027: aggregates of information. This means that, in the research context, the best interest principle should be understood
p.000027: to mean that participation in the research should not be contrary to the individual minor’s best interest. Further, the
p.000027: research should investigate a problem of relevance to minors.
p.000027: Where research can be done with consenting adults but nevertheless proposes also to include minors, the
p.000027: researchers must provide strong justification for the inclusion of minors. The REC should not make assumptions on
p.000027: behalf of the researchers. It should require all relevant information to be provided by the researchers. Note
p.000027: that all types of clinical trial research on minors should be scrutinized carefully in case extra precautions or
p.000027: conditions are necessary.
p.000027: For purposes of these guidelines
...
p.000035: substance whose short term and long-term effects on a fetus and developing infant are unknown, should be outweighed by
p.000035: the benefits. An example of a positive risk-benefit ratio would be the use of anti-retrovirals in mother to child HIV
p.000035: transmission studies. For nursing mothers, the amount of drug passing into breast milk should be established and the
p.000035: potential impact on a breast-fed infant anticipated, and the mother so advised.
p.000035:
p.000035: 36 Ethics in Health Research 2nd edition
p.000035:
p.000035:
p.000035: • in all cases, inclusion poses the least risk of harm possible for achieving the objectives of the research.
p.000035: 3.2.4 Adults with factual incapacity to provide informed consent
p.000035:
p.000035: Adults who are factually incapable of giving informed consent should participate in research only where their
p.000035: participation is indispensable to the research; i.e. the research cannot deliver the desired outcomes if
p.000035: capable adult participants were to be used instead. Further, the research should investigate a problem of
p.000035: relevance to incapacitated adults. Where research can be undertaken with capable adults but nevertheless proposes
p.000035: also to include incapacitated adults, strong justification for their inclusion must be provided.
p.000035: The primary difficulty for informed consent in this context is whether proxy consent is permissible. The
p.000035: best interest principle is often used in connection with decisions relating to whether incapacitated adults should be
p.000035: enrolled in research. However, similarly to the case of minors, this principle is difficult to apply in the
p.000035: research context because research participation is unlikely to be in the best interest of an incapacitated adult.
p.000035: Good research design does not permit a best interest analysis easily. Rather, the design draws on
p.000035: aggregates of information. This means that, in the research context, the best interest principle should
p.000035: be understood to mean that participation in the research should not be contrary to the individual’s best
p.000035: interest.
...
p.000035: minor children to choose whether to participate in research. If the minor
p.000035:
p.000035: 32 Georgetown University Informed Consent and Limitations on Decision making Capacity Chapter 2
p.000035: https://bioethicsarchive.georgetown.edu/nbac/capacity/Informed.htm
p.000035:
p.000035: Ethics in Health Research 2nd edition
p.000037: 37
p.000037:
p.000037: is unable to communicate at all or lacks the capacity to choose, then the parent or guardian should choose whether
p.000037: the minor may be enrolled. In other words, the parent acts as a proxy decision maker. In the case of a
p.000037: minor who remains intellectually or mentally impaired after reaching the age of majority, the situation changes
p.000037: because the person becomes an adult with decision-making incapacity (see 3.2.4.3 below).
p.000037: 3.2.4.3 Adults incapable of giving adequate informed consent
p.000037: Proxy decision makers are not permitted for adult persons who lack capacity unless the proxy is a court-appointed
p.000037: curator. Neither the National Health Act 61 of 2003 nor the Mental Health Care Act 17 of 2002 makes
p.000037: provision for proxy decision makers for research purposes but they provide clear lists of proxy decision makers for
p.000037: treatment purposes.
p.000037: Since it would be unethical to exclude a category of persons from research participation without adequate
p.000037: justification, arguably, an ethical argument can be made for using the statutory treatment proxies to
p.000037: provide permission for participation in research that complies with the stipulations set out below. However,
p.000037: RECs must be careful not to confuse the distinction between treatment and research. In unusual circumstances,
p.000037: e.g. major incident research (see 3.4.1), it may be ethically permissible to permit proxy consent also in
p.000037: a situation where no statutory proxy is available but the risk of harm to knowledge ratio justifies it.
p.000037: In particular circumstances, the REC may approve delayed consent.
p.000037: Note this does not mean that informed consent is waived.
p.000037: RECs should ensure that a clear and full justification for the proposed delay accompanies the research proposal. The
...
Health / Motherhood/Family
Searching for indicator family:
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p.000023: procedures. The provisions underpin the importance of comprehensive SOPs and rigorous adherence thereto. It
p.000023: should be remembered that research records including informed consent documentation may be solicited by
p.000023: interested parties via application in terms of the Promotion of Access to Information Act 2 of 2000.
p.000023: 3.1.9 Obtaining informed consent
p.000023: The principle of respect for persons underpins the requirement that a person must choose voluntarily whether to
p.000023: participate in research on the basis of information that allows an informed choice to be made. The
p.000023: process of providing the necessary information and of engaging with the person before a decision is
p.000023: reached is known as the informed consent process. It should be noted that informed consent is a necessary but
p.000023: insufficient element of ethical research, i.e. that a person voluntarily chooses to participate does not mean that the
p.000023: research proposal is ethical. All the other elements should also stand up to ethical scrutiny.
p.000023: An important element of making an informed choice is the nature and quality of information made available to the
p.000023: potential participant. See below for expectations regarding information disclosure.
p.000023: Adults, i.e. persons over the age of 18 years, may make independent decisions. However, they may wish to consult with
p.000023: family members or others in keeping with personal preference or cultural practices. Consequently, the process should
p.000023: permit sufficient time for consultation between the recruitment approach and the point of decision-making. No person
p.000023: should be required to make an immediate decision. The informed consent process for adults with diminished
p.000023: or no decision-making capacity (factually incapacitated) and for minors (legally incapacitated) is described at
p.000023: 3.2.4.3 and 3.2.4.2 respectively.
p.000023: RECs should assess the proposed process for informed consent as well as the information that potential participants
p.000023: will be given and the measures to facilitate understanding. Considerations for assessment include whether
p.000023: • the setting will
p.000023: o minimise the possibility of undue influence
p.000023: o be sufficiently private and appropriate
p.000023:
p.000023: 16 ‘Biometrics means a technique of personal identification that is based on physical, physiological or behaviour
p.000023: characterisation including blood typing, fingerprinting, DNA analysis, retinal scanning and voice recognition’ (s 1 of
p.000023: the Act).
p.000023:
p.000023: Ethics in Health Research 2nd edition
p.000025: 25
p.000025:
p.000025: • the person who will conduct the process
...
p.000033: request that the authority to give permission should be included expressly in the court order authorising
p.000033: foster care)28
p.000033: v. If no foster parent (per iv. above), then caregiver (s 1 Children’s Act: defined as ‘…any person
p.000033: other than a parent or guardian, who factually cares for a child and includes – a) a foster parent; b) a person who
p.000033: cares for the child with the implied or express consent of a parent or guardian of the child; c) a person who cares for
p.000033: the child whilst the child is in temporary safe care; d) the person at the head of a child and youth care centre where
p.000033: a child has been placed; e) the person at the head of a shelter; f) a child and youth care worker who cares
p.000033: for a child who is without appropriate family care in the community; and g) the child at the head of a child-
p.000033: headed household’)
p.000033: vi. If minor is caregiver in child-headed household and no supervisory adult (s 137 Children’s Act), then
p.000033: trusted adult nominated by minor, including but not limited to social worker, community worker or teacher.
p.000033: 3.2.2.4 Minors’ independent consent
p.000033: In particular circumstances, e.g. for reasons of sensitivity, like discussion about sexual activities,
p.000033: substance abuse etc., it may be desirable and ethically justifiable for minors (especially older minors i.e.
p.000033: 16 years and older) to choose independently i.e. without parental assistance, whether to participate in research.
p.000033: Generally, only minimal risk research is suitable for independent consent by minors. Reasons
p.000033: supporting the desirability of independent consent may include recruiting sufficient numbers of minors
p.000033: who otherwise would be unwilling to participate if they must tell their parents about the nature of the
p.000033: research in order to obtain parental permission.
...
p.000043: 35See World Health Organization. Informed Consent Templates. Consent for Storage and Future Use of Unused Samples
p.000043: http://www.who.int/rpc/research_ethics/informed_consent/en/
p.000043: 36See also Human Heredity and Health in Africa (H3Africa) Guidelines for Informed Consent. August 2013.
p.000043: http://h3africa.org/ethics/17- ethics/71-informed-consent
p.000043: 37Human Heredity and Health in Africa (H3Africa) Initiative http://h3africa.org/
p.000043:
p.000043: 44 Ethics in Health Research 2nd edition
p.000043:
p.000043:
p.000043: i. Use of existing or archived material collected for clinical or diagnostic purposes, including waste
p.000043: and surplus samples, requires expedited review. The nature of the previously obtained consent should be determined to
p.000043: ascertain whether subsequent usage was envisaged and whether it falls within the scope of the current proposal. If so,
p.000043: new consent is not required.
p.000043: ii. If the scope of the current proposal is different, then new consent may be required.
p.000043: iii. If samples are anonymous and the results of research would not place any individual, family or
p.000043: community at social, psychological, legal or economic risk of harm, then new consent is not required.
p.000043: iv. If the link to identifiers exists but is not provided to the research team and the results of
p.000043: research will not place any individual, family or community at social, psychological, legal or economic risk
p.000043: of harm, then new consent is not required.
p.000043: v. The person who holds the code or link should sign an explicit written agreement not to release the identifiers
p.000043: to the research team. This agreement should accompany the submission to the REC.
p.000043: vi. If the samples can be linked to identifiers, the REC must decide on a case-by-case basis whether expedited or
p.000043: full review is necessary.
p.000043: 3.3.8 Genetic research
p.000043: Genetics refers to the study of genes (human DNA), heredity and variation as well as how they affect inheritance of
p.000043: traits and conditions between generations of people, especially regarding human health and disease. A gene is
p.000043: the unit of heredity.
p.000043: From an ethical perspective, genetic research may hold out positive and negative implications.
p.000043: While its purpose may be to shed increasing light on causes of diseases and how to prevent or combat them,
p.000043: participants in such research may experience negative effects like stigmatisation, unfair discrimination and so
p.000043: on. Furthermore, genetic information is not specific to one individual but reveals much about that person’s relatives
p.000043: and others with a shared ancestry.
p.000043: When assessing the ethics of proposed genetic research, RECs must pay particular attention to multiple
p.000043: considerations, including the proposed social value of the research; consent, privacy, confidentiality as well
...
p.000043: to potential participants. Plans to share findings with participants must include opportunities for
p.000043: participants to choose whether they wish to receive the information personally, and whether the information may be
p.000043: shared with biological relatives. Genetic counselling must be available if findings will be disclosed to participants.
p.000043: 3.3.9 Genomics research
p.000043: Genomics research refers to the study of all of a person’s genes (the genome) and how they interact with each other
p.000043: and with the person’s environment. Genomics research permits investigation into diseases at a population level
p.000043: to take into account not only genetic, but also environmental factors.
p.000043: The stated goal of the H3Africa initiative is to
p.000043:
p.000043: Ethics in Health Research 2nd edition
p.000045: 45
p.000045:
p.000045: enhance the capacity of African researchers to undertake cutting edge research to advance understanding of
p.000045: the genetic and environment determinants of common diseases and use this knowledge to improve the health of
p.000045: African populations.38
p.000045: Collection and storage of data and human biological materials should balance the need for adequate participant
p.000045: safeguards with optimal advancement of such research in line with the stated goal expressed above.
p.000045: Special or additional protections for participants’ interests may be necessary, e.g. in instances where identifiable
p.000045: samples or data are collected; where findings in genetic studies may pose social, psychological, legal or economic
p.000045: risks for a participant, his family or his community. Most data and biological material can be de-identified
p.000045: after collection or can be collected without identification of the donor.
p.000045: 3.3.10 Commercially available cell lines
p.000045: Biosafety and ethical issues may arise from use of commercially available cell lines depending on the nature of the
p.000045: planned research work. For example, if cells are to be infected, biosafety and hence also ethical issues, arise
p.000045: for researchers rather than participants. If cells will undergo genetic modification, there may also be ethical
p.000045: implications.
p.000045: Whether REC review is required, depends on whether institutions have properly functioning research review and biosafety
p.000045: infrastructures. Where these do not yet exist, RECs should be part of the process to ensure biosafety and ethical
p.000045: standards are maintained.
p.000045: Note that ‘blanket approval’ for use of commercially available cell lines is not permitted. At minimum, a researcher
p.000045: is expected to liaise with the REC about the biosafety and ethical implications of the planned work. RECs
p.000045: should draw up a SOP and query template to assist establishing the implications.
p.000045: 3.4 Considerations specific to research methods or contexts
p.000045:
p.000045: Particular types of research require careful scrutiny in case additional precautions or monitoring
p.000045: procedures are required.
p.000045: Types of research discussed include:
p.000045: • Major incidents39 and research
p.000045: • Intensive care research
p.000045: • Terminal care research
p.000045: • Innovative therapy or interventions
p.000045: • Indigenous medicines research
...
p.000045: for diagnostic purposes, or additional handling of a low birth-weight infant to make research- related observations,
p.000045: requires very careful justification and skill, especially in assessing the risk-benefit ratio. Input from neonatal
p.000045: intensive care experts should be sought.
p.000045:
p.000045: Ethics in Health Research 2nd edition
p.000047: 47
p.000047:
p.000047: 3.4.3 Terminal care research
p.000047:
p.000047: Terminal care research is distinguished by the short remaining life expectancy of participants and their potential
p.000047: vulnerability to unrealistic expectations of benefits from participation in research. In principle, because of their
p.000047: extreme vulnerability, terminally ill patients should not participate in research that is more than minimally invasive
p.000047: without adequate justification.
p.000047: The prospect of any direct benefit from research participation must not be overstated or used to justify a risk of harm
p.000047: higher than that involved in current treatment. Research participation must not be used to prevent or devalue the needs
p.000047: and wishes of participants rather to spend time as they choose, particularly with family members.
p.000047: 3.4.4 Traditional medicines research
p.000047:
p.000047: In line with the constitutional guarantees for cultural and language rights, 40 indigenous cultures and
p.000047: traditional values of all communities must be respected. However, since fundamental rights do not trump
p.000047: each other without careful justification, participants in research involving traditional medical systems and
p.000047: beliefs must be accorded the same respect and protection as any other human research participant. 41 The
p.000047: context of the research activity, interaction or intervention is important for determining whether, how and when to
p.000047: incorporate traditional values and their cultural expression in research.
p.000047: In terms of the Traditional Health Practitioners Act 22 of 2007,
p.000047: 'Traditional medicine' means an object or substance used in traditional health practice for-
p.000047: (a) the diagnosis, treatment or prevention of a physical or mental illness; or
p.000047: (b) any curative or therapeutic purpose, including the maintenance or restoration of physical or mental health or
p.000047: well-being in human beings,
p.000047: but does not include a dependence-producing or dangerous substance or drug.
p.000047: 'Traditional health practice' means the performance of a function, activity, process or service based on a
p.000047: traditional philosophy that includes the utilisation of traditional medicine or traditional practice and which has as
p.000047: its object-
p.000047: (a) the maintenance or restoration of physical or mental health or function; or
p.000047: (b) the diagnosis, treatment or prevention of a physical or mental illness; or
p.000047: (c) the rehabilitation of a person to enable that person to resume normal functioning within the family or community;
p.000047: or
p.000047: (d) the physical or mental preparation of an individual for puberty, adulthood, pregnancy, childbirth and
p.000047: death,
p.000047: but excludes the professional activities of a person practising any of the professions contemplated in the
p.000047: Pharmacy Act 53 of 1974, the Health Professions Act 56 of 1974, the Nursing Act 50 of 1974, the Allied Health
p.000047: Professions Act 63 of 1982, or the Dental Technicians Act 19 of 1979, and any other activity not based on
p.000047: traditional philosophy.
p.000047:
p.000047:
p.000047:
p.000047: 40 Sections 30 and 31 of the Constitution.
p.000047: 41 In terms of s 12(2)(c) of the Constitution and s 71 of the National Health Act.
p.000047:
p.000047: 48 Ethics in Health Research 2nd edition
p.000047:
p.000047:
p.000047: 'Traditional philosophy' means indigenous African techniques, principles, theories, ideologies, beliefs, opinions and
p.000047: customs and uses of traditional medicines communicated from ancestors to descendants or from generations
p.000047: to generations, with or without written documentation, whether supported by science or not, and which are
p.000047: generally used in traditional health practice.
p.000047: RECs should pay attention to indications that intellectual property may be intended to be acquired by
...
p.000049: ‘Experimental treatment’ means a therapy, intervention or procedure (not standard of care) delivered to a specific
p.000049: individual patient for therapeutic purposes in an attempt to cure or alleviate symptoms.
p.000049: ’Novel, innovative and unproven therapies’ means
p.000049: • a newly introduced or locally untested treatment or procedure; or
p.000049: • a modification to an existing treatment, intervention or procedure where no systematic research
p.000049: profile or side effect profile about the modification exists; or
p.000049: • an experimental treatment, intervention or procedure; or
p.000049: • a treatment, intervention or procedure not included in the usual package of care
p.000049: which is sought to be used on an experimental or compassionate basis in circumstances where it is thought,
p.000049: on reasonable grounds, that a theoretical justification exists for such use, despite the absence of a systematic
p.000049: research profile or side effect profile.
p.000049:
p.000049: 50 Ethics in Health Research 2nd edition
p.000049:
p.000049:
p.000049: ‘Research’ means a systematic investigation or study designed to produce generalizable knowledge on the basis
p.000049: of conventional scientific and ethical standards appropriate for the context.
p.000049: iii. The treatment context
p.000049: The wish to use a novel, innovative or unproven treatment usually arises in a context suffused by the
p.000049: rule of rescue. In other words, a health care worker may face a situation where all standard options have been
p.000049: exhausted, the desire to provide further rescue interventions exists and the patient (or the patient’s family) is
p.000049: willing to risk the unknown. While the health care worker takes primary responsibility to act in the best interest of
p.000049: the patient, in these circumstances, the health care worker should not make unilateral decisions. Responsibility and
p.000049: accountability should be shared in accordance with these Guidelines.
p.000049: Ethical principles must inform the process of deciding whether a novel, innovative or unproven therapy is
p.000049: appropriate in the circumstances. And, importantly, the decision-making should be predicated on a deliberative process
p.000049: undertaken by well-informed people. Although innovation is often the driving force in the advancement of new knowledge
p.000049: in health care, when time and emotional pressures prevail, especially at the individual level, deliberate
p.000049: objective thinking may be undermined, which can lead to decision-making that is not appropriately
p.000049: responsible. In light of s 27 of the Constitution, which guarantees the right of access to health care services to all,
p.000049: elevation of one individual’s claim to more than standard of care necessarily has implication for accountability
p.000049: and responsible decision-making in health facilities.
p.000049: iv. The legal and ethical context
p.000049: Use of locally novel, innovative or unproven therapy involves legal, ethical and practical considerations.
p.000049: The National Health Act 61 of 2003 (NHA) makes provision for ‘health services for experimental or research
p.000049: purposes’ (s 11) and requires that, prior to treatment, the patient must be informed of the experimental or innovative
p.000049: status of the intended treatment.
...
p.000081: World Health Organization Operational Guidelines for Ethics Committees that review Biomedical
p.000081: Research TDR/PRD/ETHICS/2000
p.000081: World Health Organization Standards and Operational Guidance for Ethics Review of Health- Related Research with Human
p.000081: Participants (2011)
p.000081: World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human
p.000081: Subjects 1964, most recently amended in 2013
p.000081: World Medical Association: Declaration of Helsinki (2013)
p.000081:
p.000081: Ethics in Health Research 2nd edition
p.000083: 83
p.000083:
p.000083:
p.000083: APPENDIX 3
p.000083:
p.000083: Templates
p.000083:
p.000083: 1. Mandatory reporting of abuse
p.000083:
p.000083: How to respond adequately to the reporting requirement within a research context:
p.000083: Note that arrangements and negotiations e.g. with Childline South Africa or other agencies, should be made in advance
p.000083: of the application for ethics review. The applicant should be able to assure the REC about the referral arrangements.
p.000083: 1. Disclosure by any adolescent under 16 years of sexual or other abuse, or on whose behalf abuse is reported by a
p.000083: peer, caregiver, guardian or family member or other relevant person, should trigger an immediate
p.000083: termination of further interviews with the respondent and members of the household.
p.000083: 2. If there is a clear statement that the parties involved in the abuse include an adult (anyone 18
p.000083: years or older) or anyone who is more than two years older than the adolescent (s 56(2)(b)), the
p.000083: interviewer should report the matter to Childline South Africa at toll free: 0800 055 555 [or another child protection
p.000083: agency]. Childline should contact a registered social worker in the area who should investigate and inform the South
p.000083: African Police Service (SAPS) accordingly. The interviewer should record details of the child’s name,
p.000083: physical address and the name of the school the child attends. As proof of complying with the
p.000083: statutory reporting obligation, the interviewer should insist on a Childline reference number.
p.000083: 3. Any secondary reporting of abuse, e.g. where a child indicates that she has reported the abuse to a teacher or
p.000083: another adult but that no action has been taken, the matter should be brought to the attention of Childline, who should
p.000083: deal with the matter. Again, the interviewer should insist on a Childline reference number, as proof of reporting.
...
p.000083: insurance payment as full settlement of the claim for medical costs.
p.000083:
p.000083: Ethics in Health Research 2nd edition
p.000085: 85
p.000085:
p.000085: However, accepting this offer of insurance cover does not mean you give up your right to make a separate claim for
p.000085: other losses based on negligence, in a South African court.
p.000085: It is important to follow the study doctor’s instructions and to report straight away if you have a side effect
p.000085: from the study medicine.
p.000085:
p.000085: See also Medicines Control Council Clinical Trial Compensation Guidelines available at
p.000085: http://www.sahealthinfo.org.ethics/book1.htm
p.000085:
p.000085: 86 Ethics in Health Research 2nd edition
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: 3. Novel, Innovative or Unproven Treatment
p.000085:
p.000085: < Insert hospital name >
p.000085:
p.000085: NOVEL, INNOVATIVE OR UNPROVEN TREATMENT CONSENT FORM
p.000085:
p.000085: How to use this Consent Form
p.000085: Read carefully through the whole document
p.000085: Fill in the RED areas ELECTRONICALLY (for future data collection) Make sure that all the necessary information is
p.000085: included
p.000085: The information written in BLUE is for guidance and should be removed before finalizing the document
p.000085: Print three (3) copies: one for patient’s folder, one for PTC, and one for the patient or her family
p.000085: This document is for a single patient use and a single treatment course only.
p.000085:
p.000085: This document tells you about a treatment for your (your child’s) condition that is still experimental but which your
p.000085: doctors would like to try. You are not being asked to join a research project. Important differences
p.000085: exist between experimental treatment and a research project.
p.000085: This treatment is experimental because
p.000085: < delete options that do not apply >
p.000085: It has been tested for conditions other than yours (your child’s).
p.000085: It has been tested for use with adults but not for use with children (< 18 years; < 12 years) It has not been registered
p.000085: in South Africa for use for your condition.
p.000085:
p.000085:
p.000085:
p.000085: Name of Drug Or Intervention
p.000085: Single Patient Use of < Insert Investigational Drug or Intervention Name >
p.000085:
p.000085:
p.000085: Treating Health care worker(s):
p.000085: < Insert Name >
p.000085: < Insert Address/Medical ward details >
p.000085: < Insert Phone Numbers/ Medical ward extension >
p.000085:
p.000085:
p.000085: Emergency Contact < Insert Emergency Contact Information >
p.000085: < Insert Phone Number/Pager, etc >
p.000085:
p.000085:
...
p.000087:
p.000087:
p.000087: What if new information about the experimental treatment becomes available?
p.000087: While you are using this treatment, we may find out more information that could be important to your treatment.
p.000087: This includes information that might cause you to change your mind about taking the drug. We will tell you as
p.000087: soon as possible if such information becomes available so that you are informed at all times.
p.000087:
p.000087: What other choices do I have if I do not use this experimental treatment?
p.000087: Your doctors think that, at the moment, there are no other satisfactory alternatives available to you. You do have the
p.000087: option of deciding to refuse further treatment and only accept care for comfort. You can discuss these options with
p.000087: your doctors.
p.000087:
p.000087: What happens if I am harmed because of using the experimental treatment?
p.000087: We will give you the necessary medical care to treat the harms or injuries that result directly from using the
p.000087: experimental treatment.
p.000087:
p.000087: When will my participation be over?
p.000087: Your participation will last until < insert endpoint in appropriate language based on investigational drug
p.000087: being used >.
p.000087:
p.000087: If you decide to use this experimental treatment, you are free to stop taking it any time. Please
p.000087: inform your treating physician(S) if you choose to do this, so appropriate follow-up can occur.
p.000087:
p.000087: [Ensure that whether withdrawal is possible is clear to patient or family member]
p.000087:
p.000087: Who can see or use my information? How will my personal information be protected?
p.000087: The personal information in your medical record will be kept confidential as is usual with health
p.000087: information. However, we cannot guarantee total privacy. Your personal information may be shared with other health care
p.000087: professionals where it is in your best interest to do so and if required by law.
p.000087:
p.000087: Who can I call if I have questions, concerns or complaints?
p.000087: If you have questions, concerns or complaints, you should speak to your doctor listed on page one of this form.
p.000087:
p.000087: Who will know that I am receiving an experimental treatment?
p.000087: Your doctors and the rest of the medical team will know that you are using an experimental treatment.
p.000087: As explained above, your doctor will have obtained permission from the hospital authorities to use it.
p.000087: As is usual, your privacy interests will be respected and information about your treatment and condition will be
p.000087: confidential to the extent possible.
p.000087: Because of its experimental nature, we will want to write a report about what we learn from using this therapy for your
p.000087: treatment. This is to make the information available so that other doctors can learn more about it too. However, your
p.000087: identity will not be revealed when we write up our notes for publication or discuss the treatment at meetings or
p.000087: conferences.
p.000087: When you sign this form, you are agreeing to use the experimental treatment for your < insert patient’s
p.000087: condition >. Your signature indicates that you have read this form, your questions have been answered, and you have
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.000025: or its successor.
p.000025:
p.000025: 26 Ethics in Health Research 2nd edition
p.000025:
p.000025:
p.000025: 3.2 Vulnerability and incapacity
p.000025:
p.000025: Vulnerability is not an absolute condition but rather occurs on a sliding scale. In South Africa, arguably, the
p.000025: majority of potential research participants are vulnerable when compared to those in North America or Europe,
p.000025: from whence much funding is sourced. 19 Whether vulnerability is present is a matter of fact and degree.
p.000025: However, certain groups of participants 20 require careful consideration to ensure that, where appropriate,
p.000025: additional precautions are put into place. For example, advanced age, very young age, personal or
p.000025: environmental factors like extreme poverty and ordinarily poor access to health care may increase
p.000025: vulnerability
p.000025: 3.2.1 Contextual circumstances
p.000025: Personal circumstances, such as mental or intellectual impairment, acute illness, advanced age, and pregnancy and
p.000025: childbirth may increase vulnerability. Persons may be factually incapable or less capable of understanding
p.000025: information and processing it to reach a decision
p.000025: e.g. about whether to participate in research. Environmental circumstances may also increase vulnerability such as very
p.000025: poor socio-economic conditions, low levels of formal education and literacy, or restricted access to health care
p.000025: services. Such persons may be more easily persuaded to agree to participate without a properly considered
p.000025: understanding of the implications.
p.000025: It is important to note the difference between legal incapacity and factual incapacity. No person may
p.000025: claim that, because a minor is factually capable, the legal incapacity should be waived. On the other hand, no adult
p.000025: may be assumed to be incapable unless incapacity is established factually. Consequently, mental incapacity must
...
p.000047: higher than that involved in current treatment. Research participation must not be used to prevent or devalue the needs
p.000047: and wishes of participants rather to spend time as they choose, particularly with family members.
p.000047: 3.4.4 Traditional medicines research
p.000047:
p.000047: In line with the constitutional guarantees for cultural and language rights, 40 indigenous cultures and
p.000047: traditional values of all communities must be respected. However, since fundamental rights do not trump
p.000047: each other without careful justification, participants in research involving traditional medical systems and
p.000047: beliefs must be accorded the same respect and protection as any other human research participant. 41 The
p.000047: context of the research activity, interaction or intervention is important for determining whether, how and when to
p.000047: incorporate traditional values and their cultural expression in research.
p.000047: In terms of the Traditional Health Practitioners Act 22 of 2007,
p.000047: 'Traditional medicine' means an object or substance used in traditional health practice for-
p.000047: (a) the diagnosis, treatment or prevention of a physical or mental illness; or
p.000047: (b) any curative or therapeutic purpose, including the maintenance or restoration of physical or mental health or
p.000047: well-being in human beings,
p.000047: but does not include a dependence-producing or dangerous substance or drug.
p.000047: 'Traditional health practice' means the performance of a function, activity, process or service based on a
p.000047: traditional philosophy that includes the utilisation of traditional medicine or traditional practice and which has as
p.000047: its object-
p.000047: (a) the maintenance or restoration of physical or mental health or function; or
p.000047: (b) the diagnosis, treatment or prevention of a physical or mental illness; or
p.000047: (c) the rehabilitation of a person to enable that person to resume normal functioning within the family or community;
p.000047: or
p.000047: (d) the physical or mental preparation of an individual for puberty, adulthood, pregnancy, childbirth and
p.000047: death,
p.000047: but excludes the professional activities of a person practising any of the professions contemplated in the
p.000047: Pharmacy Act 53 of 1974, the Health Professions Act 56 of 1974, the Nursing Act 50 of 1974, the Allied Health
p.000047: Professions Act 63 of 1982, or the Dental Technicians Act 19 of 1979, and any other activity not based on
p.000047: traditional philosophy.
p.000047:
p.000047:
p.000047:
p.000047: 40 Sections 30 and 31 of the Constitution.
p.000047: 41 In terms of s 12(2)(c) of the Constitution and s 71 of the National Health Act.
p.000047:
p.000047: 48 Ethics in Health Research 2nd edition
p.000047:
p.000047:
p.000047: 'Traditional philosophy' means indigenous African techniques, principles, theories, ideologies, beliefs, opinions and
p.000047: customs and uses of traditional medicines communicated from ancestors to descendants or from generations
p.000047: to generations, with or without written documentation, whether supported by science or not, and which are
p.000047: generally used in traditional health practice.
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000035: will be addressed, so that an informed choice can be made about whether to participate. Appropriate
p.000035: engagement with role-players such as child rights and child care organizations may assist researchers to make
p.000035: appropriate and meaningful referrals.
p.000035: 3.2.3 Women
p.000035:
p.000035: Exclusion of women as research participants has led to a lack of data needed to promote women’s health. Any proposed
p.000035: exclusion of women participants must be justifiable in light of research priorities as well as the specific research
p.000035: question under consideration. For example, women are appropriately excluded from prostate cancer research
p.000035: because the relevant population is male. In particular, systematic class exclusion must be guarded against to avoid
p.000035: unfair participant selection.
p.000035: Additional health concerns arise during pregnancy, including the need to avoid unnecessary risk to the fetus.
p.000035: Consequently, researchers and RECs should exercise extra caution when women participants are or may become
p.000035: pregnant. Exclusion of women from research may be justifiable
p.000035: a) to protect the health of the fetus; and
p.000035: b) if exclusion is scientifically supportable.
p.000035: Note that the informed consent documents must explain carefully and fully what the possible effect of the research
p.000035: activities on the fetus might be.
p.000035: Usually, research involving pregnant women should be undertaken when
p.000035: • the purpose of the proposed research is to meet the health needs of the mother of the particular fetus;
p.000035: • appropriate studies on animals and non-pregnant individuals have been completed;31
p.000035: • the risk of harm to the fetus is minimal; and
p.000035:
p.000035: 31 Clinical trials involving pregnant women or nursing mothers should ideally involve products where the toxicology in
p.000035: adults is established and is acceptable. In the case of pregnant women, the potential risks associated with using a
p.000035: substance whose short term and long-term effects on a fetus and developing infant are unknown, should be outweighed by
p.000035: the benefits. An example of a positive risk-benefit ratio would be the use of anti-retrovirals in mother to child HIV
p.000035: transmission studies. For nursing mothers, the amount of drug passing into breast milk should be established and the
p.000035: potential impact on a breast-fed infant anticipated, and the mother so advised.
p.000035:
p.000035: 36 Ethics in Health Research 2nd edition
p.000035:
p.000035:
p.000035: • in all cases, inclusion poses the least risk of harm possible for achieving the objectives of the research.
p.000035: 3.2.4 Adults with factual incapacity to provide informed consent
p.000035:
...
p.000083: deal with the matter. Again, the interviewer should insist on a Childline reference number, as proof of reporting.
p.000083: If there is uncertainty about whether to report, the interviewer should consult with the Principal
p.000083: Investigator. [Insert conditions appropriate to the circumstances]
p.000083: Examples in practice Action by researcher
p.000083:
p.000083: A 14 year old tells of having sex with her 17 year old boyfriend
p.000083: A 12 year old reports ‘having sex’ with 19 year old neighbour
p.000083: An 11 year old tells of a previously reported incident of ‘bad touching’ by adult aunt that went to court
p.000083: Childline ◇ Police Childline ◇ Police
p.000083: No action; ask whether the child wants to talk to someone
p.000083: A 15 year old relates rape by father Childline ◇ Police
p.000083:
p.000083: A 13 year old boy relates anecdote of sex with 15 year old girlfriend
p.000083: Not over two years, so no action
p.000083:
p.000083: 84 Ethics in Health Research 2nd edition
p.000083:
p.000083:
p.000083:
p.000083: A 13 year old says she is ‘having sex’ but does not disclose who the partner is
p.000083: A 17 year old brags that he has ‘forced’ many girls into having sex with him
p.000083: A 17 year old learner speaks of having become pregnant by a school teacher who she does not identify
p.000083: A 18 year old learner points out a female school teacher with whom he says he is ‘sleeping’
p.000083:
p.000083: No action No action
p.000083: Ask whether she wants to speak to someone
p.000083: Ask whether he wants to speak to someone
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: 2. Insurance information for consent documentation
p.000083:
p.000083: This template is based on DoH 2006, MCC Clinical Trials Compensation Guidelines and Venter v Roche Products (Pty)
p.000083: Ltd et al (12285/08) [2013] WCHC 7 May 2013 and on appeal (A11/2014) 22 October 2014.
p.000083:
p.000083: Notes for researchers:
p.000083: i. Research study insurance does not substitute malpractice insurance
p.000083: ii. ABPI guidelines on compensation apply only to unlicensed substances used in Phase II and III clinical
p.000083: trials; reference to ABPI compensation should not be a standard paragraph in all consent documents
p.000083: iii. Participants may not recognize symptoms of side effects or have ready means to take action
p.000083:
p.000083:
p.000083: ‘What happens if I get hurt taking part in this study?’ (or equivalent heading)
p.000083:
p.000083: This research study is covered by an insurance policy taken out by [name of institution] in the event that you suffer a
p.000083: bodily injury as a result of taking part in the study.
p.000083: The insurer will pay for all reasonable medical costs required to treat your bodily injury, in accordance with the SA
p.000083: Good Clinical Practice Guidelines (2006 or latest version), which are based on the Association of the British
p.000083: Pharmaceutical Industry Guidelines. You may request a copy of these guidelines from the study doctor.
...
Health / Terminally Ill
Searching for indicator terminally:
(return to top)
p.000045: the child’s best interest. The small size and extreme vulnerability of some infants are unique features of this
p.000045: class of participants. This means that all but minimally intrusive interventions are likely to be contrary to the
p.000045: child’s best interest. Collection of even small blood samples for research in addition to those required
p.000045: for diagnostic purposes, or additional handling of a low birth-weight infant to make research- related observations,
p.000045: requires very careful justification and skill, especially in assessing the risk-benefit ratio. Input from neonatal
p.000045: intensive care experts should be sought.
p.000045:
p.000045: Ethics in Health Research 2nd edition
p.000047: 47
p.000047:
p.000047: 3.4.3 Terminal care research
p.000047:
p.000047: Terminal care research is distinguished by the short remaining life expectancy of participants and their potential
p.000047: vulnerability to unrealistic expectations of benefits from participation in research. In principle, because of their
p.000047: extreme vulnerability, terminally ill patients should not participate in research that is more than minimally invasive
p.000047: without adequate justification.
p.000047: The prospect of any direct benefit from research participation must not be overstated or used to justify a risk of harm
p.000047: higher than that involved in current treatment. Research participation must not be used to prevent or devalue the needs
p.000047: and wishes of participants rather to spend time as they choose, particularly with family members.
p.000047: 3.4.4 Traditional medicines research
p.000047:
p.000047: In line with the constitutional guarantees for cultural and language rights, 40 indigenous cultures and
p.000047: traditional values of all communities must be respected. However, since fundamental rights do not trump
p.000047: each other without careful justification, participants in research involving traditional medical systems and
p.000047: beliefs must be accorded the same respect and protection as any other human research participant. 41 The
p.000047: context of the research activity, interaction or intervention is important for determining whether, how and when to
p.000047: incorporate traditional values and their cultural expression in research.
p.000047: In terms of the Traditional Health Practitioners Act 22 of 2007,
...
Searching for indicator terminal:
(return to top)
p.000036: 3.2.6 Patients highly dependent on medical care 38
p.000036: 3.2.7 Persons with physical disabilities
p.000038: 38
p.000038: 3.2.8 Prisoners
p.000039: 39
p.000039: 3.2.9 Collectivities
p.000040: 40
p.000040: 3.3 Data & biological material for research purposes 40
p.000040: 3.3.1 Introduction
p.000040: 40
p.000040: 3.3.2 Permitted usage of biological material 41
p.000040: 3.3.3 Identifiability of biological materials and data 41
p.000040: 3.3.4 Collection of biological materials and data 42
p.000040: 3.3.5 Restrictions on collection of biological material 42
p.000040: 3.3.6 Informed consent
p.000042: 42
p.000042: 3.3.7 Secondary use of material or data 43
p.000042: 3.3.8 Genetic research
p.000044: 44
p.000044: 3.3.9 Genomics research
p.000044: 44
p.000044: 3.3.10 Commercially available cell lines
p.000045: 45
p.000045: 3.4 Considerations specific to research methods or contexts 45
p.000045: 3.4.1 Major incidents & research
p.000045: 45
p.000045: 3.4.2 Intensive care research
p.000046: 46
p.000046: 3.4.3 Terminal care research
p.000047: 47
p.000047: 3.4.4 Traditional medicine research
p.000047: 47
p.000047: 3.4.5 Research involving deception or withholding information 48
p.000047:
p.000047: Ethics in Health Research 2nd edition
p.000019: 19
p.000019: 3.5 Special topics
p.000049: 49
p.000049: 3.5.1 Novel, innovative & unproven therapies
p.000049: 49
p.000049: 3.5.2 Data bases, registries & repositories
p.000051: 51
p.000051: 3.5.3 Insurance against research-related bodily injury 53
p.000051:
p.000051: This chapter describes the substantive norms and the operational processes and procedures that Research Ethics
p.000051: Committees (RECs) are expected to adhere to when reviewing and engaging in decision-making about the
p.000051: ethics of research proposals. In what follows, the minimum benchmark for promoting responsible, ethical and safe
p.000051: research involving human participants is described and discussed.
p.000051: Note that while the norms and procedures apply also to research with animals as appropriate, this chapter is aimed
p.000051: more at research with human participants. Details regarding norms and operational processes for research using
p.000051: animals may be found in The care and use of animals for scientific purposes SANS 10386:2008 or its
p.000051: successor.
p.000051: The aim of this chapter is to
p.000051: • provide descriptions of best ethical practices in research involving human participants;
p.000051: • guide compliance with national and international ethical and regulatory requirements;
...
p.000045: samples or data are collected; where findings in genetic studies may pose social, psychological, legal or economic
p.000045: risks for a participant, his family or his community. Most data and biological material can be de-identified
p.000045: after collection or can be collected without identification of the donor.
p.000045: 3.3.10 Commercially available cell lines
p.000045: Biosafety and ethical issues may arise from use of commercially available cell lines depending on the nature of the
p.000045: planned research work. For example, if cells are to be infected, biosafety and hence also ethical issues, arise
p.000045: for researchers rather than participants. If cells will undergo genetic modification, there may also be ethical
p.000045: implications.
p.000045: Whether REC review is required, depends on whether institutions have properly functioning research review and biosafety
p.000045: infrastructures. Where these do not yet exist, RECs should be part of the process to ensure biosafety and ethical
p.000045: standards are maintained.
p.000045: Note that ‘blanket approval’ for use of commercially available cell lines is not permitted. At minimum, a researcher
p.000045: is expected to liaise with the REC about the biosafety and ethical implications of the planned work. RECs
p.000045: should draw up a SOP and query template to assist establishing the implications.
p.000045: 3.4 Considerations specific to research methods or contexts
p.000045:
p.000045: Particular types of research require careful scrutiny in case additional precautions or monitoring
p.000045: procedures are required.
p.000045: Types of research discussed include:
p.000045: • Major incidents39 and research
p.000045: • Intensive care research
p.000045: • Terminal care research
p.000045: • Innovative therapy or interventions
p.000045: • Indigenous medicines research
p.000045: • Deception, concealment or covert data collection
p.000045: Note this list is not exhaustive, merely illustrative.
p.000045:
p.000045: 3.4.1 Major incidents and research
p.000045:
p.000045: Major incidents include any sudden event that occurs where local resources are constrained, so that responding
p.000045: urgently and appropriately is difficult. Major incidents include acute disasters – natural or man-made –
p.000045: such as floods, tornados, earthquakes, outbreaks of deadly disease, or political violence and armed
p.000045: conflict with resultant injuries to humans.
p.000045:
p.000045: 38The Human Heredity and Health in Africa (H3Africa) Initiative http://h3africa.org/about/vision.
p.000045: 39 Previously known as disaster research.
p.000045:
p.000045: 46 Ethics in Health Research 2nd edition
p.000045:
p.000045:
p.000045: They may also take the form of an unusual and sudden demand on local resources or other emergency with consequent
p.000045: ethical implications for patient care. Research in these contexts is important for advancing emergency health
p.000045: care interventions and treatments, and for refining resource allocation policies. The potential benefits of major
p.000045: incident research include improved triage methods and procedures, effective treatment for life-threatening conditions
...
p.000045: ventilation assistance and impairment of cognition in heavily sedated individuals.
p.000045: Whenever possible, informed consent for planned intensive care research should be obtained from potential participants
p.000045: before admission to that care. See 3.2.4.3, 3.2.4.4 & 3.2.6.
p.000045: Research involving infants receiving neonatal intensive care should be conducted in strict accordance with
p.000045: the principles set out for minors (see 3.2.1 above). These principles do not permit research that is contrary to
p.000045: the child’s best interest. The small size and extreme vulnerability of some infants are unique features of this
p.000045: class of participants. This means that all but minimally intrusive interventions are likely to be contrary to the
p.000045: child’s best interest. Collection of even small blood samples for research in addition to those required
p.000045: for diagnostic purposes, or additional handling of a low birth-weight infant to make research- related observations,
p.000045: requires very careful justification and skill, especially in assessing the risk-benefit ratio. Input from neonatal
p.000045: intensive care experts should be sought.
p.000045:
p.000045: Ethics in Health Research 2nd edition
p.000047: 47
p.000047:
p.000047: 3.4.3 Terminal care research
p.000047:
p.000047: Terminal care research is distinguished by the short remaining life expectancy of participants and their potential
p.000047: vulnerability to unrealistic expectations of benefits from participation in research. In principle, because of their
p.000047: extreme vulnerability, terminally ill patients should not participate in research that is more than minimally invasive
p.000047: without adequate justification.
p.000047: The prospect of any direct benefit from research participation must not be overstated or used to justify a risk of harm
p.000047: higher than that involved in current treatment. Research participation must not be used to prevent or devalue the needs
p.000047: and wishes of participants rather to spend time as they choose, particularly with family members.
p.000047: 3.4.4 Traditional medicines research
p.000047:
p.000047: In line with the constitutional guarantees for cultural and language rights, 40 indigenous cultures and
p.000047: traditional values of all communities must be respected. However, since fundamental rights do not trump
p.000047: each other without careful justification, participants in research involving traditional medical systems and
...
Health / Unconscious People
Searching for indicator unconscious:
(return to top)
p.000045: Although patients in a major incident context face extreme vulnerability, RECs should be cautious about
p.000045: being overly restrictive about the type of research that may be conducted. The development of new drugs and procedures
p.000045: to treat emergency patients safely depends on being able to conduct research, including carefully designed randomised
p.000045: controlled trials.
p.000045: In order to carry out research in such contexts, planning of the research and ethics clearance processes usually must
p.000045: occur very rapidly. From the REC perspective, proposals for major incident research usually demand expedited
p.000045: processing, which means that the time for deliberation is curtailed.
p.000045: When research is not actually dependent on a major incident context, the proposal should be approached cautiously.
p.000045: RECs should consider carefully whether sufficient justification is presented for expedited processing. In the
p.000045: same way that research involving minors should be done only when adult participants cannot provide the necessary data,
p.000045: so major incident research should take place about matters that are unlikely to or do not occur in ‘ordinary’ contexts.
p.000045: Informed consent usually has to be obtained rapidly and at a time when vulnerability of patients and
p.000045: families is likely to be extreme. Patients may be incapacitated (i.e. unconscious or on a ventilator), which points to
p.000045: the likelihood of difficulties with the usual approach to informed consent. Consequently, RECs may consider
p.000045: alternative approaches such as proxy consent or delaying consent in particular circumstances. (See 3.2.4.3, 3.2.4.4 &
p.000045: 3.2.6.)
p.000045: 3.4.2 Intensive care research
p.000045:
p.000045: Characteristic features of intensive care research include difficulties in communicating with patients receiving
p.000045: ventilation assistance and impairment of cognition in heavily sedated individuals.
p.000045: Whenever possible, informed consent for planned intensive care research should be obtained from potential participants
p.000045: before admission to that care. See 3.2.4.3, 3.2.4.4 & 3.2.6.
p.000045: Research involving infants receiving neonatal intensive care should be conducted in strict accordance with
p.000045: the principles set out for minors (see 3.2.1 above). These principles do not permit research that is contrary to
p.000045: the child’s best interest. The small size and extreme vulnerability of some infants are unique features of this
p.000045: class of participants. This means that all but minimally intrusive interventions are likely to be contrary to the
p.000045: child’s best interest. Collection of even small blood samples for research in addition to those required
...
Health / ill
Searching for indicator ill:
(return to top)
p.000041: RECs must also consider the implications for donor welfare of complete anonymisation: it prevents
p.000041: disclosure of material findings, an offer of benefits of research findings, and withdrawal of material from
p.000041: research use. Informed consent documentation must be carefully scrutinised to ensure that the proposed approach
p.000041: and its implications are adequately disclosed and explained.
p.000041: 3.3.4 Collection of biological materials and data
p.000041: Biological materials and data are collected in a variety of ways
p.000041: • specifically for research purposes
p.000041: • incidentally to diagnostic or therapeutic procedures
p.000041: • for a combination of purposes, including the intention of possible future research use
p.000041: Collection of materials or data specifically for research use requires prospective informed consent,
p.000041: usually from the living donor (see 3.3.6). Where a donor is unable to provide informed consent, a proxy
p.000041: may be permissible (see 3.2.4.3 above). Where materials or data from a deceased person are sought, permission from an
p.000041: authorised person is required (see 3.3.6).
p.000041: 3.3.5 Restrictions on collection of biological materials
p.000041: Certain persons are specially protected: without Ministerial permission, biological materials may not be
p.000041: taken from mentally ill persons; biological materials that are not naturally replaceable may not be taken
p.000041: from a minor; no gametes may be taken from a minor; and no fetal biological material except for umbilical cord
p.000041: progenitor cells may be collected from anyone. These restrictions are absolute which means that research
p.000041: with the categories of person mentioned requires special permission. RECs must satisfy themselves that the
p.000041: necessary special permission has been obtained, where appropriate.
p.000041: 3.3.6 Informed consent
p.000041: Written informed consent is required prior to removal of biological material from a living donor (NHA ss
p.000041: 56 and 62).
p.000041: In the case of a deceased person, consent to removal and use of biological materials may be found in the Will of the
p.000041: person, in a written statement or in a witnessed oral statement (NHA s 62(1)(a)) or may be provided by ‘the spouse,
p.000041: partner, major child, parent, guardian, major brother or major sister of that person in the specific order mentioned’
p.000041: (NHA s 62(2))
p.000041: Because biological specimens may be collected for diagnostic, therapeutic or health research purposes, RECs should
p.000041: assess whether the nature of the planned usage is explained adequately so that the purpose for which consent
...
p.000045: the child’s best interest. The small size and extreme vulnerability of some infants are unique features of this
p.000045: class of participants. This means that all but minimally intrusive interventions are likely to be contrary to the
p.000045: child’s best interest. Collection of even small blood samples for research in addition to those required
p.000045: for diagnostic purposes, or additional handling of a low birth-weight infant to make research- related observations,
p.000045: requires very careful justification and skill, especially in assessing the risk-benefit ratio. Input from neonatal
p.000045: intensive care experts should be sought.
p.000045:
p.000045: Ethics in Health Research 2nd edition
p.000047: 47
p.000047:
p.000047: 3.4.3 Terminal care research
p.000047:
p.000047: Terminal care research is distinguished by the short remaining life expectancy of participants and their potential
p.000047: vulnerability to unrealistic expectations of benefits from participation in research. In principle, because of their
p.000047: extreme vulnerability, terminally ill patients should not participate in research that is more than minimally invasive
p.000047: without adequate justification.
p.000047: The prospect of any direct benefit from research participation must not be overstated or used to justify a risk of harm
p.000047: higher than that involved in current treatment. Research participation must not be used to prevent or devalue the needs
p.000047: and wishes of participants rather to spend time as they choose, particularly with family members.
p.000047: 3.4.4 Traditional medicines research
p.000047:
p.000047: In line with the constitutional guarantees for cultural and language rights, 40 indigenous cultures and
p.000047: traditional values of all communities must be respected. However, since fundamental rights do not trump
p.000047: each other without careful justification, participants in research involving traditional medical systems and
p.000047: beliefs must be accorded the same respect and protection as any other human research participant. 41 The
p.000047: context of the research activity, interaction or intervention is important for determining whether, how and when to
p.000047: incorporate traditional values and their cultural expression in research.
p.000047: In terms of the Traditional Health Practitioners Act 22 of 2007,
p.000047: 'Traditional medicine' means an object or substance used in traditional health practice for-
...
Health / stem cells
Searching for indicator stem cells:
(return to top)
p.000007: especially those who work in the humanities and social and behavioural sciences, may find the statutory
p.000007: definition of ‘health research’ to favour biomedical research. In particular, they may perceive that the
p.000007: so-called ‘medical model’ for ethics review dominates and is applied frequently but inappropriately to social
p.000007: science, especially qualitative research.
p.000007: 1.1.6 These guidelines do not advocate the so-called ‘medical model’ of ethics review, especially not for
p.000007: social science, behavioural or humanities research. For purposes of this document, ‘health research’ has both a broad
p.000007: and narrow meaning. In the narrow sense, it refers to research carried out in a health care environment,
p.000007: usually with patients, whether in a hospital, clinic or home-based. In the broad sense, it refers to research
p.000007: conducted outside a health care environment, usually not with patients.
p.000007: 1.1.7 The core ethical principles outlined in these guidelines apply to all forms of research that involve living
p.000007: human participants and use of animals, placing their safety, welfare and interests of both humans and animals as
p.000007: paramount. The principles also apply to research that involves use of human biological materials and data collected
p.000007: from living or deceased persons, including human embryos, fetuses, fetal tissue, reproductive materials, and
p.000007: stem cells.
p.000007: 1.1.8 Research that relies exclusively on publicly available information or accessible through legislation or
p.000007: regulation usually need not undergo formal ethics review. This does not mean that ethical considerations are irrelevant
p.000007: to the research.
p.000007: 1.1.9 Research involving observation of people in public spaces and natural environments usually need not undergo
p.000007: formal ethics review, provided that
p.000007:
p.000007: 8 Ethics in Health Research 2nd edition
p.000007:
p.000007:
p.000007: • the researcher does not interact directly with individuals or groups
p.000007: • the researcher does not stage any intervention
p.000007: • the individuals or groups do not have a reasonable expectation of privacy
p.000007: • dissemination of research findings does not identify individuals or groups
p.000007: 1.1.10 Research that relies exclusively on secondary use of anonymous information or anonymous human
p.000007: biological materials usually need not undergo formal ethics review, provided that no identifiable
p.000007: information is generated. See 3.3 below for further information regarding human biological materials.
p.000007: 1.1.11 Quality assurance and quality improvement studies (audits), programme evaluation activities and
p.000007: performance reviews usually do not constitute research and thus usually do not undergo formal ethics review. It should
...
p.000041: 41
p.000041:
p.000041: material are separate from their source (e.g. a particular patient), they symbolise that person. Hence,
p.000041: ethical considerations concerning their use involve how to access, and use them appropriately, how to manage
p.000041: potential privacy concerns that may arise from information management, as well as how to address the special
p.000041: status some segments of the population ascribe to the human body and its parts. RECs and researchers must demonstrate
p.000041: sensitivity to the values, beliefs and attitudes of the persons from whom the materials are derived.33
p.000041: Use of data and human biological materials34 causes an inevitable and unavoidable overlap between clinical and
p.000041: research domains. For this reason, RECs should have comprehensive SOPs to guide review of research that proposes
p.000041: use of human data or biological materials; be meticulous in their deliberations, and should ensure the integrity and
p.000041: comprehensiveness of the informed consent documentation. In particular, consent documentation must distinguish clearly
p.000041: between biological materials or data collected for clinical purposes and those collected for research purposes.
p.000041: For purposes of this section
p.000041: ‘Anonymous data or specimen’ means data or material without any overt identifying information or link to a
p.000041: specific participant or donor
p.000041: ‘Biological specimen’ means material from a person including blood and blood products, DNA, RNA, blastomeres, polar
p.000041: bodies, cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors
p.000041: ‘Broad consent’ means the donor donates materials with permission to use them for a broad range of future
p.000041: studies, subject only to further prior ethics review and approval
p.000041: ‘Coded data or specimen’ means a number, a symbol or other method provides a coded substitute for identifiers; and a
p.000041: key to the code exists so that the specimen can be linked to its original source
p.000041: ‘Donor’ means the person (living or deceased) from whose body a biological specimen has been removed or withdrawn
p.000041: ‘Identifier’ means information such as a name, initials, address, folder number, or biometric identifier (e.g. finger
p.000041: print) that can identify a particular donor
p.000041: 3.3.2 Permitted usage of biological materials
p.000041: Biological material may be removed from living and deceased persons (NHA ss 55 and 62) for diagnostic, therapeutic and
p.000041: health research purposes (NHA s 64(1)).
p.000041: 3.3.3 Identifiability of biological materials and data
p.000041: RECs must assess the extent to which human biological materials or data could be used to identify a donor. Materials
p.000041: with direct identifiers can directly identify a donor. Coded materials may identify a donor if security and
p.000041: confidentiality measures are not adequate. Anonymised materials without any linkage to donors are unlikely to identify
p.000041: a donor. Materials collected
p.000041:
p.000041: 33 Tri-Council Policy Statement (Canada) 2010, 169.
p.000041: 34 Human biological materials means ‘material from a human being, including DNA, RNA, blastomeres, polar bodies,
p.000041: cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors from the same’
p.000041: (Regulation 177 GG 35099 2 March 2012);
p.000041: blood and blood products are also included (Regulation 180 GG 35099 2 March 2012).
p.000041:
p.000041: 42 Ethics in Health Research 2nd edition
p.000041:
p.000041:
p.000041: without identifiers of any kind are unlikely to identify an individual donor. Genetic markers make it possible to
p.000041: identify groups rather than individuals. RECs must pay attention to eliminating or at least minimising
p.000041: risks to privacy and autonomy as a result of re- identification.
p.000041: RECs must also consider the implications for donor welfare of complete anonymisation: it prevents
p.000041: disclosure of material findings, an offer of benefits of research findings, and withdrawal of material from
p.000041: research use. Informed consent documentation must be carefully scrutinised to ensure that the proposed approach
p.000041: and its implications are adequately disclosed and explained.
p.000041: 3.3.4 Collection of biological materials and data
p.000041: Biological materials and data are collected in a variety of ways
p.000041: • specifically for research purposes
p.000041: • incidentally to diagnostic or therapeutic procedures
p.000041: • for a combination of purposes, including the intention of possible future research use
p.000041: Collection of materials or data specifically for research use requires prospective informed consent,
...
Social / Access to Social Goods
Searching for indicator social goods:
(return to top)
p.000079: Risk – function of the magnitude of harm and the probability that it will occur
p.000079: Risk of harm to likelihood of benefit ratio – analysis of whether the risk of harm implied is justifiable in light of
p.000079: the likelihood of benefit
p.000079: Therapeutic intervention –interventions directed towards direct health-related benefit for a participant (NHA Reg 135)
p.000079: Tiered consent – donor permits use of biological materials for current study; and chooses whether to permit storage
p.000079: for future use, sample and data sharing.
p.000079: Undue influence – effect of an unequal power relationship on voluntariness; may occur when recruitment of
p.000079: participants is done by authority figure
p.000079: Virtual Repository– a digitised system that manages distributed bar-coded electronic versions of material,
p.000079: data or images through shared data systems
p.000079: Vulnerability – diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000079: project; may be caused by limited capacity or limited access to social goods like rights, opportunities and power
p.000079:
p.000079: 80 Ethics in Health Research 2nd edition
p.000079:
p.000079:
p.000079:
p.000079: APPENDIX 2
p.000079:
p.000079: Resources
p.000079:
p.000079: Online training opportunities
p.000079:
p.000079: These links are to FREE online training in research ethics and some also do Responsible Conduct of Research
p.000079: 1. The AMANET (African Malaria Network Trust)
p.000079: http://webcourses.amanet-trust.org/mod/resource/view.php?inpopup=true&id=116
p.000079: The AMANET (African Malaria Network Trust) web-based health research ethics training programme aims at
p.000079: providing the basic understanding in biomedical research ethics. On the premise of scarcity of resources and
p.000079: opportunities for such training for Africans, this effort hopes to provide this service to the many African members of
p.000079: IRB’s and investigators who may wish to undertake the course at home or in their office and at their own time up to a
p.000079: maximum period of four months for each student number issued.
p.000079: 2. Cameroon Bioethics Initiative (CAMBIN)
p.000079: www.cambin.org/cambin-training
p.000079:
p.000079: 3. https://camtools.cam.ac.uk/wiki/site/e30faf26-bc0c-4533-acbc-
p.000079: cff4f9234e1b/ethnographic%20and%20field%20study.html
p.000079:
p.000079: 4. http://www.fhi360.org/training/en/RETC2/index.html
p.000079:
p.000079: 5. http://www.responsibleresearch.org/
p.000079:
...
Searching for indicator social welfare:
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p.000005: the Bill of Rights in the SA Constitution, protects against research abuse by providing that
p.000005: ‘Everyone has the right to bodily and psychological integrity, which includes the right –
p.000005: (a) to make decisions concerning reproduction;
p.000005: (b) to security in and control over their body; and
p.000005: (c) not to be subjected to medical or scientific experiments 1 without their informed consent’.
p.000005:
p.000005:
p.000005:
p.000005: Note: Where ‘she’ or other version is found, ‘he’ or other version is implied and vice versa.
p.000005:
p.000005: 1 The term ‘experiments’ originates from Article 7 of the International Covenant on Civil and Political Rights - UN
p.000005: 1966 and echoes the Nuremberg Code; in the constitutional context, it is intended to mean ‘research’.
p.000005:
p.000005: Ethics in Health Research 2nd edition
p.000007: 7
p.000007:
p.000007: 1.1.2 The National Health Act 61 of 2003 (NHA) provides statutory authority for governance of ‘health research’ and
p.000007: the necessary research ethics regulatory infrastructure.
p.000007: 1.1.3 ‘Health research’ per the NHA may be understood to include but is not limited to research that
p.000007: contributes to knowledge of
p.000007: • biological, clinical, psychological, or social welfare matters including processes as regards humans
p.000007: • the causes and effects of and responses to disease
p.000007: • effects of the environment on humans
p.000007: • methods to improve health care service delivery
p.000007: • new pharmaceuticals, medicines, interventions and devices
p.000007: • new technologies to improve health and health care
p.000007: 1.1.4 In general terms, research includes a wide range of activities conducted by many different
p.000007: disciplines that may use different methodologies and explanatory frameworks. In the physical and
p.000007: biological sciences, research may be described as a systematic study or inquiry, usually using quantitative data, in
p.000007: seeking generalisable new knowledge. Health-related research is increasingly also using qualitative
p.000007: methodologies. The humanities, social and behavioural sciences use both qualitative and quantitative methods and
p.000007: analytic frameworks, all of which may be aimed at contributing to knowledge about the human condition in its
p.000007: environment and context.
p.000007: 1.1.5 The statutory definition can be interpreted as having a wide or a narrow meaning. Many researchers,
p.000007: especially those who work in the humanities and social and behavioural sciences, may find the statutory
p.000007: definition of ‘health research’ to favour biomedical research. In particular, they may perceive that the
p.000007: so-called ‘medical model’ for ethics review dominates and is applied frequently but inappropriately to social
p.000007: science, especially qualitative research.
p.000007: 1.1.6 These guidelines do not advocate the so-called ‘medical model’ of ethics review, especially not for
...
p.000077: retrieval
p.000077: Decisional analysis – use of a systematic approach to ethical evaluation especially the ratio of risk of harm to
p.000077: likelihood of benefit
p.000077: Discomfort – a negative effect experienced in research less serious than harm
p.000077: Donor – the person (living or deceased) from whose body biological materials have been removed or withdrawn
p.000077: Ethics review –review of research proposals or protocols by RECs prior to commencement of the research
p.000077: Guardian – a person appointed by a court to look after the financial and welfare interests of a minor, or a person
p.000077: appointed by a parent with sole responsibility for the minor in terms of that parent’s Will
p.000077:
p.000077: 78 Ethics in Health Research 2nd edition
p.000077:
p.000077:
p.000077: Harm – anything that has a negative effect on participants’ welfare, broadly construed; its nature may be physical,
p.000077: emotional, psychological, social or legal
p.000077: Health research – contributes to knowledge of biological, clinical, psychological, or social welfare matters including
p.000077: processes; causes and effects of and responses to diseases; effects of environment on humans; methods to improve health
p.000077: care delivery; new pharmaceuticals, medicines, interventions and devices; new technologies to improve health and health
p.000077: care
p.000077: Identifiable information – reasonably expected to identify an individual alone or in combination with other
p.000077: information
p.000077: Directly identifying – direct identifiers e.g. name, identity number
p.000077: Indirectly identifying – combination of indirect identifiers e.g. date of birth, address, unique personal
p.000077: characteristic
p.000077: Coded information – direct identifiers removed; replaced by code Anonymised information – irrevocably stripped of
p.000077: direct identifiers; no code Anonymous information – never had identifiers
p.000077: Identifier– information such as a name, initials, address, folder number, or biometric identifier (e.g.
p.000077: finger print) that can identify a particular donor
p.000077: Incentive – anything offered to encourage participation in research
p.000077: Incidental findings – unanticipated discoveries made in the course of research that are outside the scope of the
p.000077: research
p.000077: Inconvenience – a minor negative effect experienced in research less serious than discomfort
p.000077: Low risk research – where the only foreseeable risk is one of discomfort
p.000077: Minimal risk research – where probability and magnitude of possible harms implied by participation are no
...
Searching for indicator access:
(return to top)
p.000005:
p.000005: Contents
p.000005:
p.000005:
p.000005: 1.1 Introduction p 6
p.000005: 1.2 The research context 9
p.000005: 1.3 Regulatory authority 9
p.000005: 1.4 Research with humans 11
p.000005: 1.5 Research using animals 11
p.000005: 1.6 Ethical research review 12
p.000005: 1.7 Glossary & resources 12
p.000005: 1.8 Purpose & status of these Guidelines 13
p.000005: 1.9 Structure of these Guidelines 13
p.000005:
p.000005:
p.000005: This chapter explains ethics in research and provides an overview of the South African research context,
p.000005: including the remit of this document.
p.000005:
p.000005: Introduction
p.000005:
p.000005: 1.1.1 South Africa is a democratic state in which human dignity, equality and the advancement of human
p.000005: rights are respected, promoted and protected in terms of the Constitution of the Republic of South Africa, 1996 (the
p.000005: Constitution). In particular, s 27(1) guarantees the right of access to health care services, while section 12(2) of
p.000005: the Bill of Rights in the SA Constitution, protects against research abuse by providing that
p.000005: ‘Everyone has the right to bodily and psychological integrity, which includes the right –
p.000005: (a) to make decisions concerning reproduction;
p.000005: (b) to security in and control over their body; and
p.000005: (c) not to be subjected to medical or scientific experiments 1 without their informed consent’.
p.000005:
p.000005:
p.000005:
p.000005: Note: Where ‘she’ or other version is found, ‘he’ or other version is implied and vice versa.
p.000005:
p.000005: 1 The term ‘experiments’ originates from Article 7 of the International Covenant on Civil and Political Rights - UN
p.000005: 1966 and echoes the Nuremberg Code; in the constitutional context, it is intended to mean ‘research’.
p.000005:
p.000005: Ethics in Health Research 2nd edition
p.000007: 7
p.000007:
p.000007: 1.1.2 The National Health Act 61 of 2003 (NHA) provides statutory authority for governance of ‘health research’ and
p.000007: the necessary research ethics regulatory infrastructure.
p.000007: 1.1.3 ‘Health research’ per the NHA may be understood to include but is not limited to research that
p.000007: contributes to knowledge of
p.000007: • biological, clinical, psychological, or social welfare matters including processes as regards humans
...
p.000009: guidelines also draw on and refer to international and national standards and guidelines for research using animals.
p.000009: 1.3.5 Researchers should be familiar with legislation and other binding instruments relevant to research including4
p.000009: • Animal Diseases Act 35 of 1984
p.000009: • Animal Health Act 7 of 2002
p.000009: • Animals Protection Act 71 of 1962
p.000009: • Basic Conditions of Employment Act 75 of 1997
p.000009: • Cartagena Protocol on Biosafety May 2000
p.000009: • Child Justice Act 75 of 2008
p.000009: • Children’s Act 38 of 2005
p.000009: • Choice on Termination of Pregnancy Act 92 of 1996
p.000009: • Constitution of the Republic of South Africa, 1996
p.000009: • Convention on Biological Diversity
p.000009: • Criminal Law (Sexual Offences and Related Matters) Amendment Act 32 of 2007
p.000009: • Domestic Violence Act 116 of 1998
p.000009: • Employment Equity Act 55 of 1998
p.000009: • Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act 36 of 1947
p.000009: • Genetically Modified Organisms Act, Act No 15 of 1997
p.000009: • Hazardous Substances Act 15 of 1973
p.000009: • Health Professions Act 56 of 1974
p.000009: • Labour Relations Act 66 of 1995
p.000009: • Medical Schemes Act 131 of 1998
p.000009: • Medicines and Related Substances Control Act 101 of 1965
p.000009: • Mental Health Care Act 17 of 2002
p.000009: • Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits,5
p.000009: • National Environmental Management: Biodiversity Act, Act 10 of 2004
p.000009: • National Health Act, Act No 61 of 2003
p.000009: • National Health Laboratory Service Act 37 of 2000
p.000009: • Patents Act 57 of 1978
p.000009: • Performing Animals Protection Act 24 of 1935
p.000009: • Promotion of Access to Information Act 2 of 2000
p.000009: • Promotion of Equality and Prevention of Unfair Discrimination Act 4 of 2000
p.000009: • Protected Disclosures Act 26 of 2000
p.000009: • Protection of Personal Information Act 4 of 2013
p.000009: • Provincial Nature Conservation Acts or Ordinances
p.000009:
p.000009:
p.000009:
p.000009: 4 Note this list is not exhaustive.
p.000009: 5Ratified by South Africa on 11 May 2011. For further information, see http://www.cbd.int/abs/
p.000009:
p.000009: Ethics in Health Research 2nd edition
p.000011: 11
p.000011:
p.000011: • Rules Relating to the Practising of the Para-Veterinary Profession of Laboratory Animal Technologist.
p.000011: Department of Agriculture (1997) GN 1445 of 3 October 1997
p.000011: • Rules Relating to the Practising of the Profession of Veterinary Nurse. Department of Agriculture (1991) GN 1065
p.000011: of 17 May 1991
p.000011: • Societies for the Prevention of Cruelty to Animals Act 169 of 1993
p.000011: • Sterilization Act 44 of 1998
p.000011: • Veterinary and Para-veterinary Professions Act 19 of 1982
p.000011:
p.000011: 1.4 Research with humans
p.000011:
p.000011: 1.4.1 The National Health Act (NHAs 72(6)(c)) gives authority to the NHREC for setting norms and
p.000011: standards for health and health-related research that involves humans.
p.000011: 1.4.2 Every organisation/institution, health agency and health establishment at which health and health-related
p.000011: research involving human participants is conducted, must establish or have access to a registered Human Research
p.000011: Ethics Committee (REC) (NHA s 73(1)).
p.000011: 1.4.3 RECs that review research involving human participants must register with the NHREC (NHA s 73(1)).
p.000011: 1.5 Research using animals
p.000011:
p.000011: 1.5.1 The National Health Act (NHA) gives authority to the NHREC for setting norms and standards for health research
p.000011: that uses animals (NHA s 72(6)(c)).
p.000011: 1.5.2 Every organisation/institution, health agency and health establishment at which health research using animals
p.000011: is conducted, must establish or have access to a registered Animal Research Ethics Committee (AREC) (NHA s 73(1)).
p.000011: 1.5.3 ARECs that review health research using animals must register with the NHREC (NHA s 73(1)).
p.000011: 1.5.4 The South African Bureau of Standards’ South African National Standard (SANS 10386:2008 or latest
p.000011: version) for the Care and Use of Animals for Scientific Purposes and MRC Guidelines on Ethics for Medical Research: Use
p.000011: of Animals in Research and Training (2004) provide the minimum benchmark to ensure ethical and humane care of animals
p.000011: used for scientific purposes as well as for teaching activities, in line with the fundamental principles of
p.000011: Replace, Reduce and Refine animal use. ARECs and researchers are expected to familiarise themselves
p.000011: with the content of both documents in addition to these Guidelines, as appropriate.
p.000011: 1.5.5 International and foreign codes for animal research include the Directive 2010/63/EU of the European
p.000011: Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes
p.000011: and the Australian Code for the Care and Use of Animals for Scientific Purposes (8th Edition) 2013.
p.000011:
p.000011: 12 Ethics in Health Research 2nd edition
p.000011:
p.000011:
p.000011: 1.6 Ethical research review
p.000011:
p.000011: 1.6.1 The NHA (s 72(1))requires that proposals to conduct ‘health research’ must undergo independent ethics review
p.000011: before the research is commenced.
...
p.000015: language (s 8 of the Constitution). Similarly, persons should not be unfairly targeted for research merely on the basis
p.000015: of one or other of these grounds.
p.000015: 2.3.6 Informed consent
p.000015: In general, participation in research must be voluntary and predicated on informed choices. Voluntariness and
p.000015: informed choices are evidenced by the informed consent process which must take place before the research
p.000015: commences, in principle, and be affirmed during the
p.000015:
p.000015: Ethics in Health Research 2nd edition
p.000017: 17
p.000017:
p.000017: course of the study, as part of the commitment to an ongoing consent process. In some circumstances,
p.000017: research may not require prior consent (see 3.2.5 & 3.3)
p.000017: 2.3.7 Ongoing respect for enrolled participants
p.000017: A research participant has the right to privacy and to confidentiality. This requires that a proposal
p.000017: must explain how these constitutionally protected rights will be managed and protected in the course of the
p.000017: research. Simply stated, privacy is concerned with who has access to personal information and records about the
p.000017: participant; including clinical health care records. On the other hand, ‘confidentiality’ is about ensuring that
p.000017: appropriate measures will be implemented to prevent disclosure of information that might identify the participant
p.000017: (inadvertently or not) either during the course of the research or afterwards. The Protection of Personal Information
p.000017: Act 4 of 2013 (partially in effect) has increased the need to ensure computer safety, locked record storage
p.000017: facilities and careful gate keeping about access to raw data including completed informed consent documents
p.000017: (see also 3.1.8). Researchers should take measures to ensure privacy and confidentiality interests throughout the
p.000017: research period, including when disseminating results or findings.
p.000017: 2.3.8 Researcher Competence and Expertise
p.000017: Researchers must be suitably qualified and technically competent to carry out the proposed research. The principal
p.000017: investigator (PI) or research leader has primary responsibility to ensure the safety and well-being of
p.000017: participants, the scientific integrity of the protocol and responsible implementation of that protocol. For
p.000017: international multi-centre research, at least one (co-) PI must be South Africa-based.
p.000017: Competence is demonstrated mainly by academic qualifications, credentials, scientific and technical
p.000017: competence as evidenced in previous publications or testimonials. Competence includes research competence,
p.000017: which is assessed in terms of education, knowledge, certification and experience. In addition, researchers
p.000017: should produce evidence of appropriate research ethics training within the previous three years.
p.000017: Principal investigators or research leaders must disseminate research results or findings, whether positive
p.000017: or negative, in a timely, accessible, responsible and competent manner. This includes reporting back to participant
p.000017: communities where appropriate, in accordance with the norm of role player engagement and collaboration.
p.000017:
...
p.000021: the category of person involved, should outweigh the risk of harm to the participants as well as to the community
p.000021: or society as a whole. In weighing risk of harm against likelihood of benefit, the analysis is concerned
p.000021: not only with the participants themselves but also with community or societal interests.
p.000021: The ratio may be analysed by considering whether
p.000021: • the harms and benefits are adequately identified, evaluated and described;
p.000021: • the harms stated in the proposal match those stated in the informed consent documentation;
p.000021: • the risk of harm is reasonable in relation to anticipated benefit;
p.000021: • the risk of harm is reasonable in relation to the importance of the anticipated knowledge to be
p.000021: gained;
p.000021: • counselling and support services will be made available if appropriate.10
p.000021:
p.000021:
p.000021:
p.000021: 9‘Researchers’ includes PIs and research assistants and others who will do the work of research.
p.000021: 10E.g. if emotional distress is a likely side effect of research procedures, arrangements to facilitate access to
p.000021: assistance should be made.
p.000021:
p.000021: 22 Ethics in Health Research 2nd edition
p.000021:
p.000021:
p.000021: Anticipated harms should be minimised by preventing occurrence as far as possible and by implementing appropriate
p.000021: remedial interventions should the harm occur. The nature of harms will vary in accordance with the type of
p.000021: research under consideration and may include physical, psychological, legal, social (including stigma) and
p.000021: financial harms. The REC should also assess the possibility of harm to the researcher, study or project personnel e.g.
p.000021: safety concerns.
p.000021: 3.1.7 Reimbursements and inducements for participants
p.000021: Participants should not have to incur expenses to take part in research. Consequently, researchers should
p.000021: budget to reimburse expenses incurred by participants for travel, refreshments and also for inconvenience,
p.000021: depending on the circumstances. If no travel or other expenses are incurred, reimbursement is not required
p.000021: unless an inconvenience reimbursement is justifiable.
p.000021: A fair rate of reimbursement should be calculated using the Time, Inconvenience and Expenses (TIE)
p.000021: method to determine the cost to participants for time expended, inconvenience and refreshments
p.000021: associated with research participation. This method costs expenses at the current hourly rate for unskilled
...
p.000021: paternalistic view of the rate of reimbursement. The proposal and the informed consent documentation should indicate
p.000021: whether reimbursements are pro rata if the participant does not complete the study; i.e. whether only some of the
p.000021: offered reimbursement is available if participation is stopped before the anticipated end of the study.
p.000021: Where minors are the participants, their accompanying parent or guardian should also receive reimbursement
p.000021: for travel costs and refreshments.
p.000021: Inducements encourage participation. They may be offered in some circumstances where
p.000021: e.g. recruitment, especially of healthy participants, is anticipated to be difficult. However, a justification for
p.000021: this tactic should be provided and the inducement should not unduly influence an informed choice about
p.000021: participation. In particular, an inducement should not undermine a potential participant’s assessment of risk of
p.000021: harm. All inducements should be clearly explained and justified to the REC. Input from community members on the REC or
p.000021: other role players may be constructive.
p.000021: 3.1.8 Participants’ privacy and confidentiality interests
p.000021: The principle of respect for persons requires careful attention to privacy and confidentiality interests. Privacy
p.000021: describes the person’s interest in controlling access to her personal information. Confidentiality is about
p.000021: whether and how research data might be disclosed
p.000021:
p.000021:
p.000021:
p.000021: 11 Available at http://nhrec.org.za – the current rate (2014) for unskilled construction workers is approximately R15
p.000021: - R25 per hour depending on the tasks (see Department of Labour’s sectoral determinations).
p.000021:
p.000021: Ethics in Health Research 2nd edition
p.000023: 23
p.000023:
p.000023: carelessly or inadvertently, thus revealing the participant’s identity or category, making him vulnerable to harm. (See
p.000023: also 2.3.7)
p.000023: The proposal should explain how data records (written, audio or visual) are to be secured, the length of time they will
p.000023: be retained12 and who will be responsible for storage and/or final disposal. The proposal should explain why
p.000023: particular identifying information is required for the study that purports to collect data anonymously. RECs should
p.000023: assess whether notifiable activities might occur amongst participants, e.g. abuse of minors or notifiable diseases and,
p.000023: consequently, whether appropriate measures are in place and are explained in the research proposal. Furthermore, the
p.000023: REC must ensure that the required notification or reporting and its management are explained in the consent documents.
p.000023: Where focus groups are planned, RECs should check that the information for participants explains clearly
p.000023: that researchers cannot guarantee confidentiality because members of the focus group may disclose information
p.000023: outside the research setting, despite agreeing not to do so. For this reason, consent documentation should advise
p.000023: potential focus group participants not to disclose personally sensitive information, as the researcher cannot
p.000023: guarantee confidentiality, even if other participants are urged to respect confidentiality.
p.000023: The Protection of Personal Information Act 4 of 2013 was assented to on 19 November 2013. 13 This Act
p.000023: provides guidance on how the right to privacy regarding personal information is protected. It stipulates
p.000023: that the right to privacy includes ‘protection against unlawful collection, retention, dissemination and use of
p.000023: personal information’ (Preamble to Act). A tension between the right to privacy and the need for free flow of
p.000023: information in a society that seeks to make progress on economic, social, health care and educational fronts, is
p.000023: immediately evident. The Act does not appear to hold out negative implications for research activities
p.000023: that record personal information about research participants. However, special attention should be given to
p.000023: ensuring that computers and electronically stored data are protected from unauthorised access, inadvertent or
p.000023: accidental dissemination and distribution in form of a ‘data dump’, etc.
p.000023: Research activities are a legitimate purpose, provided that protective measures are adhered to. Thus researchers and
p.000023: RECs should pay careful attention to measures that will protect privacy and confidentiality interests.
p.000023: In general terms, a person should know what information is being collected, why it is being collected, what
p.000023: will happen to it, how long it will be retained, whether it will identify the person, whether it will be shared with
p.000023: others and why, whether it will be sent outside South Africa and why. The person should agree to these terms.
p.000023: Some specific terms are summarised:
p.000023: • in the case of a child (person under the age of 18 years), a parent or guardian14 must give permission for the
p.000023: information to be collected (s 35(1)(a));15
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: 12Storage requirements may vary according to institutional requirements; usually between five and fifteen years.
p.000023: 13Some parts came into effect on 11 April 2014: s 1 (definitions); part A of Chapter 5 (establishment of Information
p.000023: Regulator); s 112 (about making Regulations); and s 113 (procedures for making Regulations) by Proclamation in GG 37544
p.000023: R.25, 2014.
p.000023: 14Note a caregiver, a foster parent, and a schoolteacher or principal are not guardians.
...
p.000025: Word’s spelling & grammar check tool as ‘readability statistics’. No more than Grade 8 equivalency should be the target
p.000025: complexity level.
p.000025: 18See Department of Health (2006) Guidelines for Good Practice in the Conduct of Clinical Trials with Human
p.000025: Participants in South Africa
p.000025: or its successor.
p.000025:
p.000025: 26 Ethics in Health Research 2nd edition
p.000025:
p.000025:
p.000025: 3.2 Vulnerability and incapacity
p.000025:
p.000025: Vulnerability is not an absolute condition but rather occurs on a sliding scale. In South Africa, arguably, the
p.000025: majority of potential research participants are vulnerable when compared to those in North America or Europe,
p.000025: from whence much funding is sourced. 19 Whether vulnerability is present is a matter of fact and degree.
p.000025: However, certain groups of participants 20 require careful consideration to ensure that, where appropriate,
p.000025: additional precautions are put into place. For example, advanced age, very young age, personal or
p.000025: environmental factors like extreme poverty and ordinarily poor access to health care may increase
p.000025: vulnerability
p.000025: 3.2.1 Contextual circumstances
p.000025: Personal circumstances, such as mental or intellectual impairment, acute illness, advanced age, and pregnancy and
p.000025: childbirth may increase vulnerability. Persons may be factually incapable or less capable of understanding
p.000025: information and processing it to reach a decision
p.000025: e.g. about whether to participate in research. Environmental circumstances may also increase vulnerability such as very
p.000025: poor socio-economic conditions, low levels of formal education and literacy, or restricted access to health care
p.000025: services. Such persons may be more easily persuaded to agree to participate without a properly considered
p.000025: understanding of the implications.
p.000025: It is important to note the difference between legal incapacity and factual incapacity. No person may
p.000025: claim that, because a minor is factually capable, the legal incapacity should be waived. On the other hand, no adult
p.000025: may be assumed to be incapable unless incapacity is established factually. Consequently, mental incapacity must
p.000025: be established by a factual assessment of the individual’s abilities to understand and to
p.000025: communicate that understanding. Legal incapacity prevails notwithstanding the existence of factual capacity.
p.000025: South Africa is home to a number of vulnerable communities. Where factors usually associated with
p.000025: vulnerability are integral to the research, the proposal should demonstrate how vulnerability would be managed.
p.000025: Particular caution should be exercised before undertaking research involving participants in such
p.000025: communities, and RECs should ensure that
p.000025: • persons in these communities are not being involved in research merely because they are expediently accessible,
p.000025: while the research could be carried out in a less vulnerable community;
p.000025: • the research is relevant to the health needs and priorities of the community in which it is to be carried out;
p.000025: and that
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 19 UNAIDS defines ‘vulnerable community’ as having some or all of the following characteristics: limited economic
p.000025: development; inadequate protection of human rights and discrimination on the basis of the health status; inadequate
p.000025: community/cultural experience and understanding of scientific research; limited access to health care and treatment
p.000025: options; limited ability of individuals in the community to provide informed consent.
p.000025: 20 For further, more detailed, discussion on special classes of participants, see CIOMS International Ethical
p.000025: Guidelines for Biomedical
p.000025: Research Involving Human Subjects (2002) Guidelines 13-17,
p.000025: http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm; US Department of Health & Human Services,
p.000025: Office for Human Research Protections, http://www.hhs.gov/ohrp.
p.000025:
p.000025: Ethics in Health Research 2nd edition
p.000027: 27
p.000027:
p.000027: • research participants know they will take part in research; and that the research will be carried out only with
p.000027: their consent.21 Particular attention should be given to the content, language(s) and procedures used to obtain
p.000027: informed consent.
p.000027: Note, however, that RECs should avoid patronising assumptions about a community’s ability to make responsible
p.000027: decisions. Factual information is required before deciding that a community is too vulnerable to be invited to
p.000027: choose whether to participate in research.
p.000027: In order to ensure optimal protection of vulnerable participants, the REC may impose additional protective
...
p.000033: ZACC 35; 2014 (2) SA 168 (CC); see also J v NDPP [2014] ZACC 13.
p.000033: 30See Draft Criminal Law (Sexual Offences & related matters) Amendment Act Amendment Bill [B-2014].
p.000033:
p.000033: Ethics in Health Research 2nd edition
p.000035: 35
p.000035:
p.000035: researchers is whether to ignore the strict letter of the law or to report as indicated in terms of the Sexual Offences
p.000035: Act and the Children’s Act. The matter is not simple.
p.000035: The clash of interests is obvious, e.g. using the law to protect the minor from abuse may have the unintended
p.000035: consequence of increased harm (physical and social) for that child. Further, thoughtless reporting may
p.000035: violate privacy and confidentiality interests of the minor e.g. in terms of the Choice on Termination of Pregnancy
p.000035: Act, the Children’s Act and the Child Justice Act. Whether a researcher, who has but a research interest
p.000035: in the life of the child, but no further right of access or duty of intervention ought to take on
p.000035: the responsibility of a social worker is unclear. Consequently, researchers should think very
p.000035: carefully about the anticipated consequences of reporting in light of the legal context. The proposal submitted
p.000035: for ethics review should explain fully the approach to be adopted, and justify how reporting obligations
p.000035: will be managed, so that the REC can deliberate effectively. The consent documents should clearly inform the
p.000035: minor (and proxy consent providers where necessary) about when reporting obligations arise and how they
p.000035: will be addressed, so that an informed choice can be made about whether to participate. Appropriate
p.000035: engagement with role-players such as child rights and child care organizations may assist researchers to make
p.000035: appropriate and meaningful referrals.
p.000035: 3.2.3 Women
p.000035:
p.000035: Exclusion of women as research participants has led to a lack of data needed to promote women’s health. Any proposed
p.000035: exclusion of women participants must be justifiable in light of research priorities as well as the specific research
...
p.000039: • participation of members acknowledged as representatives is involved. Research involving collectivities should
p.000039: include measures to ensure
p.000039: • dispute resolution mechanisms for anticipated or actual disagreements between the researcher and the collectivity
p.000039: • respectful negotiation with the collectivity or its leaders
p.000039: • permission is sought from appropriate representatives of the collectivity to approach individual participants
p.000039: • an informed consent process for individual participants
p.000039: • fair distribution of research-related benefits and harms among affected collaborating parties
p.000039: • agreement about ownership of data and rights of publication of research findings;
p.000039: • agreement about feedback to the collectivity about the findings.
p.000039:
p.000039: 3.3 Data and biological materials for research purposes
p.000039:
p.000039: 3.3.1 Introduction
p.000039: Researchers often wish to collect data, including images, or human biological materials from participants for
p.000039: research purposes or to use previously collected diagnostic or therapeutic biological material for
p.000039: research. Once collected, biological material may be stored in repositories as a future research resource (see
p.000039: 3.5.2 below). Although data and biological
p.000039:
p.000039: Ethics in Health Research 2nd edition
p.000041: 41
p.000041:
p.000041: material are separate from their source (e.g. a particular patient), they symbolise that person. Hence,
p.000041: ethical considerations concerning their use involve how to access, and use them appropriately, how to manage
p.000041: potential privacy concerns that may arise from information management, as well as how to address the special
p.000041: status some segments of the population ascribe to the human body and its parts. RECs and researchers must demonstrate
p.000041: sensitivity to the values, beliefs and attitudes of the persons from whom the materials are derived.33
p.000041: Use of data and human biological materials34 causes an inevitable and unavoidable overlap between clinical and
p.000041: research domains. For this reason, RECs should have comprehensive SOPs to guide review of research that proposes
p.000041: use of human data or biological materials; be meticulous in their deliberations, and should ensure the integrity and
p.000041: comprehensiveness of the informed consent documentation. In particular, consent documentation must distinguish clearly
p.000041: between biological materials or data collected for clinical purposes and those collected for research purposes.
p.000041: For purposes of this section
p.000041: ‘Anonymous data or specimen’ means data or material without any overt identifying information or link to a
p.000041: specific participant or donor
p.000041: ‘Biological specimen’ means material from a person including blood and blood products, DNA, RNA, blastomeres, polar
p.000041: bodies, cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors
p.000041: ‘Broad consent’ means the donor donates materials with permission to use them for a broad range of future
...
p.000047: to generations, with or without written documentation, whether supported by science or not, and which are
p.000047: generally used in traditional health practice.
p.000047: RECs should pay attention to indications that intellectual property may be intended to be acquired by
p.000047: non-South Africans and should advise that appropriate advice be sought. Intellectual property in indigenous
p.000047: flora, fauna and medicines is a particularly sensitive matter currently and not easily regulated. Protection of
p.000047: intellectual property relating to South African medicinal plants is a cross-cutting issue, responsibility for which is
p.000047: spread amongst several government departments, including the Department of Health; Trade and Industry; Science &
p.000047: Technology; Environmental Affairs; Tourism; Agriculture, Forestry & Fisheries; and Rural Development & Land
p.000047: Affairs. International and domestic legislation, policies and regulatory guidelines applicable in these
p.000047: departments must be taken in account when conducting research on traditional medicinal plants and
p.000047: genetic material, to ensure compliance.
p.000047: Current legislation that governs intellectual property relating to traditional knowledge and genetic material
p.000047: includes
p.000047: • The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits,
p.000047: 42 which advances Articles 15 & 8(j) of the Convention on Biological Diversity
p.000047: • The National Environmental Management: Biodiversity Act 10 of 2004 and its Regulations
p.000047: • The Patents Act 57 of 1978
p.000047: • The Department of Trade & Industry’s policies on Intellectual Property including the Intellectual Property
p.000047: Amendment Bill 2008.43
p.000047: Prior ethics review of the proposed research is required to ensure that norms and standards for health research in
p.000047: South Africa are being upheld. Toxicology tests must be performed on substances to be used on or ingested by
p.000047: participants; and equivalent rigour must apply to such research. Researchers should furnish proof of safety of the
p.000047: substances to the REC. The practice of requiring a randomised controlled trial may not be appropriate in all
p.000047: circumstances for indigenous treatments and interventions. However, RECs must consider methodology carefully
p.000047: and make decisions on a case-by-case basis.
p.000047: 3.4.5 Research involving deception or withholding information
p.000047:
p.000047: Sometimes, to ensure validity of research, researchers withhold certain information in the consent process.
p.000047: This may take the form of withholding information about the purpose of specific procedures. In most such cases, the
...
p.000049:
p.000049:
p.000049: ‘Research’ means a systematic investigation or study designed to produce generalizable knowledge on the basis
p.000049: of conventional scientific and ethical standards appropriate for the context.
p.000049: iii. The treatment context
p.000049: The wish to use a novel, innovative or unproven treatment usually arises in a context suffused by the
p.000049: rule of rescue. In other words, a health care worker may face a situation where all standard options have been
p.000049: exhausted, the desire to provide further rescue interventions exists and the patient (or the patient’s family) is
p.000049: willing to risk the unknown. While the health care worker takes primary responsibility to act in the best interest of
p.000049: the patient, in these circumstances, the health care worker should not make unilateral decisions. Responsibility and
p.000049: accountability should be shared in accordance with these Guidelines.
p.000049: Ethical principles must inform the process of deciding whether a novel, innovative or unproven therapy is
p.000049: appropriate in the circumstances. And, importantly, the decision-making should be predicated on a deliberative process
p.000049: undertaken by well-informed people. Although innovation is often the driving force in the advancement of new knowledge
p.000049: in health care, when time and emotional pressures prevail, especially at the individual level, deliberate
p.000049: objective thinking may be undermined, which can lead to decision-making that is not appropriately
p.000049: responsible. In light of s 27 of the Constitution, which guarantees the right of access to health care services to all,
p.000049: elevation of one individual’s claim to more than standard of care necessarily has implication for accountability
p.000049: and responsible decision-making in health facilities.
p.000049: iv. The legal and ethical context
p.000049: Use of locally novel, innovative or unproven therapy involves legal, ethical and practical considerations.
p.000049: The National Health Act 61 of 2003 (NHA) makes provision for ‘health services for experimental or research
p.000049: purposes’ (s 11) and requires that, prior to treatment, the patient must be informed of the experimental or innovative
p.000049: status of the intended treatment.
p.000049: The Act further stipulates that institutional authorities responsible for oversight of treatment must give written
p.000049: permission for the treatment. This means that the decision whether the proposed therapy is experimental treatment or
p.000049: research must precede the decision whether to permit its use for the patient. Where the intended novel therapy is
p.000049: classed as research, the REC must review and approve the research proposal before therapy begins.
p.000049: The Declaration of Helsinki (2013) indicates that ‘unproven interventions in clinical practice’ (par 37) may be used,
p.000049: subject to obtaining expert advice, and appropriate informed consent from the patient. All information about the
p.000049: intervention must be recorded and made publicly available as appropriate. Further, the intervention should
p.000049: subsequently be researched formally so that safety and efficacy can be evaluated.
p.000049: v. Clinical ethics versus research ethics
...
p.000051: knowledge. However, journal editors may require evidence of patients’ written consent as a condition of
p.000051: publication. In social sciences, however, a case study (n=1) is a fully valid research activity. For example,
p.000051: documenting an exception to a rule, theory and so on is a particularly powerful research finding. Exemption from ethics
p.000051: scrutiny is thus unlikely. A biomedical case series ( >3 cases) usually triggers the need for research ethics review,
p.000051: since generalizable knowledge can be generated.
p.000051: 3.5.2 Databases, registries and repositories
p.000051: Databases, registries (data banks) and repositories (tissue banks) may be created for research, diagnostic
p.000051: or clinical purposes.44 They constitute a valuable research resource and allow researchers to pursue questions that
p.000051: were not anticipated at the time of collection of either data or material.
p.000051: 3.5.2.1 Terminology
p.000051: From a regulatory and ethics point of view, the three forms of data or specimen storage are treated similarly.
p.000051: Consequently, in these Guidelines, references to repositories apply also to databases, registries or tissue banks.
p.000051: ‘Database’ means a collection of information including images (data) arranged to facilitate swift search and retrieval.
p.000051: It may be electronic or paper-based.
p.000051: ‘Registry’ means a collection of information (data) from multiple sources, maintained over time with controlled access
p.000051: through a gatekeeper organizer.
p.000051: ‘Repository’ means a collection, storage and distribution system for human biological materials for research
p.000051: purposes including blood, urine, faeces, bone marrow, cell aspirates, diagnostic specimens, pathology specimens and
p.000051: so on. Usually demographic and medical information about the donors is included in the repository as are codes
p.000051: that link the material to the donors.
p.000051:
p.000051:
p.000051:
p.000051: 44 The National Health Act 61 of 2003 regulates tissue banks for transplantation purposes in Regulation 182 GG 35099 2
p.000051: March 2012. The focus primarily appears to be on compliance with the Declaration of Istanbul on Organ Trafficking and
p.000051: Transplant Tourism of 2009 and WHO guiding principles. Stem cell banks are regulated by Regulation 183 GG 35099 2 March
p.000051: 2012.
p.000051:
p.000051: 52 Ethics in Health Research 2nd edition
p.000051:
p.000051:
p.000051: ‘Virtual Repository’ means a digitised system that manages distributed bar-coded electronic versions
p.000051: of material, data or images through shared data systems.
p.000051: 3.5.2.2 REC oversight of repositories
p.000051: Institutions and researchers that maintain repositories (biobanks or tissue banks) must have appropriate facilities,
p.000051: equipment, policies and procedures to store human biological materials and data safely and in compliance with
p.000051: accepted standards. Appropriate safeguards, including physical, administrative and technical, must exist to protect
p.000051: against unauthorised handling. Institutional repositories created, maintained and used for present or future
...
p.000053: bodily injuries as a result of interventions or investigational drugs. In the absence of pharmaceutical
p.000053: company sponsorship, no commercially sponsored insurance cover is available.
p.000053: RECs must pay careful attention to the measures proposed for dealing with research-related injury in this context. In
p.000053: order to address this potential problem, some academic institutions provide insurance cover themselves to address
p.000053: research-related bodily injury that eventuates in a non-commercially sponsored interventional study.
p.000053: Where insurance cover is offered, commonly the documentation explains that the insurance policy will pay for medical
p.000053: expenses in the event of a research-related bodily injury. However, most protocols do not explain clearly in
p.000053: simple terms the exact nature and scope of the insurance cover offered. This section explains the
p.000053: relationship between research-related injuries and insurance cover.
p.000053: 3.5.3.1 Scope of insurance cover
p.000053: The lay understanding seems to be that insurance against research-related bodily injury covers reasonable
p.000053: medical expenses and also pain and suffering, loss of income, and related claims. This view is not correct. The
p.000053: recent case of Venter v Roche Products (Pty) Ltd 48 highlighted the need for clarification so that
p.000053: clinicians, research ethics committee members, researchers and participants all understand the scope of insurance
p.000053: cover when the protocol and consent documents are developed and approved.
p.000053:
p.000053:
p.000053:
p.000053:
p.000053: 46See H3Africa’s data sharing and access policy (August 2014)http://h3africa.org/consortium/documents
p.000053: 47 Detailed guidance for conducting clinical trials is provided elsewhere – see DoH SAGCP 2006 or its successor.
p.000053: However, because insurance cover is relevant also to other interventional clinical research, the topic is addressed
p.000053: here too.
p.000053: 48(12285/08) [2013] WCHC 7 May 2013; and on appeal (A11/2014) 22 October 2014.
p.000053:
p.000053: 54 Ethics in Health Research 2nd edition
p.000053:
p.000053:
p.000053: The Department of Health’s ‘Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in
p.000053: South Africa’ (known as SA GCP 4.11)49requires a clinical trial sponsor to take out insurance cover. If a
p.000053: trial-related serious bodily injury of an enduring nature occurs as a result of participation in the trial, then
p.000053: the sponsor’s insurer pays the medical costs of necessary treatment to restore the participant to his previous
p.000053: position, if possible.
p.000053: This offer of payment has a moral rather than a legal basis. SA GCP follows the lead of the Association of the British
p.000053: Pharmaceutical Industry (ABPI), which recommends that sponsors adopt the morally right position of paying for treatment
p.000053: in the event of trial-related injury. This recommendation is followed in many countries. In South Africa, it is
p.000053: mandatory to have this insurance cover for clinical trials and RECs should assess whether it is in place and valid.
p.000053: Payment for medical expenses is made without acknowledgment of any liability and is thus to be understood as an ex
p.000053: gratia payment.
...
p.000058: proposal, with or without additional conditions (NHA s 71(1)(a) read with s 73(2)).
p.000058: Independent ethics review by a registered REC is a basic requirement to engender confidence in the ethical
p.000058: character of research. ‘Independent’ means that the members of the REC are encouraged to be objective, informed
p.000058: and to act without fear or favour in their scientific and ethical reviews. Concerns should be raised
p.000058: and deliberated on by the committee; and decisions to impose additional conditions to protect human
p.000058: participants, animals or researchers should be taken where necessary.
p.000058: This chapter describes the legislative framework; the role of RECs; REC membership composition; operational
p.000058: procedures; and standard operating procedures for RECs. Note that detailed information about ARECs is to be found in
p.000058: SANS 10386:2008 South African National Standard The care and use of animals for scientific purposes or its successor
p.000058: and in MRC Guidelines on Ethics for Medical Research Book 3: Use of animals in research and training (2004).
p.000058:
p.000058: Ethics in Health Research 2nd edition
p.000057: 57
p.000057:
p.000057: 4.2 Legislative Framework
p.000057:
p.000057: Section 73 of the National Health Act (NHA) requires every institution, health agency and health
p.000057: establishment at which health research is conducted, to establish or have access to an REC, which is registered with
p.000057: the National Health Research Ethics Council (NHREC).
p.000057: Researchers without affiliation to an institution or organisation with an REC should approach a registered REC to
p.000057: request it to review their health research proposals. If the REC is willing to review external applications, a fee for
p.000057: service may be levied.
p.000057: 4.3 Role of Research Ethics Committees
p.000057:
p.000057: The primary role of the REC is to protect the interests (rights and welfare) of the research participants who
p.000057: volunteer to take part in scientifically sound research. Consequently, the primary responsibility of each REC
p.000057: member is to decide independently whether the proposed research protects the interests of participants adequately and
p.000057: keeps to exemplary standards in research activities. In the case of research with animals, the primary role of the AREC
p.000057: is to protect the welfare interests of animals used or to be used in research.
p.000057: The role and function of an Animal Research Ethics Committee (AREC) are set out in SANS 10386:2008 South African
p.000057: National Standard The care and use of animals for scientific purposes or its successor and in MRC Guidelines
p.000057: on Ethics for Medical Research Book 3: Use of animals in research and training (2004).
...
p.000070: research community, mainly through interactions with REC Chairpersons.
p.000070: 5.2.4 Working Groups and Committees
p.000070: Various Working Groups and Committees have been established to deal with the Council’s responsibilities in a systematic
p.000070: manner. They include
p.000070: i. The EXCO
p.000070: ii. Complaints, Advisory and Disciplinary Committee
p.000070: iii. Quality Promotion and Enhancement Working Group
p.000070: iv. Norms and Standards Working Group
p.000070: v. Legal and Regulatory Working Group.
p.000070:
p.000070: 5.2.5 Terms of Reference
p.000070: The statutory functions of the NHREC include
p.000070:
p.000070: 56 See http://www.nhrec.org.za for documentation.
p.000070:
p.000070: Ethics in Health Research 2nd edition
p.000069: 69
p.000069:
p.000069: i. Registration and auditing of RECs
p.000069: ii. Adjudication of complaints about RECs
p.000069: iii. Referral of matters concerning violations of ethical or professional rules to the relevant health
p.000069: professional council as appropriate
p.000069: iv. Recommendation, where applicable, of disciplinary action against persons found to have violated the
p.000069: norms and standards for responsible and ethical conduct of health research
p.000069: v. Advising the national and provincial departments of health on matters concerning research ethics and
p.000069: health research.
p.000069: 5.3 Research Ethics Committees
p.000069:
p.000069: Every institution, health agency and health establishment at which health research is conducted must
p.000069: establish or have access to an REC (NHA s 73). The main responsibility of each REC is to conduct rigorous ethics
p.000069: review of research proposals to ensure that the welfare and other interests of participants, researchers
p.000069: and animals used in research are properly protected and that the research will be conducted in accordance with the
p.000069: required ethical norms and standards. Section 73 states that RECs must ‘grant approval…where research
p.000069: proposals and protocol meet the ethical standards of that health research ethics committee’.
p.000069: 5.4 Registration and audit of committees
p.000069:
p.000069: Section 72(6)(b) of the NHA requires the NHREC to register and audit health RECs. The principle of
p.000069: empowerment is central to the registration and audit process.
p.000069: 5.4.1 Introduction
p.000069: Health research is intended to improve health practice and, consequently, the health and well being of South Africa’s
p.000069: people. Part of the framework that facilitates this process includes standardization of infrastructure and standard
p.000069: operating procedures for RECs, with a strong emphasis on guidance, training, support and feedback. To this end, the
p.000069: NHREC conducted a comprehensive administrative audit of RECs in South Africa, requiring each to register and to comply
p.000069: with various administrative and record keeping standards. Follow-up contact is designed to facilitate
p.000069: improvement and compliance with expected standards. When an REC or AREC persistently fails to comply with expected
p.000069: standards, the NHREC is required to enforce the standards, e.g. by suspending operations until compliance is
...
p.000071: may not have paid their annual fees necessary to maintain registration with the SA Nursing Council. To practise without
p.000071: being registered or being in possession of an annual practising certificate is to commit an offence in terms of the
p.000071: Nursing Act (s 55). It is important for nurse members of a research team to evidence registration as part
p.000071: of professional competency requirements.
p.000071: 5.5.4 Provincial Research Committees
p.000071: The White Paper on the Transformation of the Health System in South Africa outlines the importance of knowledge,
p.000071: information and empirical evidence as the backbone of health policy. The Health Research Policy in South
p.000071: Africa (2001) identified Provincial Health Research Committees as important mechanisms for coordinating
p.000071: health research and facilitating efficient use of limited research resources. Provincial HealthResearch Committees
p.000071: are not mentioned in the National Health Act (Act No. 61 of 2003),which establishes the National
p.000071: Research Coordination Committee, but they are clearly integral to the system. Research, especially that
p.000071: using state or provincial facilities and resources, should link to health care system priorities and
p.000071: findings should be integrated into policy planning and management of health programmes.
p.000071: Provincial Research Committees58 were established to liaise with researchers to ensure that the greatest health needs
p.000071: of each province are being addressed. Their focus is also on the effect of research activities on services. To that
p.000071: end, they perform a gate-keeping role by managing access to health facilities. They accept ethics approval
p.000071: granted by a registered
p.000071:
p.000071: 58 In some provinces, the legislation calls them Provincial Research and Ethics Committees, which may blur the
p.000071: different roles.
p.000071:
p.000071: 72 Ethics in Health Research 2nd edition
p.000071:
p.000071:
p.000071: REC. Some provinces have also established separate provincial research ethics committees. These committees are
p.000071: important in areas of the country where other RECs are not active. They are in the process of registering with the
p.000071: NHREC.
p.000071:
p.000071: Ethics in Health Research 2nd edition
p.000073: 73
p.000073:
p.000073:
p.000073: Chapter 6
p.000073:
p.000073: QUALITATIVE RESEARCH59
p.000073:
p.000073: Contents
p.000073:
p.000073:
p.000073:
p.000073: 6.1 Introduction
p.000073: p 73
p.000073: 6.2 Nature of qualitative research 74
p.000073: 6.3 Methodological approaches and requirements 74
p.000073: 6.3.1 Diversity of approaches 74
p.000073: 6.3.2 Inductive understanding 74
p.000073: 6.3.4 Diverse, multiple & evolving contexts 74
...
p.000075: not differ just because a different methodology is to be used. Consequently, the principles outlined and discussed in
p.000075: chapter 2 are relevant also to qualitative research.
p.000075: While researchers may refer to discipline- or paradigm-specific ethical norms and frameworks,
p.000075: adherence to national research ethics guidance is also required. As in quantitative research, RECs must
p.000075: consider any ethical tensions arising from specific methodologies and analytic approaches competently,
p.000075: fairly and without prejudice.
p.000075: As in quantitative proposals, researchers should explain the intended process of the research, including its
p.000075: predictability or lack thereof, and how foreseeable ethical issues will be managed. This information must
p.000075: also appear in the information for potential participants.
p.000075: 6.5 Criteria for review process
p.000075:
p.000075: In chapter 3 (3.1) the key criteria for the review process are outlined and discussed. These same criteria are relevant
p.000075: to review of qualitative research, with adjustments to emphasise aspects peculiar to qualitative research. However, the
p.000075: general requirements for role player engagement, social value, scientific validity and integrity, informed consent,
p.000075: risk/benefit ratio, protection of privacy and confidentiality are the same for all research. The discussion that
p.000075: follows should be read together with chapter 3.
p.000075: Specific ethical issues may arise with gaining access, building rapport, conducting ethnographic
p.000075: observations, in-depth interviews and focus groups, using data and reporting results. Attention should be given
p.000075: to issues of consent, confidentiality, social and psychological harms, privacy as well as the anticipated
p.000075: relationships between researchers and participants when assessing the design, review, conduct and reporting of the
p.000075: research. Some may be evident in the design phase, while others will only arise during the research, in which case the
p.000075: researcher must exercise discretion, sound judgement, consultation and flexibility in accordance with the level of risk
p.000075: of harm and possible benefits of the research. The basis for the exercise of discretion and the degree of
p.000075: flexibility should be considered at the design phase. The REC Chairperson should be consulted when doubt arises.
p.000075:
p.000075: 76 Ethics in Health Research 2nd edition
p.000075:
p.000075:
p.000075:
p.000075: APPENDIX 1
p.000075:
p.000075: Glossary
p.000075:
p.000075: Academic freedom – the collective freedom of researchers, including students, to conduct research and to disseminate
p.000075: ideas or findings without religious, political or institutional restrictions; it includes freedom of inquiry
p.000075: and freedom to challenge conventional thought. Academic freedom does not mean freedom to ignore ethical issues
...
p.000077: investigations (diagnostic medicines, e.g. medicines used during special X-ray examinations to map out
p.000077: kidneys).
p.000077: Coded data or materials– identifiers are substituted by a number, symbol or other method to provide a code; a key to
p.000077: the code exists so that the specimen can be linked to its original source
p.000077: Coercion – extreme form of undue influence, involving a threat of harm or punishment for failure to participate in
p.000077: research; see UndueXinfluence
p.000077: Collaborative research – involves co-operation of researchers, institutions, organizations or communities, each
p.000077: contributing distinct expertise, characterized by respectful relationships
p.000077: Community – a group of people with a shared identity or interest that has the capacity to act or express itself as a
p.000077: collective; it may be territorial, organizational or a community of interest
p.000077: Community engagement – a process that establishes an interaction between researchers and a community regarding a
p.000077: research project; it signifies the intention of forming a collaborative relationship; the degree of
p.000077: collaboration may vary depending on the circumstances
p.000077: Confidentiality – the responsibility to protect information entrusted to researchers for research purposes
p.000077: from unauthorized access, use, disclosure, modification, loss or theft
p.000077: Conflict of interest – incompatibility of duties, responsibilities or interests (personal or professional)
p.000077: of a person or an institution as regards ethical conduct of research so that one cannot be fulfilled without
p.000077: compromising another
p.000077: Consent – indication of agreement to participate in research, based on adequate knowledge and understanding of relevant
p.000077: information, and freely given
p.000077: Database– a collection of information including images (data) arranged to facilitate swift search and
p.000077: retrieval
p.000077: Decisional analysis – use of a systematic approach to ethical evaluation especially the ratio of risk of harm to
p.000077: likelihood of benefit
p.000077: Discomfort – a negative effect experienced in research less serious than harm
p.000077: Donor – the person (living or deceased) from whose body biological materials have been removed or withdrawn
p.000077: Ethics review –review of research proposals or protocols by RECs prior to commencement of the research
p.000077: Guardian – a person appointed by a court to look after the financial and welfare interests of a minor, or a person
p.000077: appointed by a parent with sole responsibility for the minor in terms of that parent’s Will
p.000077:
...
p.000077: e.g. when a researcher observes individuals or measures particular outcomes, without intervention e.g.
p.000077: no treatment is given);an observational study describes a wide range of study designs including
p.000077: prospective and retrospective cohort studies, case-control studies, and cross-sectional studies, a defining
p.000077: feature of which is that any intervention studied is determined by clinical practice and not the protocol.
p.000077: Orphan– a child without a surviving parent to care for him (s 1 Children’s Act)
p.000077:
p.000077: Ethics in Health Research 2nd edition
p.000079: 79
p.000079:
p.000079: Privacy risks – potential harms to participants from collection, use and disclosure of personal information
p.000079: for research purposes
p.000079: Protocol – document that provides background, rationale and objectives of research; describes its design,
p.000079: methodology, organization and conditions under which it is to be conducted and managed
p.000079: Qualitative research – involves studied use of empirical materials such as case studies, personal experience, life
p.000079: stories, interviews, observations, and cultural texts
p.000079: Registry– a collection of information (data) from multiple sources, maintained over time with controlled
p.000079: access through a gatekeeper organizer
p.000079: Reimbursement – payment to participants to ensure they are not disadvantaged financially directly or indirectly by
p.000079: participation in research; directly means actual costs incurred and indirectly means losses that arise because
p.000079: of participation
p.000079: Repository– a collection, storage and distribution system for human biological materials for research purposes
p.000079: including blood, urine, faeces, bone marrow, cell aspirates, diagnostic specimens, pathology specimens and
p.000079: so on. Usually demographic and medical information about the donors is included in the repository as are
p.000079: codes that link the material to the donors
p.000079: Research – includes a range of activities conducted by many different disciplines that may use different
p.000079: methodologies and explanatory frameworks to extend knowledge through disciplined inquiry or systematic
p.000079: investigation
p.000079: Risk – function of the magnitude of harm and the probability that it will occur
p.000079: Risk of harm to likelihood of benefit ratio – analysis of whether the risk of harm implied is justifiable in light of
p.000079: the likelihood of benefit
p.000079: Therapeutic intervention –interventions directed towards direct health-related benefit for a participant (NHA Reg 135)
p.000079: Tiered consent – donor permits use of biological materials for current study; and chooses whether to permit storage
p.000079: for future use, sample and data sharing.
p.000079: Undue influence – effect of an unequal power relationship on voluntariness; may occur when recruitment of
p.000079: participants is done by authority figure
p.000079: Virtual Repository– a digitised system that manages distributed bar-coded electronic versions of material,
p.000079: data or images through shared data systems
p.000079: Vulnerability – diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000079: project; may be caused by limited capacity or limited access to social goods like rights, opportunities and power
p.000079:
p.000079: 80 Ethics in Health Research 2nd edition
p.000079:
p.000079:
p.000079:
p.000079: APPENDIX 2
p.000079:
p.000079: Resources
p.000079:
p.000079: Online training opportunities
p.000079:
p.000079: These links are to FREE online training in research ethics and some also do Responsible Conduct of Research
p.000079: 1. The AMANET (African Malaria Network Trust)
p.000079: http://webcourses.amanet-trust.org/mod/resource/view.php?inpopup=true&id=116
p.000079: The AMANET (African Malaria Network Trust) web-based health research ethics training programme aims at
p.000079: providing the basic understanding in biomedical research ethics. On the premise of scarcity of resources and
p.000079: opportunities for such training for Africans, this effort hopes to provide this service to the many African members of
p.000079: IRB’s and investigators who may wish to undertake the course at home or in their office and at their own time up to a
p.000079: maximum period of four months for each student number issued.
p.000079: 2. Cameroon Bioethics Initiative (CAMBIN)
p.000079: www.cambin.org/cambin-training
p.000079:
p.000079: 3. https://camtools.cam.ac.uk/wiki/site/e30faf26-bc0c-4533-acbc-
p.000079: cff4f9234e1b/ethnographic%20and%20field%20study.html
p.000079:
...
p.000079: issues related to human and animal research, as well as to offer best practices and strategies for implementing
p.000079: successful programs for human subjects’ protection and animal care and use. PRIM&R's conferences, educational
p.000079: programs,
p.000079:
p.000079: Ethics in Health Research 2nd edition
p.000081: 81
p.000081:
p.000081: web-based seminars (“webinars”), and reference materials have become standard resources in the fields of research
p.000081: ethics and subjects protections.’
p.000081: 10. TRREE (for Training and Resources in Research Ethics Evaluation)
p.000081: http://elearning.trree.org/mod/resource/view.php?id=70
p.000081:
p.000081: TRREE is headed by a consortium of interested persons from Northern and Southern countries. It aims to provide basic
p.000081: training, while building capacities, on the ethics of health research involving humans so that research meets highest
p.000081: standards of ethics and promotes the welfare of participants. TRREE achieves this goal primarily by
p.000081: developing a training programme with local collaborators. In its initial stages TRREE focused primarily, but not
p.000081: exclusively, on the needs of African countries.
p.000081: TRREE provides free-of-charge access to:
p.000081: • e-Learning: a distance learning program and certification on research ethics evaluation
p.000081: • e-Resources : a participatory web-site with international, regional and national regulatory and policy resources
p.000081: There are other opportunities available but not all are free.
p.000081:
p.000081:
p.000081: Guidelines
p.000081:
p.000081: Australian code for the care and use of animals for scientific purposes (8th Edition) 2013 Australian National
p.000081: Statement on Ethical Conduct in Human Research (2007)
p.000081: AVMA Guidelines for the Euthanasia of Animals: 2013 Edition
p.000081: Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2010)
p.000081: Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health
p.000081: Organization (WHO) International Ethical Guidelines for Biomedical Research Involving Human Subjects Geneva 2002
p.000081: Council for International Organizations of Medical Sciences (CIOMS) (2002)
p.000081: Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the
p.000081: Application of Biology and Medicine: Convention on Human Rights and Biomedicine Oviedo 1997
p.000081: Council of Europe Steering Committee on Bioethics: Guide for Research Ethics Committee Members (2011)
p.000081: Department of Health RSA Ethics in Health Research: Principles, Structures and Processes
p.000081: Pretoria 2004
p.000081: Department of Health RSA Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South
p.000081: Africa Pretoria 2006
...
Searching for indicator accessXtoXinformation:
(return to top)
p.000009: • Cartagena Protocol on Biosafety May 2000
p.000009: • Child Justice Act 75 of 2008
p.000009: • Children’s Act 38 of 2005
p.000009: • Choice on Termination of Pregnancy Act 92 of 1996
p.000009: • Constitution of the Republic of South Africa, 1996
p.000009: • Convention on Biological Diversity
p.000009: • Criminal Law (Sexual Offences and Related Matters) Amendment Act 32 of 2007
p.000009: • Domestic Violence Act 116 of 1998
p.000009: • Employment Equity Act 55 of 1998
p.000009: • Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act 36 of 1947
p.000009: • Genetically Modified Organisms Act, Act No 15 of 1997
p.000009: • Hazardous Substances Act 15 of 1973
p.000009: • Health Professions Act 56 of 1974
p.000009: • Labour Relations Act 66 of 1995
p.000009: • Medical Schemes Act 131 of 1998
p.000009: • Medicines and Related Substances Control Act 101 of 1965
p.000009: • Mental Health Care Act 17 of 2002
p.000009: • Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits,5
p.000009: • National Environmental Management: Biodiversity Act, Act 10 of 2004
p.000009: • National Health Act, Act No 61 of 2003
p.000009: • National Health Laboratory Service Act 37 of 2000
p.000009: • Patents Act 57 of 1978
p.000009: • Performing Animals Protection Act 24 of 1935
p.000009: • Promotion of Access to Information Act 2 of 2000
p.000009: • Promotion of Equality and Prevention of Unfair Discrimination Act 4 of 2000
p.000009: • Protected Disclosures Act 26 of 2000
p.000009: • Protection of Personal Information Act 4 of 2013
p.000009: • Provincial Nature Conservation Acts or Ordinances
p.000009:
p.000009:
p.000009:
p.000009: 4 Note this list is not exhaustive.
p.000009: 5Ratified by South Africa on 11 May 2011. For further information, see http://www.cbd.int/abs/
p.000009:
p.000009: Ethics in Health Research 2nd edition
p.000011: 11
p.000011:
p.000011: • Rules Relating to the Practising of the Para-Veterinary Profession of Laboratory Animal Technologist.
p.000011: Department of Agriculture (1997) GN 1445 of 3 October 1997
p.000011: • Rules Relating to the Practising of the Profession of Veterinary Nurse. Department of Agriculture (1991) GN 1065
p.000011: of 17 May 1991
p.000011: • Societies for the Prevention of Cruelty to Animals Act 169 of 1993
p.000011: • Sterilization Act 44 of 1998
p.000011: • Veterinary and Para-veterinary Professions Act 19 of 1982
p.000011:
p.000011: 1.4 Research with humans
p.000011:
p.000011: 1.4.1 The National Health Act (NHAs 72(6)(c)) gives authority to the NHREC for setting norms and
p.000011: standards for health and health-related research that involves humans.
p.000011: 1.4.2 Every organisation/institution, health agency and health establishment at which health and health-related
p.000011: research involving human participants is conducted, must establish or have access to a registered Human Research
...
p.000023: (see 3.2.2).
p.000023:
p.000023: 24 Ethics in Health Research 2nd edition
p.000023:
p.000023:
p.000023: • if the information is to be sent outside the Republic, the recipient must assure that the level of protection
p.000023: afforded in that country is commensurate with that expected in South Africa (s 18(1)(g));
p.000023: • information about a person’s race or ethnic origin must be necessary (s 29(a)) or for affirmative action purposes
p.000023: (s 29(b));
p.000023: • information about a person’s health or sex life must be necessary for the research activity (s 27(1)(d));
p.000023: • information about a person’s inherited characteristics must be necessary for the research activity (s
p.000023: 32(5)(b));
p.000023: • biometric16 information about a person must be necessary for the research activity (s 27(1)(d)).
p.000023: In effect, the Act outlines and requires the usual requirements for ethical and responsible informed consent
p.000023: procedures. The provisions underpin the importance of comprehensive SOPs and rigorous adherence thereto. It
p.000023: should be remembered that research records including informed consent documentation may be solicited by
p.000023: interested parties via application in terms of the Promotion of Access to Information Act 2 of 2000.
p.000023: 3.1.9 Obtaining informed consent
p.000023: The principle of respect for persons underpins the requirement that a person must choose voluntarily whether to
p.000023: participate in research on the basis of information that allows an informed choice to be made. The
p.000023: process of providing the necessary information and of engaging with the person before a decision is
p.000023: reached is known as the informed consent process. It should be noted that informed consent is a necessary but
p.000023: insufficient element of ethical research, i.e. that a person voluntarily chooses to participate does not mean that the
p.000023: research proposal is ethical. All the other elements should also stand up to ethical scrutiny.
p.000023: An important element of making an informed choice is the nature and quality of information made available to the
p.000023: potential participant. See below for expectations regarding information disclosure.
p.000023: Adults, i.e. persons over the age of 18 years, may make independent decisions. However, they may wish to consult with
p.000023: family members or others in keeping with personal preference or cultural practices. Consequently, the process should
p.000023: permit sufficient time for consultation between the recruitment approach and the point of decision-making. No person
...
Social / Age
Searching for indicator age:
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p.000015: outweigh the anticipated risk of harm to participants. However, this does not mean that
p.000015: participants should be exposed to unacceptable risks of harm on the basis that the participants are likely to
p.000015: benefit from the research. In assessing the risk of harm, both the magnitude or seriousness of the harm and the
p.000015: probability of its occurrence should be addressed.
p.000015: Usually, participants who might face undue risk of harm should not be included in the study, even if they represent a
p.000015: category of person that may benefit from the research. On the other hand, research with such persons may
p.000015: nevertheless be approved after careful review and acceptable justification that demonstrates the anticipated
p.000015: importance and value of the research for society. In such cases, a carefully phased approach should be adopted.
p.000015: 2.3.5 Fair selection of participants
p.000015: This means recruitment, selection, exclusion and inclusion of participants for research must be just and fair,
p.000015: based on sound scientific and ethical principles. Persons should not be excluded unreasonably or unfairly
p.000015: on the basis of any of the prohibited grounds for discrimination: race, age, sex, sexual orientation,
p.000015: disability, education, religious belief, pregnancy, marital status, ethnic or social origin, conscience, belief or
p.000015: language (s 8 of the Constitution). Similarly, persons should not be unfairly targeted for research merely on the basis
p.000015: of one or other of these grounds.
p.000015: 2.3.6 Informed consent
p.000015: In general, participation in research must be voluntary and predicated on informed choices. Voluntariness and
p.000015: informed choices are evidenced by the informed consent process which must take place before the research
p.000015: commences, in principle, and be affirmed during the
p.000015:
p.000015: Ethics in Health Research 2nd edition
p.000017: 17
p.000017:
p.000017: course of the study, as part of the commitment to an ongoing consent process. In some circumstances,
p.000017: research may not require prior consent (see 3.2.5 & 3.3)
p.000017: 2.3.7 Ongoing respect for enrolled participants
p.000017: A research participant has the right to privacy and to confidentiality. This requires that a proposal
...
p.000023: personal information’ (Preamble to Act). A tension between the right to privacy and the need for free flow of
p.000023: information in a society that seeks to make progress on economic, social, health care and educational fronts, is
p.000023: immediately evident. The Act does not appear to hold out negative implications for research activities
p.000023: that record personal information about research participants. However, special attention should be given to
p.000023: ensuring that computers and electronically stored data are protected from unauthorised access, inadvertent or
p.000023: accidental dissemination and distribution in form of a ‘data dump’, etc.
p.000023: Research activities are a legitimate purpose, provided that protective measures are adhered to. Thus researchers and
p.000023: RECs should pay careful attention to measures that will protect privacy and confidentiality interests.
p.000023: In general terms, a person should know what information is being collected, why it is being collected, what
p.000023: will happen to it, how long it will be retained, whether it will identify the person, whether it will be shared with
p.000023: others and why, whether it will be sent outside South Africa and why. The person should agree to these terms.
p.000023: Some specific terms are summarised:
p.000023: • in the case of a child (person under the age of 18 years), a parent or guardian14 must give permission for the
p.000023: information to be collected (s 35(1)(a));15
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: 12Storage requirements may vary according to institutional requirements; usually between five and fifteen years.
p.000023: 13Some parts came into effect on 11 April 2014: s 1 (definitions); part A of Chapter 5 (establishment of Information
p.000023: Regulator); s 112 (about making Regulations); and s 113 (procedures for making Regulations) by Proclamation in GG 37544
p.000023: R.25, 2014.
p.000023: 14Note a caregiver, a foster parent, and a schoolteacher or principal are not guardians.
p.000023: 15 This requirement is compatible with the consent requirements for minors as described elsewhere in these Guidelines
p.000023: (see 3.2.2).
p.000023:
p.000023: 24 Ethics in Health Research 2nd edition
p.000023:
p.000023:
p.000023: • if the information is to be sent outside the Republic, the recipient must assure that the level of protection
p.000023: afforded in that country is commensurate with that expected in South Africa (s 18(1)(g));
p.000023: • information about a person’s race or ethnic origin must be necessary (s 29(a)) or for affirmative action purposes
p.000023: (s 29(b));
p.000023: • information about a person’s health or sex life must be necessary for the research activity (s 27(1)(d));
...
p.000023: In effect, the Act outlines and requires the usual requirements for ethical and responsible informed consent
p.000023: procedures. The provisions underpin the importance of comprehensive SOPs and rigorous adherence thereto. It
p.000023: should be remembered that research records including informed consent documentation may be solicited by
p.000023: interested parties via application in terms of the Promotion of Access to Information Act 2 of 2000.
p.000023: 3.1.9 Obtaining informed consent
p.000023: The principle of respect for persons underpins the requirement that a person must choose voluntarily whether to
p.000023: participate in research on the basis of information that allows an informed choice to be made. The
p.000023: process of providing the necessary information and of engaging with the person before a decision is
p.000023: reached is known as the informed consent process. It should be noted that informed consent is a necessary but
p.000023: insufficient element of ethical research, i.e. that a person voluntarily chooses to participate does not mean that the
p.000023: research proposal is ethical. All the other elements should also stand up to ethical scrutiny.
p.000023: An important element of making an informed choice is the nature and quality of information made available to the
p.000023: potential participant. See below for expectations regarding information disclosure.
p.000023: Adults, i.e. persons over the age of 18 years, may make independent decisions. However, they may wish to consult with
p.000023: family members or others in keeping with personal preference or cultural practices. Consequently, the process should
p.000023: permit sufficient time for consultation between the recruitment approach and the point of decision-making. No person
p.000023: should be required to make an immediate decision. The informed consent process for adults with diminished
p.000023: or no decision-making capacity (factually incapacitated) and for minors (legally incapacitated) is described at
p.000023: 3.2.4.3 and 3.2.4.2 respectively.
p.000023: RECs should assess the proposed process for informed consent as well as the information that potential participants
p.000023: will be given and the measures to facilitate understanding. Considerations for assessment include whether
p.000023: • the setting will
p.000023: o minimise the possibility of undue influence
p.000023: o be sufficiently private and appropriate
p.000023:
p.000023: 16 ‘Biometrics means a technique of personal identification that is based on physical, physiological or behaviour
p.000023: characterisation including blood typing, fingerprinting, DNA analysis, retinal scanning and voice recognition’ (s 1 of
p.000023: the Act).
p.000023:
...
p.000025: Where a clinical trial is proposed, additional information for prospective participants is required.18
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 17The Flesch-Kinkaid readability tool should be used to assess the complexity of text. This tool is built into MS
p.000025: Word’s spelling & grammar check tool as ‘readability statistics’. No more than Grade 8 equivalency should be the target
p.000025: complexity level.
p.000025: 18See Department of Health (2006) Guidelines for Good Practice in the Conduct of Clinical Trials with Human
p.000025: Participants in South Africa
p.000025: or its successor.
p.000025:
p.000025: 26 Ethics in Health Research 2nd edition
p.000025:
p.000025:
p.000025: 3.2 Vulnerability and incapacity
p.000025:
p.000025: Vulnerability is not an absolute condition but rather occurs on a sliding scale. In South Africa, arguably, the
p.000025: majority of potential research participants are vulnerable when compared to those in North America or Europe,
p.000025: from whence much funding is sourced. 19 Whether vulnerability is present is a matter of fact and degree.
p.000025: However, certain groups of participants 20 require careful consideration to ensure that, where appropriate,
p.000025: additional precautions are put into place. For example, advanced age, very young age, personal or
p.000025: environmental factors like extreme poverty and ordinarily poor access to health care may increase
p.000025: vulnerability
p.000025: 3.2.1 Contextual circumstances
p.000025: Personal circumstances, such as mental or intellectual impairment, acute illness, advanced age, and pregnancy and
p.000025: childbirth may increase vulnerability. Persons may be factually incapable or less capable of understanding
p.000025: information and processing it to reach a decision
p.000025: e.g. about whether to participate in research. Environmental circumstances may also increase vulnerability such as very
p.000025: poor socio-economic conditions, low levels of formal education and literacy, or restricted access to health care
p.000025: services. Such persons may be more easily persuaded to agree to participate without a properly considered
p.000025: understanding of the implications.
p.000025: It is important to note the difference between legal incapacity and factual incapacity. No person may
p.000025: claim that, because a minor is factually capable, the legal incapacity should be waived. On the other hand, no adult
p.000025: may be assumed to be incapable unless incapacity is established factually. Consequently, mental incapacity must
...
p.000027: circumstances of the proposal before the REC. For example, an automatic assumption that impoverished people cannot
p.000027: choose responsibly whether to participate in research is disrespectful because it denies their autonomy.
p.000027: If compliance with the additional measures is poor and participants’ welfare is negatively affected,
p.000027: approval for the study may be withdrawn, temporarily or permanently, as the case may be.
p.000027: Groups of participants discussed here include
p.000027: • minors (children and adolescents)
p.000027: • women
p.000027: • adults with incapacity to provide informed consent
p.000027: • persons in dependent relationships
p.000027: • persons highly dependent on medical care
p.000027: • persons with physical disabilities
p.000027: • prisoners
p.000027: • collectivities
p.000027:
p.000027: Note this list is not exhaustive but provides an indication of the types of consideration to be applied
p.000027: 3.2.2 Minors (children and adolescents)
p.000027:
p.000027: Below the age of majority, the law protects young people from their own emotional, cognitive and physical immaturity
p.000027: and limited life experience through the legal status of minority. In other words, minors, i.e. persons under 18 years
p.000027: of age,22 are legally incapable of performing legal transactions without assistance from a parent or guardian. In the
p.000027: research context, this means that, in principle, anyone under the age of 18 years may not choose independently whether
p.000027: to participate in research; a parent or guardian must give permission for the minor
p.000027:
p.000027: 21 Note that this requirement does not mean that a REC may not approve a waiver of personal informed consent for types
p.000027: of research into e.g. record reviews or such like.
p.000027: 22 Section 28 of the Constitution; and s 17 of the Children’s Act 38 of 2005.
p.000027:
p.000027: 28 Ethics in Health Research 2nd edition
p.000027:
p.000027:
p.000027: to choose. This is because young persons’ understanding of key aspects of the research initiative may be
p.000027: compromised and, consequently, they may be exposed to increased risk of harm from particular research procedures.
p.000027: Exceptions to the requirement for parental permission are discussed at 3.2.2.4.
p.000027: Tension exists between the views that, in general, children and adolescents should not bear the burden of research
p.000027: unnecessarily, on the one hand, and that children and adolescents are entitled to improved health care based on
p.000027: findings drawn from rigorous research conducted in the child population of South Africa, on the other.
...
p.000027: then the parent or guardian chooses whether the minor should participate.
p.000027: The best interest of a child should be paramount in decisions that affect the child. 24 This principle is
p.000027: difficult to apply in the research context because research participation is unlikely to be in the best interest of a
p.000027: minor. Good research design does not accommodate a best interest analysis easily. Rather, the design draws on
p.000027: aggregates of information. This means that, in the research context, the best interest principle should be understood
p.000027: to mean that participation in the research should not be contrary to the individual minor’s best interest. Further, the
p.000027: research should investigate a problem of relevance to minors.
p.000027: Where research can be done with consenting adults but nevertheless proposes also to include minors, the
p.000027: researchers must provide strong justification for the inclusion of minors. The REC should not make assumptions on
p.000027: behalf of the researchers. It should require all relevant information to be provided by the researchers. Note
p.000027: that all types of clinical trial research on minors should be scrutinized carefully in case extra precautions or
p.000027: conditions are necessary.
p.000027: For purposes of these guidelines
p.000027: ‘Adolescent’ means a child between the ages of 12 and 17 years of age (ICH Topic E 11 Clinical Investigation of
p.000027: Medicinal Products in the Paediatric Population. 2000
p.000027: [http://www.emea.eu.int/pdfs/human/ich/271199EN.pdf]
p.000027: ‘Caregiver’ means a person who factually cares for a child (s 1 Children’s Act, 38 of 2005; a caregiver is obliged
p.000027: (in terms of s 32(1)) to safeguard the child’s health, well-being and development; and to protect the child
p.000027: from abuse and other harms. Further a caregiver may exercise the parental right to consent to medical examination or
p.000027: treatment of the child (in terms of s 32(2))
p.000027:
p.000027:
p.000027: 23 Section 10 of the Children’s Act 38 of 2005. Note that a caregiver, a foster parent and a schoolteacher or
p.000027: principal are not guardians. Note that legal incapacity is not the same as factual incapacity. Minority is a legal
p.000027: incapacity status.
p.000027: 24 See also s 9 of the Children’s Act 38 of 2005.
p.000027:
p.000027: Ethics in Health Research 2nd edition
p.000029: 29
p.000029:
p.000029: ‘Child’ means a person under the age of 18 years (s 28 Constitution; s 1 Children’s Act 38 of 2005)
p.000029: ‘Child-headed household’ means a household per s 137 Children’s Act 38 of 2005
p.000029: ‘Guardian’ means a person appointed by a court to look after the financial and welfare interests of a
p.000029: minor, or a person appointed by a parent with sole responsibility for the minor in terms of the parent’s Will
p.000029: ‘Harm’ means physical, emotional, psychological, social or legal harm
p.000029: ‘Minor’ means a person (child) less than 18 years (s 17 Children’s Act 38 of 2005) ‘Neonate’ means a newborn child,
p.000029: including an infant less than a month old
p.000029: ‘Orphan’ means a child who has no surviving parent caring for him or her (s 1 Children’s Act 38 of 2005)
...
p.000029: Pregnancy Act 92 of 1996 (s 5(2)). Consequently, in principle, the consent process for a minor’s participation in
p.000029: research requires
p.000029: • Permission in writing from parents or legal guardian for the minor to be approached and invited to
p.000029: participate (in accordance with s 10 of the Children’s Act 38 of 2005);
p.000029: • Assent from the minor in writing (i.e. agreement to participate) if he or she chooses to participate.
p.000029: Note that an unmarried minor mother may not agree to the participation of her child in research without assistance. Her
p.000029: guardian (usually her parent) is also the guardian of her child while she is a minor and must consent to the child’s
p.000029: participation. In other words, pregnancy and childbirth do not change the legal status of the minor mother. When the
p.000029: mother reaches the age of majority (18 years), she may consent to her child’s participation in research.
p.000029: f) Children should participate in research that takes cognisance of their privacy interests. Although children are
p.000029: legally dependent, they have significant privacy interests. Their
p.000029:
p.000029: Ethics in Health Research 2nd edition
p.000031: 31
p.000031:
p.000031: genetic privacy interests, in particular, may be more important than those of adults who manifest a particular genetic
p.000031: condition.
p.000031: g) When parents or a guardian give permission for their minor child to choose whether to participate in research, this
p.000031: permission is given based on a detailed description of all diagnostic and therapeutic interventions that will
p.000031: affect the child in the study. However, this does not mean that parents are entitled to know the outcome of all
p.000031: diagnostic and therapeutic interventions, especially as regards older minors (adolescents). The
p.000031: informed consent documentation must explain whether results of tests will be made known to child-participants
...
p.000033:
p.000033: 34 Ethics in Health Research 2nd edition
p.000033:
p.000033:
p.000033: 3.2.2.5 Mandatory reporting obligations
p.000033: There is no general obligation to report either the commission of or the intention to commit a crime. However, if a
p.000033: researcher has information indicating that direct harm to another person may occur as a result of the intention to
p.000033: commit harm (e.g. a participant says ‘I’m going to kill her…’), then there may be an obligation, especially when the
p.000033: third person is known to the researcher. For specifically designated persons, there are statutory reporting
p.000033: obligations. (See Appendix 3 for SOP Template.)
p.000033: i. Reporting obligations for abuse and neglect
p.000033: The Children’s Act requires anyone who reasonably believes a child to be suffering physical abuse causing injury,
p.000033: deliberate neglect and sexual abuse to report this to a child protection agency, the provincial social development
p.000033: department, or to a police official.
p.000033: ii. Reporting obligations for under-age sexual activity
p.000033: The age at which minors can lawfully consent to sexual activity is 16 years, in terms of the Criminal Law (Sexual
p.000033: Offences and Related Matters) Amendment Act 32 of 2007 (Sexual Offences Act). Anyone with knowledge of a
p.000033: sexual offence against a minor is required to report this to a police official. In effect, any adult or person >16
p.000033: years who engages in sexual activity with a minor < 16 years commits a crime and may be prosecuted. The Act
p.000033: describes a broad range of sexual offences, including rape, sexual assault, sexual grooming, sexual
p.000033: exploitation, and use of children in pornography including photographs. This means that the range of activities
p.000033: that may constitute a sexual offence is extensive.
p.000033: The Sexual Offences Act differentiates between adolescents (12 - < 16 years) and older minors (16 and 17
p.000033: years). In the case of children younger than 12 years, sexual activity is unlawful even with consent. For adolescents,
p.000033: the situation is as follows. The Teddy Bear Clinic case 29 found criminalisation of consensual sexual acts
p.000033: between adolescents aged 12 – < 16 years to be unconstitutional, on the basis that adolescents should not be subjected
...
p.000035: 3.2.4.2 Minors and decision-making incapacity
p.000035: Parents or guardians of minors with intellectual or mental impairments should give permission for their
p.000035: minor children to choose whether to participate in research. If the minor
p.000035:
p.000035: 32 Georgetown University Informed Consent and Limitations on Decision making Capacity Chapter 2
p.000035: https://bioethicsarchive.georgetown.edu/nbac/capacity/Informed.htm
p.000035:
p.000035: Ethics in Health Research 2nd edition
p.000037: 37
p.000037:
p.000037: is unable to communicate at all or lacks the capacity to choose, then the parent or guardian should choose whether
p.000037: the minor may be enrolled. In other words, the parent acts as a proxy decision maker. In the case of a
p.000037: minor who remains intellectually or mentally impaired after reaching the age of majority, the situation changes
p.000037: because the person becomes an adult with decision-making incapacity (see 3.2.4.3 below).
p.000037: 3.2.4.3 Adults incapable of giving adequate informed consent
p.000037: Proxy decision makers are not permitted for adult persons who lack capacity unless the proxy is a court-appointed
p.000037: curator. Neither the National Health Act 61 of 2003 nor the Mental Health Care Act 17 of 2002 makes
p.000037: provision for proxy decision makers for research purposes but they provide clear lists of proxy decision makers for
p.000037: treatment purposes.
p.000037: Since it would be unethical to exclude a category of persons from research participation without adequate
p.000037: justification, arguably, an ethical argument can be made for using the statutory treatment proxies to
p.000037: provide permission for participation in research that complies with the stipulations set out below. However,
p.000037: RECs must be careful not to confuse the distinction between treatment and research. In unusual circumstances,
p.000037: e.g. major incident research (see 3.4.1), it may be ethically permissible to permit proxy consent also in
p.000037: a situation where no statutory proxy is available but the risk of harm to knowledge ratio justifies it.
p.000037: In particular circumstances, the REC may approve delayed consent.
...
p.000075: relationships between researchers and participants when assessing the design, review, conduct and reporting of the
p.000075: research. Some may be evident in the design phase, while others will only arise during the research, in which case the
p.000075: researcher must exercise discretion, sound judgement, consultation and flexibility in accordance with the level of risk
p.000075: of harm and possible benefits of the research. The basis for the exercise of discretion and the degree of
p.000075: flexibility should be considered at the design phase. The REC Chairperson should be consulted when doubt arises.
p.000075:
p.000075: 76 Ethics in Health Research 2nd edition
p.000075:
p.000075:
p.000075:
p.000075: APPENDIX 1
p.000075:
p.000075: Glossary
p.000075:
p.000075: Academic freedom – the collective freedom of researchers, including students, to conduct research and to disseminate
p.000075: ideas or findings without religious, political or institutional restrictions; it includes freedom of inquiry
p.000075: and freedom to challenge conventional thought. Academic freedom does not mean freedom to ignore ethical issues
p.000075: Accountability – the measure by which it can be demonstrated that responsibilities have been or are being fulfilled;
p.000075: it may involve reporting upwards in a hierarchical structure
p.000075: Adolescent – a child between 12 and 17 years of age
p.000075: Anonymous data or specimen–data or biological materials without any overt identifying information or link to a
p.000075: specific donor
p.000075: Audit– subset of research; not clinical practice but a review of clinical practice
p.000075: Autonomy – the capacity to understand information; to act on it voluntarily; to use own judgement to make decisions
p.000075: about own actions, including whether to participate in research
p.000075: Biobank – see Repository
p.000075: Human biological materials– materials including blood and blood products, DNA, RNA, blastomeres, polar bodies,
p.000075: cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors
p.000075: Broad consent– donor permits use of biological materials for future studies, subject only to further prior ethics
p.000075: review and approval
p.000075: Capacity – the ability to understand relevant information; to appreciate the consequences of decisions based on the
p.000075: information
p.000075: Caregiver– a person who in fact cares for a child (s 1 Children’s Act, 38 of 2005); a caregiver must
p.000075: safeguard the child’s health, well-being and development; and protect the child from abuse and other
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Social / Child
Searching for indicator child:
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p.000009: individuals involved in research, particularly vulnerable participants; to protect the welfare and safety
p.000009: interests of animals used in research; and to protect safety and other interests of researchers.
p.000009:
p.000009: 3 Available at http://www.health-e.org.za/wp-content/uploads/2014/08/SA-DoH-Strategic-Plan-2014-to-2019.pdf
p.000009:
p.000009: 10 Ethics in Health Research 2nd edition
p.000009:
p.000009:
p.000009: 1.3.4 The guidelines draw on prevailing international, foreign and national codes of conduct,
p.000009: declarations, and other documents relevant to research with humans, to strengthen processes of translational
p.000009: research collaboration, while taking into account the socioeconomic, ethnic and cultural diversity in South Africa. The
p.000009: guidelines also draw on and refer to international and national standards and guidelines for research using animals.
p.000009: 1.3.5 Researchers should be familiar with legislation and other binding instruments relevant to research including4
p.000009: • Animal Diseases Act 35 of 1984
p.000009: • Animal Health Act 7 of 2002
p.000009: • Animals Protection Act 71 of 1962
p.000009: • Basic Conditions of Employment Act 75 of 1997
p.000009: • Cartagena Protocol on Biosafety May 2000
p.000009: • Child Justice Act 75 of 2008
p.000009: • Children’s Act 38 of 2005
p.000009: • Choice on Termination of Pregnancy Act 92 of 1996
p.000009: • Constitution of the Republic of South Africa, 1996
p.000009: • Convention on Biological Diversity
p.000009: • Criminal Law (Sexual Offences and Related Matters) Amendment Act 32 of 2007
p.000009: • Domestic Violence Act 116 of 1998
p.000009: • Employment Equity Act 55 of 1998
p.000009: • Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act 36 of 1947
p.000009: • Genetically Modified Organisms Act, Act No 15 of 1997
p.000009: • Hazardous Substances Act 15 of 1973
p.000009: • Health Professions Act 56 of 1974
p.000009: • Labour Relations Act 66 of 1995
p.000009: • Medical Schemes Act 131 of 1998
p.000009: • Medicines and Related Substances Control Act 101 of 1965
p.000009: • Mental Health Care Act 17 of 2002
p.000009: • Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits,5
p.000009: • National Environmental Management: Biodiversity Act, Act 10 of 2004
p.000009: • National Health Act, Act No 61 of 2003
p.000009: • National Health Laboratory Service Act 37 of 2000
p.000009: • Patents Act 57 of 1978
p.000009: • Performing Animals Protection Act 24 of 1935
p.000009: • Promotion of Access to Information Act 2 of 2000
...
p.000023: that the right to privacy includes ‘protection against unlawful collection, retention, dissemination and use of
p.000023: personal information’ (Preamble to Act). A tension between the right to privacy and the need for free flow of
p.000023: information in a society that seeks to make progress on economic, social, health care and educational fronts, is
p.000023: immediately evident. The Act does not appear to hold out negative implications for research activities
p.000023: that record personal information about research participants. However, special attention should be given to
p.000023: ensuring that computers and electronically stored data are protected from unauthorised access, inadvertent or
p.000023: accidental dissemination and distribution in form of a ‘data dump’, etc.
p.000023: Research activities are a legitimate purpose, provided that protective measures are adhered to. Thus researchers and
p.000023: RECs should pay careful attention to measures that will protect privacy and confidentiality interests.
p.000023: In general terms, a person should know what information is being collected, why it is being collected, what
p.000023: will happen to it, how long it will be retained, whether it will identify the person, whether it will be shared with
p.000023: others and why, whether it will be sent outside South Africa and why. The person should agree to these terms.
p.000023: Some specific terms are summarised:
p.000023: • in the case of a child (person under the age of 18 years), a parent or guardian14 must give permission for the
p.000023: information to be collected (s 35(1)(a));15
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: 12Storage requirements may vary according to institutional requirements; usually between five and fifteen years.
p.000023: 13Some parts came into effect on 11 April 2014: s 1 (definitions); part A of Chapter 5 (establishment of Information
p.000023: Regulator); s 112 (about making Regulations); and s 113 (procedures for making Regulations) by Proclamation in GG 37544
p.000023: R.25, 2014.
p.000023: 14Note a caregiver, a foster parent, and a schoolteacher or principal are not guardians.
p.000023: 15 This requirement is compatible with the consent requirements for minors as described elsewhere in these Guidelines
p.000023: (see 3.2.2).
p.000023:
p.000023: 24 Ethics in Health Research 2nd edition
p.000023:
p.000023:
p.000023: • if the information is to be sent outside the Republic, the recipient must assure that the level of protection
p.000023: afforded in that country is commensurate with that expected in South Africa (s 18(1)(g));
p.000023: • information about a person’s race or ethnic origin must be necessary (s 29(a)) or for affirmative action purposes
p.000023: (s 29(b));
...
p.000027: to participate in research; a parent or guardian must give permission for the minor
p.000027:
p.000027: 21 Note that this requirement does not mean that a REC may not approve a waiver of personal informed consent for types
p.000027: of research into e.g. record reviews or such like.
p.000027: 22 Section 28 of the Constitution; and s 17 of the Children’s Act 38 of 2005.
p.000027:
p.000027: 28 Ethics in Health Research 2nd edition
p.000027:
p.000027:
p.000027: to choose. This is because young persons’ understanding of key aspects of the research initiative may be
p.000027: compromised and, consequently, they may be exposed to increased risk of harm from particular research procedures.
p.000027: Exceptions to the requirement for parental permission are discussed at 3.2.2.4.
p.000027: Tension exists between the views that, in general, children and adolescents should not bear the burden of research
p.000027: unnecessarily, on the one hand, and that children and adolescents are entitled to improved health care based on
p.000027: findings drawn from rigorous research conducted in the child population of South Africa, on the other.
p.000027: The solution lies in the approach that minors should participate in research only where their
p.000027: participation is indispensable to the research; i.e. the research cannot deliver the desired outcomes if adult
p.000027: participants were to be used instead.
p.000027: Because of their status of legal incapacity, in principle, minors may not choose independently whether to participate
p.000027: in research. A parent or guardian must give permission for the minor to choose. It should be noted that the parent or
p.000027: guardian does not choose for the minor who is capable of choosing;23 rather, the parent or guardian gives
p.000027: permission for the minor to choose. Where a minor is very young or is factually incapable of exercising a choice,
p.000027: then the parent or guardian chooses whether the minor should participate.
p.000027: The best interest of a child should be paramount in decisions that affect the child. 24 This principle is
p.000027: difficult to apply in the research context because research participation is unlikely to be in the best interest of a
p.000027: minor. Good research design does not accommodate a best interest analysis easily. Rather, the design draws on
p.000027: aggregates of information. This means that, in the research context, the best interest principle should be understood
p.000027: to mean that participation in the research should not be contrary to the individual minor’s best interest. Further, the
p.000027: research should investigate a problem of relevance to minors.
p.000027: Where research can be done with consenting adults but nevertheless proposes also to include minors, the
p.000027: researchers must provide strong justification for the inclusion of minors. The REC should not make assumptions on
p.000027: behalf of the researchers. It should require all relevant information to be provided by the researchers. Note
p.000027: that all types of clinical trial research on minors should be scrutinized carefully in case extra precautions or
p.000027: conditions are necessary.
p.000027: For purposes of these guidelines
p.000027: ‘Adolescent’ means a child between the ages of 12 and 17 years of age (ICH Topic E 11 Clinical Investigation of
p.000027: Medicinal Products in the Paediatric Population. 2000
p.000027: [http://www.emea.eu.int/pdfs/human/ich/271199EN.pdf]
p.000027: ‘Caregiver’ means a person who factually cares for a child (s 1 Children’s Act, 38 of 2005; a caregiver is obliged
p.000027: (in terms of s 32(1)) to safeguard the child’s health, well-being and development; and to protect the child
p.000027: from abuse and other harms. Further a caregiver may exercise the parental right to consent to medical examination or
p.000027: treatment of the child (in terms of s 32(2))
p.000027:
p.000027:
p.000027: 23 Section 10 of the Children’s Act 38 of 2005. Note that a caregiver, a foster parent and a schoolteacher or
p.000027: principal are not guardians. Note that legal incapacity is not the same as factual incapacity. Minority is a legal
p.000027: incapacity status.
p.000027: 24 See also s 9 of the Children’s Act 38 of 2005.
p.000027:
p.000027: Ethics in Health Research 2nd edition
p.000029: 29
p.000029:
p.000029: ‘Child’ means a person under the age of 18 years (s 28 Constitution; s 1 Children’s Act 38 of 2005)
p.000029: ‘Child-headed household’ means a household per s 137 Children’s Act 38 of 2005
p.000029: ‘Guardian’ means a person appointed by a court to look after the financial and welfare interests of a
p.000029: minor, or a person appointed by a parent with sole responsibility for the minor in terms of the parent’s Will
p.000029: ‘Harm’ means physical, emotional, psychological, social or legal harm
p.000029: ‘Minor’ means a person (child) less than 18 years (s 17 Children’s Act 38 of 2005) ‘Neonate’ means a newborn child,
p.000029: including an infant less than a month old
p.000029: ‘Orphan’ means a child who has no surviving parent caring for him or her (s 1 Children’s Act 38 of 2005)
p.000029: ‘Parent’ includes an adoptive parent (s 1 Children’s Act 38 of 2005)
p.000029: ‘Therapeutic research’ means research that includes interventions that may hold out the prospect of direct
p.000029: health-related benefit for the participant (Regulation 135)
p.000029: ‘Non-therapeutic research’ means research that includes interventions that will not hold out the prospect of direct
p.000029: health-related benefit for the participant but may produce results that contribute to generalisable knowledge
p.000029: (Regulation 135)
p.000029: 3.2.2.1 Minimum conditions for research involving minors
p.000029: The following considerations are critical when RECs review proposals to involve child participants:
p.000029: a) Children should participate in research when their participation is scientifically indispensable to the
p.000029: research. In the case of interventional clinical research, equipoise 25 should exist. Research should
p.000029: investigate a problem of relevance to children. The protocol should provide sufficient information to
p.000029: justify clearly why children should be included as participants.
p.000029: b) Children should participate in research only where such research poses acceptable risks of harm. That is,
p.000029: research involving minors should be approved only if:
p.000029: i. The research, including observational research, is not contrary to the best interest of the minor;
p.000029: ii. The research, including observational research, places the minor at no more than minimal risk of harm (i.e. the
p.000029: ‘everyday risks standard’ which means the risk of harm is commensurate with daily life in a stable society
...
p.000029:
p.000029:
p.000029: iv. The research, including observational research, involves greater than minimal risk of harm, with no prospect of
p.000029: direct benefit to the minor, but has a high probability of providing significant generalizable knowledge. The degree of
p.000029: risk of harm should be justified by the risk-knowledge ratio.
p.000029: v. Greater than minimal risk of harm should represent no more than a minor increase over minimal risk.
p.000029: vi. Where appropriate, the minor will assent to participation.
p.000029: c) Research involving children must be reviewed appropriately. The National Health Act distinguishes research with
p.000029: children as ‘therapeutic’ and ‘non-therapeutic’ research. The intention is to place special emphasis on
p.000029: deliberation by the REC about the degree of risk of harm posed by a proposal and the likelihood of benefit to the
p.000029: child- participant. This distinction is of little practical import since most research involves a mix of ‘therapeutic’
p.000029: and ‘non-therapeutic’ interventions or components and reviewers usually assess the proposal as a whole.
p.000029: d) The degree of risk of harm should be evaluated against the likelihood of benefit to the child-participant as
p.000029: outlined in b) above. Furthermore, registered RECs that have been granted permission in writing to exercise the
p.000029: Minister’s delegated power to approve research with children that includes non-therapeutic components must
p.000029: ensure that their deliberations on these components are properly minuted and recorded as required by the
p.000029: Regulations. RECs that review research with child participants must include members with appropriate paediatric
p.000029: research experience.
p.000029: e) Children should participate in research only where the proper written permissions have been obtained. The
p.000029: general principle is that minors cannot agree to research participation without assistance of a parent or
p.000029: guardian (exceptions to the general principle are discussed in 3.2.2.4). This principle holds notwithstanding the
p.000029: exceptions created in the Children’s Act 38 of 2005 for consent to medical treatment and surgical operations (s 129);
p.000029: consent to HIV-testing (s 130); and the exception for female minors created in the Choice on Termination of
p.000029: Pregnancy Act 92 of 1996 (s 5(2)). Consequently, in principle, the consent process for a minor’s participation in
p.000029: research requires
p.000029: • Permission in writing from parents or legal guardian for the minor to be approached and invited to
p.000029: participate (in accordance with s 10 of the Children’s Act 38 of 2005);
p.000029: • Assent from the minor in writing (i.e. agreement to participate) if he or she chooses to participate.
p.000029: Note that an unmarried minor mother may not agree to the participation of her child in research without assistance. Her
p.000029: guardian (usually her parent) is also the guardian of her child while she is a minor and must consent to the child’s
p.000029: participation. In other words, pregnancy and childbirth do not change the legal status of the minor mother. When the
p.000029: mother reaches the age of majority (18 years), she may consent to her child’s participation in research.
p.000029: f) Children should participate in research that takes cognisance of their privacy interests. Although children are
p.000029: legally dependent, they have significant privacy interests. Their
p.000029:
p.000029: Ethics in Health Research 2nd edition
p.000031: 31
p.000031:
p.000031: genetic privacy interests, in particular, may be more important than those of adults who manifest a particular genetic
p.000031: condition.
p.000031: g) When parents or a guardian give permission for their minor child to choose whether to participate in research, this
p.000031: permission is given based on a detailed description of all diagnostic and therapeutic interventions that will
p.000031: affect the child in the study. However, this does not mean that parents are entitled to know the outcome of all
p.000031: diagnostic and therapeutic interventions, especially as regards older minors (adolescents). The
p.000031: informed consent documentation must explain whether results of tests will be made known to child-participants
p.000031: and their parents. Whether this happens, depends to an extent on the socio-cultural context and the best
p.000031: interest standard.
p.000031: h) The minor’s interest in confidentiality, i.e. being identified or identifiable without permission of the
p.000031: minor and her parent or guardian must be respected.
p.000031: i) Research involving children must respect their evolving capacity to give consent. Minors who turn 18
p.000031: years old during the course of a study should be approached at the time of their birthday to re-consent. This
p.000031: is because they must now provide independent consent to continue to be a participant. In cases where
p.000031: minors are permitted to decide independently whether to participate, 26 the consent process should address
p.000031: how re-consent will be managed when they change status from minority to majority. Similarly, in the case of
p.000031: large and longitudinal studies, attention must be given to how the change from minority to majority will be managed.
p.000031: Where a study is no longer in active interaction with participants, re-consent procedures may be less important.
p.000031: j) Researchers must familiarise themselves with the legal obligations to report child abuse and neglect.
p.000031: See 3.2.2.5.
p.000031: 3.2.2.2 Parental permission
p.000031: The Children’s Act 38 of 2005 emphasises the right of a child to participate in any matter concerning that child,
p.000031: provided he or she has sufficient maturity to participate appropriately and meaningfully (s 10), notwithstanding
p.000031: legal incapacity. This means that parents or guardians may not decide whether their minor child should
p.000031: participate in research without the minor’s contribution to the decision. The choice of whether to participate is not a
p.000031: legal decision but rather a factual choice. Consequently, the process should be that the parent or guardian is
p.000031: requested to give permission for the minor to be approached to be invited to participate in the study. The factual
p.000031: decision whether to participate is the minor’s and not the parent’s.
p.000031: Parental permission and minor’s decision must be consistent, i.e. if the minor decides not to participate, the parent
p.000031: may not override this decision. If the parent is reluctant for the minor to participate but the minor wants to
p.000031: do so, the matter must be managed carefully to establish what the concerns are and whether they may be
p.000031: resolved. The minor cannot choose to participate if the parent withholds permission for that minor
p.000031: to choose. Researchers are unlikely to be able to intervene where the suspicion is that the parent is
p.000031:
...
p.000031: are often described as ‘orphans and vulnerable children’ or OVC. The absence of a legally appropriate parental
p.000031: substitute poses a problem for researchers because of the lack of clear guidance as to an acceptable substitute in
p.000031: the informed consent process for research participation. (Note that for treatment purposes, substituted
p.000031: consent occurs on the basis of necessity, which is not applicable to the research context.)
p.000031: ii. Justification
p.000031: Important research that seeks to understand and improve psychosocial, economic and educational conditions for
p.000031: orphans and vulnerable children to improve their future well being generally involves no more than minimal risk
p.000031: of harm. Other research including clinical research that may involve a minor increase over minimal risk of harm
p.000031: may also be justified on the basis that it would be unjustifiable to exclude a significant segment of the
p.000031: child population from research on the basis of their legal status. Consequently, it is ethical and reasonable to
p.000031: designate parental substitutes in these circumstances.
p.000031: iii. Pragmatic parental substitutes27
p.000031: In the interest of fostering consistency as well as compliance with the spirit of the legal provisions
p.000031: that protect minors’ interests, especially the Constitution and the Children’s Act, pragmatic guidance is provided
p.000031: here to deal with situations where no biological parent or legal guardian exists. The permissible level of
p.000031: risk is limited (see 3.2.2.1).
p.000031: Note this guidance does not permit expedient substitution e.g. where a parent is temporarily unavailable.
p.000031: This guidance takes its lead from the Constitution, the Children’s Act, the National Health Act, the Criminal Law
p.000031: (Sexual Offences) Amendment Act; the South African Good Clinical Practice Guidelines (2006) available at
p.000031: www.doh.gov.za/docs/factsheets/guidelines/clinical/2006/index.html.
p.000031: The guidance is premised on three conditions, all of which must be satisfied:
p.000031: 1. The risk standards set out in 3.2.2.1 b) must be adhered to; and
p.000031: 2. It is not possible to do the research with adult participants; and
...
p.000031: National Health Act 61 of 2003, which otherwise might prevent important ethical research.
p.000031:
p.000031: Ethics in Health Research 2nd edition
p.000033: 33
p.000033:
p.000033: ii. The parent gives assistance with understanding (so the minor makes an informed choice)
p.000033: iii. If no parent, then guardian: either court-appointed OR as indicated by the parent in a Will (s 27 Children’s Act)
p.000033: iv. If no guardian, then foster parent (per order of Children’s Court) (Note that social workers should
p.000033: request that the authority to give permission should be included expressly in the court order authorising
p.000033: foster care)28
p.000033: v. If no foster parent (per iv. above), then caregiver (s 1 Children’s Act: defined as ‘…any person
p.000033: other than a parent or guardian, who factually cares for a child and includes – a) a foster parent; b) a person who
p.000033: cares for the child with the implied or express consent of a parent or guardian of the child; c) a person who cares for
p.000033: the child whilst the child is in temporary safe care; d) the person at the head of a child and youth care centre where
p.000033: a child has been placed; e) the person at the head of a shelter; f) a child and youth care worker who cares
p.000033: for a child who is without appropriate family care in the community; and g) the child at the head of a child-
p.000033: headed household’)
p.000033: vi. If minor is caregiver in child-headed household and no supervisory adult (s 137 Children’s Act), then
p.000033: trusted adult nominated by minor, including but not limited to social worker, community worker or teacher.
p.000033: 3.2.2.4 Minors’ independent consent
p.000033: In particular circumstances, e.g. for reasons of sensitivity, like discussion about sexual activities,
p.000033: substance abuse etc., it may be desirable and ethically justifiable for minors (especially older minors i.e.
p.000033: 16 years and older) to choose independently i.e. without parental assistance, whether to participate in research.
p.000033: Generally, only minimal risk research is suitable for independent consent by minors. Reasons
p.000033: supporting the desirability of independent consent may include recruiting sufficient numbers of minors
p.000033: who otherwise would be unwilling to participate if they must tell their parents about the nature of the
p.000033: research in order to obtain parental permission.
p.000033: An ethical justification for independent consent by minors may be made in the following manner:
p.000033: • By prior engagement with participating community role players, the PI can request (and justify explicitly)
...
p.000033: independent choice by their minor children, then the REC may grant a waiver of the requirement of written
p.000033: parental permission and must document the process carefully.
p.000033:
p.000033:
p.000033: 28Note a caregiver, a foster parent and a schoolteacher or principal are not guardians.
p.000033:
p.000033: 34 Ethics in Health Research 2nd edition
p.000033:
p.000033:
p.000033: 3.2.2.5 Mandatory reporting obligations
p.000033: There is no general obligation to report either the commission of or the intention to commit a crime. However, if a
p.000033: researcher has information indicating that direct harm to another person may occur as a result of the intention to
p.000033: commit harm (e.g. a participant says ‘I’m going to kill her…’), then there may be an obligation, especially when the
p.000033: third person is known to the researcher. For specifically designated persons, there are statutory reporting
p.000033: obligations. (See Appendix 3 for SOP Template.)
p.000033: i. Reporting obligations for abuse and neglect
p.000033: The Children’s Act requires anyone who reasonably believes a child to be suffering physical abuse causing injury,
p.000033: deliberate neglect and sexual abuse to report this to a child protection agency, the provincial social development
p.000033: department, or to a police official.
p.000033: ii. Reporting obligations for under-age sexual activity
p.000033: The age at which minors can lawfully consent to sexual activity is 16 years, in terms of the Criminal Law (Sexual
p.000033: Offences and Related Matters) Amendment Act 32 of 2007 (Sexual Offences Act). Anyone with knowledge of a
p.000033: sexual offence against a minor is required to report this to a police official. In effect, any adult or person >16
p.000033: years who engages in sexual activity with a minor < 16 years commits a crime and may be prosecuted. The Act
p.000033: describes a broad range of sexual offences, including rape, sexual assault, sexual grooming, sexual
p.000033: exploitation, and use of children in pornography including photographs. This means that the range of activities
p.000033: that may constitute a sexual offence is extensive.
p.000033: The Sexual Offences Act differentiates between adolescents (12 - < 16 years) and older minors (16 and 17
...
p.000033: iii. Sexual and reproductive health research with minors
p.000033: Research with minors that focuses on their sexuality and reproductive health is likely to encounter instances of
p.000033: abuse and underage sexual activity. The dilemma for
p.000033:
p.000033:
p.000033: 29The Teddy Bear Clinic for Abused Children v Minister of Justice and Constitutional Development (CCT 12/13) [2013]
p.000033: ZACC 35; 2014 (2) SA 168 (CC); see also J v NDPP [2014] ZACC 13.
p.000033: 30See Draft Criminal Law (Sexual Offences & related matters) Amendment Act Amendment Bill [B-2014].
p.000033:
p.000033: Ethics in Health Research 2nd edition
p.000035: 35
p.000035:
p.000035: researchers is whether to ignore the strict letter of the law or to report as indicated in terms of the Sexual Offences
p.000035: Act and the Children’s Act. The matter is not simple.
p.000035: The clash of interests is obvious, e.g. using the law to protect the minor from abuse may have the unintended
p.000035: consequence of increased harm (physical and social) for that child. Further, thoughtless reporting may
p.000035: violate privacy and confidentiality interests of the minor e.g. in terms of the Choice on Termination of Pregnancy
p.000035: Act, the Children’s Act and the Child Justice Act. Whether a researcher, who has but a research interest
p.000035: in the life of the child, but no further right of access or duty of intervention ought to take on
p.000035: the responsibility of a social worker is unclear. Consequently, researchers should think very
p.000035: carefully about the anticipated consequences of reporting in light of the legal context. The proposal submitted
p.000035: for ethics review should explain fully the approach to be adopted, and justify how reporting obligations
p.000035: will be managed, so that the REC can deliberate effectively. The consent documents should clearly inform the
p.000035: minor (and proxy consent providers where necessary) about when reporting obligations arise and how they
p.000035: will be addressed, so that an informed choice can be made about whether to participate. Appropriate
p.000035: engagement with role-players such as child rights and child care organizations may assist researchers to make
p.000035: appropriate and meaningful referrals.
p.000035: 3.2.3 Women
p.000035:
p.000035: Exclusion of women as research participants has led to a lack of data needed to promote women’s health. Any proposed
p.000035: exclusion of women participants must be justifiable in light of research priorities as well as the specific research
p.000035: question under consideration. For example, women are appropriately excluded from prostate cancer research
p.000035: because the relevant population is male. In particular, systematic class exclusion must be guarded against to avoid
p.000035: unfair participant selection.
p.000035: Additional health concerns arise during pregnancy, including the need to avoid unnecessary risk to the fetus.
p.000035: Consequently, researchers and RECs should exercise extra caution when women participants are or may become
p.000035: pregnant. Exclusion of women from research may be justifiable
p.000035: a) to protect the health of the fetus; and
p.000035: b) if exclusion is scientifically supportable.
...
p.000035: Usually, research involving pregnant women should be undertaken when
p.000035: • the purpose of the proposed research is to meet the health needs of the mother of the particular fetus;
p.000035: • appropriate studies on animals and non-pregnant individuals have been completed;31
p.000035: • the risk of harm to the fetus is minimal; and
p.000035:
p.000035: 31 Clinical trials involving pregnant women or nursing mothers should ideally involve products where the toxicology in
p.000035: adults is established and is acceptable. In the case of pregnant women, the potential risks associated with using a
p.000035: substance whose short term and long-term effects on a fetus and developing infant are unknown, should be outweighed by
p.000035: the benefits. An example of a positive risk-benefit ratio would be the use of anti-retrovirals in mother to child HIV
p.000035: transmission studies. For nursing mothers, the amount of drug passing into breast milk should be established and the
p.000035: potential impact on a breast-fed infant anticipated, and the mother so advised.
p.000035:
p.000035: 36 Ethics in Health Research 2nd edition
p.000035:
p.000035:
p.000035: • in all cases, inclusion poses the least risk of harm possible for achieving the objectives of the research.
p.000035: 3.2.4 Adults with factual incapacity to provide informed consent
p.000035:
p.000035: Adults who are factually incapable of giving informed consent should participate in research only where their
p.000035: participation is indispensable to the research; i.e. the research cannot deliver the desired outcomes if
p.000035: capable adult participants were to be used instead. Further, the research should investigate a problem of
p.000035: relevance to incapacitated adults. Where research can be undertaken with capable adults but nevertheless proposes
p.000035: also to include incapacitated adults, strong justification for their inclusion must be provided.
...
p.000037: incapacitated adult. The degree of risk must be justified by the potential benefit; or
p.000037: iv. The research, including observational research, involves greater than minimal risk, with no prospect
p.000037: of direct benefit to the incapacitated adult, but has a high probability of providing generalizable knowledge; i.e.
p.000037: the risk should be justified by the risk- knowledge ratio;
p.000037: v. Greater than minimal risk must represent no more than a minor increase over minimal risk;
p.000037: vi. The legally appropriate person (treatment proxies as stipulated in NHA s 7 or s 27(1)(a) of the
p.000037: Mental Health Care Act 17 of 2002) gives permission for the person to participate; and
p.000037: vii. Where appropriate, the person will assent to participation. Note that the incapacitated person’s refusal or
p.000037: resistance to participate, as indicated by words or behaviour, takes precedence over permission by a proxy.
p.000037: The National Health Act specifies the sequence of legally appropriate treatment proxies as spouse or partner; parent;
p.000037: grandparent; adult child; brother or sister. The Mental Health Care Act provides, in no particular sequence, that
p.000037: legally appropriate proxies are spouse; next of kin; partner; associate (defined as ‘a person with a
p.000037: substantial or material interest in the well-being of a mental health care user or a person who is in substantial
p.000037: contact with the user’); and parent or guardian.
p.000037: 3.2.5 Persons in dependent relationships
p.000037:
p.000037: This class of persons includes persons in junior or subordinate positions in hierarchically structured
p.000037: groups and may include relationships between older persons and their care-givers; persons with chronic conditions
p.000037: or disabilities and their care-givers; persons with life- threatening illnesses; patients and health care
p.000037: professionals; wards of state and guardians; students and teachers (including university teachers); employees and
p.000037: employers, including farm workers, members of the uniformed services and hospital staff and their
p.000037: respective employers.
p.000037: Particular attention should be given to ensuring that participants are adequately informed and can choose
p.000037: voluntarily whether to participate in research.
p.000037: 3.2.6 Patients highly dependent on medical care
p.000037:
p.000037: Patients who are highly dependent on medical care deserve special attention when considering research
...
p.000041: may be permissible (see 3.2.4.3 above). Where materials or data from a deceased person are sought, permission from an
p.000041: authorised person is required (see 3.3.6).
p.000041: 3.3.5 Restrictions on collection of biological materials
p.000041: Certain persons are specially protected: without Ministerial permission, biological materials may not be
p.000041: taken from mentally ill persons; biological materials that are not naturally replaceable may not be taken
p.000041: from a minor; no gametes may be taken from a minor; and no fetal biological material except for umbilical cord
p.000041: progenitor cells may be collected from anyone. These restrictions are absolute which means that research
p.000041: with the categories of person mentioned requires special permission. RECs must satisfy themselves that the
p.000041: necessary special permission has been obtained, where appropriate.
p.000041: 3.3.6 Informed consent
p.000041: Written informed consent is required prior to removal of biological material from a living donor (NHA ss
p.000041: 56 and 62).
p.000041: In the case of a deceased person, consent to removal and use of biological materials may be found in the Will of the
p.000041: person, in a written statement or in a witnessed oral statement (NHA s 62(1)(a)) or may be provided by ‘the spouse,
p.000041: partner, major child, parent, guardian, major brother or major sister of that person in the specific order mentioned’
p.000041: (NHA s 62(2))
p.000041: Because biological specimens may be collected for diagnostic, therapeutic or health research purposes, RECs should
p.000041: assess whether the nature of the planned usage is explained adequately so that the purpose for which consent
p.000041: is being requested is completely clear.
p.000041: RECs must also consider the circumstances under which re-consent from donors would be sought, bearing in mind specific
p.000041: local or national needs.
p.000041: Different forms of consent are implicated:
p.000041:
p.000041: Ethics in Health Research 2nd edition
p.000043: 43
p.000043:
p.000043: i. Narrow (restrictive) consent: the donor permits use of the biological specimen for single use only; no
p.000043: storage of leftover specimen; and no sharing of data or specimen. This form necessitates new consent if further use is
p.000043: desirable.
p.000043: ii. Tiered consent: the donor provides consent for the primary study and chooses whether to permit
p.000043: storage for future use, sample and data sharing.
...
p.000045: Informed consent usually has to be obtained rapidly and at a time when vulnerability of patients and
p.000045: families is likely to be extreme. Patients may be incapacitated (i.e. unconscious or on a ventilator), which points to
p.000045: the likelihood of difficulties with the usual approach to informed consent. Consequently, RECs may consider
p.000045: alternative approaches such as proxy consent or delaying consent in particular circumstances. (See 3.2.4.3, 3.2.4.4 &
p.000045: 3.2.6.)
p.000045: 3.4.2 Intensive care research
p.000045:
p.000045: Characteristic features of intensive care research include difficulties in communicating with patients receiving
p.000045: ventilation assistance and impairment of cognition in heavily sedated individuals.
p.000045: Whenever possible, informed consent for planned intensive care research should be obtained from potential participants
p.000045: before admission to that care. See 3.2.4.3, 3.2.4.4 & 3.2.6.
p.000045: Research involving infants receiving neonatal intensive care should be conducted in strict accordance with
p.000045: the principles set out for minors (see 3.2.1 above). These principles do not permit research that is contrary to
p.000045: the child’s best interest. The small size and extreme vulnerability of some infants are unique features of this
p.000045: class of participants. This means that all but minimally intrusive interventions are likely to be contrary to the
p.000045: child’s best interest. Collection of even small blood samples for research in addition to those required
p.000045: for diagnostic purposes, or additional handling of a low birth-weight infant to make research- related observations,
p.000045: requires very careful justification and skill, especially in assessing the risk-benefit ratio. Input from neonatal
p.000045: intensive care experts should be sought.
p.000045:
p.000045: Ethics in Health Research 2nd edition
p.000047: 47
p.000047:
p.000047: 3.4.3 Terminal care research
p.000047:
p.000047: Terminal care research is distinguished by the short remaining life expectancy of participants and their potential
p.000047: vulnerability to unrealistic expectations of benefits from participation in research. In principle, because of their
p.000047: extreme vulnerability, terminally ill patients should not participate in research that is more than minimally invasive
p.000047: without adequate justification.
p.000047: The prospect of any direct benefit from research participation must not be overstated or used to justify a risk of harm
p.000047: higher than that involved in current treatment. Research participation must not be used to prevent or devalue the needs
...
p.000075: relationships between researchers and participants when assessing the design, review, conduct and reporting of the
p.000075: research. Some may be evident in the design phase, while others will only arise during the research, in which case the
p.000075: researcher must exercise discretion, sound judgement, consultation and flexibility in accordance with the level of risk
p.000075: of harm and possible benefits of the research. The basis for the exercise of discretion and the degree of
p.000075: flexibility should be considered at the design phase. The REC Chairperson should be consulted when doubt arises.
p.000075:
p.000075: 76 Ethics in Health Research 2nd edition
p.000075:
p.000075:
p.000075:
p.000075: APPENDIX 1
p.000075:
p.000075: Glossary
p.000075:
p.000075: Academic freedom – the collective freedom of researchers, including students, to conduct research and to disseminate
p.000075: ideas or findings without religious, political or institutional restrictions; it includes freedom of inquiry
p.000075: and freedom to challenge conventional thought. Academic freedom does not mean freedom to ignore ethical issues
p.000075: Accountability – the measure by which it can be demonstrated that responsibilities have been or are being fulfilled;
p.000075: it may involve reporting upwards in a hierarchical structure
p.000075: Adolescent – a child between 12 and 17 years of age
p.000075: Anonymous data or specimen–data or biological materials without any overt identifying information or link to a
p.000075: specific donor
p.000075: Audit– subset of research; not clinical practice but a review of clinical practice
p.000075: Autonomy – the capacity to understand information; to act on it voluntarily; to use own judgement to make decisions
p.000075: about own actions, including whether to participate in research
p.000075: Biobank – see Repository
p.000075: Human biological materials– materials including blood and blood products, DNA, RNA, blastomeres, polar bodies,
p.000075: cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors
p.000075: Broad consent– donor permits use of biological materials for future studies, subject only to further prior ethics
p.000075: review and approval
p.000075: Capacity – the ability to understand relevant information; to appreciate the consequences of decisions based on the
p.000075: information
p.000075: Caregiver– a person who in fact cares for a child (s 1 Children’s Act, 38 of 2005); a caregiver must
p.000075: safeguard the child’s health, well-being and development; and protect the child from abuse and other
p.000075: harms; a caregiver exercises the parental right to consent to medical examination or treatment of the child
p.000075: Child – a person under 18 years (s 28 Constitution; s 1 Children’s Act)
p.000075: Child-headed household– a household per s 137 Children’s Act
p.000075: Clinical equipoise – literally means a state of balance or equilibrium; in the research context it means
p.000075: that, amongst health care experts, uncertainty prevails about whether a particular treatment or intervention
p.000075: is better than another. This principle forms the basis for conducting clinical research
p.000075: Clinical research –research intended to test safety (not harmful or dangerous to human health), quality (ingredients
p.000075: are of good quality), effectiveness (working to diagnose, treat, prevent or cure a disease condition) and efficacy
p.000075: (better/ best when compared with other treatment or medicine for a similar condition) of new and/or existing
p.000075: or old medicines, medical devices and/or treatment options, using human participants. (South African Clinical Trials
p.000075: Registration http://www.sanctr.gov.za/Resources/Whatisaclinicaltrial/tabid/175/Default.aspx);
p.000075:
p.000075: Ethics in Health Research 2nd edition
p.000077: 77
p.000077:
p.000077: the Ottawa Statement defines ‘trial’ as a prospective controlled or uncontrolled research study evaluating
p.000077: the effects of one or more health-related interventions related to prevention, health promotion,
p.000077: screening, diagnosis, treatment, rehabilitation, or organization and financing of care.
p.000077: ‘Intervention’ refers to a deliberate act applied to an individual or group of individuals. Health-related
p.000077: interventions include but are not limited to the use of pharmaceuticals, biological products, surgery,
...
p.000077: Incentive – anything offered to encourage participation in research
p.000077: Incidental findings – unanticipated discoveries made in the course of research that are outside the scope of the
p.000077: research
p.000077: Inconvenience – a minor negative effect experienced in research less serious than discomfort
p.000077: Low risk research – where the only foreseeable risk is one of discomfort
p.000077: Minimal risk research – where probability and magnitude of possible harms implied by participation are no
p.000077: greater than those posed by daily life in a stable society or routine medical, dental, educational or
p.000077: psychological tests or examinations
p.000077: Minor– a person under 18 years (s 17 Children’s Act)
p.000077: Narrow consent – donor permits single use only of biological materials; no storage; no sharing of data or
p.000077: specimen; new consent if further use wanted.
p.000077: Negligible risk research – where the only foreseeable risk is one of inconvenience
p.000077: Neonate – a newborn child
p.000077: Non-therapeutic interventions–interventions not directed towards health-related benefit for a participant but towards
p.000077: improving generalisable knowledge (NHA Reg 135)
p.000077: Observational research – study of behaviour in a natural environment where people involved in their usual
p.000077: activities are observed with or without their knowledge; observational research also occurs in clinical research
p.000077: e.g. when a researcher observes individuals or measures particular outcomes, without intervention e.g.
p.000077: no treatment is given);an observational study describes a wide range of study designs including
p.000077: prospective and retrospective cohort studies, case-control studies, and cross-sectional studies, a defining
p.000077: feature of which is that any intervention studied is determined by clinical practice and not the protocol.
p.000077: Orphan– a child without a surviving parent to care for him (s 1 Children’s Act)
p.000077:
p.000077: Ethics in Health Research 2nd edition
p.000079: 79
p.000079:
p.000079: Privacy risks – potential harms to participants from collection, use and disclosure of personal information
p.000079: for research purposes
p.000079: Protocol – document that provides background, rationale and objectives of research; describes its design,
p.000079: methodology, organization and conditions under which it is to be conducted and managed
p.000079: Qualitative research – involves studied use of empirical materials such as case studies, personal experience, life
p.000079: stories, interviews, observations, and cultural texts
p.000079: Registry– a collection of information (data) from multiple sources, maintained over time with controlled
p.000079: access through a gatekeeper organizer
p.000079: Reimbursement – payment to participants to ensure they are not disadvantaged financially directly or indirectly by
p.000079: participation in research; directly means actual costs incurred and indirectly means losses that arise because
p.000079: of participation
p.000079: Repository– a collection, storage and distribution system for human biological materials for research purposes
p.000079: including blood, urine, faeces, bone marrow, cell aspirates, diagnostic specimens, pathology specimens and
p.000079: so on. Usually demographic and medical information about the donors is included in the repository as are
...
p.000081: Subjects 1964, most recently amended in 2013
p.000081: World Medical Association: Declaration of Helsinki (2013)
p.000081:
p.000081: Ethics in Health Research 2nd edition
p.000083: 83
p.000083:
p.000083:
p.000083: APPENDIX 3
p.000083:
p.000083: Templates
p.000083:
p.000083: 1. Mandatory reporting of abuse
p.000083:
p.000083: How to respond adequately to the reporting requirement within a research context:
p.000083: Note that arrangements and negotiations e.g. with Childline South Africa or other agencies, should be made in advance
p.000083: of the application for ethics review. The applicant should be able to assure the REC about the referral arrangements.
p.000083: 1. Disclosure by any adolescent under 16 years of sexual or other abuse, or on whose behalf abuse is reported by a
p.000083: peer, caregiver, guardian or family member or other relevant person, should trigger an immediate
p.000083: termination of further interviews with the respondent and members of the household.
p.000083: 2. If there is a clear statement that the parties involved in the abuse include an adult (anyone 18
p.000083: years or older) or anyone who is more than two years older than the adolescent (s 56(2)(b)), the
p.000083: interviewer should report the matter to Childline South Africa at toll free: 0800 055 555 [or another child protection
p.000083: agency]. Childline should contact a registered social worker in the area who should investigate and inform the South
p.000083: African Police Service (SAPS) accordingly. The interviewer should record details of the child’s name,
p.000083: physical address and the name of the school the child attends. As proof of complying with the
p.000083: statutory reporting obligation, the interviewer should insist on a Childline reference number.
p.000083: 3. Any secondary reporting of abuse, e.g. where a child indicates that she has reported the abuse to a teacher or
p.000083: another adult but that no action has been taken, the matter should be brought to the attention of Childline, who should
p.000083: deal with the matter. Again, the interviewer should insist on a Childline reference number, as proof of reporting.
p.000083: If there is uncertainty about whether to report, the interviewer should consult with the Principal
p.000083: Investigator. [Insert conditions appropriate to the circumstances]
p.000083: Examples in practice Action by researcher
p.000083:
p.000083: A 14 year old tells of having sex with her 17 year old boyfriend
p.000083: A 12 year old reports ‘having sex’ with 19 year old neighbour
p.000083: An 11 year old tells of a previously reported incident of ‘bad touching’ by adult aunt that went to court
p.000083: Childline ◇ Police Childline ◇ Police
p.000083: No action; ask whether the child wants to talk to someone
p.000083: A 15 year old relates rape by father Childline ◇ Police
p.000083:
p.000083: A 13 year old boy relates anecdote of sex with 15 year old girlfriend
p.000083: Not over two years, so no action
p.000083:
p.000083: 84 Ethics in Health Research 2nd edition
p.000083:
p.000083:
p.000083:
p.000083: A 13 year old says she is ‘having sex’ but does not disclose who the partner is
p.000083: A 17 year old brags that he has ‘forced’ many girls into having sex with him
p.000083: A 17 year old learner speaks of having become pregnant by a school teacher who she does not identify
p.000083: A 18 year old learner points out a female school teacher with whom he says he is ‘sleeping’
p.000083:
p.000083: No action No action
p.000083: Ask whether she wants to speak to someone
p.000083: Ask whether he wants to speak to someone
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: 2. Insurance information for consent documentation
p.000083:
p.000083: This template is based on DoH 2006, MCC Clinical Trials Compensation Guidelines and Venter v Roche Products (Pty)
p.000083: Ltd et al (12285/08) [2013] WCHC 7 May 2013 and on appeal (A11/2014) 22 October 2014.
p.000083:
p.000083: Notes for researchers:
p.000083: i. Research study insurance does not substitute malpractice insurance
p.000083: ii. ABPI guidelines on compensation apply only to unlicensed substances used in Phase II and III clinical
...
p.000085: other losses based on negligence, in a South African court.
p.000085: It is important to follow the study doctor’s instructions and to report straight away if you have a side effect
p.000085: from the study medicine.
p.000085:
p.000085: See also Medicines Control Council Clinical Trial Compensation Guidelines available at
p.000085: http://www.sahealthinfo.org.ethics/book1.htm
p.000085:
p.000085: 86 Ethics in Health Research 2nd edition
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: 3. Novel, Innovative or Unproven Treatment
p.000085:
p.000085: < Insert hospital name >
p.000085:
p.000085: NOVEL, INNOVATIVE OR UNPROVEN TREATMENT CONSENT FORM
p.000085:
p.000085: How to use this Consent Form
p.000085: Read carefully through the whole document
p.000085: Fill in the RED areas ELECTRONICALLY (for future data collection) Make sure that all the necessary information is
p.000085: included
p.000085: The information written in BLUE is for guidance and should be removed before finalizing the document
p.000085: Print three (3) copies: one for patient’s folder, one for PTC, and one for the patient or her family
p.000085: This document is for a single patient use and a single treatment course only.
p.000085:
p.000085: This document tells you about a treatment for your (your child’s) condition that is still experimental but which your
p.000085: doctors would like to try. You are not being asked to join a research project. Important differences
p.000085: exist between experimental treatment and a research project.
p.000085: This treatment is experimental because
p.000085: < delete options that do not apply >
p.000085: It has been tested for conditions other than yours (your child’s).
p.000085: It has been tested for use with adults but not for use with children (< 18 years; < 12 years) It has not been registered
p.000085: in South Africa for use for your condition.
p.000085:
p.000085:
p.000085:
p.000085: Name of Drug Or Intervention
p.000085: Single Patient Use of < Insert Investigational Drug or Intervention Name >
p.000085:
p.000085:
p.000085: Treating Health care worker(s):
p.000085: < Insert Name >
p.000085: < Insert Address/Medical ward details >
p.000085: < Insert Phone Numbers/ Medical ward extension >
p.000085:
p.000085:
p.000085: Emergency Contact < Insert Emergency Contact Information >
p.000085: < Insert Phone Number/Pager, etc >
p.000085:
p.000085:
p.000085: < Insert name of investigational drug or other intervention > is a treatment that < insert either current approval status
p.000085: by the Medicines Control Council for another condition or provide a patient appropriate explanation of what
p.000085: the investigational drug or intervention is intended to do >.
p.000085:
p.000085: This treatment is not approved for < indicate what condition the patient has >, which means its use is experimental. We
p.000085: are not sure that this experimental treatment will cure or improve your condition. But in your circumstances, we offer
p.000085: you the opportunity to try it.
p.000085:
...
Searching for indicator children:
(return to top)
p.000009: interests of animals used in research; and to protect safety and other interests of researchers.
p.000009:
p.000009: 3 Available at http://www.health-e.org.za/wp-content/uploads/2014/08/SA-DoH-Strategic-Plan-2014-to-2019.pdf
p.000009:
p.000009: 10 Ethics in Health Research 2nd edition
p.000009:
p.000009:
p.000009: 1.3.4 The guidelines draw on prevailing international, foreign and national codes of conduct,
p.000009: declarations, and other documents relevant to research with humans, to strengthen processes of translational
p.000009: research collaboration, while taking into account the socioeconomic, ethnic and cultural diversity in South Africa. The
p.000009: guidelines also draw on and refer to international and national standards and guidelines for research using animals.
p.000009: 1.3.5 Researchers should be familiar with legislation and other binding instruments relevant to research including4
p.000009: • Animal Diseases Act 35 of 1984
p.000009: • Animal Health Act 7 of 2002
p.000009: • Animals Protection Act 71 of 1962
p.000009: • Basic Conditions of Employment Act 75 of 1997
p.000009: • Cartagena Protocol on Biosafety May 2000
p.000009: • Child Justice Act 75 of 2008
p.000009: • Children’s Act 38 of 2005
p.000009: • Choice on Termination of Pregnancy Act 92 of 1996
p.000009: • Constitution of the Republic of South Africa, 1996
p.000009: • Convention on Biological Diversity
p.000009: • Criminal Law (Sexual Offences and Related Matters) Amendment Act 32 of 2007
p.000009: • Domestic Violence Act 116 of 1998
p.000009: • Employment Equity Act 55 of 1998
p.000009: • Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act 36 of 1947
p.000009: • Genetically Modified Organisms Act, Act No 15 of 1997
p.000009: • Hazardous Substances Act 15 of 1973
p.000009: • Health Professions Act 56 of 1974
p.000009: • Labour Relations Act 66 of 1995
p.000009: • Medical Schemes Act 131 of 1998
p.000009: • Medicines and Related Substances Control Act 101 of 1965
p.000009: • Mental Health Care Act 17 of 2002
p.000009: • Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits,5
p.000009: • National Environmental Management: Biodiversity Act, Act 10 of 2004
p.000009: • National Health Act, Act No 61 of 2003
p.000009: • National Health Laboratory Service Act 37 of 2000
p.000009: • Patents Act 57 of 1978
p.000009: • Performing Animals Protection Act 24 of 1935
p.000009: • Promotion of Access to Information Act 2 of 2000
p.000009: • Promotion of Equality and Prevention of Unfair Discrimination Act 4 of 2000
p.000009: • Protected Disclosures Act 26 of 2000
p.000009: • Protection of Personal Information Act 4 of 2013
...
p.000017:
p.000017: 18 Ethics in Health Research 2nd edition
p.000017:
p.000017:
p.000017:
p.000017: Chapter 3
p.000017:
p.000017: SUBSTANTIVE NORMS AND OPERATIONAL PROCESSES FOR ETHICS REVIEW
p.000017:
p.000017: Contents
p.000017:
p.000017:
p.000017: 3.1 Ethical basis for decision making in the review process p 19
p.000017: 3.1.1 Scientific design, aims & objectives 19
p.000017: 3.1.2 Inclusion & exclusion criteria
p.000020: 20
p.000020: 3.1.3 Selection of study population & sampling 20
p.000020: 3.1.4 Recruitment & enrolment
p.000020: 20
p.000020: 3.1.5 Research procedures
p.000021: 21
p.000021: 3.1.6 Risks of harm & likelihood of benefit 21
p.000021: 3.1.7 Reimbursements, inducements & costs for participants 22
p.000021: 3.1.8 Participants’ privacy & confidentiality interests 22
p.000021: 3.1.9 Obtaining informed consent 24
p.000021: 3.2 Vulnerability & incapacity
p.000026: 26
p.000026: 3.2.1 Contextual circumstances
p.000026: 26
p.000026: 3.2.2 Minors (children & adolescents) 27
p.000026: 3.2.3 Women
p.000035: 35
p.000035: 3.2.4 Adults with factual incapacity
p.000036: 36
p.000036: 3.2.5 Persons in dependent relationships 38
p.000036: 3.2.6 Patients highly dependent on medical care 38
p.000036: 3.2.7 Persons with physical disabilities
p.000038: 38
p.000038: 3.2.8 Prisoners
p.000039: 39
p.000039: 3.2.9 Collectivities
p.000040: 40
p.000040: 3.3 Data & biological material for research purposes 40
p.000040: 3.3.1 Introduction
p.000040: 40
p.000040: 3.3.2 Permitted usage of biological material 41
p.000040: 3.3.3 Identifiability of biological materials and data 41
p.000040: 3.3.4 Collection of biological materials and data 42
p.000040: 3.3.5 Restrictions on collection of biological material 42
p.000040: 3.3.6 Informed consent
p.000042: 42
p.000042: 3.3.7 Secondary use of material or data 43
p.000042: 3.3.8 Genetic research
p.000044: 44
...
p.000027: choose whether to participate in research.
p.000027: In order to ensure optimal protection of vulnerable participants, the REC may impose additional protective
p.000027: measures for the informed consent process; or require increased monitoring and interim reporting on
p.000027: participants’ welfare; or require post-recruitment reviews of the effectiveness of the protective measures
p.000027: imposed. Other measures may also be appropriate.
p.000027: Note that the decision to impose additional measures should flow from an assessment of the nature of the research and
p.000027: the circumstances of the potential participants. In other words, additional protective measures should not be automatic
p.000027: just because a vulnerable group will be recruited; rather, the decision should be based on the particular
p.000027: circumstances of the proposal before the REC. For example, an automatic assumption that impoverished people cannot
p.000027: choose responsibly whether to participate in research is disrespectful because it denies their autonomy.
p.000027: If compliance with the additional measures is poor and participants’ welfare is negatively affected,
p.000027: approval for the study may be withdrawn, temporarily or permanently, as the case may be.
p.000027: Groups of participants discussed here include
p.000027: • minors (children and adolescents)
p.000027: • women
p.000027: • adults with incapacity to provide informed consent
p.000027: • persons in dependent relationships
p.000027: • persons highly dependent on medical care
p.000027: • persons with physical disabilities
p.000027: • prisoners
p.000027: • collectivities
p.000027:
p.000027: Note this list is not exhaustive but provides an indication of the types of consideration to be applied
p.000027: 3.2.2 Minors (children and adolescents)
p.000027:
p.000027: Below the age of majority, the law protects young people from their own emotional, cognitive and physical immaturity
p.000027: and limited life experience through the legal status of minority. In other words, minors, i.e. persons under 18 years
p.000027: of age,22 are legally incapable of performing legal transactions without assistance from a parent or guardian. In the
p.000027: research context, this means that, in principle, anyone under the age of 18 years may not choose independently whether
p.000027: to participate in research; a parent or guardian must give permission for the minor
p.000027:
p.000027: 21 Note that this requirement does not mean that a REC may not approve a waiver of personal informed consent for types
p.000027: of research into e.g. record reviews or such like.
p.000027: 22 Section 28 of the Constitution; and s 17 of the Children’s Act 38 of 2005.
p.000027:
p.000027: 28 Ethics in Health Research 2nd edition
p.000027:
p.000027:
p.000027: to choose. This is because young persons’ understanding of key aspects of the research initiative may be
p.000027: compromised and, consequently, they may be exposed to increased risk of harm from particular research procedures.
p.000027: Exceptions to the requirement for parental permission are discussed at 3.2.2.4.
p.000027: Tension exists between the views that, in general, children and adolescents should not bear the burden of research
p.000027: unnecessarily, on the one hand, and that children and adolescents are entitled to improved health care based on
p.000027: findings drawn from rigorous research conducted in the child population of South Africa, on the other.
p.000027: The solution lies in the approach that minors should participate in research only where their
p.000027: participation is indispensable to the research; i.e. the research cannot deliver the desired outcomes if adult
p.000027: participants were to be used instead.
p.000027: Because of their status of legal incapacity, in principle, minors may not choose independently whether to participate
p.000027: in research. A parent or guardian must give permission for the minor to choose. It should be noted that the parent or
p.000027: guardian does not choose for the minor who is capable of choosing;23 rather, the parent or guardian gives
p.000027: permission for the minor to choose. Where a minor is very young or is factually incapable of exercising a choice,
p.000027: then the parent or guardian chooses whether the minor should participate.
...
p.000027: minor. Good research design does not accommodate a best interest analysis easily. Rather, the design draws on
p.000027: aggregates of information. This means that, in the research context, the best interest principle should be understood
p.000027: to mean that participation in the research should not be contrary to the individual minor’s best interest. Further, the
p.000027: research should investigate a problem of relevance to minors.
p.000027: Where research can be done with consenting adults but nevertheless proposes also to include minors, the
p.000027: researchers must provide strong justification for the inclusion of minors. The REC should not make assumptions on
p.000027: behalf of the researchers. It should require all relevant information to be provided by the researchers. Note
p.000027: that all types of clinical trial research on minors should be scrutinized carefully in case extra precautions or
p.000027: conditions are necessary.
p.000027: For purposes of these guidelines
p.000027: ‘Adolescent’ means a child between the ages of 12 and 17 years of age (ICH Topic E 11 Clinical Investigation of
p.000027: Medicinal Products in the Paediatric Population. 2000
p.000027: [http://www.emea.eu.int/pdfs/human/ich/271199EN.pdf]
p.000027: ‘Caregiver’ means a person who factually cares for a child (s 1 Children’s Act, 38 of 2005; a caregiver is obliged
p.000027: (in terms of s 32(1)) to safeguard the child’s health, well-being and development; and to protect the child
p.000027: from abuse and other harms. Further a caregiver may exercise the parental right to consent to medical examination or
p.000027: treatment of the child (in terms of s 32(2))
p.000027:
p.000027:
p.000027: 23 Section 10 of the Children’s Act 38 of 2005. Note that a caregiver, a foster parent and a schoolteacher or
p.000027: principal are not guardians. Note that legal incapacity is not the same as factual incapacity. Minority is a legal
p.000027: incapacity status.
p.000027: 24 See also s 9 of the Children’s Act 38 of 2005.
p.000027:
p.000027: Ethics in Health Research 2nd edition
p.000029: 29
p.000029:
p.000029: ‘Child’ means a person under the age of 18 years (s 28 Constitution; s 1 Children’s Act 38 of 2005)
p.000029: ‘Child-headed household’ means a household per s 137 Children’s Act 38 of 2005
p.000029: ‘Guardian’ means a person appointed by a court to look after the financial and welfare interests of a
p.000029: minor, or a person appointed by a parent with sole responsibility for the minor in terms of the parent’s Will
p.000029: ‘Harm’ means physical, emotional, psychological, social or legal harm
p.000029: ‘Minor’ means a person (child) less than 18 years (s 17 Children’s Act 38 of 2005) ‘Neonate’ means a newborn child,
p.000029: including an infant less than a month old
p.000029: ‘Orphan’ means a child who has no surviving parent caring for him or her (s 1 Children’s Act 38 of 2005)
p.000029: ‘Parent’ includes an adoptive parent (s 1 Children’s Act 38 of 2005)
p.000029: ‘Therapeutic research’ means research that includes interventions that may hold out the prospect of direct
p.000029: health-related benefit for the participant (Regulation 135)
p.000029: ‘Non-therapeutic research’ means research that includes interventions that will not hold out the prospect of direct
p.000029: health-related benefit for the participant but may produce results that contribute to generalisable knowledge
p.000029: (Regulation 135)
p.000029: 3.2.2.1 Minimum conditions for research involving minors
p.000029: The following considerations are critical when RECs review proposals to involve child participants:
p.000029: a) Children should participate in research when their participation is scientifically indispensable to the
p.000029: research. In the case of interventional clinical research, equipoise 25 should exist. Research should
p.000029: investigate a problem of relevance to children. The protocol should provide sufficient information to
p.000029: justify clearly why children should be included as participants.
p.000029: b) Children should participate in research only where such research poses acceptable risks of harm. That is,
p.000029: research involving minors should be approved only if:
p.000029: i. The research, including observational research, is not contrary to the best interest of the minor;
p.000029: ii. The research, including observational research, places the minor at no more than minimal risk of harm (i.e. the
p.000029: ‘everyday risks standard’ which means the risk of harm is commensurate with daily life in a stable society
p.000029: or routine medical, dental, educational or psychological tests or examinations – referred to as ‘negligible risk’ in
p.000029: some guidelines); or
p.000029: iii. The research involves greater than minimal risk of harm but provides the prospect of direct benefit
p.000029: for the minor. The degree of risk of harm should be justified by the potential benefit; or
p.000029:
p.000029: 25 ‘Equipoise’ literally means a state of balance or equilibrium; in the research context it means that, amongst
p.000029: health care experts, uncertainty prevails about whether a particular treatment or intervention is better than another.
p.000029: This principle forms the basis for conducting clinical research.
p.000029:
p.000029: 30 Ethics in Health Research 2nd edition
p.000029:
p.000029:
p.000029: iv. The research, including observational research, involves greater than minimal risk of harm, with no prospect of
p.000029: direct benefit to the minor, but has a high probability of providing significant generalizable knowledge. The degree of
p.000029: risk of harm should be justified by the risk-knowledge ratio.
p.000029: v. Greater than minimal risk of harm should represent no more than a minor increase over minimal risk.
p.000029: vi. Where appropriate, the minor will assent to participation.
p.000029: c) Research involving children must be reviewed appropriately. The National Health Act distinguishes research with
p.000029: children as ‘therapeutic’ and ‘non-therapeutic’ research. The intention is to place special emphasis on
p.000029: deliberation by the REC about the degree of risk of harm posed by a proposal and the likelihood of benefit to the
p.000029: child- participant. This distinction is of little practical import since most research involves a mix of ‘therapeutic’
p.000029: and ‘non-therapeutic’ interventions or components and reviewers usually assess the proposal as a whole.
p.000029: d) The degree of risk of harm should be evaluated against the likelihood of benefit to the child-participant as
p.000029: outlined in b) above. Furthermore, registered RECs that have been granted permission in writing to exercise the
p.000029: Minister’s delegated power to approve research with children that includes non-therapeutic components must
p.000029: ensure that their deliberations on these components are properly minuted and recorded as required by the
p.000029: Regulations. RECs that review research with child participants must include members with appropriate paediatric
p.000029: research experience.
p.000029: e) Children should participate in research only where the proper written permissions have been obtained. The
p.000029: general principle is that minors cannot agree to research participation without assistance of a parent or
p.000029: guardian (exceptions to the general principle are discussed in 3.2.2.4). This principle holds notwithstanding the
p.000029: exceptions created in the Children’s Act 38 of 2005 for consent to medical treatment and surgical operations (s 129);
p.000029: consent to HIV-testing (s 130); and the exception for female minors created in the Choice on Termination of
p.000029: Pregnancy Act 92 of 1996 (s 5(2)). Consequently, in principle, the consent process for a minor’s participation in
p.000029: research requires
p.000029: • Permission in writing from parents or legal guardian for the minor to be approached and invited to
p.000029: participate (in accordance with s 10 of the Children’s Act 38 of 2005);
p.000029: • Assent from the minor in writing (i.e. agreement to participate) if he or she chooses to participate.
p.000029: Note that an unmarried minor mother may not agree to the participation of her child in research without assistance. Her
p.000029: guardian (usually her parent) is also the guardian of her child while she is a minor and must consent to the child’s
p.000029: participation. In other words, pregnancy and childbirth do not change the legal status of the minor mother. When the
p.000029: mother reaches the age of majority (18 years), she may consent to her child’s participation in research.
p.000029: f) Children should participate in research that takes cognisance of their privacy interests. Although children are
p.000029: legally dependent, they have significant privacy interests. Their
p.000029:
p.000029: Ethics in Health Research 2nd edition
p.000031: 31
p.000031:
p.000031: genetic privacy interests, in particular, may be more important than those of adults who manifest a particular genetic
p.000031: condition.
p.000031: g) When parents or a guardian give permission for their minor child to choose whether to participate in research, this
p.000031: permission is given based on a detailed description of all diagnostic and therapeutic interventions that will
p.000031: affect the child in the study. However, this does not mean that parents are entitled to know the outcome of all
p.000031: diagnostic and therapeutic interventions, especially as regards older minors (adolescents). The
p.000031: informed consent documentation must explain whether results of tests will be made known to child-participants
p.000031: and their parents. Whether this happens, depends to an extent on the socio-cultural context and the best
p.000031: interest standard.
p.000031: h) The minor’s interest in confidentiality, i.e. being identified or identifiable without permission of the
p.000031: minor and her parent or guardian must be respected.
p.000031: i) Research involving children must respect their evolving capacity to give consent. Minors who turn 18
p.000031: years old during the course of a study should be approached at the time of their birthday to re-consent. This
p.000031: is because they must now provide independent consent to continue to be a participant. In cases where
p.000031: minors are permitted to decide independently whether to participate, 26 the consent process should address
p.000031: how re-consent will be managed when they change status from minority to majority. Similarly, in the case of
p.000031: large and longitudinal studies, attention must be given to how the change from minority to majority will be managed.
p.000031: Where a study is no longer in active interaction with participants, re-consent procedures may be less important.
p.000031: j) Researchers must familiarise themselves with the legal obligations to report child abuse and neglect.
p.000031: See 3.2.2.5.
p.000031: 3.2.2.2 Parental permission
p.000031: The Children’s Act 38 of 2005 emphasises the right of a child to participate in any matter concerning that child,
p.000031: provided he or she has sufficient maturity to participate appropriately and meaningfully (s 10), notwithstanding
p.000031: legal incapacity. This means that parents or guardians may not decide whether their minor child should
p.000031: participate in research without the minor’s contribution to the decision. The choice of whether to participate is not a
p.000031: legal decision but rather a factual choice. Consequently, the process should be that the parent or guardian is
p.000031: requested to give permission for the minor to be approached to be invited to participate in the study. The factual
p.000031: decision whether to participate is the minor’s and not the parent’s.
p.000031: Parental permission and minor’s decision must be consistent, i.e. if the minor decides not to participate, the parent
p.000031: may not override this decision. If the parent is reluctant for the minor to participate but the minor wants to
p.000031: do so, the matter must be managed carefully to establish what the concerns are and whether they may be
p.000031: resolved. The minor cannot choose to participate if the parent withholds permission for that minor
p.000031: to choose. Researchers are unlikely to be able to intervene where the suspicion is that the parent is
p.000031:
p.000031: 26 See 3.2.2.4.
p.000031:
p.000031: 32 Ethics in Health Research 2nd edition
p.000031:
p.000031:
p.000031: withholding permission unreasonably, since a best interest analysis in this context is irrelevant.
p.000031: 3.2.2.3 Orphans without guardians
p.000031: i. Introduction
p.000031: Many minors in South Africa do not have parents and very few have court-appointed guardians. These minors
p.000031: are often described as ‘orphans and vulnerable children’ or OVC. The absence of a legally appropriate parental
p.000031: substitute poses a problem for researchers because of the lack of clear guidance as to an acceptable substitute in
p.000031: the informed consent process for research participation. (Note that for treatment purposes, substituted
p.000031: consent occurs on the basis of necessity, which is not applicable to the research context.)
p.000031: ii. Justification
p.000031: Important research that seeks to understand and improve psychosocial, economic and educational conditions for
p.000031: orphans and vulnerable children to improve their future well being generally involves no more than minimal risk
p.000031: of harm. Other research including clinical research that may involve a minor increase over minimal risk of harm
p.000031: may also be justified on the basis that it would be unjustifiable to exclude a significant segment of the
p.000031: child population from research on the basis of their legal status. Consequently, it is ethical and reasonable to
p.000031: designate parental substitutes in these circumstances.
p.000031: iii. Pragmatic parental substitutes27
p.000031: In the interest of fostering consistency as well as compliance with the spirit of the legal provisions
p.000031: that protect minors’ interests, especially the Constitution and the Children’s Act, pragmatic guidance is provided
p.000031: here to deal with situations where no biological parent or legal guardian exists. The permissible level of
p.000031: risk is limited (see 3.2.2.1).
p.000031: Note this guidance does not permit expedient substitution e.g. where a parent is temporarily unavailable.
p.000031: This guidance takes its lead from the Constitution, the Children’s Act, the National Health Act, the Criminal Law
p.000031: (Sexual Offences) Amendment Act; the South African Good Clinical Practice Guidelines (2006) available at
p.000031: www.doh.gov.za/docs/factsheets/guidelines/clinical/2006/index.html.
p.000031: The guidance is premised on three conditions, all of which must be satisfied:
p.000031: 1. The risk standards set out in 3.2.2.1 b) must be adhered to; and
p.000031: 2. It is not possible to do the research with adult participants; and
p.000031: 3. The research proposes to investigate a problem of relevance to minors.
p.000031: Note that if the proposed research holds out more than a minimal risk of harm, there must be a
p.000031: compelling justification for why orphans should be included as participants, e.g. the research focus has particular
p.000031: relevance for OVC and cannot be studied without their enrolment.
p.000031: The parental substitutes should be used in descending order, as listed.
p.000031: i. The minor chooses whether to participate and thus expresses her will AFTER
p.000031:
p.000031: 27 This pragmatic guidance is provided to temper the chilling effect of a literal interpretation of s 71 of the
p.000031: National Health Act 61 of 2003, which otherwise might prevent important ethical research.
p.000031:
p.000031: Ethics in Health Research 2nd edition
p.000033: 33
p.000033:
p.000033: ii. The parent gives assistance with understanding (so the minor makes an informed choice)
p.000033: iii. If no parent, then guardian: either court-appointed OR as indicated by the parent in a Will (s 27 Children’s Act)
p.000033: iv. If no guardian, then foster parent (per order of Children’s Court) (Note that social workers should
p.000033: request that the authority to give permission should be included expressly in the court order authorising
p.000033: foster care)28
p.000033: v. If no foster parent (per iv. above), then caregiver (s 1 Children’s Act: defined as ‘…any person
p.000033: other than a parent or guardian, who factually cares for a child and includes – a) a foster parent; b) a person who
p.000033: cares for the child with the implied or express consent of a parent or guardian of the child; c) a person who cares for
p.000033: the child whilst the child is in temporary safe care; d) the person at the head of a child and youth care centre where
p.000033: a child has been placed; e) the person at the head of a shelter; f) a child and youth care worker who cares
p.000033: for a child who is without appropriate family care in the community; and g) the child at the head of a child-
p.000033: headed household’)
p.000033: vi. If minor is caregiver in child-headed household and no supervisory adult (s 137 Children’s Act), then
p.000033: trusted adult nominated by minor, including but not limited to social worker, community worker or teacher.
p.000033: 3.2.2.4 Minors’ independent consent
p.000033: In particular circumstances, e.g. for reasons of sensitivity, like discussion about sexual activities,
p.000033: substance abuse etc., it may be desirable and ethically justifiable for minors (especially older minors i.e.
p.000033: 16 years and older) to choose independently i.e. without parental assistance, whether to participate in research.
p.000033: Generally, only minimal risk research is suitable for independent consent by minors. Reasons
p.000033: supporting the desirability of independent consent may include recruiting sufficient numbers of minors
p.000033: who otherwise would be unwilling to participate if they must tell their parents about the nature of the
p.000033: research in order to obtain parental permission.
p.000033: An ethical justification for independent consent by minors may be made in the following manner:
p.000033: • By prior engagement with participating community role players, the PI can request (and justify explicitly)
p.000033: REC approval of a waiver of the parental (or substitute) permission requirement. Engagement could include
p.000033: outreach to relevant role players such as canvassing the opinion of a representative body of parents e.g. via schools.
p.000033: • Factual evidence of such engagement must form part of the PI’s justification in the protocol. Factual evidence
p.000033: may be in the form of a letter from a relevant role player (like a community leader, school principal or a CAB)
p.000033: that confirms the view that independent consent is acceptable to the parents.
p.000033: • If the REC accepts the ethical justification and the factual evidence of parental support for
p.000033: independent choice by their minor children, then the REC may grant a waiver of the requirement of written
p.000033: parental permission and must document the process carefully.
p.000033:
p.000033:
p.000033: 28Note a caregiver, a foster parent and a schoolteacher or principal are not guardians.
p.000033:
p.000033: 34 Ethics in Health Research 2nd edition
p.000033:
p.000033:
p.000033: 3.2.2.5 Mandatory reporting obligations
p.000033: There is no general obligation to report either the commission of or the intention to commit a crime. However, if a
p.000033: researcher has information indicating that direct harm to another person may occur as a result of the intention to
p.000033: commit harm (e.g. a participant says ‘I’m going to kill her…’), then there may be an obligation, especially when the
p.000033: third person is known to the researcher. For specifically designated persons, there are statutory reporting
p.000033: obligations. (See Appendix 3 for SOP Template.)
p.000033: i. Reporting obligations for abuse and neglect
p.000033: The Children’s Act requires anyone who reasonably believes a child to be suffering physical abuse causing injury,
p.000033: deliberate neglect and sexual abuse to report this to a child protection agency, the provincial social development
p.000033: department, or to a police official.
p.000033: ii. Reporting obligations for under-age sexual activity
p.000033: The age at which minors can lawfully consent to sexual activity is 16 years, in terms of the Criminal Law (Sexual
p.000033: Offences and Related Matters) Amendment Act 32 of 2007 (Sexual Offences Act). Anyone with knowledge of a
p.000033: sexual offence against a minor is required to report this to a police official. In effect, any adult or person >16
p.000033: years who engages in sexual activity with a minor < 16 years commits a crime and may be prosecuted. The Act
p.000033: describes a broad range of sexual offences, including rape, sexual assault, sexual grooming, sexual
p.000033: exploitation, and use of children in pornography including photographs. This means that the range of activities
p.000033: that may constitute a sexual offence is extensive.
p.000033: The Sexual Offences Act differentiates between adolescents (12 - < 16 years) and older minors (16 and 17
p.000033: years). In the case of children younger than 12 years, sexual activity is unlawful even with consent. For adolescents,
p.000033: the situation is as follows. The Teddy Bear Clinic case 29 found criminalisation of consensual sexual acts
p.000033: between adolescents aged 12 – < 16 years to be unconstitutional, on the basis that adolescents should not be subjected
p.000033: to criminal sanctions when they exercise their entitlement to determine their personal relationships in light of their
p.000033: rights to autonomy, dignity and privacy. The Constitutional Court imposed a moratorium on action against adolescents in
p.000033: terms of ss 15 and 16 of the Sexual Offences Act. This moratorium of 18 months is to give Parliament time to revise the
p.000033: offending legislative provisions by April 2015.30
p.000033: Consensual sexual acts between adolescents aged 12 - < 16 years are not criminal and are not reportable. Sexual acts
p.000033: with adolescents aged 12 - < 16 years by an adult or a person >16 years, even if consensual, are criminal and
p.000033: reportable. Sexual acts with children < 12 years are criminal and reportable.
p.000033: iii. Sexual and reproductive health research with minors
p.000033: Research with minors that focuses on their sexuality and reproductive health is likely to encounter instances of
p.000033: abuse and underage sexual activity. The dilemma for
p.000033:
p.000033:
p.000033: 29The Teddy Bear Clinic for Abused Children v Minister of Justice and Constitutional Development (CCT 12/13) [2013]
p.000033: ZACC 35; 2014 (2) SA 168 (CC); see also J v NDPP [2014] ZACC 13.
p.000033: 30See Draft Criminal Law (Sexual Offences & related matters) Amendment Act Amendment Bill [B-2014].
p.000033:
p.000033: Ethics in Health Research 2nd edition
p.000035: 35
p.000035:
p.000035: researchers is whether to ignore the strict letter of the law or to report as indicated in terms of the Sexual Offences
p.000035: Act and the Children’s Act. The matter is not simple.
p.000035: The clash of interests is obvious, e.g. using the law to protect the minor from abuse may have the unintended
p.000035: consequence of increased harm (physical and social) for that child. Further, thoughtless reporting may
p.000035: violate privacy and confidentiality interests of the minor e.g. in terms of the Choice on Termination of Pregnancy
p.000035: Act, the Children’s Act and the Child Justice Act. Whether a researcher, who has but a research interest
p.000035: in the life of the child, but no further right of access or duty of intervention ought to take on
p.000035: the responsibility of a social worker is unclear. Consequently, researchers should think very
p.000035: carefully about the anticipated consequences of reporting in light of the legal context. The proposal submitted
p.000035: for ethics review should explain fully the approach to be adopted, and justify how reporting obligations
p.000035: will be managed, so that the REC can deliberate effectively. The consent documents should clearly inform the
p.000035: minor (and proxy consent providers where necessary) about when reporting obligations arise and how they
p.000035: will be addressed, so that an informed choice can be made about whether to participate. Appropriate
p.000035: engagement with role-players such as child rights and child care organizations may assist researchers to make
p.000035: appropriate and meaningful referrals.
...
p.000035: thus vital that researchers bear this in mind because to ignore this fact is to seriously violate the person’s
p.000035: constitutional right to dignity as well as the ethical principle of respect (autonomy).
p.000035: When recruiting participants, the crucial elements are whether the person retains the capacity to decide
p.000035: whether to participate and whether he is able to communicate that decision. The first point to note,
p.000035: therefore, is the difference between the capacity to decide and the ability to communicate the decision. The capacity
p.000035: to decide necessarily includes the capacity to understand the information that is communicated to him. The
p.000035: ability to communicate includes the ability to hear and to speak or otherwise signal or express her
p.000035: wishes. For example, deafness should never be mistaken for incapacity to decide. Similarly, the inability to speak
p.000035: should not be mistaken for a lack of capacity to decide whether to participate.32
p.000035: 3.2.4.2 Minors and decision-making incapacity
p.000035: Parents or guardians of minors with intellectual or mental impairments should give permission for their
p.000035: minor children to choose whether to participate in research. If the minor
p.000035:
p.000035: 32 Georgetown University Informed Consent and Limitations on Decision making Capacity Chapter 2
p.000035: https://bioethicsarchive.georgetown.edu/nbac/capacity/Informed.htm
p.000035:
p.000035: Ethics in Health Research 2nd edition
p.000037: 37
p.000037:
p.000037: is unable to communicate at all or lacks the capacity to choose, then the parent or guardian should choose whether
p.000037: the minor may be enrolled. In other words, the parent acts as a proxy decision maker. In the case of a
p.000037: minor who remains intellectually or mentally impaired after reaching the age of majority, the situation changes
p.000037: because the person becomes an adult with decision-making incapacity (see 3.2.4.3 below).
p.000037: 3.2.4.3 Adults incapable of giving adequate informed consent
...
p.000075: it may involve reporting upwards in a hierarchical structure
p.000075: Adolescent – a child between 12 and 17 years of age
p.000075: Anonymous data or specimen–data or biological materials without any overt identifying information or link to a
p.000075: specific donor
p.000075: Audit– subset of research; not clinical practice but a review of clinical practice
p.000075: Autonomy – the capacity to understand information; to act on it voluntarily; to use own judgement to make decisions
p.000075: about own actions, including whether to participate in research
p.000075: Biobank – see Repository
p.000075: Human biological materials– materials including blood and blood products, DNA, RNA, blastomeres, polar bodies,
p.000075: cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors
p.000075: Broad consent– donor permits use of biological materials for future studies, subject only to further prior ethics
p.000075: review and approval
p.000075: Capacity – the ability to understand relevant information; to appreciate the consequences of decisions based on the
p.000075: information
p.000075: Caregiver– a person who in fact cares for a child (s 1 Children’s Act, 38 of 2005); a caregiver must
p.000075: safeguard the child’s health, well-being and development; and protect the child from abuse and other
p.000075: harms; a caregiver exercises the parental right to consent to medical examination or treatment of the child
p.000075: Child – a person under 18 years (s 28 Constitution; s 1 Children’s Act)
p.000075: Child-headed household– a household per s 137 Children’s Act
p.000075: Clinical equipoise – literally means a state of balance or equilibrium; in the research context it means
p.000075: that, amongst health care experts, uncertainty prevails about whether a particular treatment or intervention
p.000075: is better than another. This principle forms the basis for conducting clinical research
p.000075: Clinical research –research intended to test safety (not harmful or dangerous to human health), quality (ingredients
p.000075: are of good quality), effectiveness (working to diagnose, treat, prevent or cure a disease condition) and efficacy
p.000075: (better/ best when compared with other treatment or medicine for a similar condition) of new and/or existing
p.000075: or old medicines, medical devices and/or treatment options, using human participants. (South African Clinical Trials
p.000075: Registration http://www.sanctr.gov.za/Resources/Whatisaclinicaltrial/tabid/175/Default.aspx);
p.000075:
p.000075: Ethics in Health Research 2nd edition
p.000077: 77
p.000077:
p.000077: the Ottawa Statement defines ‘trial’ as a prospective controlled or uncontrolled research study evaluating
p.000077: the effects of one or more health-related interventions related to prevention, health promotion,
p.000077: screening, diagnosis, treatment, rehabilitation, or organization and financing of care.
p.000077: ‘Intervention’ refers to a deliberate act applied to an individual or group of individuals. Health-related
p.000077: interventions include but are not limited to the use of pharmaceuticals, biological products, surgery,
p.000077: procedures, radiation, devices, education, counseling, behaviour change, complementary health modalities, and
...
p.000077: care
p.000077: Identifiable information – reasonably expected to identify an individual alone or in combination with other
p.000077: information
p.000077: Directly identifying – direct identifiers e.g. name, identity number
p.000077: Indirectly identifying – combination of indirect identifiers e.g. date of birth, address, unique personal
p.000077: characteristic
p.000077: Coded information – direct identifiers removed; replaced by code Anonymised information – irrevocably stripped of
p.000077: direct identifiers; no code Anonymous information – never had identifiers
p.000077: Identifier– information such as a name, initials, address, folder number, or biometric identifier (e.g.
p.000077: finger print) that can identify a particular donor
p.000077: Incentive – anything offered to encourage participation in research
p.000077: Incidental findings – unanticipated discoveries made in the course of research that are outside the scope of the
p.000077: research
p.000077: Inconvenience – a minor negative effect experienced in research less serious than discomfort
p.000077: Low risk research – where the only foreseeable risk is one of discomfort
p.000077: Minimal risk research – where probability and magnitude of possible harms implied by participation are no
p.000077: greater than those posed by daily life in a stable society or routine medical, dental, educational or
p.000077: psychological tests or examinations
p.000077: Minor– a person under 18 years (s 17 Children’s Act)
p.000077: Narrow consent – donor permits single use only of biological materials; no storage; no sharing of data or
p.000077: specimen; new consent if further use wanted.
p.000077: Negligible risk research – where the only foreseeable risk is one of inconvenience
p.000077: Neonate – a newborn child
p.000077: Non-therapeutic interventions–interventions not directed towards health-related benefit for a participant but towards
p.000077: improving generalisable knowledge (NHA Reg 135)
p.000077: Observational research – study of behaviour in a natural environment where people involved in their usual
p.000077: activities are observed with or without their knowledge; observational research also occurs in clinical research
p.000077: e.g. when a researcher observes individuals or measures particular outcomes, without intervention e.g.
p.000077: no treatment is given);an observational study describes a wide range of study designs including
p.000077: prospective and retrospective cohort studies, case-control studies, and cross-sectional studies, a defining
p.000077: feature of which is that any intervention studied is determined by clinical practice and not the protocol.
p.000077: Orphan– a child without a surviving parent to care for him (s 1 Children’s Act)
p.000077:
p.000077: Ethics in Health Research 2nd edition
p.000079: 79
p.000079:
p.000079: Privacy risks – potential harms to participants from collection, use and disclosure of personal information
p.000079: for research purposes
p.000079: Protocol – document that provides background, rationale and objectives of research; describes its design,
p.000079: methodology, organization and conditions under which it is to be conducted and managed
p.000079: Qualitative research – involves studied use of empirical materials such as case studies, personal experience, life
p.000079: stories, interviews, observations, and cultural texts
p.000079: Registry– a collection of information (data) from multiple sources, maintained over time with controlled
p.000079: access through a gatekeeper organizer
p.000079: Reimbursement – payment to participants to ensure they are not disadvantaged financially directly or indirectly by
p.000079: participation in research; directly means actual costs incurred and indirectly means losses that arise because
p.000079: of participation
p.000079: Repository– a collection, storage and distribution system for human biological materials for research purposes
p.000079: including blood, urine, faeces, bone marrow, cell aspirates, diagnostic specimens, pathology specimens and
p.000079: so on. Usually demographic and medical information about the donors is included in the repository as are
p.000079: codes that link the material to the donors
p.000079: Research – includes a range of activities conducted by many different disciplines that may use different
...
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: 3. Novel, Innovative or Unproven Treatment
p.000085:
p.000085: < Insert hospital name >
p.000085:
p.000085: NOVEL, INNOVATIVE OR UNPROVEN TREATMENT CONSENT FORM
p.000085:
p.000085: How to use this Consent Form
p.000085: Read carefully through the whole document
p.000085: Fill in the RED areas ELECTRONICALLY (for future data collection) Make sure that all the necessary information is
p.000085: included
p.000085: The information written in BLUE is for guidance and should be removed before finalizing the document
p.000085: Print three (3) copies: one for patient’s folder, one for PTC, and one for the patient or her family
p.000085: This document is for a single patient use and a single treatment course only.
p.000085:
p.000085: This document tells you about a treatment for your (your child’s) condition that is still experimental but which your
p.000085: doctors would like to try. You are not being asked to join a research project. Important differences
p.000085: exist between experimental treatment and a research project.
p.000085: This treatment is experimental because
p.000085: < delete options that do not apply >
p.000085: It has been tested for conditions other than yours (your child’s).
p.000085: It has been tested for use with adults but not for use with children (< 18 years; < 12 years) It has not been registered
p.000085: in South Africa for use for your condition.
p.000085:
p.000085:
p.000085:
p.000085: Name of Drug Or Intervention
p.000085: Single Patient Use of < Insert Investigational Drug or Intervention Name >
p.000085:
p.000085:
p.000085: Treating Health care worker(s):
p.000085: < Insert Name >
p.000085: < Insert Address/Medical ward details >
p.000085: < Insert Phone Numbers/ Medical ward extension >
p.000085:
p.000085:
p.000085: Emergency Contact < Insert Emergency Contact Information >
p.000085: < Insert Phone Number/Pager, etc >
p.000085:
p.000085:
p.000085: < Insert name of investigational drug or other intervention > is a treatment that < insert either current approval status
p.000085: by the Medicines Control Council for another condition or provide a patient appropriate explanation of what
p.000085: the investigational drug or intervention is intended to do >.
p.000085:
p.000085: This treatment is not approved for < indicate what condition the patient has >, which means its use is experimental. We
p.000085: are not sure that this experimental treatment will cure or improve your condition. But in your circumstances, we offer
p.000085: you the opportunity to try it.
p.000085:
p.000085: Ethics in Health Research 2nd edition
p.000087: 87
p.000087:
...
Social / Ethnicity
Searching for indicator ethnic:
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p.000009: should reflect core values of respect, scientific merit and integrity, justice and beneficence. Of highest
p.000009: priority are refinement of ethics guidelines, establishment of research ethics and animal research ethics
p.000009: committees, and strengthening of review processes, to protect the rights, safety and welfare interests of
p.000009: individuals involved in research, particularly vulnerable participants; to protect the welfare and safety
p.000009: interests of animals used in research; and to protect safety and other interests of researchers.
p.000009:
p.000009: 3 Available at http://www.health-e.org.za/wp-content/uploads/2014/08/SA-DoH-Strategic-Plan-2014-to-2019.pdf
p.000009:
p.000009: 10 Ethics in Health Research 2nd edition
p.000009:
p.000009:
p.000009: 1.3.4 The guidelines draw on prevailing international, foreign and national codes of conduct,
p.000009: declarations, and other documents relevant to research with humans, to strengthen processes of translational
p.000009: research collaboration, while taking into account the socioeconomic, ethnic and cultural diversity in South Africa. The
p.000009: guidelines also draw on and refer to international and national standards and guidelines for research using animals.
p.000009: 1.3.5 Researchers should be familiar with legislation and other binding instruments relevant to research including4
p.000009: • Animal Diseases Act 35 of 1984
p.000009: • Animal Health Act 7 of 2002
p.000009: • Animals Protection Act 71 of 1962
p.000009: • Basic Conditions of Employment Act 75 of 1997
p.000009: • Cartagena Protocol on Biosafety May 2000
p.000009: • Child Justice Act 75 of 2008
p.000009: • Children’s Act 38 of 2005
p.000009: • Choice on Termination of Pregnancy Act 92 of 1996
p.000009: • Constitution of the Republic of South Africa, 1996
p.000009: • Convention on Biological Diversity
p.000009: • Criminal Law (Sexual Offences and Related Matters) Amendment Act 32 of 2007
p.000009: • Domestic Violence Act 116 of 1998
p.000009: • Employment Equity Act 55 of 1998
p.000009: • Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act 36 of 1947
p.000009: • Genetically Modified Organisms Act, Act No 15 of 1997
p.000009: • Hazardous Substances Act 15 of 1973
p.000009: • Health Professions Act 56 of 1974
p.000009: • Labour Relations Act 66 of 1995
p.000009: • Medical Schemes Act 131 of 1998
p.000009: • Medicines and Related Substances Control Act 101 of 1965
p.000009: • Mental Health Care Act 17 of 2002
...
p.000015: benefit from the research. In assessing the risk of harm, both the magnitude or seriousness of the harm and the
p.000015: probability of its occurrence should be addressed.
p.000015: Usually, participants who might face undue risk of harm should not be included in the study, even if they represent a
p.000015: category of person that may benefit from the research. On the other hand, research with such persons may
p.000015: nevertheless be approved after careful review and acceptable justification that demonstrates the anticipated
p.000015: importance and value of the research for society. In such cases, a carefully phased approach should be adopted.
p.000015: 2.3.5 Fair selection of participants
p.000015: This means recruitment, selection, exclusion and inclusion of participants for research must be just and fair,
p.000015: based on sound scientific and ethical principles. Persons should not be excluded unreasonably or unfairly
p.000015: on the basis of any of the prohibited grounds for discrimination: race, age, sex, sexual orientation,
p.000015: disability, education, religious belief, pregnancy, marital status, ethnic or social origin, conscience, belief or
p.000015: language (s 8 of the Constitution). Similarly, persons should not be unfairly targeted for research merely on the basis
p.000015: of one or other of these grounds.
p.000015: 2.3.6 Informed consent
p.000015: In general, participation in research must be voluntary and predicated on informed choices. Voluntariness and
p.000015: informed choices are evidenced by the informed consent process which must take place before the research
p.000015: commences, in principle, and be affirmed during the
p.000015:
p.000015: Ethics in Health Research 2nd edition
p.000017: 17
p.000017:
p.000017: course of the study, as part of the commitment to an ongoing consent process. In some circumstances,
p.000017: research may not require prior consent (see 3.2.5 & 3.3)
p.000017: 2.3.7 Ongoing respect for enrolled participants
p.000017: A research participant has the right to privacy and to confidentiality. This requires that a proposal
p.000017: must explain how these constitutionally protected rights will be managed and protected in the course of the
p.000017: research. Simply stated, privacy is concerned with who has access to personal information and records about the
p.000017: participant; including clinical health care records. On the other hand, ‘confidentiality’ is about ensuring that
...
p.000023: Some specific terms are summarised:
p.000023: • in the case of a child (person under the age of 18 years), a parent or guardian14 must give permission for the
p.000023: information to be collected (s 35(1)(a));15
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: 12Storage requirements may vary according to institutional requirements; usually between five and fifteen years.
p.000023: 13Some parts came into effect on 11 April 2014: s 1 (definitions); part A of Chapter 5 (establishment of Information
p.000023: Regulator); s 112 (about making Regulations); and s 113 (procedures for making Regulations) by Proclamation in GG 37544
p.000023: R.25, 2014.
p.000023: 14Note a caregiver, a foster parent, and a schoolteacher or principal are not guardians.
p.000023: 15 This requirement is compatible with the consent requirements for minors as described elsewhere in these Guidelines
p.000023: (see 3.2.2).
p.000023:
p.000023: 24 Ethics in Health Research 2nd edition
p.000023:
p.000023:
p.000023: • if the information is to be sent outside the Republic, the recipient must assure that the level of protection
p.000023: afforded in that country is commensurate with that expected in South Africa (s 18(1)(g));
p.000023: • information about a person’s race or ethnic origin must be necessary (s 29(a)) or for affirmative action purposes
p.000023: (s 29(b));
p.000023: • information about a person’s health or sex life must be necessary for the research activity (s 27(1)(d));
p.000023: • information about a person’s inherited characteristics must be necessary for the research activity (s
p.000023: 32(5)(b));
p.000023: • biometric16 information about a person must be necessary for the research activity (s 27(1)(d)).
p.000023: In effect, the Act outlines and requires the usual requirements for ethical and responsible informed consent
p.000023: procedures. The provisions underpin the importance of comprehensive SOPs and rigorous adherence thereto. It
p.000023: should be remembered that research records including informed consent documentation may be solicited by
p.000023: interested parties via application in terms of the Promotion of Access to Information Act 2 of 2000.
p.000023: 3.1.9 Obtaining informed consent
p.000023: The principle of respect for persons underpins the requirement that a person must choose voluntarily whether to
p.000023: participate in research on the basis of information that allows an informed choice to be made. The
p.000023: process of providing the necessary information and of engaging with the person before a decision is
p.000023: reached is known as the informed consent process. It should be noted that informed consent is a necessary but
...
Searching for indicator ethnicity:
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p.000057: and refresher courses should be available; that members should be expected, at least once during a term of
p.000057: appointment, to produce evidence of recent training; and that membership should be managed to ensure an optimal mix of
p.000057: experienced and new members to promote good succession planning. The term of office of members may vary
p.000057: according to institutional requirements. Consideration should be given to succession planning and accumulation of
p.000057: institutional memory for RECs. A reasonable term of office is between two and four years, renewable twice, after which
p.000057: the person should stand down for at least one term. This ensures that both expertise and responsibility are
p.000057: fairly distributed and encouraged in a range of members, and that institutional memory is accumulated.
p.000057: 4.4.1 Formal membership requirements for RECs and ARECs
p.000057:
p.000057: 4.4.1.1 General
p.000057: Subject to institutional requirements, a Chairperson could be appointed or elected at the first meeting of the REC, and
p.000057: thereafter confirmed annually. Alternately, the Chairperson, suitably qualified, could be appointed by the
p.000057: institutional leadership for a period of two to four years, renewable if so specified. The Chairperson should be
p.000057: assisted by at least one Deputy Chairperson, depending on the size of the committee. The Deputy
p.000057: Chairperson should be elected by the members and be expected to assist the Chairperson with responsibilities and
p.000057: inter-meeting matters, as well as to step into the role of Chairperson when necessary.
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057: 51Diversity of REC membership refers mostly to ethnicity, culture and gender of members.
p.000057:
p.000057: Ethics in Health Research 2nd edition
p.000059: 59
p.000059:
p.000059: 4.4.1.2 Research Ethics Committees
p.000059: All REC members should have documented proof of research ethics training, refreshed at least once within
p.000059: the period of appointment.
p.000059: REC membership should consist of
p.000059: i. at least nine members with a quorum being a simple majority
p.000059: ii. where the number of members is more than 15, the quorum may be 33%
p.000059: iii. at least one layperson
p.000059: iv. at least one member with knowledge of, and current experience in, the professional care, counselling or
p.000059: health-related treatment of people. Such a member might be e.g. a medical practitioner, psychologist, social worker or
p.000059: nurse
p.000059: v. at least one member with professional training and experience in qualitative research methodologies
p.000059: vi. members with professional training and experience in quantitative research methodologies
p.000059: vii. a member with expertise in bio-statistics
p.000059: viii. a member with expertise in research ethics
p.000059: ix. at least one member who is legally qualified
p.000059:
p.000059: 4.4.1.3 Animal Research Ethics Committees
p.000059: Various categories of members are dictated by international and national standards including the SABS SANS 10386 (2008
p.000059: or later version).
p.000059: Four categories of member are required:
...
Social / Fetus/Neonate
Searching for indicator fetus:
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p.000035: will be managed, so that the REC can deliberate effectively. The consent documents should clearly inform the
p.000035: minor (and proxy consent providers where necessary) about when reporting obligations arise and how they
p.000035: will be addressed, so that an informed choice can be made about whether to participate. Appropriate
p.000035: engagement with role-players such as child rights and child care organizations may assist researchers to make
p.000035: appropriate and meaningful referrals.
p.000035: 3.2.3 Women
p.000035:
p.000035: Exclusion of women as research participants has led to a lack of data needed to promote women’s health. Any proposed
p.000035: exclusion of women participants must be justifiable in light of research priorities as well as the specific research
p.000035: question under consideration. For example, women are appropriately excluded from prostate cancer research
p.000035: because the relevant population is male. In particular, systematic class exclusion must be guarded against to avoid
p.000035: unfair participant selection.
p.000035: Additional health concerns arise during pregnancy, including the need to avoid unnecessary risk to the fetus.
p.000035: Consequently, researchers and RECs should exercise extra caution when women participants are or may become
p.000035: pregnant. Exclusion of women from research may be justifiable
p.000035: a) to protect the health of the fetus; and
p.000035: b) if exclusion is scientifically supportable.
p.000035: Note that the informed consent documents must explain carefully and fully what the possible effect of the research
p.000035: activities on the fetus might be.
p.000035: Usually, research involving pregnant women should be undertaken when
p.000035: • the purpose of the proposed research is to meet the health needs of the mother of the particular fetus;
p.000035: • appropriate studies on animals and non-pregnant individuals have been completed;31
p.000035: • the risk of harm to the fetus is minimal; and
p.000035:
p.000035: 31 Clinical trials involving pregnant women or nursing mothers should ideally involve products where the toxicology in
p.000035: adults is established and is acceptable. In the case of pregnant women, the potential risks associated with using a
p.000035: substance whose short term and long-term effects on a fetus and developing infant are unknown, should be outweighed by
p.000035: the benefits. An example of a positive risk-benefit ratio would be the use of anti-retrovirals in mother to child HIV
p.000035: transmission studies. For nursing mothers, the amount of drug passing into breast milk should be established and the
p.000035: potential impact on a breast-fed infant anticipated, and the mother so advised.
p.000035:
p.000035: 36 Ethics in Health Research 2nd edition
p.000035:
p.000035:
p.000035: • in all cases, inclusion poses the least risk of harm possible for achieving the objectives of the research.
p.000035: 3.2.4 Adults with factual incapacity to provide informed consent
p.000035:
p.000035: Adults who are factually incapable of giving informed consent should participate in research only where their
p.000035: participation is indispensable to the research; i.e. the research cannot deliver the desired outcomes if
...
Searching for indicator neonate:
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p.000027: incapacity status.
p.000027: 24 See also s 9 of the Children’s Act 38 of 2005.
p.000027:
p.000027: Ethics in Health Research 2nd edition
p.000029: 29
p.000029:
p.000029: ‘Child’ means a person under the age of 18 years (s 28 Constitution; s 1 Children’s Act 38 of 2005)
p.000029: ‘Child-headed household’ means a household per s 137 Children’s Act 38 of 2005
p.000029: ‘Guardian’ means a person appointed by a court to look after the financial and welfare interests of a
p.000029: minor, or a person appointed by a parent with sole responsibility for the minor in terms of the parent’s Will
p.000029: ‘Harm’ means physical, emotional, psychological, social or legal harm
p.000029: ‘Minor’ means a person (child) less than 18 years (s 17 Children’s Act 38 of 2005) ‘Neonate’ means a newborn child,
p.000029: including an infant less than a month old
p.000029: ‘Orphan’ means a child who has no surviving parent caring for him or her (s 1 Children’s Act 38 of 2005)
p.000029: ‘Parent’ includes an adoptive parent (s 1 Children’s Act 38 of 2005)
p.000029: ‘Therapeutic research’ means research that includes interventions that may hold out the prospect of direct
p.000029: health-related benefit for the participant (Regulation 135)
p.000029: ‘Non-therapeutic research’ means research that includes interventions that will not hold out the prospect of direct
p.000029: health-related benefit for the participant but may produce results that contribute to generalisable knowledge
p.000029: (Regulation 135)
p.000029: 3.2.2.1 Minimum conditions for research involving minors
p.000029: The following considerations are critical when RECs review proposals to involve child participants:
p.000029: a) Children should participate in research when their participation is scientifically indispensable to the
p.000029: research. In the case of interventional clinical research, equipoise 25 should exist. Research should
...
p.000077: finger print) that can identify a particular donor
p.000077: Incentive – anything offered to encourage participation in research
p.000077: Incidental findings – unanticipated discoveries made in the course of research that are outside the scope of the
p.000077: research
p.000077: Inconvenience – a minor negative effect experienced in research less serious than discomfort
p.000077: Low risk research – where the only foreseeable risk is one of discomfort
p.000077: Minimal risk research – where probability and magnitude of possible harms implied by participation are no
p.000077: greater than those posed by daily life in a stable society or routine medical, dental, educational or
p.000077: psychological tests or examinations
p.000077: Minor– a person under 18 years (s 17 Children’s Act)
p.000077: Narrow consent – donor permits single use only of biological materials; no storage; no sharing of data or
p.000077: specimen; new consent if further use wanted.
p.000077: Negligible risk research – where the only foreseeable risk is one of inconvenience
p.000077: Neonate – a newborn child
p.000077: Non-therapeutic interventions–interventions not directed towards health-related benefit for a participant but towards
p.000077: improving generalisable knowledge (NHA Reg 135)
p.000077: Observational research – study of behaviour in a natural environment where people involved in their usual
p.000077: activities are observed with or without their knowledge; observational research also occurs in clinical research
p.000077: e.g. when a researcher observes individuals or measures particular outcomes, without intervention e.g.
p.000077: no treatment is given);an observational study describes a wide range of study designs including
p.000077: prospective and retrospective cohort studies, case-control studies, and cross-sectional studies, a defining
p.000077: feature of which is that any intervention studied is determined by clinical practice and not the protocol.
p.000077: Orphan– a child without a surviving parent to care for him (s 1 Children’s Act)
p.000077:
p.000077: Ethics in Health Research 2nd edition
p.000079: 79
p.000079:
p.000079: Privacy risks – potential harms to participants from collection, use and disclosure of personal information
p.000079: for research purposes
p.000079: Protocol – document that provides background, rationale and objectives of research; describes its design,
p.000079: methodology, organization and conditions under which it is to be conducted and managed
...
Searching for indicator fetuses:
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p.000007: environment and context.
p.000007: 1.1.5 The statutory definition can be interpreted as having a wide or a narrow meaning. Many researchers,
p.000007: especially those who work in the humanities and social and behavioural sciences, may find the statutory
p.000007: definition of ‘health research’ to favour biomedical research. In particular, they may perceive that the
p.000007: so-called ‘medical model’ for ethics review dominates and is applied frequently but inappropriately to social
p.000007: science, especially qualitative research.
p.000007: 1.1.6 These guidelines do not advocate the so-called ‘medical model’ of ethics review, especially not for
p.000007: social science, behavioural or humanities research. For purposes of this document, ‘health research’ has both a broad
p.000007: and narrow meaning. In the narrow sense, it refers to research carried out in a health care environment,
p.000007: usually with patients, whether in a hospital, clinic or home-based. In the broad sense, it refers to research
p.000007: conducted outside a health care environment, usually not with patients.
p.000007: 1.1.7 The core ethical principles outlined in these guidelines apply to all forms of research that involve living
p.000007: human participants and use of animals, placing their safety, welfare and interests of both humans and animals as
p.000007: paramount. The principles also apply to research that involves use of human biological materials and data collected
p.000007: from living or deceased persons, including human embryos, fetuses, fetal tissue, reproductive materials, and
p.000007: stem cells.
p.000007: 1.1.8 Research that relies exclusively on publicly available information or accessible through legislation or
p.000007: regulation usually need not undergo formal ethics review. This does not mean that ethical considerations are irrelevant
p.000007: to the research.
p.000007: 1.1.9 Research involving observation of people in public spaces and natural environments usually need not undergo
p.000007: formal ethics review, provided that
p.000007:
p.000007: 8 Ethics in Health Research 2nd edition
p.000007:
p.000007:
p.000007: • the researcher does not interact directly with individuals or groups
p.000007: • the researcher does not stage any intervention
p.000007: • the individuals or groups do not have a reasonable expectation of privacy
p.000007: • dissemination of research findings does not identify individuals or groups
p.000007: 1.1.10 Research that relies exclusively on secondary use of anonymous information or anonymous human
p.000007: biological materials usually need not undergo formal ethics review, provided that no identifiable
p.000007: information is generated. See 3.3 below for further information regarding human biological materials.
p.000007: 1.1.11 Quality assurance and quality improvement studies (audits), programme evaluation activities and
...
Social / Incarcerated
Searching for indicator incarcerated:
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p.000039: Recruitment strategies for research participation in general should be sensitive to the possibility that
p.000039: persons with physical disabilities may wish to volunteer and therefore should ensure that there are no unintended
p.000039: barriers to such participation; e.g. the absence of ramps or a lift for wheelchair-bound potential participants.
p.000039: Research involving participants with physical disabilities should anticipate possible barriers and include
p.000039: measures to minimise them.
p.000039: 3.2.8 Prisoners
p.000039:
p.000039: The chief reason to consider prisoners as a vulnerable class of persons is the potential effect of incarceration on
p.000039: the voluntariness of the decision to participate in research. Neither coercion (direct threat of negative
p.000039: sanction) nor undue influence is acceptable in the informed consent process. Researchers should pay
p.000039: attention to whether their intended participants are awaiting trial prisoners or convicted prisoners. Quite
p.000039: obviously, different ethical issues arise for the former group who remain innocent until proven
p.000039: guilty, notwithstanding being incarcerated. The recruitment strategy design must pay careful attention to
p.000039: how coercion and undue influence will be avoided. Similarly, persons administering questionnaires
p.000039: or conducting interviews must be conscious of environmental factors that may influence voluntariness.
p.000039: The REC should include, at least on an ad hoc basis, a member with experience and knowledge of working
p.000039: with prisoners when deliberating on the protocol. The researchers must comply also with the requirements of
p.000039: the Department of Correctional Services as listed at http://www.dcs.gov.za/services/Research.aspx.
p.000039:
p.000039: 40 Ethics in Health Research 2nd edition
p.000039:
p.000039:
p.000039: Research should be conducted amongst prisoners only if
p.000039: • their participation is indispensable to the research
p.000039: • the research cannot be conducted with non-prisoners
p.000039: • the research concerns a problem of relevance to prisoners
p.000039: • sound informed consent processes can be ensured
p.000039: • engagement with relevant role players about the proposed research has occurred.
...
Searching for indicator restricted:
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p.000025: However, certain groups of participants 20 require careful consideration to ensure that, where appropriate,
p.000025: additional precautions are put into place. For example, advanced age, very young age, personal or
p.000025: environmental factors like extreme poverty and ordinarily poor access to health care may increase
p.000025: vulnerability
p.000025: 3.2.1 Contextual circumstances
p.000025: Personal circumstances, such as mental or intellectual impairment, acute illness, advanced age, and pregnancy and
p.000025: childbirth may increase vulnerability. Persons may be factually incapable or less capable of understanding
p.000025: information and processing it to reach a decision
p.000025: e.g. about whether to participate in research. Environmental circumstances may also increase vulnerability such as very
p.000025: poor socio-economic conditions, low levels of formal education and literacy, or restricted access to health care
p.000025: services. Such persons may be more easily persuaded to agree to participate without a properly considered
p.000025: understanding of the implications.
p.000025: It is important to note the difference between legal incapacity and factual incapacity. No person may
p.000025: claim that, because a minor is factually capable, the legal incapacity should be waived. On the other hand, no adult
p.000025: may be assumed to be incapable unless incapacity is established factually. Consequently, mental incapacity must
p.000025: be established by a factual assessment of the individual’s abilities to understand and to
p.000025: communicate that understanding. Legal incapacity prevails notwithstanding the existence of factual capacity.
p.000025: South Africa is home to a number of vulnerable communities. Where factors usually associated with
p.000025: vulnerability are integral to the research, the proposal should demonstrate how vulnerability would be managed.
...
Social / Infant
Searching for indicator infant:
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p.000027:
p.000027: Ethics in Health Research 2nd edition
p.000029: 29
p.000029:
p.000029: ‘Child’ means a person under the age of 18 years (s 28 Constitution; s 1 Children’s Act 38 of 2005)
p.000029: ‘Child-headed household’ means a household per s 137 Children’s Act 38 of 2005
p.000029: ‘Guardian’ means a person appointed by a court to look after the financial and welfare interests of a
p.000029: minor, or a person appointed by a parent with sole responsibility for the minor in terms of the parent’s Will
p.000029: ‘Harm’ means physical, emotional, psychological, social or legal harm
p.000029: ‘Minor’ means a person (child) less than 18 years (s 17 Children’s Act 38 of 2005) ‘Neonate’ means a newborn child,
p.000029: including an infant less than a month old
p.000029: ‘Orphan’ means a child who has no surviving parent caring for him or her (s 1 Children’s Act 38 of 2005)
p.000029: ‘Parent’ includes an adoptive parent (s 1 Children’s Act 38 of 2005)
p.000029: ‘Therapeutic research’ means research that includes interventions that may hold out the prospect of direct
p.000029: health-related benefit for the participant (Regulation 135)
p.000029: ‘Non-therapeutic research’ means research that includes interventions that will not hold out the prospect of direct
p.000029: health-related benefit for the participant but may produce results that contribute to generalisable knowledge
p.000029: (Regulation 135)
p.000029: 3.2.2.1 Minimum conditions for research involving minors
p.000029: The following considerations are critical when RECs review proposals to involve child participants:
p.000029: a) Children should participate in research when their participation is scientifically indispensable to the
p.000029: research. In the case of interventional clinical research, equipoise 25 should exist. Research should
p.000029: investigate a problem of relevance to children. The protocol should provide sufficient information to
p.000029: justify clearly why children should be included as participants.
...
p.000035: Note that the informed consent documents must explain carefully and fully what the possible effect of the research
p.000035: activities on the fetus might be.
p.000035: Usually, research involving pregnant women should be undertaken when
p.000035: • the purpose of the proposed research is to meet the health needs of the mother of the particular fetus;
p.000035: • appropriate studies on animals and non-pregnant individuals have been completed;31
p.000035: • the risk of harm to the fetus is minimal; and
p.000035:
p.000035: 31 Clinical trials involving pregnant women or nursing mothers should ideally involve products where the toxicology in
p.000035: adults is established and is acceptable. In the case of pregnant women, the potential risks associated with using a
p.000035: substance whose short term and long-term effects on a fetus and developing infant are unknown, should be outweighed by
p.000035: the benefits. An example of a positive risk-benefit ratio would be the use of anti-retrovirals in mother to child HIV
p.000035: transmission studies. For nursing mothers, the amount of drug passing into breast milk should be established and the
p.000035: potential impact on a breast-fed infant anticipated, and the mother so advised.
p.000035:
p.000035: 36 Ethics in Health Research 2nd edition
p.000035:
p.000035:
p.000035: • in all cases, inclusion poses the least risk of harm possible for achieving the objectives of the research.
p.000035: 3.2.4 Adults with factual incapacity to provide informed consent
p.000035:
p.000035: Adults who are factually incapable of giving informed consent should participate in research only where their
p.000035: participation is indispensable to the research; i.e. the research cannot deliver the desired outcomes if
p.000035: capable adult participants were to be used instead. Further, the research should investigate a problem of
p.000035: relevance to incapacitated adults. Where research can be undertaken with capable adults but nevertheless proposes
p.000035: also to include incapacitated adults, strong justification for their inclusion must be provided.
p.000035: The primary difficulty for informed consent in this context is whether proxy consent is permissible. The
p.000035: best interest principle is often used in connection with decisions relating to whether incapacitated adults should be
...
p.000045: alternative approaches such as proxy consent or delaying consent in particular circumstances. (See 3.2.4.3, 3.2.4.4 &
p.000045: 3.2.6.)
p.000045: 3.4.2 Intensive care research
p.000045:
p.000045: Characteristic features of intensive care research include difficulties in communicating with patients receiving
p.000045: ventilation assistance and impairment of cognition in heavily sedated individuals.
p.000045: Whenever possible, informed consent for planned intensive care research should be obtained from potential participants
p.000045: before admission to that care. See 3.2.4.3, 3.2.4.4 & 3.2.6.
p.000045: Research involving infants receiving neonatal intensive care should be conducted in strict accordance with
p.000045: the principles set out for minors (see 3.2.1 above). These principles do not permit research that is contrary to
p.000045: the child’s best interest. The small size and extreme vulnerability of some infants are unique features of this
p.000045: class of participants. This means that all but minimally intrusive interventions are likely to be contrary to the
p.000045: child’s best interest. Collection of even small blood samples for research in addition to those required
p.000045: for diagnostic purposes, or additional handling of a low birth-weight infant to make research- related observations,
p.000045: requires very careful justification and skill, especially in assessing the risk-benefit ratio. Input from neonatal
p.000045: intensive care experts should be sought.
p.000045:
p.000045: Ethics in Health Research 2nd edition
p.000047: 47
p.000047:
p.000047: 3.4.3 Terminal care research
p.000047:
p.000047: Terminal care research is distinguished by the short remaining life expectancy of participants and their potential
p.000047: vulnerability to unrealistic expectations of benefits from participation in research. In principle, because of their
p.000047: extreme vulnerability, terminally ill patients should not participate in research that is more than minimally invasive
p.000047: without adequate justification.
p.000047: The prospect of any direct benefit from research participation must not be overstated or used to justify a risk of harm
p.000047: higher than that involved in current treatment. Research participation must not be used to prevent or devalue the needs
p.000047: and wishes of participants rather to spend time as they choose, particularly with family members.
p.000047: 3.4.4 Traditional medicines research
p.000047:
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000015: probability of its occurrence should be addressed.
p.000015: Usually, participants who might face undue risk of harm should not be included in the study, even if they represent a
p.000015: category of person that may benefit from the research. On the other hand, research with such persons may
p.000015: nevertheless be approved after careful review and acceptable justification that demonstrates the anticipated
p.000015: importance and value of the research for society. In such cases, a carefully phased approach should be adopted.
p.000015: 2.3.5 Fair selection of participants
p.000015: This means recruitment, selection, exclusion and inclusion of participants for research must be just and fair,
p.000015: based on sound scientific and ethical principles. Persons should not be excluded unreasonably or unfairly
p.000015: on the basis of any of the prohibited grounds for discrimination: race, age, sex, sexual orientation,
p.000015: disability, education, religious belief, pregnancy, marital status, ethnic or social origin, conscience, belief or
p.000015: language (s 8 of the Constitution). Similarly, persons should not be unfairly targeted for research merely on the basis
p.000015: of one or other of these grounds.
p.000015: 2.3.6 Informed consent
p.000015: In general, participation in research must be voluntary and predicated on informed choices. Voluntariness and
p.000015: informed choices are evidenced by the informed consent process which must take place before the research
p.000015: commences, in principle, and be affirmed during the
p.000015:
p.000015: Ethics in Health Research 2nd edition
p.000017: 17
p.000017:
p.000017: course of the study, as part of the commitment to an ongoing consent process. In some circumstances,
p.000017: research may not require prior consent (see 3.2.5 & 3.3)
p.000017: 2.3.7 Ongoing respect for enrolled participants
p.000017: A research participant has the right to privacy and to confidentiality. This requires that a proposal
p.000017: must explain how these constitutionally protected rights will be managed and protected in the course of the
p.000017: research. Simply stated, privacy is concerned with who has access to personal information and records about the
p.000017: participant; including clinical health care records. On the other hand, ‘confidentiality’ is about ensuring that
p.000017: appropriate measures will be implemented to prevent disclosure of information that might identify the participant
...
p.000023: permit sufficient time for consultation between the recruitment approach and the point of decision-making. No person
p.000023: should be required to make an immediate decision. The informed consent process for adults with diminished
p.000023: or no decision-making capacity (factually incapacitated) and for minors (legally incapacitated) is described at
p.000023: 3.2.4.3 and 3.2.4.2 respectively.
p.000023: RECs should assess the proposed process for informed consent as well as the information that potential participants
p.000023: will be given and the measures to facilitate understanding. Considerations for assessment include whether
p.000023: • the setting will
p.000023: o minimise the possibility of undue influence
p.000023: o be sufficiently private and appropriate
p.000023:
p.000023: 16 ‘Biometrics means a technique of personal identification that is based on physical, physiological or behaviour
p.000023: characterisation including blood typing, fingerprinting, DNA analysis, retinal scanning and voice recognition’ (s 1 of
p.000023: the Act).
p.000023:
p.000023: Ethics in Health Research 2nd edition
p.000025: 25
p.000025:
p.000025: • the person who will conduct the process
p.000025: o will be appropriately trained, independent and bias-free
p.000025: • the text
p.000025: o is in plain language and appropriate to the participants’ level of understanding17
p.000025: o is free of jargon and unexplained acronyms
p.000025: o is clear and explains technical terminology e.g. randomisation
p.000025: o is translated into language(s) appropriate to the context
p.000025: o states that participants may contact the REC at the contact details provided if they have queries or complaints
p.000025: about their rights and welfare as research participants
p.000025: o states that participants may contact the researcher at the contact details provided if they have queries about the
p.000025: research project
p.000025: o conforms to the proposal
p.000025: • the information explains
p.000025: o that the person is being asked to participate in research
p.000025: o that the choice whether to participate is voluntary
p.000025: o that refusal to participate will not be penalised
p.000025: o that choosing to participate can be reversed, i.e. the person may decide to terminate participation at
p.000025: any time without explanation or prejudice
p.000025: o the purpose and nature of the research procedures and components
p.000025: o the research-related activities and procedures that the participant is being asked to consent to
p.000025: o the expected duration of participation
p.000025: o the nature of the participant’s responsibilities
p.000025: o the nature of the researcher’s responsibilities
p.000025: o the anticipated risks of harm or discomfort
p.000025: o the measures to minimise risk of harm
p.000025: o the extent to which confidentiality is possible
p.000025: o whether reimbursement for expenses is available
p.000025: o that sponsors of the research and regulatory authorities may inspect research records
p.000025: o who the researchers are and the nature of their expertise
...
p.000025: • the research is relevant to the health needs and priorities of the community in which it is to be carried out;
p.000025: and that
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 19 UNAIDS defines ‘vulnerable community’ as having some or all of the following characteristics: limited economic
p.000025: development; inadequate protection of human rights and discrimination on the basis of the health status; inadequate
p.000025: community/cultural experience and understanding of scientific research; limited access to health care and treatment
p.000025: options; limited ability of individuals in the community to provide informed consent.
p.000025: 20 For further, more detailed, discussion on special classes of participants, see CIOMS International Ethical
p.000025: Guidelines for Biomedical
p.000025: Research Involving Human Subjects (2002) Guidelines 13-17,
p.000025: http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm; US Department of Health & Human Services,
p.000025: Office for Human Research Protections, http://www.hhs.gov/ohrp.
p.000025:
p.000025: Ethics in Health Research 2nd edition
p.000027: 27
p.000027:
p.000027: • research participants know they will take part in research; and that the research will be carried out only with
p.000027: their consent.21 Particular attention should be given to the content, language(s) and procedures used to obtain
p.000027: informed consent.
p.000027: Note, however, that RECs should avoid patronising assumptions about a community’s ability to make responsible
p.000027: decisions. Factual information is required before deciding that a community is too vulnerable to be invited to
p.000027: choose whether to participate in research.
p.000027: In order to ensure optimal protection of vulnerable participants, the REC may impose additional protective
p.000027: measures for the informed consent process; or require increased monitoring and interim reporting on
p.000027: participants’ welfare; or require post-recruitment reviews of the effectiveness of the protective measures
p.000027: imposed. Other measures may also be appropriate.
p.000027: Note that the decision to impose additional measures should flow from an assessment of the nature of the research and
p.000027: the circumstances of the potential participants. In other words, additional protective measures should not be automatic
p.000027: just because a vulnerable group will be recruited; rather, the decision should be based on the particular
p.000027: circumstances of the proposal before the REC. For example, an automatic assumption that impoverished people cannot
p.000027: choose responsibly whether to participate in research is disrespectful because it denies their autonomy.
...
p.000045: intensive care experts should be sought.
p.000045:
p.000045: Ethics in Health Research 2nd edition
p.000047: 47
p.000047:
p.000047: 3.4.3 Terminal care research
p.000047:
p.000047: Terminal care research is distinguished by the short remaining life expectancy of participants and their potential
p.000047: vulnerability to unrealistic expectations of benefits from participation in research. In principle, because of their
p.000047: extreme vulnerability, terminally ill patients should not participate in research that is more than minimally invasive
p.000047: without adequate justification.
p.000047: The prospect of any direct benefit from research participation must not be overstated or used to justify a risk of harm
p.000047: higher than that involved in current treatment. Research participation must not be used to prevent or devalue the needs
p.000047: and wishes of participants rather to spend time as they choose, particularly with family members.
p.000047: 3.4.4 Traditional medicines research
p.000047:
p.000047: In line with the constitutional guarantees for cultural and language rights, 40 indigenous cultures and
p.000047: traditional values of all communities must be respected. However, since fundamental rights do not trump
p.000047: each other without careful justification, participants in research involving traditional medical systems and
p.000047: beliefs must be accorded the same respect and protection as any other human research participant. 41 The
p.000047: context of the research activity, interaction or intervention is important for determining whether, how and when to
p.000047: incorporate traditional values and their cultural expression in research.
p.000047: In terms of the Traditional Health Practitioners Act 22 of 2007,
p.000047: 'Traditional medicine' means an object or substance used in traditional health practice for-
p.000047: (a) the diagnosis, treatment or prevention of a physical or mental illness; or
p.000047: (b) any curative or therapeutic purpose, including the maintenance or restoration of physical or mental health or
p.000047: well-being in human beings,
p.000047: but does not include a dependence-producing or dangerous substance or drug.
p.000047: 'Traditional health practice' means the performance of a function, activity, process or service based on a
p.000047: traditional philosophy that includes the utilisation of traditional medicine or traditional practice and which has as
p.000047: its object-
...
p.000061: • protocol deviations and protocol violations
p.000061: • non-compliance consequences
p.000061: • suspension and termination
p.000061: • compliance checks and audits
p.000061: • informed consent
p.000061: • privacy and confidentiality regarding participants and their health care information
p.000061: • research involving minors
p.000061: • research involving vulnerable persons
p.000061: • data collection and storage
p.000061: • biological materials collection and storage
p.000061: • databases, registries and repositories
p.000061: • complaints procedures
p.000061: • whistleblower protection
p.000061:
p.000061: 4.5.1.1 Applications for ethics review
p.000061: i. Each research proposal should include a description of the ethical considerations implicated in the
p.000061: research.
p.000061: ii. The protocol should reflect adequate consideration of participants’ welfare, rights, beliefs,
p.000061: perceptions, customs and cultural heritage.
p.000061: iii. All documents and other material to be used to inform potential participants should be included in the ethics
p.000061: review application, such as information sheets, consent forms, questionnaires, advertisements, videos, dramatisations
p.000061: and letters.
p.000061: iv. Researchers should ensure that plain language adapted to anticipated literacy levels is used in the participant
p.000061: documentation. An indication of the readability level should be included (see also 3.1.9).
p.000061: v. Where research is to be conducted in community settings, evidence of consultation and plans for ongoing
p.000061: involvement should be included.
p.000061: vi. Animal research protocols should explain comprehensively how the welfare interests of the animals will be
p.000061: attended to.
p.000061: vii. Animal research protocols should include monitoring schedules listing the responsible persons and their
p.000061: contact numbers, the schedule and indicators for analgesia delivery and so forth.
p.000061: viii. Protocols for clinical trials and studies involving a moderate increase over minimal risk should include
p.000061: monitoring schedules, the responsible persons and their contact numbers.
p.000061:
p.000061: 62 Ethics in Health Research 2nd edition
p.000061:
p.000061:
p.000061: ix. Researchers should disclose conflicts of interest, financial interests and information that may result
p.000061: in perceptions of conflict of interest.
p.000061: 4.5.1.2 Decision making and feedback to applicants
p.000061: i. After the deliberative review process, the REC should approve, require amendment to, or reject a research
p.000061: proposal.
p.000061: ii. In considering a research protocol, the REC may seek assistance from experts, but such experts may have no
p.000061: conflicts of interest in relation to the application.
p.000061: iii. Decisions of the REC should be recorded in writing.
...
p.000063: • Copy of the signed final proposal or protocol approved
p.000063: • Whether and how consultation occurred
p.000063: • Records of adverse events
p.000063: • Records of amendments
p.000063: • Reports of adverse and serious adverse events and action taken
p.000063: • Other relevant information such as complaints from participants
p.000063: iv. RECs should correspond primarily with the principal investigator or a delegated signatory, and not with
p.000063: the sponsor unless dictated by particular circumstances.
p.000063: 4.5.1.7 Conflict of interest
p.000063: i. REC members should disclose information that may lead to perceptions of conflict of interest.
p.000063: ii. REC members should not review or make decisions about research proposals in which they are involved personally or
p.000063: financially. When such a proposal is to be discussed, the member concerned should declare the potential conflict
p.000063: and offer to recuse herself from the meeting for that time. Should the member be permitted to remain for the
p.000063: discussion at the discretion of the Chairperson, the member may not participate in the final decision-making on the
p.000063: application in question.
p.000063:
p.000063: 64 Ethics in Health Research 2nd edition
p.000063:
p.000063:
p.000063: 4.5.1.8 Advocacy
p.000063: The REC should be alert to whether an advocate for special interest groups of participants proposed for particular
p.000063: research would add value to the review process for informed responsible decision making in the context.
p.000063: 4.5.1.9 Translators
p.000063: i. Where research participants do not adequately comprehend or speak the language used in the protocol,
p.000063: translation of information and consent documentation is important. Similarly, it is often desirable to
p.000063: have people who are fluent in the language of the intended participants to assist with the consent process.
p.000063: ii. The REC should be alert to the potential for poor consent processes in the absence of appropriately translated
p.000063: materials and the availability of translators.
p.000063: iii. If a translator will be used in the consent process and be present for the discussions, the information
p.000063: materials should state that privacy will be compromised to that extent.
p.000063: iv. A translator should not influence potential participants unduly during the interpretation
p.000063: process.
p.000063: 4.5.1.10 Monitoring
p.000063: i. RECs have the right to monitor the research it approves (Declaration of Helsinki 2013 par 23). Researchers should
p.000063: provide appropriate information to the REC to facilitate monitoring, including alerts and investigator brochures.
p.000063: The frequency and type of monitoring should reflect the degree and extent of risk of harm to
p.000063: participants or animals.
p.000063: ii. RECs may recommend and adopt any additional appropriate mechanism for monitoring, including
p.000063: random inspection of research sites, welfare monitoring sheets, data and signed consent forms, and records of
...
p.000085: < Insert Phone Number/Pager, etc >
p.000085:
p.000085:
p.000085: < Insert name of investigational drug or other intervention > is a treatment that < insert either current approval status
p.000085: by the Medicines Control Council for another condition or provide a patient appropriate explanation of what
p.000085: the investigational drug or intervention is intended to do >.
p.000085:
p.000085: This treatment is not approved for < indicate what condition the patient has >, which means its use is experimental. We
p.000085: are not sure that this experimental treatment will cure or improve your condition. But in your circumstances, we offer
p.000085: you the opportunity to try it.
p.000085:
p.000085: Ethics in Health Research 2nd edition
p.000087: 87
p.000087:
p.000087: We must get permission from the hospital authorities before we may use this experimental treatment
p.000087: for you. The hospital authorities keep a careful watch over your welfare interests, especially that you
p.000087: should choose voluntarily. This is why you are asked to choose whether you would like to try the experimental treatment
p.000087: before we request permission to use the drug for you.
p.000087: You do not have to use the experimental treatment.
p.000087: Why is this experimental treatment being offered?
p.000087: Your doctors think this experimental treatment may offer an option for your clinical care, as < insert in plain language
p.000087: a description that describes why this treatment is the best option for the patient in the circumstances >
p.000087:
p.000087: How long will I take this experimental treatment?
p.000087: The total length of time you would receive this treatment will depend on many factors including: (i) how your medical
p.000087: condition responds to the experimental treatment, and (ii) further information about this use of the drug in
p.000087: your medical condition
p.000087: [Incorporate a specific schedule for the receipt of the investigational drug, if one is known] What does the
p.000087: experimental treatment involve?
p.000087: You will receive this experimental treatment in < location where the treatment (i.e. hospital
p.000087: (clinic/medical ward/OPD), home, private care, etc) will be given >. You will be asked to take a < insert appropriate
p.000087: dose (mg/mcg/ml) > dose < insert dosing schedule, i.e. once-off, once per day, 12 hourly, etc >
p.000087:
p.000087: [Be sure to include any other drugs that are taken in combination with the experimental treatment drug if appropriate
p.000087: Provide information pertaining to any safety or other assessments needed during the time that the patient receives the
p.000087: experimental treatment drug]
p.000087:
p.000087: What are the possible side effects or risks of harm?
p.000087: •Likely: < Provide appropriate risk listing >
...
p.000087: threatening
p.000087:
p.000087: What are the possible benefits of using this experimental treatment?
p.000087: You may or may not receive any benefit from using this treatment; in other words, your condition may not respond
p.000087: to the treatment.
p.000087:
p.000087: 88 Ethics in Health Research 2nd edition
p.000087:
p.000087:
p.000087: What if new information about the experimental treatment becomes available?
p.000087: While you are using this treatment, we may find out more information that could be important to your treatment.
p.000087: This includes information that might cause you to change your mind about taking the drug. We will tell you as
p.000087: soon as possible if such information becomes available so that you are informed at all times.
p.000087:
p.000087: What other choices do I have if I do not use this experimental treatment?
p.000087: Your doctors think that, at the moment, there are no other satisfactory alternatives available to you. You do have the
p.000087: option of deciding to refuse further treatment and only accept care for comfort. You can discuss these options with
p.000087: your doctors.
p.000087:
p.000087: What happens if I am harmed because of using the experimental treatment?
p.000087: We will give you the necessary medical care to treat the harms or injuries that result directly from using the
p.000087: experimental treatment.
p.000087:
p.000087: When will my participation be over?
p.000087: Your participation will last until < insert endpoint in appropriate language based on investigational drug
p.000087: being used >.
p.000087:
p.000087: If you decide to use this experimental treatment, you are free to stop taking it any time. Please
p.000087: inform your treating physician(S) if you choose to do this, so appropriate follow-up can occur.
p.000087:
p.000087: [Ensure that whether withdrawal is possible is clear to patient or family member]
p.000087:
p.000087: Who can see or use my information? How will my personal information be protected?
p.000087: The personal information in your medical record will be kept confidential as is usual with health
p.000087: information. However, we cannot guarantee total privacy. Your personal information may be shared with other health care
p.000087: professionals where it is in your best interest to do so and if required by law.
p.000087:
p.000087: Who can I call if I have questions, concerns or complaints?
p.000087: If you have questions, concerns or complaints, you should speak to your doctor listed on page one of this form.
p.000087:
p.000087: Who will know that I am receiving an experimental treatment?
p.000087: Your doctors and the rest of the medical team will know that you are using an experimental treatment.
p.000087: As explained above, your doctor will have obtained permission from the hospital authorities to use it.
p.000087: As is usual, your privacy interests will be respected and information about your treatment and condition will be
p.000087: confidential to the extent possible.
p.000087: Because of its experimental nature, we will want to write a report about what we learn from using this therapy for your
p.000087: treatment. This is to make the information available so that other doctors can learn more about it too. However, your
...
Social / Literacy
Searching for indicator illiterate:
(return to top)
p.000091: the project is completed (Tick one choice from each of the following boxes)
p.000091:
p.000091: □ I wish my [TYPE OF SAMPLE] sample to be destroyed immediately.
p.000091: □ I want my [TYPE OF SAMPLE] sample to be destroyed after years.
p.000091: □ I give permission for my [TYPE OF SAMPLE] sample to be stored indefinitely AND (if the sample is to be stored)
p.000091:
p.000091: □ I give permission for my (TYPE OF SAMPLE) sample to be stored and used in future research but only on the same
p.000091: subject as the current research project : [give name of current research]
p.000091: □ I give my permission for my [TYPE OF SAMPLE] sample to be stored and used in future research of any
p.000091: type which has been properly approved
p.000091: □ I give permission for my [TYPE OF SAMPLE] sample to be stored and used in future research except for research about
p.000091: [NAME TYPE OF RESEARCH]
p.000091:
p.000091: AND
p.000091:
p.000091: □ I want my identity to be removed from my (TYPE OF SAMPLE) sample.
p.000091: □ I want my identity to be kept with my (TYPE OF SAMPLE) sample.
p.000091:
p.000091:
p.000091:
p.000091: I have read the information, or it has been read to me. I have had the opportunity to ask questions about it and my
p.000091: questions have been answered to my satisfaction. I consent voluntarily to have my samples stored in the manner
p.000091: and for the purpose indicated above.
p.000091:
p.000091: Print Name of Participant
p.000091:
p.000091:
p.000091: Signature of Participant Date
p.000091:
p.000091: Day/month/year
p.000091:
p.000091:
p.000091: If illiterate, a literate witness must sign (if possible, this person should be selected by the participant and
p.000091: should have no connection to the research team). Participants who are illiterate should make their mark.
p.000091:
p.000091: Ethics in Health Research 2nd edition
p.000093: 93
p.000093: I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had
p.000093: the opportunity to ask questions. I confirm that the individual has given consent freely.
p.000093:
p.000093: Print name of witness Signature of witness
p.000093: Date
p.000093: Day/month/year
p.000093: AND mark of participant
p.000093:
p.000093:
p.000093:
p.000093: Statement by the researcher/person taking consent
p.000093: I have read out the information sheet to the potential participant accurately and, to the best of my ability, I have
p.000093: ensured that the participant understands that the following will be done:
p.000093: 1.
p.000093: 2.
p.000093: 3.
p.000093: I confirm that the participant had the opportunity to ask questions about the nature and manner of
p.000093: storage of the samples, and that all the questions asked by the participant were answered to the best of my
p.000093: ability. I confirm that consent has been given freely and voluntarily.
p.000093: A copy of this document has been provided to the participant.
p.000093:
p.000093:
p.000093: Print Name of Researcher/person taking the consent
p.000093:
p.000093:
p.000093: Signature of Researcher /person taking the consent Date
p.000093:
...
Searching for indicator literacy:
(return to top)
p.000025: However, certain groups of participants 20 require careful consideration to ensure that, where appropriate,
p.000025: additional precautions are put into place. For example, advanced age, very young age, personal or
p.000025: environmental factors like extreme poverty and ordinarily poor access to health care may increase
p.000025: vulnerability
p.000025: 3.2.1 Contextual circumstances
p.000025: Personal circumstances, such as mental or intellectual impairment, acute illness, advanced age, and pregnancy and
p.000025: childbirth may increase vulnerability. Persons may be factually incapable or less capable of understanding
p.000025: information and processing it to reach a decision
p.000025: e.g. about whether to participate in research. Environmental circumstances may also increase vulnerability such as very
p.000025: poor socio-economic conditions, low levels of formal education and literacy, or restricted access to health care
p.000025: services. Such persons may be more easily persuaded to agree to participate without a properly considered
p.000025: understanding of the implications.
p.000025: It is important to note the difference between legal incapacity and factual incapacity. No person may
p.000025: claim that, because a minor is factually capable, the legal incapacity should be waived. On the other hand, no adult
p.000025: may be assumed to be incapable unless incapacity is established factually. Consequently, mental incapacity must
p.000025: be established by a factual assessment of the individual’s abilities to understand and to
p.000025: communicate that understanding. Legal incapacity prevails notwithstanding the existence of factual capacity.
p.000025: South Africa is home to a number of vulnerable communities. Where factors usually associated with
p.000025: vulnerability are integral to the research, the proposal should demonstrate how vulnerability would be managed.
...
p.000061: • suspension and termination
p.000061: • compliance checks and audits
p.000061: • informed consent
p.000061: • privacy and confidentiality regarding participants and their health care information
p.000061: • research involving minors
p.000061: • research involving vulnerable persons
p.000061: • data collection and storage
p.000061: • biological materials collection and storage
p.000061: • databases, registries and repositories
p.000061: • complaints procedures
p.000061: • whistleblower protection
p.000061:
p.000061: 4.5.1.1 Applications for ethics review
p.000061: i. Each research proposal should include a description of the ethical considerations implicated in the
p.000061: research.
p.000061: ii. The protocol should reflect adequate consideration of participants’ welfare, rights, beliefs,
p.000061: perceptions, customs and cultural heritage.
p.000061: iii. All documents and other material to be used to inform potential participants should be included in the ethics
p.000061: review application, such as information sheets, consent forms, questionnaires, advertisements, videos, dramatisations
p.000061: and letters.
p.000061: iv. Researchers should ensure that plain language adapted to anticipated literacy levels is used in the participant
p.000061: documentation. An indication of the readability level should be included (see also 3.1.9).
p.000061: v. Where research is to be conducted in community settings, evidence of consultation and plans for ongoing
p.000061: involvement should be included.
p.000061: vi. Animal research protocols should explain comprehensively how the welfare interests of the animals will be
p.000061: attended to.
p.000061: vii. Animal research protocols should include monitoring schedules listing the responsible persons and their
p.000061: contact numbers, the schedule and indicators for analgesia delivery and so forth.
p.000061: viii. Protocols for clinical trials and studies involving a moderate increase over minimal risk should include
p.000061: monitoring schedules, the responsible persons and their contact numbers.
p.000061:
p.000061: 62 Ethics in Health Research 2nd edition
p.000061:
p.000061:
p.000061: ix. Researchers should disclose conflicts of interest, financial interests and information that may result
p.000061: in perceptions of conflict of interest.
p.000061: 4.5.1.2 Decision making and feedback to applicants
p.000061: i. After the deliberative review process, the REC should approve, require amendment to, or reject a research
p.000061: proposal.
p.000061: ii. In considering a research protocol, the REC may seek assistance from experts, but such experts may have no
p.000061: conflicts of interest in relation to the application.
p.000061: iii. Decisions of the REC should be recorded in writing.
...
Searching for indicator literate:
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p.000091: the project is completed (Tick one choice from each of the following boxes)
p.000091:
p.000091: □ I wish my [TYPE OF SAMPLE] sample to be destroyed immediately.
p.000091: □ I want my [TYPE OF SAMPLE] sample to be destroyed after years.
p.000091: □ I give permission for my [TYPE OF SAMPLE] sample to be stored indefinitely AND (if the sample is to be stored)
p.000091:
p.000091: □ I give permission for my (TYPE OF SAMPLE) sample to be stored and used in future research but only on the same
p.000091: subject as the current research project : [give name of current research]
p.000091: □ I give my permission for my [TYPE OF SAMPLE] sample to be stored and used in future research of any
p.000091: type which has been properly approved
p.000091: □ I give permission for my [TYPE OF SAMPLE] sample to be stored and used in future research except for research about
p.000091: [NAME TYPE OF RESEARCH]
p.000091:
p.000091: AND
p.000091:
p.000091: □ I want my identity to be removed from my (TYPE OF SAMPLE) sample.
p.000091: □ I want my identity to be kept with my (TYPE OF SAMPLE) sample.
p.000091:
p.000091:
p.000091:
p.000091: I have read the information, or it has been read to me. I have had the opportunity to ask questions about it and my
p.000091: questions have been answered to my satisfaction. I consent voluntarily to have my samples stored in the manner
p.000091: and for the purpose indicated above.
p.000091:
p.000091: Print Name of Participant
p.000091:
p.000091:
p.000091: Signature of Participant Date
p.000091:
p.000091: Day/month/year
p.000091:
p.000091:
p.000091: If illiterate, a literate witness must sign (if possible, this person should be selected by the participant and
p.000091: should have no connection to the research team). Participants who are illiterate should make their mark.
p.000091:
p.000091: Ethics in Health Research 2nd edition
p.000093: 93
p.000093: I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had
p.000093: the opportunity to ask questions. I confirm that the individual has given consent freely.
p.000093:
p.000093: Print name of witness Signature of witness
p.000093: Date
p.000093: Day/month/year
p.000093: AND mark of participant
p.000093:
p.000093:
p.000093:
p.000093: Statement by the researcher/person taking consent
p.000093: I have read out the information sheet to the potential participant accurately and, to the best of my ability, I have
p.000093: ensured that the participant understands that the following will be done:
p.000093: 1.
p.000093: 2.
p.000093: 3.
p.000093: I confirm that the participant had the opportunity to ask questions about the nature and manner of
p.000093: storage of the samples, and that all the questions asked by the participant were answered to the best of my
p.000093: ability. I confirm that consent has been given freely and voluntarily.
p.000093: A copy of this document has been provided to the participant.
p.000093:
p.000093:
...
Social / Marital Status
Searching for indicator marital status:
(return to top)
p.000015: benefit from the research. In assessing the risk of harm, both the magnitude or seriousness of the harm and the
p.000015: probability of its occurrence should be addressed.
p.000015: Usually, participants who might face undue risk of harm should not be included in the study, even if they represent a
p.000015: category of person that may benefit from the research. On the other hand, research with such persons may
p.000015: nevertheless be approved after careful review and acceptable justification that demonstrates the anticipated
p.000015: importance and value of the research for society. In such cases, a carefully phased approach should be adopted.
p.000015: 2.3.5 Fair selection of participants
p.000015: This means recruitment, selection, exclusion and inclusion of participants for research must be just and fair,
p.000015: based on sound scientific and ethical principles. Persons should not be excluded unreasonably or unfairly
p.000015: on the basis of any of the prohibited grounds for discrimination: race, age, sex, sexual orientation,
p.000015: disability, education, religious belief, pregnancy, marital status, ethnic or social origin, conscience, belief or
p.000015: language (s 8 of the Constitution). Similarly, persons should not be unfairly targeted for research merely on the basis
p.000015: of one or other of these grounds.
p.000015: 2.3.6 Informed consent
p.000015: In general, participation in research must be voluntary and predicated on informed choices. Voluntariness and
p.000015: informed choices are evidenced by the informed consent process which must take place before the research
p.000015: commences, in principle, and be affirmed during the
p.000015:
p.000015: Ethics in Health Research 2nd edition
p.000017: 17
p.000017:
p.000017: course of the study, as part of the commitment to an ongoing consent process. In some circumstances,
p.000017: research may not require prior consent (see 3.2.5 & 3.3)
p.000017: 2.3.7 Ongoing respect for enrolled participants
p.000017: A research participant has the right to privacy and to confidentiality. This requires that a proposal
p.000017: must explain how these constitutionally protected rights will be managed and protected in the course of the
p.000017: research. Simply stated, privacy is concerned with who has access to personal information and records about the
...
Searching for indicator single:
(return to top)
p.000041: Written informed consent is required prior to removal of biological material from a living donor (NHA ss
p.000041: 56 and 62).
p.000041: In the case of a deceased person, consent to removal and use of biological materials may be found in the Will of the
p.000041: person, in a written statement or in a witnessed oral statement (NHA s 62(1)(a)) or may be provided by ‘the spouse,
p.000041: partner, major child, parent, guardian, major brother or major sister of that person in the specific order mentioned’
p.000041: (NHA s 62(2))
p.000041: Because biological specimens may be collected for diagnostic, therapeutic or health research purposes, RECs should
p.000041: assess whether the nature of the planned usage is explained adequately so that the purpose for which consent
p.000041: is being requested is completely clear.
p.000041: RECs must also consider the circumstances under which re-consent from donors would be sought, bearing in mind specific
p.000041: local or national needs.
p.000041: Different forms of consent are implicated:
p.000041:
p.000041: Ethics in Health Research 2nd edition
p.000043: 43
p.000043:
p.000043: i. Narrow (restrictive) consent: the donor permits use of the biological specimen for single use only; no
p.000043: storage of leftover specimen; and no sharing of data or specimen. This form necessitates new consent if further use is
p.000043: desirable.
p.000043: ii. Tiered consent: the donor provides consent for the primary study and chooses whether to permit
p.000043: storage for future use, sample and data sharing.
p.000043: iii. Broad consent: the donor permits use of the specimen for current research, for storage and possible
p.000043: future research purposes,35 even though the precise nature of future research may be unclear at present. The nature of
p.000043: the further usage should be described as fully as possible and should stipulate that further prior ethics review of the
p.000043: new study is necessary. Permission may be sought to re-contact the person if intended future use is
p.000043: outside the scope of the current consent.36
p.000043: RECs should also bear in mind the vision of the H3Africa Initiative and its recommendation that consent should be
p.000043: ‘broad enough to allow for future and secondary uses of data, in line with the opportunities to use
p.000043: such data in advancing knowledge to improve health. The consent processes need to be appropriate for the
p.000043: cultural contexts in which the research takes place and tailored accordingly’.37
...
p.000049: efficacy and risk of harm of the proposed therapy, intervention or procedure to the patient; the
p.000049: clinical information that supports its use;
p.000049:
p.000049: Ethics in Health Research 2nd edition
p.000051: 51
p.000051:
p.000051: whether a research profile regarding its use exists; the availability and cost implications of the therapy,
p.000051: intervention or procedure; and whether other patients might also benefit from the therapy, intervention or
p.000051: procedure. On the other hand, research ethics considerations require a research study to be planned and
p.000051: conducted in accordance with the highest scientific and ethical standards. This means that prior review of the
p.000051: proposal is conducted by peers and by persons with expertise in research ethics.
p.000051: In the context of considering motivations for novel, innovative or unproven therapy, the roles of the two committees
p.000051: complement each other directly. In other words, whether use of a therapy, intervention or procedure that is not
p.000051: standard of care is clinically ethical may require consideration also of whether a research study is called for in
p.000051: order to answer the clinically ethical question. If so, then research ethics considerations are triggered.
p.000051: Current biomedical research ethics guidelines indicate that a single case report (≤ 3 patients) is usually exempt from
p.000051: research ethics approval. This is because a single case report does not generate sufficient generalisable
p.000051: knowledge. However, journal editors may require evidence of patients’ written consent as a condition of
p.000051: publication. In social sciences, however, a case study (n=1) is a fully valid research activity. For example,
p.000051: documenting an exception to a rule, theory and so on is a particularly powerful research finding. Exemption from ethics
p.000051: scrutiny is thus unlikely. A biomedical case series ( >3 cases) usually triggers the need for research ethics review,
p.000051: since generalizable knowledge can be generated.
p.000051: 3.5.2 Databases, registries and repositories
p.000051: Databases, registries (data banks) and repositories (tissue banks) may be created for research, diagnostic
p.000051: or clinical purposes.44 They constitute a valuable research resource and allow researchers to pursue questions that
p.000051: were not anticipated at the time of collection of either data or material.
p.000051: 3.5.2.1 Terminology
p.000051: From a regulatory and ethics point of view, the three forms of data or specimen storage are treated similarly.
p.000051: Consequently, in these Guidelines, references to repositories apply also to databases, registries or tissue banks.
p.000051: ‘Database’ means a collection of information including images (data) arranged to facilitate swift search and retrieval.
p.000051: It may be electronic or paper-based.
p.000051: ‘Registry’ means a collection of information (data) from multiple sources, maintained over time with controlled access
p.000051: through a gatekeeper organizer.
...
p.000077: Indirectly identifying – combination of indirect identifiers e.g. date of birth, address, unique personal
p.000077: characteristic
p.000077: Coded information – direct identifiers removed; replaced by code Anonymised information – irrevocably stripped of
p.000077: direct identifiers; no code Anonymous information – never had identifiers
p.000077: Identifier– information such as a name, initials, address, folder number, or biometric identifier (e.g.
p.000077: finger print) that can identify a particular donor
p.000077: Incentive – anything offered to encourage participation in research
p.000077: Incidental findings – unanticipated discoveries made in the course of research that are outside the scope of the
p.000077: research
p.000077: Inconvenience – a minor negative effect experienced in research less serious than discomfort
p.000077: Low risk research – where the only foreseeable risk is one of discomfort
p.000077: Minimal risk research – where probability and magnitude of possible harms implied by participation are no
p.000077: greater than those posed by daily life in a stable society or routine medical, dental, educational or
p.000077: psychological tests or examinations
p.000077: Minor– a person under 18 years (s 17 Children’s Act)
p.000077: Narrow consent – donor permits single use only of biological materials; no storage; no sharing of data or
p.000077: specimen; new consent if further use wanted.
p.000077: Negligible risk research – where the only foreseeable risk is one of inconvenience
p.000077: Neonate – a newborn child
p.000077: Non-therapeutic interventions–interventions not directed towards health-related benefit for a participant but towards
p.000077: improving generalisable knowledge (NHA Reg 135)
p.000077: Observational research – study of behaviour in a natural environment where people involved in their usual
p.000077: activities are observed with or without their knowledge; observational research also occurs in clinical research
p.000077: e.g. when a researcher observes individuals or measures particular outcomes, without intervention e.g.
p.000077: no treatment is given);an observational study describes a wide range of study designs including
p.000077: prospective and retrospective cohort studies, case-control studies, and cross-sectional studies, a defining
p.000077: feature of which is that any intervention studied is determined by clinical practice and not the protocol.
p.000077: Orphan– a child without a surviving parent to care for him (s 1 Children’s Act)
p.000077:
p.000077: Ethics in Health Research 2nd edition
...
p.000083:
p.000083: Ethics in Health Research 2nd edition
p.000085: 85
p.000085:
p.000085: However, accepting this offer of insurance cover does not mean you give up your right to make a separate claim for
p.000085: other losses based on negligence, in a South African court.
p.000085: It is important to follow the study doctor’s instructions and to report straight away if you have a side effect
p.000085: from the study medicine.
p.000085:
p.000085: See also Medicines Control Council Clinical Trial Compensation Guidelines available at
p.000085: http://www.sahealthinfo.org.ethics/book1.htm
p.000085:
p.000085: 86 Ethics in Health Research 2nd edition
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: 3. Novel, Innovative or Unproven Treatment
p.000085:
p.000085: < Insert hospital name >
p.000085:
p.000085: NOVEL, INNOVATIVE OR UNPROVEN TREATMENT CONSENT FORM
p.000085:
p.000085: How to use this Consent Form
p.000085: Read carefully through the whole document
p.000085: Fill in the RED areas ELECTRONICALLY (for future data collection) Make sure that all the necessary information is
p.000085: included
p.000085: The information written in BLUE is for guidance and should be removed before finalizing the document
p.000085: Print three (3) copies: one for patient’s folder, one for PTC, and one for the patient or her family
p.000085: This document is for a single patient use and a single treatment course only.
p.000085:
p.000085: This document tells you about a treatment for your (your child’s) condition that is still experimental but which your
p.000085: doctors would like to try. You are not being asked to join a research project. Important differences
p.000085: exist between experimental treatment and a research project.
p.000085: This treatment is experimental because
p.000085: < delete options that do not apply >
p.000085: It has been tested for conditions other than yours (your child’s).
p.000085: It has been tested for use with adults but not for use with children (< 18 years; < 12 years) It has not been registered
p.000085: in South Africa for use for your condition.
p.000085:
p.000085:
p.000085:
p.000085: Name of Drug Or Intervention
p.000085: Single Patient Use of < Insert Investigational Drug or Intervention Name >
p.000085:
p.000085:
p.000085: Treating Health care worker(s):
p.000085: < Insert Name >
p.000085: < Insert Address/Medical ward details >
p.000085: < Insert Phone Numbers/ Medical ward extension >
p.000085:
p.000085:
p.000085: Emergency Contact < Insert Emergency Contact Information >
p.000085: < Insert Phone Number/Pager, etc >
p.000085:
p.000085:
p.000085: < Insert name of investigational drug or other intervention > is a treatment that < insert either current approval status
p.000085: by the Medicines Control Council for another condition or provide a patient appropriate explanation of what
p.000085: the investigational drug or intervention is intended to do >.
p.000085:
p.000085: This treatment is not approved for < indicate what condition the patient has >, which means its use is experimental. We
p.000085: are not sure that this experimental treatment will cure or improve your condition. But in your circumstances, we offer
p.000085: you the opportunity to try it.
p.000085:
p.000085: Ethics in Health Research 2nd edition
p.000087: 87
p.000087:
p.000087: We must get permission from the hospital authorities before we may use this experimental treatment
p.000087: for you. The hospital authorities keep a careful watch over your welfare interests, especially that you
...
Searching for indicator unmarried:
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p.000029: research experience.
p.000029: e) Children should participate in research only where the proper written permissions have been obtained. The
p.000029: general principle is that minors cannot agree to research participation without assistance of a parent or
p.000029: guardian (exceptions to the general principle are discussed in 3.2.2.4). This principle holds notwithstanding the
p.000029: exceptions created in the Children’s Act 38 of 2005 for consent to medical treatment and surgical operations (s 129);
p.000029: consent to HIV-testing (s 130); and the exception for female minors created in the Choice on Termination of
p.000029: Pregnancy Act 92 of 1996 (s 5(2)). Consequently, in principle, the consent process for a minor’s participation in
p.000029: research requires
p.000029: • Permission in writing from parents or legal guardian for the minor to be approached and invited to
p.000029: participate (in accordance with s 10 of the Children’s Act 38 of 2005);
p.000029: • Assent from the minor in writing (i.e. agreement to participate) if he or she chooses to participate.
p.000029: Note that an unmarried minor mother may not agree to the participation of her child in research without assistance. Her
p.000029: guardian (usually her parent) is also the guardian of her child while she is a minor and must consent to the child’s
p.000029: participation. In other words, pregnancy and childbirth do not change the legal status of the minor mother. When the
p.000029: mother reaches the age of majority (18 years), she may consent to her child’s participation in research.
p.000029: f) Children should participate in research that takes cognisance of their privacy interests. Although children are
p.000029: legally dependent, they have significant privacy interests. Their
p.000029:
p.000029: Ethics in Health Research 2nd edition
p.000031: 31
p.000031:
p.000031: genetic privacy interests, in particular, may be more important than those of adults who manifest a particular genetic
p.000031: condition.
...
Social / Mothers
Searching for indicator mothers:
(return to top)
p.000035: Consequently, researchers and RECs should exercise extra caution when women participants are or may become
p.000035: pregnant. Exclusion of women from research may be justifiable
p.000035: a) to protect the health of the fetus; and
p.000035: b) if exclusion is scientifically supportable.
p.000035: Note that the informed consent documents must explain carefully and fully what the possible effect of the research
p.000035: activities on the fetus might be.
p.000035: Usually, research involving pregnant women should be undertaken when
p.000035: • the purpose of the proposed research is to meet the health needs of the mother of the particular fetus;
p.000035: • appropriate studies on animals and non-pregnant individuals have been completed;31
p.000035: • the risk of harm to the fetus is minimal; and
p.000035:
p.000035: 31 Clinical trials involving pregnant women or nursing mothers should ideally involve products where the toxicology in
p.000035: adults is established and is acceptable. In the case of pregnant women, the potential risks associated with using a
p.000035: substance whose short term and long-term effects on a fetus and developing infant are unknown, should be outweighed by
p.000035: the benefits. An example of a positive risk-benefit ratio would be the use of anti-retrovirals in mother to child HIV
p.000035: transmission studies. For nursing mothers, the amount of drug passing into breast milk should be established and the
p.000035: potential impact on a breast-fed infant anticipated, and the mother so advised.
p.000035:
p.000035: 36 Ethics in Health Research 2nd edition
p.000035:
p.000035:
p.000035: • in all cases, inclusion poses the least risk of harm possible for achieving the objectives of the research.
p.000035: 3.2.4 Adults with factual incapacity to provide informed consent
p.000035:
p.000035: Adults who are factually incapable of giving informed consent should participate in research only where their
p.000035: participation is indispensable to the research; i.e. the research cannot deliver the desired outcomes if
p.000035: capable adult participants were to be used instead. Further, the research should investigate a problem of
p.000035: relevance to incapacitated adults. Where research can be undertaken with capable adults but nevertheless proposes
p.000035: also to include incapacitated adults, strong justification for their inclusion must be provided.
...
Social / Police Officer
Searching for indicator police:
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p.000033: 28Note a caregiver, a foster parent and a schoolteacher or principal are not guardians.
p.000033:
p.000033: 34 Ethics in Health Research 2nd edition
p.000033:
p.000033:
p.000033: 3.2.2.5 Mandatory reporting obligations
p.000033: There is no general obligation to report either the commission of or the intention to commit a crime. However, if a
p.000033: researcher has information indicating that direct harm to another person may occur as a result of the intention to
p.000033: commit harm (e.g. a participant says ‘I’m going to kill her…’), then there may be an obligation, especially when the
p.000033: third person is known to the researcher. For specifically designated persons, there are statutory reporting
p.000033: obligations. (See Appendix 3 for SOP Template.)
p.000033: i. Reporting obligations for abuse and neglect
p.000033: The Children’s Act requires anyone who reasonably believes a child to be suffering physical abuse causing injury,
p.000033: deliberate neglect and sexual abuse to report this to a child protection agency, the provincial social development
p.000033: department, or to a police official.
p.000033: ii. Reporting obligations for under-age sexual activity
p.000033: The age at which minors can lawfully consent to sexual activity is 16 years, in terms of the Criminal Law (Sexual
p.000033: Offences and Related Matters) Amendment Act 32 of 2007 (Sexual Offences Act). Anyone with knowledge of a
p.000033: sexual offence against a minor is required to report this to a police official. In effect, any adult or person >16
p.000033: years who engages in sexual activity with a minor < 16 years commits a crime and may be prosecuted. The Act
p.000033: describes a broad range of sexual offences, including rape, sexual assault, sexual grooming, sexual
p.000033: exploitation, and use of children in pornography including photographs. This means that the range of activities
p.000033: that may constitute a sexual offence is extensive.
p.000033: The Sexual Offences Act differentiates between adolescents (12 - < 16 years) and older minors (16 and 17
p.000033: years). In the case of children younger than 12 years, sexual activity is unlawful even with consent. For adolescents,
p.000033: the situation is as follows. The Teddy Bear Clinic case 29 found criminalisation of consensual sexual acts
p.000033: between adolescents aged 12 – < 16 years to be unconstitutional, on the basis that adolescents should not be subjected
p.000033: to criminal sanctions when they exercise their entitlement to determine their personal relationships in light of their
p.000033: rights to autonomy, dignity and privacy. The Constitutional Court imposed a moratorium on action against adolescents in
p.000033: terms of ss 15 and 16 of the Sexual Offences Act. This moratorium of 18 months is to give Parliament time to revise the
p.000033: offending legislative provisions by April 2015.30
...
p.000083: 83
p.000083:
p.000083:
p.000083: APPENDIX 3
p.000083:
p.000083: Templates
p.000083:
p.000083: 1. Mandatory reporting of abuse
p.000083:
p.000083: How to respond adequately to the reporting requirement within a research context:
p.000083: Note that arrangements and negotiations e.g. with Childline South Africa or other agencies, should be made in advance
p.000083: of the application for ethics review. The applicant should be able to assure the REC about the referral arrangements.
p.000083: 1. Disclosure by any adolescent under 16 years of sexual or other abuse, or on whose behalf abuse is reported by a
p.000083: peer, caregiver, guardian or family member or other relevant person, should trigger an immediate
p.000083: termination of further interviews with the respondent and members of the household.
p.000083: 2. If there is a clear statement that the parties involved in the abuse include an adult (anyone 18
p.000083: years or older) or anyone who is more than two years older than the adolescent (s 56(2)(b)), the
p.000083: interviewer should report the matter to Childline South Africa at toll free: 0800 055 555 [or another child protection
p.000083: agency]. Childline should contact a registered social worker in the area who should investigate and inform the South
p.000083: African Police Service (SAPS) accordingly. The interviewer should record details of the child’s name,
p.000083: physical address and the name of the school the child attends. As proof of complying with the
p.000083: statutory reporting obligation, the interviewer should insist on a Childline reference number.
p.000083: 3. Any secondary reporting of abuse, e.g. where a child indicates that she has reported the abuse to a teacher or
p.000083: another adult but that no action has been taken, the matter should be brought to the attention of Childline, who should
p.000083: deal with the matter. Again, the interviewer should insist on a Childline reference number, as proof of reporting.
p.000083: If there is uncertainty about whether to report, the interviewer should consult with the Principal
p.000083: Investigator. [Insert conditions appropriate to the circumstances]
p.000083: Examples in practice Action by researcher
p.000083:
p.000083: A 14 year old tells of having sex with her 17 year old boyfriend
p.000083: A 12 year old reports ‘having sex’ with 19 year old neighbour
p.000083: An 11 year old tells of a previously reported incident of ‘bad touching’ by adult aunt that went to court
p.000083: Childline ◇ Police Childline ◇ Police
p.000083: No action; ask whether the child wants to talk to someone
p.000083: A 15 year old relates rape by father Childline ◇ Police
p.000083:
p.000083: A 13 year old boy relates anecdote of sex with 15 year old girlfriend
p.000083: Not over two years, so no action
p.000083:
p.000083: 84 Ethics in Health Research 2nd edition
p.000083:
p.000083:
p.000083:
p.000083: A 13 year old says she is ‘having sex’ but does not disclose who the partner is
p.000083: A 17 year old brags that he has ‘forced’ many girls into having sex with him
p.000083: A 17 year old learner speaks of having become pregnant by a school teacher who she does not identify
p.000083: A 18 year old learner points out a female school teacher with whom he says he is ‘sleeping’
p.000083:
p.000083: No action No action
p.000083: Ask whether she wants to speak to someone
p.000083: Ask whether he wants to speak to someone
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: 2. Insurance information for consent documentation
p.000083:
p.000083: This template is based on DoH 2006, MCC Clinical Trials Compensation Guidelines and Venter v Roche Products (Pty)
p.000083: Ltd et al (12285/08) [2013] WCHC 7 May 2013 and on appeal (A11/2014) 22 October 2014.
p.000083:
p.000083: Notes for researchers:
p.000083: i. Research study insurance does not substitute malpractice insurance
p.000083: ii. ABPI guidelines on compensation apply only to unlicensed substances used in Phase II and III clinical
p.000083: trials; reference to ABPI compensation should not be a standard paragraph in all consent documents
p.000083: iii. Participants may not recognize symptoms of side effects or have ready means to take action
p.000083:
...
Social / Property Ownership
Searching for indicator home:
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p.000007: 1.1.4 In general terms, research includes a wide range of activities conducted by many different
p.000007: disciplines that may use different methodologies and explanatory frameworks. In the physical and
p.000007: biological sciences, research may be described as a systematic study or inquiry, usually using quantitative data, in
p.000007: seeking generalisable new knowledge. Health-related research is increasingly also using qualitative
p.000007: methodologies. The humanities, social and behavioural sciences use both qualitative and quantitative methods and
p.000007: analytic frameworks, all of which may be aimed at contributing to knowledge about the human condition in its
p.000007: environment and context.
p.000007: 1.1.5 The statutory definition can be interpreted as having a wide or a narrow meaning. Many researchers,
p.000007: especially those who work in the humanities and social and behavioural sciences, may find the statutory
p.000007: definition of ‘health research’ to favour biomedical research. In particular, they may perceive that the
p.000007: so-called ‘medical model’ for ethics review dominates and is applied frequently but inappropriately to social
p.000007: science, especially qualitative research.
p.000007: 1.1.6 These guidelines do not advocate the so-called ‘medical model’ of ethics review, especially not for
p.000007: social science, behavioural or humanities research. For purposes of this document, ‘health research’ has both a broad
p.000007: and narrow meaning. In the narrow sense, it refers to research carried out in a health care environment,
p.000007: usually with patients, whether in a hospital, clinic or home-based. In the broad sense, it refers to research
p.000007: conducted outside a health care environment, usually not with patients.
p.000007: 1.1.7 The core ethical principles outlined in these guidelines apply to all forms of research that involve living
p.000007: human participants and use of animals, placing their safety, welfare and interests of both humans and animals as
p.000007: paramount. The principles also apply to research that involves use of human biological materials and data collected
p.000007: from living or deceased persons, including human embryos, fetuses, fetal tissue, reproductive materials, and
p.000007: stem cells.
p.000007: 1.1.8 Research that relies exclusively on publicly available information or accessible through legislation or
p.000007: regulation usually need not undergo formal ethics review. This does not mean that ethical considerations are irrelevant
p.000007: to the research.
p.000007: 1.1.9 Research involving observation of people in public spaces and natural environments usually need not undergo
p.000007: formal ethics review, provided that
p.000007:
p.000007: 8 Ethics in Health Research 2nd edition
p.000007:
p.000007:
p.000007: • the researcher does not interact directly with individuals or groups
p.000007: • the researcher does not stage any intervention
p.000007: • the individuals or groups do not have a reasonable expectation of privacy
p.000007: • dissemination of research findings does not identify individuals or groups
...
p.000025: poor socio-economic conditions, low levels of formal education and literacy, or restricted access to health care
p.000025: services. Such persons may be more easily persuaded to agree to participate without a properly considered
p.000025: understanding of the implications.
p.000025: It is important to note the difference between legal incapacity and factual incapacity. No person may
p.000025: claim that, because a minor is factually capable, the legal incapacity should be waived. On the other hand, no adult
p.000025: may be assumed to be incapable unless incapacity is established factually. Consequently, mental incapacity must
p.000025: be established by a factual assessment of the individual’s abilities to understand and to
p.000025: communicate that understanding. Legal incapacity prevails notwithstanding the existence of factual capacity.
p.000025: South Africa is home to a number of vulnerable communities. Where factors usually associated with
p.000025: vulnerability are integral to the research, the proposal should demonstrate how vulnerability would be managed.
p.000025: Particular caution should be exercised before undertaking research involving participants in such
p.000025: communities, and RECs should ensure that
p.000025: • persons in these communities are not being involved in research merely because they are expediently accessible,
p.000025: while the research could be carried out in a less vulnerable community;
p.000025: • the research is relevant to the health needs and priorities of the community in which it is to be carried out;
p.000025: and that
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 19 UNAIDS defines ‘vulnerable community’ as having some or all of the following characteristics: limited economic
p.000025: development; inadequate protection of human rights and discrimination on the basis of the health status; inadequate
p.000025: community/cultural experience and understanding of scientific research; limited access to health care and treatment
p.000025: options; limited ability of individuals in the community to provide informed consent.
p.000025: 20 For further, more detailed, discussion on special classes of participants, see CIOMS International Ethical
p.000025: Guidelines for Biomedical
...
p.000079: data or images through shared data systems
p.000079: Vulnerability – diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000079: project; may be caused by limited capacity or limited access to social goods like rights, opportunities and power
p.000079:
p.000079: 80 Ethics in Health Research 2nd edition
p.000079:
p.000079:
p.000079:
p.000079: APPENDIX 2
p.000079:
p.000079: Resources
p.000079:
p.000079: Online training opportunities
p.000079:
p.000079: These links are to FREE online training in research ethics and some also do Responsible Conduct of Research
p.000079: 1. The AMANET (African Malaria Network Trust)
p.000079: http://webcourses.amanet-trust.org/mod/resource/view.php?inpopup=true&id=116
p.000079: The AMANET (African Malaria Network Trust) web-based health research ethics training programme aims at
p.000079: providing the basic understanding in biomedical research ethics. On the premise of scarcity of resources and
p.000079: opportunities for such training for Africans, this effort hopes to provide this service to the many African members of
p.000079: IRB’s and investigators who may wish to undertake the course at home or in their office and at their own time up to a
p.000079: maximum period of four months for each student number issued.
p.000079: 2. Cameroon Bioethics Initiative (CAMBIN)
p.000079: www.cambin.org/cambin-training
p.000079:
p.000079: 3. https://camtools.cam.ac.uk/wiki/site/e30faf26-bc0c-4533-acbc-
p.000079: cff4f9234e1b/ethnographic%20and%20field%20study.html
p.000079:
p.000079: 4. http://www.fhi360.org/training/en/RETC2/index.html
p.000079:
p.000079: 5. http://www.responsibleresearch.org/
p.000079:
p.000079: 6. NIH Office of Extramural Research
p.000079: http://phrp.nihtraining.com/users/login.php
p.000079:
p.000079: 7. Macquarie University Australia: Human Research Ethics for the Social Sciences and Humanities
p.000079: http://www.mq.edu.au/ethics_training/index.php
p.000079:
p.000079: 8. PEERRS, the University of Michigan's Program for Education and Evaluation in Responsible Research and
p.000079: Scholarship
p.000079: http://my.research.umich.edu/peerrs/
p.000079:
p.000079: 9. PRIM&R Public Responsibility in Medicine and Research
p.000079: http://www.primr.org/ResourceCenter.aspx?id=262
p.000079: ‘For more than 38 years, PRIM&R has offered learning opportunities in the fields of biomedical and
p.000079: social/behavioral/educational research. Our goal is to provide current information on the ethics and legal
p.000079: issues related to human and animal research, as well as to offer best practices and strategies for implementing
...
p.000087: 87
p.000087:
p.000087: We must get permission from the hospital authorities before we may use this experimental treatment
p.000087: for you. The hospital authorities keep a careful watch over your welfare interests, especially that you
p.000087: should choose voluntarily. This is why you are asked to choose whether you would like to try the experimental treatment
p.000087: before we request permission to use the drug for you.
p.000087: You do not have to use the experimental treatment.
p.000087: Why is this experimental treatment being offered?
p.000087: Your doctors think this experimental treatment may offer an option for your clinical care, as < insert in plain language
p.000087: a description that describes why this treatment is the best option for the patient in the circumstances >
p.000087:
p.000087: How long will I take this experimental treatment?
p.000087: The total length of time you would receive this treatment will depend on many factors including: (i) how your medical
p.000087: condition responds to the experimental treatment, and (ii) further information about this use of the drug in
p.000087: your medical condition
p.000087: [Incorporate a specific schedule for the receipt of the investigational drug, if one is known] What does the
p.000087: experimental treatment involve?
p.000087: You will receive this experimental treatment in < location where the treatment (i.e. hospital
p.000087: (clinic/medical ward/OPD), home, private care, etc) will be given >. You will be asked to take a < insert appropriate
p.000087: dose (mg/mcg/ml) > dose < insert dosing schedule, i.e. once-off, once per day, 12 hourly, etc >
p.000087:
p.000087: [Be sure to include any other drugs that are taken in combination with the experimental treatment drug if appropriate
p.000087: Provide information pertaining to any safety or other assessments needed during the time that the patient receives the
p.000087: experimental treatment drug]
p.000087:
p.000087: What are the possible side effects or risks of harm?
p.000087: •Likely: < Provide appropriate risk listing >
p.000087: •Less Likely: < Provide appropriate risk listing >
p.000087: •Rare: < Provide appropriate risk listing >
p.000087: •Unknown Side Effects:
p.000087: There may also be other side effects, unknown at present, that could harm you while you are using this experimental
p.000087: treatment or after you have finished using it. We cannot predict what these currently unknown side effects
p.000087: may be. This is why it is very important that you must report any side effects you experience to your doctors
p.000087: immediately. We want to be able to treat any reaction quickly and appropriately.
p.000087: The possibility exists that you could have a reaction that, if not treated properly, could be life
p.000087: threatening
p.000087:
p.000087: What are the possible benefits of using this experimental treatment?
...
Searching for indicator property:
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p.000015: capacity for deliberation about their choices must be protected against harm from irresponsible choices.
p.000015: Respect for persons recognises that dignity, well-being and safety interests of all research participants are the
p.000015: primary concern in research that involves human participants. Respect for persons includes ‘the dual moral
p.000015: obligations to respect autonomy and to protect those with developing, impaired or diminished autonomy’.8 Autonomy
p.000015: includes the ability to deliberate about a decision and to act on that decision. Interests of participants should
p.000015: usually outweigh the interests of science and society. Consequently, involvement of persons or particular
p.000015: categories of people in the research should be justified in research proposals. Respect for persons means also that
p.000015: the interests of researchers must be considered. These include welfare and safety interests, authorship and
p.000015: intellectual property interests, and collegial and professional interests.
p.000015: 2.2 Role of ethical principles
p.000015:
p.000015: Ethical principles assist RECs to identify and protect the interests of research participants in a variety of research
p.000015: contexts and to promote development of high-quality knowledge that may benefit future generations. These ethics
p.000015: principles are articulated in national and international research ethics guidelines. Persons who conduct research
p.000015: in South Africa are expected to adhere to these principles which underscore responsible and ethical research
p.000015: conduct.
p.000015: Note: Detailed discussion about how to apply these principles is in Chapter 3.
p.000015:
p.000015: 2.3 Key norms and standards
p.000015:
p.000015: The key ethical norms and standards are:
p.000015: • Relevance and value
p.000015: • Scientific integrity
p.000015: • Role-player engagement
p.000015: • Fair selection of participants
p.000015: • Fair balance of risks and benefits
p.000015: • Informed consent
p.000015: • Ongoing respect for participants, including privacy and confidentiality
p.000015: • Researcher competence and expertise
p.000015: Note that the fundamental principles for research that uses animals are Replace, Reduce and Refine animal use in
p.000015: research. (See SANS 10386:2008 (or later version); see 1.5.4.)
p.000015: 2.3.1 Relevance and value
p.000015: Research should be relevant and responsive to the needs of the people of South Africa. The proposal should explain
p.000015: the anticipated contribution to knowledge generation and, ideally,
p.000015:
p.000015:
...
p.000039:
p.000039:
p.000039: Research should be conducted amongst prisoners only if
p.000039: • their participation is indispensable to the research
p.000039: • the research cannot be conducted with non-prisoners
p.000039: • the research concerns a problem of relevance to prisoners
p.000039: • sound informed consent processes can be ensured
p.000039: • engagement with relevant role players about the proposed research has occurred.
p.000039: In the case of minor prisoners, the limitations and restrictions on independent consent must be remembered. In general
p.000039: terms, it is unlikely that independent consent by the minors will be justifiable.
p.000039: 3.2.9 Collectivities i.e. persons participating in research as groups
p.000039:
p.000039: ‘Collectivity’ is a term used to distinguish some distinct groups from informal communities, commercial or social
p.000039: groups. Collectivities are groups distinguished by
p.000039: • common beliefs, values, social structures and other features that identify them as a separate group
p.000039: • customary collective decision-making according to tradition and beliefs
p.000039: • the custom that leaders express a collective view
p.000039: • members of the collectivity being aware of common activities and common interests. Research involves a
p.000039: collectivity when
p.000039: • property or information private to the group as a whole is studied or used
p.000039: • permission of people occupying positions of authority, whether formal or informal, is required
p.000039: • participation of members acknowledged as representatives is involved. Research involving collectivities should
p.000039: include measures to ensure
p.000039: • dispute resolution mechanisms for anticipated or actual disagreements between the researcher and the collectivity
p.000039: • respectful negotiation with the collectivity or its leaders
p.000039: • permission is sought from appropriate representatives of the collectivity to approach individual participants
p.000039: • an informed consent process for individual participants
p.000039: • fair distribution of research-related benefits and harms among affected collaborating parties
p.000039: • agreement about ownership of data and rights of publication of research findings;
p.000039: • agreement about feedback to the collectivity about the findings.
p.000039:
p.000039: 3.3 Data and biological materials for research purposes
p.000039:
p.000039: 3.3.1 Introduction
p.000039: Researchers often wish to collect data, including images, or human biological materials from participants for
p.000039: research purposes or to use previously collected diagnostic or therapeutic biological material for
p.000039: research. Once collected, biological material may be stored in repositories as a future research resource (see
p.000039: 3.5.2 below). Although data and biological
p.000039:
p.000039: Ethics in Health Research 2nd edition
p.000041: 41
p.000041:
...
p.000047: (c) the rehabilitation of a person to enable that person to resume normal functioning within the family or community;
p.000047: or
p.000047: (d) the physical or mental preparation of an individual for puberty, adulthood, pregnancy, childbirth and
p.000047: death,
p.000047: but excludes the professional activities of a person practising any of the professions contemplated in the
p.000047: Pharmacy Act 53 of 1974, the Health Professions Act 56 of 1974, the Nursing Act 50 of 1974, the Allied Health
p.000047: Professions Act 63 of 1982, or the Dental Technicians Act 19 of 1979, and any other activity not based on
p.000047: traditional philosophy.
p.000047:
p.000047:
p.000047:
p.000047: 40 Sections 30 and 31 of the Constitution.
p.000047: 41 In terms of s 12(2)(c) of the Constitution and s 71 of the National Health Act.
p.000047:
p.000047: 48 Ethics in Health Research 2nd edition
p.000047:
p.000047:
p.000047: 'Traditional philosophy' means indigenous African techniques, principles, theories, ideologies, beliefs, opinions and
p.000047: customs and uses of traditional medicines communicated from ancestors to descendants or from generations
p.000047: to generations, with or without written documentation, whether supported by science or not, and which are
p.000047: generally used in traditional health practice.
p.000047: RECs should pay attention to indications that intellectual property may be intended to be acquired by
p.000047: non-South Africans and should advise that appropriate advice be sought. Intellectual property in indigenous
p.000047: flora, fauna and medicines is a particularly sensitive matter currently and not easily regulated. Protection of
p.000047: intellectual property relating to South African medicinal plants is a cross-cutting issue, responsibility for which is
p.000047: spread amongst several government departments, including the Department of Health; Trade and Industry; Science &
p.000047: Technology; Environmental Affairs; Tourism; Agriculture, Forestry & Fisheries; and Rural Development & Land
p.000047: Affairs. International and domestic legislation, policies and regulatory guidelines applicable in these
p.000047: departments must be taken in account when conducting research on traditional medicinal plants and
p.000047: genetic material, to ensure compliance.
p.000047: Current legislation that governs intellectual property relating to traditional knowledge and genetic material
p.000047: includes
p.000047: • The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits,
p.000047: 42 which advances Articles 15 & 8(j) of the Convention on Biological Diversity
p.000047: • The National Environmental Management: Biodiversity Act 10 of 2004 and its Regulations
p.000047: • The Patents Act 57 of 1978
p.000047: • The Department of Trade & Industry’s policies on Intellectual Property including the Intellectual Property
p.000047: Amendment Bill 2008.43
p.000047: Prior ethics review of the proposed research is required to ensure that norms and standards for health research in
p.000047: South Africa are being upheld. Toxicology tests must be performed on substances to be used on or ingested by
p.000047: participants; and equivalent rigour must apply to such research. Researchers should furnish proof of safety of the
p.000047: substances to the REC. The practice of requiring a randomised controlled trial may not be appropriate in all
p.000047: circumstances for indigenous treatments and interventions. However, RECs must consider methodology carefully
p.000047: and make decisions on a case-by-case basis.
p.000047: 3.4.5 Research involving deception or withholding information
p.000047:
p.000047: Sometimes, to ensure validity of research, researchers withhold certain information in the consent process.
p.000047: This may take the form of withholding information about the purpose of specific procedures. In most such cases, the
p.000047: prospective participants are asked to consent to remain uninformed as to the purpose of some procedures until the
p.000047: research is completed. After conclusion of the study, participants are given the omitted information. In other cases,
p.000047:
p.000047: 42Ratified by South Africa on 11 May 2011. For further information, see http://www.cbd.int/abs/
p.000047: 43 Informed by a series of international conventions such as the Berne Convention of 1967, Universal Declaration of
p.000047: Human Rights (1948), Declaration on the Rights of Indigenous Peoples (2007) (Art. 13), International Covenant on
...
Social / Racial Minority
Searching for indicator minority:
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p.000027: choose responsibly whether to participate in research is disrespectful because it denies their autonomy.
p.000027: If compliance with the additional measures is poor and participants’ welfare is negatively affected,
p.000027: approval for the study may be withdrawn, temporarily or permanently, as the case may be.
p.000027: Groups of participants discussed here include
p.000027: • minors (children and adolescents)
p.000027: • women
p.000027: • adults with incapacity to provide informed consent
p.000027: • persons in dependent relationships
p.000027: • persons highly dependent on medical care
p.000027: • persons with physical disabilities
p.000027: • prisoners
p.000027: • collectivities
p.000027:
p.000027: Note this list is not exhaustive but provides an indication of the types of consideration to be applied
p.000027: 3.2.2 Minors (children and adolescents)
p.000027:
p.000027: Below the age of majority, the law protects young people from their own emotional, cognitive and physical immaturity
p.000027: and limited life experience through the legal status of minority. In other words, minors, i.e. persons under 18 years
p.000027: of age,22 are legally incapable of performing legal transactions without assistance from a parent or guardian. In the
p.000027: research context, this means that, in principle, anyone under the age of 18 years may not choose independently whether
p.000027: to participate in research; a parent or guardian must give permission for the minor
p.000027:
p.000027: 21 Note that this requirement does not mean that a REC may not approve a waiver of personal informed consent for types
p.000027: of research into e.g. record reviews or such like.
p.000027: 22 Section 28 of the Constitution; and s 17 of the Children’s Act 38 of 2005.
p.000027:
p.000027: 28 Ethics in Health Research 2nd edition
p.000027:
p.000027:
p.000027: to choose. This is because young persons’ understanding of key aspects of the research initiative may be
p.000027: compromised and, consequently, they may be exposed to increased risk of harm from particular research procedures.
p.000027: Exceptions to the requirement for parental permission are discussed at 3.2.2.4.
...
p.000027: conditions are necessary.
p.000027: For purposes of these guidelines
p.000027: ‘Adolescent’ means a child between the ages of 12 and 17 years of age (ICH Topic E 11 Clinical Investigation of
p.000027: Medicinal Products in the Paediatric Population. 2000
p.000027: [http://www.emea.eu.int/pdfs/human/ich/271199EN.pdf]
p.000027: ‘Caregiver’ means a person who factually cares for a child (s 1 Children’s Act, 38 of 2005; a caregiver is obliged
p.000027: (in terms of s 32(1)) to safeguard the child’s health, well-being and development; and to protect the child
p.000027: from abuse and other harms. Further a caregiver may exercise the parental right to consent to medical examination or
p.000027: treatment of the child (in terms of s 32(2))
p.000027:
p.000027:
p.000027: 23 Section 10 of the Children’s Act 38 of 2005. Note that a caregiver, a foster parent and a schoolteacher or
p.000027: principal are not guardians. Note that legal incapacity is not the same as factual incapacity. Minority is a legal
p.000027: incapacity status.
p.000027: 24 See also s 9 of the Children’s Act 38 of 2005.
p.000027:
p.000027: Ethics in Health Research 2nd edition
p.000029: 29
p.000029:
p.000029: ‘Child’ means a person under the age of 18 years (s 28 Constitution; s 1 Children’s Act 38 of 2005)
p.000029: ‘Child-headed household’ means a household per s 137 Children’s Act 38 of 2005
p.000029: ‘Guardian’ means a person appointed by a court to look after the financial and welfare interests of a
p.000029: minor, or a person appointed by a parent with sole responsibility for the minor in terms of the parent’s Will
p.000029: ‘Harm’ means physical, emotional, psychological, social or legal harm
...
p.000031: informed consent documentation must explain whether results of tests will be made known to child-participants
p.000031: and their parents. Whether this happens, depends to an extent on the socio-cultural context and the best
p.000031: interest standard.
p.000031: h) The minor’s interest in confidentiality, i.e. being identified or identifiable without permission of the
p.000031: minor and her parent or guardian must be respected.
p.000031: i) Research involving children must respect their evolving capacity to give consent. Minors who turn 18
p.000031: years old during the course of a study should be approached at the time of their birthday to re-consent. This
p.000031: is because they must now provide independent consent to continue to be a participant. In cases where
p.000031: minors are permitted to decide independently whether to participate, 26 the consent process should address
p.000031: how re-consent will be managed when they change status from minority to majority. Similarly, in the case of
p.000031: large and longitudinal studies, attention must be given to how the change from minority to majority will be managed.
p.000031: Where a study is no longer in active interaction with participants, re-consent procedures may be less important.
p.000031: j) Researchers must familiarise themselves with the legal obligations to report child abuse and neglect.
p.000031: See 3.2.2.5.
p.000031: 3.2.2.2 Parental permission
p.000031: The Children’s Act 38 of 2005 emphasises the right of a child to participate in any matter concerning that child,
p.000031: provided he or she has sufficient maturity to participate appropriately and meaningfully (s 10), notwithstanding
p.000031: legal incapacity. This means that parents or guardians may not decide whether their minor child should
p.000031: participate in research without the minor’s contribution to the decision. The choice of whether to participate is not a
p.000031: legal decision but rather a factual choice. Consequently, the process should be that the parent or guardian is
p.000031: requested to give permission for the minor to be approached to be invited to participate in the study. The factual
...
Searching for indicator race:
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p.000015: society, from the knowledge to be gained from the research. In other words, the likelihood of benefit should
p.000015: outweigh the anticipated risk of harm to participants. However, this does not mean that
p.000015: participants should be exposed to unacceptable risks of harm on the basis that the participants are likely to
p.000015: benefit from the research. In assessing the risk of harm, both the magnitude or seriousness of the harm and the
p.000015: probability of its occurrence should be addressed.
p.000015: Usually, participants who might face undue risk of harm should not be included in the study, even if they represent a
p.000015: category of person that may benefit from the research. On the other hand, research with such persons may
p.000015: nevertheless be approved after careful review and acceptable justification that demonstrates the anticipated
p.000015: importance and value of the research for society. In such cases, a carefully phased approach should be adopted.
p.000015: 2.3.5 Fair selection of participants
p.000015: This means recruitment, selection, exclusion and inclusion of participants for research must be just and fair,
p.000015: based on sound scientific and ethical principles. Persons should not be excluded unreasonably or unfairly
p.000015: on the basis of any of the prohibited grounds for discrimination: race, age, sex, sexual orientation,
p.000015: disability, education, religious belief, pregnancy, marital status, ethnic or social origin, conscience, belief or
p.000015: language (s 8 of the Constitution). Similarly, persons should not be unfairly targeted for research merely on the basis
p.000015: of one or other of these grounds.
p.000015: 2.3.6 Informed consent
p.000015: In general, participation in research must be voluntary and predicated on informed choices. Voluntariness and
p.000015: informed choices are evidenced by the informed consent process which must take place before the research
p.000015: commences, in principle, and be affirmed during the
p.000015:
p.000015: Ethics in Health Research 2nd edition
p.000017: 17
p.000017:
p.000017: course of the study, as part of the commitment to an ongoing consent process. In some circumstances,
p.000017: research may not require prior consent (see 3.2.5 & 3.3)
p.000017: 2.3.7 Ongoing respect for enrolled participants
...
p.000023: others and why, whether it will be sent outside South Africa and why. The person should agree to these terms.
p.000023: Some specific terms are summarised:
p.000023: • in the case of a child (person under the age of 18 years), a parent or guardian14 must give permission for the
p.000023: information to be collected (s 35(1)(a));15
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: 12Storage requirements may vary according to institutional requirements; usually between five and fifteen years.
p.000023: 13Some parts came into effect on 11 April 2014: s 1 (definitions); part A of Chapter 5 (establishment of Information
p.000023: Regulator); s 112 (about making Regulations); and s 113 (procedures for making Regulations) by Proclamation in GG 37544
p.000023: R.25, 2014.
p.000023: 14Note a caregiver, a foster parent, and a schoolteacher or principal are not guardians.
p.000023: 15 This requirement is compatible with the consent requirements for minors as described elsewhere in these Guidelines
p.000023: (see 3.2.2).
p.000023:
p.000023: 24 Ethics in Health Research 2nd edition
p.000023:
p.000023:
p.000023: • if the information is to be sent outside the Republic, the recipient must assure that the level of protection
p.000023: afforded in that country is commensurate with that expected in South Africa (s 18(1)(g));
p.000023: • information about a person’s race or ethnic origin must be necessary (s 29(a)) or for affirmative action purposes
p.000023: (s 29(b));
p.000023: • information about a person’s health or sex life must be necessary for the research activity (s 27(1)(d));
p.000023: • information about a person’s inherited characteristics must be necessary for the research activity (s
p.000023: 32(5)(b));
p.000023: • biometric16 information about a person must be necessary for the research activity (s 27(1)(d)).
p.000023: In effect, the Act outlines and requires the usual requirements for ethical and responsible informed consent
p.000023: procedures. The provisions underpin the importance of comprehensive SOPs and rigorous adherence thereto. It
p.000023: should be remembered that research records including informed consent documentation may be solicited by
p.000023: interested parties via application in terms of the Promotion of Access to Information Act 2 of 2000.
p.000023: 3.1.9 Obtaining informed consent
p.000023: The principle of respect for persons underpins the requirement that a person must choose voluntarily whether to
p.000023: participate in research on the basis of information that allows an informed choice to be made. The
p.000023: process of providing the necessary information and of engaging with the person before a decision is
p.000023: reached is known as the informed consent process. It should be noted that informed consent is a necessary but
...
Social / Religion
Searching for indicator faith:
(return to top)
p.000059: work of the REC can be done in compliance with these minimum standards.
p.000059: ii. Procedures and criteria for recruitment and appointment of REC members should be in place, transparent and
p.000059: accessible.
p.000059: iii. REC and AREC members should be given a formal appointment letter that sets out, at a minimum, the term of
p.000059: office; where to find the necessary information for new members; and the assurance that members are
p.000059: indemnified from personal liability against claims that may arise in the course of ordinary business of the REC or
p.000059: AREC.
p.000059: iv. Opportunities for training and refresher courses in research ethics (human and animal) and Good
p.000059: Clinical Practice (GCP) should be made available or accessible for
p.000059:
p.000059: 60 Ethics in Health Research 2nd edition
p.000059:
p.000059:
p.000059: committee members and researchers. Committee members should receive research ethics training and orientation on
p.000059: appointment and should refresh at least once every three years. REC members who review clinical trial proposals
p.000059: should have GCP training, evidenced by a certificate issued not more than 2 years previously.
p.000059: v. Institutions should indemnify committee members from personal liability and should ensure that adequate public
p.000059: liability insurance exists. The institution should take legal responsibility for the decisions and advice of the
p.000059: REC and AREC, provided that members act in good faith.
p.000059: 4.5 Standard Operating Procedures
p.000059:
p.000059: i. RECs and ARECs should have written standard operating procedures (SOPs) to ensure
p.000059: • standardised best practices for health research
p.000059: • compliance with national and international ethical and regulatory requirements
p.000059: • consistent processes about ethical issues in health research
p.000059: • declarations regarding confidentiality and conflict of interest for each meeting.
p.000059: ii. Ethical issues in research often require case-by-case deliberation. The ethics review process should not be
p.000059: mechanical. Although consistency of review outcomes for similar studies may be desirable, it is not always
p.000059: possible or appropriate in light of the details of an application.
p.000059: iii. REC members and researchers should be encouraged to
p.000059: • be mindful of the basic ethical principles that should inform planning, designing and conducting health research
p.000059: • be open-minded and not allow personal biases to cloud their application of these guidelines
p.000059: • accept that consensus about how ethical principles should be balanced is difficult to achieve and that divergence
p.000059: enriches deliberations
p.000059: • be mindful of the influence that the context (social, cultural and economic) has on how to prioritise principles
p.000059: • be deliberate, reflective and thoughtful in discussions about how to balance ethical considerations.
p.000059: iv. SOPs should be regarded as living documents, to be reviewed, revised and updated at regular intervals.
...
Searching for indicator belief:
(return to top)
p.000015: benefit from the research. In assessing the risk of harm, both the magnitude or seriousness of the harm and the
p.000015: probability of its occurrence should be addressed.
p.000015: Usually, participants who might face undue risk of harm should not be included in the study, even if they represent a
p.000015: category of person that may benefit from the research. On the other hand, research with such persons may
p.000015: nevertheless be approved after careful review and acceptable justification that demonstrates the anticipated
p.000015: importance and value of the research for society. In such cases, a carefully phased approach should be adopted.
p.000015: 2.3.5 Fair selection of participants
p.000015: This means recruitment, selection, exclusion and inclusion of participants for research must be just and fair,
p.000015: based on sound scientific and ethical principles. Persons should not be excluded unreasonably or unfairly
p.000015: on the basis of any of the prohibited grounds for discrimination: race, age, sex, sexual orientation,
p.000015: disability, education, religious belief, pregnancy, marital status, ethnic or social origin, conscience, belief or
p.000015: language (s 8 of the Constitution). Similarly, persons should not be unfairly targeted for research merely on the basis
p.000015: of one or other of these grounds.
p.000015: 2.3.6 Informed consent
p.000015: In general, participation in research must be voluntary and predicated on informed choices. Voluntariness and
p.000015: informed choices are evidenced by the informed consent process which must take place before the research
p.000015: commences, in principle, and be affirmed during the
p.000015:
p.000015: Ethics in Health Research 2nd edition
p.000017: 17
p.000017:
p.000017: course of the study, as part of the commitment to an ongoing consent process. In some circumstances,
p.000017: research may not require prior consent (see 3.2.5 & 3.3)
p.000017: 2.3.7 Ongoing respect for enrolled participants
p.000017: A research participant has the right to privacy and to confidentiality. This requires that a proposal
p.000017: must explain how these constitutionally protected rights will be managed and protected in the course of the
p.000017: research. Simply stated, privacy is concerned with who has access to personal information and records about the
p.000017: participant; including clinical health care records. On the other hand, ‘confidentiality’ is about ensuring that
p.000017: appropriate measures will be implemented to prevent disclosure of information that might identify the participant
...
Searching for indicator religious:
(return to top)
p.000015: participants should be exposed to unacceptable risks of harm on the basis that the participants are likely to
p.000015: benefit from the research. In assessing the risk of harm, both the magnitude or seriousness of the harm and the
p.000015: probability of its occurrence should be addressed.
p.000015: Usually, participants who might face undue risk of harm should not be included in the study, even if they represent a
p.000015: category of person that may benefit from the research. On the other hand, research with such persons may
p.000015: nevertheless be approved after careful review and acceptable justification that demonstrates the anticipated
p.000015: importance and value of the research for society. In such cases, a carefully phased approach should be adopted.
p.000015: 2.3.5 Fair selection of participants
p.000015: This means recruitment, selection, exclusion and inclusion of participants for research must be just and fair,
p.000015: based on sound scientific and ethical principles. Persons should not be excluded unreasonably or unfairly
p.000015: on the basis of any of the prohibited grounds for discrimination: race, age, sex, sexual orientation,
p.000015: disability, education, religious belief, pregnancy, marital status, ethnic or social origin, conscience, belief or
p.000015: language (s 8 of the Constitution). Similarly, persons should not be unfairly targeted for research merely on the basis
p.000015: of one or other of these grounds.
p.000015: 2.3.6 Informed consent
p.000015: In general, participation in research must be voluntary and predicated on informed choices. Voluntariness and
p.000015: informed choices are evidenced by the informed consent process which must take place before the research
p.000015: commences, in principle, and be affirmed during the
p.000015:
p.000015: Ethics in Health Research 2nd edition
p.000017: 17
p.000017:
p.000017: course of the study, as part of the commitment to an ongoing consent process. In some circumstances,
p.000017: research may not require prior consent (see 3.2.5 & 3.3)
p.000017: 2.3.7 Ongoing respect for enrolled participants
p.000017: A research participant has the right to privacy and to confidentiality. This requires that a proposal
p.000017: must explain how these constitutionally protected rights will be managed and protected in the course of the
...
p.000075: follows should be read together with chapter 3.
p.000075: Specific ethical issues may arise with gaining access, building rapport, conducting ethnographic
p.000075: observations, in-depth interviews and focus groups, using data and reporting results. Attention should be given
p.000075: to issues of consent, confidentiality, social and psychological harms, privacy as well as the anticipated
p.000075: relationships between researchers and participants when assessing the design, review, conduct and reporting of the
p.000075: research. Some may be evident in the design phase, while others will only arise during the research, in which case the
p.000075: researcher must exercise discretion, sound judgement, consultation and flexibility in accordance with the level of risk
p.000075: of harm and possible benefits of the research. The basis for the exercise of discretion and the degree of
p.000075: flexibility should be considered at the design phase. The REC Chairperson should be consulted when doubt arises.
p.000075:
p.000075: 76 Ethics in Health Research 2nd edition
p.000075:
p.000075:
p.000075:
p.000075: APPENDIX 1
p.000075:
p.000075: Glossary
p.000075:
p.000075: Academic freedom – the collective freedom of researchers, including students, to conduct research and to disseminate
p.000075: ideas or findings without religious, political or institutional restrictions; it includes freedom of inquiry
p.000075: and freedom to challenge conventional thought. Academic freedom does not mean freedom to ignore ethical issues
p.000075: Accountability – the measure by which it can be demonstrated that responsibilities have been or are being fulfilled;
p.000075: it may involve reporting upwards in a hierarchical structure
p.000075: Adolescent – a child between 12 and 17 years of age
p.000075: Anonymous data or specimen–data or biological materials without any overt identifying information or link to a
p.000075: specific donor
p.000075: Audit– subset of research; not clinical practice but a review of clinical practice
p.000075: Autonomy – the capacity to understand information; to act on it voluntarily; to use own judgement to make decisions
p.000075: about own actions, including whether to participate in research
p.000075: Biobank – see Repository
p.000075: Human biological materials– materials including blood and blood products, DNA, RNA, blastomeres, polar bodies,
p.000075: cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors
p.000075: Broad consent– donor permits use of biological materials for future studies, subject only to further prior ethics
p.000075: review and approval
p.000075: Capacity – the ability to understand relevant information; to appreciate the consequences of decisions based on the
p.000075: information
...
Social / Soldier
Searching for indicator military:
(return to top)
p.000081: Africa Pretoria 2006
p.000081: DIRECTIVE 2010/63/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22
p.000081: September 2010 on the protection of animals used for scientific purposes
p.000081: http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-
p.000081: policy/ethical-issues-international-research
p.000081:
p.000081: 82 Ethics in Health Research 2nd edition
p.000081:
p.000081:
p.000081: ICH Guidelines
p.000081: International Compilation of Human Research Standards compiled by the Office for Human Research Protections
p.000081: US Department of Health and Human Services
p.000081: http://www.hhs.gov/ohrp/international/index.html.
p.000081:
p.000081: Medical Research Council of South Africa Guidelines on Ethics for Medical Research: General Principles Pretoria 2002
p.000081: Medical Research Council of South Africa Guidelines on Ethics for Medical Research: Use of Animals in Research and
p.000081: Training (2004)
p.000081: Montreal Statement (2013)
p.000081: NIH ARENA/OLAW IACUC Guidebook, 2002, Institutional Animal Care and Use Committee Guidebook
p.000081: Nuffield Council on Bioethics: the Ethics of Research Related to Healthcare in Developing Countries (1999)
p.000081: Nuremberg Code (From ‘Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council
p.000081: Law No 10’ Vol 2, Nuremberg, October 1946 – April 1949)
p.000081: Singapore Statement (2010)
p.000081: South African Bureau of Standards’ South African National Standard (SANS 10386:2008 or latest version) for the Care
p.000081: and Use of Animals for Scientific Purposes
p.000081: The IACUC Handbook, Third Edition, Published: May 20, 2014 by CRC Press Content:827 Pages Editor(s):Jerald
p.000081: Silverman, Mark A. Suckow, Sreekant Murthy
p.000081: US Federal Policy for the Protection of Human Subjects Code of Federal Regulations (CFR also know as the Common
p.000081: Rule)http://osp.od.nih.gov/office-clinical-research-and-bioethics-
p.000081: policy/clinical-research-policy/research-involving-human-subjects
p.000081: World Health Organization (2000) Operational Guidelines for Ethics Committees that Review Biomedical Research
p.000081: TDR/PRD/ETHICS/2000.1
p.000081: World Health Organization Operational Guidelines for Ethics Committees that review Biomedical
p.000081: Research TDR/PRD/ETHICS/2000
p.000081: World Health Organization Standards and Operational Guidance for Ethics Review of Health- Related Research with Human
p.000081: Participants (2011)
p.000081: World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human
p.000081: Subjects 1964, most recently amended in 2013
p.000081: World Medical Association: Declaration of Helsinki (2013)
p.000081:
...
Social / Student
Searching for indicator student:
(return to top)
p.000051: study population that will bear the risks associated with participation is likely to benefit from the research, if not
p.000051: immediately, then at least in the foreseeable future or, at least, whether the group represented by the participants is
p.000051: likely to benefit from the research. In other words, the risk-benefit ratio can include that risk of harm to
p.000051: participants might be offset against likelihood of benefit to others, in some circumstances.
p.000051: 3.1.4 Recruitment and enrolment
p.000051: Recruitment strategies should be neutral, and should describe the purpose of the research, the anticipated risks of
p.000051: harm and potential benefit of participation and other relevant details.
p.000051:
p.000051: Ethics in Health Research 2nd edition
p.000021: 21
p.000021:
p.000021: Recruitment methods should be properly described in the proposal and the recruitment materials should be
p.000021: included with the proposal e.g. posters, flyers, and advertisements. Recruitment and enrolment processes
p.000021: should endeavour to avoid perceptions of selection bias. The location, context and timing of recruitment and
p.000021: enrolment should be appropriate for protection of privacy and confidentiality interests. If potential
p.000021: participants are in a dependent relationship with the researchers or recruiter, e.g. student/lecturer,
p.000021: patient
p.000021: /doctor, employee/employer, the proposal should explain the measures that ensure that the potential participant’s
p.000021: ability to make a voluntary choice is unrestricted. Where the researcher will recruit personally, the possibility
p.000021: of perceptions of undue influence or therapeutic misconception must be managed. The REC should enquire also
p.000021: whether the selected sample group has been or is currently involved in previously approved research so as to assess the
p.000021: possibility of excessive burden or risk exposure.
p.000021: 3.1.5 Research procedures
p.000021: The research procedures should be described in a manner that ensures the rationale and details are clear to
p.000021: the REC. Procedures that are standard of care should be differentiated from procedures necessary only for research
p.000021: purposes, to assist with weighing the risk of harm against the likelihood of benefit. The proposal should explain
p.000021: whether specific results of data collection, e.g. incidental findings, clinical test results and other
p.000021: clinically relevant findings, will be made known to participants.
p.000021: The appropriate expertise and qualifications of researchers, 9 study and project leaders to perform
p.000021: procedures should be assured, e.g. paediatric training is required for paediatric research procedures.
p.000021: Research procedures should not adversely affect routine treatment and management of patients or the functioning of
p.000021: health care facilities. In the case of research conducted in other settings, care should be exercised not to disrupt
...
p.000079: project; may be caused by limited capacity or limited access to social goods like rights, opportunities and power
p.000079:
p.000079: 80 Ethics in Health Research 2nd edition
p.000079:
p.000079:
p.000079:
p.000079: APPENDIX 2
p.000079:
p.000079: Resources
p.000079:
p.000079: Online training opportunities
p.000079:
p.000079: These links are to FREE online training in research ethics and some also do Responsible Conduct of Research
p.000079: 1. The AMANET (African Malaria Network Trust)
p.000079: http://webcourses.amanet-trust.org/mod/resource/view.php?inpopup=true&id=116
p.000079: The AMANET (African Malaria Network Trust) web-based health research ethics training programme aims at
p.000079: providing the basic understanding in biomedical research ethics. On the premise of scarcity of resources and
p.000079: opportunities for such training for Africans, this effort hopes to provide this service to the many African members of
p.000079: IRB’s and investigators who may wish to undertake the course at home or in their office and at their own time up to a
p.000079: maximum period of four months for each student number issued.
p.000079: 2. Cameroon Bioethics Initiative (CAMBIN)
p.000079: www.cambin.org/cambin-training
p.000079:
p.000079: 3. https://camtools.cam.ac.uk/wiki/site/e30faf26-bc0c-4533-acbc-
p.000079: cff4f9234e1b/ethnographic%20and%20field%20study.html
p.000079:
p.000079: 4. http://www.fhi360.org/training/en/RETC2/index.html
p.000079:
p.000079: 5. http://www.responsibleresearch.org/
p.000079:
p.000079: 6. NIH Office of Extramural Research
p.000079: http://phrp.nihtraining.com/users/login.php
p.000079:
p.000079: 7. Macquarie University Australia: Human Research Ethics for the Social Sciences and Humanities
p.000079: http://www.mq.edu.au/ethics_training/index.php
p.000079:
p.000079: 8. PEERRS, the University of Michigan's Program for Education and Evaluation in Responsible Research and
p.000079: Scholarship
p.000079: http://my.research.umich.edu/peerrs/
p.000079:
p.000079: 9. PRIM&R Public Responsibility in Medicine and Research
p.000079: http://www.primr.org/ResourceCenter.aspx?id=262
p.000079: ‘For more than 38 years, PRIM&R has offered learning opportunities in the fields of biomedical and
p.000079: social/behavioral/educational research. Our goal is to provide current information on the ethics and legal
p.000079: issues related to human and animal research, as well as to offer best practices and strategies for implementing
p.000079: successful programs for human subjects’ protection and animal care and use. PRIM&R's conferences, educational
...
Social / Threat of Stigma
Searching for indicator stigma:
(return to top)
p.000021: The ratio may be analysed by considering whether
p.000021: • the harms and benefits are adequately identified, evaluated and described;
p.000021: • the harms stated in the proposal match those stated in the informed consent documentation;
p.000021: • the risk of harm is reasonable in relation to anticipated benefit;
p.000021: • the risk of harm is reasonable in relation to the importance of the anticipated knowledge to be
p.000021: gained;
p.000021: • counselling and support services will be made available if appropriate.10
p.000021:
p.000021:
p.000021:
p.000021: 9‘Researchers’ includes PIs and research assistants and others who will do the work of research.
p.000021: 10E.g. if emotional distress is a likely side effect of research procedures, arrangements to facilitate access to
p.000021: assistance should be made.
p.000021:
p.000021: 22 Ethics in Health Research 2nd edition
p.000021:
p.000021:
p.000021: Anticipated harms should be minimised by preventing occurrence as far as possible and by implementing appropriate
p.000021: remedial interventions should the harm occur. The nature of harms will vary in accordance with the type of
p.000021: research under consideration and may include physical, psychological, legal, social (including stigma) and
p.000021: financial harms. The REC should also assess the possibility of harm to the researcher, study or project personnel e.g.
p.000021: safety concerns.
p.000021: 3.1.7 Reimbursements and inducements for participants
p.000021: Participants should not have to incur expenses to take part in research. Consequently, researchers should
p.000021: budget to reimburse expenses incurred by participants for travel, refreshments and also for inconvenience,
p.000021: depending on the circumstances. If no travel or other expenses are incurred, reimbursement is not required
p.000021: unless an inconvenience reimbursement is justifiable.
p.000021: A fair rate of reimbursement should be calculated using the Time, Inconvenience and Expenses (TIE)
p.000021: method to determine the cost to participants for time expended, inconvenience and refreshments
p.000021: associated with research participation. This method costs expenses at the current hourly rate for unskilled
p.000021: labour in the market place, regardless of whether the participant is employed. See NHREC (2012) Payment of
p.000021: trial participants in South Africa: ethical consideration for Research Ethics Committees.11
p.000021: Researchers must submit planned payment schedules and amounts together with a justification to the REC
p.000021: when making application for ethics review. RECs should exercise caution against taking an unreasonably
p.000021: paternalistic view of the rate of reimbursement. The proposal and the informed consent documentation should indicate
...
Searching for indicator threat:
(return to top)
p.000039: or alternative methods of treatment; and
p.000039: • the research is based on valid scientific hypotheses that support a reasonable possibility of more
p.000039: benefit than that offered by standard care; and
p.000039: • as soon as reasonably possible, the participant and her relatives or legal representatives
p.000039: will be informed of the participant’s inclusion in the research; be requested to give delayed consent;, and
p.000039: advised of the right to withdraw from the research without any reduction in quality of care.
p.000039: 3.2.7 Persons with physical disabilities
p.000039:
p.000039: Recruitment strategies for research participation in general should be sensitive to the possibility that
p.000039: persons with physical disabilities may wish to volunteer and therefore should ensure that there are no unintended
p.000039: barriers to such participation; e.g. the absence of ramps or a lift for wheelchair-bound potential participants.
p.000039: Research involving participants with physical disabilities should anticipate possible barriers and include
p.000039: measures to minimise them.
p.000039: 3.2.8 Prisoners
p.000039:
p.000039: The chief reason to consider prisoners as a vulnerable class of persons is the potential effect of incarceration on
p.000039: the voluntariness of the decision to participate in research. Neither coercion (direct threat of negative
p.000039: sanction) nor undue influence is acceptable in the informed consent process. Researchers should pay
p.000039: attention to whether their intended participants are awaiting trial prisoners or convicted prisoners. Quite
p.000039: obviously, different ethical issues arise for the former group who remain innocent until proven
p.000039: guilty, notwithstanding being incarcerated. The recruitment strategy design must pay careful attention to
p.000039: how coercion and undue influence will be avoided. Similarly, persons administering questionnaires
p.000039: or conducting interviews must be conscious of environmental factors that may influence voluntariness.
p.000039: The REC should include, at least on an ad hoc basis, a member with experience and knowledge of working
p.000039: with prisoners when deliberating on the protocol. The researchers must comply also with the requirements of
p.000039: the Department of Correctional Services as listed at http://www.dcs.gov.za/services/Research.aspx.
p.000039:
p.000039: 40 Ethics in Health Research 2nd edition
p.000039:
p.000039:
...
p.000075: Registration http://www.sanctr.gov.za/Resources/Whatisaclinicaltrial/tabid/175/Default.aspx);
p.000075:
p.000075: Ethics in Health Research 2nd edition
p.000077: 77
p.000077:
p.000077: the Ottawa Statement defines ‘trial’ as a prospective controlled or uncontrolled research study evaluating
p.000077: the effects of one or more health-related interventions related to prevention, health promotion,
p.000077: screening, diagnosis, treatment, rehabilitation, or organization and financing of care.
p.000077: ‘Intervention’ refers to a deliberate act applied to an individual or group of individuals. Health-related
p.000077: interventions include but are not limited to the use of pharmaceuticals, biological products, surgery,
p.000077: procedures, radiation, devices, education, counseling, behaviour change, complementary health modalities, and
p.000077: management or economic policies. The word ‘medicine’ includes medicines used to treat diseases (therapeutic
p.000077: medicines), to prevent diseases (prophylactic medicines, e.g. vaccines), and those used in special
p.000077: investigations (diagnostic medicines, e.g. medicines used during special X-ray examinations to map out
p.000077: kidneys).
p.000077: Coded data or materials– identifiers are substituted by a number, symbol or other method to provide a code; a key to
p.000077: the code exists so that the specimen can be linked to its original source
p.000077: Coercion – extreme form of undue influence, involving a threat of harm or punishment for failure to participate in
p.000077: research; see UndueXinfluence
p.000077: Collaborative research – involves co-operation of researchers, institutions, organizations or communities, each
p.000077: contributing distinct expertise, characterized by respectful relationships
p.000077: Community – a group of people with a shared identity or interest that has the capacity to act or express itself as a
p.000077: collective; it may be territorial, organizational or a community of interest
p.000077: Community engagement – a process that establishes an interaction between researchers and a community regarding a
p.000077: research project; it signifies the intention of forming a collaborative relationship; the degree of
p.000077: collaboration may vary depending on the circumstances
p.000077: Confidentiality – the responsibility to protect information entrusted to researchers for research purposes
p.000077: from unauthorized access, use, disclosure, modification, loss or theft
p.000077: Conflict of interest – incompatibility of duties, responsibilities or interests (personal or professional)
p.000077: of a person or an institution as regards ethical conduct of research so that one cannot be fulfilled without
p.000077: compromising another
p.000077: Consent – indication of agreement to participate in research, based on adequate knowledge and understanding of relevant
p.000077: information, and freely given
...
Social / Threat of Violence
Searching for indicator violence:
(return to top)
p.000009:
p.000009: 10 Ethics in Health Research 2nd edition
p.000009:
p.000009:
p.000009: 1.3.4 The guidelines draw on prevailing international, foreign and national codes of conduct,
p.000009: declarations, and other documents relevant to research with humans, to strengthen processes of translational
p.000009: research collaboration, while taking into account the socioeconomic, ethnic and cultural diversity in South Africa. The
p.000009: guidelines also draw on and refer to international and national standards and guidelines for research using animals.
p.000009: 1.3.5 Researchers should be familiar with legislation and other binding instruments relevant to research including4
p.000009: • Animal Diseases Act 35 of 1984
p.000009: • Animal Health Act 7 of 2002
p.000009: • Animals Protection Act 71 of 1962
p.000009: • Basic Conditions of Employment Act 75 of 1997
p.000009: • Cartagena Protocol on Biosafety May 2000
p.000009: • Child Justice Act 75 of 2008
p.000009: • Children’s Act 38 of 2005
p.000009: • Choice on Termination of Pregnancy Act 92 of 1996
p.000009: • Constitution of the Republic of South Africa, 1996
p.000009: • Convention on Biological Diversity
p.000009: • Criminal Law (Sexual Offences and Related Matters) Amendment Act 32 of 2007
p.000009: • Domestic Violence Act 116 of 1998
p.000009: • Employment Equity Act 55 of 1998
p.000009: • Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act 36 of 1947
p.000009: • Genetically Modified Organisms Act, Act No 15 of 1997
p.000009: • Hazardous Substances Act 15 of 1973
p.000009: • Health Professions Act 56 of 1974
p.000009: • Labour Relations Act 66 of 1995
p.000009: • Medical Schemes Act 131 of 1998
p.000009: • Medicines and Related Substances Control Act 101 of 1965
p.000009: • Mental Health Care Act 17 of 2002
p.000009: • Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits,5
p.000009: • National Environmental Management: Biodiversity Act, Act 10 of 2004
p.000009: • National Health Act, Act No 61 of 2003
p.000009: • National Health Laboratory Service Act 37 of 2000
p.000009: • Patents Act 57 of 1978
p.000009: • Performing Animals Protection Act 24 of 1935
p.000009: • Promotion of Access to Information Act 2 of 2000
p.000009: • Promotion of Equality and Prevention of Unfair Discrimination Act 4 of 2000
p.000009: • Protected Disclosures Act 26 of 2000
p.000009: • Protection of Personal Information Act 4 of 2013
p.000009: • Provincial Nature Conservation Acts or Ordinances
p.000009:
p.000009:
p.000009:
p.000009: 4 Note this list is not exhaustive.
p.000009: 5Ratified by South Africa on 11 May 2011. For further information, see http://www.cbd.int/abs/
p.000009:
p.000009: Ethics in Health Research 2nd edition
p.000011: 11
p.000011:
...
p.000045: Whether REC review is required, depends on whether institutions have properly functioning research review and biosafety
p.000045: infrastructures. Where these do not yet exist, RECs should be part of the process to ensure biosafety and ethical
p.000045: standards are maintained.
p.000045: Note that ‘blanket approval’ for use of commercially available cell lines is not permitted. At minimum, a researcher
p.000045: is expected to liaise with the REC about the biosafety and ethical implications of the planned work. RECs
p.000045: should draw up a SOP and query template to assist establishing the implications.
p.000045: 3.4 Considerations specific to research methods or contexts
p.000045:
p.000045: Particular types of research require careful scrutiny in case additional precautions or monitoring
p.000045: procedures are required.
p.000045: Types of research discussed include:
p.000045: • Major incidents39 and research
p.000045: • Intensive care research
p.000045: • Terminal care research
p.000045: • Innovative therapy or interventions
p.000045: • Indigenous medicines research
p.000045: • Deception, concealment or covert data collection
p.000045: Note this list is not exhaustive, merely illustrative.
p.000045:
p.000045: 3.4.1 Major incidents and research
p.000045:
p.000045: Major incidents include any sudden event that occurs where local resources are constrained, so that responding
p.000045: urgently and appropriately is difficult. Major incidents include acute disasters – natural or man-made –
p.000045: such as floods, tornados, earthquakes, outbreaks of deadly disease, or political violence and armed
p.000045: conflict with resultant injuries to humans.
p.000045:
p.000045: 38The Human Heredity and Health in Africa (H3Africa) Initiative http://h3africa.org/about/vision.
p.000045: 39 Previously known as disaster research.
p.000045:
p.000045: 46 Ethics in Health Research 2nd edition
p.000045:
p.000045:
p.000045: They may also take the form of an unusual and sudden demand on local resources or other emergency with consequent
p.000045: ethical implications for patient care. Research in these contexts is important for advancing emergency health
p.000045: care interventions and treatments, and for refining resource allocation policies. The potential benefits of major
p.000045: incident research include improved triage methods and procedures, effective treatment for life-threatening conditions
p.000045: and improving therapies for survival and quality of life.
p.000045: Although patients in a major incident context face extreme vulnerability, RECs should be cautious about
p.000045: being overly restrictive about the type of research that may be conducted. The development of new drugs and procedures
p.000045: to treat emergency patients safely depends on being able to conduct research, including carefully designed randomised
p.000045: controlled trials.
p.000045: In order to carry out research in such contexts, planning of the research and ethics clearance processes usually must
...
Social / Victim of Abuse
Searching for indicator abuse:
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p.000005: 1.2 The research context 9
p.000005: 1.3 Regulatory authority 9
p.000005: 1.4 Research with humans 11
p.000005: 1.5 Research using animals 11
p.000005: 1.6 Ethical research review 12
p.000005: 1.7 Glossary & resources 12
p.000005: 1.8 Purpose & status of these Guidelines 13
p.000005: 1.9 Structure of these Guidelines 13
p.000005:
p.000005:
p.000005: This chapter explains ethics in research and provides an overview of the South African research context,
p.000005: including the remit of this document.
p.000005:
p.000005: Introduction
p.000005:
p.000005: 1.1.1 South Africa is a democratic state in which human dignity, equality and the advancement of human
p.000005: rights are respected, promoted and protected in terms of the Constitution of the Republic of South Africa, 1996 (the
p.000005: Constitution). In particular, s 27(1) guarantees the right of access to health care services, while section 12(2) of
p.000005: the Bill of Rights in the SA Constitution, protects against research abuse by providing that
p.000005: ‘Everyone has the right to bodily and psychological integrity, which includes the right –
p.000005: (a) to make decisions concerning reproduction;
p.000005: (b) to security in and control over their body; and
p.000005: (c) not to be subjected to medical or scientific experiments 1 without their informed consent’.
p.000005:
p.000005:
p.000005:
p.000005: Note: Where ‘she’ or other version is found, ‘he’ or other version is implied and vice versa.
p.000005:
p.000005: 1 The term ‘experiments’ originates from Article 7 of the International Covenant on Civil and Political Rights - UN
p.000005: 1966 and echoes the Nuremberg Code; in the constitutional context, it is intended to mean ‘research’.
p.000005:
p.000005: Ethics in Health Research 2nd edition
p.000007: 7
p.000007:
p.000007: 1.1.2 The National Health Act 61 of 2003 (NHA) provides statutory authority for governance of ‘health research’ and
p.000007: the necessary research ethics regulatory infrastructure.
p.000007: 1.1.3 ‘Health research’ per the NHA may be understood to include but is not limited to research that
p.000007: contributes to knowledge of
p.000007: • biological, clinical, psychological, or social welfare matters including processes as regards humans
p.000007: • the causes and effects of and responses to disease
p.000007: • effects of the environment on humans
p.000007: • methods to improve health care service delivery
p.000007: • new pharmaceuticals, medicines, interventions and devices
...
p.000021: harm. All inducements should be clearly explained and justified to the REC. Input from community members on the REC or
p.000021: other role players may be constructive.
p.000021: 3.1.8 Participants’ privacy and confidentiality interests
p.000021: The principle of respect for persons requires careful attention to privacy and confidentiality interests. Privacy
p.000021: describes the person’s interest in controlling access to her personal information. Confidentiality is about
p.000021: whether and how research data might be disclosed
p.000021:
p.000021:
p.000021:
p.000021: 11 Available at http://nhrec.org.za – the current rate (2014) for unskilled construction workers is approximately R15
p.000021: - R25 per hour depending on the tasks (see Department of Labour’s sectoral determinations).
p.000021:
p.000021: Ethics in Health Research 2nd edition
p.000023: 23
p.000023:
p.000023: carelessly or inadvertently, thus revealing the participant’s identity or category, making him vulnerable to harm. (See
p.000023: also 2.3.7)
p.000023: The proposal should explain how data records (written, audio or visual) are to be secured, the length of time they will
p.000023: be retained12 and who will be responsible for storage and/or final disposal. The proposal should explain why
p.000023: particular identifying information is required for the study that purports to collect data anonymously. RECs should
p.000023: assess whether notifiable activities might occur amongst participants, e.g. abuse of minors or notifiable diseases and,
p.000023: consequently, whether appropriate measures are in place and are explained in the research proposal. Furthermore, the
p.000023: REC must ensure that the required notification or reporting and its management are explained in the consent documents.
p.000023: Where focus groups are planned, RECs should check that the information for participants explains clearly
p.000023: that researchers cannot guarantee confidentiality because members of the focus group may disclose information
p.000023: outside the research setting, despite agreeing not to do so. For this reason, consent documentation should advise
p.000023: potential focus group participants not to disclose personally sensitive information, as the researcher cannot
p.000023: guarantee confidentiality, even if other participants are urged to respect confidentiality.
p.000023: The Protection of Personal Information Act 4 of 2013 was assented to on 19 November 2013. 13 This Act
p.000023: provides guidance on how the right to privacy regarding personal information is protected. It stipulates
p.000023: that the right to privacy includes ‘protection against unlawful collection, retention, dissemination and use of
p.000023: personal information’ (Preamble to Act). A tension between the right to privacy and the need for free flow of
p.000023: information in a society that seeks to make progress on economic, social, health care and educational fronts, is
...
p.000027: to mean that participation in the research should not be contrary to the individual minor’s best interest. Further, the
p.000027: research should investigate a problem of relevance to minors.
p.000027: Where research can be done with consenting adults but nevertheless proposes also to include minors, the
p.000027: researchers must provide strong justification for the inclusion of minors. The REC should not make assumptions on
p.000027: behalf of the researchers. It should require all relevant information to be provided by the researchers. Note
p.000027: that all types of clinical trial research on minors should be scrutinized carefully in case extra precautions or
p.000027: conditions are necessary.
p.000027: For purposes of these guidelines
p.000027: ‘Adolescent’ means a child between the ages of 12 and 17 years of age (ICH Topic E 11 Clinical Investigation of
p.000027: Medicinal Products in the Paediatric Population. 2000
p.000027: [http://www.emea.eu.int/pdfs/human/ich/271199EN.pdf]
p.000027: ‘Caregiver’ means a person who factually cares for a child (s 1 Children’s Act, 38 of 2005; a caregiver is obliged
p.000027: (in terms of s 32(1)) to safeguard the child’s health, well-being and development; and to protect the child
p.000027: from abuse and other harms. Further a caregiver may exercise the parental right to consent to medical examination or
p.000027: treatment of the child (in terms of s 32(2))
p.000027:
p.000027:
p.000027: 23 Section 10 of the Children’s Act 38 of 2005. Note that a caregiver, a foster parent and a schoolteacher or
p.000027: principal are not guardians. Note that legal incapacity is not the same as factual incapacity. Minority is a legal
p.000027: incapacity status.
p.000027: 24 See also s 9 of the Children’s Act 38 of 2005.
p.000027:
p.000027: Ethics in Health Research 2nd edition
p.000029: 29
p.000029:
p.000029: ‘Child’ means a person under the age of 18 years (s 28 Constitution; s 1 Children’s Act 38 of 2005)
p.000029: ‘Child-headed household’ means a household per s 137 Children’s Act 38 of 2005
p.000029: ‘Guardian’ means a person appointed by a court to look after the financial and welfare interests of a
...
p.000031: minor and her parent or guardian must be respected.
p.000031: i) Research involving children must respect their evolving capacity to give consent. Minors who turn 18
p.000031: years old during the course of a study should be approached at the time of their birthday to re-consent. This
p.000031: is because they must now provide independent consent to continue to be a participant. In cases where
p.000031: minors are permitted to decide independently whether to participate, 26 the consent process should address
p.000031: how re-consent will be managed when they change status from minority to majority. Similarly, in the case of
p.000031: large and longitudinal studies, attention must be given to how the change from minority to majority will be managed.
p.000031: Where a study is no longer in active interaction with participants, re-consent procedures may be less important.
p.000031: j) Researchers must familiarise themselves with the legal obligations to report child abuse and neglect.
p.000031: See 3.2.2.5.
p.000031: 3.2.2.2 Parental permission
p.000031: The Children’s Act 38 of 2005 emphasises the right of a child to participate in any matter concerning that child,
p.000031: provided he or she has sufficient maturity to participate appropriately and meaningfully (s 10), notwithstanding
p.000031: legal incapacity. This means that parents or guardians may not decide whether their minor child should
p.000031: participate in research without the minor’s contribution to the decision. The choice of whether to participate is not a
p.000031: legal decision but rather a factual choice. Consequently, the process should be that the parent or guardian is
p.000031: requested to give permission for the minor to be approached to be invited to participate in the study. The factual
p.000031: decision whether to participate is the minor’s and not the parent’s.
p.000031: Parental permission and minor’s decision must be consistent, i.e. if the minor decides not to participate, the parent
...
p.000033: the child whilst the child is in temporary safe care; d) the person at the head of a child and youth care centre where
p.000033: a child has been placed; e) the person at the head of a shelter; f) a child and youth care worker who cares
p.000033: for a child who is without appropriate family care in the community; and g) the child at the head of a child-
p.000033: headed household’)
p.000033: vi. If minor is caregiver in child-headed household and no supervisory adult (s 137 Children’s Act), then
p.000033: trusted adult nominated by minor, including but not limited to social worker, community worker or teacher.
p.000033: 3.2.2.4 Minors’ independent consent
p.000033: In particular circumstances, e.g. for reasons of sensitivity, like discussion about sexual activities,
p.000033: substance abuse etc., it may be desirable and ethically justifiable for minors (especially older minors i.e.
p.000033: 16 years and older) to choose independently i.e. without parental assistance, whether to participate in research.
p.000033: Generally, only minimal risk research is suitable for independent consent by minors. Reasons
p.000033: supporting the desirability of independent consent may include recruiting sufficient numbers of minors
p.000033: who otherwise would be unwilling to participate if they must tell their parents about the nature of the
p.000033: research in order to obtain parental permission.
p.000033: An ethical justification for independent consent by minors may be made in the following manner:
p.000033: • By prior engagement with participating community role players, the PI can request (and justify explicitly)
p.000033: REC approval of a waiver of the parental (or substitute) permission requirement. Engagement could include
p.000033: outreach to relevant role players such as canvassing the opinion of a representative body of parents e.g. via schools.
p.000033: • Factual evidence of such engagement must form part of the PI’s justification in the protocol. Factual evidence
p.000033: may be in the form of a letter from a relevant role player (like a community leader, school principal or a CAB)
p.000033: that confirms the view that independent consent is acceptable to the parents.
p.000033: • If the REC accepts the ethical justification and the factual evidence of parental support for
p.000033: independent choice by their minor children, then the REC may grant a waiver of the requirement of written
p.000033: parental permission and must document the process carefully.
p.000033:
p.000033:
p.000033: 28Note a caregiver, a foster parent and a schoolteacher or principal are not guardians.
p.000033:
p.000033: 34 Ethics in Health Research 2nd edition
p.000033:
p.000033:
p.000033: 3.2.2.5 Mandatory reporting obligations
p.000033: There is no general obligation to report either the commission of or the intention to commit a crime. However, if a
p.000033: researcher has information indicating that direct harm to another person may occur as a result of the intention to
p.000033: commit harm (e.g. a participant says ‘I’m going to kill her…’), then there may be an obligation, especially when the
p.000033: third person is known to the researcher. For specifically designated persons, there are statutory reporting
p.000033: obligations. (See Appendix 3 for SOP Template.)
p.000033: i. Reporting obligations for abuse and neglect
p.000033: The Children’s Act requires anyone who reasonably believes a child to be suffering physical abuse causing injury,
p.000033: deliberate neglect and sexual abuse to report this to a child protection agency, the provincial social development
p.000033: department, or to a police official.
p.000033: ii. Reporting obligations for under-age sexual activity
p.000033: The age at which minors can lawfully consent to sexual activity is 16 years, in terms of the Criminal Law (Sexual
p.000033: Offences and Related Matters) Amendment Act 32 of 2007 (Sexual Offences Act). Anyone with knowledge of a
p.000033: sexual offence against a minor is required to report this to a police official. In effect, any adult or person >16
p.000033: years who engages in sexual activity with a minor < 16 years commits a crime and may be prosecuted. The Act
p.000033: describes a broad range of sexual offences, including rape, sexual assault, sexual grooming, sexual
p.000033: exploitation, and use of children in pornography including photographs. This means that the range of activities
p.000033: that may constitute a sexual offence is extensive.
p.000033: The Sexual Offences Act differentiates between adolescents (12 - < 16 years) and older minors (16 and 17
p.000033: years). In the case of children younger than 12 years, sexual activity is unlawful even with consent. For adolescents,
p.000033: the situation is as follows. The Teddy Bear Clinic case 29 found criminalisation of consensual sexual acts
p.000033: between adolescents aged 12 – < 16 years to be unconstitutional, on the basis that adolescents should not be subjected
p.000033: to criminal sanctions when they exercise their entitlement to determine their personal relationships in light of their
p.000033: rights to autonomy, dignity and privacy. The Constitutional Court imposed a moratorium on action against adolescents in
p.000033: terms of ss 15 and 16 of the Sexual Offences Act. This moratorium of 18 months is to give Parliament time to revise the
p.000033: offending legislative provisions by April 2015.30
p.000033: Consensual sexual acts between adolescents aged 12 - < 16 years are not criminal and are not reportable. Sexual acts
p.000033: with adolescents aged 12 - < 16 years by an adult or a person >16 years, even if consensual, are criminal and
p.000033: reportable. Sexual acts with children < 12 years are criminal and reportable.
p.000033: iii. Sexual and reproductive health research with minors
p.000033: Research with minors that focuses on their sexuality and reproductive health is likely to encounter instances of
p.000033: abuse and underage sexual activity. The dilemma for
p.000033:
p.000033:
p.000033: 29The Teddy Bear Clinic for Abused Children v Minister of Justice and Constitutional Development (CCT 12/13) [2013]
p.000033: ZACC 35; 2014 (2) SA 168 (CC); see also J v NDPP [2014] ZACC 13.
p.000033: 30See Draft Criminal Law (Sexual Offences & related matters) Amendment Act Amendment Bill [B-2014].
p.000033:
p.000033: Ethics in Health Research 2nd edition
p.000035: 35
p.000035:
p.000035: researchers is whether to ignore the strict letter of the law or to report as indicated in terms of the Sexual Offences
p.000035: Act and the Children’s Act. The matter is not simple.
p.000035: The clash of interests is obvious, e.g. using the law to protect the minor from abuse may have the unintended
p.000035: consequence of increased harm (physical and social) for that child. Further, thoughtless reporting may
p.000035: violate privacy and confidentiality interests of the minor e.g. in terms of the Choice on Termination of Pregnancy
p.000035: Act, the Children’s Act and the Child Justice Act. Whether a researcher, who has but a research interest
p.000035: in the life of the child, but no further right of access or duty of intervention ought to take on
p.000035: the responsibility of a social worker is unclear. Consequently, researchers should think very
p.000035: carefully about the anticipated consequences of reporting in light of the legal context. The proposal submitted
p.000035: for ethics review should explain fully the approach to be adopted, and justify how reporting obligations
p.000035: will be managed, so that the REC can deliberate effectively. The consent documents should clearly inform the
p.000035: minor (and proxy consent providers where necessary) about when reporting obligations arise and how they
...
p.000075: Anonymous data or specimen–data or biological materials without any overt identifying information or link to a
p.000075: specific donor
p.000075: Audit– subset of research; not clinical practice but a review of clinical practice
p.000075: Autonomy – the capacity to understand information; to act on it voluntarily; to use own judgement to make decisions
p.000075: about own actions, including whether to participate in research
p.000075: Biobank – see Repository
p.000075: Human biological materials– materials including blood and blood products, DNA, RNA, blastomeres, polar bodies,
p.000075: cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors
p.000075: Broad consent– donor permits use of biological materials for future studies, subject only to further prior ethics
p.000075: review and approval
p.000075: Capacity – the ability to understand relevant information; to appreciate the consequences of decisions based on the
p.000075: information
p.000075: Caregiver– a person who in fact cares for a child (s 1 Children’s Act, 38 of 2005); a caregiver must
p.000075: safeguard the child’s health, well-being and development; and protect the child from abuse and other
p.000075: harms; a caregiver exercises the parental right to consent to medical examination or treatment of the child
p.000075: Child – a person under 18 years (s 28 Constitution; s 1 Children’s Act)
p.000075: Child-headed household– a household per s 137 Children’s Act
p.000075: Clinical equipoise – literally means a state of balance or equilibrium; in the research context it means
p.000075: that, amongst health care experts, uncertainty prevails about whether a particular treatment or intervention
p.000075: is better than another. This principle forms the basis for conducting clinical research
p.000075: Clinical research –research intended to test safety (not harmful or dangerous to human health), quality (ingredients
p.000075: are of good quality), effectiveness (working to diagnose, treat, prevent or cure a disease condition) and efficacy
p.000075: (better/ best when compared with other treatment or medicine for a similar condition) of new and/or existing
p.000075: or old medicines, medical devices and/or treatment options, using human participants. (South African Clinical Trials
p.000075: Registration http://www.sanctr.gov.za/Resources/Whatisaclinicaltrial/tabid/175/Default.aspx);
p.000075:
p.000075: Ethics in Health Research 2nd edition
p.000077: 77
p.000077:
p.000077: the Ottawa Statement defines ‘trial’ as a prospective controlled or uncontrolled research study evaluating
...
p.000081: and Use of Animals for Scientific Purposes
p.000081: The IACUC Handbook, Third Edition, Published: May 20, 2014 by CRC Press Content:827 Pages Editor(s):Jerald
p.000081: Silverman, Mark A. Suckow, Sreekant Murthy
p.000081: US Federal Policy for the Protection of Human Subjects Code of Federal Regulations (CFR also know as the Common
p.000081: Rule)http://osp.od.nih.gov/office-clinical-research-and-bioethics-
p.000081: policy/clinical-research-policy/research-involving-human-subjects
p.000081: World Health Organization (2000) Operational Guidelines for Ethics Committees that Review Biomedical Research
p.000081: TDR/PRD/ETHICS/2000.1
p.000081: World Health Organization Operational Guidelines for Ethics Committees that review Biomedical
p.000081: Research TDR/PRD/ETHICS/2000
p.000081: World Health Organization Standards and Operational Guidance for Ethics Review of Health- Related Research with Human
p.000081: Participants (2011)
p.000081: World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human
p.000081: Subjects 1964, most recently amended in 2013
p.000081: World Medical Association: Declaration of Helsinki (2013)
p.000081:
p.000081: Ethics in Health Research 2nd edition
p.000083: 83
p.000083:
p.000083:
p.000083: APPENDIX 3
p.000083:
p.000083: Templates
p.000083:
p.000083: 1. Mandatory reporting of abuse
p.000083:
p.000083: How to respond adequately to the reporting requirement within a research context:
p.000083: Note that arrangements and negotiations e.g. with Childline South Africa or other agencies, should be made in advance
p.000083: of the application for ethics review. The applicant should be able to assure the REC about the referral arrangements.
p.000083: 1. Disclosure by any adolescent under 16 years of sexual or other abuse, or on whose behalf abuse is reported by a
p.000083: peer, caregiver, guardian or family member or other relevant person, should trigger an immediate
p.000083: termination of further interviews with the respondent and members of the household.
p.000083: 2. If there is a clear statement that the parties involved in the abuse include an adult (anyone 18
p.000083: years or older) or anyone who is more than two years older than the adolescent (s 56(2)(b)), the
p.000083: interviewer should report the matter to Childline South Africa at toll free: 0800 055 555 [or another child protection
p.000083: agency]. Childline should contact a registered social worker in the area who should investigate and inform the South
p.000083: African Police Service (SAPS) accordingly. The interviewer should record details of the child’s name,
p.000083: physical address and the name of the school the child attends. As proof of complying with the
p.000083: statutory reporting obligation, the interviewer should insist on a Childline reference number.
p.000083: 3. Any secondary reporting of abuse, e.g. where a child indicates that she has reported the abuse to a teacher or
p.000083: another adult but that no action has been taken, the matter should be brought to the attention of Childline, who should
p.000083: deal with the matter. Again, the interviewer should insist on a Childline reference number, as proof of reporting.
p.000083: If there is uncertainty about whether to report, the interviewer should consult with the Principal
p.000083: Investigator. [Insert conditions appropriate to the circumstances]
p.000083: Examples in practice Action by researcher
p.000083:
p.000083: A 14 year old tells of having sex with her 17 year old boyfriend
p.000083: A 12 year old reports ‘having sex’ with 19 year old neighbour
p.000083: An 11 year old tells of a previously reported incident of ‘bad touching’ by adult aunt that went to court
p.000083: Childline ◇ Police Childline ◇ Police
p.000083: No action; ask whether the child wants to talk to someone
p.000083: A 15 year old relates rape by father Childline ◇ Police
p.000083:
p.000083: A 13 year old boy relates anecdote of sex with 15 year old girlfriend
p.000083: Not over two years, so no action
p.000083:
p.000083: 84 Ethics in Health Research 2nd edition
p.000083:
p.000083:
p.000083:
p.000083: A 13 year old says she is ‘having sex’ but does not disclose who the partner is
p.000083: A 17 year old brags that he has ‘forced’ many girls into having sex with him
...
Social / Women
Searching for indicator women:
(return to top)
p.000017:
p.000017:
p.000017:
p.000017: Chapter 3
p.000017:
p.000017: SUBSTANTIVE NORMS AND OPERATIONAL PROCESSES FOR ETHICS REVIEW
p.000017:
p.000017: Contents
p.000017:
p.000017:
p.000017: 3.1 Ethical basis for decision making in the review process p 19
p.000017: 3.1.1 Scientific design, aims & objectives 19
p.000017: 3.1.2 Inclusion & exclusion criteria
p.000020: 20
p.000020: 3.1.3 Selection of study population & sampling 20
p.000020: 3.1.4 Recruitment & enrolment
p.000020: 20
p.000020: 3.1.5 Research procedures
p.000021: 21
p.000021: 3.1.6 Risks of harm & likelihood of benefit 21
p.000021: 3.1.7 Reimbursements, inducements & costs for participants 22
p.000021: 3.1.8 Participants’ privacy & confidentiality interests 22
p.000021: 3.1.9 Obtaining informed consent 24
p.000021: 3.2 Vulnerability & incapacity
p.000026: 26
p.000026: 3.2.1 Contextual circumstances
p.000026: 26
p.000026: 3.2.2 Minors (children & adolescents) 27
p.000026: 3.2.3 Women
p.000035: 35
p.000035: 3.2.4 Adults with factual incapacity
p.000036: 36
p.000036: 3.2.5 Persons in dependent relationships 38
p.000036: 3.2.6 Patients highly dependent on medical care 38
p.000036: 3.2.7 Persons with physical disabilities
p.000038: 38
p.000038: 3.2.8 Prisoners
p.000039: 39
p.000039: 3.2.9 Collectivities
p.000040: 40
p.000040: 3.3 Data & biological material for research purposes 40
p.000040: 3.3.1 Introduction
p.000040: 40
p.000040: 3.3.2 Permitted usage of biological material 41
p.000040: 3.3.3 Identifiability of biological materials and data 41
p.000040: 3.3.4 Collection of biological materials and data 42
p.000040: 3.3.5 Restrictions on collection of biological material 42
p.000040: 3.3.6 Informed consent
p.000042: 42
p.000042: 3.3.7 Secondary use of material or data 43
p.000042: 3.3.8 Genetic research
p.000044: 44
p.000044: 3.3.9 Genomics research
p.000044: 44
p.000044: 3.3.10 Commercially available cell lines
p.000045: 45
...
p.000027: measures for the informed consent process; or require increased monitoring and interim reporting on
p.000027: participants’ welfare; or require post-recruitment reviews of the effectiveness of the protective measures
p.000027: imposed. Other measures may also be appropriate.
p.000027: Note that the decision to impose additional measures should flow from an assessment of the nature of the research and
p.000027: the circumstances of the potential participants. In other words, additional protective measures should not be automatic
p.000027: just because a vulnerable group will be recruited; rather, the decision should be based on the particular
p.000027: circumstances of the proposal before the REC. For example, an automatic assumption that impoverished people cannot
p.000027: choose responsibly whether to participate in research is disrespectful because it denies their autonomy.
p.000027: If compliance with the additional measures is poor and participants’ welfare is negatively affected,
p.000027: approval for the study may be withdrawn, temporarily or permanently, as the case may be.
p.000027: Groups of participants discussed here include
p.000027: • minors (children and adolescents)
p.000027: • women
p.000027: • adults with incapacity to provide informed consent
p.000027: • persons in dependent relationships
p.000027: • persons highly dependent on medical care
p.000027: • persons with physical disabilities
p.000027: • prisoners
p.000027: • collectivities
p.000027:
p.000027: Note this list is not exhaustive but provides an indication of the types of consideration to be applied
p.000027: 3.2.2 Minors (children and adolescents)
p.000027:
p.000027: Below the age of majority, the law protects young people from their own emotional, cognitive and physical immaturity
p.000027: and limited life experience through the legal status of minority. In other words, minors, i.e. persons under 18 years
p.000027: of age,22 are legally incapable of performing legal transactions without assistance from a parent or guardian. In the
p.000027: research context, this means that, in principle, anyone under the age of 18 years may not choose independently whether
p.000027: to participate in research; a parent or guardian must give permission for the minor
p.000027:
...
p.000035: Act, the Children’s Act and the Child Justice Act. Whether a researcher, who has but a research interest
p.000035: in the life of the child, but no further right of access or duty of intervention ought to take on
p.000035: the responsibility of a social worker is unclear. Consequently, researchers should think very
p.000035: carefully about the anticipated consequences of reporting in light of the legal context. The proposal submitted
p.000035: for ethics review should explain fully the approach to be adopted, and justify how reporting obligations
p.000035: will be managed, so that the REC can deliberate effectively. The consent documents should clearly inform the
p.000035: minor (and proxy consent providers where necessary) about when reporting obligations arise and how they
p.000035: will be addressed, so that an informed choice can be made about whether to participate. Appropriate
p.000035: engagement with role-players such as child rights and child care organizations may assist researchers to make
p.000035: appropriate and meaningful referrals.
p.000035: 3.2.3 Women
p.000035:
p.000035: Exclusion of women as research participants has led to a lack of data needed to promote women’s health. Any proposed
p.000035: exclusion of women participants must be justifiable in light of research priorities as well as the specific research
p.000035: question under consideration. For example, women are appropriately excluded from prostate cancer research
p.000035: because the relevant population is male. In particular, systematic class exclusion must be guarded against to avoid
p.000035: unfair participant selection.
p.000035: Additional health concerns arise during pregnancy, including the need to avoid unnecessary risk to the fetus.
p.000035: Consequently, researchers and RECs should exercise extra caution when women participants are or may become
p.000035: pregnant. Exclusion of women from research may be justifiable
p.000035: a) to protect the health of the fetus; and
p.000035: b) if exclusion is scientifically supportable.
p.000035: Note that the informed consent documents must explain carefully and fully what the possible effect of the research
p.000035: activities on the fetus might be.
p.000035: Usually, research involving pregnant women should be undertaken when
p.000035: • the purpose of the proposed research is to meet the health needs of the mother of the particular fetus;
p.000035: • appropriate studies on animals and non-pregnant individuals have been completed;31
p.000035: • the risk of harm to the fetus is minimal; and
p.000035:
p.000035: 31 Clinical trials involving pregnant women or nursing mothers should ideally involve products where the toxicology in
p.000035: adults is established and is acceptable. In the case of pregnant women, the potential risks associated with using a
p.000035: substance whose short term and long-term effects on a fetus and developing infant are unknown, should be outweighed by
p.000035: the benefits. An example of a positive risk-benefit ratio would be the use of anti-retrovirals in mother to child HIV
p.000035: transmission studies. For nursing mothers, the amount of drug passing into breast milk should be established and the
p.000035: potential impact on a breast-fed infant anticipated, and the mother so advised.
p.000035:
p.000035: 36 Ethics in Health Research 2nd edition
p.000035:
p.000035:
p.000035: • in all cases, inclusion poses the least risk of harm possible for achieving the objectives of the research.
p.000035: 3.2.4 Adults with factual incapacity to provide informed consent
p.000035:
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000025: vulnerability
p.000025: 3.2.1 Contextual circumstances
p.000025: Personal circumstances, such as mental or intellectual impairment, acute illness, advanced age, and pregnancy and
p.000025: childbirth may increase vulnerability. Persons may be factually incapable or less capable of understanding
p.000025: information and processing it to reach a decision
p.000025: e.g. about whether to participate in research. Environmental circumstances may also increase vulnerability such as very
p.000025: poor socio-economic conditions, low levels of formal education and literacy, or restricted access to health care
p.000025: services. Such persons may be more easily persuaded to agree to participate without a properly considered
p.000025: understanding of the implications.
p.000025: It is important to note the difference between legal incapacity and factual incapacity. No person may
p.000025: claim that, because a minor is factually capable, the legal incapacity should be waived. On the other hand, no adult
p.000025: may be assumed to be incapable unless incapacity is established factually. Consequently, mental incapacity must
p.000025: be established by a factual assessment of the individual’s abilities to understand and to
p.000025: communicate that understanding. Legal incapacity prevails notwithstanding the existence of factual capacity.
p.000025: South Africa is home to a number of vulnerable communities. Where factors usually associated with
p.000025: vulnerability are integral to the research, the proposal should demonstrate how vulnerability would be managed.
p.000025: Particular caution should be exercised before undertaking research involving participants in such
p.000025: communities, and RECs should ensure that
p.000025: • persons in these communities are not being involved in research merely because they are expediently accessible,
p.000025: while the research could be carried out in a less vulnerable community;
p.000025: • the research is relevant to the health needs and priorities of the community in which it is to be carried out;
p.000025: and that
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
...
p.000027: • adults with incapacity to provide informed consent
p.000027: • persons in dependent relationships
p.000027: • persons highly dependent on medical care
p.000027: • persons with physical disabilities
p.000027: • prisoners
p.000027: • collectivities
p.000027:
p.000027: Note this list is not exhaustive but provides an indication of the types of consideration to be applied
p.000027: 3.2.2 Minors (children and adolescents)
p.000027:
p.000027: Below the age of majority, the law protects young people from their own emotional, cognitive and physical immaturity
p.000027: and limited life experience through the legal status of minority. In other words, minors, i.e. persons under 18 years
p.000027: of age,22 are legally incapable of performing legal transactions without assistance from a parent or guardian. In the
p.000027: research context, this means that, in principle, anyone under the age of 18 years may not choose independently whether
p.000027: to participate in research; a parent or guardian must give permission for the minor
p.000027:
p.000027: 21 Note that this requirement does not mean that a REC may not approve a waiver of personal informed consent for types
p.000027: of research into e.g. record reviews or such like.
p.000027: 22 Section 28 of the Constitution; and s 17 of the Children’s Act 38 of 2005.
p.000027:
p.000027: 28 Ethics in Health Research 2nd edition
p.000027:
p.000027:
p.000027: to choose. This is because young persons’ understanding of key aspects of the research initiative may be
p.000027: compromised and, consequently, they may be exposed to increased risk of harm from particular research procedures.
p.000027: Exceptions to the requirement for parental permission are discussed at 3.2.2.4.
p.000027: Tension exists between the views that, in general, children and adolescents should not bear the burden of research
p.000027: unnecessarily, on the one hand, and that children and adolescents are entitled to improved health care based on
p.000027: findings drawn from rigorous research conducted in the child population of South Africa, on the other.
p.000027: The solution lies in the approach that minors should participate in research only where their
p.000027: participation is indispensable to the research; i.e. the research cannot deliver the desired outcomes if adult
p.000027: participants were to be used instead.
p.000027: Because of their status of legal incapacity, in principle, minors may not choose independently whether to participate
p.000027: in research. A parent or guardian must give permission for the minor to choose. It should be noted that the parent or
p.000027: guardian does not choose for the minor who is capable of choosing;23 rather, the parent or guardian gives
p.000027: permission for the minor to choose. Where a minor is very young or is factually incapable of exercising a choice,
p.000027: then the parent or guardian chooses whether the minor should participate.
p.000027: The best interest of a child should be paramount in decisions that affect the child. 24 This principle is
p.000027: difficult to apply in the research context because research participation is unlikely to be in the best interest of a
p.000027: minor. Good research design does not accommodate a best interest analysis easily. Rather, the design draws on
p.000027: aggregates of information. This means that, in the research context, the best interest principle should be understood
p.000027: to mean that participation in the research should not be contrary to the individual minor’s best interest. Further, the
p.000027: research should investigate a problem of relevance to minors.
p.000027: Where research can be done with consenting adults but nevertheless proposes also to include minors, the
p.000027: researchers must provide strong justification for the inclusion of minors. The REC should not make assumptions on
p.000027: behalf of the researchers. It should require all relevant information to be provided by the researchers. Note
p.000027: that all types of clinical trial research on minors should be scrutinized carefully in case extra precautions or
p.000027: conditions are necessary.
p.000027: For purposes of these guidelines
p.000027: ‘Adolescent’ means a child between the ages of 12 and 17 years of age (ICH Topic E 11 Clinical Investigation of
p.000027: Medicinal Products in the Paediatric Population. 2000
p.000027: [http://www.emea.eu.int/pdfs/human/ich/271199EN.pdf]
p.000027: ‘Caregiver’ means a person who factually cares for a child (s 1 Children’s Act, 38 of 2005; a caregiver is obliged
p.000027: (in terms of s 32(1)) to safeguard the child’s health, well-being and development; and to protect the child
p.000027: from abuse and other harms. Further a caregiver may exercise the parental right to consent to medical examination or
p.000027: treatment of the child (in terms of s 32(2))
p.000027:
p.000027:
p.000027: 23 Section 10 of the Children’s Act 38 of 2005. Note that a caregiver, a foster parent and a schoolteacher or
p.000027: principal are not guardians. Note that legal incapacity is not the same as factual incapacity. Minority is a legal
p.000027: incapacity status.
p.000027: 24 See also s 9 of the Children’s Act 38 of 2005.
p.000027:
p.000027: Ethics in Health Research 2nd edition
p.000029: 29
p.000029:
p.000029: ‘Child’ means a person under the age of 18 years (s 28 Constitution; s 1 Children’s Act 38 of 2005)
p.000029: ‘Child-headed household’ means a household per s 137 Children’s Act 38 of 2005
p.000029: ‘Guardian’ means a person appointed by a court to look after the financial and welfare interests of a
p.000029: minor, or a person appointed by a parent with sole responsibility for the minor in terms of the parent’s Will
p.000029: ‘Harm’ means physical, emotional, psychological, social or legal harm
p.000029: ‘Minor’ means a person (child) less than 18 years (s 17 Children’s Act 38 of 2005) ‘Neonate’ means a newborn child,
p.000029: including an infant less than a month old
p.000029: ‘Orphan’ means a child who has no surviving parent caring for him or her (s 1 Children’s Act 38 of 2005)
p.000029: ‘Parent’ includes an adoptive parent (s 1 Children’s Act 38 of 2005)
p.000029: ‘Therapeutic research’ means research that includes interventions that may hold out the prospect of direct
p.000029: health-related benefit for the participant (Regulation 135)
p.000029: ‘Non-therapeutic research’ means research that includes interventions that will not hold out the prospect of direct
p.000029: health-related benefit for the participant but may produce results that contribute to generalisable knowledge
p.000029: (Regulation 135)
p.000029: 3.2.2.1 Minimum conditions for research involving minors
p.000029: The following considerations are critical when RECs review proposals to involve child participants:
p.000029: a) Children should participate in research when their participation is scientifically indispensable to the
p.000029: research. In the case of interventional clinical research, equipoise 25 should exist. Research should
p.000029: investigate a problem of relevance to children. The protocol should provide sufficient information to
p.000029: justify clearly why children should be included as participants.
p.000029: b) Children should participate in research only where such research poses acceptable risks of harm. That is,
p.000029: research involving minors should be approved only if:
p.000029: i. The research, including observational research, is not contrary to the best interest of the minor;
p.000029: ii. The research, including observational research, places the minor at no more than minimal risk of harm (i.e. the
p.000029: ‘everyday risks standard’ which means the risk of harm is commensurate with daily life in a stable society
p.000029: or routine medical, dental, educational or psychological tests or examinations – referred to as ‘negligible risk’ in
p.000029: some guidelines); or
p.000029: iii. The research involves greater than minimal risk of harm but provides the prospect of direct benefit
p.000029: for the minor. The degree of risk of harm should be justified by the potential benefit; or
p.000029:
p.000029: 25 ‘Equipoise’ literally means a state of balance or equilibrium; in the research context it means that, amongst
p.000029: health care experts, uncertainty prevails about whether a particular treatment or intervention is better than another.
p.000029: This principle forms the basis for conducting clinical research.
p.000029:
p.000029: 30 Ethics in Health Research 2nd edition
p.000029:
p.000029:
p.000029: iv. The research, including observational research, involves greater than minimal risk of harm, with no prospect of
p.000029: direct benefit to the minor, but has a high probability of providing significant generalizable knowledge. The degree of
p.000029: risk of harm should be justified by the risk-knowledge ratio.
p.000029: v. Greater than minimal risk of harm should represent no more than a minor increase over minimal risk.
p.000029: vi. Where appropriate, the minor will assent to participation.
p.000029: c) Research involving children must be reviewed appropriately. The National Health Act distinguishes research with
p.000029: children as ‘therapeutic’ and ‘non-therapeutic’ research. The intention is to place special emphasis on
p.000029: deliberation by the REC about the degree of risk of harm posed by a proposal and the likelihood of benefit to the
p.000029: child- participant. This distinction is of little practical import since most research involves a mix of ‘therapeutic’
p.000029: and ‘non-therapeutic’ interventions or components and reviewers usually assess the proposal as a whole.
p.000029: d) The degree of risk of harm should be evaluated against the likelihood of benefit to the child-participant as
p.000029: outlined in b) above. Furthermore, registered RECs that have been granted permission in writing to exercise the
p.000029: Minister’s delegated power to approve research with children that includes non-therapeutic components must
p.000029: ensure that their deliberations on these components are properly minuted and recorded as required by the
p.000029: Regulations. RECs that review research with child participants must include members with appropriate paediatric
p.000029: research experience.
p.000029: e) Children should participate in research only where the proper written permissions have been obtained. The
p.000029: general principle is that minors cannot agree to research participation without assistance of a parent or
p.000029: guardian (exceptions to the general principle are discussed in 3.2.2.4). This principle holds notwithstanding the
p.000029: exceptions created in the Children’s Act 38 of 2005 for consent to medical treatment and surgical operations (s 129);
p.000029: consent to HIV-testing (s 130); and the exception for female minors created in the Choice on Termination of
p.000029: Pregnancy Act 92 of 1996 (s 5(2)). Consequently, in principle, the consent process for a minor’s participation in
p.000029: research requires
p.000029: • Permission in writing from parents or legal guardian for the minor to be approached and invited to
p.000029: participate (in accordance with s 10 of the Children’s Act 38 of 2005);
p.000029: • Assent from the minor in writing (i.e. agreement to participate) if he or she chooses to participate.
p.000029: Note that an unmarried minor mother may not agree to the participation of her child in research without assistance. Her
p.000029: guardian (usually her parent) is also the guardian of her child while she is a minor and must consent to the child’s
p.000029: participation. In other words, pregnancy and childbirth do not change the legal status of the minor mother. When the
p.000029: mother reaches the age of majority (18 years), she may consent to her child’s participation in research.
p.000029: f) Children should participate in research that takes cognisance of their privacy interests. Although children are
p.000029: legally dependent, they have significant privacy interests. Their
p.000029:
p.000029: Ethics in Health Research 2nd edition
p.000031: 31
p.000031:
p.000031: genetic privacy interests, in particular, may be more important than those of adults who manifest a particular genetic
p.000031: condition.
p.000031: g) When parents or a guardian give permission for their minor child to choose whether to participate in research, this
p.000031: permission is given based on a detailed description of all diagnostic and therapeutic interventions that will
p.000031: affect the child in the study. However, this does not mean that parents are entitled to know the outcome of all
p.000031: diagnostic and therapeutic interventions, especially as regards older minors (adolescents). The
p.000031: informed consent documentation must explain whether results of tests will be made known to child-participants
p.000031: and their parents. Whether this happens, depends to an extent on the socio-cultural context and the best
p.000031: interest standard.
p.000031: h) The minor’s interest in confidentiality, i.e. being identified or identifiable without permission of the
p.000031: minor and her parent or guardian must be respected.
p.000031: i) Research involving children must respect their evolving capacity to give consent. Minors who turn 18
p.000031: years old during the course of a study should be approached at the time of their birthday to re-consent. This
p.000031: is because they must now provide independent consent to continue to be a participant. In cases where
p.000031: minors are permitted to decide independently whether to participate, 26 the consent process should address
p.000031: how re-consent will be managed when they change status from minority to majority. Similarly, in the case of
p.000031: large and longitudinal studies, attention must be given to how the change from minority to majority will be managed.
p.000031: Where a study is no longer in active interaction with participants, re-consent procedures may be less important.
p.000031: j) Researchers must familiarise themselves with the legal obligations to report child abuse and neglect.
p.000031: See 3.2.2.5.
p.000031: 3.2.2.2 Parental permission
p.000031: The Children’s Act 38 of 2005 emphasises the right of a child to participate in any matter concerning that child,
p.000031: provided he or she has sufficient maturity to participate appropriately and meaningfully (s 10), notwithstanding
p.000031: legal incapacity. This means that parents or guardians may not decide whether their minor child should
p.000031: participate in research without the minor’s contribution to the decision. The choice of whether to participate is not a
p.000031: legal decision but rather a factual choice. Consequently, the process should be that the parent or guardian is
p.000031: requested to give permission for the minor to be approached to be invited to participate in the study. The factual
p.000031: decision whether to participate is the minor’s and not the parent’s.
p.000031: Parental permission and minor’s decision must be consistent, i.e. if the minor decides not to participate, the parent
p.000031: may not override this decision. If the parent is reluctant for the minor to participate but the minor wants to
p.000031: do so, the matter must be managed carefully to establish what the concerns are and whether they may be
p.000031: resolved. The minor cannot choose to participate if the parent withholds permission for that minor
p.000031: to choose. Researchers are unlikely to be able to intervene where the suspicion is that the parent is
p.000031:
p.000031: 26 See 3.2.2.4.
p.000031:
p.000031: 32 Ethics in Health Research 2nd edition
p.000031:
p.000031:
p.000031: withholding permission unreasonably, since a best interest analysis in this context is irrelevant.
p.000031: 3.2.2.3 Orphans without guardians
p.000031: i. Introduction
p.000031: Many minors in South Africa do not have parents and very few have court-appointed guardians. These minors
p.000031: are often described as ‘orphans and vulnerable children’ or OVC. The absence of a legally appropriate parental
p.000031: substitute poses a problem for researchers because of the lack of clear guidance as to an acceptable substitute in
p.000031: the informed consent process for research participation. (Note that for treatment purposes, substituted
p.000031: consent occurs on the basis of necessity, which is not applicable to the research context.)
p.000031: ii. Justification
p.000031: Important research that seeks to understand and improve psychosocial, economic and educational conditions for
p.000031: orphans and vulnerable children to improve their future well being generally involves no more than minimal risk
p.000031: of harm. Other research including clinical research that may involve a minor increase over minimal risk of harm
p.000031: may also be justified on the basis that it would be unjustifiable to exclude a significant segment of the
p.000031: child population from research on the basis of their legal status. Consequently, it is ethical and reasonable to
p.000031: designate parental substitutes in these circumstances.
p.000031: iii. Pragmatic parental substitutes27
p.000031: In the interest of fostering consistency as well as compliance with the spirit of the legal provisions
p.000031: that protect minors’ interests, especially the Constitution and the Children’s Act, pragmatic guidance is provided
p.000031: here to deal with situations where no biological parent or legal guardian exists. The permissible level of
p.000031: risk is limited (see 3.2.2.1).
p.000031: Note this guidance does not permit expedient substitution e.g. where a parent is temporarily unavailable.
p.000031: This guidance takes its lead from the Constitution, the Children’s Act, the National Health Act, the Criminal Law
p.000031: (Sexual Offences) Amendment Act; the South African Good Clinical Practice Guidelines (2006) available at
p.000031: www.doh.gov.za/docs/factsheets/guidelines/clinical/2006/index.html.
p.000031: The guidance is premised on three conditions, all of which must be satisfied:
p.000031: 1. The risk standards set out in 3.2.2.1 b) must be adhered to; and
p.000031: 2. It is not possible to do the research with adult participants; and
p.000031: 3. The research proposes to investigate a problem of relevance to minors.
p.000031: Note that if the proposed research holds out more than a minimal risk of harm, there must be a
p.000031: compelling justification for why orphans should be included as participants, e.g. the research focus has particular
p.000031: relevance for OVC and cannot be studied without their enrolment.
p.000031: The parental substitutes should be used in descending order, as listed.
p.000031: i. The minor chooses whether to participate and thus expresses her will AFTER
p.000031:
p.000031: 27 This pragmatic guidance is provided to temper the chilling effect of a literal interpretation of s 71 of the
p.000031: National Health Act 61 of 2003, which otherwise might prevent important ethical research.
p.000031:
p.000031: Ethics in Health Research 2nd edition
p.000033: 33
p.000033:
p.000033: ii. The parent gives assistance with understanding (so the minor makes an informed choice)
p.000033: iii. If no parent, then guardian: either court-appointed OR as indicated by the parent in a Will (s 27 Children’s Act)
p.000033: iv. If no guardian, then foster parent (per order of Children’s Court) (Note that social workers should
p.000033: request that the authority to give permission should be included expressly in the court order authorising
p.000033: foster care)28
p.000033: v. If no foster parent (per iv. above), then caregiver (s 1 Children’s Act: defined as ‘…any person
p.000033: other than a parent or guardian, who factually cares for a child and includes – a) a foster parent; b) a person who
p.000033: cares for the child with the implied or express consent of a parent or guardian of the child; c) a person who cares for
p.000033: the child whilst the child is in temporary safe care; d) the person at the head of a child and youth care centre where
p.000033: a child has been placed; e) the person at the head of a shelter; f) a child and youth care worker who cares
p.000033: for a child who is without appropriate family care in the community; and g) the child at the head of a child-
p.000033: headed household’)
p.000033: vi. If minor is caregiver in child-headed household and no supervisory adult (s 137 Children’s Act), then
p.000033: trusted adult nominated by minor, including but not limited to social worker, community worker or teacher.
p.000033: 3.2.2.4 Minors’ independent consent
p.000033: In particular circumstances, e.g. for reasons of sensitivity, like discussion about sexual activities,
p.000033: substance abuse etc., it may be desirable and ethically justifiable for minors (especially older minors i.e.
p.000033: 16 years and older) to choose independently i.e. without parental assistance, whether to participate in research.
p.000033: Generally, only minimal risk research is suitable for independent consent by minors. Reasons
p.000033: supporting the desirability of independent consent may include recruiting sufficient numbers of minors
p.000033: who otherwise would be unwilling to participate if they must tell their parents about the nature of the
p.000033: research in order to obtain parental permission.
p.000033: An ethical justification for independent consent by minors may be made in the following manner:
p.000033: • By prior engagement with participating community role players, the PI can request (and justify explicitly)
p.000033: REC approval of a waiver of the parental (or substitute) permission requirement. Engagement could include
p.000033: outreach to relevant role players such as canvassing the opinion of a representative body of parents e.g. via schools.
p.000033: • Factual evidence of such engagement must form part of the PI’s justification in the protocol. Factual evidence
p.000033: may be in the form of a letter from a relevant role player (like a community leader, school principal or a CAB)
p.000033: that confirms the view that independent consent is acceptable to the parents.
p.000033: • If the REC accepts the ethical justification and the factual evidence of parental support for
p.000033: independent choice by their minor children, then the REC may grant a waiver of the requirement of written
p.000033: parental permission and must document the process carefully.
p.000033:
p.000033:
p.000033: 28Note a caregiver, a foster parent and a schoolteacher or principal are not guardians.
p.000033:
p.000033: 34 Ethics in Health Research 2nd edition
p.000033:
p.000033:
p.000033: 3.2.2.5 Mandatory reporting obligations
p.000033: There is no general obligation to report either the commission of or the intention to commit a crime. However, if a
p.000033: researcher has information indicating that direct harm to another person may occur as a result of the intention to
p.000033: commit harm (e.g. a participant says ‘I’m going to kill her…’), then there may be an obligation, especially when the
p.000033: third person is known to the researcher. For specifically designated persons, there are statutory reporting
p.000033: obligations. (See Appendix 3 for SOP Template.)
p.000033: i. Reporting obligations for abuse and neglect
p.000033: The Children’s Act requires anyone who reasonably believes a child to be suffering physical abuse causing injury,
p.000033: deliberate neglect and sexual abuse to report this to a child protection agency, the provincial social development
p.000033: department, or to a police official.
p.000033: ii. Reporting obligations for under-age sexual activity
p.000033: The age at which minors can lawfully consent to sexual activity is 16 years, in terms of the Criminal Law (Sexual
p.000033: Offences and Related Matters) Amendment Act 32 of 2007 (Sexual Offences Act). Anyone with knowledge of a
p.000033: sexual offence against a minor is required to report this to a police official. In effect, any adult or person >16
p.000033: years who engages in sexual activity with a minor < 16 years commits a crime and may be prosecuted. The Act
p.000033: describes a broad range of sexual offences, including rape, sexual assault, sexual grooming, sexual
p.000033: exploitation, and use of children in pornography including photographs. This means that the range of activities
p.000033: that may constitute a sexual offence is extensive.
p.000033: The Sexual Offences Act differentiates between adolescents (12 - < 16 years) and older minors (16 and 17
p.000033: years). In the case of children younger than 12 years, sexual activity is unlawful even with consent. For adolescents,
p.000033: the situation is as follows. The Teddy Bear Clinic case 29 found criminalisation of consensual sexual acts
p.000033: between adolescents aged 12 – < 16 years to be unconstitutional, on the basis that adolescents should not be subjected
p.000033: to criminal sanctions when they exercise their entitlement to determine their personal relationships in light of their
p.000033: rights to autonomy, dignity and privacy. The Constitutional Court imposed a moratorium on action against adolescents in
p.000033: terms of ss 15 and 16 of the Sexual Offences Act. This moratorium of 18 months is to give Parliament time to revise the
p.000033: offending legislative provisions by April 2015.30
p.000033: Consensual sexual acts between adolescents aged 12 - < 16 years are not criminal and are not reportable. Sexual acts
p.000033: with adolescents aged 12 - < 16 years by an adult or a person >16 years, even if consensual, are criminal and
p.000033: reportable. Sexual acts with children < 12 years are criminal and reportable.
p.000033: iii. Sexual and reproductive health research with minors
p.000033: Research with minors that focuses on their sexuality and reproductive health is likely to encounter instances of
p.000033: abuse and underage sexual activity. The dilemma for
p.000033:
p.000033:
p.000033: 29The Teddy Bear Clinic for Abused Children v Minister of Justice and Constitutional Development (CCT 12/13) [2013]
p.000033: ZACC 35; 2014 (2) SA 168 (CC); see also J v NDPP [2014] ZACC 13.
p.000033: 30See Draft Criminal Law (Sexual Offences & related matters) Amendment Act Amendment Bill [B-2014].
p.000033:
p.000033: Ethics in Health Research 2nd edition
p.000035: 35
p.000035:
p.000035: researchers is whether to ignore the strict letter of the law or to report as indicated in terms of the Sexual Offences
p.000035: Act and the Children’s Act. The matter is not simple.
p.000035: The clash of interests is obvious, e.g. using the law to protect the minor from abuse may have the unintended
p.000035: consequence of increased harm (physical and social) for that child. Further, thoughtless reporting may
p.000035: violate privacy and confidentiality interests of the minor e.g. in terms of the Choice on Termination of Pregnancy
p.000035: Act, the Children’s Act and the Child Justice Act. Whether a researcher, who has but a research interest
p.000035: in the life of the child, but no further right of access or duty of intervention ought to take on
p.000035: the responsibility of a social worker is unclear. Consequently, researchers should think very
p.000035: carefully about the anticipated consequences of reporting in light of the legal context. The proposal submitted
p.000035: for ethics review should explain fully the approach to be adopted, and justify how reporting obligations
p.000035: will be managed, so that the REC can deliberate effectively. The consent documents should clearly inform the
p.000035: minor (and proxy consent providers where necessary) about when reporting obligations arise and how they
p.000035: will be addressed, so that an informed choice can be made about whether to participate. Appropriate
p.000035: engagement with role-players such as child rights and child care organizations may assist researchers to make
p.000035: appropriate and meaningful referrals.
p.000035: 3.2.3 Women
p.000035:
p.000035: Exclusion of women as research participants has led to a lack of data needed to promote women’s health. Any proposed
p.000035: exclusion of women participants must be justifiable in light of research priorities as well as the specific research
p.000035: question under consideration. For example, women are appropriately excluded from prostate cancer research
p.000035: because the relevant population is male. In particular, systematic class exclusion must be guarded against to avoid
p.000035: unfair participant selection.
p.000035: Additional health concerns arise during pregnancy, including the need to avoid unnecessary risk to the fetus.
p.000035: Consequently, researchers and RECs should exercise extra caution when women participants are or may become
...
p.000035: thus vital that researchers bear this in mind because to ignore this fact is to seriously violate the person’s
p.000035: constitutional right to dignity as well as the ethical principle of respect (autonomy).
p.000035: When recruiting participants, the crucial elements are whether the person retains the capacity to decide
p.000035: whether to participate and whether he is able to communicate that decision. The first point to note,
p.000035: therefore, is the difference between the capacity to decide and the ability to communicate the decision. The capacity
p.000035: to decide necessarily includes the capacity to understand the information that is communicated to him. The
p.000035: ability to communicate includes the ability to hear and to speak or otherwise signal or express her
p.000035: wishes. For example, deafness should never be mistaken for incapacity to decide. Similarly, the inability to speak
p.000035: should not be mistaken for a lack of capacity to decide whether to participate.32
p.000035: 3.2.4.2 Minors and decision-making incapacity
p.000035: Parents or guardians of minors with intellectual or mental impairments should give permission for their
p.000035: minor children to choose whether to participate in research. If the minor
p.000035:
p.000035: 32 Georgetown University Informed Consent and Limitations on Decision making Capacity Chapter 2
p.000035: https://bioethicsarchive.georgetown.edu/nbac/capacity/Informed.htm
p.000035:
p.000035: Ethics in Health Research 2nd edition
p.000037: 37
p.000037:
p.000037: is unable to communicate at all or lacks the capacity to choose, then the parent or guardian should choose whether
p.000037: the minor may be enrolled. In other words, the parent acts as a proxy decision maker. In the case of a
p.000037: minor who remains intellectually or mentally impaired after reaching the age of majority, the situation changes
p.000037: because the person becomes an adult with decision-making incapacity (see 3.2.4.3 below).
p.000037: 3.2.4.3 Adults incapable of giving adequate informed consent
p.000037: Proxy decision makers are not permitted for adult persons who lack capacity unless the proxy is a court-appointed
p.000037: curator. Neither the National Health Act 61 of 2003 nor the Mental Health Care Act 17 of 2002 makes
p.000037: provision for proxy decision makers for research purposes but they provide clear lists of proxy decision makers for
p.000037: treatment purposes.
p.000037: Since it would be unethical to exclude a category of persons from research participation without adequate
p.000037: justification, arguably, an ethical argument can be made for using the statutory treatment proxies to
p.000037: provide permission for participation in research that complies with the stipulations set out below. However,
p.000037: RECs must be careful not to confuse the distinction between treatment and research. In unusual circumstances,
p.000037: e.g. major incident research (see 3.4.1), it may be ethically permissible to permit proxy consent also in
...
p.000037: (i.e. the ‘everyday risk standard’ which means the risk is commensurate with ‘daily life or routine medical,
p.000037: dental or psychological examinations and in social or education settings activities’ – referred to as ‘negligible risk’
p.000037: in some guidelines); or
p.000037:
p.000037: 38 Ethics in Health Research 2nd edition
p.000037:
p.000037:
p.000037: iii. The research involves greater than minimal risk but provides the prospect of direct benefit for the
p.000037: incapacitated adult. The degree of risk must be justified by the potential benefit; or
p.000037: iv. The research, including observational research, involves greater than minimal risk, with no prospect
p.000037: of direct benefit to the incapacitated adult, but has a high probability of providing generalizable knowledge; i.e.
p.000037: the risk should be justified by the risk- knowledge ratio;
p.000037: v. Greater than minimal risk must represent no more than a minor increase over minimal risk;
p.000037: vi. The legally appropriate person (treatment proxies as stipulated in NHA s 7 or s 27(1)(a) of the
p.000037: Mental Health Care Act 17 of 2002) gives permission for the person to participate; and
p.000037: vii. Where appropriate, the person will assent to participation. Note that the incapacitated person’s refusal or
p.000037: resistance to participate, as indicated by words or behaviour, takes precedence over permission by a proxy.
p.000037: The National Health Act specifies the sequence of legally appropriate treatment proxies as spouse or partner; parent;
p.000037: grandparent; adult child; brother or sister. The Mental Health Care Act provides, in no particular sequence, that
p.000037: legally appropriate proxies are spouse; next of kin; partner; associate (defined as ‘a person with a
p.000037: substantial or material interest in the well-being of a mental health care user or a person who is in substantial
p.000037: contact with the user’); and parent or guardian.
p.000037: 3.2.5 Persons in dependent relationships
p.000037:
p.000037: This class of persons includes persons in junior or subordinate positions in hierarchically structured
p.000037: groups and may include relationships between older persons and their care-givers; persons with chronic conditions
p.000037: or disabilities and their care-givers; persons with life- threatening illnesses; patients and health care
...
p.000039: how coercion and undue influence will be avoided. Similarly, persons administering questionnaires
p.000039: or conducting interviews must be conscious of environmental factors that may influence voluntariness.
p.000039: The REC should include, at least on an ad hoc basis, a member with experience and knowledge of working
p.000039: with prisoners when deliberating on the protocol. The researchers must comply also with the requirements of
p.000039: the Department of Correctional Services as listed at http://www.dcs.gov.za/services/Research.aspx.
p.000039:
p.000039: 40 Ethics in Health Research 2nd edition
p.000039:
p.000039:
p.000039: Research should be conducted amongst prisoners only if
p.000039: • their participation is indispensable to the research
p.000039: • the research cannot be conducted with non-prisoners
p.000039: • the research concerns a problem of relevance to prisoners
p.000039: • sound informed consent processes can be ensured
p.000039: • engagement with relevant role players about the proposed research has occurred.
p.000039: In the case of minor prisoners, the limitations and restrictions on independent consent must be remembered. In general
p.000039: terms, it is unlikely that independent consent by the minors will be justifiable.
p.000039: 3.2.9 Collectivities i.e. persons participating in research as groups
p.000039:
p.000039: ‘Collectivity’ is a term used to distinguish some distinct groups from informal communities, commercial or social
p.000039: groups. Collectivities are groups distinguished by
p.000039: • common beliefs, values, social structures and other features that identify them as a separate group
p.000039: • customary collective decision-making according to tradition and beliefs
p.000039: • the custom that leaders express a collective view
p.000039: • members of the collectivity being aware of common activities and common interests. Research involves a
p.000039: collectivity when
p.000039: • property or information private to the group as a whole is studied or used
p.000039: • permission of people occupying positions of authority, whether formal or informal, is required
p.000039: • participation of members acknowledged as representatives is involved. Research involving collectivities should
p.000039: include measures to ensure
p.000039: • dispute resolution mechanisms for anticipated or actual disagreements between the researcher and the collectivity
p.000039: • respectful negotiation with the collectivity or its leaders
p.000039: • permission is sought from appropriate representatives of the collectivity to approach individual participants
...
p.000041: disclosure of material findings, an offer of benefits of research findings, and withdrawal of material from
p.000041: research use. Informed consent documentation must be carefully scrutinised to ensure that the proposed approach
p.000041: and its implications are adequately disclosed and explained.
p.000041: 3.3.4 Collection of biological materials and data
p.000041: Biological materials and data are collected in a variety of ways
p.000041: • specifically for research purposes
p.000041: • incidentally to diagnostic or therapeutic procedures
p.000041: • for a combination of purposes, including the intention of possible future research use
p.000041: Collection of materials or data specifically for research use requires prospective informed consent,
p.000041: usually from the living donor (see 3.3.6). Where a donor is unable to provide informed consent, a proxy
p.000041: may be permissible (see 3.2.4.3 above). Where materials or data from a deceased person are sought, permission from an
p.000041: authorised person is required (see 3.3.6).
p.000041: 3.3.5 Restrictions on collection of biological materials
p.000041: Certain persons are specially protected: without Ministerial permission, biological materials may not be
p.000041: taken from mentally ill persons; biological materials that are not naturally replaceable may not be taken
p.000041: from a minor; no gametes may be taken from a minor; and no fetal biological material except for umbilical cord
p.000041: progenitor cells may be collected from anyone. These restrictions are absolute which means that research
p.000041: with the categories of person mentioned requires special permission. RECs must satisfy themselves that the
p.000041: necessary special permission has been obtained, where appropriate.
p.000041: 3.3.6 Informed consent
p.000041: Written informed consent is required prior to removal of biological material from a living donor (NHA ss
p.000041: 56 and 62).
p.000041: In the case of a deceased person, consent to removal and use of biological materials may be found in the Will of the
p.000041: person, in a written statement or in a witnessed oral statement (NHA s 62(1)(a)) or may be provided by ‘the spouse,
p.000041: partner, major child, parent, guardian, major brother or major sister of that person in the specific order mentioned’
p.000041: (NHA s 62(2))
p.000041: Because biological specimens may be collected for diagnostic, therapeutic or health research purposes, RECs should
p.000041: assess whether the nature of the planned usage is explained adequately so that the purpose for which consent
p.000041: is being requested is completely clear.
p.000041: RECs must also consider the circumstances under which re-consent from donors would be sought, bearing in mind specific
p.000041: local or national needs.
...
p.000077: Confidentiality – the responsibility to protect information entrusted to researchers for research purposes
p.000077: from unauthorized access, use, disclosure, modification, loss or theft
p.000077: Conflict of interest – incompatibility of duties, responsibilities or interests (personal or professional)
p.000077: of a person or an institution as regards ethical conduct of research so that one cannot be fulfilled without
p.000077: compromising another
p.000077: Consent – indication of agreement to participate in research, based on adequate knowledge and understanding of relevant
p.000077: information, and freely given
p.000077: Database– a collection of information including images (data) arranged to facilitate swift search and
p.000077: retrieval
p.000077: Decisional analysis – use of a systematic approach to ethical evaluation especially the ratio of risk of harm to
p.000077: likelihood of benefit
p.000077: Discomfort – a negative effect experienced in research less serious than harm
p.000077: Donor – the person (living or deceased) from whose body biological materials have been removed or withdrawn
p.000077: Ethics review –review of research proposals or protocols by RECs prior to commencement of the research
p.000077: Guardian – a person appointed by a court to look after the financial and welfare interests of a minor, or a person
p.000077: appointed by a parent with sole responsibility for the minor in terms of that parent’s Will
p.000077:
p.000077: 78 Ethics in Health Research 2nd edition
p.000077:
p.000077:
p.000077: Harm – anything that has a negative effect on participants’ welfare, broadly construed; its nature may be physical,
p.000077: emotional, psychological, social or legal
p.000077: Health research – contributes to knowledge of biological, clinical, psychological, or social welfare matters including
p.000077: processes; causes and effects of and responses to diseases; effects of environment on humans; methods to improve health
p.000077: care delivery; new pharmaceuticals, medicines, interventions and devices; new technologies to improve health and health
p.000077: care
p.000077: Identifiable information – reasonably expected to identify an individual alone or in combination with other
p.000077: information
p.000077: Directly identifying – direct identifiers e.g. name, identity number
p.000077: Indirectly identifying – combination of indirect identifiers e.g. date of birth, address, unique personal
p.000077: characteristic
p.000077: Coded information – direct identifiers removed; replaced by code Anonymised information – irrevocably stripped of
p.000077: direct identifiers; no code Anonymous information – never had identifiers
p.000077: Identifier– information such as a name, initials, address, folder number, or biometric identifier (e.g.
p.000077: finger print) that can identify a particular donor
p.000077: Incentive – anything offered to encourage participation in research
p.000077: Incidental findings – unanticipated discoveries made in the course of research that are outside the scope of the
p.000077: research
p.000077: Inconvenience – a minor negative effect experienced in research less serious than discomfort
p.000077: Low risk research – where the only foreseeable risk is one of discomfort
p.000077: Minimal risk research – where probability and magnitude of possible harms implied by participation are no
p.000077: greater than those posed by daily life in a stable society or routine medical, dental, educational or
p.000077: psychological tests or examinations
p.000077: Minor– a person under 18 years (s 17 Children’s Act)
p.000077: Narrow consent – donor permits single use only of biological materials; no storage; no sharing of data or
p.000077: specimen; new consent if further use wanted.
p.000077: Negligible risk research – where the only foreseeable risk is one of inconvenience
p.000077: Neonate – a newborn child
p.000077: Non-therapeutic interventions–interventions not directed towards health-related benefit for a participant but towards
p.000077: improving generalisable knowledge (NHA Reg 135)
p.000077: Observational research – study of behaviour in a natural environment where people involved in their usual
p.000077: activities are observed with or without their knowledge; observational research also occurs in clinical research
p.000077: e.g. when a researcher observes individuals or measures particular outcomes, without intervention e.g.
p.000077: no treatment is given);an observational study describes a wide range of study designs including
p.000077: prospective and retrospective cohort studies, case-control studies, and cross-sectional studies, a defining
p.000077: feature of which is that any intervention studied is determined by clinical practice and not the protocol.
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Searching for indicator youth:
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p.000033: iv. If no guardian, then foster parent (per order of Children’s Court) (Note that social workers should
p.000033: request that the authority to give permission should be included expressly in the court order authorising
p.000033: foster care)28
p.000033: v. If no foster parent (per iv. above), then caregiver (s 1 Children’s Act: defined as ‘…any person
p.000033: other than a parent or guardian, who factually cares for a child and includes – a) a foster parent; b) a person who
p.000033: cares for the child with the implied or express consent of a parent or guardian of the child; c) a person who cares for
p.000033: the child whilst the child is in temporary safe care; d) the person at the head of a child and youth care centre where
p.000033: a child has been placed; e) the person at the head of a shelter; f) a child and youth care worker who cares
p.000033: for a child who is without appropriate family care in the community; and g) the child at the head of a child-
p.000033: headed household’)
p.000033: vi. If minor is caregiver in child-headed household and no supervisory adult (s 137 Children’s Act), then
p.000033: trusted adult nominated by minor, including but not limited to social worker, community worker or teacher.
p.000033: 3.2.2.4 Minors’ independent consent
p.000033: In particular circumstances, e.g. for reasons of sensitivity, like discussion about sexual activities,
p.000033: substance abuse etc., it may be desirable and ethically justifiable for minors (especially older minors i.e.
p.000033: 16 years and older) to choose independently i.e. without parental assistance, whether to participate in research.
p.000033: Generally, only minimal risk research is suitable for independent consent by minors. Reasons
...
Social / education
Searching for indicator education:
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p.000007: 1.1.14 This document does not deal with clinical trials which form the subject matter of the Department of Health’s
p.000007: Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa, 2nd edition
p.000007: (2006) or its successor. However, this document includes guidance on insurance against research-related bodily injury,
p.000007: including in clinical trials.
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: 2 Also known as ‘human subjects research’; a human subject is a living individual about whom a researcher obtains (i)
p.000007: data through interventions or interactions; or (ii) identifiable private information.
p.000007:
p.000007: Ethics in Health Research 2nd edition
p.000009: 9
p.000009:
p.000009:
p.000009: 1.2 The research context
p.000009:
p.000009: 1.2.1 South Africa provides a rich arena for health and health-related research because of its excellent health care
p.000009: and research infrastructure, skills, and expertise. The country is also characterised by a high burden of disease,
p.000009: including diseases associated with poverty and underdevelopment, along with non-communicable diseases, creating
p.000009: a need for a broad spectrum of health and health-related research. See the Department of Health’s Strategic Health Plan
p.000009: 2014-2019 or its successor.3
p.000009: 1.2.2 South Africa is also an attractive research site for social scientists, behavioural scientists,
p.000009: political scientists, economists, researchers engaged in social development, education, and many more disciplines,
p.000009: because of its political history and current socio-economic, educational, political and social development
p.000009: status.
p.000009: 1.2.3 To ensure that South Africa’s people are fairly and respectfully treated by researchers and that all research
p.000009: conducted in the country stands up to ethical scrutiny, South Africa’s research ethics systems and infrastructure
p.000009: are regularly upgraded and strengthened.
p.000009: 1.3 Regulatory authority
p.000009:
p.000009: 1.3.1 The National Health Research Ethics Council (NHREC) was established in 2006 in terms of s 72 of the
p.000009: National Health Act (NHA).
p.000009: 1.3.2 In terms of the NHA, the NHREC must
p.000009: a) set norms and standards for health research involving humans and animals, as well as for conducting clinical trials
p.000009: b) determine guidelines to facilitate best practice for research ethics committees
p.000009: c) register and audit research ethics committees
p.000009: d) adjudicate complaints about research ethics and Animal Research Ethics committees
p.000009: e) refer matters concerning violations of ethical or professional rules to the relevant health professions
p.000009: council;
...
p.000015: participants should be exposed to unacceptable risks of harm on the basis that the participants are likely to
p.000015: benefit from the research. In assessing the risk of harm, both the magnitude or seriousness of the harm and the
p.000015: probability of its occurrence should be addressed.
p.000015: Usually, participants who might face undue risk of harm should not be included in the study, even if they represent a
p.000015: category of person that may benefit from the research. On the other hand, research with such persons may
p.000015: nevertheless be approved after careful review and acceptable justification that demonstrates the anticipated
p.000015: importance and value of the research for society. In such cases, a carefully phased approach should be adopted.
p.000015: 2.3.5 Fair selection of participants
p.000015: This means recruitment, selection, exclusion and inclusion of participants for research must be just and fair,
p.000015: based on sound scientific and ethical principles. Persons should not be excluded unreasonably or unfairly
p.000015: on the basis of any of the prohibited grounds for discrimination: race, age, sex, sexual orientation,
p.000015: disability, education, religious belief, pregnancy, marital status, ethnic or social origin, conscience, belief or
p.000015: language (s 8 of the Constitution). Similarly, persons should not be unfairly targeted for research merely on the basis
p.000015: of one or other of these grounds.
p.000015: 2.3.6 Informed consent
p.000015: In general, participation in research must be voluntary and predicated on informed choices. Voluntariness and
p.000015: informed choices are evidenced by the informed consent process which must take place before the research
p.000015: commences, in principle, and be affirmed during the
p.000015:
p.000015: Ethics in Health Research 2nd edition
p.000017: 17
p.000017:
p.000017: course of the study, as part of the commitment to an ongoing consent process. In some circumstances,
p.000017: research may not require prior consent (see 3.2.5 & 3.3)
p.000017: 2.3.7 Ongoing respect for enrolled participants
p.000017: A research participant has the right to privacy and to confidentiality. This requires that a proposal
p.000017: must explain how these constitutionally protected rights will be managed and protected in the course of the
...
p.000017: participant; including clinical health care records. On the other hand, ‘confidentiality’ is about ensuring that
p.000017: appropriate measures will be implemented to prevent disclosure of information that might identify the participant
p.000017: (inadvertently or not) either during the course of the research or afterwards. The Protection of Personal Information
p.000017: Act 4 of 2013 (partially in effect) has increased the need to ensure computer safety, locked record storage
p.000017: facilities and careful gate keeping about access to raw data including completed informed consent documents
p.000017: (see also 3.1.8). Researchers should take measures to ensure privacy and confidentiality interests throughout the
p.000017: research period, including when disseminating results or findings.
p.000017: 2.3.8 Researcher Competence and Expertise
p.000017: Researchers must be suitably qualified and technically competent to carry out the proposed research. The principal
p.000017: investigator (PI) or research leader has primary responsibility to ensure the safety and well-being of
p.000017: participants, the scientific integrity of the protocol and responsible implementation of that protocol. For
p.000017: international multi-centre research, at least one (co-) PI must be South Africa-based.
p.000017: Competence is demonstrated mainly by academic qualifications, credentials, scientific and technical
p.000017: competence as evidenced in previous publications or testimonials. Competence includes research competence,
p.000017: which is assessed in terms of education, knowledge, certification and experience. In addition, researchers
p.000017: should produce evidence of appropriate research ethics training within the previous three years.
p.000017: Principal investigators or research leaders must disseminate research results or findings, whether positive
p.000017: or negative, in a timely, accessible, responsible and competent manner. This includes reporting back to participant
p.000017: communities where appropriate, in accordance with the norm of role player engagement and collaboration.
p.000017:
p.000017: 18 Ethics in Health Research 2nd edition
p.000017:
p.000017:
p.000017:
p.000017: Chapter 3
p.000017:
p.000017: SUBSTANTIVE NORMS AND OPERATIONAL PROCESSES FOR ETHICS REVIEW
p.000017:
p.000017: Contents
p.000017:
p.000017:
p.000017: 3.1 Ethical basis for decision making in the review process p 19
p.000017: 3.1.1 Scientific design, aims & objectives 19
p.000017: 3.1.2 Inclusion & exclusion criteria
p.000020: 20
p.000020: 3.1.3 Selection of study population & sampling 20
p.000020: 3.1.4 Recruitment & enrolment
p.000020: 20
p.000020: 3.1.5 Research procedures
p.000021: 21
p.000021: 3.1.6 Risks of harm & likelihood of benefit 21
p.000021: 3.1.7 Reimbursements, inducements & costs for participants 22
...
p.000025: from whence much funding is sourced. 19 Whether vulnerability is present is a matter of fact and degree.
p.000025: However, certain groups of participants 20 require careful consideration to ensure that, where appropriate,
p.000025: additional precautions are put into place. For example, advanced age, very young age, personal or
p.000025: environmental factors like extreme poverty and ordinarily poor access to health care may increase
p.000025: vulnerability
p.000025: 3.2.1 Contextual circumstances
p.000025: Personal circumstances, such as mental or intellectual impairment, acute illness, advanced age, and pregnancy and
p.000025: childbirth may increase vulnerability. Persons may be factually incapable or less capable of understanding
p.000025: information and processing it to reach a decision
p.000025: e.g. about whether to participate in research. Environmental circumstances may also increase vulnerability such as very
p.000025: poor socio-economic conditions, low levels of formal education and literacy, or restricted access to health care
p.000025: services. Such persons may be more easily persuaded to agree to participate without a properly considered
p.000025: understanding of the implications.
p.000025: It is important to note the difference between legal incapacity and factual incapacity. No person may
p.000025: claim that, because a minor is factually capable, the legal incapacity should be waived. On the other hand, no adult
p.000025: may be assumed to be incapable unless incapacity is established factually. Consequently, mental incapacity must
p.000025: be established by a factual assessment of the individual’s abilities to understand and to
p.000025: communicate that understanding. Legal incapacity prevails notwithstanding the existence of factual capacity.
p.000025: South Africa is home to a number of vulnerable communities. Where factors usually associated with
...
p.000037: • the research is based on valid scientific hypotheses that support a reasonable possibility of more
p.000037: benefit than that offered by standard care; and
p.000037: • participation is not contrary to the medical interests of the patient;
p.000037: • the research interventions pose no more risk of harm than that inherent in the patient’s condition
p.000037: or alternative methods of treatment;
p.000037: • the participant and her relatives or legal representatives will be informed of the participant’s
p.000037: inclusion in the research as soon as reasonably possible, and advised of her right to withdraw from the research
p.000037: without any reduction in quality of care.
p.000037: 3.2.4.4 Minimum conditions for research involving incapacitated adults
p.000037: Research involving incapacitated adults should be approved only if
p.000037: i. The research, including observational research, is not contrary to the best interest of the individual;
p.000037: ii. The research, including observational research, places the incapacitated adult at no more than minimal risk
p.000037: (i.e. the ‘everyday risk standard’ which means the risk is commensurate with ‘daily life or routine medical,
p.000037: dental or psychological examinations and in social or education settings activities’ – referred to as ‘negligible risk’
p.000037: in some guidelines); or
p.000037:
p.000037: 38 Ethics in Health Research 2nd edition
p.000037:
p.000037:
p.000037: iii. The research involves greater than minimal risk but provides the prospect of direct benefit for the
p.000037: incapacitated adult. The degree of risk must be justified by the potential benefit; or
p.000037: iv. The research, including observational research, involves greater than minimal risk, with no prospect
p.000037: of direct benefit to the incapacitated adult, but has a high probability of providing generalizable knowledge; i.e.
p.000037: the risk should be justified by the risk- knowledge ratio;
p.000037: v. Greater than minimal risk must represent no more than a minor increase over minimal risk;
p.000037: vi. The legally appropriate person (treatment proxies as stipulated in NHA s 7 or s 27(1)(a) of the
p.000037: Mental Health Care Act 17 of 2002) gives permission for the person to participate; and
...
p.000070:
p.000070: This chapter presents an overview of the statutory infrastructure and systems designed to regulate and oversee health
p.000070: research. The framework includes the National Health Act 61 of 2003, the Health Research Policy,52 and the
p.000070: National Department of Health Strategic Plan 2014/15 – 2018/19; 53 The care and use of animals
p.000070: for scientific purposes SANS 10386:2008,54 and MRC Guidelines on Ethics for Medical Research Book 3: Use of
p.000070: animals in research and training (2004). International instruments also inform the governance of the conduct
p.000070: of health research.55
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: 52 Available at http://www.gov.za/documents/download.php?f=70285
p.000070: 53 Available at http://www.health-e.org.za/wp-content/uploads/2014/08/SA-DoH-Strategic-Plan-2014-to-2019.pdf
p.000070: 54 Available at http://www.doh.gov.za; South African National Standard ‘The care and use of animals for scientific
p.000070: purposes SANS 10386:2008 (or later version) www.sabs.co.za.
p.000070: 55 Like the Declaration of Helsinki (2013) http://www.wma.net; see Appendix 2 for further examples.
p.000070:
p.000070: 68 Ethics in Health Research 2nd edition
p.000070:
p.000070:
p.000070: The National Health Act 61 of 2003 authorizes the appointment of the National Health Research Ethics
p.000070: Council (s 72(1)) and mandates the Minister of Health to appoint members of the Council (s 72(2)(a)). Nominations are
p.000070: called for by notice in the Government Gazette.
p.000070: Most higher education (tertiary level) and research institutions as well as health institutions have RECs, which are
p.000070: responsible for the ethical review and scrutiny of proposals to do research with human participants.
p.000070: Animal Research Ethics committees (ARECs) exist in institutions where research that uses animals is conducted.
p.000070: 5.2 National Health Research Ethics Council
p.000070:
p.000070: 5.2.1 Establishment
p.000070: The National Health Research Ethics Council(NHREC) was established in terms of the National Health Act (NHA). The
p.000070: Council’s core responsibilities are to advise the Minister of Health, to set ethical norms and standards for health
p.000070: research and to advance research ethics in South Africa, by promoting compliance by researchers and RECs using existing
p.000070: and new regulations and guidelines. The Council is mandated to register and audit RECs. In addition, the Council has
p.000070: responsibility for adjudicating complaints, for advising institutional committees, researchers and
p.000070: members of the public, as appropriate.56
p.000070: 5.2.2 Appointment of Members
p.000070: The NHA requires the Minister of Health to appoint 15 NHREC members who have knowledge and experience in research
p.000070: ethics or the law and are interested in promoting research ethics. The members’ occupational diversity is prescribed. A
p.000070: Code of Conduct guides activities and expectations of members.
p.000070: 5.2.3 Operation
...
p.000075: Clinical equipoise – literally means a state of balance or equilibrium; in the research context it means
p.000075: that, amongst health care experts, uncertainty prevails about whether a particular treatment or intervention
p.000075: is better than another. This principle forms the basis for conducting clinical research
p.000075: Clinical research –research intended to test safety (not harmful or dangerous to human health), quality (ingredients
p.000075: are of good quality), effectiveness (working to diagnose, treat, prevent or cure a disease condition) and efficacy
p.000075: (better/ best when compared with other treatment or medicine for a similar condition) of new and/or existing
p.000075: or old medicines, medical devices and/or treatment options, using human participants. (South African Clinical Trials
p.000075: Registration http://www.sanctr.gov.za/Resources/Whatisaclinicaltrial/tabid/175/Default.aspx);
p.000075:
p.000075: Ethics in Health Research 2nd edition
p.000077: 77
p.000077:
p.000077: the Ottawa Statement defines ‘trial’ as a prospective controlled or uncontrolled research study evaluating
p.000077: the effects of one or more health-related interventions related to prevention, health promotion,
p.000077: screening, diagnosis, treatment, rehabilitation, or organization and financing of care.
p.000077: ‘Intervention’ refers to a deliberate act applied to an individual or group of individuals. Health-related
p.000077: interventions include but are not limited to the use of pharmaceuticals, biological products, surgery,
p.000077: procedures, radiation, devices, education, counseling, behaviour change, complementary health modalities, and
p.000077: management or economic policies. The word ‘medicine’ includes medicines used to treat diseases (therapeutic
p.000077: medicines), to prevent diseases (prophylactic medicines, e.g. vaccines), and those used in special
p.000077: investigations (diagnostic medicines, e.g. medicines used during special X-ray examinations to map out
p.000077: kidneys).
p.000077: Coded data or materials– identifiers are substituted by a number, symbol or other method to provide a code; a key to
p.000077: the code exists so that the specimen can be linked to its original source
p.000077: Coercion – extreme form of undue influence, involving a threat of harm or punishment for failure to participate in
p.000077: research; see UndueXinfluence
p.000077: Collaborative research – involves co-operation of researchers, institutions, organizations or communities, each
p.000077: contributing distinct expertise, characterized by respectful relationships
p.000077: Community – a group of people with a shared identity or interest that has the capacity to act or express itself as a
p.000077: collective; it may be territorial, organizational or a community of interest
p.000077: Community engagement – a process that establishes an interaction between researchers and a community regarding a
p.000077: research project; it signifies the intention of forming a collaborative relationship; the degree of
p.000077: collaboration may vary depending on the circumstances
...
p.000079: 1. The AMANET (African Malaria Network Trust)
p.000079: http://webcourses.amanet-trust.org/mod/resource/view.php?inpopup=true&id=116
p.000079: The AMANET (African Malaria Network Trust) web-based health research ethics training programme aims at
p.000079: providing the basic understanding in biomedical research ethics. On the premise of scarcity of resources and
p.000079: opportunities for such training for Africans, this effort hopes to provide this service to the many African members of
p.000079: IRB’s and investigators who may wish to undertake the course at home or in their office and at their own time up to a
p.000079: maximum period of four months for each student number issued.
p.000079: 2. Cameroon Bioethics Initiative (CAMBIN)
p.000079: www.cambin.org/cambin-training
p.000079:
p.000079: 3. https://camtools.cam.ac.uk/wiki/site/e30faf26-bc0c-4533-acbc-
p.000079: cff4f9234e1b/ethnographic%20and%20field%20study.html
p.000079:
p.000079: 4. http://www.fhi360.org/training/en/RETC2/index.html
p.000079:
p.000079: 5. http://www.responsibleresearch.org/
p.000079:
p.000079: 6. NIH Office of Extramural Research
p.000079: http://phrp.nihtraining.com/users/login.php
p.000079:
p.000079: 7. Macquarie University Australia: Human Research Ethics for the Social Sciences and Humanities
p.000079: http://www.mq.edu.au/ethics_training/index.php
p.000079:
p.000079: 8. PEERRS, the University of Michigan's Program for Education and Evaluation in Responsible Research and
p.000079: Scholarship
p.000079: http://my.research.umich.edu/peerrs/
p.000079:
p.000079: 9. PRIM&R Public Responsibility in Medicine and Research
p.000079: http://www.primr.org/ResourceCenter.aspx?id=262
p.000079: ‘For more than 38 years, PRIM&R has offered learning opportunities in the fields of biomedical and
p.000079: social/behavioral/educational research. Our goal is to provide current information on the ethics and legal
p.000079: issues related to human and animal research, as well as to offer best practices and strategies for implementing
p.000079: successful programs for human subjects’ protection and animal care and use. PRIM&R's conferences, educational
p.000079: programs,
p.000079:
p.000079: Ethics in Health Research 2nd edition
p.000081: 81
p.000081:
p.000081: web-based seminars (“webinars”), and reference materials have become standard resources in the fields of research
p.000081: ethics and subjects protections.’
p.000081: 10. TRREE (for Training and Resources in Research Ethics Evaluation)
p.000081: http://elearning.trree.org/mod/resource/view.php?id=70
p.000081:
p.000081: TRREE is headed by a consortium of interested persons from Northern and Southern countries. It aims to provide basic
...
Searching for indicator educational:
(return to top)
p.000007: including in clinical trials.
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: 2 Also known as ‘human subjects research’; a human subject is a living individual about whom a researcher obtains (i)
p.000007: data through interventions or interactions; or (ii) identifiable private information.
p.000007:
p.000007: Ethics in Health Research 2nd edition
p.000009: 9
p.000009:
p.000009:
p.000009: 1.2 The research context
p.000009:
p.000009: 1.2.1 South Africa provides a rich arena for health and health-related research because of its excellent health care
p.000009: and research infrastructure, skills, and expertise. The country is also characterised by a high burden of disease,
p.000009: including diseases associated with poverty and underdevelopment, along with non-communicable diseases, creating
p.000009: a need for a broad spectrum of health and health-related research. See the Department of Health’s Strategic Health Plan
p.000009: 2014-2019 or its successor.3
p.000009: 1.2.2 South Africa is also an attractive research site for social scientists, behavioural scientists,
p.000009: political scientists, economists, researchers engaged in social development, education, and many more disciplines,
p.000009: because of its political history and current socio-economic, educational, political and social development
p.000009: status.
p.000009: 1.2.3 To ensure that South Africa’s people are fairly and respectfully treated by researchers and that all research
p.000009: conducted in the country stands up to ethical scrutiny, South Africa’s research ethics systems and infrastructure
p.000009: are regularly upgraded and strengthened.
p.000009: 1.3 Regulatory authority
p.000009:
p.000009: 1.3.1 The National Health Research Ethics Council (NHREC) was established in 2006 in terms of s 72 of the
p.000009: National Health Act (NHA).
p.000009: 1.3.2 In terms of the NHA, the NHREC must
p.000009: a) set norms and standards for health research involving humans and animals, as well as for conducting clinical trials
p.000009: b) determine guidelines to facilitate best practice for research ethics committees
p.000009: c) register and audit research ethics committees
p.000009: d) adjudicate complaints about research ethics and Animal Research Ethics committees
p.000009: e) refer matters concerning violations of ethical or professional rules to the relevant health professions
p.000009: council;
p.000009: f) recommend disciplinary action against persons found to have violated the norms and standards set for
p.000009: the responsible and ethical conduct of health research
p.000009: g) advise the national and provincial departments of health on ethical matters concerning research.
...
p.000023: consequently, whether appropriate measures are in place and are explained in the research proposal. Furthermore, the
p.000023: REC must ensure that the required notification or reporting and its management are explained in the consent documents.
p.000023: Where focus groups are planned, RECs should check that the information for participants explains clearly
p.000023: that researchers cannot guarantee confidentiality because members of the focus group may disclose information
p.000023: outside the research setting, despite agreeing not to do so. For this reason, consent documentation should advise
p.000023: potential focus group participants not to disclose personally sensitive information, as the researcher cannot
p.000023: guarantee confidentiality, even if other participants are urged to respect confidentiality.
p.000023: The Protection of Personal Information Act 4 of 2013 was assented to on 19 November 2013. 13 This Act
p.000023: provides guidance on how the right to privacy regarding personal information is protected. It stipulates
p.000023: that the right to privacy includes ‘protection against unlawful collection, retention, dissemination and use of
p.000023: personal information’ (Preamble to Act). A tension between the right to privacy and the need for free flow of
p.000023: information in a society that seeks to make progress on economic, social, health care and educational fronts, is
p.000023: immediately evident. The Act does not appear to hold out negative implications for research activities
p.000023: that record personal information about research participants. However, special attention should be given to
p.000023: ensuring that computers and electronically stored data are protected from unauthorised access, inadvertent or
p.000023: accidental dissemination and distribution in form of a ‘data dump’, etc.
p.000023: Research activities are a legitimate purpose, provided that protective measures are adhered to. Thus researchers and
p.000023: RECs should pay careful attention to measures that will protect privacy and confidentiality interests.
p.000023: In general terms, a person should know what information is being collected, why it is being collected, what
p.000023: will happen to it, how long it will be retained, whether it will identify the person, whether it will be shared with
p.000023: others and why, whether it will be sent outside South Africa and why. The person should agree to these terms.
p.000023: Some specific terms are summarised:
p.000023: • in the case of a child (person under the age of 18 years), a parent or guardian14 must give permission for the
p.000023: information to be collected (s 35(1)(a));15
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: 12Storage requirements may vary according to institutional requirements; usually between five and fifteen years.
p.000023: 13Some parts came into effect on 11 April 2014: s 1 (definitions); part A of Chapter 5 (establishment of Information
...
p.000029: The following considerations are critical when RECs review proposals to involve child participants:
p.000029: a) Children should participate in research when their participation is scientifically indispensable to the
p.000029: research. In the case of interventional clinical research, equipoise 25 should exist. Research should
p.000029: investigate a problem of relevance to children. The protocol should provide sufficient information to
p.000029: justify clearly why children should be included as participants.
p.000029: b) Children should participate in research only where such research poses acceptable risks of harm. That is,
p.000029: research involving minors should be approved only if:
p.000029: i. The research, including observational research, is not contrary to the best interest of the minor;
p.000029: ii. The research, including observational research, places the minor at no more than minimal risk of harm (i.e. the
p.000029: ‘everyday risks standard’ which means the risk of harm is commensurate with daily life in a stable society
p.000029: or routine medical, dental, educational or psychological tests or examinations – referred to as ‘negligible risk’ in
p.000029: some guidelines); or
p.000029: iii. The research involves greater than minimal risk of harm but provides the prospect of direct benefit
p.000029: for the minor. The degree of risk of harm should be justified by the potential benefit; or
p.000029:
p.000029: 25 ‘Equipoise’ literally means a state of balance or equilibrium; in the research context it means that, amongst
p.000029: health care experts, uncertainty prevails about whether a particular treatment or intervention is better than another.
p.000029: This principle forms the basis for conducting clinical research.
p.000029:
p.000029: 30 Ethics in Health Research 2nd edition
p.000029:
p.000029:
p.000029: iv. The research, including observational research, involves greater than minimal risk of harm, with no prospect of
p.000029: direct benefit to the minor, but has a high probability of providing significant generalizable knowledge. The degree of
p.000029: risk of harm should be justified by the risk-knowledge ratio.
...
p.000031: to choose. Researchers are unlikely to be able to intervene where the suspicion is that the parent is
p.000031:
p.000031: 26 See 3.2.2.4.
p.000031:
p.000031: 32 Ethics in Health Research 2nd edition
p.000031:
p.000031:
p.000031: withholding permission unreasonably, since a best interest analysis in this context is irrelevant.
p.000031: 3.2.2.3 Orphans without guardians
p.000031: i. Introduction
p.000031: Many minors in South Africa do not have parents and very few have court-appointed guardians. These minors
p.000031: are often described as ‘orphans and vulnerable children’ or OVC. The absence of a legally appropriate parental
p.000031: substitute poses a problem for researchers because of the lack of clear guidance as to an acceptable substitute in
p.000031: the informed consent process for research participation. (Note that for treatment purposes, substituted
p.000031: consent occurs on the basis of necessity, which is not applicable to the research context.)
p.000031: ii. Justification
p.000031: Important research that seeks to understand and improve psychosocial, economic and educational conditions for
p.000031: orphans and vulnerable children to improve their future well being generally involves no more than minimal risk
p.000031: of harm. Other research including clinical research that may involve a minor increase over minimal risk of harm
p.000031: may also be justified on the basis that it would be unjustifiable to exclude a significant segment of the
p.000031: child population from research on the basis of their legal status. Consequently, it is ethical and reasonable to
p.000031: designate parental substitutes in these circumstances.
p.000031: iii. Pragmatic parental substitutes27
p.000031: In the interest of fostering consistency as well as compliance with the spirit of the legal provisions
p.000031: that protect minors’ interests, especially the Constitution and the Children’s Act, pragmatic guidance is provided
p.000031: here to deal with situations where no biological parent or legal guardian exists. The permissible level of
p.000031: risk is limited (see 3.2.2.1).
p.000031: Note this guidance does not permit expedient substitution e.g. where a parent is temporarily unavailable.
...
p.000077: care delivery; new pharmaceuticals, medicines, interventions and devices; new technologies to improve health and health
p.000077: care
p.000077: Identifiable information – reasonably expected to identify an individual alone or in combination with other
p.000077: information
p.000077: Directly identifying – direct identifiers e.g. name, identity number
p.000077: Indirectly identifying – combination of indirect identifiers e.g. date of birth, address, unique personal
p.000077: characteristic
p.000077: Coded information – direct identifiers removed; replaced by code Anonymised information – irrevocably stripped of
p.000077: direct identifiers; no code Anonymous information – never had identifiers
p.000077: Identifier– information such as a name, initials, address, folder number, or biometric identifier (e.g.
p.000077: finger print) that can identify a particular donor
p.000077: Incentive – anything offered to encourage participation in research
p.000077: Incidental findings – unanticipated discoveries made in the course of research that are outside the scope of the
p.000077: research
p.000077: Inconvenience – a minor negative effect experienced in research less serious than discomfort
p.000077: Low risk research – where the only foreseeable risk is one of discomfort
p.000077: Minimal risk research – where probability and magnitude of possible harms implied by participation are no
p.000077: greater than those posed by daily life in a stable society or routine medical, dental, educational or
p.000077: psychological tests or examinations
p.000077: Minor– a person under 18 years (s 17 Children’s Act)
p.000077: Narrow consent – donor permits single use only of biological materials; no storage; no sharing of data or
p.000077: specimen; new consent if further use wanted.
p.000077: Negligible risk research – where the only foreseeable risk is one of inconvenience
p.000077: Neonate – a newborn child
p.000077: Non-therapeutic interventions–interventions not directed towards health-related benefit for a participant but towards
p.000077: improving generalisable knowledge (NHA Reg 135)
p.000077: Observational research – study of behaviour in a natural environment where people involved in their usual
p.000077: activities are observed with or without their knowledge; observational research also occurs in clinical research
p.000077: e.g. when a researcher observes individuals or measures particular outcomes, without intervention e.g.
p.000077: no treatment is given);an observational study describes a wide range of study designs including
p.000077: prospective and retrospective cohort studies, case-control studies, and cross-sectional studies, a defining
p.000077: feature of which is that any intervention studied is determined by clinical practice and not the protocol.
...
p.000079: opportunities for such training for Africans, this effort hopes to provide this service to the many African members of
p.000079: IRB’s and investigators who may wish to undertake the course at home or in their office and at their own time up to a
p.000079: maximum period of four months for each student number issued.
p.000079: 2. Cameroon Bioethics Initiative (CAMBIN)
p.000079: www.cambin.org/cambin-training
p.000079:
p.000079: 3. https://camtools.cam.ac.uk/wiki/site/e30faf26-bc0c-4533-acbc-
p.000079: cff4f9234e1b/ethnographic%20and%20field%20study.html
p.000079:
p.000079: 4. http://www.fhi360.org/training/en/RETC2/index.html
p.000079:
p.000079: 5. http://www.responsibleresearch.org/
p.000079:
p.000079: 6. NIH Office of Extramural Research
p.000079: http://phrp.nihtraining.com/users/login.php
p.000079:
p.000079: 7. Macquarie University Australia: Human Research Ethics for the Social Sciences and Humanities
p.000079: http://www.mq.edu.au/ethics_training/index.php
p.000079:
p.000079: 8. PEERRS, the University of Michigan's Program for Education and Evaluation in Responsible Research and
p.000079: Scholarship
p.000079: http://my.research.umich.edu/peerrs/
p.000079:
p.000079: 9. PRIM&R Public Responsibility in Medicine and Research
p.000079: http://www.primr.org/ResourceCenter.aspx?id=262
p.000079: ‘For more than 38 years, PRIM&R has offered learning opportunities in the fields of biomedical and
p.000079: social/behavioral/educational research. Our goal is to provide current information on the ethics and legal
p.000079: issues related to human and animal research, as well as to offer best practices and strategies for implementing
p.000079: successful programs for human subjects’ protection and animal care and use. PRIM&R's conferences, educational
p.000079: programs,
p.000079:
p.000079: Ethics in Health Research 2nd edition
p.000081: 81
p.000081:
p.000081: web-based seminars (“webinars”), and reference materials have become standard resources in the fields of research
p.000081: ethics and subjects protections.’
p.000081: 10. TRREE (for Training and Resources in Research Ethics Evaluation)
p.000081: http://elearning.trree.org/mod/resource/view.php?id=70
p.000081:
p.000081: TRREE is headed by a consortium of interested persons from Northern and Southern countries. It aims to provide basic
p.000081: training, while building capacities, on the ethics of health research involving humans so that research meets highest
p.000081: standards of ethics and promotes the welfare of participants. TRREE achieves this goal primarily by
p.000081: developing a training programme with local collaborators. In its initial stages TRREE focused primarily, but not
p.000081: exclusively, on the needs of African countries.
p.000081: TRREE provides free-of-charge access to:
p.000081: • e-Learning: a distance learning program and certification on research ethics evaluation
p.000081: • e-Resources : a participatory web-site with international, regional and national regulatory and policy resources
p.000081: There are other opportunities available but not all are free.
p.000081:
p.000081:
p.000081: Guidelines
...
Social / employees
Searching for indicator employees:
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p.000037: vi. The legally appropriate person (treatment proxies as stipulated in NHA s 7 or s 27(1)(a) of the
p.000037: Mental Health Care Act 17 of 2002) gives permission for the person to participate; and
p.000037: vii. Where appropriate, the person will assent to participation. Note that the incapacitated person’s refusal or
p.000037: resistance to participate, as indicated by words or behaviour, takes precedence over permission by a proxy.
p.000037: The National Health Act specifies the sequence of legally appropriate treatment proxies as spouse or partner; parent;
p.000037: grandparent; adult child; brother or sister. The Mental Health Care Act provides, in no particular sequence, that
p.000037: legally appropriate proxies are spouse; next of kin; partner; associate (defined as ‘a person with a
p.000037: substantial or material interest in the well-being of a mental health care user or a person who is in substantial
p.000037: contact with the user’); and parent or guardian.
p.000037: 3.2.5 Persons in dependent relationships
p.000037:
p.000037: This class of persons includes persons in junior or subordinate positions in hierarchically structured
p.000037: groups and may include relationships between older persons and their care-givers; persons with chronic conditions
p.000037: or disabilities and their care-givers; persons with life- threatening illnesses; patients and health care
p.000037: professionals; wards of state and guardians; students and teachers (including university teachers); employees and
p.000037: employers, including farm workers, members of the uniformed services and hospital staff and their
p.000037: respective employers.
p.000037: Particular attention should be given to ensuring that participants are adequately informed and can choose
p.000037: voluntarily whether to participate in research.
p.000037: 3.2.6 Patients highly dependent on medical care
p.000037:
p.000037: Patients who are highly dependent on medical care deserve special attention when considering research
p.000037: participation. The gravity of their medical condition may require invasive measures that carry increased risk of
p.000037: harm. The quality of informed consent may be compromised by the effect the medical condition has on the
p.000037: participant’s decision-making or communication abilities. A patient may be reluctant to refuse consent for fear that
p.000037: this may compromise his medical treatment. Adequate provision must be made for informing patients and their relatives
p.000037: about the research, to ensure that stress and other emotional factors do not impair their understanding. The dependency
p.000037: of patients and their relatives on caregivers should not unduly affect research participation decisions.
p.000037:
p.000037: Ethics in Health Research 2nd edition
p.000039: 39
p.000039:
...
Social / gender
Searching for indicator gender:
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p.000057: appointment, to produce evidence of recent training; and that membership should be managed to ensure an optimal mix of
p.000057: experienced and new members to promote good succession planning. The term of office of members may vary
p.000057: according to institutional requirements. Consideration should be given to succession planning and accumulation of
p.000057: institutional memory for RECs. A reasonable term of office is between two and four years, renewable twice, after which
p.000057: the person should stand down for at least one term. This ensures that both expertise and responsibility are
p.000057: fairly distributed and encouraged in a range of members, and that institutional memory is accumulated.
p.000057: 4.4.1 Formal membership requirements for RECs and ARECs
p.000057:
p.000057: 4.4.1.1 General
p.000057: Subject to institutional requirements, a Chairperson could be appointed or elected at the first meeting of the REC, and
p.000057: thereafter confirmed annually. Alternately, the Chairperson, suitably qualified, could be appointed by the
p.000057: institutional leadership for a period of two to four years, renewable if so specified. The Chairperson should be
p.000057: assisted by at least one Deputy Chairperson, depending on the size of the committee. The Deputy
p.000057: Chairperson should be elected by the members and be expected to assist the Chairperson with responsibilities and
p.000057: inter-meeting matters, as well as to step into the role of Chairperson when necessary.
p.000057:
p.000057:
p.000057:
p.000057:
p.000057:
p.000057: 51Diversity of REC membership refers mostly to ethnicity, culture and gender of members.
p.000057:
p.000057: Ethics in Health Research 2nd edition
p.000059: 59
p.000059:
p.000059: 4.4.1.2 Research Ethics Committees
p.000059: All REC members should have documented proof of research ethics training, refreshed at least once within
p.000059: the period of appointment.
p.000059: REC membership should consist of
p.000059: i. at least nine members with a quorum being a simple majority
p.000059: ii. where the number of members is more than 15, the quorum may be 33%
p.000059: iii. at least one layperson
p.000059: iv. at least one member with knowledge of, and current experience in, the professional care, counselling or
p.000059: health-related treatment of people. Such a member might be e.g. a medical practitioner, psychologist, social worker or
p.000059: nurse
p.000059: v. at least one member with professional training and experience in qualitative research methodologies
p.000059: vi. members with professional training and experience in quantitative research methodologies
p.000059: vii. a member with expertise in bio-statistics
p.000059: viii. a member with expertise in research ethics
p.000059: ix. at least one member who is legally qualified
p.000059:
p.000059: 4.4.1.3 Animal Research Ethics Committees
p.000059: Various categories of members are dictated by international and national standards including the SABS SANS 10386 (2008
p.000059: or later version).
p.000059: Four categories of member are required:
p.000059: A: Veterinarians
...
Social / orphan
Searching for indicator orphan:
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p.000029: 29
p.000029:
p.000029: ‘Child’ means a person under the age of 18 years (s 28 Constitution; s 1 Children’s Act 38 of 2005)
p.000029: ‘Child-headed household’ means a household per s 137 Children’s Act 38 of 2005
p.000029: ‘Guardian’ means a person appointed by a court to look after the financial and welfare interests of a
p.000029: minor, or a person appointed by a parent with sole responsibility for the minor in terms of the parent’s Will
p.000029: ‘Harm’ means physical, emotional, psychological, social or legal harm
p.000029: ‘Minor’ means a person (child) less than 18 years (s 17 Children’s Act 38 of 2005) ‘Neonate’ means a newborn child,
p.000029: including an infant less than a month old
p.000029: ‘Orphan’ means a child who has no surviving parent caring for him or her (s 1 Children’s Act 38 of 2005)
p.000029: ‘Parent’ includes an adoptive parent (s 1 Children’s Act 38 of 2005)
p.000029: ‘Therapeutic research’ means research that includes interventions that may hold out the prospect of direct
p.000029: health-related benefit for the participant (Regulation 135)
p.000029: ‘Non-therapeutic research’ means research that includes interventions that will not hold out the prospect of direct
p.000029: health-related benefit for the participant but may produce results that contribute to generalisable knowledge
p.000029: (Regulation 135)
p.000029: 3.2.2.1 Minimum conditions for research involving minors
p.000029: The following considerations are critical when RECs review proposals to involve child participants:
p.000029: a) Children should participate in research when their participation is scientifically indispensable to the
p.000029: research. In the case of interventional clinical research, equipoise 25 should exist. Research should
p.000029: investigate a problem of relevance to children. The protocol should provide sufficient information to
p.000029: justify clearly why children should be included as participants.
...
p.000077: psychological tests or examinations
p.000077: Minor– a person under 18 years (s 17 Children’s Act)
p.000077: Narrow consent – donor permits single use only of biological materials; no storage; no sharing of data or
p.000077: specimen; new consent if further use wanted.
p.000077: Negligible risk research – where the only foreseeable risk is one of inconvenience
p.000077: Neonate – a newborn child
p.000077: Non-therapeutic interventions–interventions not directed towards health-related benefit for a participant but towards
p.000077: improving generalisable knowledge (NHA Reg 135)
p.000077: Observational research – study of behaviour in a natural environment where people involved in their usual
p.000077: activities are observed with or without their knowledge; observational research also occurs in clinical research
p.000077: e.g. when a researcher observes individuals or measures particular outcomes, without intervention e.g.
p.000077: no treatment is given);an observational study describes a wide range of study designs including
p.000077: prospective and retrospective cohort studies, case-control studies, and cross-sectional studies, a defining
p.000077: feature of which is that any intervention studied is determined by clinical practice and not the protocol.
p.000077: Orphan– a child without a surviving parent to care for him (s 1 Children’s Act)
p.000077:
p.000077: Ethics in Health Research 2nd edition
p.000079: 79
p.000079:
p.000079: Privacy risks – potential harms to participants from collection, use and disclosure of personal information
p.000079: for research purposes
p.000079: Protocol – document that provides background, rationale and objectives of research; describes its design,
p.000079: methodology, organization and conditions under which it is to be conducted and managed
p.000079: Qualitative research – involves studied use of empirical materials such as case studies, personal experience, life
p.000079: stories, interviews, observations, and cultural texts
p.000079: Registry– a collection of information (data) from multiple sources, maintained over time with controlled
p.000079: access through a gatekeeper organizer
p.000079: Reimbursement – payment to participants to ensure they are not disadvantaged financially directly or indirectly by
p.000079: participation in research; directly means actual costs incurred and indirectly means losses that arise because
p.000079: of participation
p.000079: Repository– a collection, storage and distribution system for human biological materials for research purposes
p.000079: including blood, urine, faeces, bone marrow, cell aspirates, diagnostic specimens, pathology specimens and
...
Social / parents
Searching for indicator parent:
(return to top)
p.000021: budget to reimburse expenses incurred by participants for travel, refreshments and also for inconvenience,
p.000021: depending on the circumstances. If no travel or other expenses are incurred, reimbursement is not required
p.000021: unless an inconvenience reimbursement is justifiable.
p.000021: A fair rate of reimbursement should be calculated using the Time, Inconvenience and Expenses (TIE)
p.000021: method to determine the cost to participants for time expended, inconvenience and refreshments
p.000021: associated with research participation. This method costs expenses at the current hourly rate for unskilled
p.000021: labour in the market place, regardless of whether the participant is employed. See NHREC (2012) Payment of
p.000021: trial participants in South Africa: ethical consideration for Research Ethics Committees.11
p.000021: Researchers must submit planned payment schedules and amounts together with a justification to the REC
p.000021: when making application for ethics review. RECs should exercise caution against taking an unreasonably
p.000021: paternalistic view of the rate of reimbursement. The proposal and the informed consent documentation should indicate
p.000021: whether reimbursements are pro rata if the participant does not complete the study; i.e. whether only some of the
p.000021: offered reimbursement is available if participation is stopped before the anticipated end of the study.
p.000021: Where minors are the participants, their accompanying parent or guardian should also receive reimbursement
p.000021: for travel costs and refreshments.
p.000021: Inducements encourage participation. They may be offered in some circumstances where
p.000021: e.g. recruitment, especially of healthy participants, is anticipated to be difficult. However, a justification for
p.000021: this tactic should be provided and the inducement should not unduly influence an informed choice about
p.000021: participation. In particular, an inducement should not undermine a potential participant’s assessment of risk of
p.000021: harm. All inducements should be clearly explained and justified to the REC. Input from community members on the REC or
p.000021: other role players may be constructive.
p.000021: 3.1.8 Participants’ privacy and confidentiality interests
p.000021: The principle of respect for persons requires careful attention to privacy and confidentiality interests. Privacy
p.000021: describes the person’s interest in controlling access to her personal information. Confidentiality is about
p.000021: whether and how research data might be disclosed
p.000021:
p.000021:
p.000021:
p.000021: 11 Available at http://nhrec.org.za – the current rate (2014) for unskilled construction workers is approximately R15
p.000021: - R25 per hour depending on the tasks (see Department of Labour’s sectoral determinations).
p.000021:
p.000021: Ethics in Health Research 2nd edition
p.000023: 23
p.000023:
...
p.000023: personal information’ (Preamble to Act). A tension between the right to privacy and the need for free flow of
p.000023: information in a society that seeks to make progress on economic, social, health care and educational fronts, is
p.000023: immediately evident. The Act does not appear to hold out negative implications for research activities
p.000023: that record personal information about research participants. However, special attention should be given to
p.000023: ensuring that computers and electronically stored data are protected from unauthorised access, inadvertent or
p.000023: accidental dissemination and distribution in form of a ‘data dump’, etc.
p.000023: Research activities are a legitimate purpose, provided that protective measures are adhered to. Thus researchers and
p.000023: RECs should pay careful attention to measures that will protect privacy and confidentiality interests.
p.000023: In general terms, a person should know what information is being collected, why it is being collected, what
p.000023: will happen to it, how long it will be retained, whether it will identify the person, whether it will be shared with
p.000023: others and why, whether it will be sent outside South Africa and why. The person should agree to these terms.
p.000023: Some specific terms are summarised:
p.000023: • in the case of a child (person under the age of 18 years), a parent or guardian14 must give permission for the
p.000023: information to be collected (s 35(1)(a));15
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: 12Storage requirements may vary according to institutional requirements; usually between five and fifteen years.
p.000023: 13Some parts came into effect on 11 April 2014: s 1 (definitions); part A of Chapter 5 (establishment of Information
p.000023: Regulator); s 112 (about making Regulations); and s 113 (procedures for making Regulations) by Proclamation in GG 37544
p.000023: R.25, 2014.
p.000023: 14Note a caregiver, a foster parent, and a schoolteacher or principal are not guardians.
p.000023: 15 This requirement is compatible with the consent requirements for minors as described elsewhere in these Guidelines
p.000023: (see 3.2.2).
p.000023:
p.000023: 24 Ethics in Health Research 2nd edition
p.000023:
p.000023:
p.000023: • if the information is to be sent outside the Republic, the recipient must assure that the level of protection
p.000023: afforded in that country is commensurate with that expected in South Africa (s 18(1)(g));
p.000023: • information about a person’s race or ethnic origin must be necessary (s 29(a)) or for affirmative action purposes
p.000023: (s 29(b));
p.000023: • information about a person’s health or sex life must be necessary for the research activity (s 27(1)(d));
p.000023: • information about a person’s inherited characteristics must be necessary for the research activity (s
p.000023: 32(5)(b));
p.000023: • biometric16 information about a person must be necessary for the research activity (s 27(1)(d)).
p.000023: In effect, the Act outlines and requires the usual requirements for ethical and responsible informed consent
p.000023: procedures. The provisions underpin the importance of comprehensive SOPs and rigorous adherence thereto. It
p.000023: should be remembered that research records including informed consent documentation may be solicited by
...
p.000027: approval for the study may be withdrawn, temporarily or permanently, as the case may be.
p.000027: Groups of participants discussed here include
p.000027: • minors (children and adolescents)
p.000027: • women
p.000027: • adults with incapacity to provide informed consent
p.000027: • persons in dependent relationships
p.000027: • persons highly dependent on medical care
p.000027: • persons with physical disabilities
p.000027: • prisoners
p.000027: • collectivities
p.000027:
p.000027: Note this list is not exhaustive but provides an indication of the types of consideration to be applied
p.000027: 3.2.2 Minors (children and adolescents)
p.000027:
p.000027: Below the age of majority, the law protects young people from their own emotional, cognitive and physical immaturity
p.000027: and limited life experience through the legal status of minority. In other words, minors, i.e. persons under 18 years
p.000027: of age,22 are legally incapable of performing legal transactions without assistance from a parent or guardian. In the
p.000027: research context, this means that, in principle, anyone under the age of 18 years may not choose independently whether
p.000027: to participate in research; a parent or guardian must give permission for the minor
p.000027:
p.000027: 21 Note that this requirement does not mean that a REC may not approve a waiver of personal informed consent for types
p.000027: of research into e.g. record reviews or such like.
p.000027: 22 Section 28 of the Constitution; and s 17 of the Children’s Act 38 of 2005.
p.000027:
p.000027: 28 Ethics in Health Research 2nd edition
p.000027:
p.000027:
p.000027: to choose. This is because young persons’ understanding of key aspects of the research initiative may be
p.000027: compromised and, consequently, they may be exposed to increased risk of harm from particular research procedures.
p.000027: Exceptions to the requirement for parental permission are discussed at 3.2.2.4.
p.000027: Tension exists between the views that, in general, children and adolescents should not bear the burden of research
p.000027: unnecessarily, on the one hand, and that children and adolescents are entitled to improved health care based on
p.000027: findings drawn from rigorous research conducted in the child population of South Africa, on the other.
p.000027: The solution lies in the approach that minors should participate in research only where their
p.000027: participation is indispensable to the research; i.e. the research cannot deliver the desired outcomes if adult
p.000027: participants were to be used instead.
p.000027: Because of their status of legal incapacity, in principle, minors may not choose independently whether to participate
p.000027: in research. A parent or guardian must give permission for the minor to choose. It should be noted that the parent or
p.000027: guardian does not choose for the minor who is capable of choosing;23 rather, the parent or guardian gives
p.000027: permission for the minor to choose. Where a minor is very young or is factually incapable of exercising a choice,
p.000027: then the parent or guardian chooses whether the minor should participate.
p.000027: The best interest of a child should be paramount in decisions that affect the child. 24 This principle is
p.000027: difficult to apply in the research context because research participation is unlikely to be in the best interest of a
p.000027: minor. Good research design does not accommodate a best interest analysis easily. Rather, the design draws on
p.000027: aggregates of information. This means that, in the research context, the best interest principle should be understood
p.000027: to mean that participation in the research should not be contrary to the individual minor’s best interest. Further, the
p.000027: research should investigate a problem of relevance to minors.
p.000027: Where research can be done with consenting adults but nevertheless proposes also to include minors, the
p.000027: researchers must provide strong justification for the inclusion of minors. The REC should not make assumptions on
p.000027: behalf of the researchers. It should require all relevant information to be provided by the researchers. Note
p.000027: that all types of clinical trial research on minors should be scrutinized carefully in case extra precautions or
p.000027: conditions are necessary.
p.000027: For purposes of these guidelines
p.000027: ‘Adolescent’ means a child between the ages of 12 and 17 years of age (ICH Topic E 11 Clinical Investigation of
p.000027: Medicinal Products in the Paediatric Population. 2000
p.000027: [http://www.emea.eu.int/pdfs/human/ich/271199EN.pdf]
p.000027: ‘Caregiver’ means a person who factually cares for a child (s 1 Children’s Act, 38 of 2005; a caregiver is obliged
p.000027: (in terms of s 32(1)) to safeguard the child’s health, well-being and development; and to protect the child
p.000027: from abuse and other harms. Further a caregiver may exercise the parental right to consent to medical examination or
p.000027: treatment of the child (in terms of s 32(2))
p.000027:
p.000027:
p.000027: 23 Section 10 of the Children’s Act 38 of 2005. Note that a caregiver, a foster parent and a schoolteacher or
p.000027: principal are not guardians. Note that legal incapacity is not the same as factual incapacity. Minority is a legal
p.000027: incapacity status.
p.000027: 24 See also s 9 of the Children’s Act 38 of 2005.
p.000027:
p.000027: Ethics in Health Research 2nd edition
p.000029: 29
p.000029:
p.000029: ‘Child’ means a person under the age of 18 years (s 28 Constitution; s 1 Children’s Act 38 of 2005)
p.000029: ‘Child-headed household’ means a household per s 137 Children’s Act 38 of 2005
p.000029: ‘Guardian’ means a person appointed by a court to look after the financial and welfare interests of a
p.000029: minor, or a person appointed by a parent with sole responsibility for the minor in terms of the parent’s Will
p.000029: ‘Harm’ means physical, emotional, psychological, social or legal harm
p.000029: ‘Minor’ means a person (child) less than 18 years (s 17 Children’s Act 38 of 2005) ‘Neonate’ means a newborn child,
p.000029: including an infant less than a month old
p.000029: ‘Orphan’ means a child who has no surviving parent caring for him or her (s 1 Children’s Act 38 of 2005)
p.000029: ‘Parent’ includes an adoptive parent (s 1 Children’s Act 38 of 2005)
p.000029: ‘Therapeutic research’ means research that includes interventions that may hold out the prospect of direct
p.000029: health-related benefit for the participant (Regulation 135)
p.000029: ‘Non-therapeutic research’ means research that includes interventions that will not hold out the prospect of direct
p.000029: health-related benefit for the participant but may produce results that contribute to generalisable knowledge
p.000029: (Regulation 135)
p.000029: 3.2.2.1 Minimum conditions for research involving minors
p.000029: The following considerations are critical when RECs review proposals to involve child participants:
p.000029: a) Children should participate in research when their participation is scientifically indispensable to the
p.000029: research. In the case of interventional clinical research, equipoise 25 should exist. Research should
p.000029: investigate a problem of relevance to children. The protocol should provide sufficient information to
p.000029: justify clearly why children should be included as participants.
p.000029: b) Children should participate in research only where such research poses acceptable risks of harm. That is,
p.000029: research involving minors should be approved only if:
p.000029: i. The research, including observational research, is not contrary to the best interest of the minor;
...
p.000029: deliberation by the REC about the degree of risk of harm posed by a proposal and the likelihood of benefit to the
p.000029: child- participant. This distinction is of little practical import since most research involves a mix of ‘therapeutic’
p.000029: and ‘non-therapeutic’ interventions or components and reviewers usually assess the proposal as a whole.
p.000029: d) The degree of risk of harm should be evaluated against the likelihood of benefit to the child-participant as
p.000029: outlined in b) above. Furthermore, registered RECs that have been granted permission in writing to exercise the
p.000029: Minister’s delegated power to approve research with children that includes non-therapeutic components must
p.000029: ensure that their deliberations on these components are properly minuted and recorded as required by the
p.000029: Regulations. RECs that review research with child participants must include members with appropriate paediatric
p.000029: research experience.
p.000029: e) Children should participate in research only where the proper written permissions have been obtained. The
p.000029: general principle is that minors cannot agree to research participation without assistance of a parent or
p.000029: guardian (exceptions to the general principle are discussed in 3.2.2.4). This principle holds notwithstanding the
p.000029: exceptions created in the Children’s Act 38 of 2005 for consent to medical treatment and surgical operations (s 129);
p.000029: consent to HIV-testing (s 130); and the exception for female minors created in the Choice on Termination of
p.000029: Pregnancy Act 92 of 1996 (s 5(2)). Consequently, in principle, the consent process for a minor’s participation in
p.000029: research requires
p.000029: • Permission in writing from parents or legal guardian for the minor to be approached and invited to
p.000029: participate (in accordance with s 10 of the Children’s Act 38 of 2005);
p.000029: • Assent from the minor in writing (i.e. agreement to participate) if he or she chooses to participate.
p.000029: Note that an unmarried minor mother may not agree to the participation of her child in research without assistance. Her
p.000029: guardian (usually her parent) is also the guardian of her child while she is a minor and must consent to the child’s
p.000029: participation. In other words, pregnancy and childbirth do not change the legal status of the minor mother. When the
p.000029: mother reaches the age of majority (18 years), she may consent to her child’s participation in research.
p.000029: f) Children should participate in research that takes cognisance of their privacy interests. Although children are
p.000029: legally dependent, they have significant privacy interests. Their
p.000029:
p.000029: Ethics in Health Research 2nd edition
p.000031: 31
p.000031:
p.000031: genetic privacy interests, in particular, may be more important than those of adults who manifest a particular genetic
p.000031: condition.
p.000031: g) When parents or a guardian give permission for their minor child to choose whether to participate in research, this
p.000031: permission is given based on a detailed description of all diagnostic and therapeutic interventions that will
p.000031: affect the child in the study. However, this does not mean that parents are entitled to know the outcome of all
p.000031: diagnostic and therapeutic interventions, especially as regards older minors (adolescents). The
p.000031: informed consent documentation must explain whether results of tests will be made known to child-participants
p.000031: and their parents. Whether this happens, depends to an extent on the socio-cultural context and the best
p.000031: interest standard.
p.000031: h) The minor’s interest in confidentiality, i.e. being identified or identifiable without permission of the
p.000031: minor and her parent or guardian must be respected.
p.000031: i) Research involving children must respect their evolving capacity to give consent. Minors who turn 18
p.000031: years old during the course of a study should be approached at the time of their birthday to re-consent. This
p.000031: is because they must now provide independent consent to continue to be a participant. In cases where
p.000031: minors are permitted to decide independently whether to participate, 26 the consent process should address
p.000031: how re-consent will be managed when they change status from minority to majority. Similarly, in the case of
p.000031: large and longitudinal studies, attention must be given to how the change from minority to majority will be managed.
p.000031: Where a study is no longer in active interaction with participants, re-consent procedures may be less important.
p.000031: j) Researchers must familiarise themselves with the legal obligations to report child abuse and neglect.
p.000031: See 3.2.2.5.
p.000031: 3.2.2.2 Parental permission
p.000031: The Children’s Act 38 of 2005 emphasises the right of a child to participate in any matter concerning that child,
p.000031: provided he or she has sufficient maturity to participate appropriately and meaningfully (s 10), notwithstanding
p.000031: legal incapacity. This means that parents or guardians may not decide whether their minor child should
p.000031: participate in research without the minor’s contribution to the decision. The choice of whether to participate is not a
p.000031: legal decision but rather a factual choice. Consequently, the process should be that the parent or guardian is
p.000031: requested to give permission for the minor to be approached to be invited to participate in the study. The factual
p.000031: decision whether to participate is the minor’s and not the parent’s.
p.000031: Parental permission and minor’s decision must be consistent, i.e. if the minor decides not to participate, the parent
p.000031: may not override this decision. If the parent is reluctant for the minor to participate but the minor wants to
p.000031: do so, the matter must be managed carefully to establish what the concerns are and whether they may be
p.000031: resolved. The minor cannot choose to participate if the parent withholds permission for that minor
p.000031: to choose. Researchers are unlikely to be able to intervene where the suspicion is that the parent is
p.000031:
p.000031: 26 See 3.2.2.4.
p.000031:
p.000031: 32 Ethics in Health Research 2nd edition
p.000031:
p.000031:
p.000031: withholding permission unreasonably, since a best interest analysis in this context is irrelevant.
p.000031: 3.2.2.3 Orphans without guardians
p.000031: i. Introduction
p.000031: Many minors in South Africa do not have parents and very few have court-appointed guardians. These minors
p.000031: are often described as ‘orphans and vulnerable children’ or OVC. The absence of a legally appropriate parental
p.000031: substitute poses a problem for researchers because of the lack of clear guidance as to an acceptable substitute in
p.000031: the informed consent process for research participation. (Note that for treatment purposes, substituted
p.000031: consent occurs on the basis of necessity, which is not applicable to the research context.)
p.000031: ii. Justification
p.000031: Important research that seeks to understand and improve psychosocial, economic and educational conditions for
p.000031: orphans and vulnerable children to improve their future well being generally involves no more than minimal risk
p.000031: of harm. Other research including clinical research that may involve a minor increase over minimal risk of harm
p.000031: may also be justified on the basis that it would be unjustifiable to exclude a significant segment of the
p.000031: child population from research on the basis of their legal status. Consequently, it is ethical and reasonable to
p.000031: designate parental substitutes in these circumstances.
p.000031: iii. Pragmatic parental substitutes27
p.000031: In the interest of fostering consistency as well as compliance with the spirit of the legal provisions
p.000031: that protect minors’ interests, especially the Constitution and the Children’s Act, pragmatic guidance is provided
p.000031: here to deal with situations where no biological parent or legal guardian exists. The permissible level of
p.000031: risk is limited (see 3.2.2.1).
p.000031: Note this guidance does not permit expedient substitution e.g. where a parent is temporarily unavailable.
p.000031: This guidance takes its lead from the Constitution, the Children’s Act, the National Health Act, the Criminal Law
p.000031: (Sexual Offences) Amendment Act; the South African Good Clinical Practice Guidelines (2006) available at
p.000031: www.doh.gov.za/docs/factsheets/guidelines/clinical/2006/index.html.
p.000031: The guidance is premised on three conditions, all of which must be satisfied:
p.000031: 1. The risk standards set out in 3.2.2.1 b) must be adhered to; and
p.000031: 2. It is not possible to do the research with adult participants; and
p.000031: 3. The research proposes to investigate a problem of relevance to minors.
p.000031: Note that if the proposed research holds out more than a minimal risk of harm, there must be a
p.000031: compelling justification for why orphans should be included as participants, e.g. the research focus has particular
p.000031: relevance for OVC and cannot be studied without their enrolment.
p.000031: The parental substitutes should be used in descending order, as listed.
p.000031: i. The minor chooses whether to participate and thus expresses her will AFTER
p.000031:
p.000031: 27 This pragmatic guidance is provided to temper the chilling effect of a literal interpretation of s 71 of the
p.000031: National Health Act 61 of 2003, which otherwise might prevent important ethical research.
p.000031:
p.000031: Ethics in Health Research 2nd edition
p.000033: 33
p.000033:
p.000033: ii. The parent gives assistance with understanding (so the minor makes an informed choice)
p.000033: iii. If no parent, then guardian: either court-appointed OR as indicated by the parent in a Will (s 27 Children’s Act)
p.000033: iv. If no guardian, then foster parent (per order of Children’s Court) (Note that social workers should
p.000033: request that the authority to give permission should be included expressly in the court order authorising
p.000033: foster care)28
p.000033: v. If no foster parent (per iv. above), then caregiver (s 1 Children’s Act: defined as ‘…any person
p.000033: other than a parent or guardian, who factually cares for a child and includes – a) a foster parent; b) a person who
p.000033: cares for the child with the implied or express consent of a parent or guardian of the child; c) a person who cares for
p.000033: the child whilst the child is in temporary safe care; d) the person at the head of a child and youth care centre where
p.000033: a child has been placed; e) the person at the head of a shelter; f) a child and youth care worker who cares
p.000033: for a child who is without appropriate family care in the community; and g) the child at the head of a child-
p.000033: headed household’)
p.000033: vi. If minor is caregiver in child-headed household and no supervisory adult (s 137 Children’s Act), then
p.000033: trusted adult nominated by minor, including but not limited to social worker, community worker or teacher.
p.000033: 3.2.2.4 Minors’ independent consent
p.000033: In particular circumstances, e.g. for reasons of sensitivity, like discussion about sexual activities,
...
p.000033: research in order to obtain parental permission.
p.000033: An ethical justification for independent consent by minors may be made in the following manner:
p.000033: • By prior engagement with participating community role players, the PI can request (and justify explicitly)
p.000033: REC approval of a waiver of the parental (or substitute) permission requirement. Engagement could include
p.000033: outreach to relevant role players such as canvassing the opinion of a representative body of parents e.g. via schools.
p.000033: • Factual evidence of such engagement must form part of the PI’s justification in the protocol. Factual evidence
p.000033: may be in the form of a letter from a relevant role player (like a community leader, school principal or a CAB)
p.000033: that confirms the view that independent consent is acceptable to the parents.
p.000033: • If the REC accepts the ethical justification and the factual evidence of parental support for
p.000033: independent choice by their minor children, then the REC may grant a waiver of the requirement of written
p.000033: parental permission and must document the process carefully.
p.000033:
p.000033:
p.000033: 28Note a caregiver, a foster parent and a schoolteacher or principal are not guardians.
p.000033:
p.000033: 34 Ethics in Health Research 2nd edition
p.000033:
p.000033:
p.000033: 3.2.2.5 Mandatory reporting obligations
p.000033: There is no general obligation to report either the commission of or the intention to commit a crime. However, if a
p.000033: researcher has information indicating that direct harm to another person may occur as a result of the intention to
p.000033: commit harm (e.g. a participant says ‘I’m going to kill her…’), then there may be an obligation, especially when the
p.000033: third person is known to the researcher. For specifically designated persons, there are statutory reporting
p.000033: obligations. (See Appendix 3 for SOP Template.)
p.000033: i. Reporting obligations for abuse and neglect
p.000033: The Children’s Act requires anyone who reasonably believes a child to be suffering physical abuse causing injury,
p.000033: deliberate neglect and sexual abuse to report this to a child protection agency, the provincial social development
p.000033: department, or to a police official.
...
p.000035: ability to communicate includes the ability to hear and to speak or otherwise signal or express her
p.000035: wishes. For example, deafness should never be mistaken for incapacity to decide. Similarly, the inability to speak
p.000035: should not be mistaken for a lack of capacity to decide whether to participate.32
p.000035: 3.2.4.2 Minors and decision-making incapacity
p.000035: Parents or guardians of minors with intellectual or mental impairments should give permission for their
p.000035: minor children to choose whether to participate in research. If the minor
p.000035:
p.000035: 32 Georgetown University Informed Consent and Limitations on Decision making Capacity Chapter 2
p.000035: https://bioethicsarchive.georgetown.edu/nbac/capacity/Informed.htm
p.000035:
p.000035: Ethics in Health Research 2nd edition
p.000037: 37
p.000037:
p.000037: is unable to communicate at all or lacks the capacity to choose, then the parent or guardian should choose whether
p.000037: the minor may be enrolled. In other words, the parent acts as a proxy decision maker. In the case of a
p.000037: minor who remains intellectually or mentally impaired after reaching the age of majority, the situation changes
p.000037: because the person becomes an adult with decision-making incapacity (see 3.2.4.3 below).
p.000037: 3.2.4.3 Adults incapable of giving adequate informed consent
p.000037: Proxy decision makers are not permitted for adult persons who lack capacity unless the proxy is a court-appointed
p.000037: curator. Neither the National Health Act 61 of 2003 nor the Mental Health Care Act 17 of 2002 makes
p.000037: provision for proxy decision makers for research purposes but they provide clear lists of proxy decision makers for
p.000037: treatment purposes.
p.000037: Since it would be unethical to exclude a category of persons from research participation without adequate
p.000037: justification, arguably, an ethical argument can be made for using the statutory treatment proxies to
p.000037: provide permission for participation in research that complies with the stipulations set out below. However,
p.000037: RECs must be careful not to confuse the distinction between treatment and research. In unusual circumstances,
p.000037: e.g. major incident research (see 3.4.1), it may be ethically permissible to permit proxy consent also in
...
p.000037:
p.000037: iii. The research involves greater than minimal risk but provides the prospect of direct benefit for the
p.000037: incapacitated adult. The degree of risk must be justified by the potential benefit; or
p.000037: iv. The research, including observational research, involves greater than minimal risk, with no prospect
p.000037: of direct benefit to the incapacitated adult, but has a high probability of providing generalizable knowledge; i.e.
p.000037: the risk should be justified by the risk- knowledge ratio;
p.000037: v. Greater than minimal risk must represent no more than a minor increase over minimal risk;
p.000037: vi. The legally appropriate person (treatment proxies as stipulated in NHA s 7 or s 27(1)(a) of the
p.000037: Mental Health Care Act 17 of 2002) gives permission for the person to participate; and
p.000037: vii. Where appropriate, the person will assent to participation. Note that the incapacitated person’s refusal or
p.000037: resistance to participate, as indicated by words or behaviour, takes precedence over permission by a proxy.
p.000037: The National Health Act specifies the sequence of legally appropriate treatment proxies as spouse or partner; parent;
p.000037: grandparent; adult child; brother or sister. The Mental Health Care Act provides, in no particular sequence, that
p.000037: legally appropriate proxies are spouse; next of kin; partner; associate (defined as ‘a person with a
p.000037: substantial or material interest in the well-being of a mental health care user or a person who is in substantial
p.000037: contact with the user’); and parent or guardian.
p.000037: 3.2.5 Persons in dependent relationships
p.000037:
p.000037: This class of persons includes persons in junior or subordinate positions in hierarchically structured
p.000037: groups and may include relationships between older persons and their care-givers; persons with chronic conditions
p.000037: or disabilities and their care-givers; persons with life- threatening illnesses; patients and health care
p.000037: professionals; wards of state and guardians; students and teachers (including university teachers); employees and
p.000037: employers, including farm workers, members of the uniformed services and hospital staff and their
p.000037: respective employers.
p.000037: Particular attention should be given to ensuring that participants are adequately informed and can choose
p.000037: voluntarily whether to participate in research.
p.000037: 3.2.6 Patients highly dependent on medical care
p.000037:
p.000037: Patients who are highly dependent on medical care deserve special attention when considering research
p.000037: participation. The gravity of their medical condition may require invasive measures that carry increased risk of
p.000037: harm. The quality of informed consent may be compromised by the effect the medical condition has on the
p.000037: participant’s decision-making or communication abilities. A patient may be reluctant to refuse consent for fear that
...
p.000041: may be permissible (see 3.2.4.3 above). Where materials or data from a deceased person are sought, permission from an
p.000041: authorised person is required (see 3.3.6).
p.000041: 3.3.5 Restrictions on collection of biological materials
p.000041: Certain persons are specially protected: without Ministerial permission, biological materials may not be
p.000041: taken from mentally ill persons; biological materials that are not naturally replaceable may not be taken
p.000041: from a minor; no gametes may be taken from a minor; and no fetal biological material except for umbilical cord
p.000041: progenitor cells may be collected from anyone. These restrictions are absolute which means that research
p.000041: with the categories of person mentioned requires special permission. RECs must satisfy themselves that the
p.000041: necessary special permission has been obtained, where appropriate.
p.000041: 3.3.6 Informed consent
p.000041: Written informed consent is required prior to removal of biological material from a living donor (NHA ss
p.000041: 56 and 62).
p.000041: In the case of a deceased person, consent to removal and use of biological materials may be found in the Will of the
p.000041: person, in a written statement or in a witnessed oral statement (NHA s 62(1)(a)) or may be provided by ‘the spouse,
p.000041: partner, major child, parent, guardian, major brother or major sister of that person in the specific order mentioned’
p.000041: (NHA s 62(2))
p.000041: Because biological specimens may be collected for diagnostic, therapeutic or health research purposes, RECs should
p.000041: assess whether the nature of the planned usage is explained adequately so that the purpose for which consent
p.000041: is being requested is completely clear.
p.000041: RECs must also consider the circumstances under which re-consent from donors would be sought, bearing in mind specific
p.000041: local or national needs.
p.000041: Different forms of consent are implicated:
p.000041:
p.000041: Ethics in Health Research 2nd edition
p.000043: 43
p.000043:
p.000043: i. Narrow (restrictive) consent: the donor permits use of the biological specimen for single use only; no
p.000043: storage of leftover specimen; and no sharing of data or specimen. This form necessitates new consent if further use is
p.000043: desirable.
p.000043: ii. Tiered consent: the donor provides consent for the primary study and chooses whether to permit
p.000043: storage for future use, sample and data sharing.
...
p.000077: from unauthorized access, use, disclosure, modification, loss or theft
p.000077: Conflict of interest – incompatibility of duties, responsibilities or interests (personal or professional)
p.000077: of a person or an institution as regards ethical conduct of research so that one cannot be fulfilled without
p.000077: compromising another
p.000077: Consent – indication of agreement to participate in research, based on adequate knowledge and understanding of relevant
p.000077: information, and freely given
p.000077: Database– a collection of information including images (data) arranged to facilitate swift search and
p.000077: retrieval
p.000077: Decisional analysis – use of a systematic approach to ethical evaluation especially the ratio of risk of harm to
p.000077: likelihood of benefit
p.000077: Discomfort – a negative effect experienced in research less serious than harm
p.000077: Donor – the person (living or deceased) from whose body biological materials have been removed or withdrawn
p.000077: Ethics review –review of research proposals or protocols by RECs prior to commencement of the research
p.000077: Guardian – a person appointed by a court to look after the financial and welfare interests of a minor, or a person
p.000077: appointed by a parent with sole responsibility for the minor in terms of that parent’s Will
p.000077:
p.000077: 78 Ethics in Health Research 2nd edition
p.000077:
p.000077:
p.000077: Harm – anything that has a negative effect on participants’ welfare, broadly construed; its nature may be physical,
p.000077: emotional, psychological, social or legal
p.000077: Health research – contributes to knowledge of biological, clinical, psychological, or social welfare matters including
p.000077: processes; causes and effects of and responses to diseases; effects of environment on humans; methods to improve health
p.000077: care delivery; new pharmaceuticals, medicines, interventions and devices; new technologies to improve health and health
p.000077: care
p.000077: Identifiable information – reasonably expected to identify an individual alone or in combination with other
p.000077: information
p.000077: Directly identifying – direct identifiers e.g. name, identity number
p.000077: Indirectly identifying – combination of indirect identifiers e.g. date of birth, address, unique personal
p.000077: characteristic
p.000077: Coded information – direct identifiers removed; replaced by code Anonymised information – irrevocably stripped of
p.000077: direct identifiers; no code Anonymous information – never had identifiers
p.000077: Identifier– information such as a name, initials, address, folder number, or biometric identifier (e.g.
p.000077: finger print) that can identify a particular donor
p.000077: Incentive – anything offered to encourage participation in research
...
p.000077: Narrow consent – donor permits single use only of biological materials; no storage; no sharing of data or
p.000077: specimen; new consent if further use wanted.
p.000077: Negligible risk research – where the only foreseeable risk is one of inconvenience
p.000077: Neonate – a newborn child
p.000077: Non-therapeutic interventions–interventions not directed towards health-related benefit for a participant but towards
p.000077: improving generalisable knowledge (NHA Reg 135)
p.000077: Observational research – study of behaviour in a natural environment where people involved in their usual
p.000077: activities are observed with or without their knowledge; observational research also occurs in clinical research
p.000077: e.g. when a researcher observes individuals or measures particular outcomes, without intervention e.g.
p.000077: no treatment is given);an observational study describes a wide range of study designs including
p.000077: prospective and retrospective cohort studies, case-control studies, and cross-sectional studies, a defining
p.000077: feature of which is that any intervention studied is determined by clinical practice and not the protocol.
p.000077: Orphan– a child without a surviving parent to care for him (s 1 Children’s Act)
p.000077:
p.000077: Ethics in Health Research 2nd edition
p.000079: 79
p.000079:
p.000079: Privacy risks – potential harms to participants from collection, use and disclosure of personal information
p.000079: for research purposes
p.000079: Protocol – document that provides background, rationale and objectives of research; describes its design,
p.000079: methodology, organization and conditions under which it is to be conducted and managed
p.000079: Qualitative research – involves studied use of empirical materials such as case studies, personal experience, life
p.000079: stories, interviews, observations, and cultural texts
p.000079: Registry– a collection of information (data) from multiple sources, maintained over time with controlled
p.000079: access through a gatekeeper organizer
p.000079: Reimbursement – payment to participants to ensure they are not disadvantaged financially directly or indirectly by
p.000079: participation in research; directly means actual costs incurred and indirectly means losses that arise because
p.000079: of participation
p.000079: Repository– a collection, storage and distribution system for human biological materials for research purposes
p.000079: including blood, urine, faeces, bone marrow, cell aspirates, diagnostic specimens, pathology specimens and
p.000079: so on. Usually demographic and medical information about the donors is included in the repository as are
p.000079: codes that link the material to the donors
...
p.000087: If you have questions, concerns or complaints, you should speak to your doctor listed on page one of this form.
p.000087:
p.000087: Who will know that I am receiving an experimental treatment?
p.000087: Your doctors and the rest of the medical team will know that you are using an experimental treatment.
p.000087: As explained above, your doctor will have obtained permission from the hospital authorities to use it.
p.000087: As is usual, your privacy interests will be respected and information about your treatment and condition will be
p.000087: confidential to the extent possible.
p.000087: Because of its experimental nature, we will want to write a report about what we learn from using this therapy for your
p.000087: treatment. This is to make the information available so that other doctors can learn more about it too. However, your
p.000087: identity will not be revealed when we write up our notes for publication or discuss the treatment at meetings or
p.000087: conferences.
p.000087: When you sign this form, you are agreeing to use the experimental treatment for your < insert patient’s
p.000087: condition >. Your signature indicates that you have read this form, your questions have been answered, and you have
p.000087: decided to use the experimental treatment. You understand also that we will want to write a report for publication.
p.000087: You will have a copy of this form to keep.
p.000087:
p.000087: Ethics in Health Research 2nd edition
p.000089: 89
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089:
p.000089: Name of Patient Signature of Patient Date
p.000089:
p.000089:
p.000089:
p.000089: Name of Parent/Guardian/ Signature Date Treatment proxy
p.000089:
p.000089:
p.000089: Name of Health care worker Signature of Health care worker Date
p.000089:
p.000089: 90 Ethics in Health Research 2nd edition
p.000089:
p.000089:
p.000089: 4. Consent for storage and future use of unused samples of biological materials
p.000089:
p.000089:
p.000089:
p.000089: Research Ethics Review Committee (WHO ERC)
p.000089:
p.000089: 20, AVENUE APPIA – CH-1211 GENEVA 27 –SWITZERLAND –
p.000089: HTTP://INTRANET.WHO.INT/HOMES/RPC/ERC –
p.000089: HTTP://WWW.WHO.INT/RPC/RESEARCH_ETHICS
p.000089:
p.000089: Informed Consent Form Template for Consent for Storage and Future Use of
p.000089: Unused Samples
p.000089:
p.000089:
p.000089: Notes to Researchers:
p.000089: 1. Please note that this is a template developed by the WHO ERC to assist the Principal Investigator in
p.000089: the design of their informed consent forms (ICF). It is important that Principal Investigators adapt their own ICFs to
p.000089: the outline and requirements of their particular study.
p.000089: The logo of the Institution must be used on the ICF and not the WHO logo.
p.000089: 2. The informed consent form consists of two parts: the information sheet and the consent certificate.
...
Searching for indicator parents:
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p.000029: Minister’s delegated power to approve research with children that includes non-therapeutic components must
p.000029: ensure that their deliberations on these components are properly minuted and recorded as required by the
p.000029: Regulations. RECs that review research with child participants must include members with appropriate paediatric
p.000029: research experience.
p.000029: e) Children should participate in research only where the proper written permissions have been obtained. The
p.000029: general principle is that minors cannot agree to research participation without assistance of a parent or
p.000029: guardian (exceptions to the general principle are discussed in 3.2.2.4). This principle holds notwithstanding the
p.000029: exceptions created in the Children’s Act 38 of 2005 for consent to medical treatment and surgical operations (s 129);
p.000029: consent to HIV-testing (s 130); and the exception for female minors created in the Choice on Termination of
p.000029: Pregnancy Act 92 of 1996 (s 5(2)). Consequently, in principle, the consent process for a minor’s participation in
p.000029: research requires
p.000029: • Permission in writing from parents or legal guardian for the minor to be approached and invited to
p.000029: participate (in accordance with s 10 of the Children’s Act 38 of 2005);
p.000029: • Assent from the minor in writing (i.e. agreement to participate) if he or she chooses to participate.
p.000029: Note that an unmarried minor mother may not agree to the participation of her child in research without assistance. Her
p.000029: guardian (usually her parent) is also the guardian of her child while she is a minor and must consent to the child’s
p.000029: participation. In other words, pregnancy and childbirth do not change the legal status of the minor mother. When the
p.000029: mother reaches the age of majority (18 years), she may consent to her child’s participation in research.
p.000029: f) Children should participate in research that takes cognisance of their privacy interests. Although children are
p.000029: legally dependent, they have significant privacy interests. Their
p.000029:
p.000029: Ethics in Health Research 2nd edition
p.000031: 31
p.000031:
p.000031: genetic privacy interests, in particular, may be more important than those of adults who manifest a particular genetic
p.000031: condition.
p.000031: g) When parents or a guardian give permission for their minor child to choose whether to participate in research, this
p.000031: permission is given based on a detailed description of all diagnostic and therapeutic interventions that will
p.000031: affect the child in the study. However, this does not mean that parents are entitled to know the outcome of all
p.000031: diagnostic and therapeutic interventions, especially as regards older minors (adolescents). The
p.000031: informed consent documentation must explain whether results of tests will be made known to child-participants
p.000031: and their parents. Whether this happens, depends to an extent on the socio-cultural context and the best
p.000031: interest standard.
p.000031: h) The minor’s interest in confidentiality, i.e. being identified or identifiable without permission of the
p.000031: minor and her parent or guardian must be respected.
p.000031: i) Research involving children must respect their evolving capacity to give consent. Minors who turn 18
p.000031: years old during the course of a study should be approached at the time of their birthday to re-consent. This
p.000031: is because they must now provide independent consent to continue to be a participant. In cases where
p.000031: minors are permitted to decide independently whether to participate, 26 the consent process should address
p.000031: how re-consent will be managed when they change status from minority to majority. Similarly, in the case of
p.000031: large and longitudinal studies, attention must be given to how the change from minority to majority will be managed.
p.000031: Where a study is no longer in active interaction with participants, re-consent procedures may be less important.
p.000031: j) Researchers must familiarise themselves with the legal obligations to report child abuse and neglect.
p.000031: See 3.2.2.5.
p.000031: 3.2.2.2 Parental permission
p.000031: The Children’s Act 38 of 2005 emphasises the right of a child to participate in any matter concerning that child,
p.000031: provided he or she has sufficient maturity to participate appropriately and meaningfully (s 10), notwithstanding
p.000031: legal incapacity. This means that parents or guardians may not decide whether their minor child should
p.000031: participate in research without the minor’s contribution to the decision. The choice of whether to participate is not a
p.000031: legal decision but rather a factual choice. Consequently, the process should be that the parent or guardian is
p.000031: requested to give permission for the minor to be approached to be invited to participate in the study. The factual
p.000031: decision whether to participate is the minor’s and not the parent’s.
p.000031: Parental permission and minor’s decision must be consistent, i.e. if the minor decides not to participate, the parent
p.000031: may not override this decision. If the parent is reluctant for the minor to participate but the minor wants to
p.000031: do so, the matter must be managed carefully to establish what the concerns are and whether they may be
p.000031: resolved. The minor cannot choose to participate if the parent withholds permission for that minor
p.000031: to choose. Researchers are unlikely to be able to intervene where the suspicion is that the parent is
p.000031:
p.000031: 26 See 3.2.2.4.
p.000031:
p.000031: 32 Ethics in Health Research 2nd edition
p.000031:
p.000031:
p.000031: withholding permission unreasonably, since a best interest analysis in this context is irrelevant.
p.000031: 3.2.2.3 Orphans without guardians
p.000031: i. Introduction
p.000031: Many minors in South Africa do not have parents and very few have court-appointed guardians. These minors
p.000031: are often described as ‘orphans and vulnerable children’ or OVC. The absence of a legally appropriate parental
p.000031: substitute poses a problem for researchers because of the lack of clear guidance as to an acceptable substitute in
p.000031: the informed consent process for research participation. (Note that for treatment purposes, substituted
p.000031: consent occurs on the basis of necessity, which is not applicable to the research context.)
p.000031: ii. Justification
p.000031: Important research that seeks to understand and improve psychosocial, economic and educational conditions for
p.000031: orphans and vulnerable children to improve their future well being generally involves no more than minimal risk
p.000031: of harm. Other research including clinical research that may involve a minor increase over minimal risk of harm
p.000031: may also be justified on the basis that it would be unjustifiable to exclude a significant segment of the
p.000031: child population from research on the basis of their legal status. Consequently, it is ethical and reasonable to
...
p.000033: headed household’)
p.000033: vi. If minor is caregiver in child-headed household and no supervisory adult (s 137 Children’s Act), then
p.000033: trusted adult nominated by minor, including but not limited to social worker, community worker or teacher.
p.000033: 3.2.2.4 Minors’ independent consent
p.000033: In particular circumstances, e.g. for reasons of sensitivity, like discussion about sexual activities,
p.000033: substance abuse etc., it may be desirable and ethically justifiable for minors (especially older minors i.e.
p.000033: 16 years and older) to choose independently i.e. without parental assistance, whether to participate in research.
p.000033: Generally, only minimal risk research is suitable for independent consent by minors. Reasons
p.000033: supporting the desirability of independent consent may include recruiting sufficient numbers of minors
p.000033: who otherwise would be unwilling to participate if they must tell their parents about the nature of the
p.000033: research in order to obtain parental permission.
p.000033: An ethical justification for independent consent by minors may be made in the following manner:
p.000033: • By prior engagement with participating community role players, the PI can request (and justify explicitly)
p.000033: REC approval of a waiver of the parental (or substitute) permission requirement. Engagement could include
p.000033: outreach to relevant role players such as canvassing the opinion of a representative body of parents e.g. via schools.
p.000033: • Factual evidence of such engagement must form part of the PI’s justification in the protocol. Factual evidence
p.000033: may be in the form of a letter from a relevant role player (like a community leader, school principal or a CAB)
p.000033: that confirms the view that independent consent is acceptable to the parents.
p.000033: • If the REC accepts the ethical justification and the factual evidence of parental support for
p.000033: independent choice by their minor children, then the REC may grant a waiver of the requirement of written
p.000033: parental permission and must document the process carefully.
p.000033:
p.000033:
p.000033: 28Note a caregiver, a foster parent and a schoolteacher or principal are not guardians.
p.000033:
p.000033: 34 Ethics in Health Research 2nd edition
p.000033:
p.000033:
p.000033: 3.2.2.5 Mandatory reporting obligations
p.000033: There is no general obligation to report either the commission of or the intention to commit a crime. However, if a
p.000033: researcher has information indicating that direct harm to another person may occur as a result of the intention to
p.000033: commit harm (e.g. a participant says ‘I’m going to kill her…’), then there may be an obligation, especially when the
p.000033: third person is known to the researcher. For specifically designated persons, there are statutory reporting
p.000033: obligations. (See Appendix 3 for SOP Template.)
p.000033: i. Reporting obligations for abuse and neglect
...
p.000035: purposes, a person has been declared legally incompetent, she may retain the capacity to make decisions. It is
p.000035: thus vital that researchers bear this in mind because to ignore this fact is to seriously violate the person’s
p.000035: constitutional right to dignity as well as the ethical principle of respect (autonomy).
p.000035: When recruiting participants, the crucial elements are whether the person retains the capacity to decide
p.000035: whether to participate and whether he is able to communicate that decision. The first point to note,
p.000035: therefore, is the difference between the capacity to decide and the ability to communicate the decision. The capacity
p.000035: to decide necessarily includes the capacity to understand the information that is communicated to him. The
p.000035: ability to communicate includes the ability to hear and to speak or otherwise signal or express her
p.000035: wishes. For example, deafness should never be mistaken for incapacity to decide. Similarly, the inability to speak
p.000035: should not be mistaken for a lack of capacity to decide whether to participate.32
p.000035: 3.2.4.2 Minors and decision-making incapacity
p.000035: Parents or guardians of minors with intellectual or mental impairments should give permission for their
p.000035: minor children to choose whether to participate in research. If the minor
p.000035:
p.000035: 32 Georgetown University Informed Consent and Limitations on Decision making Capacity Chapter 2
p.000035: https://bioethicsarchive.georgetown.edu/nbac/capacity/Informed.htm
p.000035:
p.000035: Ethics in Health Research 2nd edition
p.000037: 37
p.000037:
p.000037: is unable to communicate at all or lacks the capacity to choose, then the parent or guardian should choose whether
p.000037: the minor may be enrolled. In other words, the parent acts as a proxy decision maker. In the case of a
p.000037: minor who remains intellectually or mentally impaired after reaching the age of majority, the situation changes
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.000033: 3.2.2.4 Minors’ independent consent
p.000033: In particular circumstances, e.g. for reasons of sensitivity, like discussion about sexual activities,
p.000033: substance abuse etc., it may be desirable and ethically justifiable for minors (especially older minors i.e.
p.000033: 16 years and older) to choose independently i.e. without parental assistance, whether to participate in research.
p.000033: Generally, only minimal risk research is suitable for independent consent by minors. Reasons
p.000033: supporting the desirability of independent consent may include recruiting sufficient numbers of minors
p.000033: who otherwise would be unwilling to participate if they must tell their parents about the nature of the
p.000033: research in order to obtain parental permission.
p.000033: An ethical justification for independent consent by minors may be made in the following manner:
p.000033: • By prior engagement with participating community role players, the PI can request (and justify explicitly)
p.000033: REC approval of a waiver of the parental (or substitute) permission requirement. Engagement could include
p.000033: outreach to relevant role players such as canvassing the opinion of a representative body of parents e.g. via schools.
p.000033: • Factual evidence of such engagement must form part of the PI’s justification in the protocol. Factual evidence
p.000033: may be in the form of a letter from a relevant role player (like a community leader, school principal or a CAB)
p.000033: that confirms the view that independent consent is acceptable to the parents.
p.000033: • If the REC accepts the ethical justification and the factual evidence of parental support for
p.000033: independent choice by their minor children, then the REC may grant a waiver of the requirement of written
p.000033: parental permission and must document the process carefully.
p.000033:
p.000033:
p.000033: 28Note a caregiver, a foster parent and a schoolteacher or principal are not guardians.
p.000033:
p.000033: 34 Ethics in Health Research 2nd edition
p.000033:
p.000033:
p.000033: 3.2.2.5 Mandatory reporting obligations
p.000033: There is no general obligation to report either the commission of or the intention to commit a crime. However, if a
p.000033: researcher has information indicating that direct harm to another person may occur as a result of the intention to
...
Searching for indicator philosophy:
(return to top)
p.000047: traditional values of all communities must be respected. However, since fundamental rights do not trump
p.000047: each other without careful justification, participants in research involving traditional medical systems and
p.000047: beliefs must be accorded the same respect and protection as any other human research participant. 41 The
p.000047: context of the research activity, interaction or intervention is important for determining whether, how and when to
p.000047: incorporate traditional values and their cultural expression in research.
p.000047: In terms of the Traditional Health Practitioners Act 22 of 2007,
p.000047: 'Traditional medicine' means an object or substance used in traditional health practice for-
p.000047: (a) the diagnosis, treatment or prevention of a physical or mental illness; or
p.000047: (b) any curative or therapeutic purpose, including the maintenance or restoration of physical or mental health or
p.000047: well-being in human beings,
p.000047: but does not include a dependence-producing or dangerous substance or drug.
p.000047: 'Traditional health practice' means the performance of a function, activity, process or service based on a
p.000047: traditional philosophy that includes the utilisation of traditional medicine or traditional practice and which has as
p.000047: its object-
p.000047: (a) the maintenance or restoration of physical or mental health or function; or
p.000047: (b) the diagnosis, treatment or prevention of a physical or mental illness; or
p.000047: (c) the rehabilitation of a person to enable that person to resume normal functioning within the family or community;
p.000047: or
p.000047: (d) the physical or mental preparation of an individual for puberty, adulthood, pregnancy, childbirth and
p.000047: death,
p.000047: but excludes the professional activities of a person practising any of the professions contemplated in the
p.000047: Pharmacy Act 53 of 1974, the Health Professions Act 56 of 1974, the Nursing Act 50 of 1974, the Allied Health
p.000047: Professions Act 63 of 1982, or the Dental Technicians Act 19 of 1979, and any other activity not based on
p.000047: traditional philosophy.
p.000047:
p.000047:
p.000047:
p.000047: 40 Sections 30 and 31 of the Constitution.
p.000047: 41 In terms of s 12(2)(c) of the Constitution and s 71 of the National Health Act.
p.000047:
p.000047: 48 Ethics in Health Research 2nd edition
p.000047:
p.000047:
p.000047: 'Traditional philosophy' means indigenous African techniques, principles, theories, ideologies, beliefs, opinions and
p.000047: customs and uses of traditional medicines communicated from ancestors to descendants or from generations
p.000047: to generations, with or without written documentation, whether supported by science or not, and which are
p.000047: generally used in traditional health practice.
p.000047: RECs should pay attention to indications that intellectual property may be intended to be acquired by
p.000047: non-South Africans and should advise that appropriate advice be sought. Intellectual property in indigenous
p.000047: flora, fauna and medicines is a particularly sensitive matter currently and not easily regulated. Protection of
p.000047: intellectual property relating to South African medicinal plants is a cross-cutting issue, responsibility for which is
p.000047: spread amongst several government departments, including the Department of Health; Trade and Industry; Science &
p.000047: Technology; Environmental Affairs; Tourism; Agriculture, Forestry & Fisheries; and Rural Development & Land
p.000047: Affairs. International and domestic legislation, policies and regulatory guidelines applicable in these
p.000047: departments must be taken in account when conducting research on traditional medicinal plants and
p.000047: genetic material, to ensure compliance.
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.000015: Note: Detailed discussion about how to apply these principles is in Chapter 3.
p.000015:
p.000015: 2.3 Key norms and standards
p.000015:
p.000015: The key ethical norms and standards are:
p.000015: • Relevance and value
p.000015: • Scientific integrity
p.000015: • Role-player engagement
p.000015: • Fair selection of participants
p.000015: • Fair balance of risks and benefits
p.000015: • Informed consent
p.000015: • Ongoing respect for participants, including privacy and confidentiality
p.000015: • Researcher competence and expertise
p.000015: Note that the fundamental principles for research that uses animals are Replace, Reduce and Refine animal use in
p.000015: research. (See SANS 10386:2008 (or later version); see 1.5.4.)
p.000015: 2.3.1 Relevance and value
p.000015: Research should be relevant and responsive to the needs of the people of South Africa. The proposal should explain
p.000015: the anticipated contribution to knowledge generation and, ideally,
p.000015:
p.000015:
p.000015: 8 Tri-Council Policy Statement (Canada) 2010, 8.
p.000015:
p.000015: 16 Ethics in Health Research 2nd edition
p.000015:
p.000015:
p.000015: how the findings might be translated into products, interventions, processes or services likely to improve living
p.000015: standards and well being of South Africans.
p.000015: 2.3.2 Scientific integrity
p.000015: The study’s design and methodology are vital for research integrity, regardless of the discipline. Sound
p.000015: design and methodology are likely to result in reliable and valid data and outcomes that address the research
p.000015: objectives. Poor design and inappropriate methods may expose participants to unnecessary risk of harm and burden with
p.000015: little or no compensating benefit in the form of useful knowledge gained.
p.000015: 2.3.3 Role player engagement
p.000015: Researchers should engage key role players at various stages of planning and conducting research to improve
p.000015: the quality and rigour of the research, to increase its acceptability to the key role players, to harness role
p.000015: player expertise where possible, and to offset power differentials where these exist. Engagement efforts
p.000015: may comprise of various activities, including awareness-raising initiatives for role players, including
p.000015: but not limited to participating communities.
p.000015: 2.3.4 Favourable risk-benefit ratio
p.000015: A risk-benefit analysis should precede carrying out the research. A desirable ratio is one where, at
p.000015: minimum, the potential risk of harm to a participant is outweighed by the likelihood of benefit, for participants or to
p.000015: society, from the knowledge to be gained from the research. In other words, the likelihood of benefit should
p.000015: outweigh the anticipated risk of harm to participants. However, this does not mean that
...
p.000025: Word’s spelling & grammar check tool as ‘readability statistics’. No more than Grade 8 equivalency should be the target
p.000025: complexity level.
p.000025: 18See Department of Health (2006) Guidelines for Good Practice in the Conduct of Clinical Trials with Human
p.000025: Participants in South Africa
p.000025: or its successor.
p.000025:
p.000025: 26 Ethics in Health Research 2nd edition
p.000025:
p.000025:
p.000025: 3.2 Vulnerability and incapacity
p.000025:
p.000025: Vulnerability is not an absolute condition but rather occurs on a sliding scale. In South Africa, arguably, the
p.000025: majority of potential research participants are vulnerable when compared to those in North America or Europe,
p.000025: from whence much funding is sourced. 19 Whether vulnerability is present is a matter of fact and degree.
p.000025: However, certain groups of participants 20 require careful consideration to ensure that, where appropriate,
p.000025: additional precautions are put into place. For example, advanced age, very young age, personal or
p.000025: environmental factors like extreme poverty and ordinarily poor access to health care may increase
p.000025: vulnerability
p.000025: 3.2.1 Contextual circumstances
p.000025: Personal circumstances, such as mental or intellectual impairment, acute illness, advanced age, and pregnancy and
p.000025: childbirth may increase vulnerability. Persons may be factually incapable or less capable of understanding
p.000025: information and processing it to reach a decision
p.000025: e.g. about whether to participate in research. Environmental circumstances may also increase vulnerability such as very
p.000025: poor socio-economic conditions, low levels of formal education and literacy, or restricted access to health care
p.000025: services. Such persons may be more easily persuaded to agree to participate without a properly considered
p.000025: understanding of the implications.
p.000025: It is important to note the difference between legal incapacity and factual incapacity. No person may
p.000025: claim that, because a minor is factually capable, the legal incapacity should be waived. On the other hand, no adult
p.000025: may be assumed to be incapable unless incapacity is established factually. Consequently, mental incapacity must
p.000025: be established by a factual assessment of the individual’s abilities to understand and to
p.000025: communicate that understanding. Legal incapacity prevails notwithstanding the existence of factual capacity.
p.000025: South Africa is home to a number of vulnerable communities. Where factors usually associated with
...
p.000027: Note, however, that RECs should avoid patronising assumptions about a community’s ability to make responsible
p.000027: decisions. Factual information is required before deciding that a community is too vulnerable to be invited to
p.000027: choose whether to participate in research.
p.000027: In order to ensure optimal protection of vulnerable participants, the REC may impose additional protective
p.000027: measures for the informed consent process; or require increased monitoring and interim reporting on
p.000027: participants’ welfare; or require post-recruitment reviews of the effectiveness of the protective measures
p.000027: imposed. Other measures may also be appropriate.
p.000027: Note that the decision to impose additional measures should flow from an assessment of the nature of the research and
p.000027: the circumstances of the potential participants. In other words, additional protective measures should not be automatic
p.000027: just because a vulnerable group will be recruited; rather, the decision should be based on the particular
p.000027: circumstances of the proposal before the REC. For example, an automatic assumption that impoverished people cannot
p.000027: choose responsibly whether to participate in research is disrespectful because it denies their autonomy.
p.000027: If compliance with the additional measures is poor and participants’ welfare is negatively affected,
p.000027: approval for the study may be withdrawn, temporarily or permanently, as the case may be.
p.000027: Groups of participants discussed here include
p.000027: • minors (children and adolescents)
p.000027: • women
p.000027: • adults with incapacity to provide informed consent
p.000027: • persons in dependent relationships
p.000027: • persons highly dependent on medical care
p.000027: • persons with physical disabilities
p.000027: • prisoners
p.000027: • collectivities
p.000027:
p.000027: Note this list is not exhaustive but provides an indication of the types of consideration to be applied
p.000027: 3.2.2 Minors (children and adolescents)
p.000027:
p.000027: Below the age of majority, the law protects young people from their own emotional, cognitive and physical immaturity
p.000027: and limited life experience through the legal status of minority. In other words, minors, i.e. persons under 18 years
...
p.000063: 4.5.1.7 Conflict of interest
p.000063: i. REC members should disclose information that may lead to perceptions of conflict of interest.
p.000063: ii. REC members should not review or make decisions about research proposals in which they are involved personally or
p.000063: financially. When such a proposal is to be discussed, the member concerned should declare the potential conflict
p.000063: and offer to recuse herself from the meeting for that time. Should the member be permitted to remain for the
p.000063: discussion at the discretion of the Chairperson, the member may not participate in the final decision-making on the
p.000063: application in question.
p.000063:
p.000063: 64 Ethics in Health Research 2nd edition
p.000063:
p.000063:
p.000063: 4.5.1.8 Advocacy
p.000063: The REC should be alert to whether an advocate for special interest groups of participants proposed for particular
p.000063: research would add value to the review process for informed responsible decision making in the context.
p.000063: 4.5.1.9 Translators
p.000063: i. Where research participants do not adequately comprehend or speak the language used in the protocol,
p.000063: translation of information and consent documentation is important. Similarly, it is often desirable to
p.000063: have people who are fluent in the language of the intended participants to assist with the consent process.
p.000063: ii. The REC should be alert to the potential for poor consent processes in the absence of appropriately translated
p.000063: materials and the availability of translators.
p.000063: iii. If a translator will be used in the consent process and be present for the discussions, the information
p.000063: materials should state that privacy will be compromised to that extent.
p.000063: iv. A translator should not influence potential participants unduly during the interpretation
p.000063: process.
p.000063: 4.5.1.10 Monitoring
p.000063: i. RECs have the right to monitor the research it approves (Declaration of Helsinki 2013 par 23). Researchers should
p.000063: provide appropriate information to the REC to facilitate monitoring, including alerts and investigator brochures.
p.000063: The frequency and type of monitoring should reflect the degree and extent of risk of harm to
p.000063: participants or animals.
p.000063: ii. RECs may recommend and adopt any additional appropriate mechanism for monitoring, including
p.000063: random inspection of research sites, welfare monitoring sheets, data and signed consent forms, and records of
p.000063: interviews. Information and consent materials should indicate that such monitoring may take place.
p.000063: iii. RECs should request regular, at least annual, reports from principal investigators on matters including but not
p.000063: limited to
...
Searching for indicator poverty:
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p.002015:
p.002015:
p.002015:
p.002015:
p.002015:
p.002015:
p.002015:
p.002015:
p.002015:
p.002015: Ethics in Health Research
p.002015: Principles, Processes and Structures
p.002015:
p.002015:
p.002015:
p.002015:
p.002015: Second Edition
p.002015:
p.002015:
p.002015:
p.002015:
p.002015:
p.002015:
p.002015:
p.002015:
p.002015:
p.002015: Department of Health Republic of South Africa
p.002015:
p.002015: 2015
p.002015:
p.002015: 2 Ethics in Health Research 2nd edition
p.002015:
p.002015:
p.002015: FOREWORD
p.002015: Health research is vital for the advancement of health care services for the people of South Africa. Because of its
p.002015: excellent health care and research infrastructure, skills and expertise, South Africa provides a rich arena for health
p.002015: and health-related research. The country is also characterised by a high burden of disease, including diseases
p.002015: associated with poverty and underdevelopment, along with non-communicable diseases, creating the need for a
p.002015: broad spectrum of health and health-related research. To ensure that South Africa’s people are fairly and
p.002015: respectfully treated by researchers and that all research conducted in the country stands up to ethical scrutiny, South
p.002015: Africa’s research ethics systems and infrastructure are regularly updated and strengthened. This assists with the
p.002015: project of ensuring that research is conducted in accordance with the highest ethical norms and standards.
p.002015: The core ethical principles – respect, scientific merit and integrity, distributive justice and
p.002015: beneficence– apply to all forms of research that involve living persons and use of animals, thereby placing their
p.002015: safety, welfare and other interests as paramount. These principles apply also to research with human biological
p.002015: materials and data collected from living or deceased persons.
p.002015: These Guidelines, entitled ‘Ethics in Health Research: Principles, Processes and Structures’, are the second edition
p.002015: and replace the 2004 edition. They contain the national policy for conducting research responsibly and
p.002015: ethically, tailored to South Africa’s needs as appropriate.
p.002015: • They describe the minimum national benchmark of norms and standards
p.002015: • They provide detailed explication of the process of ethics review and focused guidance about specific
p.002015: topics and research methodologies
...
p.000007: so that all research involving human participants or animals may be conducted in accordance with the highest
p.000007: ethical norms and standards. This is consistent with the understanding that research means a systematic
p.000007: collection and analysis of new information undertaken with the goal of producing generalisable knowledge or
p.000007: improved understanding of the human condition in its environment or context.
p.000007: 1.1.14 This document does not deal with clinical trials which form the subject matter of the Department of Health’s
p.000007: Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa, 2nd edition
p.000007: (2006) or its successor. However, this document includes guidance on insurance against research-related bodily injury,
p.000007: including in clinical trials.
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: 2 Also known as ‘human subjects research’; a human subject is a living individual about whom a researcher obtains (i)
p.000007: data through interventions or interactions; or (ii) identifiable private information.
p.000007:
p.000007: Ethics in Health Research 2nd edition
p.000009: 9
p.000009:
p.000009:
p.000009: 1.2 The research context
p.000009:
p.000009: 1.2.1 South Africa provides a rich arena for health and health-related research because of its excellent health care
p.000009: and research infrastructure, skills, and expertise. The country is also characterised by a high burden of disease,
p.000009: including diseases associated with poverty and underdevelopment, along with non-communicable diseases, creating
p.000009: a need for a broad spectrum of health and health-related research. See the Department of Health’s Strategic Health Plan
p.000009: 2014-2019 or its successor.3
p.000009: 1.2.2 South Africa is also an attractive research site for social scientists, behavioural scientists,
p.000009: political scientists, economists, researchers engaged in social development, education, and many more disciplines,
p.000009: because of its political history and current socio-economic, educational, political and social development
p.000009: status.
p.000009: 1.2.3 To ensure that South Africa’s people are fairly and respectfully treated by researchers and that all research
p.000009: conducted in the country stands up to ethical scrutiny, South Africa’s research ethics systems and infrastructure
p.000009: are regularly upgraded and strengthened.
p.000009: 1.3 Regulatory authority
p.000009:
p.000009: 1.3.1 The National Health Research Ethics Council (NHREC) was established in 2006 in terms of s 72 of the
p.000009: National Health Act (NHA).
p.000009: 1.3.2 In terms of the NHA, the NHREC must
p.000009: a) set norms and standards for health research involving humans and animals, as well as for conducting clinical trials
...
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 17The Flesch-Kinkaid readability tool should be used to assess the complexity of text. This tool is built into MS
p.000025: Word’s spelling & grammar check tool as ‘readability statistics’. No more than Grade 8 equivalency should be the target
p.000025: complexity level.
p.000025: 18See Department of Health (2006) Guidelines for Good Practice in the Conduct of Clinical Trials with Human
p.000025: Participants in South Africa
p.000025: or its successor.
p.000025:
p.000025: 26 Ethics in Health Research 2nd edition
p.000025:
p.000025:
p.000025: 3.2 Vulnerability and incapacity
p.000025:
p.000025: Vulnerability is not an absolute condition but rather occurs on a sliding scale. In South Africa, arguably, the
p.000025: majority of potential research participants are vulnerable when compared to those in North America or Europe,
p.000025: from whence much funding is sourced. 19 Whether vulnerability is present is a matter of fact and degree.
p.000025: However, certain groups of participants 20 require careful consideration to ensure that, where appropriate,
p.000025: additional precautions are put into place. For example, advanced age, very young age, personal or
p.000025: environmental factors like extreme poverty and ordinarily poor access to health care may increase
p.000025: vulnerability
p.000025: 3.2.1 Contextual circumstances
p.000025: Personal circumstances, such as mental or intellectual impairment, acute illness, advanced age, and pregnancy and
p.000025: childbirth may increase vulnerability. Persons may be factually incapable or less capable of understanding
p.000025: information and processing it to reach a decision
p.000025: e.g. about whether to participate in research. Environmental circumstances may also increase vulnerability such as very
p.000025: poor socio-economic conditions, low levels of formal education and literacy, or restricted access to health care
p.000025: services. Such persons may be more easily persuaded to agree to participate without a properly considered
p.000025: understanding of the implications.
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000017: Contents
p.000017:
p.000017:
p.000017: 3.1 Ethical basis for decision making in the review process p 19
p.000017: 3.1.1 Scientific design, aims & objectives 19
p.000017: 3.1.2 Inclusion & exclusion criteria
p.000020: 20
p.000020: 3.1.3 Selection of study population & sampling 20
p.000020: 3.1.4 Recruitment & enrolment
p.000020: 20
p.000020: 3.1.5 Research procedures
p.000021: 21
p.000021: 3.1.6 Risks of harm & likelihood of benefit 21
p.000021: 3.1.7 Reimbursements, inducements & costs for participants 22
p.000021: 3.1.8 Participants’ privacy & confidentiality interests 22
p.000021: 3.1.9 Obtaining informed consent 24
p.000021: 3.2 Vulnerability & incapacity
p.000026: 26
p.000026: 3.2.1 Contextual circumstances
p.000026: 26
p.000026: 3.2.2 Minors (children & adolescents) 27
p.000026: 3.2.3 Women
p.000035: 35
p.000035: 3.2.4 Adults with factual incapacity
p.000036: 36
p.000036: 3.2.5 Persons in dependent relationships 38
p.000036: 3.2.6 Patients highly dependent on medical care 38
p.000036: 3.2.7 Persons with physical disabilities
p.000038: 38
p.000038: 3.2.8 Prisoners
p.000039: 39
p.000039: 3.2.9 Collectivities
p.000040: 40
p.000040: 3.3 Data & biological material for research purposes 40
p.000040: 3.3.1 Introduction
p.000040: 40
p.000040: 3.3.2 Permitted usage of biological material 41
p.000040: 3.3.3 Identifiability of biological materials and data 41
p.000040: 3.3.4 Collection of biological materials and data 42
p.000040: 3.3.5 Restrictions on collection of biological material 42
p.000040: 3.3.6 Informed consent
p.000042: 42
p.000042: 3.3.7 Secondary use of material or data 43
p.000042: 3.3.8 Genetic research
p.000044: 44
p.000044: 3.3.9 Genomics research
p.000044: 44
p.000044: 3.3.10 Commercially available cell lines
p.000045: 45
p.000045: 3.4 Considerations specific to research methods or contexts 45
p.000045: 3.4.1 Major incidents & research
p.000045: 45
p.000045: 3.4.2 Intensive care research
p.000046: 46
p.000046: 3.4.3 Terminal care research
p.000047: 47
p.000047: 3.4.4 Traditional medicine research
p.000047: 47
...
p.000051: to the advancement of knowledge that research aims to achieve. RECs should assess whether the selected
p.000051: study population that will bear the risks associated with participation is likely to benefit from the research, if not
p.000051: immediately, then at least in the foreseeable future or, at least, whether the group represented by the participants is
p.000051: likely to benefit from the research. In other words, the risk-benefit ratio can include that risk of harm to
p.000051: participants might be offset against likelihood of benefit to others, in some circumstances.
p.000051: 3.1.4 Recruitment and enrolment
p.000051: Recruitment strategies should be neutral, and should describe the purpose of the research, the anticipated risks of
p.000051: harm and potential benefit of participation and other relevant details.
p.000051:
p.000051: Ethics in Health Research 2nd edition
p.000021: 21
p.000021:
p.000021: Recruitment methods should be properly described in the proposal and the recruitment materials should be
p.000021: included with the proposal e.g. posters, flyers, and advertisements. Recruitment and enrolment processes
p.000021: should endeavour to avoid perceptions of selection bias. The location, context and timing of recruitment and
p.000021: enrolment should be appropriate for protection of privacy and confidentiality interests. If potential
p.000021: participants are in a dependent relationship with the researchers or recruiter, e.g. student/lecturer,
p.000021: patient
p.000021: /doctor, employee/employer, the proposal should explain the measures that ensure that the potential participant’s
p.000021: ability to make a voluntary choice is unrestricted. Where the researcher will recruit personally, the possibility
p.000021: of perceptions of undue influence or therapeutic misconception must be managed. The REC should enquire also
p.000021: whether the selected sample group has been or is currently involved in previously approved research so as to assess the
p.000021: possibility of excessive burden or risk exposure.
p.000021: 3.1.5 Research procedures
p.000021: The research procedures should be described in a manner that ensures the rationale and details are clear to
p.000021: the REC. Procedures that are standard of care should be differentiated from procedures necessary only for research
p.000021: purposes, to assist with weighing the risk of harm against the likelihood of benefit. The proposal should explain
p.000021: whether specific results of data collection, e.g. incidental findings, clinical test results and other
p.000021: clinically relevant findings, will be made known to participants.
p.000021: The appropriate expertise and qualifications of researchers, 9 study and project leaders to perform
p.000021: procedures should be assured, e.g. paediatric training is required for paediatric research procedures.
p.000021: Research procedures should not adversely affect routine treatment and management of patients or the functioning of
...
p.000027: participants’ welfare; or require post-recruitment reviews of the effectiveness of the protective measures
p.000027: imposed. Other measures may also be appropriate.
p.000027: Note that the decision to impose additional measures should flow from an assessment of the nature of the research and
p.000027: the circumstances of the potential participants. In other words, additional protective measures should not be automatic
p.000027: just because a vulnerable group will be recruited; rather, the decision should be based on the particular
p.000027: circumstances of the proposal before the REC. For example, an automatic assumption that impoverished people cannot
p.000027: choose responsibly whether to participate in research is disrespectful because it denies their autonomy.
p.000027: If compliance with the additional measures is poor and participants’ welfare is negatively affected,
p.000027: approval for the study may be withdrawn, temporarily or permanently, as the case may be.
p.000027: Groups of participants discussed here include
p.000027: • minors (children and adolescents)
p.000027: • women
p.000027: • adults with incapacity to provide informed consent
p.000027: • persons in dependent relationships
p.000027: • persons highly dependent on medical care
p.000027: • persons with physical disabilities
p.000027: • prisoners
p.000027: • collectivities
p.000027:
p.000027: Note this list is not exhaustive but provides an indication of the types of consideration to be applied
p.000027: 3.2.2 Minors (children and adolescents)
p.000027:
p.000027: Below the age of majority, the law protects young people from their own emotional, cognitive and physical immaturity
p.000027: and limited life experience through the legal status of minority. In other words, minors, i.e. persons under 18 years
p.000027: of age,22 are legally incapable of performing legal transactions without assistance from a parent or guardian. In the
p.000027: research context, this means that, in principle, anyone under the age of 18 years may not choose independently whether
p.000027: to participate in research; a parent or guardian must give permission for the minor
p.000027:
p.000027: 21 Note that this requirement does not mean that a REC may not approve a waiver of personal informed consent for types
p.000027: of research into e.g. record reviews or such like.
p.000027: 22 Section 28 of the Constitution; and s 17 of the Children’s Act 38 of 2005.
...
p.000029: participate (in accordance with s 10 of the Children’s Act 38 of 2005);
p.000029: • Assent from the minor in writing (i.e. agreement to participate) if he or she chooses to participate.
p.000029: Note that an unmarried minor mother may not agree to the participation of her child in research without assistance. Her
p.000029: guardian (usually her parent) is also the guardian of her child while she is a minor and must consent to the child’s
p.000029: participation. In other words, pregnancy and childbirth do not change the legal status of the minor mother. When the
p.000029: mother reaches the age of majority (18 years), she may consent to her child’s participation in research.
p.000029: f) Children should participate in research that takes cognisance of their privacy interests. Although children are
p.000029: legally dependent, they have significant privacy interests. Their
p.000029:
p.000029: Ethics in Health Research 2nd edition
p.000031: 31
p.000031:
p.000031: genetic privacy interests, in particular, may be more important than those of adults who manifest a particular genetic
p.000031: condition.
p.000031: g) When parents or a guardian give permission for their minor child to choose whether to participate in research, this
p.000031: permission is given based on a detailed description of all diagnostic and therapeutic interventions that will
p.000031: affect the child in the study. However, this does not mean that parents are entitled to know the outcome of all
p.000031: diagnostic and therapeutic interventions, especially as regards older minors (adolescents). The
p.000031: informed consent documentation must explain whether results of tests will be made known to child-participants
p.000031: and their parents. Whether this happens, depends to an extent on the socio-cultural context and the best
p.000031: interest standard.
p.000031: h) The minor’s interest in confidentiality, i.e. being identified or identifiable without permission of the
...
p.000037: the risk should be justified by the risk- knowledge ratio;
p.000037: v. Greater than minimal risk must represent no more than a minor increase over minimal risk;
p.000037: vi. The legally appropriate person (treatment proxies as stipulated in NHA s 7 or s 27(1)(a) of the
p.000037: Mental Health Care Act 17 of 2002) gives permission for the person to participate; and
p.000037: vii. Where appropriate, the person will assent to participation. Note that the incapacitated person’s refusal or
p.000037: resistance to participate, as indicated by words or behaviour, takes precedence over permission by a proxy.
p.000037: The National Health Act specifies the sequence of legally appropriate treatment proxies as spouse or partner; parent;
p.000037: grandparent; adult child; brother or sister. The Mental Health Care Act provides, in no particular sequence, that
p.000037: legally appropriate proxies are spouse; next of kin; partner; associate (defined as ‘a person with a
p.000037: substantial or material interest in the well-being of a mental health care user or a person who is in substantial
p.000037: contact with the user’); and parent or guardian.
p.000037: 3.2.5 Persons in dependent relationships
p.000037:
p.000037: This class of persons includes persons in junior or subordinate positions in hierarchically structured
p.000037: groups and may include relationships between older persons and their care-givers; persons with chronic conditions
p.000037: or disabilities and their care-givers; persons with life- threatening illnesses; patients and health care
p.000037: professionals; wards of state and guardians; students and teachers (including university teachers); employees and
p.000037: employers, including farm workers, members of the uniformed services and hospital staff and their
p.000037: respective employers.
p.000037: Particular attention should be given to ensuring that participants are adequately informed and can choose
p.000037: voluntarily whether to participate in research.
p.000037: 3.2.6 Patients highly dependent on medical care
p.000037:
p.000037: Patients who are highly dependent on medical care deserve special attention when considering research
p.000037: participation. The gravity of their medical condition may require invasive measures that carry increased risk of
p.000037: harm. The quality of informed consent may be compromised by the effect the medical condition has on the
p.000037: participant’s decision-making or communication abilities. A patient may be reluctant to refuse consent for fear that
p.000037: this may compromise his medical treatment. Adequate provision must be made for informing patients and their relatives
p.000037: about the research, to ensure that stress and other emotional factors do not impair their understanding. The dependency
p.000037: of patients and their relatives on caregivers should not unduly affect research participation decisions.
p.000037:
p.000037: Ethics in Health Research 2nd edition
p.000039: 39
p.000039:
p.000039: In particular circumstances, the REC may approve delayed consent.
p.000039: Note this does not mean that informed consent is waived.
p.000039: RECs should ensure that a clear and full justification for the proposed delay accompanies the research proposal. The
p.000039: individual circumstances of the patient must be carefully considered to prevent inadvertent violation of personal or
p.000039: cultural values.
p.000039: The REC may approve a delay in obtaining informed consent for research participation by patients highly dependent on
p.000039: medical care if
p.000039: • the research is based on valid scientific hypotheses that support a reasonable possibility of more
p.000039: benefit than that offered by standard care; and
p.000039: • participation is not contrary to the medical interests of the patient; and
p.000039: • the research interventions pose no more risk of harm than that inherent in the patient’s condition
p.000039: or alternative methods of treatment; and
p.000039: • the research is based on valid scientific hypotheses that support a reasonable possibility of more
p.000039: benefit than that offered by standard care; and
p.000039: • as soon as reasonably possible, the participant and her relatives or legal representatives
p.000039: will be informed of the participant’s inclusion in the research; be requested to give delayed consent;, and
p.000039: advised of the right to withdraw from the research without any reduction in quality of care.
p.000039: 3.2.7 Persons with physical disabilities
p.000039:
p.000039: Recruitment strategies for research participation in general should be sensitive to the possibility that
p.000039: persons with physical disabilities may wish to volunteer and therefore should ensure that there are no unintended
p.000039: barriers to such participation; e.g. the absence of ramps or a lift for wheelchair-bound potential participants.
p.000039: Research involving participants with physical disabilities should anticipate possible barriers and include
p.000039: measures to minimise them.
...
p.000045:
p.000045: 46 Ethics in Health Research 2nd edition
p.000045:
p.000045:
p.000045: They may also take the form of an unusual and sudden demand on local resources or other emergency with consequent
p.000045: ethical implications for patient care. Research in these contexts is important for advancing emergency health
p.000045: care interventions and treatments, and for refining resource allocation policies. The potential benefits of major
p.000045: incident research include improved triage methods and procedures, effective treatment for life-threatening conditions
p.000045: and improving therapies for survival and quality of life.
p.000045: Although patients in a major incident context face extreme vulnerability, RECs should be cautious about
p.000045: being overly restrictive about the type of research that may be conducted. The development of new drugs and procedures
p.000045: to treat emergency patients safely depends on being able to conduct research, including carefully designed randomised
p.000045: controlled trials.
p.000045: In order to carry out research in such contexts, planning of the research and ethics clearance processes usually must
p.000045: occur very rapidly. From the REC perspective, proposals for major incident research usually demand expedited
p.000045: processing, which means that the time for deliberation is curtailed.
p.000045: When research is not actually dependent on a major incident context, the proposal should be approached cautiously.
p.000045: RECs should consider carefully whether sufficient justification is presented for expedited processing. In the
p.000045: same way that research involving minors should be done only when adult participants cannot provide the necessary data,
p.000045: so major incident research should take place about matters that are unlikely to or do not occur in ‘ordinary’ contexts.
p.000045: Informed consent usually has to be obtained rapidly and at a time when vulnerability of patients and
p.000045: families is likely to be extreme. Patients may be incapacitated (i.e. unconscious or on a ventilator), which points to
p.000045: the likelihood of difficulties with the usual approach to informed consent. Consequently, RECs may consider
p.000045: alternative approaches such as proxy consent or delaying consent in particular circumstances. (See 3.2.4.3, 3.2.4.4 &
p.000045: 3.2.6.)
p.000045: 3.4.2 Intensive care research
p.000045:
p.000045: Characteristic features of intensive care research include difficulties in communicating with patients receiving
p.000045: ventilation assistance and impairment of cognition in heavily sedated individuals.
p.000045: Whenever possible, informed consent for planned intensive care research should be obtained from potential participants
...
p.000073: consideration of specialised published guidance and authorities.
p.000073: It is important that RECs review different methodologies appropriately and in accordance with accepted
p.000073: methodological standards of different research and academic disciplines.
p.000073: It is important to recognize that, although research methodologies and analytic paradigms may differ, all research must
p.000073: be judged against the same ethical principles. No philosophical justification exists for judging different
p.000073: methodologies against different ethical standards. However, RECs must be familiar with qualitative research
p.000073: paradigms so that methodological issues are competently reviewed.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073: 59 This chapter draws heavily on the Tri-Council Policy Statement (Canada) 2010 chapter 10; Wassenaar & Mamotte
p.000073: ‘Ethical Issues and Ethics Reviews in Social Science Research’ in Ferrero et al The Oxford Handbook of International
p.000073: Psychological Ethics 2012.
p.000073:
p.000073: 74 Ethics in Health Research 2nd edition
p.000073:
p.000073:
p.000073: 6.2 Nature of qualitative research
p.000073:
p.000073: Researchers use qualitative research methods to find out and understand ‘how people think about the world and how they
p.000073: act and behave in it…[Understanding is] based on discourse, actions and documents’. 60 Individuals, organisations
p.000073: and communities and interactions between and among them may be seen as socially constructed61 and hence dependent on
p.000073: the social context in which they are found. The perspective of the researcher thus adds to the knowledge construction
p.000073: as observer, participant (for some methodologies) and analyst. Consequently, qualitative researchers have specific
p.000073: criteria that are applied to determining the credibility and trustworthiness of their data (analogous to
p.000073: reliability and validity of quantitative data).
p.000073: 6.3 Methodological approaches and requirements62
p.000073: 6.3.1 Diversity of approaches
p.000073: Methodological approaches to qualitative research include but are not limited to ethnography, participatory action
p.000073: research, oral history, phenomenology, narrative inquiry, grounded theory and discourse analysis.
p.000073: 6.3.2 Inductive understanding
p.000073: Usually, an inductive understanding of participants’ worlds precedes attempts to gain an analytic
p.000073: understanding of their experiences.
p.000073: 6.3.3 Dynamic, reflective and continuous research process
p.000073: During the course of the research, questions, concepts, theories, strategies and ways to engage with and
p.000073: gather data may emerge which may require that the researcher practise ongoing reflective, flexible and responsive
p.000073: approaches to ensure that the rigour, credibility and trustworthiness of data collection and analysis are maintained.
p.000073: 6.3.4 Data collection and sample size
p.000073: In general terms, depth of research is emphasised over breadth of research. Consequently, samples and sites are
p.000073: selected for their usefulness as rich sources of information. Selection of participants may be guided by emerging
p.000073: patterns over the course of data collection. Sample sizes are usually small.
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
(return to top)
p.000017: harm). Research that involves human participants should seek to improve the human condition. If the research cannot do
p.000017: this, then it is unlikely to be ethical.
p.000017: • distributive justice (equality)
p.000017: This means that there should be a fair balance of risks and benefits amongst all role-players involved in research,
p.000017: including participants, participating communities and the broader South African society. In this way the principle of
p.000017: equality is expressed in the research context. ‘No segment of the population should be unduly burdened by the harms of
p.000017: research or denied the benefits of knowledge derived from it.’7 There should be a reasonable likelihood that the
p.000017:
p.000017: 7 Tri-Council Policy Statement (Canada) 2010, 10.
p.000017:
p.000017: Ethics in Health Research 2nd edition
p.000015: 15
p.000015:
p.000015: population from which participants are drawn will benefit from the research results, if not immediately, then in the
p.000015: future.
p.000015: • respect for persons (dignity and autonomy)
p.000015: This principle requires that persons capable of deliberation about their choices must be treated with
p.000015: respect and permitted to exercise self-determination. Further, persons who lack capacity or who have diminished
p.000015: capacity for deliberation about their choices must be protected against harm from irresponsible choices.
p.000015: Respect for persons recognises that dignity, well-being and safety interests of all research participants are the
p.000015: primary concern in research that involves human participants. Respect for persons includes ‘the dual moral
p.000015: obligations to respect autonomy and to protect those with developing, impaired or diminished autonomy’.8 Autonomy
p.000015: includes the ability to deliberate about a decision and to act on that decision. Interests of participants should
p.000015: usually outweigh the interests of science and society. Consequently, involvement of persons or particular
p.000015: categories of people in the research should be justified in research proposals. Respect for persons means also that
p.000015: the interests of researchers must be considered. These include welfare and safety interests, authorship and
p.000015: intellectual property interests, and collegial and professional interests.
p.000015: 2.2 Role of ethical principles
p.000015:
p.000015: Ethical principles assist RECs to identify and protect the interests of research participants in a variety of research
p.000015: contexts and to promote development of high-quality knowledge that may benefit future generations. These ethics
p.000015: principles are articulated in national and international research ethics guidelines. Persons who conduct research
p.000015: in South Africa are expected to adhere to these principles which underscore responsible and ethical research
p.000015: conduct.
p.000015: Note: Detailed discussion about how to apply these principles is in Chapter 3.
p.000015:
p.000015: 2.3 Key norms and standards
p.000015:
p.000015: The key ethical norms and standards are:
p.000015: • Relevance and value
p.000015: • Scientific integrity
p.000015: • Role-player engagement
...
p.000023: 3.1.9 Obtaining informed consent
p.000023: The principle of respect for persons underpins the requirement that a person must choose voluntarily whether to
p.000023: participate in research on the basis of information that allows an informed choice to be made. The
p.000023: process of providing the necessary information and of engaging with the person before a decision is
p.000023: reached is known as the informed consent process. It should be noted that informed consent is a necessary but
p.000023: insufficient element of ethical research, i.e. that a person voluntarily chooses to participate does not mean that the
p.000023: research proposal is ethical. All the other elements should also stand up to ethical scrutiny.
p.000023: An important element of making an informed choice is the nature and quality of information made available to the
p.000023: potential participant. See below for expectations regarding information disclosure.
p.000023: Adults, i.e. persons over the age of 18 years, may make independent decisions. However, they may wish to consult with
p.000023: family members or others in keeping with personal preference or cultural practices. Consequently, the process should
p.000023: permit sufficient time for consultation between the recruitment approach and the point of decision-making. No person
p.000023: should be required to make an immediate decision. The informed consent process for adults with diminished
p.000023: or no decision-making capacity (factually incapacitated) and for minors (legally incapacitated) is described at
p.000023: 3.2.4.3 and 3.2.4.2 respectively.
p.000023: RECs should assess the proposed process for informed consent as well as the information that potential participants
p.000023: will be given and the measures to facilitate understanding. Considerations for assessment include whether
p.000023: • the setting will
p.000023: o minimise the possibility of undue influence
p.000023: o be sufficiently private and appropriate
p.000023:
p.000023: 16 ‘Biometrics means a technique of personal identification that is based on physical, physiological or behaviour
p.000023: characterisation including blood typing, fingerprinting, DNA analysis, retinal scanning and voice recognition’ (s 1 of
p.000023: the Act).
p.000023:
p.000023: Ethics in Health Research 2nd edition
p.000025: 25
p.000025:
p.000025: • the person who will conduct the process
p.000025: o will be appropriately trained, independent and bias-free
p.000025: • the text
p.000025: o is in plain language and appropriate to the participants’ level of understanding17
p.000025: o is free of jargon and unexplained acronyms
p.000025: o is clear and explains technical terminology e.g. randomisation
p.000025: o is translated into language(s) appropriate to the context
...
p.000079: codes that link the material to the donors
p.000079: Research – includes a range of activities conducted by many different disciplines that may use different
p.000079: methodologies and explanatory frameworks to extend knowledge through disciplined inquiry or systematic
p.000079: investigation
p.000079: Risk – function of the magnitude of harm and the probability that it will occur
p.000079: Risk of harm to likelihood of benefit ratio – analysis of whether the risk of harm implied is justifiable in light of
p.000079: the likelihood of benefit
p.000079: Therapeutic intervention –interventions directed towards direct health-related benefit for a participant (NHA Reg 135)
p.000079: Tiered consent – donor permits use of biological materials for current study; and chooses whether to permit storage
p.000079: for future use, sample and data sharing.
p.000079: Undue influence – effect of an unequal power relationship on voluntariness; may occur when recruitment of
p.000079: participants is done by authority figure
p.000079: Virtual Repository– a digitised system that manages distributed bar-coded electronic versions of material,
p.000079: data or images through shared data systems
p.000079: Vulnerability – diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000079: project; may be caused by limited capacity or limited access to social goods like rights, opportunities and power
p.000079:
p.000079: 80 Ethics in Health Research 2nd edition
p.000079:
p.000079:
p.000079:
p.000079: APPENDIX 2
p.000079:
p.000079: Resources
p.000079:
p.000079: Online training opportunities
p.000079:
p.000079: These links are to FREE online training in research ethics and some also do Responsible Conduct of Research
p.000079: 1. The AMANET (African Malaria Network Trust)
p.000079: http://webcourses.amanet-trust.org/mod/resource/view.php?inpopup=true&id=116
p.000079: The AMANET (African Malaria Network Trust) web-based health research ethics training programme aims at
p.000079: providing the basic understanding in biomedical research ethics. On the premise of scarcity of resources and
p.000079: opportunities for such training for Africans, this effort hopes to provide this service to the many African members of
p.000079: IRB’s and investigators who may wish to undertake the course at home or in their office and at their own time up to a
p.000079: maximum period of four months for each student number issued.
p.000079: 2. Cameroon Bioethics Initiative (CAMBIN)
p.000079: www.cambin.org/cambin-training
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000017: posed by the research must be reasonable in light of anticipated benefits; that research design must be
p.000017: sound, and that researchers must be competent to carry out the proposed research activities. Beneficence prohibits
p.000017: deliberate infliction of harm on persons; sometimes expressed as a separate principle: non-maleficence (do no
p.000017: harm). Research that involves human participants should seek to improve the human condition. If the research cannot do
p.000017: this, then it is unlikely to be ethical.
p.000017: • distributive justice (equality)
p.000017: This means that there should be a fair balance of risks and benefits amongst all role-players involved in research,
p.000017: including participants, participating communities and the broader South African society. In this way the principle of
p.000017: equality is expressed in the research context. ‘No segment of the population should be unduly burdened by the harms of
p.000017: research or denied the benefits of knowledge derived from it.’7 There should be a reasonable likelihood that the
p.000017:
p.000017: 7 Tri-Council Policy Statement (Canada) 2010, 10.
p.000017:
p.000017: Ethics in Health Research 2nd edition
p.000015: 15
p.000015:
p.000015: population from which participants are drawn will benefit from the research results, if not immediately, then in the
p.000015: future.
p.000015: • respect for persons (dignity and autonomy)
p.000015: This principle requires that persons capable of deliberation about their choices must be treated with
p.000015: respect and permitted to exercise self-determination. Further, persons who lack capacity or who have diminished
p.000015: capacity for deliberation about their choices must be protected against harm from irresponsible choices.
p.000015: Respect for persons recognises that dignity, well-being and safety interests of all research participants are the
p.000015: primary concern in research that involves human participants. Respect for persons includes ‘the dual moral
p.000015: obligations to respect autonomy and to protect those with developing, impaired or diminished autonomy’.8 Autonomy
p.000015: includes the ability to deliberate about a decision and to act on that decision. Interests of participants should
p.000015: usually outweigh the interests of science and society. Consequently, involvement of persons or particular
p.000015: categories of people in the research should be justified in research proposals. Respect for persons means also that
p.000015: the interests of researchers must be considered. These include welfare and safety interests, authorship and
p.000015: intellectual property interests, and collegial and professional interests.
p.000015: 2.2 Role of ethical principles
p.000015:
p.000015: Ethical principles assist RECs to identify and protect the interests of research participants in a variety of research
p.000015: contexts and to promote development of high-quality knowledge that may benefit future generations. These ethics
p.000015: principles are articulated in national and international research ethics guidelines. Persons who conduct research
p.000015: in South Africa are expected to adhere to these principles which underscore responsible and ethical research
p.000015: conduct.
p.000015: Note: Detailed discussion about how to apply these principles is in Chapter 3.
p.000015:
p.000015: 2.3 Key norms and standards
p.000015:
p.000015: The key ethical norms and standards are:
p.000015: • Relevance and value
p.000015: • Scientific integrity
p.000015: • Role-player engagement
p.000015: • Fair selection of participants
p.000015: • Fair balance of risks and benefits
...
p.000027: informed consent.
p.000027: Note, however, that RECs should avoid patronising assumptions about a community’s ability to make responsible
p.000027: decisions. Factual information is required before deciding that a community is too vulnerable to be invited to
p.000027: choose whether to participate in research.
p.000027: In order to ensure optimal protection of vulnerable participants, the REC may impose additional protective
p.000027: measures for the informed consent process; or require increased monitoring and interim reporting on
p.000027: participants’ welfare; or require post-recruitment reviews of the effectiveness of the protective measures
p.000027: imposed. Other measures may also be appropriate.
p.000027: Note that the decision to impose additional measures should flow from an assessment of the nature of the research and
p.000027: the circumstances of the potential participants. In other words, additional protective measures should not be automatic
p.000027: just because a vulnerable group will be recruited; rather, the decision should be based on the particular
p.000027: circumstances of the proposal before the REC. For example, an automatic assumption that impoverished people cannot
p.000027: choose responsibly whether to participate in research is disrespectful because it denies their autonomy.
p.000027: If compliance with the additional measures is poor and participants’ welfare is negatively affected,
p.000027: approval for the study may be withdrawn, temporarily or permanently, as the case may be.
p.000027: Groups of participants discussed here include
p.000027: • minors (children and adolescents)
p.000027: • women
p.000027: • adults with incapacity to provide informed consent
p.000027: • persons in dependent relationships
p.000027: • persons highly dependent on medical care
p.000027: • persons with physical disabilities
p.000027: • prisoners
p.000027: • collectivities
p.000027:
p.000027: Note this list is not exhaustive but provides an indication of the types of consideration to be applied
p.000027: 3.2.2 Minors (children and adolescents)
p.000027:
p.000027: Below the age of majority, the law protects young people from their own emotional, cognitive and physical immaturity
p.000027: and limited life experience through the legal status of minority. In other words, minors, i.e. persons under 18 years
...
p.000033: sexual offence against a minor is required to report this to a police official. In effect, any adult or person >16
p.000033: years who engages in sexual activity with a minor < 16 years commits a crime and may be prosecuted. The Act
p.000033: describes a broad range of sexual offences, including rape, sexual assault, sexual grooming, sexual
p.000033: exploitation, and use of children in pornography including photographs. This means that the range of activities
p.000033: that may constitute a sexual offence is extensive.
p.000033: The Sexual Offences Act differentiates between adolescents (12 - < 16 years) and older minors (16 and 17
p.000033: years). In the case of children younger than 12 years, sexual activity is unlawful even with consent. For adolescents,
p.000033: the situation is as follows. The Teddy Bear Clinic case 29 found criminalisation of consensual sexual acts
p.000033: between adolescents aged 12 – < 16 years to be unconstitutional, on the basis that adolescents should not be subjected
p.000033: to criminal sanctions when they exercise their entitlement to determine their personal relationships in light of their
p.000033: rights to autonomy, dignity and privacy. The Constitutional Court imposed a moratorium on action against adolescents in
p.000033: terms of ss 15 and 16 of the Sexual Offences Act. This moratorium of 18 months is to give Parliament time to revise the
p.000033: offending legislative provisions by April 2015.30
p.000033: Consensual sexual acts between adolescents aged 12 - < 16 years are not criminal and are not reportable. Sexual acts
p.000033: with adolescents aged 12 - < 16 years by an adult or a person >16 years, even if consensual, are criminal and
p.000033: reportable. Sexual acts with children < 12 years are criminal and reportable.
p.000033: iii. Sexual and reproductive health research with minors
p.000033: Research with minors that focuses on their sexuality and reproductive health is likely to encounter instances of
p.000033: abuse and underage sexual activity. The dilemma for
p.000033:
p.000033:
p.000033: 29The Teddy Bear Clinic for Abused Children v Minister of Justice and Constitutional Development (CCT 12/13) [2013]
p.000033: ZACC 35; 2014 (2) SA 168 (CC); see also J v NDPP [2014] ZACC 13.
p.000033: 30See Draft Criminal Law (Sexual Offences & related matters) Amendment Act Amendment Bill [B-2014].
p.000033:
p.000033: Ethics in Health Research 2nd edition
p.000035: 35
p.000035:
...
p.000035: enrolled in research. However, similarly to the case of minors, this principle is difficult to apply in the
p.000035: research context because research participation is unlikely to be in the best interest of an incapacitated adult.
p.000035: Good research design does not permit a best interest analysis easily. Rather, the design draws on
p.000035: aggregates of information. This means that, in the research context, the best interest principle should
p.000035: be understood to mean that participation in the research should not be contrary to the individual’s best
p.000035: interest.
p.000035: Note that all types of clinical trial research on incapacitated adults should be scrutinized carefully in case extra
p.000035: precautions or conditions are necessary.
p.000035: 3.2.4.1 Capacity and communication
p.000035: Decision-making incapacity may result from a variety of causes and take various forms. The most important insight is
p.000035: that incapacity to decide is a question of fact to be determined on a case-by-case basis. Even if for other
p.000035: purposes, a person has been declared legally incompetent, she may retain the capacity to make decisions. It is
p.000035: thus vital that researchers bear this in mind because to ignore this fact is to seriously violate the person’s
p.000035: constitutional right to dignity as well as the ethical principle of respect (autonomy).
p.000035: When recruiting participants, the crucial elements are whether the person retains the capacity to decide
p.000035: whether to participate and whether he is able to communicate that decision. The first point to note,
p.000035: therefore, is the difference between the capacity to decide and the ability to communicate the decision. The capacity
p.000035: to decide necessarily includes the capacity to understand the information that is communicated to him. The
p.000035: ability to communicate includes the ability to hear and to speak or otherwise signal or express her
p.000035: wishes. For example, deafness should never be mistaken for incapacity to decide. Similarly, the inability to speak
p.000035: should not be mistaken for a lack of capacity to decide whether to participate.32
p.000035: 3.2.4.2 Minors and decision-making incapacity
p.000035: Parents or guardians of minors with intellectual or mental impairments should give permission for their
p.000035: minor children to choose whether to participate in research. If the minor
p.000035:
...
p.000041: print) that can identify a particular donor
p.000041: 3.3.2 Permitted usage of biological materials
p.000041: Biological material may be removed from living and deceased persons (NHA ss 55 and 62) for diagnostic, therapeutic and
p.000041: health research purposes (NHA s 64(1)).
p.000041: 3.3.3 Identifiability of biological materials and data
p.000041: RECs must assess the extent to which human biological materials or data could be used to identify a donor. Materials
p.000041: with direct identifiers can directly identify a donor. Coded materials may identify a donor if security and
p.000041: confidentiality measures are not adequate. Anonymised materials without any linkage to donors are unlikely to identify
p.000041: a donor. Materials collected
p.000041:
p.000041: 33 Tri-Council Policy Statement (Canada) 2010, 169.
p.000041: 34 Human biological materials means ‘material from a human being, including DNA, RNA, blastomeres, polar bodies,
p.000041: cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors from the same’
p.000041: (Regulation 177 GG 35099 2 March 2012);
p.000041: blood and blood products are also included (Regulation 180 GG 35099 2 March 2012).
p.000041:
p.000041: 42 Ethics in Health Research 2nd edition
p.000041:
p.000041:
p.000041: without identifiers of any kind are unlikely to identify an individual donor. Genetic markers make it possible to
p.000041: identify groups rather than individuals. RECs must pay attention to eliminating or at least minimising
p.000041: risks to privacy and autonomy as a result of re- identification.
p.000041: RECs must also consider the implications for donor welfare of complete anonymisation: it prevents
p.000041: disclosure of material findings, an offer of benefits of research findings, and withdrawal of material from
p.000041: research use. Informed consent documentation must be carefully scrutinised to ensure that the proposed approach
p.000041: and its implications are adequately disclosed and explained.
p.000041: 3.3.4 Collection of biological materials and data
p.000041: Biological materials and data are collected in a variety of ways
p.000041: • specifically for research purposes
p.000041: • incidentally to diagnostic or therapeutic procedures
p.000041: • for a combination of purposes, including the intention of possible future research use
p.000041: Collection of materials or data specifically for research use requires prospective informed consent,
p.000041: usually from the living donor (see 3.3.6). Where a donor is unable to provide informed consent, a proxy
p.000041: may be permissible (see 3.2.4.3 above). Where materials or data from a deceased person are sought, permission from an
p.000041: authorised person is required (see 3.3.6).
p.000041: 3.3.5 Restrictions on collection of biological materials
p.000041: Certain persons are specially protected: without Ministerial permission, biological materials may not be
p.000041: taken from mentally ill persons; biological materials that are not naturally replaceable may not be taken
...
p.000075: of harm and possible benefits of the research. The basis for the exercise of discretion and the degree of
p.000075: flexibility should be considered at the design phase. The REC Chairperson should be consulted when doubt arises.
p.000075:
p.000075: 76 Ethics in Health Research 2nd edition
p.000075:
p.000075:
p.000075:
p.000075: APPENDIX 1
p.000075:
p.000075: Glossary
p.000075:
p.000075: Academic freedom – the collective freedom of researchers, including students, to conduct research and to disseminate
p.000075: ideas or findings without religious, political or institutional restrictions; it includes freedom of inquiry
p.000075: and freedom to challenge conventional thought. Academic freedom does not mean freedom to ignore ethical issues
p.000075: Accountability – the measure by which it can be demonstrated that responsibilities have been or are being fulfilled;
p.000075: it may involve reporting upwards in a hierarchical structure
p.000075: Adolescent – a child between 12 and 17 years of age
p.000075: Anonymous data or specimen–data or biological materials without any overt identifying information or link to a
p.000075: specific donor
p.000075: Audit– subset of research; not clinical practice but a review of clinical practice
p.000075: Autonomy – the capacity to understand information; to act on it voluntarily; to use own judgement to make decisions
p.000075: about own actions, including whether to participate in research
p.000075: Biobank – see Repository
p.000075: Human biological materials– materials including blood and blood products, DNA, RNA, blastomeres, polar bodies,
p.000075: cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors
p.000075: Broad consent– donor permits use of biological materials for future studies, subject only to further prior ethics
p.000075: review and approval
p.000075: Capacity – the ability to understand relevant information; to appreciate the consequences of decisions based on the
p.000075: information
p.000075: Caregiver– a person who in fact cares for a child (s 1 Children’s Act, 38 of 2005); a caregiver must
p.000075: safeguard the child’s health, well-being and development; and protect the child from abuse and other
p.000075: harms; a caregiver exercises the parental right to consent to medical examination or treatment of the child
...
General/Other / Incapacitated
Searching for indicator incapacitated:
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p.000023: participate in research on the basis of information that allows an informed choice to be made. The
p.000023: process of providing the necessary information and of engaging with the person before a decision is
p.000023: reached is known as the informed consent process. It should be noted that informed consent is a necessary but
p.000023: insufficient element of ethical research, i.e. that a person voluntarily chooses to participate does not mean that the
p.000023: research proposal is ethical. All the other elements should also stand up to ethical scrutiny.
p.000023: An important element of making an informed choice is the nature and quality of information made available to the
p.000023: potential participant. See below for expectations regarding information disclosure.
p.000023: Adults, i.e. persons over the age of 18 years, may make independent decisions. However, they may wish to consult with
p.000023: family members or others in keeping with personal preference or cultural practices. Consequently, the process should
p.000023: permit sufficient time for consultation between the recruitment approach and the point of decision-making. No person
p.000023: should be required to make an immediate decision. The informed consent process for adults with diminished
p.000023: or no decision-making capacity (factually incapacitated) and for minors (legally incapacitated) is described at
p.000023: 3.2.4.3 and 3.2.4.2 respectively.
p.000023: RECs should assess the proposed process for informed consent as well as the information that potential participants
p.000023: will be given and the measures to facilitate understanding. Considerations for assessment include whether
p.000023: • the setting will
p.000023: o minimise the possibility of undue influence
p.000023: o be sufficiently private and appropriate
p.000023:
p.000023: 16 ‘Biometrics means a technique of personal identification that is based on physical, physiological or behaviour
p.000023: characterisation including blood typing, fingerprinting, DNA analysis, retinal scanning and voice recognition’ (s 1 of
p.000023: the Act).
p.000023:
p.000023: Ethics in Health Research 2nd edition
p.000025: 25
p.000025:
p.000025: • the person who will conduct the process
p.000025: o will be appropriately trained, independent and bias-free
p.000025: • the text
p.000025: o is in plain language and appropriate to the participants’ level of understanding17
p.000025: o is free of jargon and unexplained acronyms
p.000025: o is clear and explains technical terminology e.g. randomisation
p.000025: o is translated into language(s) appropriate to the context
p.000025: o states that participants may contact the REC at the contact details provided if they have queries or complaints
p.000025: about their rights and welfare as research participants
...
p.000035: the benefits. An example of a positive risk-benefit ratio would be the use of anti-retrovirals in mother to child HIV
p.000035: transmission studies. For nursing mothers, the amount of drug passing into breast milk should be established and the
p.000035: potential impact on a breast-fed infant anticipated, and the mother so advised.
p.000035:
p.000035: 36 Ethics in Health Research 2nd edition
p.000035:
p.000035:
p.000035: • in all cases, inclusion poses the least risk of harm possible for achieving the objectives of the research.
p.000035: 3.2.4 Adults with factual incapacity to provide informed consent
p.000035:
p.000035: Adults who are factually incapable of giving informed consent should participate in research only where their
p.000035: participation is indispensable to the research; i.e. the research cannot deliver the desired outcomes if
p.000035: capable adult participants were to be used instead. Further, the research should investigate a problem of
p.000035: relevance to incapacitated adults. Where research can be undertaken with capable adults but nevertheless proposes
p.000035: also to include incapacitated adults, strong justification for their inclusion must be provided.
p.000035: The primary difficulty for informed consent in this context is whether proxy consent is permissible. The
p.000035: best interest principle is often used in connection with decisions relating to whether incapacitated adults should be
p.000035: enrolled in research. However, similarly to the case of minors, this principle is difficult to apply in the
p.000035: research context because research participation is unlikely to be in the best interest of an incapacitated adult.
p.000035: Good research design does not permit a best interest analysis easily. Rather, the design draws on
p.000035: aggregates of information. This means that, in the research context, the best interest principle should
p.000035: be understood to mean that participation in the research should not be contrary to the individual’s best
p.000035: interest.
p.000035: Note that all types of clinical trial research on incapacitated adults should be scrutinized carefully in case extra
p.000035: precautions or conditions are necessary.
p.000035: 3.2.4.1 Capacity and communication
p.000035: Decision-making incapacity may result from a variety of causes and take various forms. The most important insight is
p.000035: that incapacity to decide is a question of fact to be determined on a case-by-case basis. Even if for other
p.000035: purposes, a person has been declared legally incompetent, she may retain the capacity to make decisions. It is
p.000035: thus vital that researchers bear this in mind because to ignore this fact is to seriously violate the person’s
p.000035: constitutional right to dignity as well as the ethical principle of respect (autonomy).
p.000035: When recruiting participants, the crucial elements are whether the person retains the capacity to decide
p.000035: whether to participate and whether he is able to communicate that decision. The first point to note,
p.000035: therefore, is the difference between the capacity to decide and the ability to communicate the decision. The capacity
p.000035: to decide necessarily includes the capacity to understand the information that is communicated to him. The
...
p.000037: In particular circumstances, the REC may approve delayed consent.
p.000037: Note this does not mean that informed consent is waived.
p.000037: RECs should ensure that a clear and full justification for the proposed delay accompanies the research proposal. The
p.000037: individual circumstances of the patient must be carefully considered to prevent inadvertent violation of personal or
p.000037: cultural values.
p.000037: The REC may approve a delay in obtaining informed consent for emergency care research if
p.000037: • the research is based on valid scientific hypotheses that support a reasonable possibility of more
p.000037: benefit than that offered by standard care; and
p.000037: • participation is not contrary to the medical interests of the patient;
p.000037: • the research interventions pose no more risk of harm than that inherent in the patient’s condition
p.000037: or alternative methods of treatment;
p.000037: • the participant and her relatives or legal representatives will be informed of the participant’s
p.000037: inclusion in the research as soon as reasonably possible, and advised of her right to withdraw from the research
p.000037: without any reduction in quality of care.
p.000037: 3.2.4.4 Minimum conditions for research involving incapacitated adults
p.000037: Research involving incapacitated adults should be approved only if
p.000037: i. The research, including observational research, is not contrary to the best interest of the individual;
p.000037: ii. The research, including observational research, places the incapacitated adult at no more than minimal risk
p.000037: (i.e. the ‘everyday risk standard’ which means the risk is commensurate with ‘daily life or routine medical,
p.000037: dental or psychological examinations and in social or education settings activities’ – referred to as ‘negligible risk’
p.000037: in some guidelines); or
p.000037:
p.000037: 38 Ethics in Health Research 2nd edition
p.000037:
p.000037:
p.000037: iii. The research involves greater than minimal risk but provides the prospect of direct benefit for the
p.000037: incapacitated adult. The degree of risk must be justified by the potential benefit; or
p.000037: iv. The research, including observational research, involves greater than minimal risk, with no prospect
p.000037: of direct benefit to the incapacitated adult, but has a high probability of providing generalizable knowledge; i.e.
p.000037: the risk should be justified by the risk- knowledge ratio;
p.000037: v. Greater than minimal risk must represent no more than a minor increase over minimal risk;
p.000037: vi. The legally appropriate person (treatment proxies as stipulated in NHA s 7 or s 27(1)(a) of the
p.000037: Mental Health Care Act 17 of 2002) gives permission for the person to participate; and
p.000037: vii. Where appropriate, the person will assent to participation. Note that the incapacitated person’s refusal or
p.000037: resistance to participate, as indicated by words or behaviour, takes precedence over permission by a proxy.
p.000037: The National Health Act specifies the sequence of legally appropriate treatment proxies as spouse or partner; parent;
p.000037: grandparent; adult child; brother or sister. The Mental Health Care Act provides, in no particular sequence, that
p.000037: legally appropriate proxies are spouse; next of kin; partner; associate (defined as ‘a person with a
p.000037: substantial or material interest in the well-being of a mental health care user or a person who is in substantial
p.000037: contact with the user’); and parent or guardian.
p.000037: 3.2.5 Persons in dependent relationships
p.000037:
p.000037: This class of persons includes persons in junior or subordinate positions in hierarchically structured
p.000037: groups and may include relationships between older persons and their care-givers; persons with chronic conditions
p.000037: or disabilities and their care-givers; persons with life- threatening illnesses; patients and health care
p.000037: professionals; wards of state and guardians; students and teachers (including university teachers); employees and
p.000037: employers, including farm workers, members of the uniformed services and hospital staff and their
p.000037: respective employers.
p.000037: Particular attention should be given to ensuring that participants are adequately informed and can choose
p.000037: voluntarily whether to participate in research.
...
p.000045: and improving therapies for survival and quality of life.
p.000045: Although patients in a major incident context face extreme vulnerability, RECs should be cautious about
p.000045: being overly restrictive about the type of research that may be conducted. The development of new drugs and procedures
p.000045: to treat emergency patients safely depends on being able to conduct research, including carefully designed randomised
p.000045: controlled trials.
p.000045: In order to carry out research in such contexts, planning of the research and ethics clearance processes usually must
p.000045: occur very rapidly. From the REC perspective, proposals for major incident research usually demand expedited
p.000045: processing, which means that the time for deliberation is curtailed.
p.000045: When research is not actually dependent on a major incident context, the proposal should be approached cautiously.
p.000045: RECs should consider carefully whether sufficient justification is presented for expedited processing. In the
p.000045: same way that research involving minors should be done only when adult participants cannot provide the necessary data,
p.000045: so major incident research should take place about matters that are unlikely to or do not occur in ‘ordinary’ contexts.
p.000045: Informed consent usually has to be obtained rapidly and at a time when vulnerability of patients and
p.000045: families is likely to be extreme. Patients may be incapacitated (i.e. unconscious or on a ventilator), which points to
p.000045: the likelihood of difficulties with the usual approach to informed consent. Consequently, RECs may consider
p.000045: alternative approaches such as proxy consent or delaying consent in particular circumstances. (See 3.2.4.3, 3.2.4.4 &
p.000045: 3.2.6.)
p.000045: 3.4.2 Intensive care research
p.000045:
p.000045: Characteristic features of intensive care research include difficulties in communicating with patients receiving
p.000045: ventilation assistance and impairment of cognition in heavily sedated individuals.
p.000045: Whenever possible, informed consent for planned intensive care research should be obtained from potential participants
p.000045: before admission to that care. See 3.2.4.3, 3.2.4.4 & 3.2.6.
p.000045: Research involving infants receiving neonatal intensive care should be conducted in strict accordance with
p.000045: the principles set out for minors (see 3.2.1 above). These principles do not permit research that is contrary to
p.000045: the child’s best interest. The small size and extreme vulnerability of some infants are unique features of this
p.000045: class of participants. This means that all but minimally intrusive interventions are likely to be contrary to the
p.000045: child’s best interest. Collection of even small blood samples for research in addition to those required
...
Searching for indicator incapacity:
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p.000003: The current NHREC comprises of Prof D du Toit (Chairperson), Prof D van Bogaert (Deputy Chairperson), Ms K Nevhutalu
p.000003: (NDoH), Ms C Slack, Adv LT Nevondwe, Prof A van Niekerk, Dr NP Sithebe, Ms ET Zwane, Ms T Sebata, Prof A
p.000003: Pope, the late Dr L Schoeman, Dr M Sekhoacha, Dr S Ncanana, Dr NJ Ramalivhana.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: MS MP. MATSOSO
p.000003: DIRECTOR-GENERAL: DEPARTMENT OF HEALTH DATE: 1 March 2015
p.000003:
p.000003: 4 Ethics in Health Research 2nd edition
p.000003:
p.000003: CONTENTS
p.000003: Chapter 1 Ethics in research p 6
p.000003:
p.000003: 1.1 Introduction
p.000003: 1.2 The research context
p.000003: 1.3 Regulatory authority
p.000003: 1.4 Research with humans
p.000003: 1.5 Research using animals
p.000003: 1.6 Ethical research review
p.000003: 1.7 Glossary and resources
p.000003: 1.8 Purpose and status of these Guidelines
p.000003: 1.9 Structure of these Guidelines
p.000003:
p.000003: Chapter 2 Guiding principles for ethical research
p.000014: 14
p.000014:
p.000014: 2.1 Ethical principles
p.000014: 2.2 Role of ethical principles
p.000014: 2.3 Key norms & standards
p.000014:
p.000014: Chapter 3 Substantive norms and operational processes 18
p.000014:
p.000014: 3.1 Ethical basis for decision-making in the review process
p.000014: 3.2 Vulnerability and incapacity
p.000014: 3.3 Data and biological materials for research purposes
p.000014: 3.4 Considerations specific to research methods or contexts
p.000014: 3.5 Special topics
p.000014:
p.000014: Chapter 4 Research Ethics Committees 56
p.000014:
p.000014: 4.1 Introduction
p.000014: 4.2 Legislative framework
p.000014: 4.3 Role of Research Ethics Committees
p.000014: 4.4 Membership
p.000014: 4.5 Standard operating procedures
p.000014: 4.6 Compliance reporting to NHREC
p.000014:
p.000014:
p.000014: Chapter 5 Health research ethics infrastructure
p.000067: 67
p.000067:
p.000067: 5.1 Introduction
p.000067: 5.2 National Health Research Ethics Council
p.000067: 5.3 Research Ethics committees
p.000067:
p.000067: Ethics in Health Research 2nd edition
p.000005: 5
p.000005: 5.4 Registration and audit of committees
p.000005: 5.5 Statutory entities relevant to research
p.000005: Chapter 6 Qualitative research 73
p.000005:
p.000005: 6.1 Introduction
p.000005: 6.2 Nature of qualitative research
p.000005: 6.3 Methodological approaches and requirements
p.000005: 6.4 Approach to ethics review of qualitative research
p.000005: 6.5 Criteria for review process
...
p.000017: communities where appropriate, in accordance with the norm of role player engagement and collaboration.
p.000017:
p.000017: 18 Ethics in Health Research 2nd edition
p.000017:
p.000017:
p.000017:
p.000017: Chapter 3
p.000017:
p.000017: SUBSTANTIVE NORMS AND OPERATIONAL PROCESSES FOR ETHICS REVIEW
p.000017:
p.000017: Contents
p.000017:
p.000017:
p.000017: 3.1 Ethical basis for decision making in the review process p 19
p.000017: 3.1.1 Scientific design, aims & objectives 19
p.000017: 3.1.2 Inclusion & exclusion criteria
p.000020: 20
p.000020: 3.1.3 Selection of study population & sampling 20
p.000020: 3.1.4 Recruitment & enrolment
p.000020: 20
p.000020: 3.1.5 Research procedures
p.000021: 21
p.000021: 3.1.6 Risks of harm & likelihood of benefit 21
p.000021: 3.1.7 Reimbursements, inducements & costs for participants 22
p.000021: 3.1.8 Participants’ privacy & confidentiality interests 22
p.000021: 3.1.9 Obtaining informed consent 24
p.000021: 3.2 Vulnerability & incapacity
p.000026: 26
p.000026: 3.2.1 Contextual circumstances
p.000026: 26
p.000026: 3.2.2 Minors (children & adolescents) 27
p.000026: 3.2.3 Women
p.000035: 35
p.000035: 3.2.4 Adults with factual incapacity
p.000036: 36
p.000036: 3.2.5 Persons in dependent relationships 38
p.000036: 3.2.6 Patients highly dependent on medical care 38
p.000036: 3.2.7 Persons with physical disabilities
p.000038: 38
p.000038: 3.2.8 Prisoners
p.000039: 39
p.000039: 3.2.9 Collectivities
p.000040: 40
p.000040: 3.3 Data & biological material for research purposes 40
p.000040: 3.3.1 Introduction
p.000040: 40
p.000040: 3.3.2 Permitted usage of biological material 41
p.000040: 3.3.3 Identifiability of biological materials and data 41
p.000040: 3.3.4 Collection of biological materials and data 42
p.000040: 3.3.5 Restrictions on collection of biological material 42
p.000040: 3.3.6 Informed consent
p.000042: 42
p.000042: 3.3.7 Secondary use of material or data 43
p.000042: 3.3.8 Genetic research
p.000044: 44
p.000044: 3.3.9 Genomics research
p.000044: 44
p.000044: 3.3.10 Commercially available cell lines
p.000045: 45
p.000045: 3.4 Considerations specific to research methods or contexts 45
p.000045: 3.4.1 Major incidents & research
p.000045: 45
...
p.000025: o the extent to which confidentiality is possible
p.000025: o whether reimbursement for expenses is available
p.000025: o that sponsors of the research and regulatory authorities may inspect research records
p.000025: o who the researchers are and the nature of their expertise
p.000025: o the potential benefits, if any, for participants both during and after the research
p.000025: o that the research may be terminated early in particular circumstances
p.000025: o that the research has been approved by a registered REC (include identifying details)
p.000025: • a measure to probe understanding and comprehension of the information is planned and how it proposes to do so
p.000025: especially for very vulnerable potential participants
p.000025: Where a clinical trial is proposed, additional information for prospective participants is required.18
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 17The Flesch-Kinkaid readability tool should be used to assess the complexity of text. This tool is built into MS
p.000025: Word’s spelling & grammar check tool as ‘readability statistics’. No more than Grade 8 equivalency should be the target
p.000025: complexity level.
p.000025: 18See Department of Health (2006) Guidelines for Good Practice in the Conduct of Clinical Trials with Human
p.000025: Participants in South Africa
p.000025: or its successor.
p.000025:
p.000025: 26 Ethics in Health Research 2nd edition
p.000025:
p.000025:
p.000025: 3.2 Vulnerability and incapacity
p.000025:
p.000025: Vulnerability is not an absolute condition but rather occurs on a sliding scale. In South Africa, arguably, the
p.000025: majority of potential research participants are vulnerable when compared to those in North America or Europe,
p.000025: from whence much funding is sourced. 19 Whether vulnerability is present is a matter of fact and degree.
p.000025: However, certain groups of participants 20 require careful consideration to ensure that, where appropriate,
p.000025: additional precautions are put into place. For example, advanced age, very young age, personal or
p.000025: environmental factors like extreme poverty and ordinarily poor access to health care may increase
p.000025: vulnerability
p.000025: 3.2.1 Contextual circumstances
p.000025: Personal circumstances, such as mental or intellectual impairment, acute illness, advanced age, and pregnancy and
p.000025: childbirth may increase vulnerability. Persons may be factually incapable or less capable of understanding
p.000025: information and processing it to reach a decision
p.000025: e.g. about whether to participate in research. Environmental circumstances may also increase vulnerability such as very
p.000025: poor socio-economic conditions, low levels of formal education and literacy, or restricted access to health care
p.000025: services. Such persons may be more easily persuaded to agree to participate without a properly considered
p.000025: understanding of the implications.
p.000025: It is important to note the difference between legal incapacity and factual incapacity. No person may
p.000025: claim that, because a minor is factually capable, the legal incapacity should be waived. On the other hand, no adult
p.000025: may be assumed to be incapable unless incapacity is established factually. Consequently, mental incapacity must
p.000025: be established by a factual assessment of the individual’s abilities to understand and to
p.000025: communicate that understanding. Legal incapacity prevails notwithstanding the existence of factual capacity.
p.000025: South Africa is home to a number of vulnerable communities. Where factors usually associated with
p.000025: vulnerability are integral to the research, the proposal should demonstrate how vulnerability would be managed.
p.000025: Particular caution should be exercised before undertaking research involving participants in such
p.000025: communities, and RECs should ensure that
p.000025: • persons in these communities are not being involved in research merely because they are expediently accessible,
p.000025: while the research could be carried out in a less vulnerable community;
p.000025: • the research is relevant to the health needs and priorities of the community in which it is to be carried out;
p.000025: and that
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 19 UNAIDS defines ‘vulnerable community’ as having some or all of the following characteristics: limited economic
p.000025: development; inadequate protection of human rights and discrimination on the basis of the health status; inadequate
p.000025: community/cultural experience and understanding of scientific research; limited access to health care and treatment
...
p.000027: measures for the informed consent process; or require increased monitoring and interim reporting on
p.000027: participants’ welfare; or require post-recruitment reviews of the effectiveness of the protective measures
p.000027: imposed. Other measures may also be appropriate.
p.000027: Note that the decision to impose additional measures should flow from an assessment of the nature of the research and
p.000027: the circumstances of the potential participants. In other words, additional protective measures should not be automatic
p.000027: just because a vulnerable group will be recruited; rather, the decision should be based on the particular
p.000027: circumstances of the proposal before the REC. For example, an automatic assumption that impoverished people cannot
p.000027: choose responsibly whether to participate in research is disrespectful because it denies their autonomy.
p.000027: If compliance with the additional measures is poor and participants’ welfare is negatively affected,
p.000027: approval for the study may be withdrawn, temporarily or permanently, as the case may be.
p.000027: Groups of participants discussed here include
p.000027: • minors (children and adolescents)
p.000027: • women
p.000027: • adults with incapacity to provide informed consent
p.000027: • persons in dependent relationships
p.000027: • persons highly dependent on medical care
p.000027: • persons with physical disabilities
p.000027: • prisoners
p.000027: • collectivities
p.000027:
p.000027: Note this list is not exhaustive but provides an indication of the types of consideration to be applied
p.000027: 3.2.2 Minors (children and adolescents)
p.000027:
p.000027: Below the age of majority, the law protects young people from their own emotional, cognitive and physical immaturity
p.000027: and limited life experience through the legal status of minority. In other words, minors, i.e. persons under 18 years
p.000027: of age,22 are legally incapable of performing legal transactions without assistance from a parent or guardian. In the
p.000027: research context, this means that, in principle, anyone under the age of 18 years may not choose independently whether
p.000027: to participate in research; a parent or guardian must give permission for the minor
p.000027:
p.000027: 21 Note that this requirement does not mean that a REC may not approve a waiver of personal informed consent for types
p.000027: of research into e.g. record reviews or such like.
p.000027: 22 Section 28 of the Constitution; and s 17 of the Children’s Act 38 of 2005.
p.000027:
p.000027: 28 Ethics in Health Research 2nd edition
p.000027:
p.000027:
p.000027: to choose. This is because young persons’ understanding of key aspects of the research initiative may be
p.000027: compromised and, consequently, they may be exposed to increased risk of harm from particular research procedures.
p.000027: Exceptions to the requirement for parental permission are discussed at 3.2.2.4.
p.000027: Tension exists between the views that, in general, children and adolescents should not bear the burden of research
p.000027: unnecessarily, on the one hand, and that children and adolescents are entitled to improved health care based on
p.000027: findings drawn from rigorous research conducted in the child population of South Africa, on the other.
p.000027: The solution lies in the approach that minors should participate in research only where their
p.000027: participation is indispensable to the research; i.e. the research cannot deliver the desired outcomes if adult
p.000027: participants were to be used instead.
p.000027: Because of their status of legal incapacity, in principle, minors may not choose independently whether to participate
p.000027: in research. A parent or guardian must give permission for the minor to choose. It should be noted that the parent or
p.000027: guardian does not choose for the minor who is capable of choosing;23 rather, the parent or guardian gives
p.000027: permission for the minor to choose. Where a minor is very young or is factually incapable of exercising a choice,
p.000027: then the parent or guardian chooses whether the minor should participate.
p.000027: The best interest of a child should be paramount in decisions that affect the child. 24 This principle is
p.000027: difficult to apply in the research context because research participation is unlikely to be in the best interest of a
p.000027: minor. Good research design does not accommodate a best interest analysis easily. Rather, the design draws on
p.000027: aggregates of information. This means that, in the research context, the best interest principle should be understood
...
p.000027: that all types of clinical trial research on minors should be scrutinized carefully in case extra precautions or
p.000027: conditions are necessary.
p.000027: For purposes of these guidelines
p.000027: ‘Adolescent’ means a child between the ages of 12 and 17 years of age (ICH Topic E 11 Clinical Investigation of
p.000027: Medicinal Products in the Paediatric Population. 2000
p.000027: [http://www.emea.eu.int/pdfs/human/ich/271199EN.pdf]
p.000027: ‘Caregiver’ means a person who factually cares for a child (s 1 Children’s Act, 38 of 2005; a caregiver is obliged
p.000027: (in terms of s 32(1)) to safeguard the child’s health, well-being and development; and to protect the child
p.000027: from abuse and other harms. Further a caregiver may exercise the parental right to consent to medical examination or
p.000027: treatment of the child (in terms of s 32(2))
p.000027:
p.000027:
p.000027: 23 Section 10 of the Children’s Act 38 of 2005. Note that a caregiver, a foster parent and a schoolteacher or
p.000027: principal are not guardians. Note that legal incapacity is not the same as factual incapacity. Minority is a legal
p.000027: incapacity status.
p.000027: 24 See also s 9 of the Children’s Act 38 of 2005.
p.000027:
p.000027: Ethics in Health Research 2nd edition
p.000029: 29
p.000029:
p.000029: ‘Child’ means a person under the age of 18 years (s 28 Constitution; s 1 Children’s Act 38 of 2005)
p.000029: ‘Child-headed household’ means a household per s 137 Children’s Act 38 of 2005
p.000029: ‘Guardian’ means a person appointed by a court to look after the financial and welfare interests of a
p.000029: minor, or a person appointed by a parent with sole responsibility for the minor in terms of the parent’s Will
p.000029: ‘Harm’ means physical, emotional, psychological, social or legal harm
p.000029: ‘Minor’ means a person (child) less than 18 years (s 17 Children’s Act 38 of 2005) ‘Neonate’ means a newborn child,
...
p.000031: years old during the course of a study should be approached at the time of their birthday to re-consent. This
p.000031: is because they must now provide independent consent to continue to be a participant. In cases where
p.000031: minors are permitted to decide independently whether to participate, 26 the consent process should address
p.000031: how re-consent will be managed when they change status from minority to majority. Similarly, in the case of
p.000031: large and longitudinal studies, attention must be given to how the change from minority to majority will be managed.
p.000031: Where a study is no longer in active interaction with participants, re-consent procedures may be less important.
p.000031: j) Researchers must familiarise themselves with the legal obligations to report child abuse and neglect.
p.000031: See 3.2.2.5.
p.000031: 3.2.2.2 Parental permission
p.000031: The Children’s Act 38 of 2005 emphasises the right of a child to participate in any matter concerning that child,
p.000031: provided he or she has sufficient maturity to participate appropriately and meaningfully (s 10), notwithstanding
p.000031: legal incapacity. This means that parents or guardians may not decide whether their minor child should
p.000031: participate in research without the minor’s contribution to the decision. The choice of whether to participate is not a
p.000031: legal decision but rather a factual choice. Consequently, the process should be that the parent or guardian is
p.000031: requested to give permission for the minor to be approached to be invited to participate in the study. The factual
p.000031: decision whether to participate is the minor’s and not the parent’s.
p.000031: Parental permission and minor’s decision must be consistent, i.e. if the minor decides not to participate, the parent
p.000031: may not override this decision. If the parent is reluctant for the minor to participate but the minor wants to
p.000031: do so, the matter must be managed carefully to establish what the concerns are and whether they may be
...
p.000035: adults is established and is acceptable. In the case of pregnant women, the potential risks associated with using a
p.000035: substance whose short term and long-term effects on a fetus and developing infant are unknown, should be outweighed by
p.000035: the benefits. An example of a positive risk-benefit ratio would be the use of anti-retrovirals in mother to child HIV
p.000035: transmission studies. For nursing mothers, the amount of drug passing into breast milk should be established and the
p.000035: potential impact on a breast-fed infant anticipated, and the mother so advised.
p.000035:
p.000035: 36 Ethics in Health Research 2nd edition
p.000035:
p.000035:
p.000035: • in all cases, inclusion poses the least risk of harm possible for achieving the objectives of the research.
p.000035: 3.2.4 Adults with factual incapacity to provide informed consent
p.000035:
p.000035: Adults who are factually incapable of giving informed consent should participate in research only where their
p.000035: participation is indispensable to the research; i.e. the research cannot deliver the desired outcomes if
p.000035: capable adult participants were to be used instead. Further, the research should investigate a problem of
p.000035: relevance to incapacitated adults. Where research can be undertaken with capable adults but nevertheless proposes
p.000035: also to include incapacitated adults, strong justification for their inclusion must be provided.
p.000035: The primary difficulty for informed consent in this context is whether proxy consent is permissible. The
p.000035: best interest principle is often used in connection with decisions relating to whether incapacitated adults should be
p.000035: enrolled in research. However, similarly to the case of minors, this principle is difficult to apply in the
p.000035: research context because research participation is unlikely to be in the best interest of an incapacitated adult.
p.000035: Good research design does not permit a best interest analysis easily. Rather, the design draws on
p.000035: aggregates of information. This means that, in the research context, the best interest principle should
p.000035: be understood to mean that participation in the research should not be contrary to the individual’s best
p.000035: interest.
p.000035: Note that all types of clinical trial research on incapacitated adults should be scrutinized carefully in case extra
p.000035: precautions or conditions are necessary.
p.000035: 3.2.4.1 Capacity and communication
p.000035: Decision-making incapacity may result from a variety of causes and take various forms. The most important insight is
p.000035: that incapacity to decide is a question of fact to be determined on a case-by-case basis. Even if for other
p.000035: purposes, a person has been declared legally incompetent, she may retain the capacity to make decisions. It is
p.000035: thus vital that researchers bear this in mind because to ignore this fact is to seriously violate the person’s
p.000035: constitutional right to dignity as well as the ethical principle of respect (autonomy).
p.000035: When recruiting participants, the crucial elements are whether the person retains the capacity to decide
p.000035: whether to participate and whether he is able to communicate that decision. The first point to note,
p.000035: therefore, is the difference between the capacity to decide and the ability to communicate the decision. The capacity
p.000035: to decide necessarily includes the capacity to understand the information that is communicated to him. The
p.000035: ability to communicate includes the ability to hear and to speak or otherwise signal or express her
p.000035: wishes. For example, deafness should never be mistaken for incapacity to decide. Similarly, the inability to speak
p.000035: should not be mistaken for a lack of capacity to decide whether to participate.32
p.000035: 3.2.4.2 Minors and decision-making incapacity
p.000035: Parents or guardians of minors with intellectual or mental impairments should give permission for their
p.000035: minor children to choose whether to participate in research. If the minor
p.000035:
p.000035: 32 Georgetown University Informed Consent and Limitations on Decision making Capacity Chapter 2
p.000035: https://bioethicsarchive.georgetown.edu/nbac/capacity/Informed.htm
p.000035:
p.000035: Ethics in Health Research 2nd edition
p.000037: 37
p.000037:
p.000037: is unable to communicate at all or lacks the capacity to choose, then the parent or guardian should choose whether
p.000037: the minor may be enrolled. In other words, the parent acts as a proxy decision maker. In the case of a
p.000037: minor who remains intellectually or mentally impaired after reaching the age of majority, the situation changes
p.000037: because the person becomes an adult with decision-making incapacity (see 3.2.4.3 below).
p.000037: 3.2.4.3 Adults incapable of giving adequate informed consent
p.000037: Proxy decision makers are not permitted for adult persons who lack capacity unless the proxy is a court-appointed
p.000037: curator. Neither the National Health Act 61 of 2003 nor the Mental Health Care Act 17 of 2002 makes
p.000037: provision for proxy decision makers for research purposes but they provide clear lists of proxy decision makers for
p.000037: treatment purposes.
p.000037: Since it would be unethical to exclude a category of persons from research participation without adequate
p.000037: justification, arguably, an ethical argument can be made for using the statutory treatment proxies to
p.000037: provide permission for participation in research that complies with the stipulations set out below. However,
p.000037: RECs must be careful not to confuse the distinction between treatment and research. In unusual circumstances,
p.000037: e.g. major incident research (see 3.4.1), it may be ethically permissible to permit proxy consent also in
p.000037: a situation where no statutory proxy is available but the risk of harm to knowledge ratio justifies it.
p.000037: In particular circumstances, the REC may approve delayed consent.
p.000037: Note this does not mean that informed consent is waived.
...
General/Other / Public Emergency
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p.000037: provision for proxy decision makers for research purposes but they provide clear lists of proxy decision makers for
p.000037: treatment purposes.
p.000037: Since it would be unethical to exclude a category of persons from research participation without adequate
p.000037: justification, arguably, an ethical argument can be made for using the statutory treatment proxies to
p.000037: provide permission for participation in research that complies with the stipulations set out below. However,
p.000037: RECs must be careful not to confuse the distinction between treatment and research. In unusual circumstances,
p.000037: e.g. major incident research (see 3.4.1), it may be ethically permissible to permit proxy consent also in
p.000037: a situation where no statutory proxy is available but the risk of harm to knowledge ratio justifies it.
p.000037: In particular circumstances, the REC may approve delayed consent.
p.000037: Note this does not mean that informed consent is waived.
p.000037: RECs should ensure that a clear and full justification for the proposed delay accompanies the research proposal. The
p.000037: individual circumstances of the patient must be carefully considered to prevent inadvertent violation of personal or
p.000037: cultural values.
p.000037: The REC may approve a delay in obtaining informed consent for emergency care research if
p.000037: • the research is based on valid scientific hypotheses that support a reasonable possibility of more
p.000037: benefit than that offered by standard care; and
p.000037: • participation is not contrary to the medical interests of the patient;
p.000037: • the research interventions pose no more risk of harm than that inherent in the patient’s condition
p.000037: or alternative methods of treatment;
p.000037: • the participant and her relatives or legal representatives will be informed of the participant’s
p.000037: inclusion in the research as soon as reasonably possible, and advised of her right to withdraw from the research
p.000037: without any reduction in quality of care.
p.000037: 3.2.4.4 Minimum conditions for research involving incapacitated adults
p.000037: Research involving incapacitated adults should be approved only if
p.000037: i. The research, including observational research, is not contrary to the best interest of the individual;
p.000037: ii. The research, including observational research, places the incapacitated adult at no more than minimal risk
p.000037: (i.e. the ‘everyday risk standard’ which means the risk is commensurate with ‘daily life or routine medical,
...
p.000045: 3.4 Considerations specific to research methods or contexts
p.000045:
p.000045: Particular types of research require careful scrutiny in case additional precautions or monitoring
p.000045: procedures are required.
p.000045: Types of research discussed include:
p.000045: • Major incidents39 and research
p.000045: • Intensive care research
p.000045: • Terminal care research
p.000045: • Innovative therapy or interventions
p.000045: • Indigenous medicines research
p.000045: • Deception, concealment or covert data collection
p.000045: Note this list is not exhaustive, merely illustrative.
p.000045:
p.000045: 3.4.1 Major incidents and research
p.000045:
p.000045: Major incidents include any sudden event that occurs where local resources are constrained, so that responding
p.000045: urgently and appropriately is difficult. Major incidents include acute disasters – natural or man-made –
p.000045: such as floods, tornados, earthquakes, outbreaks of deadly disease, or political violence and armed
p.000045: conflict with resultant injuries to humans.
p.000045:
p.000045: 38The Human Heredity and Health in Africa (H3Africa) Initiative http://h3africa.org/about/vision.
p.000045: 39 Previously known as disaster research.
p.000045:
p.000045: 46 Ethics in Health Research 2nd edition
p.000045:
p.000045:
p.000045: They may also take the form of an unusual and sudden demand on local resources or other emergency with consequent
p.000045: ethical implications for patient care. Research in these contexts is important for advancing emergency health
p.000045: care interventions and treatments, and for refining resource allocation policies. The potential benefits of major
p.000045: incident research include improved triage methods and procedures, effective treatment for life-threatening conditions
p.000045: and improving therapies for survival and quality of life.
p.000045: Although patients in a major incident context face extreme vulnerability, RECs should be cautious about
p.000045: being overly restrictive about the type of research that may be conducted. The development of new drugs and procedures
p.000045: to treat emergency patients safely depends on being able to conduct research, including carefully designed randomised
p.000045: controlled trials.
p.000045: In order to carry out research in such contexts, planning of the research and ethics clearance processes usually must
p.000045: occur very rapidly. From the REC perspective, proposals for major incident research usually demand expedited
p.000045: processing, which means that the time for deliberation is curtailed.
p.000045: When research is not actually dependent on a major incident context, the proposal should be approached cautiously.
p.000045: RECs should consider carefully whether sufficient justification is presented for expedited processing. In the
p.000045: same way that research involving minors should be done only when adult participants cannot provide the necessary data,
p.000045: so major incident research should take place about matters that are unlikely to or do not occur in ‘ordinary’ contexts.
p.000045: Informed consent usually has to be obtained rapidly and at a time when vulnerability of patients and
p.000045: families is likely to be extreme. Patients may be incapacitated (i.e. unconscious or on a ventilator), which points to
p.000045: the likelihood of difficulties with the usual approach to informed consent. Consequently, RECs may consider
...
p.000085: Print three (3) copies: one for patient’s folder, one for PTC, and one for the patient or her family
p.000085: This document is for a single patient use and a single treatment course only.
p.000085:
p.000085: This document tells you about a treatment for your (your child’s) condition that is still experimental but which your
p.000085: doctors would like to try. You are not being asked to join a research project. Important differences
p.000085: exist between experimental treatment and a research project.
p.000085: This treatment is experimental because
p.000085: < delete options that do not apply >
p.000085: It has been tested for conditions other than yours (your child’s).
p.000085: It has been tested for use with adults but not for use with children (< 18 years; < 12 years) It has not been registered
p.000085: in South Africa for use for your condition.
p.000085:
p.000085:
p.000085:
p.000085: Name of Drug Or Intervention
p.000085: Single Patient Use of < Insert Investigational Drug or Intervention Name >
p.000085:
p.000085:
p.000085: Treating Health care worker(s):
p.000085: < Insert Name >
p.000085: < Insert Address/Medical ward details >
p.000085: < Insert Phone Numbers/ Medical ward extension >
p.000085:
p.000085:
p.000085: Emergency Contact < Insert Emergency Contact Information >
p.000085: < Insert Phone Number/Pager, etc >
p.000085:
p.000085:
p.000085: < Insert name of investigational drug or other intervention > is a treatment that < insert either current approval status
p.000085: by the Medicines Control Council for another condition or provide a patient appropriate explanation of what
p.000085: the investigational drug or intervention is intended to do >.
p.000085:
p.000085: This treatment is not approved for < indicate what condition the patient has >, which means its use is experimental. We
p.000085: are not sure that this experimental treatment will cure or improve your condition. But in your circumstances, we offer
p.000085: you the opportunity to try it.
p.000085:
p.000085: Ethics in Health Research 2nd edition
p.000087: 87
p.000087:
p.000087: We must get permission from the hospital authorities before we may use this experimental treatment
p.000087: for you. The hospital authorities keep a careful watch over your welfare interests, especially that you
p.000087: should choose voluntarily. This is why you are asked to choose whether you would like to try the experimental treatment
p.000087: before we request permission to use the drug for you.
p.000087: You do not have to use the experimental treatment.
p.000087: Why is this experimental treatment being offered?
p.000087: Your doctors think this experimental treatment may offer an option for your clinical care, as < insert in plain language
...
General/Other / Relationship to Authority
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p.000003: • The safety and welfare interests of animals used in research are promoted
p.000003: • Researchers are accountable for their research activities
p.000003: • Social and ethical values are promoted
p.000003: The Department is also grateful for the following officials who provided secretariat support to the NHREC and in
p.000003: particular the NHREC's Norms and Standards Working Group as well as Ms K Nevhutalu, Mr T Molebatsi, Mr J van
p.000003: der Westhuizen and Mr R Maluleke from the Secretariat, the NHREC and all interested parties for their
p.000003: role in development of these Guidelines and for their expert and technical input.
p.000003: The current NHREC comprises of Prof D du Toit (Chairperson), Prof D van Bogaert (Deputy Chairperson), Ms K Nevhutalu
p.000003: (NDoH), Ms C Slack, Adv LT Nevondwe, Prof A van Niekerk, Dr NP Sithebe, Ms ET Zwane, Ms T Sebata, Prof A
p.000003: Pope, the late Dr L Schoeman, Dr M Sekhoacha, Dr S Ncanana, Dr NJ Ramalivhana.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: MS MP. MATSOSO
p.000003: DIRECTOR-GENERAL: DEPARTMENT OF HEALTH DATE: 1 March 2015
p.000003:
p.000003: 4 Ethics in Health Research 2nd edition
p.000003:
p.000003: CONTENTS
p.000003: Chapter 1 Ethics in research p 6
p.000003:
p.000003: 1.1 Introduction
p.000003: 1.2 The research context
p.000003: 1.3 Regulatory authority
p.000003: 1.4 Research with humans
p.000003: 1.5 Research using animals
p.000003: 1.6 Ethical research review
p.000003: 1.7 Glossary and resources
p.000003: 1.8 Purpose and status of these Guidelines
p.000003: 1.9 Structure of these Guidelines
p.000003:
p.000003: Chapter 2 Guiding principles for ethical research
p.000014: 14
p.000014:
p.000014: 2.1 Ethical principles
p.000014: 2.2 Role of ethical principles
p.000014: 2.3 Key norms & standards
p.000014:
p.000014: Chapter 3 Substantive norms and operational processes 18
p.000014:
p.000014: 3.1 Ethical basis for decision-making in the review process
p.000014: 3.2 Vulnerability and incapacity
p.000014: 3.3 Data and biological materials for research purposes
p.000014: 3.4 Considerations specific to research methods or contexts
p.000014: 3.5 Special topics
p.000014:
p.000014: Chapter 4 Research Ethics Committees 56
p.000014:
p.000014: 4.1 Introduction
p.000014: 4.2 Legislative framework
p.000014: 4.3 Role of Research Ethics Committees
p.000014: 4.4 Membership
p.000014: 4.5 Standard operating procedures
p.000014: 4.6 Compliance reporting to NHREC
p.000014:
p.000014:
p.000014: Chapter 5 Health research ethics infrastructure
p.000067: 67
p.000067:
p.000067: 5.1 Introduction
p.000067: 5.2 National Health Research Ethics Council
p.000067: 5.3 Research Ethics committees
...
p.000005: documentation and guidance of the University of Cape Town Faculty of Health Sciences Human Research Ethics
p.000005: Committee
p.000005:
p.000005: http://www.health.uct.ac.za/research/humanethics/sop/.; the University of KwaZulu-Natal at
p.000005: http://research.ukzn.ac.za/Research-Ethics/Overview.aspx; the University of Pretoria at
p.000005: http://web.up.ac.za/default.asp?ipkCategoryID=2875&subid=2875&ipklookid=8&parentid=; the University of the
p.000005: Witwatersrand at http://www.wits.ac.za/academic/researchsupport/19111/code_of_ethics.html.
p.000005:
p.000005: It also draws on the South African Medical Research Council (MRC) Guidelines on Ethics for Medical Research: Use of
p.000005: Animals in Research and Training (2004); The South African Bureau of Standards’ South African National Standard (SANS
p.000005: 10386:2008 or latest version) for the Care and Use of Animals for Scientific Purposes.
p.000005:
p.000005: See Appendix 2 for bibliographic details.
p.000005:
p.000005: 6 Ethics in Health Research 2nd edition
p.000005:
p.000005:
p.000005: Chapter 1
p.000005:
p.000005: ETHICS IN RESEARCH
p.000005:
p.000005: Contents
p.000005:
p.000005:
p.000005: 1.1 Introduction p 6
p.000005: 1.2 The research context 9
p.000005: 1.3 Regulatory authority 9
p.000005: 1.4 Research with humans 11
p.000005: 1.5 Research using animals 11
p.000005: 1.6 Ethical research review 12
p.000005: 1.7 Glossary & resources 12
p.000005: 1.8 Purpose & status of these Guidelines 13
p.000005: 1.9 Structure of these Guidelines 13
p.000005:
p.000005:
p.000005: This chapter explains ethics in research and provides an overview of the South African research context,
p.000005: including the remit of this document.
p.000005:
p.000005: Introduction
p.000005:
p.000005: 1.1.1 South Africa is a democratic state in which human dignity, equality and the advancement of human
p.000005: rights are respected, promoted and protected in terms of the Constitution of the Republic of South Africa, 1996 (the
p.000005: Constitution). In particular, s 27(1) guarantees the right of access to health care services, while section 12(2) of
p.000005: the Bill of Rights in the SA Constitution, protects against research abuse by providing that
p.000005: ‘Everyone has the right to bodily and psychological integrity, which includes the right –
p.000005: (a) to make decisions concerning reproduction;
p.000005: (b) to security in and control over their body; and
p.000005: (c) not to be subjected to medical or scientific experiments 1 without their informed consent’.
p.000005:
p.000005:
p.000005:
p.000005: Note: Where ‘she’ or other version is found, ‘he’ or other version is implied and vice versa.
p.000005:
p.000005: 1 The term ‘experiments’ originates from Article 7 of the International Covenant on Civil and Political Rights - UN
p.000005: 1966 and echoes the Nuremberg Code; in the constitutional context, it is intended to mean ‘research’.
p.000005:
p.000005: Ethics in Health Research 2nd edition
p.000007: 7
p.000007:
p.000007: 1.1.2 The National Health Act 61 of 2003 (NHA) provides statutory authority for governance of ‘health research’ and
p.000007: the necessary research ethics regulatory infrastructure.
p.000007: 1.1.3 ‘Health research’ per the NHA may be understood to include but is not limited to research that
p.000007: contributes to knowledge of
p.000007: • biological, clinical, psychological, or social welfare matters including processes as regards humans
p.000007: • the causes and effects of and responses to disease
p.000007: • effects of the environment on humans
p.000007: • methods to improve health care service delivery
p.000007: • new pharmaceuticals, medicines, interventions and devices
p.000007: • new technologies to improve health and health care
p.000007: 1.1.4 In general terms, research includes a wide range of activities conducted by many different
p.000007: disciplines that may use different methodologies and explanatory frameworks. In the physical and
p.000007: biological sciences, research may be described as a systematic study or inquiry, usually using quantitative data, in
p.000007: seeking generalisable new knowledge. Health-related research is increasingly also using qualitative
p.000007: methodologies. The humanities, social and behavioural sciences use both qualitative and quantitative methods and
p.000007: analytic frameworks, all of which may be aimed at contributing to knowledge about the human condition in its
p.000007: environment and context.
p.000007: 1.1.5 The statutory definition can be interpreted as having a wide or a narrow meaning. Many researchers,
p.000007: especially those who work in the humanities and social and behavioural sciences, may find the statutory
...
p.000007: 1.1.10 Research that relies exclusively on secondary use of anonymous information or anonymous human
p.000007: biological materials usually need not undergo formal ethics review, provided that no identifiable
p.000007: information is generated. See 3.3 below for further information regarding human biological materials.
p.000007: 1.1.11 Quality assurance and quality improvement studies (audits), programme evaluation activities and
p.000007: performance reviews usually do not constitute research and thus usually do not undergo formal ethics review. It should
p.000007: be noted, however, that if publication of such studies is desirable, it is prudent to obtain ethics approval before the
p.000007: study begins. RECs may not grant retrospective ethics approval.
p.000007: 1.1.12 These guidelines express the view that the core ethical principles apply to all forms of research that involve
p.000007: humans2 or use of animals, insofar as the welfare and safety interests of both humans and animals are
p.000007: paramount. Health and safety issues include those that may arise in the environment of research e.g. viruses,
p.000007: parasites, bacteria, as well as the air, water and land.
p.000007: 1.1.13 This document is intended to be as inclusive as possible, so that all researchers who involve human
p.000007: participants or use animals in their research will find assistance in these guidelines. In other words,
p.000007: although this document derives its authority from the National Health Act, the National Health Research Ethics Council
p.000007: (NHREC)intends it to address research more broadly to achieve the specific goal of providing guidance for researchers
p.000007: so that all research involving human participants or animals may be conducted in accordance with the highest
p.000007: ethical norms and standards. This is consistent with the understanding that research means a systematic
p.000007: collection and analysis of new information undertaken with the goal of producing generalisable knowledge or
p.000007: improved understanding of the human condition in its environment or context.
p.000007: 1.1.14 This document does not deal with clinical trials which form the subject matter of the Department of Health’s
p.000007: Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa, 2nd edition
p.000007: (2006) or its successor. However, this document includes guidance on insurance against research-related bodily injury,
p.000007: including in clinical trials.
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: 2 Also known as ‘human subjects research’; a human subject is a living individual about whom a researcher obtains (i)
p.000007: data through interventions or interactions; or (ii) identifiable private information.
p.000007:
p.000007: Ethics in Health Research 2nd edition
p.000009: 9
p.000009:
p.000009:
p.000009: 1.2 The research context
p.000009:
p.000009: 1.2.1 South Africa provides a rich arena for health and health-related research because of its excellent health care
p.000009: and research infrastructure, skills, and expertise. The country is also characterised by a high burden of disease,
p.000009: including diseases associated with poverty and underdevelopment, along with non-communicable diseases, creating
p.000009: a need for a broad spectrum of health and health-related research. See the Department of Health’s Strategic Health Plan
p.000009: 2014-2019 or its successor.3
p.000009: 1.2.2 South Africa is also an attractive research site for social scientists, behavioural scientists,
p.000009: political scientists, economists, researchers engaged in social development, education, and many more disciplines,
p.000009: because of its political history and current socio-economic, educational, political and social development
p.000009: status.
p.000009: 1.2.3 To ensure that South Africa’s people are fairly and respectfully treated by researchers and that all research
p.000009: conducted in the country stands up to ethical scrutiny, South Africa’s research ethics systems and infrastructure
p.000009: are regularly upgraded and strengthened.
p.000009: 1.3 Regulatory authority
p.000009:
p.000009: 1.3.1 The National Health Research Ethics Council (NHREC) was established in 2006 in terms of s 72 of the
p.000009: National Health Act (NHA).
p.000009: 1.3.2 In terms of the NHA, the NHREC must
p.000009: a) set norms and standards for health research involving humans and animals, as well as for conducting clinical trials
p.000009: b) determine guidelines to facilitate best practice for research ethics committees
p.000009: c) register and audit research ethics committees
p.000009: d) adjudicate complaints about research ethics and Animal Research Ethics committees
p.000009: e) refer matters concerning violations of ethical or professional rules to the relevant health professions
p.000009: council;
p.000009: f) recommend disciplinary action against persons found to have violated the norms and standards set for
p.000009: the responsible and ethical conduct of health research
p.000009: g) advise the national and provincial departments of health on ethical matters concerning research.
p.000009: 1.3.3 The NHREC firmly supports ethical practice of health and health-related research and asserts that research
p.000009: should reflect core values of respect, scientific merit and integrity, justice and beneficence. Of highest
...
p.000009: • National Environmental Management: Biodiversity Act, Act 10 of 2004
p.000009: • National Health Act, Act No 61 of 2003
p.000009: • National Health Laboratory Service Act 37 of 2000
p.000009: • Patents Act 57 of 1978
p.000009: • Performing Animals Protection Act 24 of 1935
p.000009: • Promotion of Access to Information Act 2 of 2000
p.000009: • Promotion of Equality and Prevention of Unfair Discrimination Act 4 of 2000
p.000009: • Protected Disclosures Act 26 of 2000
p.000009: • Protection of Personal Information Act 4 of 2013
p.000009: • Provincial Nature Conservation Acts or Ordinances
p.000009:
p.000009:
p.000009:
p.000009: 4 Note this list is not exhaustive.
p.000009: 5Ratified by South Africa on 11 May 2011. For further information, see http://www.cbd.int/abs/
p.000009:
p.000009: Ethics in Health Research 2nd edition
p.000011: 11
p.000011:
p.000011: • Rules Relating to the Practising of the Para-Veterinary Profession of Laboratory Animal Technologist.
p.000011: Department of Agriculture (1997) GN 1445 of 3 October 1997
p.000011: • Rules Relating to the Practising of the Profession of Veterinary Nurse. Department of Agriculture (1991) GN 1065
p.000011: of 17 May 1991
p.000011: • Societies for the Prevention of Cruelty to Animals Act 169 of 1993
p.000011: • Sterilization Act 44 of 1998
p.000011: • Veterinary and Para-veterinary Professions Act 19 of 1982
p.000011:
p.000011: 1.4 Research with humans
p.000011:
p.000011: 1.4.1 The National Health Act (NHAs 72(6)(c)) gives authority to the NHREC for setting norms and
p.000011: standards for health and health-related research that involves humans.
p.000011: 1.4.2 Every organisation/institution, health agency and health establishment at which health and health-related
p.000011: research involving human participants is conducted, must establish or have access to a registered Human Research
p.000011: Ethics Committee (REC) (NHA s 73(1)).
p.000011: 1.4.3 RECs that review research involving human participants must register with the NHREC (NHA s 73(1)).
p.000011: 1.5 Research using animals
p.000011:
p.000011: 1.5.1 The National Health Act (NHA) gives authority to the NHREC for setting norms and standards for health research
p.000011: that uses animals (NHA s 72(6)(c)).
p.000011: 1.5.2 Every organisation/institution, health agency and health establishment at which health research using animals
p.000011: is conducted, must establish or have access to a registered Animal Research Ethics Committee (AREC) (NHA s 73(1)).
p.000011: 1.5.3 ARECs that review health research using animals must register with the NHREC (NHA s 73(1)).
p.000011: 1.5.4 The South African Bureau of Standards’ South African National Standard (SANS 10386:2008 or latest
p.000011: version) for the Care and Use of Animals for Scientific Purposes and MRC Guidelines on Ethics for Medical Research: Use
p.000011: of Animals in Research and Training (2004) provide the minimum benchmark to ensure ethical and humane care of animals
p.000011: used for scientific purposes as well as for teaching activities, in line with the fundamental principles of
p.000011: Replace, Reduce and Refine animal use. ARECs and researchers are expected to familiarise themselves
p.000011: with the content of both documents in addition to these Guidelines, as appropriate.
p.000011: 1.5.5 International and foreign codes for animal research include the Directive 2010/63/EU of the European
p.000011: Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes
p.000011: and the Australian Code for the Care and Use of Animals for Scientific Purposes (8th Edition) 2013.
p.000011:
...
p.000031: Note that if the proposed research holds out more than a minimal risk of harm, there must be a
p.000031: compelling justification for why orphans should be included as participants, e.g. the research focus has particular
p.000031: relevance for OVC and cannot be studied without their enrolment.
p.000031: The parental substitutes should be used in descending order, as listed.
p.000031: i. The minor chooses whether to participate and thus expresses her will AFTER
p.000031:
p.000031: 27 This pragmatic guidance is provided to temper the chilling effect of a literal interpretation of s 71 of the
p.000031: National Health Act 61 of 2003, which otherwise might prevent important ethical research.
p.000031:
p.000031: Ethics in Health Research 2nd edition
p.000033: 33
p.000033:
p.000033: ii. The parent gives assistance with understanding (so the minor makes an informed choice)
p.000033: iii. If no parent, then guardian: either court-appointed OR as indicated by the parent in a Will (s 27 Children’s Act)
p.000033: iv. If no guardian, then foster parent (per order of Children’s Court) (Note that social workers should
p.000033: request that the authority to give permission should be included expressly in the court order authorising
p.000033: foster care)28
p.000033: v. If no foster parent (per iv. above), then caregiver (s 1 Children’s Act: defined as ‘…any person
p.000033: other than a parent or guardian, who factually cares for a child and includes – a) a foster parent; b) a person who
p.000033: cares for the child with the implied or express consent of a parent or guardian of the child; c) a person who cares for
p.000033: the child whilst the child is in temporary safe care; d) the person at the head of a child and youth care centre where
p.000033: a child has been placed; e) the person at the head of a shelter; f) a child and youth care worker who cares
...
p.000039: • their participation is indispensable to the research
p.000039: • the research cannot be conducted with non-prisoners
p.000039: • the research concerns a problem of relevance to prisoners
p.000039: • sound informed consent processes can be ensured
p.000039: • engagement with relevant role players about the proposed research has occurred.
p.000039: In the case of minor prisoners, the limitations and restrictions on independent consent must be remembered. In general
p.000039: terms, it is unlikely that independent consent by the minors will be justifiable.
p.000039: 3.2.9 Collectivities i.e. persons participating in research as groups
p.000039:
p.000039: ‘Collectivity’ is a term used to distinguish some distinct groups from informal communities, commercial or social
p.000039: groups. Collectivities are groups distinguished by
p.000039: • common beliefs, values, social structures and other features that identify them as a separate group
p.000039: • customary collective decision-making according to tradition and beliefs
p.000039: • the custom that leaders express a collective view
p.000039: • members of the collectivity being aware of common activities and common interests. Research involves a
p.000039: collectivity when
p.000039: • property or information private to the group as a whole is studied or used
p.000039: • permission of people occupying positions of authority, whether formal or informal, is required
p.000039: • participation of members acknowledged as representatives is involved. Research involving collectivities should
p.000039: include measures to ensure
p.000039: • dispute resolution mechanisms for anticipated or actual disagreements between the researcher and the collectivity
p.000039: • respectful negotiation with the collectivity or its leaders
p.000039: • permission is sought from appropriate representatives of the collectivity to approach individual participants
p.000039: • an informed consent process for individual participants
p.000039: • fair distribution of research-related benefits and harms among affected collaborating parties
p.000039: • agreement about ownership of data and rights of publication of research findings;
p.000039: • agreement about feedback to the collectivity about the findings.
p.000039:
p.000039: 3.3 Data and biological materials for research purposes
p.000039:
p.000039: 3.3.1 Introduction
p.000039: Researchers often wish to collect data, including images, or human biological materials from participants for
p.000039: research purposes or to use previously collected diagnostic or therapeutic biological material for
p.000039: research. Once collected, biological material may be stored in repositories as a future research resource (see
p.000039: 3.5.2 below). Although data and biological
p.000039:
p.000039: Ethics in Health Research 2nd edition
p.000041: 41
p.000041:
p.000041: material are separate from their source (e.g. a particular patient), they symbolise that person. Hence,
...
p.000059: • declarations regarding confidentiality and conflict of interest for each meeting.
p.000059: ii. Ethical issues in research often require case-by-case deliberation. The ethics review process should not be
p.000059: mechanical. Although consistency of review outcomes for similar studies may be desirable, it is not always
p.000059: possible or appropriate in light of the details of an application.
p.000059: iii. REC members and researchers should be encouraged to
p.000059: • be mindful of the basic ethical principles that should inform planning, designing and conducting health research
p.000059: • be open-minded and not allow personal biases to cloud their application of these guidelines
p.000059: • accept that consensus about how ethical principles should be balanced is difficult to achieve and that divergence
p.000059: enriches deliberations
p.000059: • be mindful of the influence that the context (social, cultural and economic) has on how to prioritise principles
p.000059: • be deliberate, reflective and thoughtful in discussions about how to balance ethical considerations.
p.000059: iv. SOPs should be regarded as living documents, to be reviewed, revised and updated at regular intervals.
p.000059: v. REC members and researchers should ensure that they use the most recent versions of documents.
p.000059: 4.5.1 Written Standard Operating Procedures.
p.000059: SOPs should cover topics including but not limited to
p.000059: • ethical and regulatory requirements for research with humans and research using animals
p.000059: • definitions as appropriate
p.000059: • institutional lines of authority and responsibility
p.000059: • REC activities and processes, including frequency of meetings, preparation of agenda and minutes (minutes should
p.000059: be detailed and include dissenting views), registers for meetings, expectations and time-lines for reviewers
p.000059:
p.000059: Ethics in Health Research 2nd edition
p.000061: 61
p.000061:
p.000061: • guidance and specification of REC procedures required for expedited and full REC review; if the REC
p.000061: reviews US federally funded research proposals, the procedures must comply with the US Common Rule (45 CFR 46)
p.000061: • quorum requirements
p.000061: • decisional analysis guidance
p.000061: • conflict of interest and of confidentiality regarding researchers
p.000061: • the protocol review process
p.000061: • continuing review and re-certification procedures
p.000061: • protocol amendment procedures
p.000061: • adverse events and unanticipated problems
p.000061: • protocol deviations and protocol violations
p.000061: • non-compliance consequences
p.000061: • suspension and termination
p.000061: • compliance checks and audits
p.000061: • informed consent
p.000061: • privacy and confidentiality regarding participants and their health care information
p.000061: • research involving minors
p.000061: • research involving vulnerable persons
p.000061: • data collection and storage
p.000061: • biological materials collection and storage
p.000061: • databases, registries and repositories
p.000061: • complaints procedures
...
p.000079: Repository– a collection, storage and distribution system for human biological materials for research purposes
p.000079: including blood, urine, faeces, bone marrow, cell aspirates, diagnostic specimens, pathology specimens and
p.000079: so on. Usually demographic and medical information about the donors is included in the repository as are
p.000079: codes that link the material to the donors
p.000079: Research – includes a range of activities conducted by many different disciplines that may use different
p.000079: methodologies and explanatory frameworks to extend knowledge through disciplined inquiry or systematic
p.000079: investigation
p.000079: Risk – function of the magnitude of harm and the probability that it will occur
p.000079: Risk of harm to likelihood of benefit ratio – analysis of whether the risk of harm implied is justifiable in light of
p.000079: the likelihood of benefit
p.000079: Therapeutic intervention –interventions directed towards direct health-related benefit for a participant (NHA Reg 135)
p.000079: Tiered consent – donor permits use of biological materials for current study; and chooses whether to permit storage
p.000079: for future use, sample and data sharing.
p.000079: Undue influence – effect of an unequal power relationship on voluntariness; may occur when recruitment of
p.000079: participants is done by authority figure
p.000079: Virtual Repository– a digitised system that manages distributed bar-coded electronic versions of material,
p.000079: data or images through shared data systems
p.000079: Vulnerability – diminished ability to fully safeguard one’s own interests in the context of a specific research
p.000079: project; may be caused by limited capacity or limited access to social goods like rights, opportunities and power
p.000079:
p.000079: 80 Ethics in Health Research 2nd edition
p.000079:
p.000079:
p.000079:
p.000079: APPENDIX 2
p.000079:
p.000079: Resources
p.000079:
p.000079: Online training opportunities
p.000079:
p.000079: These links are to FREE online training in research ethics and some also do Responsible Conduct of Research
p.000079: 1. The AMANET (African Malaria Network Trust)
p.000079: http://webcourses.amanet-trust.org/mod/resource/view.php?inpopup=true&id=116
p.000079: The AMANET (African Malaria Network Trust) web-based health research ethics training programme aims at
p.000079: providing the basic understanding in biomedical research ethics. On the premise of scarcity of resources and
p.000079: opportunities for such training for Africans, this effort hopes to provide this service to the many African members of
...
General/Other / Undue Influence
Searching for indicator undue influence:
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p.000023: research proposal is ethical. All the other elements should also stand up to ethical scrutiny.
p.000023: An important element of making an informed choice is the nature and quality of information made available to the
p.000023: potential participant. See below for expectations regarding information disclosure.
p.000023: Adults, i.e. persons over the age of 18 years, may make independent decisions. However, they may wish to consult with
p.000023: family members or others in keeping with personal preference or cultural practices. Consequently, the process should
p.000023: permit sufficient time for consultation between the recruitment approach and the point of decision-making. No person
p.000023: should be required to make an immediate decision. The informed consent process for adults with diminished
p.000023: or no decision-making capacity (factually incapacitated) and for minors (legally incapacitated) is described at
p.000023: 3.2.4.3 and 3.2.4.2 respectively.
p.000023: RECs should assess the proposed process for informed consent as well as the information that potential participants
p.000023: will be given and the measures to facilitate understanding. Considerations for assessment include whether
p.000023: • the setting will
p.000023: o minimise the possibility of undue influence
p.000023: o be sufficiently private and appropriate
p.000023:
p.000023: 16 ‘Biometrics means a technique of personal identification that is based on physical, physiological or behaviour
p.000023: characterisation including blood typing, fingerprinting, DNA analysis, retinal scanning and voice recognition’ (s 1 of
p.000023: the Act).
p.000023:
p.000023: Ethics in Health Research 2nd edition
p.000025: 25
p.000025:
p.000025: • the person who will conduct the process
p.000025: o will be appropriately trained, independent and bias-free
p.000025: • the text
p.000025: o is in plain language and appropriate to the participants’ level of understanding17
p.000025: o is free of jargon and unexplained acronyms
p.000025: o is clear and explains technical terminology e.g. randomisation
p.000025: o is translated into language(s) appropriate to the context
p.000025: o states that participants may contact the REC at the contact details provided if they have queries or complaints
p.000025: about their rights and welfare as research participants
p.000025: o states that participants may contact the researcher at the contact details provided if they have queries about the
p.000025: research project
p.000025: o conforms to the proposal
p.000025: • the information explains
p.000025: o that the person is being asked to participate in research
p.000025: o that the choice whether to participate is voluntary
p.000025: o that refusal to participate will not be penalised
p.000025: o that choosing to participate can be reversed, i.e. the person may decide to terminate participation at
...
p.000075: or old medicines, medical devices and/or treatment options, using human participants. (South African Clinical Trials
p.000075: Registration http://www.sanctr.gov.za/Resources/Whatisaclinicaltrial/tabid/175/Default.aspx);
p.000075:
p.000075: Ethics in Health Research 2nd edition
p.000077: 77
p.000077:
p.000077: the Ottawa Statement defines ‘trial’ as a prospective controlled or uncontrolled research study evaluating
p.000077: the effects of one or more health-related interventions related to prevention, health promotion,
p.000077: screening, diagnosis, treatment, rehabilitation, or organization and financing of care.
p.000077: ‘Intervention’ refers to a deliberate act applied to an individual or group of individuals. Health-related
p.000077: interventions include but are not limited to the use of pharmaceuticals, biological products, surgery,
p.000077: procedures, radiation, devices, education, counseling, behaviour change, complementary health modalities, and
p.000077: management or economic policies. The word ‘medicine’ includes medicines used to treat diseases (therapeutic
p.000077: medicines), to prevent diseases (prophylactic medicines, e.g. vaccines), and those used in special
p.000077: investigations (diagnostic medicines, e.g. medicines used during special X-ray examinations to map out
p.000077: kidneys).
p.000077: Coded data or materials– identifiers are substituted by a number, symbol or other method to provide a code; a key to
p.000077: the code exists so that the specimen can be linked to its original source
p.000077: Coercion – extreme form of undue influence, involving a threat of harm or punishment for failure to participate in
p.000077: research; see UndueXinfluence
p.000077: Collaborative research – involves co-operation of researchers, institutions, organizations or communities, each
p.000077: contributing distinct expertise, characterized by respectful relationships
p.000077: Community – a group of people with a shared identity or interest that has the capacity to act or express itself as a
p.000077: collective; it may be territorial, organizational or a community of interest
p.000077: Community engagement – a process that establishes an interaction between researchers and a community regarding a
p.000077: research project; it signifies the intention of forming a collaborative relationship; the degree of
p.000077: collaboration may vary depending on the circumstances
p.000077: Confidentiality – the responsibility to protect information entrusted to researchers for research purposes
p.000077: from unauthorized access, use, disclosure, modification, loss or theft
p.000077: Conflict of interest – incompatibility of duties, responsibilities or interests (personal or professional)
p.000077: of a person or an institution as regards ethical conduct of research so that one cannot be fulfilled without
p.000077: compromising another
p.000077: Consent – indication of agreement to participate in research, based on adequate knowledge and understanding of relevant
p.000077: information, and freely given
p.000077: Database– a collection of information including images (data) arranged to facilitate swift search and
p.000077: retrieval
...
General/Other / cultural difference
Searching for indicator culturally:
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p.000057: considerations that should be taken into account and adhered to, as well as provide information or references to
p.000057: additional materials to assist with the process of review and application for ethics approval. The ToR and SOPs should
p.000057: be accessible to the institutional members, researchers and other interested persons, usually via internet or
p.000057: intranet sites. (See also 4.5.1.)
p.000057: 4.3.2 Code of Conduct
p.000057: The institution should have a Code of Conduct for REC members, which details conduct and integrity expectations of
p.000057: REC members, including regular and punctual attendance at meetings, diligent performance of
p.000057: responsibilities, maintenance of confidentiality, and consideration of potential conflicts of interest.
p.000057:
p.000057:
p.000057: 50Also known as Research Ethics Policy in some institutions. Note that usually an Institutional Research Ethics Policy
p.000057: is the institutional document that authorizes the creation of an REC & SOPs, rather than the SOPs themselves.
p.000057:
p.000057: 58 Ethics in Health Research 2nd edition
p.000057:
p.000057:
p.000057: 4.4 Membership
p.000057:
p.000057: RECs should be independent, multi-disciplinary, multi-sectoral and pluralistic. 51 In general terms, membership
p.000057: should include
p.000057: • as many disciplines, sectors and professions as possible, appropriate to the remit of the particular REC
p.000057: • members drawn not only from the senior ranks
p.000057: • ethnically and culturally diverse members and an appropriate mix of males and females
p.000057: • lay persons, preferably from communities in which research is conducted
p.000057: • researchers who do not do human participant research and
p.000057: • members from other disciplines.
p.000057: Collectively, the committee should include sufficient members with the necessary qualifications and
p.000057: experience, including research ethics training, to be able to review and evaluate the science, the health
p.000057: aspects, the ethics of the proposed research, as well as to assess the anticipated layperson’s perspective. REC members
p.000057: and researchers are expected to familiarise themselves with the institutional documentation as well as
p.000057: national and international research ethics guidelines and should have documented proof of such
p.000057: familiarity.
p.000057: Training of all REC members is critical, especially for RECs that review high risk research. This means that training
p.000057: and refresher courses should be available; that members should be expected, at least once during a term of
p.000057: appointment, to produce evidence of recent training; and that membership should be managed to ensure an optimal mix of
p.000057: experienced and new members to promote good succession planning. The term of office of members may vary
p.000057: according to institutional requirements. Consideration should be given to succession planning and accumulation of
p.000057: institutional memory for RECs. A reasonable term of office is between two and four years, renewable twice, after which
...
General/Other / whistleblower
Searching for indicator whistleblower:
(return to top)
p.000059: • REC activities and processes, including frequency of meetings, preparation of agenda and minutes (minutes should
p.000059: be detailed and include dissenting views), registers for meetings, expectations and time-lines for reviewers
p.000059:
p.000059: Ethics in Health Research 2nd edition
p.000061: 61
p.000061:
p.000061: • guidance and specification of REC procedures required for expedited and full REC review; if the REC
p.000061: reviews US federally funded research proposals, the procedures must comply with the US Common Rule (45 CFR 46)
p.000061: • quorum requirements
p.000061: • decisional analysis guidance
p.000061: • conflict of interest and of confidentiality regarding researchers
p.000061: • the protocol review process
p.000061: • continuing review and re-certification procedures
p.000061: • protocol amendment procedures
p.000061: • adverse events and unanticipated problems
p.000061: • protocol deviations and protocol violations
p.000061: • non-compliance consequences
p.000061: • suspension and termination
p.000061: • compliance checks and audits
p.000061: • informed consent
p.000061: • privacy and confidentiality regarding participants and their health care information
p.000061: • research involving minors
p.000061: • research involving vulnerable persons
p.000061: • data collection and storage
p.000061: • biological materials collection and storage
p.000061: • databases, registries and repositories
p.000061: • complaints procedures
p.000061: • whistleblower protection
p.000061:
p.000061: 4.5.1.1 Applications for ethics review
p.000061: i. Each research proposal should include a description of the ethical considerations implicated in the
p.000061: research.
p.000061: ii. The protocol should reflect adequate consideration of participants’ welfare, rights, beliefs,
p.000061: perceptions, customs and cultural heritage.
p.000061: iii. All documents and other material to be used to inform potential participants should be included in the ethics
p.000061: review application, such as information sheets, consent forms, questionnaires, advertisements, videos, dramatisations
p.000061: and letters.
p.000061: iv. Researchers should ensure that plain language adapted to anticipated literacy levels is used in the participant
p.000061: documentation. An indication of the readability level should be included (see also 3.1.9).
p.000061: v. Where research is to be conducted in community settings, evidence of consultation and plans for ongoing
p.000061: involvement should be included.
p.000061: vi. Animal research protocols should explain comprehensively how the welfare interests of the animals will be
p.000061: attended to.
p.000061: vii. Animal research protocols should include monitoring schedules listing the responsible persons and their
p.000061: contact numbers, the schedule and indicators for analgesia delivery and so forth.
...
Orphaned Trigger Words
p.002015: broad spectrum of health and health-related research. To ensure that South Africa’s people are fairly and
p.002015: respectfully treated by researchers and that all research conducted in the country stands up to ethical scrutiny, South
p.002015: Africa’s research ethics systems and infrastructure are regularly updated and strengthened. This assists with the
p.002015: project of ensuring that research is conducted in accordance with the highest ethical norms and standards.
p.002015: The core ethical principles – respect, scientific merit and integrity, distributive justice and
p.002015: beneficence– apply to all forms of research that involve living persons and use of animals, thereby placing their
p.002015: safety, welfare and other interests as paramount. These principles apply also to research with human biological
p.002015: materials and data collected from living or deceased persons.
p.002015: These Guidelines, entitled ‘Ethics in Health Research: Principles, Processes and Structures’, are the second edition
p.002015: and replace the 2004 edition. They contain the national policy for conducting research responsibly and
p.002015: ethically, tailored to South Africa’s needs as appropriate.
p.002015: • They describe the minimum national benchmark of norms and standards
p.002015: • They provide detailed explication of the process of ethics review and focused guidance about specific
p.002015: topics and research methodologies
p.002015: • They outline the expectations and standards for Research Ethics Committees (RECs) and Animal Research Ethics
p.002015: Committees and give guidance about standard operating procedures
p.002015: • They describe the research ethics infrastructure and regulatory framework in South Africa
p.002015: These Guidelines are intended for use by researchers who involve human participants in their research or who use
p.002015: animals, RECs, health care practitioners, health facility administrators, policy makers in government departments, and
p.002015: community representatives. This is consistent with the understanding that research means a systematic
p.002015: collection and analysis of new information undertaken with the goal of producing generalisable knowledge
p.002015: or improved understanding of the human condition in its environment or context.
p.002015: Thank you to all who participated formally or informally in writing and producing this new edition. Your work
p.002015: contributes significantly to the enhancement of dignity for all South Africa’s people.
p.002015:
p.002015:
p.002015:
p.002015:
p.002015:
p.002015:
p.002015: DR AARON MOTSOALEDI, MP
p.002015: MINISTER OF HEALTH DATE: 1 March 2015
p.002015:
p.002015: Ethics in Health Research 2nd edition
p.000003: 3
p.000003:
p.000003:
p.000003:
p.000003: ACKNOWLEDGEMENTS
p.000003: These guidelines ‘Ethics in Health Research: Principles, Processes and Structures – 2015’ provide an
p.000003: updated and strengthened guide to ensure that, in South Africa, research is conducted responsibly and
p.000003: ethically. Mandated by Section 72 of the National Health Act 61 of 2003, the National Health Research Ethics
p.000003: Council (NHREC) tasked its Working Group for Norms and Standards to produce a revision of the first edition of
p.000003: the Guidelines issued in 2004.
...
p.000067: 67
p.000067:
p.000067: 5.1 Introduction
p.000067: 5.2 National Health Research Ethics Council
p.000067: 5.3 Research Ethics committees
p.000067:
p.000067: Ethics in Health Research 2nd edition
p.000005: 5
p.000005: 5.4 Registration and audit of committees
p.000005: 5.5 Statutory entities relevant to research
p.000005: Chapter 6 Qualitative research 73
p.000005:
p.000005: 6.1 Introduction
p.000005: 6.2 Nature of qualitative research
p.000005: 6.3 Methodological approaches and requirements
p.000005: 6.4 Approach to ethics review of qualitative research
p.000005: 6.5 Criteria for review process
p.000005: APPENDIX 1 Glossary 76
p.000005: APPENDIX 2 Resources 80
p.000005: APPENDIX 3 Templates 83
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: ACKNOWLEDGEMENTS
p.000005: In addition to the National Health Act, 61 of 2003 (NHA), these Guidelines has drawn on the Australian National
p.000005: Statement on Ethical Conduct in Human Research (2007); the Canadian Tri-Council Policy Statement: Ethical Conduct
p.000005: for Research Involving Humans (2010); the Council of Europe Steering Committee on Bioethics: Guide for
p.000005: Research Ethics Committee Members (2011); the Council for International Organizations of Medical Sciences
p.000005: (CIOMS) (2002); the ICH Guidelines; the Nuffield Council on Bioethics: the Ethics of Research Related to Healthcare in
p.000005: Developing Countries (1999); the World Medical Association: Declaration of Helsinki (2013); the World Health
p.000005: Organization Operational Guidelines for Ethics Committees that review Biomedical Research TDR/PRD/ETHICS/2000; the
p.000005: World Health Organization Standards and Operational Guidance for Ethics Review of Health-Related Research
p.000005: with Human Participants (2011); the Montreal Statement (2013); Singapore Statement (2010); research ethics
p.000005: documentation and guidance of the University of Cape Town Faculty of Health Sciences Human Research Ethics
p.000005: Committee
p.000005:
p.000005: http://www.health.uct.ac.za/research/humanethics/sop/.; the University of KwaZulu-Natal at
p.000005: http://research.ukzn.ac.za/Research-Ethics/Overview.aspx; the University of Pretoria at
p.000005: http://web.up.ac.za/default.asp?ipkCategoryID=2875&subid=2875&ipklookid=8&parentid=; the University of the
p.000005: Witwatersrand at http://www.wits.ac.za/academic/researchsupport/19111/code_of_ethics.html.
p.000005:
p.000005: It also draws on the South African Medical Research Council (MRC) Guidelines on Ethics for Medical Research: Use of
p.000005: Animals in Research and Training (2004); The South African Bureau of Standards’ South African National Standard (SANS
p.000005: 10386:2008 or latest version) for the Care and Use of Animals for Scientific Purposes.
p.000005:
p.000005: See Appendix 2 for bibliographic details.
p.000005:
p.000005: 6 Ethics in Health Research 2nd edition
p.000005:
p.000005:
p.000005: Chapter 1
p.000005:
p.000005: ETHICS IN RESEARCH
p.000005:
p.000005: Contents
p.000005:
p.000005:
p.000005: 1.1 Introduction p 6
...
p.000011: 73(2)(a)).
p.000011: 1.6.4 RECs must ensure that research proposals stand up to scientific and ethical scrutiny appropriate to the
p.000011: disciplines concerned.
p.000011: 1.6.5 RECs must review research proposals and protocols prospectively to ensure that they meet the accepted ethical
p.000011: norms and standards before research commences, using these Guidelines as a minimum benchmark (NHA s 73(2)(b)).
p.000011: 1.6.6 The review process entails an independent and objective assessment of the potential effect of the proposed
p.000011: research on potential participants and on the general day-to- day functioning of the infrastructure that provides the
p.000011: site or context for the research. Ethics review is not about obstructing scientific progress or innovative
p.000011: research. Promoting ethical conduct of research entails co-operation between RECs and researchers to
p.000011: ensure a comprehensive and frank assessment of the ethical implications of proposals so that
p.000011: participants (and researchers) can be protected appropriately.6
p.000011: 1.6.7 The review must ensure that ethical and scientific standards are maintained to
p.000011: • protect participants from harm by weighing the risks of harm against the likelihood of benefit by
p.000011: minimising risks of harm to the extent possible and then by balancing the risk of harm relative to the
p.000011: likelihood of benefit
p.000011: • protect the safety and welfare of animals used in research by ensuring close adherence to the expected benchmarks
p.000011: • hold researchers accountable for the research activities
p.000011: • promote important social and ethical values.
p.000011: 1.6.8 In weighing risk of harm against likelihood of benefit, the analysis is concerned not only with current
p.000011: participants or research animals themselves but also with societal interests and future hypothetical beneficiaries.
p.000011: 1.6.9 Retrospective review and approval or clearance is not permitted.
p.000011:
p.000011: 1.7 Glossary and resources
p.000011:
p.000011: 1.7.1 A Glossary of terms used in these Guidelines appears in Appendix 1.
p.000011: 1.7.2 A list of resources appears in Appendix 2.
p.000011: 1.7.3 Templates appear in Appendix 3.
p.000011:
p.000011: 6 Wassenaar ‘Ethical issues in social science research’ in Terre Blanch, Durrheim & Painter (2006) 60-79.
p.000011:
p.000011: Ethics in Health Research 2nd edition
p.000013: 13
p.000013:
p.000013: 1.8 Purpose and status of these Guidelines
p.000013:
p.000013: 1.8.1 These Guidelines is intended to provide the minimum national benchmark of norms and standards for conducting
p.000013: responsible and ethical research.
p.000013: 1.8.2 The minimum benchmark for research that uses animals is found in the South African Bureau of Standards SANS
p.000013: 10386:2008 or later version. These Guidelines endorses the ethical principles laid down in the South African
p.000013: Bureau of Standards SANS 10386:2008 (or later version) and MRC Guidelines on Ethics for Medical Research:
p.000013: Use of Animals in Research and Training (2004).
p.000013: 1.8.3 These Guidelines further endorses the ethical principles laid down in
p.000013: • The Belmont Report: www.edu/irb/pdfs/BelmontReport.pdf
p.000013: • Declaration of Helsinki 2013: www.wma.net/e/policy/pdf/17c.pdf
...
p.000013: • The Singapore Statement on Research Integrity www.singaporestatement.org
p.000013: • Human Heredity and Health in Africa (H3Africa) Initiative http://h3africa.org/
p.000013: 1.8.3 This document should be read in conjunction with other guidelines such as the DoH Guideline for Good Practice
p.000013: in the Conduct of Clinical Trials with Human Participants in South Africa (2006); the Human Sciences Research Council
p.000013: Research (HSRC) Ethics Guideline; and international guidelines such as the Declaration of Helsinki (2013); the Council
p.000013: for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical
p.000013: Research involving Human Subjects (2002); the ICH Harmonised Tripartite Guideline: Guideline for Good Clinical
p.000013: Practice E6 (R1) 1996; the ICH Harmonised Tripartite Guideline: Clinical Investigation of Medicinal Products in the
p.000013: Pediatric Population E11 2000.
p.000013: 1.9 Structure of these Guidelines
p.000013:
p.000013: 1.9.1 Chapter 2 discusses the principles that inform the procedures and decision-making processes for
p.000013: ethics review of research proposals.
p.000013: 1.9.2 Chapter 3 provides detailed explication of the process of ethics review, and focused guidance about specific
p.000013: human participants, specific types of research or specific research contexts. Discussion is provided also
p.000013: about storage and use of biological samples and related data for research purposes, human genetic
p.000013: research and insurance against trial-related harm.
p.000013: 1.9.3 Chapter 4 outlines the expectations and standards for RECs; and describes standard operating procedures for
p.000013: ethics committees as well as the responsibilities of researchers.
p.000013: 1.9.4 Chapter 5 describes the ‘health research’ ethics infrastructure for South Africa.
p.000013:
p.000013: 14 Ethics in Health Research 2nd edition
p.000013:
p.000013:
p.000013:
p.000013: Chapter 2
p.000013:
p.000013: GUIDING PRINCIPLES FOR ETHICAL RESEARCH
p.000013:
p.000013: Contents
p.000013:
p.000013:
p.000013: 2.1 Ethical principles
p.000013: p 14
p.000013:
p.000013: 2.2 Role of ethical principles
p.000015: 15
p.000015: 2.3 Key norms & standards
p.000015: 15
p.000015: 2.3.1 Relevance & value
p.000015: 15
p.000015: 2.3.2 Scientific integrity
p.000016: 16
p.000016: 2.3.3 Role player engagement 16
p.000016: 2.3.4 Favourable risk-benefit ratio
p.000016: 16
p.000016: 2.3.5 Fair selection of participants
p.000016: 16
p.000016: 2.3.6 Informed consent
p.000017: 17
p.000017: 2.3.7 Ongoing respect for enrolled participants 17
p.000017: 2.3.8 Researcher competence & expertise 17
p.000017:
p.000017: This chapter sets out the broad principles underpinning research that inform the norms and standards, as well as the
p.000017: procedures and decision-making processes for ethics review in all disciplines of research proposals to involve human
p.000017: participants.
p.000017: 2.1 Ethical principles
p.000017:
p.000017: The broad ethical principles are
p.000017: • beneficence and non-maleficence
p.000017: This refers to the ethical obligation to maximize benefit and to minimize harm, and requires that the risks of harm
p.000017: posed by the research must be reasonable in light of anticipated benefits; that research design must be
p.000017: sound, and that researchers must be competent to carry out the proposed research activities. Beneficence prohibits
p.000017: deliberate infliction of harm on persons; sometimes expressed as a separate principle: non-maleficence (do no
p.000017: harm). Research that involves human participants should seek to improve the human condition. If the research cannot do
p.000017: this, then it is unlikely to be ethical.
p.000017: • distributive justice (equality)
p.000017: This means that there should be a fair balance of risks and benefits amongst all role-players involved in research,
p.000017: including participants, participating communities and the broader South African society. In this way the principle of
p.000017: equality is expressed in the research context. ‘No segment of the population should be unduly burdened by the harms of
p.000017: research or denied the benefits of knowledge derived from it.’7 There should be a reasonable likelihood that the
p.000017:
p.000017: 7 Tri-Council Policy Statement (Canada) 2010, 10.
p.000017:
...
p.000019: 3.5 Special topics
p.000049: 49
p.000049: 3.5.1 Novel, innovative & unproven therapies
p.000049: 49
p.000049: 3.5.2 Data bases, registries & repositories
p.000051: 51
p.000051: 3.5.3 Insurance against research-related bodily injury 53
p.000051:
p.000051: This chapter describes the substantive norms and the operational processes and procedures that Research Ethics
p.000051: Committees (RECs) are expected to adhere to when reviewing and engaging in decision-making about the
p.000051: ethics of research proposals. In what follows, the minimum benchmark for promoting responsible, ethical and safe
p.000051: research involving human participants is described and discussed.
p.000051: Note that while the norms and procedures apply also to research with animals as appropriate, this chapter is aimed
p.000051: more at research with human participants. Details regarding norms and operational processes for research using
p.000051: animals may be found in The care and use of animals for scientific purposes SANS 10386:2008 or its
p.000051: successor.
p.000051: The aim of this chapter is to
p.000051: • provide descriptions of best ethical practices in research involving human participants;
p.000051: • guide compliance with national and international ethical and regulatory requirements;
p.000051: • outline a framework within which South Africa-based research can be evaluated and conducted with confidence; and
p.000051: • facilitate consistent deliberative processes and decision-making about ethical issues in research involving
p.000051: participants or animals.
p.000051: The chapter is organized into sections that address, first, the substantive norms that inform ethics review; and
p.000051: secondly, the processes and procedures that ensure procedural and administrative consistency and
p.000051: transparency. Thirdly, guidance is provided about specific types of research or groups of research participants
p.000051: that require meticulous treatment in light of particular sensitivities or vulnerabilities. Finally, a series of
p.000051: special topics is discussed, including biological materials, genetic research issues and insurance against
p.000051: research-related bodily injury.
p.000051: 3.1 Ethical basis for decision-making in the review process
p.000051:
p.000051: RECs should use the principles outlined in Chapter 2 and articulated in international human rights and research
p.000051: ethics guidance documents as the basis for evaluating research proposals. RECs should make clear which specific
p.000051: ethical guidelines are relied on in making their decisions; the guidelines should be readily accessible to
p.000051: researchers and other interested persons, including the general public.
p.000051: Key criteria for the review and evaluation processes include
p.000051:
p.000051: 3.1.1 Scientific design, aims and objectives
p.000051: The ethical implications of the methodology and design of a research proposal must be reviewed. This
p.000051: means that the ethical acceptability of the chosen methodology and the design must be assessed as well
p.000051: as the relevant disciplinary scholarly standards, where appropriate. Sound and valid scientific methods must be
p.000051: evidenced by prior scientific review or the REC must engage specifically in scientific review that shows not
p.000051: only whether the
p.000051:
p.000051: 20 Ethics in Health Research 2nd edition
p.000051:
p.000051:
p.000051: selected design and methodology are sound but also that the study is worth doing. In other words, that the stated
p.000051: aims and objectives are achievable and will likely produce valid outcomes. In the case of qualitative
p.000051: research, the theoretical paradigm and methodology chosen must be assessed for suitability in light of the stated
p.000051: aims and objectives (see also chapter 6). The ethical implications of the selected design, methodology and research
p.000051: plan must also be analysed. Even if scientific review has occurred, the REC must assess how the research will be
p.000051: conducted, whether the researchers are suitably qualified, that adequate monitoring and safety measures are
p.000051: in place and achievable, that the site is suitably resourced, and so forth.
p.000051: Scholarly disciplines and fields of research vary considerably in regard to their traditions for scholarly review,
p.000051: including the stage at which the review takes place. These disciplinary variations must be taken into account
p.000051: by RECs. Duplication of scholarly peer review should be avoided if possible. To this end, researchers should
p.000051: provide clear evidence of previous scholarly assessments and the outcome where appropriate. RECs
p.000051: may request full documentation of scholarly reviews.
p.000051: Note that a risk of harm is unlikely to be justifiable if the research lacks scientific or scholarly merit.
p.000051: 3.1.2 Inclusion and exclusion criteria
p.000051: The selection of participants must be appropriate for the research question. The rationale for the planned number of
...
p.000049: elevation of one individual’s claim to more than standard of care necessarily has implication for accountability
p.000049: and responsible decision-making in health facilities.
p.000049: iv. The legal and ethical context
p.000049: Use of locally novel, innovative or unproven therapy involves legal, ethical and practical considerations.
p.000049: The National Health Act 61 of 2003 (NHA) makes provision for ‘health services for experimental or research
p.000049: purposes’ (s 11) and requires that, prior to treatment, the patient must be informed of the experimental or innovative
p.000049: status of the intended treatment.
p.000049: The Act further stipulates that institutional authorities responsible for oversight of treatment must give written
p.000049: permission for the treatment. This means that the decision whether the proposed therapy is experimental treatment or
p.000049: research must precede the decision whether to permit its use for the patient. Where the intended novel therapy is
p.000049: classed as research, the REC must review and approve the research proposal before therapy begins.
p.000049: The Declaration of Helsinki (2013) indicates that ‘unproven interventions in clinical practice’ (par 37) may be used,
p.000049: subject to obtaining expert advice, and appropriate informed consent from the patient. All information about the
p.000049: intervention must be recorded and made publicly available as appropriate. Further, the intervention should
p.000049: subsequently be researched formally so that safety and efficacy can be evaluated.
p.000049: v. Clinical ethics versus research ethics
p.000049: Clinical and research ethics considerations must be distinguished: each form of ethical scrutiny performs
p.000049: an important but different role in academic medicine. Clinical ethics considerations include the likely
p.000049: efficacy and risk of harm of the proposed therapy, intervention or procedure to the patient; the
p.000049: clinical information that supports its use;
p.000049:
p.000049: Ethics in Health Research 2nd edition
p.000051: 51
p.000051:
p.000051: whether a research profile regarding its use exists; the availability and cost implications of the therapy,
p.000051: intervention or procedure; and whether other patients might also benefit from the therapy, intervention or
p.000051: procedure. On the other hand, research ethics considerations require a research study to be planned and
p.000051: conducted in accordance with the highest scientific and ethical standards. This means that prior review of the
p.000051: proposal is conducted by peers and by persons with expertise in research ethics.
p.000051: In the context of considering motivations for novel, innovative or unproven therapy, the roles of the two committees
p.000051: complement each other directly. In other words, whether use of a therapy, intervention or procedure that is not
p.000051: standard of care is clinically ethical may require consideration also of whether a research study is called for in
...
p.000051: that link the material to the donors.
p.000051:
p.000051:
p.000051:
p.000051: 44 The National Health Act 61 of 2003 regulates tissue banks for transplantation purposes in Regulation 182 GG 35099 2
p.000051: March 2012. The focus primarily appears to be on compliance with the Declaration of Istanbul on Organ Trafficking and
p.000051: Transplant Tourism of 2009 and WHO guiding principles. Stem cell banks are regulated by Regulation 183 GG 35099 2 March
p.000051: 2012.
p.000051:
p.000051: 52 Ethics in Health Research 2nd edition
p.000051:
p.000051:
p.000051: ‘Virtual Repository’ means a digitised system that manages distributed bar-coded electronic versions
p.000051: of material, data or images through shared data systems.
p.000051: 3.5.2.2 REC oversight of repositories
p.000051: Institutions and researchers that maintain repositories (biobanks or tissue banks) must have appropriate facilities,
p.000051: equipment, policies and procedures to store human biological materials and data safely and in compliance with
p.000051: accepted standards. Appropriate safeguards, including physical, administrative and technical, must exist to protect
p.000051: against unauthorised handling. Institutional repositories created, maintained and used for present or future
p.000051: research purposes should preferably have prior institutional REC approval. New repositories must have prior REC
p.000051: approval. An existing research database or non-research database may be converted into a repository. RECs should
p.000051: establish procedures to guide this process and to guide use of the repository.45
p.000051: 3.5.2.3 Informed consent
p.000051: The consent documentation for donors should explain clearly
p.000051: • the purpose and nature of a repository, including the specifics for which consent is being sought, how a
p.000051: repository works and the types of research it supports
p.000051: • the conditions and requirements under which data or material will be shared with other researchers
p.000051: • how privacy and confidentiality interests will be protected
p.000051: • the nature and extent of specific risks of harm related to use and storage of material or data, especially if
p.000051: identifiers are retained
p.000051: • in the case of genetic or genomic research, information should be provided about the implications of genetic
p.000051: testing (e.g. paternity determinations, insurance risks, reproduction decisions) and associated
p.000051: confidentiality risks
p.000051: • potential benefits (if any)
p.000051: • where applicable, that material may be
p.000051: o used for future research not yet identified
p.000051: o shared with or transferred to other institutions
p.000051: • the freedom to withdraw consent at any time and to request withdrawal of data and that unused identifiable
p.000051: material be destroyed. If this is not possible, the information should clearly indicate this
p.000051: • information about the length of storage time
p.000051: • when the current consent to use material or data will expire
p.000051: • information about possible secondary use of stored material
p.000051: • information about possible creation of an immortalised cell line based on the specimen
p.000051: • the REC may approve a waiver of consent for secondary use of material or data where no more than
p.000051: minimal risk of harm is likely; and the donor’s rights and welfare interests are unlikely to be adversely affected; and
p.000051: the research cannot be conducted if the waiver were not approved
p.000051:
p.000051:
p.000051:
p.000051: 45See http://health.uct.ac.za/research/humanethics/forms/ FHS020 as an example.
p.000051:
p.000051: Ethics in Health Research 2nd edition
p.000053: 53
p.000053:
p.000053: Where data or materials are shared with researchers in other institutions, the recipient institution
p.000053: should agree to comply with the requirements of the donor institution. Furthermore, use of the data
p.000053: or material should comply also with any additional requirements of the recipient institution. Inter-institutional
p.000053: sharing agreements should be confirmed in writing.46
p.000053: 3.5.3 Insurance against research-related bodily injury47
p.000053: Research participants should not have to bear the financial cost of rectifying harms that occur when something goes
p.000053: wrong during the study. Consequently, it has become standard practice in most countries to encourage or
p.000053: even to require researchers, institutions or sponsors to assure participants that medical costs
p.000053: necessitated as a result of a research- related bodily injury will be paid by an insurer.
p.000053: Note that insurance is not a requirement for all research but, when it is foreseeable that
p.000053: research-related bodily injury might occur, researchers and RECs must give careful consideration to
p.000053: whether insurance cover is available. For example, NIH-sponsored research does not include any insurance cover,
p.000053: which may raise ethical concerns at an institutional level. This is because, were a research-related bodily
p.000053: injury to occur, the necessary consequent medical treatment is likely to have resource allocation implications for
p.000053: the health facility. It is possible also that researcher-initiated studies could lead to research-related
...
p.000053: accordance with these Guidelines.’
p.000053: 3.5.3.2 What a participant agrees to
p.000053: By choosing to participate in research, a participant agrees to the violation of bodily integrity necessitated by
p.000053: receiving investigative medication or undergoing procedures and to the possible risk of harm outlined in the
p.000053: consent documentation. This means that, in law, when one accepts the risk of harm (by consenting to the invasion of
p.000053: bodily integrity), then there is no claim for damages (compensation) if that harm materialises. This is known as
p.000053: voluntary acceptance of risk of harm.
p.000053: Thus, in the absence of an offer to pay for the necessary treatment and an acceptance of the offer by a participant, no
p.000053: claim for payment of treatment costs exists in law. This is why the SA GCP requires a clinical trial sponsor to take
p.000053: out insurance cover: it is morally right that the sponsor (responsible for causing the bodily injury) should assist the
p.000053: participant by paying for the reasonable medical expenses needed to treat the bodily injury that materialises through
p.000053: participation in the research. The possible risk of loss of income or other losses was also foreseeable and
p.000053: agreed to, but no moral argument is made for this voluntary assumption of risk to be subsidised by a sponsor. The same
p.000053: reasoning applies to researcher-initiated studies and an institutional insurance policy (see 3.5.3).
p.000053: In Venter v Roche Products (Pty) Ltd, Mr Venter argued that the sponsor owed more than necessary medical expenses to
p.000053: him. The High Court disagreed, pointing out that what was offered and accepted by the participant was as
p.000053: described in the consent documentation. Venter accepted the risk of harm as described in the consent documentation
p.000053: and during the consent discussions, and accepted the offer of payment of treatment costs, as described, in the event
p.000053: that harm occurred. More recently, in an appeal, the Western Cape High Court has confirmed this view by dismissing
p.000053: Venter’s appeal. These cases show that RECs must pay
p.000053:
p.000053: 49 South African Department of Health (2006) ‘Guidelines for Good Practice in the Conduct of Clinical Trials with
p.000053: Human Participants in South Africa’ 2nd ed (or its successor)
p.000053:
p.000053: Ethics in Health Research 2nd edition
p.000055: 55
p.000055:
p.000055: careful attention to the statements in consent documentation that explain the nature and scope of insurance
p.000055: cover offered.
p.000055: 3.5.3.3 ‘You do not give up your legal rights’
p.000055: The state of affairs described above does not, however, preclude separate litigation, based in negligence, to claim
p.000055: compensation in a South African court for e.g. loss of income. This is what the frequently used statement ‘you do not
p.000055: give up any of your legal rights’ means. If a claim is instituted against either a sponsor company or a
p.000055: researcher, this is an entirely separate matter and has nothing to do with the insurer. The cost of medical
p.000055: treatment of the research-related injury previously paid by the insurer would not form part of the subsequent claim.
p.000055: The argument that pain and suffering, loss of income and other possible claims should be paid for by a sponsor is not
p.000055: sound in South African law. Similarly, professional malpractice (negligence) insurance of health care
p.000055: practitioners is separate from the sponsor’s offer of payment for necessary medical costs to treat a
p.000055: research-related bodily injury. A sponsor’s insurer is unlikely to pay if a health care practitioner has been
p.000055: professionally negligent and caused harm.
p.000055: (See Appendix 3 for insurance cover for research-related injury Template.)
p.000055:
p.000055: 56 Ethics in Health Research 2nd edition
p.000055:
p.000055:
p.000055:
p.000055: Chapter 4
p.000055:
p.000055: RESEARCH ETHICS COMMITTEES
p.000055:
p.000055:
p.000055: Contents
p.000055:
p.000055:
p.000055: 4.1 Introduction
p.000055: p 56
p.000055: 4.2 Legislative framework
p.000057: 57
p.000057: 4.3 Role of Research Ethics Committees 57
p.000057: 4.3.1 Terms of reference & standard operating procedures 57
p.000057: 4.3.2 Code of conduct
p.000057: 57
p.000057: 4.4 Membership
p.000058: 58
p.000058: 4.4.1 Formal membership 58
p.000058: 4.4.2 Expectations of institutions 59
p.000058: 4.5 Standard operating procedures 60
p.000058: 4.5.1 Written standard operating procedures 60
p.000058: 4.6 Compliance reporting to NHREC 65
p.000058:
p.000058: Note REC includes AREC unless otherwise indicated
p.000058: 4.1 Introduction
p.000058:
p.000058: A registered REC must review proposals to do health research. If all standards are met, then the REC may approve the
p.000058: proposal, with or without additional conditions (NHA s 71(1)(a) read with s 73(2)).
p.000058: Independent ethics review by a registered REC is a basic requirement to engender confidence in the ethical
p.000058: character of research. ‘Independent’ means that the members of the REC are encouraged to be objective, informed
p.000058: and to act without fear or favour in their scientific and ethical reviews. Concerns should be raised
p.000058: and deliberated on by the committee; and decisions to impose additional conditions to protect human
...
p.000059: 59
p.000059:
p.000059: 4.4.1.2 Research Ethics Committees
p.000059: All REC members should have documented proof of research ethics training, refreshed at least once within
p.000059: the period of appointment.
p.000059: REC membership should consist of
p.000059: i. at least nine members with a quorum being a simple majority
p.000059: ii. where the number of members is more than 15, the quorum may be 33%
p.000059: iii. at least one layperson
p.000059: iv. at least one member with knowledge of, and current experience in, the professional care, counselling or
p.000059: health-related treatment of people. Such a member might be e.g. a medical practitioner, psychologist, social worker or
p.000059: nurse
p.000059: v. at least one member with professional training and experience in qualitative research methodologies
p.000059: vi. members with professional training and experience in quantitative research methodologies
p.000059: vii. a member with expertise in bio-statistics
p.000059: viii. a member with expertise in research ethics
p.000059: ix. at least one member who is legally qualified
p.000059:
p.000059: 4.4.1.3 Animal Research Ethics Committees
p.000059: Various categories of members are dictated by international and national standards including the SABS SANS 10386 (2008
p.000059: or later version).
p.000059: Four categories of member are required:
p.000059: A: Veterinarians
p.000059: B: Scientists with substantial and recent experience in the use of experimental animals
p.000059: C: Animal welfare organization representatives
p.000059: D: Representatives not involved in animal experimentation
p.000059: The size of the committee may depend on the number of animal users in the institution.
p.000059: Quorum rules should be adjusted to reflect the size of the committee but should always include at least
p.000059: one member from each category of member.
p.000059: 4.4.2 Expectations of institutions regarding RECs and ARECs
p.000059: i. Institutions should ensure that adequate administrative support and resources are provided so that the
p.000059: work of the REC can be done in compliance with these minimum standards.
p.000059: ii. Procedures and criteria for recruitment and appointment of REC members should be in place, transparent and
p.000059: accessible.
p.000059: iii. REC and AREC members should be given a formal appointment letter that sets out, at a minimum, the term of
p.000059: office; where to find the necessary information for new members; and the assurance that members are
p.000059: indemnified from personal liability against claims that may arise in the course of ordinary business of the REC or
p.000059: AREC.
p.000059: iv. Opportunities for training and refresher courses in research ethics (human and animal) and Good
p.000059: Clinical Practice (GCP) should be made available or accessible for
p.000059:
p.000059: 60 Ethics in Health Research 2nd edition
p.000059:
p.000059:
p.000059: committee members and researchers. Committee members should receive research ethics training and orientation on
...
p.000061: viii. Feedback should be instructive to assist the researchers to improve the application if appropriate.
p.000061: ix. Feedback should be sufficiently detailed so that the concerns of the REC are understandable to the
p.000061: researchers.
p.000061: x. RECs should require researchers to report immediately anything that might warrant reconsideration of ethical
p.000061: approval of the protocol, including but not limited to
p.000061: • Serious or unexpected adverse effects on participants
p.000061: • Proposed changes in the protocol
p.000061: • Unforeseen events that might affect continued ethical acceptability of the project.
p.000061: xi. RECs should require researchers to report immediately if a project is terminated or suspended before the
p.000061: anticipated date of completion.
p.000061: 4.5.1.3 Review and consultation
p.000061: i. RECs may consult with experts outside of the committee, provided they are not conflicted in relation
p.000061: to the study under consideration and subject to confidentiality assurances.
p.000061: ii. RECs may consult with other RECs if appropriate, bearing in mind confidentiality constraints.
p.000061: 4.5.1.4 Reciprocal recognition of review decisions
p.000061: i. RECs may, at their own discretion, recognize prior review and approval of a research proposal by another
p.000061: registered REC to avoid duplication of effort.
p.000061: ii. Reciprocal recognition means that two or more registered RECs decide to recognize each other’s prior review.
p.000061: ii. RECs that recognize prior review in this manner must determine the nature of the documents to be filed
p.000061: locally, which must, at minimum, include a copy of the approval letter from the other REC.
p.000061:
p.000061: Ethics in Health Research 2nd edition
p.000063: 63
p.000063:
p.000063: iii. RECs that recognize prior review in this manner may revise their decision to do so if justifying circumstances
p.000063: arise. The reasoning supporting a reversal of recognition should be documented.
p.000063: 4.5.1.5 Expedited review
p.000063: i. RECs may establish procedures for expedited review. The nature of research that may be expedited should be
p.000063: described in the procedures.
p.000063: ii. Expedited review should apply, in principle, only to research that poses no more than minimal risk of harm.
p.000063: 4.5.1.6 Record keeping
p.000063: i. RECs should keep written records of all research protocols received for review, including information
p.000063: sheets, consent forms and relevant correspondence, in the form in which they were approved. Note that electronic
p.000063: records are acceptable, provided that signatures, especially on the finally approved documentation, are
p.000063: properly documented and included in the record.
p.000063: ii. REC records must provide a reliable and authoritative record of the business of the REC that will stand up to
p.000063: scrutiny in the event of queries, conflict and audit.
p.000063: iii. The record should include at least the following:
p.000063: • Name of principal investigator
p.000063: • Protocol identification number
p.000063: • Title of the project
p.000063: • Date of approval or rejection
p.000063: • Conditions of approval, if applicable
p.000063: • Whether approval was expedited
p.000063: • Copy of the signed final proposal or protocol approved
p.000063: • Whether and how consultation occurred
p.000063: • Records of adverse events
p.000063: • Records of amendments
p.000063: • Reports of adverse and serious adverse events and action taken
p.000063: • Other relevant information such as complaints from participants
p.000063: iv. RECs should correspond primarily with the principal investigator or a delegated signatory, and not with
p.000063: the sponsor unless dictated by particular circumstances.
p.000063: 4.5.1.7 Conflict of interest
p.000063: i. REC members should disclose information that may lead to perceptions of conflict of interest.
p.000063: ii. REC members should not review or make decisions about research proposals in which they are involved personally or
p.000063: financially. When such a proposal is to be discussed, the member concerned should declare the potential conflict
p.000063: and offer to recuse herself from the meeting for that time. Should the member be permitted to remain for the
...
p.000063: provide appropriate information to the REC to facilitate monitoring, including alerts and investigator brochures.
p.000063: The frequency and type of monitoring should reflect the degree and extent of risk of harm to
p.000063: participants or animals.
p.000063: ii. RECs may recommend and adopt any additional appropriate mechanism for monitoring, including
p.000063: random inspection of research sites, welfare monitoring sheets, data and signed consent forms, and records of
p.000063: interviews. Information and consent materials should indicate that such monitoring may take place.
p.000063: iii. RECs should request regular, at least annual, reports from principal investigators on matters including but not
p.000063: limited to
p.000063: • progress to date, or outcome in the case of completed research
p.000063: • current enrolment status (numbers, active or closed)
p.000063: • whether participant follow-up is still active or completed
p.000063: • information concerning maintenance and security of records
p.000063: • evidence of compliance with the approved protocol
p.000063: • evidence of compliance with any conditions of approval
p.000063: • negative reports from monitors or GCP inspectors
p.000063: • list all adverse events in the past 12 months
p.000063: • list all amendments made in the past 12 months.
p.000063: iv. RECs should inform principal investigators in writing of concerns arising from such monitoring
p.000063: activities.
p.000063:
p.000063: Ethics in Health Research 2nd edition
p.000065: 65
p.000065:
p.000065: 4.5.1.11 Suspension or discontinuation of projects
p.000065: i. Where circumstances indicate that a project is non-compliant with the approved protocol and the
p.000065: interests of participants are at risk of harm, the REC may withdraw approval, after due process has been followed.
p.000065: ii. A clear process should be followed that permits swift but proper investigation and decision-making
p.000065: to ensure protection of participants. The investigation should include interaction with the researchers and other
p.000065: interested parties to ensure a fair and transparent process.
p.000065: iii. If the decision is to withdraw approval, the REC should inform the principal investigator and
p.000065: other interested parties, including the institutional authorities, and recommend suspension (temporary
p.000065: stoppage) or termination (permanent stoppage) of the project. It should also recommend remedial action where
p.000065: appropriate.
p.000065: iv. In the case of suspension, the principal investigator should comply with the recommendations and any
p.000065: special conditions imposed by the REC.
p.000065: 4.5.1.12Complaints
p.000065: i. Each REC should have a complaints process that is accessible to researchers and other interested
p.000065: persons. In principle, but subject to institutional requirements, complaints about REC-related business
p.000065: should be directed to the REC in the first instance. If the matter remains unresolved, it may be
p.000065: escalated to other specified institutional officials and then to the NHREC.
p.000065: ii. A standard operating procedure should detail the procedures to be followed.
p.000065: iii. The NHREC is empowered to adjudicate complaints about RECs and to hear a complaint from any
p.000065: researcher who believes that he has been discriminated against unfairly by an REC.
p.000065: iv. A framework for the management of complaints and ethics related health research misconduct has been
p.000065: developed by the Complaints and Advisory Disciplinary Committee (CADC) of the NHREC (http://nhrec.org.za).
p.000065: v. The NHREC, through its CADC, adheres to the following principles when investigating a complaint: fairness,
p.000065: confidentiality, integrity and prevention of detriment.
p.000065: vi. All information and consent documentation should include contact details for making complaints about being a
p.000065: research participant. Similarly, a research assistant, researcher or an interested community member should be
p.000065: able to lodge a complaint or grievance related to the research process.
p.000065: 4.6 Compliance Reporting to the NHREC
p.000065:
p.000065: i. The NHREC is responsible for registering and auditing RECs.
p.000065: ii. RECs should make relevant records available for inspection and audit by the NHREC (or its delegate) upon
p.000065: request.
p.000065: iii. RECs must report annually on their activities, including
p.000065: • membership and membership changes
p.000065: • the number of meetings held
p.000065: • confirmation of participation by required categories of members
p.000065: • the number of protocols presented, the number approved and the number rejected
p.000065:
p.000065: 66 Ethics in Health Research 2nd edition
p.000065:
p.000065:
p.000065: • monitoring and related matters
p.000065: • complaints received and action taken.
p.000065: iv. Reports are due by 28 February annually on the REC Reporting Template
p.000065: (http://nhrec.org.za).
p.000065:
p.000065: Ethics in Health Research 2nd edition
p.000067: 67
p.000067:
p.000067:
p.000067: Chapter 5
p.000067:
p.000067: ‘HEALTH RESEARCH’ ETHICS INFRASTRUCTURE
p.000067:
p.000067:
p.000067: Contents
p.000067:
p.000067:
p.000067: 5.1 Introduction
p.000067: p 67
p.000067: 5.2 National Health Research Ethics Council 68
p.000067: 5.2.1 Establishment
p.000068: 68
p.000068: 5.2.2 Appointment of Members 68
p.000068: 5.2.3 Operation
p.000068: 68
p.000068: 5.2.4 Working Groups & Committees 68
p.000068: 5.2.5 Terms of Reference
p.000068: 68
p.000068: 5.3 Research Ethics Committees
p.000069: 69
p.000069: 5.4 Registration & audit of committees 69
p.000069: 5.4.1 Introduction
p.000069: 69
p.000069: 5.4.2 Registration
p.000069: 69
p.000069: 5.4.3 Audit
p.000070: 70
p.000070: 5.4.4 Capacity building for ethics committees 70
p.000070: 5.5 Statutory entities relevant to research 70
p.000070: 5.5.1 The Medicines Control Council 70
p.000070: 5.5.2 South African National Clinical Trial Register 71
p.000070: 5.5.3 South African Nursing Council 71
p.000070: 5.5.4 Provincial Research Committees 71
p.000070:
p.000070: Note REC includes AREC unless otherwise indicated
p.000070:
p.000070: 5.1 Introduction
p.000070:
p.000070: This chapter presents an overview of the statutory infrastructure and systems designed to regulate and oversee health
p.000070: research. The framework includes the National Health Act 61 of 2003, the Health Research Policy,52 and the
p.000070: National Department of Health Strategic Plan 2014/15 – 2018/19; 53 The care and use of animals
p.000070: for scientific purposes SANS 10386:2008,54 and MRC Guidelines on Ethics for Medical Research Book 3: Use of
p.000070: animals in research and training (2004). International instruments also inform the governance of the conduct
p.000070: of health research.55
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070: 52 Available at http://www.gov.za/documents/download.php?f=70285
p.000070: 53 Available at http://www.health-e.org.za/wp-content/uploads/2014/08/SA-DoH-Strategic-Plan-2014-to-2019.pdf
p.000070: 54 Available at http://www.doh.gov.za; South African National Standard ‘The care and use of animals for scientific
...
p.000070: Animal Research Ethics committees (ARECs) exist in institutions where research that uses animals is conducted.
p.000070: 5.2 National Health Research Ethics Council
p.000070:
p.000070: 5.2.1 Establishment
p.000070: The National Health Research Ethics Council(NHREC) was established in terms of the National Health Act (NHA). The
p.000070: Council’s core responsibilities are to advise the Minister of Health, to set ethical norms and standards for health
p.000070: research and to advance research ethics in South Africa, by promoting compliance by researchers and RECs using existing
p.000070: and new regulations and guidelines. The Council is mandated to register and audit RECs. In addition, the Council has
p.000070: responsibility for adjudicating complaints, for advising institutional committees, researchers and
p.000070: members of the public, as appropriate.56
p.000070: 5.2.2 Appointment of Members
p.000070: The NHA requires the Minister of Health to appoint 15 NHREC members who have knowledge and experience in research
p.000070: ethics or the law and are interested in promoting research ethics. The members’ occupational diversity is prescribed. A
p.000070: Code of Conduct guides activities and expectations of members.
p.000070: 5.2.3 Operation
p.000070: The Council meets at least four times annually, submits an annual report and advises the Minister of Health through
p.000070: the National Department of Health (DoH) about research ethics matters. The NHREC has established committees and working
p.000070: groups in order to perform its functions. The NHREC is supported by a secretariat in the DoH, which maintains a
p.000070: database of health research activities in South Africa. The NHREC maintains active, bilateral relations with the
p.000070: research community, mainly through interactions with REC Chairpersons.
p.000070: 5.2.4 Working Groups and Committees
p.000070: Various Working Groups and Committees have been established to deal with the Council’s responsibilities in a systematic
p.000070: manner. They include
p.000070: i. The EXCO
p.000070: ii. Complaints, Advisory and Disciplinary Committee
p.000070: iii. Quality Promotion and Enhancement Working Group
p.000070: iv. Norms and Standards Working Group
p.000070: v. Legal and Regulatory Working Group.
p.000070:
p.000070: 5.2.5 Terms of Reference
p.000070: The statutory functions of the NHREC include
p.000070:
p.000070: 56 See http://www.nhrec.org.za for documentation.
p.000070:
p.000070: Ethics in Health Research 2nd edition
p.000069: 69
p.000069:
p.000069: i. Registration and auditing of RECs
p.000069: ii. Adjudication of complaints about RECs
p.000069: iii. Referral of matters concerning violations of ethical or professional rules to the relevant health
p.000069: professional council as appropriate
p.000069: iv. Recommendation, where applicable, of disciplinary action against persons found to have violated the
p.000069: norms and standards for responsible and ethical conduct of health research
p.000069: v. Advising the national and provincial departments of health on matters concerning research ethics and
p.000069: health research.
...
p.000069: review of research proposals to ensure that the welfare and other interests of participants, researchers
p.000069: and animals used in research are properly protected and that the research will be conducted in accordance with the
p.000069: required ethical norms and standards. Section 73 states that RECs must ‘grant approval…where research
p.000069: proposals and protocol meet the ethical standards of that health research ethics committee’.
p.000069: 5.4 Registration and audit of committees
p.000069:
p.000069: Section 72(6)(b) of the NHA requires the NHREC to register and audit health RECs. The principle of
p.000069: empowerment is central to the registration and audit process.
p.000069: 5.4.1 Introduction
p.000069: Health research is intended to improve health practice and, consequently, the health and well being of South Africa’s
p.000069: people. Part of the framework that facilitates this process includes standardization of infrastructure and standard
p.000069: operating procedures for RECs, with a strong emphasis on guidance, training, support and feedback. To this end, the
p.000069: NHREC conducted a comprehensive administrative audit of RECs in South Africa, requiring each to register and to comply
p.000069: with various administrative and record keeping standards. Follow-up contact is designed to facilitate
p.000069: improvement and compliance with expected standards. When an REC or AREC persistently fails to comply with expected
p.000069: standards, the NHREC is required to enforce the standards, e.g. by suspending operations until compliance is
p.000069: achieved. Capacity evaluation and enhancement for committees are important functions of the NHREC.
p.000069: 5.4.2 Registration
p.000069: All RECs must follow the registration process as outlined on the website. 57 Once the administrative
p.000069: registration and audit process is completed, the register is publicly listed on the website.
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069: 57http://www.nhrec.org.za.
p.000069:
p.000069: 70 Ethics in Health Research 2nd edition
p.000069:
p.000069:
p.000069: 5.4.3 Audit
p.000069: The criteria for auditing are based on this and other internationally recognized guidelines. Independent auditors
p.000069: are appointed to ensure that committees comply with essential requirements.
p.000069: After the first audit, appropriate guidance and recommendations for improvement are provided as appropriate.
p.000069: A follow-up audit is carried out to ensure that required revisions are completed. An annual review by questionnaire is
p.000069: administered to all registered committees.
p.000069: When registration is revoked, the committee concerned may not review health research. NHREC informs the
p.000069: committee of the revoked registration status and outlines the steps that should be taken to rectify matters so that
p.000069: registered status may be reinstated.
p.000069: Every three to five years, a complete audit is done to review the capacity status quo of each REC. Criteria for
p.000069: registration and auditing of committees may be changed as determined by the NHREC to reflect new ethical concerns
p.000069: or standards arising from the national or international ethics dialogue. RECs will be informed of additional
p.000069: requirements.
p.000069: 5.4.4 Capacity building for ethics committees
p.000069: As indicated above, the audit process strongly emphasizes facilitation of guidance, training, support, and feedback as
p.000069: capacity building interventions. The aim is to foster a collaborative and mutually supportive environment in the
p.000069: research ethics context. The overall goal is to achieve a system that adheres to high standards across the board so
p.000069: that South Africans can rightfully be confident that the health research ethics infrastructure conducts
p.000069: itself with integrity, according to the highest ethical standards.
p.000069: Identified resources, including Standard Operating Procedures, training materials, courses, web-based
p.000069: information, as well as query and appeal processes, are available to enable unregistered RECs to register
p.000069: and become compliant.
p.000069: 5.5 Statutory entities relevant to research
p.000069:
p.000069: Certain statutory entities and professional bodies are relevant to research insofar as gatekeeping and
p.000069: professional standards for researchers are concerned. Some of the more significant entities and bodies are
p.000069: explained below.
p.000069: 5.5.1 The Medicines Control Council
p.000069: The Medicines Control Council (MCC) is the statutory body tasked with ensuring that the pharmaceutical
p.000069: drugs available for use in South Africa are safe, are of the requisite quality, and have the required efficacy
p.000069: (effect). In order to carry out this mandate, the MCC must decide, based on sound scientific evidence and other
...
p.000071: granted by a registered
p.000071:
p.000071: 58 In some provinces, the legislation calls them Provincial Research and Ethics Committees, which may blur the
p.000071: different roles.
p.000071:
p.000071: 72 Ethics in Health Research 2nd edition
p.000071:
p.000071:
p.000071: REC. Some provinces have also established separate provincial research ethics committees. These committees are
p.000071: important in areas of the country where other RECs are not active. They are in the process of registering with the
p.000071: NHREC.
p.000071:
p.000071: Ethics in Health Research 2nd edition
p.000073: 73
p.000073:
p.000073:
p.000073: Chapter 6
p.000073:
p.000073: QUALITATIVE RESEARCH59
p.000073:
p.000073: Contents
p.000073:
p.000073:
p.000073:
p.000073: 6.1 Introduction
p.000073: p 73
p.000073: 6.2 Nature of qualitative research 74
p.000073: 6.3 Methodological approaches and requirements 74
p.000073: 6.3.1 Diversity of approaches 74
p.000073: 6.3.2 Inductive understanding 74
p.000073: 6.3.4 Diverse, multiple & evolving contexts 74
p.000073: 6.3.5 Data collection and sample size 74
p.000073: 6.4 Approach to ethics review of qualitative research 75
p.000073: 6.5 Criteria for review process 75
p.000073:
p.000073:
p.000073:
p.000073: 6.1 Introduction
p.000073:
p.000073: This chapter is offered to assist RECs and researchers to ensure that qualitative research is reviewed appropriately.
p.000073: As indicated in chapter 1, perceptions exist that the ‘medical model’ of ethics review prevails and that it is
p.000073: inappropriately applied to research that may use qualitative research methodologies. As research becomes more
p.000073: trans disciplinary, proposals increasingly include mixed methodologies, including qualitative methodologies.
p.000073: This section assists RECs and researchers by providing an approach to reviewing qualitative research proposals, but
p.000073: it does not provide detailed guidance on specific details that may arise in such proposals that will require
p.000073: consideration of specialised published guidance and authorities.
p.000073: It is important that RECs review different methodologies appropriately and in accordance with accepted
p.000073: methodological standards of different research and academic disciplines.
p.000073: It is important to recognize that, although research methodologies and analytic paradigms may differ, all research must
p.000073: be judged against the same ethical principles. No philosophical justification exists for judging different
p.000073: methodologies against different ethical standards. However, RECs must be familiar with qualitative research
p.000073: paradigms so that methodological issues are competently reviewed.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073: 59 This chapter draws heavily on the Tri-Council Policy Statement (Canada) 2010 chapter 10; Wassenaar & Mamotte
p.000073: ‘Ethical Issues and Ethics Reviews in Social Science Research’ in Ferrero et al The Oxford Handbook of International
p.000073: Psychological Ethics 2012.
p.000073:
p.000073: 74 Ethics in Health Research 2nd edition
p.000073:
p.000073:
...
p.000073: reliability and validity of quantitative data).
p.000073: 6.3 Methodological approaches and requirements62
p.000073: 6.3.1 Diversity of approaches
p.000073: Methodological approaches to qualitative research include but are not limited to ethnography, participatory action
p.000073: research, oral history, phenomenology, narrative inquiry, grounded theory and discourse analysis.
p.000073: 6.3.2 Inductive understanding
p.000073: Usually, an inductive understanding of participants’ worlds precedes attempts to gain an analytic
p.000073: understanding of their experiences.
p.000073: 6.3.3 Dynamic, reflective and continuous research process
p.000073: During the course of the research, questions, concepts, theories, strategies and ways to engage with and
p.000073: gather data may emerge which may require that the researcher practise ongoing reflective, flexible and responsive
p.000073: approaches to ensure that the rigour, credibility and trustworthiness of data collection and analysis are maintained.
p.000073: 6.3.4 Data collection and sample size
p.000073: In general terms, depth of research is emphasised over breadth of research. Consequently, samples and sites are
p.000073: selected for their usefulness as rich sources of information. Selection of participants may be guided by emerging
p.000073: patterns over the course of data collection. Sample sizes are usually small.
p.000073: Multiple methods of data gathering may be used to elicit data from multiple sources. For example,
p.000073: interviews, participant observation, and focus groups may be used. Increasingly popular but ethically
p.000073: challenging are research methods that involve capture of photographic and video data of participants or contexts.
p.000073: The risk/benefit ratio and confidentiality considerations are especially but not exclusively pertinent.
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073: 60 Tri-Council Policy Statement (Canada) 2010, 135.
p.000073: 61 Tri-Council Policy Statement (Canada) 2010, 136.
p.000073: 62 Sections 6.3 & 6.4 are very closed based on the Tri-Council Policy Statement (Canada) 2010 Chapter 10, 136-145.
p.000073:
p.000073: Ethics in Health Research 2nd edition
p.000075: 75
p.000075:
p.000075: 6.4 Approach to ethics review of qualitative research
p.000075:
p.000075: As outlined above, qualitative research is inherently dynamic and may be based on assumptions that are
p.000075: different from those that inform quantitative research.
p.000075: Best practices, standards and expectations that may exist in the different disciplines must be considered. However,
p.000075: as stated previously, the moral standards by which we judge the ethical acceptability of planned research do
p.000075: not differ just because a different methodology is to be used. Consequently, the principles outlined and discussed in
p.000075: chapter 2 are relevant also to qualitative research.
p.000075: While researchers may refer to discipline- or paradigm-specific ethical norms and frameworks,
p.000075: adherence to national research ethics guidance is also required. As in quantitative research, RECs must
p.000075: consider any ethical tensions arising from specific methodologies and analytic approaches competently,
p.000075: fairly and without prejudice.
p.000075: As in quantitative proposals, researchers should explain the intended process of the research, including its
p.000075: predictability or lack thereof, and how foreseeable ethical issues will be managed. This information must
p.000075: also appear in the information for potential participants.
p.000075: 6.5 Criteria for review process
p.000075:
p.000075: In chapter 3 (3.1) the key criteria for the review process are outlined and discussed. These same criteria are relevant
p.000075: to review of qualitative research, with adjustments to emphasise aspects peculiar to qualitative research. However, the
...
p.000083: Ask whether she wants to speak to someone
p.000083: Ask whether he wants to speak to someone
p.000083:
p.000083:
p.000083:
p.000083:
p.000083: 2. Insurance information for consent documentation
p.000083:
p.000083: This template is based on DoH 2006, MCC Clinical Trials Compensation Guidelines and Venter v Roche Products (Pty)
p.000083: Ltd et al (12285/08) [2013] WCHC 7 May 2013 and on appeal (A11/2014) 22 October 2014.
p.000083:
p.000083: Notes for researchers:
p.000083: i. Research study insurance does not substitute malpractice insurance
p.000083: ii. ABPI guidelines on compensation apply only to unlicensed substances used in Phase II and III clinical
p.000083: trials; reference to ABPI compensation should not be a standard paragraph in all consent documents
p.000083: iii. Participants may not recognize symptoms of side effects or have ready means to take action
p.000083:
p.000083:
p.000083: ‘What happens if I get hurt taking part in this study?’ (or equivalent heading)
p.000083:
p.000083: This research study is covered by an insurance policy taken out by [name of institution] in the event that you suffer a
p.000083: bodily injury as a result of taking part in the study.
p.000083: The insurer will pay for all reasonable medical costs required to treat your bodily injury, in accordance with the SA
p.000083: Good Clinical Practice Guidelines (2006 or latest version), which are based on the Association of the British
p.000083: Pharmaceutical Industry Guidelines. You may request a copy of these guidelines from the study doctor.
p.000083: The insurer will pay without you having to prove that the research was responsible for your bodily injury.
p.000083: The insurer will not pay for harm if, during the study, you
p.000083: • Use medicines or other substances that are not allowed
p.000083: • Do not follow the study doctor’s instructions
p.000083: • Do not tell the study doctor that you have a bad side effect from the study medicine
p.000083: • Do not take reasonable care of yourself and your study medicine
p.000083:
p.000083: If you are harmed and the insurer pays for the necessary medical costs, usually you will be asked to accept that
p.000083: insurance payment as full settlement of the claim for medical costs.
p.000083:
p.000083: Ethics in Health Research 2nd edition
p.000085: 85
p.000085:
p.000085: However, accepting this offer of insurance cover does not mean you give up your right to make a separate claim for
p.000085: other losses based on negligence, in a South African court.
p.000085: It is important to follow the study doctor’s instructions and to report straight away if you have a side effect
p.000085: from the study medicine.
p.000085:
p.000085: See also Medicines Control Council Clinical Trial Compensation Guidelines available at
p.000085: http://www.sahealthinfo.org.ethics/book1.htm
p.000085:
p.000085: 86 Ethics in Health Research 2nd edition
p.000085:
p.000085:
p.000085:
p.000085:
p.000085: 3. Novel, Innovative or Unproven Treatment
p.000085:
p.000085: < Insert hospital name >
p.000085:
p.000085: NOVEL, INNOVATIVE OR UNPROVEN TREATMENT CONSENT FORM
p.000085:
p.000085: How to use this Consent Form
...
p.000089:
p.000089: 90 Ethics in Health Research 2nd edition
p.000089:
p.000089:
p.000089: 4. Consent for storage and future use of unused samples of biological materials
p.000089:
p.000089:
p.000089:
p.000089: Research Ethics Review Committee (WHO ERC)
p.000089:
p.000089: 20, AVENUE APPIA – CH-1211 GENEVA 27 –SWITZERLAND –
p.000089: HTTP://INTRANET.WHO.INT/HOMES/RPC/ERC –
p.000089: HTTP://WWW.WHO.INT/RPC/RESEARCH_ETHICS
p.000089:
p.000089: Informed Consent Form Template for Consent for Storage and Future Use of
p.000089: Unused Samples
p.000089:
p.000089:
p.000089: Notes to Researchers:
p.000089: 1. Please note that this is a template developed by the WHO ERC to assist the Principal Investigator in
p.000089: the design of their informed consent forms (ICF). It is important that Principal Investigators adapt their own ICFs to
p.000089: the outline and requirements of their particular study.
p.000089: The logo of the Institution must be used on the ICF and not the WHO logo.
p.000089: 2. The informed consent form consists of two parts: the information sheet and the consent certificate.
p.000089: 3. Do not be concerned by the length of this template. It is long only because it contains guidance and explanations
p.000089: for you which you will not include in the informed consent forms that you develop and provide to participants in your
p.000089: research.
p.000089: 4. In this template:
p.000089: • square brackets indicate where specific information is to be inserted
p.000089: • bold lettering indicates sections or wording which should be included
p.000089: • standard lettering is used for explanations to researchers only and must not be included in your
p.000089: consent forms. The explanation is provided in black, and examples are provided in red in italics. Suggested
p.000089: questions to elucidate understanding are given in black in italics.
p.000089:
p.000089:
p.000089:
p.000089: TEMPLATE ON FOLLOWING PAGE
p.000089:
p.000089: Ethics in Health Research 2nd edition
p.000091: 91
p.000091:
p.000091:
p.000091:
p.000091: Additional Consent to [Name of Project]
p.000091:
p.000091: Include the following section if the research protocol calls for storage and future use of samples
p.000091:
p.000091: This Statement of Consent consists of two parts:
p.000091: • Information Sheet (to share information about unused samples with you)
p.000091: • Certificate of Consent (to record your agreement) You will be given a copy of the full Statement of Consent
p.000091: Part 1. Information Sheet
p.000091: Explain that you are seeking permission to store their unused samples for possible future use in either your own
p.000091: research or someone else's research. State that they need to make some decisions about their blood/tissue/sperm/sputum
p.000091: sample because they gave you permission only to use it for the current research.
p.000091: Explain that sometimes people don't want their samples used for research into areas they might not agree with, for
p.000091: example, research into birth control or reproductive technology. Use lay terms to explain research
p.000091: possibilities. If genetic research is a possibility, explain what this is and any implications for them. State
p.000091: that they can tell you if there is something they don't want their sample used for, or if they don't want their sample
p.000091: used at all.
p.000091: Inform the participant that, at present, the researchers can trace which
p.000091: blood/tissue/sperm/sputum sample belongs to the participant. In most cases, the participant must decide whether they
p.000091: want to let the researchers keep the sample but get rid of all identifying information, or whether they
p.000091: are comfortable with the researchers knowing whose sample it is. Explain the risks and benefits of each of these
p.000091: options. Inform the participant of researcher obligations in cases where the sample remains linked. These obligations
p.000091: include informing the participant of results that have immediate clinical relevance.
p.000091: Inform participants that their sample will not be sold for profit and that any research which uses their sample will
p.000091: have been approved.
p.000091: Right to Refuse and Withdraw
p.000091: Explain that the participant may refuse to allow samples to be kept or put restrictions on those samples with no
p.000091: loss of benefits and that the current research study will not be affected in any way. Inform the
p.000091: participant that they may withdraw permission at anytime and provide them with the name, address, and number
p.000091: of the person and sponsoring institution to contact.
p.000091: Confidentiality
p.000091: Briefly explain how confidentiality will be maintained including any limitations.
p.000091: You can ask me any more questions about any part of the information provided above, if you wish to. Do you have any
p.000091: questions?
p.000091:
p.000091: 92 Ethics in Health Research 2nd edition
p.000091:
p.000091:
p.000091: Part II. Certificate of Consent
p.000091: If any of the (TYPE OF SAMPLE i.e. blood, tissue) I have provided for this research project is unused or leftover when
p.000091: the project is completed (Tick one choice from each of the following boxes)
p.000091:
p.000091: □ I wish my [TYPE OF SAMPLE] sample to be destroyed immediately.
p.000091: □ I want my [TYPE OF SAMPLE] sample to be destroyed after years.
p.000091: □ I give permission for my [TYPE OF SAMPLE] sample to be stored indefinitely AND (if the sample is to be stored)
p.000091:
p.000091: □ I give permission for my (TYPE OF SAMPLE) sample to be stored and used in future research but only on the same
p.000091: subject as the current research project : [give name of current research]
p.000091: □ I give my permission for my [TYPE OF SAMPLE] sample to be stored and used in future research of any
p.000091: type which has been properly approved
p.000091: □ I give permission for my [TYPE OF SAMPLE] sample to be stored and used in future research except for research about
p.000091: [NAME TYPE OF RESEARCH]
p.000091:
p.000091: AND
p.000091:
p.000091: □ I want my identity to be removed from my (TYPE OF SAMPLE) sample.
p.000091: □ I want my identity to be kept with my (TYPE OF SAMPLE) sample.
p.000091:
p.000091:
p.000091:
p.000091: I have read the information, or it has been read to me. I have had the opportunity to ask questions about it and my
p.000091: questions have been answered to my satisfaction. I consent voluntarily to have my samples stored in the manner
p.000091: and for the purpose indicated above.
p.000091:
p.000091: Print Name of Participant
p.000091:
p.000091:
...
p.000093: 93
p.000093: I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had
...
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| accessXtoXinformation | Access to information |
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| belief | Religion |
| child | Child |
| children | Child |
| cognitive | Cognitive Impairment |
| crime | Illegal Activity |
| criminal | criminal |
| culturally | cultural difference |
| dependence | Drug Dependence |
| dependency | Drug Dependence |
| dependent | Dependent |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| emergency | Public Emergency |
| employees | employees |
| ethnic | Ethnicity |
| ethnicity | Ethnicity |
| faith | Religion |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| fetuses | Fetus/Neonate |
| gender | gender |
| home | Property Ownership |
| ill | ill |
| illiterate | Literacy |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| impairment | Cognitive Impairment |
| incapable | Mentally Incapacitated |
| incapacitated | Incapacitated |
| incapacity | Incapacitated |
| incarcerated | Incarcerated |
| indigenous | Indigenous |
| infant | Infant |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| literacy | Literacy |
| literate | Literacy |
| marital status | Marital Status |
| mentally | Mentally Disabled |
| military | Soldier |
| minor | Youth/Minors |
| minority | Racial Minority |
| mothers | Mothers |
| neonate | Fetus/Neonate |
| opinion | philosophical differences/differences of opinion |
| orphan | orphan |
| parent | parents |
| parents | parents |
| philosophy | philosophical differences/differences of opinion |
| police | Police Officer |
| political | political affiliation |
| poor | Economic/Poverty |
| poverty | Economic/Poverty |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| prosecuted | Prosecuted |
| race | Racial Minority |
| religious | Religion |
| restricted | Incarcerated |
| single | Marital Status |
| social goods | Access to Social Goods |
| social welfare | Access to Social Goods |
| stem cells | stem cells |
| stigma | Threat of Stigma |
| student | Student |
| substance | Drug Usage |
| terminal | Terminally Ill |
| terminally | Terminally Ill |
| threat | Threat of Stigma |
| unconscious | Unconscious People |
| undue influence | Undue Influence |
| unlawful | Illegal Activity |
| unmarried | Marital Status |
| usage | Drug Usage |
| violence | Threat of Violence |
| volunteers | Healthy People |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| whistleblower | whistleblower |
| women | Women |
| youth | Youth/Minors |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| access | ['socialXgoods', 'socialXwelfare'] |
| belief | ['faith', 'religious'] |
| child | ['children'] |
| children | ['child'] |
| cognitive | ['impaired', 'impairment'] |
| crime | ['unlawful'] |
| dependence | ['dependency'] |
| dependency | ['dependence'] |
| disability | ['mentally'] |
| drug | ['influence', 'substance', 'usage'] |
| education | ['educational'] |
| educational | ['education'] |
| ethnic | ['ethnicity'] |
| ethnicity | ['ethnic'] |
| faith | ['belief', 'religious'] |
| fetus | ['neonate', 'fetuses'] |
| fetuses | ['fetus', 'neonate'] |
| home | ['property'] |
| illiterate | ['literacy', 'literate'] |
| impaired | ['cognitive', 'impairment'] |
| impairment | ['cognitive', 'impaired'] |
| incapacitated | ['incapacity'] |
| incapacity | ['incapacitated'] |
| incarcerated | ['restricted'] |
| influence | ['drug', 'substance', 'usage'] |
| literacy | ['illiterate', 'literate'] |
| literate | ['illiterate', 'literacy'] |
| marital status | ['single', 'unmarried'] |
| mentally | ['disability'] |
| minor | ['youth'] |
| minority | ['race'] |
| neonate | ['fetus', 'fetuses'] |
| opinion | ['philosophy'] |
| parent | ['parents'] |
| parents | ['parent'] |
| philosophy | ['opinion'] |
| poor | ['poverty'] |
| poverty | ['poor'] |
| property | ['home'] |
| race | ['minority'] |
| religious | ['faith', 'belief'] |
| restricted | ['incarcerated'] |
| single | ['maritalXstatus', 'unmarried'] |
| social goods | ['socialXwelfare', 'access'] |
| social welfare | ['socialXgoods', 'access'] |
| stigma | ['threat'] |
| substance | ['drug', 'influence', 'usage'] |
| terminal | ['terminally'] |
| terminally | ['terminal'] |
| threat | ['stigma'] |
| unlawful | ['crime'] |
| unmarried | ['maritalXstatus', 'single'] |
| usage | ['drug', 'influence', 'substance'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
| youth | ['minor'] |
Trigger Words
capacity
coercion
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
self-determination
sensitive
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input