A critical review of health research ethical guidelines regarding caregiver consent for HIV research involving minors in South Africa: Ethical and legal issues

Worku, Eshetu Bekle; Davis, Arlene M.; Morrow, Brenda

doi:10.7196/sajbl.2016.v9i2.458

Cited by 6 publications

(5 citation statements)

References 10 publications

(17 reference statements)

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“…[11] With specific regard to clinical trials, the NDoH (2006) Good Clinical Practice Guidelines (2.3.1.1) also assert that in some exceptional cases (e.g. ‘emergency’), caregiver consent for clinical trial enrolment is permitted, [19,20] again illuminating the discrepancy between section 71 of the NHA and national guidance.…”

Section: Consent To Child Research In South Africa – Divergent Approamentioning

confidence: 99%

Research ethics committees in a tight spot: Approving consent strategies for child research that are prima facie illegal but are ethical in terms of national guidelines

et al. 2018

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It is an internationally accepted principle that ethics norms should be applied and enforced in research with humans through ethics review by research ethics committees (RECs). This places RECs at the very heart of the system for protecting participants and enforcing their rights. In the South African ethical-legal framework for child research, there are divergent approaches to consent. That is, section 71 of the National Health Act (No. 61 of 2003) (NHA) requires mandatory parental consent for child research, and limits the authority for proxy consent to parents and legal guardians. However, national ethics guidelines authorised by section 72 of the NHA and issued by the National Health Research Ethics Council (NHREC) acting in terms of its mandate (National Department of Health, 2015) allow a more nuanced approach – i.e. self-consent by older adolescents, provided certain conditions are met, and consent by a range of parental substitutes where there are no available parents or legal guardians. We have argued elsewhere that the consent approach in section 71 is inappropriately restrictive and are of the view that the consent approach endorsed in national ethics guidelines is more defensible. An REC that elects to approve a consent strategy allowable in ethics guidelines is effectively electing to not follow section 71, which raises the question of what the consequences might be for that REC. This article examines the legal liability of RECs through three ‘threads’ of accountability: the NHREC, the institutions hosting RECs, and the courts. We conclude that: (i) if an REC approves a child protocol with consent strategies allowable in terms of national ethics guidelines but not in terms of section 71, it is unlikely that the NHREC would discipline the REC in the face of a complaint – provided the REC acted within national ethics guidelines issued by the NHREC in terms of the latter’s section 72 mandate to set national norms and standards; (ii) if an REC approves a consent approach allowed for in ethics guidance, it is also unlikely that the host institution would discipline the REC in the face of a complaint – especially if the institution is aware of the REC’s explicit decision to follow national ethics guidelines that are authorised by section 72 of the NHA; and (iii) an REC could only be sued by a participant in terms of the law of delict (and be liable for damages) if several demanding components are proven, such as that the harm suffered by the participant resulted directly from the REC’s actions in approving a particular consent strategy for that research. Furthermore, the court may well look to national ethics guidelines in making determinations about whether an REC’s conduct was wrongful for the purposes of liability in civil law. RECs are protected from being collectively liable by insurance taken out by their host institutions. We make a series of recommendations to address this issue.

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Section: Consent To Child Research In South Africa – Divergent Approamentioning

confidence: 99%

Research ethics committees in a tight spot: Approving consent strategies for child research that are prima facie illegal but are ethical in terms of national guidelines

et al. 2018

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“…The age of consent in these circumstances has been raised extensively, and the South Africa National Research Ethics Guidelines allow for a waiver of parental consent be used in favor of adolescent self-consent in certain circumstances. (Slack & Strode, 2016; Strode & Essack, 2022; Strode et al, 2018; Worku et al, 2016) Adolescent self-consent may be granted for those over 16 years if the study is minimal risk, has received engaged the community on research questions, and investigates behaviorally sensitive information. (Strode & Essack, 2022)Interestingly, discussion of and research studies related to adolescent self-consent remains limited in African countries.…”

Section: Discussionmentioning

confidence: 99%

Ethical Considerations for Engaging Children and Adolescents Living with HIV in Research in African Countries: A Systematic Review

Gillette,

Nyandiko,

Chory

et al. 2023

Journal of Empirical Research on Human Research Ethics

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Research engaging children and adolescents living with HIV (CALWH) is critical for youth-friendly services and HIV care, and researchers need to ensure that such engagement is ethical. We conducted a systematic review to identify key ethical considerations for the engagement of CALWH in research. The review focused on primary research articles conducted in African countries that examined ethical issues in CALWH engaged in research. Ten studies met the inclusion criteria; the following seven key domains were extracted: 1) justifications for engaging CALWH in research; 2) community involvement; 3) informed consent/assent; 4) caregiver involvement; 5) perceptions of benefits; 6) perception of the risks of involvement; and 7) confidentiality. These domains can inform the ethical engagement of CALWH in research.

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“…For instance, in the Philippines, AKP were required to understand and repeat back 4 key items of consent in order to participate in a BBSS using RDS and TLS: (1) participation is voluntary, (2) information is confidential (no one will know what you tell me), (3) participation involves an interview and HIV counseling and testing, and (4) participation will help improve services for adolescents [ 23 ]. Another safeguard has been to have on-site social or health workers as “parental proxies” to provide consent on behalf of or in addition to AKP under the age of 18 years [ 24 ].…”

Section: Methodsmentioning

confidence: 99%

Ensuring Inclusion of Adolescent Key Populations at Higher Risk of HIV Exposure: Recommendations for Conducting Biological Behavioral Surveillance Surveys

Johnston

Sass

Acaba³

et al. 2017

JMIR Public Health Surveill

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Ending acquired immune deficiency syndrome (AIDS) depends on greater efforts to reduce new human immunodeficiency virus (HIV) infections and prevent AIDS-related deaths among key populations at highest HIV risk, including males who have sex with males, sex workers, and people who inject drugs. Although adolescent key populations (AKP) are disproportionately affected by HIV, they have been largely ignored in HIV biological behavioral surveillance survey (BBSS) activities to date. This paper reviews current ethical and sampling challenges and provides suggestions to ensure AKP are included in surveillance activities, with the aim being to enhance evidence-informed, strategic, and targeted funding allocations and programs toward ending AIDS among AKP. HIV BBSS, conducted every few years worldwide among adult key populations, provide information on HIV and other infections’ prevalence, HIV testing, risk behaviors, program coverage, and when at least three of these surveys are conducted, trend data with which to evaluate progress. We provide suggestions and recommendations on how to make the case to ethical review boards to involve AKP in surveillance while assuring that AKP are properly protected. We also describe two widely used probability sampling methods, time location sampling and respondent driven sampling, and offer considerations of feature modifications when sampling AKP. Effectively responding to AKP’s HIV and sexual risks requires the inclusion of AKP in HIV BBSS activities. The implementation of strategies to overcome barriers to including AKP in HIV BBSS will result in more effective and targeted prevention and intervention programs directly suited to the needs of AKP.

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A critical review of health research ethical guidelines regarding caregiver consent for HIV research involving minors in South Africa: Ethical and legal issues

Cited by 6 publications

References 10 publications

Research ethics committees in a tight spot: Approving consent strategies for child research that are prima facie illegal but are ethical in terms of national guidelines

Research ethics committees in a tight spot: Approving consent strategies for child research that are prima facie illegal but are ethical in terms of national guidelines

Ethical Considerations for Engaging Children and Adolescents Living with HIV in Research in African Countries: A Systematic Review

Ensuring Inclusion of Adolescent Key Populations at Higher Risk of HIV Exposure: Recommendations for Conducting Biological Behavioral Surveillance Surveys

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