Enrolling Adolescents in Research on HIV and Other Sensitive Issues: Lessons from South Africa

Singh, Jerome Amir; Karim, Salim S. Abdool; Karim, Quarraisha Abdool; Mlisana, Koleka; Williamson, Carolyn; Gray, Clive M.; Govender, Michele.; Gray, Andrew L.

doi:10.1371/journal.pmed.0030180

Cited by 49 publications

(65 citation statements)

References 5 publications

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“…[3,4] As a result, it has come under heavy criticism for limiting important research with children and containing impractical and unrealisable provisions. [3][4][5][6][7][8][9] The full impact of section 71 has yet to be felt, as very few research ethics committees (RECs) require researchers to comply with its standards. However, this grace period may be coming to an end; on 29 May 2013, draft Regulations Relating to Research on Human Subjects [10] were published for public comment, indicating that the full implementation of section 71 is imminent.…”

Section: Corresponding Author: a Strode (Strodea@ukznacza)mentioning

confidence: 99%

Failing the vulnerable: Three new consent norms that will undermine health research with children

et al. 2014

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a legal framework for the regulation of the health system across the country. Within the Act, section 71 introduces a number of legal norms relating to research or experimentation with human subjects, including research on HIV prevention and treatment. These norms have been criticised for the negative impact they will have on research involving children. This article describes three of the new consent requirements in section 71 of the Act. It shows, using a range of case studies, how important HIV-related research will be halted or undermined if the current provisions are implemented. The article argues that the new consent requirements are out of step with other statutory provisions and ethical guidelines, and as a result they will exclude a large population group -children in diverse settings -from much-needed evidence-based healthcare interventions. The article concludes with a clarion call for support of advocacy on this issue with the Minister of Health and the Health Portfolio Committee.

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Section: Corresponding Author: a Strode (Strodea@ukznacza)mentioning

confidence: 99%

Failing the vulnerable: Three new consent norms that will undermine health research with children

et al. 2014

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“…[14] Adolescent sexual and reproductive health research is particularly important in the SA context, owing to high teenage pregnancy, sexually transmitted disease and HIV rates in this population. [26,30] Previous authors have called for a re-examination of the informed consent language in section 71 of the National Health Act, No. 61, 2003 in order to better serve the interests of SA adolescents in sexual and reproductive health research.…”

Section: Discussionmentioning

confidence: 99%

“…However, the potential benefits of caregiver information of HIV status were not fully considered, including the ability to provide optimal medical and nutritional care of the child. [26] According to the current DoH's Good Clinical Practice guidelines, section 2.3.12.2.1, 2006, [22] consent for children to participate in HIV-related health research must be obtained only from the parents or legal guardians, thus excluding consent from caregivers as employed in this study. [27] However, this study did obtain ethical approval from the MRC and gatekeeper permission from each of the nine registered Provincial Health RECs, thus permitting the study to be conducted in their res pective facilities.…”

Section: Existing Practicementioning

confidence: 99%

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

2016

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“…As with studies on other sensitive issues such as HIV testing, trials of vaccines and microbiocides [17], research on sexual violence is fraught with a number of ethical and methodological challenges. The sensitive nature of the subject implies that issues of privacy, safety, confidentiality, interviewer skills and training are more important here than in many other areas of study [1].…”

Section: Ethical and Methodological Challenges Involved In Research Omentioning

confidence: 99%

Ethical and Methodological Challenges Involved in Research on Sexual Violence in Nigeria

Ajuwon

Adegbite

2008

Research Ethics

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Research on sexual violence is fraught with ethical and methodological challenges due to its sensitive nature. This paper describes the ethical and methodological challenges encountered in planning and conducting two exploratory studies on sexual violence that included in-depth interviews of eight female adolescent rape survivors in Ibadan and four married women in Lagos Nigeria who were raped, forced to perform sexual acts and sexually deprived. The first challenge encountered was an Institutional Review Board (IRB) requirement to obtain parental permission from adolescents, when such a requirement may place the adolescent at risk if a parent was a perpetrator of sexual violence. Using arguments emphasizing the Council for International Organization for Medical Sciences guidelines helped convince the IRB to provide a waiver of parental consent. Second, the privacy required to conduct in-depth interviews for rape survivors was difficult to achieve because five of the rape survivors were apprentices who work in public settings which are typically used to conduct business in the informal sector. To overcome this challenge, interviews were conducted in safe locations, investigator' s offices and homes of survivors. The culture of silence associated with sexual violence posed a challenge because it encourages perpetration of violence with impunity causing rape survivors to suffer in silence. None of the affected adolescents had sought judicial redress for rape despite availability of stringent punishment for this behaviour. Referral information was provided on where survivors could seek care. Interviews with the women could not be recorded on audio-tapes because of concerns that their partners might identify their voices from the tapes and punish them for this. Although research on sexual violence poses ethical and methodological challenges, it is not only desirable but also feasible to conduct such research in ways that ensure safety of participants.

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Enrolling Adolescents in Research on HIV and Other Sensitive Issues: Lessons from South Africa

Abstract: Jerome Singh and colleagues present the ethical and legal challenges surrounding the enrollment of adolescents in HIV observational studies and other types of sensitive research.

Cited by 49 publications

References 5 publications

Failing the vulnerable: Three new consent norms that will undermine health research with children

Failing the vulnerable: Three new consent norms that will undermine health research with children

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

Ethical and Methodological Challenges Involved in Research on Sexual Violence in Nigeria

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