Zaynab Essack

Child consent in South African law: Implications for researchers, service providers and policy-makers

Children under 18 are legal minors who, in South African law, are not fully capable of acting independently without assistance from parents/legal guardians. However, in recognition of the evolving capacity of children, there are exceptional circumstances where the law has granted minors the capacity to act independently. We describe legal norms for child consent to health-related interventions in South Africa, and argue that the South African Parliament has taken an inconsistent approach to: the capacity of children to consent; the persons able to consent when children do not have capacity; and restrictions on the autonomy of children or their proxies to consent. In addition, the rationale for the differing age limitations, capacity requirements and public policy restrictions has not been specified. These inconsistencies make it difficult for stakeholders interacting with children to ensure that they act lawfully.

STAKEHOLDER PERSPECTIVES ON ETHICAL CHALLENGES IN HIV VACCINE TRIALS IN SOUTH AFRICA

There is little published literature on the ethical concerns of stakeholders in HIV vaccine trials. This study explored the ethical challenges identified by various stakeholders, through an open-ended, in-depth approach. While the few previous studies have been largely quantitative, respondents in this study had the opportunity to spontaneously identify the issues that they perceived to be of priority concern in the South African context. Stakeholders spontaneously identified the following as ethical priorities: informed consent, social harms, collaborative relationships between research stakeholders, the participation of children and adolescents, access to treatment for participants who become infected with HIV, physical harms, fair participant and community selection, confidentiality, benefits, and payment. While there is some speculation that research in developing countries poses special ethical challenges, overall no issues were identified that have not been anticipated in international guidance, literature and popular frameworks. However, the South African context affords a distinctive gloss to these expected issues; for example, respondents were concerned that the predominant selection of black participants may perpetuate racist practices of apartheid. Stakeholders should be aware of contextual factors impacting on the implementation of ethical principles. We make a series of recommendations for South African trials, including amendments to the ethical-legal framework and research policies, and, for further research.

‘It Looks Like You Just Want Them When Things Get Rough’: Civil Society Perspectives on Negative Trial Results and Stakeholder Engagement in HIV Prevention Trials

Civil society organizations (CSOs) have significantly impacted on the politics of health research and the field of bioethics. In the global HIV epidemic, CSOs have served a pivotal stakeholder role. The dire need for development of new prevention technologies has raised critical challenges for the ethical engagement of community stakeholders in HIV research. This study explored the perspectives of CSO representatives involved in HIV prevention trials (HPTs) on the impact of premature trial closures on stakeholder engagement. Fourteen respondents from South African and international CSOs representing activist and advocacy groups, community mobilisation initiatives, and human and legal rights groups were purposively sampled based on involvement in HPTs. Interviews were conducted from February-May 2010. Descriptive analysis was undertaken across interviews and key themes were developed inductively. CSO representatives largely described positive outcomes of recent microbicide and HIV vaccine trial terminations, particularly in South Africa, which they attributed to improvements in stakeholder engagement. Ongoing challenges to community engagement included the need for principled justifications for selective stakeholder engagement at strategic time-points, as well as the need for legitimate alternatives to CABs as mechanisms for engagement. Key issues for CSOs in relation to research were also raised.

She made up a choice for me: 22 HIV-positive women's experiences of involuntary sterilization in two South African provinces.

Abstract Since 1998 South African law has provided that adults should have access to sterilization but only with their informed consent. However, the right to sterilization and other sexual and reproductive rights have not been fully realized as women struggle to access limited services, and there are allegations of discrimination and sterilization abuses. This qualitative study explores the experiences of 22 HIV-positive women in two provinces who reported being sterilized between 1996 and 2010 without their informed consent (n=18) or without their knowledge (n=4). Key issues reported by participants included failure to respect their autonomy, lack of information given about what sterilization entailed, and subtle or overt pressure to sign the consent form. Although the legal framework was intended to ensure informed decision-making regarding sterilization, these protections appear to have failed the HIV-positive women in this study. The findings suggest that some health professionals may consider a signature on a consent form as sufficient regardless of how it was obtained. Furthermore the women’s perceptions that they were singled out as needing to be sterilized simply because they were HIV-positive warrants further investigation. More research is required on the nature of the problem and on other stakeholders’ perceptions. Résumé Depuis 1998, la loi sud-africaine garantit l’accès des adultes de plus de 18 ans à la stérilisation, mais seulement avec leur consentement éclairé. Néanmoins, le droit à la stérilisation et d’autres droits génésiques ne sont pas pleinement réalisés puisque les femmes luttent pour accéder à des services limités et que certaines se plaignent de discrimination et de stérilisations abusives. Cette étude qualitative menée dans deux provinces analyse l’expérience de 22 femmes séropositives qui ont indiqué avoir été stérilisées sans leur consentement éclairé (n=18) ou à leur insu (n=4). Les principales questions citées par les participantes concernaient le non-respect de leur autonomie, le manque d’informations sur les conséquences de la stérilisation et les pressions subtiles ou manifestes exercées pour leur faire signer le formulaire de consentement. Même si le cadre juridique avait pour but de garantir une prise de décision éclairée sur la stérilisation, les garanties ne semblent pas avoir protégé les femmes séropositives de l’étude. Il apparaît que certains professionnels de santé considèrent comme suffisante une signature dans un formulaire de consentement, quelle que soit la manière dont elle a été obtenue. De plus, l’impression des femmes qu’elles ont été orientées vers la stérilisation simplement du fait de leur séropositivité doit être examinée plus attentivement. Davantage de recherches sont nécessaires sur la nature du problème et les perceptions d’autres parties prenantes. Resumen Desde 1998, la ley de Sudáfrica dispone que toda persona adulta debe tener acceso a esterilización pero solo con su consentimiento informado. Sin embargo, el derecho a la esterilización y otros derechos sexuales y reproductivos no se han realizado plenamente, ya que las mujeres luchan por tener acceso a servicios limitados y existen alegaciones de discriminación y abuso de esterilización. En este estudio cualitativo se exploran las experiencias de 22 mujeres VIH-positivas en dos provincias, quienes relataron haber sido esterilizadas sin su consentimiento informado (n=18) o sin su conocimiento (n=4) entre 1996 y 2010. Los asuntos clave mencionados por las participantes fueron: falta de respeto por su autonomía, falta de información respecto al procedimiento de esterilización y presión sutil o explícita para firmar el formulario de consentimiento. Aunque el marco legislativo fue creado para garantizar una toma de decisiones informadas respecto a la esterilización, estas protecciones parecen haberles fallado a las mujeres VIH-positivas en este estudio. Los hallazgos indican que algunos profesionales de la salud consideran que basta con tener una firma en el formulario de consentimiento, sin importar cómo se obtuvo. Más aún, las percepciones de las mujeres de que fueron señaladas como que necesitaban ser esterilizadas simplemente porque era VIH-positivas, merecen una investigación más a fondo. Se necesitan más investigaciones sobre la naturaleza del problema y sobre las percepciones de otras partes interesadas.

Convergent ethical issues in HIV/AIDS, tuberculosis and malaria vaccine trials in Africa: Report from the WHO/UNAIDS African AIDS Vaccine Programme's Ethics, Law and Human Rights Collaborating Centre consultation, 10-11 February 2009, Durban, South Africa

BackgroundAfrica continues to bear a disproportionate share of the global HIV/AIDS, tuberculosis (TB) and malaria burden. The development and distribution of safe, effective and affordable vaccines is critical to reduce these epidemics. However, conducting HIV/AIDS, TB, and/or malaria vaccine trials simultaneously in developing countries, or in populations affected by all three diseases, is likely to result in numerous ethical challenges.MethodsIn order to explore convergent ethical issues in HIV/AIDS, TB and malaria vaccine trials in Africa, the Ethics, Law and Human Rights Collaborating Centre of the WHO/UNAIDS African AIDS Vaccine Programme hosted a consultation on the Convergent Ethical Issues in HIV/AIDS, TB and Malaria Vaccine Trials in Africa in Durban, South Africa on the 10-11 February 2009.ResultsKey cross cutting ethical issues were prioritized during the consultation as community engagement; ancillary care obligations; care and treatment; informed consent; and resource sharing.ConclusionThe consultation revealed that while there have been few attempts to find convergence on ethical issues between HIV/AIDS, TB and malaria vaccine trial fields to date, there is much common ground and scope for convergence work between stakeholders in the three fields.

Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study

Objectives Broad international guidelines and studies in the context of individual clinical trials highlight the centrality of community stakeholder engagement in conducting ethically rigorous HIV prevention trials. We explored and identified challenges and facilitators for community stakeholder engagement in biomedical HIV prevention trials in diverse global settings. Our aim was to assess and deepen the empirical foundation for priorities included in the GPP guidelines and to highlight challenges in implementation that may merit further attention in subsequent GPP iterations. Methods From 2008–2012 we conducted an embedded, multiple case study centered in Thailand, India, South Africa and Canada. We conducted in-depth interviews and focus groups with respondents from different trial-related subsystems: civil society organization representatives, community advocates, service providers, clinical trialists/researchers, former trial participants, and key HIV risk populations. Interviews/focus groups were recorded, and coded using thematic content analysis. After intra-case analyses, we conducted cross-case analysis to contrast and synthesize themes and sub-themes across cases. Lastly, we applied the case study findings to explore and assess UNAIDS/AVAC GPP guidelines and the GPP Blueprint for Stakeholder Engagement. Results Across settings, we identified three cross-cutting themes as essential to community stakeholder engagement: trial literacy, including lexicon challenges and misconceptions that imperil sound communication; mistrust due to historical exploitation; and participatory processes: engaging early; considering the breadth of “community”; and, developing appropriate stakeholder roles. Site-specific challenges arose in resource-limited settings and settings where trials were halted. Conclusions This multiple case study revealed common themes underlying community stakeholder engagement across four country settings that largely mirror GPP goals and the GPP Blueprint, as well as highlighting challenges in the implementation of important guidelines. GPP guidance documents could be strengthened through greater focus on: identifying and addressing the community-specific roots of mistrust and its impact on trial literacy activities; achieving and evaluating representativeness in community stakeholder groups; and addressing the impact of power and funding streams on meaningful engagement and independent decision-making.

HIV prevention responsibilities in HIV vaccine trials: complexities facing South African researchers

Researchers should protect the welfare of research participants through providing methods to reduce their risk of acquiring HIV. This is especially important given that late-phase HIV vaccine trials enrol HIV-uninfected trial volunteers from high-risk populations. Current ethical guidelines may be difficult for stakeholders to implement, and we know very little about what prevention services researchers are currently providing to participants or their successes, best practices and challenges. We recommend that current normative guidance be systematically reviewed and actual practice at vaccine sites be documented. Adding new tools to the current package of prevention services will involve complex decision making with few set standards, and regulatory and scientific challenges. We recommend that stakeholders (including regulators) convene to consider standards of evidence for new tools, and that decision-making processes be explicitly documented and researched. A further critical ethical task is exploring the threshold at which adding new tools will compromise the validity of trial results.

Payment of trial participants can be ethically sound: Moving past a flat rate

The South African Medicines Control Council (MCC) policy that trial participants be paid a flat-rate of R150 per visit in clinical trials has been criticised in the press1,2; its affordability by non-industry funded trials questioned3; that it is an excessive or inappropriate reward4; or that it neglects critical factors like the design or nature of the study.3, 4 It might also be argued that this amount will act as an “undue inducement” for participants to enrol. In our view the principal problem with the MCC policy is that it violates justice in that participants are paid the same amount but do not do the same things or make the same financial sacrifices.5 It has been argued that it would be more appropriate to have a broad contextualised policy6 and that participants should be paid for their time and expenses.4 However, these recommendations have not been specified in the South African literature. To take these recommendations forward we apply two theoretical models of payment (Wage Payment and Reimbursement models) to operationalise payments for time, inconvenience and expenses (TIE). We recommend that participants be paid for their time at a rate similar to national unskilled labour rates, with increments for inconvenient procedures (set nationally), and that they be refunded their direct expenses. This is operationally complex but ethically sound. Our recommendations for stakeholders include that the NHREC assume control of payment norms and endorses payment for TIE. A new payment approach will struggle to overcome the legacy of a flat rate because of community expectations and researchers who have enjoyed a simple administrative procedure.

“I feel like half a woman all the time”: The impacts of coerced and forced sterilisations on HIV-positive women in South Africa

abstract HIV-positive women are entitled to sexual and reproductive health rights, including access to contraceptives of their choice. One such option is sterilisation. Given its permanency, a womans decision to sterilise should be voluntary and fully informed. However, there have been multiple reports that HIV-positive women are being sterilised without their informed consent, and sometimes without their knowledge, in southern Africa and elsewhere. The Article explores the socio-cultural, physical and emotional/psychological impacts of coerced and forced sterilisations on HIV-positive women. It is part of a larger qualitative study, conducted in South Africa, which explored the experiences of 22 HIV-positive women who reported being sterilised without their informed consent. Involuntary sterilisation has devastating impacts on women, affecting them mentally and physically, and impacting on their relationships with their partners, families and the wider community. Many interviewees reported that being sterilised profoundly affected their perceptions of themselves as women. Involuntary sterilisations have grave social and emotional implications for already marginalised HIV-positive women. Therefore efforts should be made to address human rights violations in South African healthcare settings and to prevent further gender-based abuses.

Civil society perspectives on negative biomedical HIV prevention trial results and implications for future trials.

Abstract Community engagement is crucial to ongoing development and testing of sorely needed new biomedical HIV prevention technologies. Yet, negative trial results raise significant challenges for community engagement in HIV prevention trials, including the early termination of the Cellulose Sulfate microbicide trial and two Phase IIb HIV vaccine trials (STEP and Phambili). The present study aimed to explore the perspectives and experiences of civil society organization (CSO) representatives regarding negative HIV prevention trial results and perceived implications for future trials. We conducted in-depth interviews with 14 respondents from a broad range of South African and international CSOs, and analyzed data using thematic analysis. CSO representatives reported disappointment in response to negative trial results, but acknowledged such outcomes as inherent to clinical research. Respondents indicated that in theory negative trial results seem likely to impact on willingness to participate in future trials, but that in practice people in South Africa have continued to volunteer. Negative trial results were described as having contributed to improving ethical standards, and to a re-evaluation of the scientific agenda. Such negative results were identified as potentially impacting on funding for trials and engagement activities. Our findings indicate that trial closures may be used constructively to support opportunities for reflection and renewed vigilance in strategies for stakeholder engagement, communicating trial outcomes, and building research literacy among communities; however, these strategies require sustained resources for community engagement and capacity-building.