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. (shrink)

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. (shrink)

South Africa is a major hub of HIV prevention trials, with plans for a licensure trial to start in 2015. The appropriate standards of care and of prevention in HIV vaccine trials are complex and debated issues and ethical guidelines offer some direction. However, there has been limited empirical exploration of South African stakeholders’ perspectives on ethical guidance related to prevention and care in HIV vaccine trials.

Civil society organizations (CSOs) have significantly impacted on the politics of health research and the field of bioethics. In the globalHIVepidemic,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 inHIVresearch. This study explored the perspectives ofCSOrepresentatives involved inHIVprevention trials (HPTs) on the impact of premature trial closures on stakeholder engagement. Fourteen respondents fromSouthAfrican and internationalCSOs representing activist and advocacy groups, community mobilisation initiatives, (...) and human and legal rights groups were purposively sampled based on involvement inHPTs. Interviews were conducted fromFebruary‐May 2010. Descriptive analysis was undertaken across interviews and key themes were developed inductively.CSOrepresentatives largely described positive outcomes of recent microbicide andHIVvaccine trial terminations, particularly inSouthAfrica, 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 toCABs as mechanisms for engagement. Key issues forCSOs in relation to research were also raised. (shrink)

Researchers and sponsors are required to assist HIV prevention trial participants to remain HIV-uninfected by ensuring access to prevention services. Ethics guidelines require that these HIV risk-reduction services be state of the art. This and related ethics recommendations have been intensely debated. This descriptive study aimed to identify actual HIV prevention practices for two HIV vaccine trials at five South African sites, to explore whether actual practices meet guideline recommendations and to discuss implications for practices and ethics guidelines. Practices were (...) examined through a review of site documents and interviews with site staff and network representatives, as well as community advisory board and research ethics committee representatives. A thematic analysis of HIV prevention practices, perspectives and perceived challenges was undertaken. Findings indicated that there was a high degree of correspondence between actual practices in South African HIV vaccine trials and guideline recommendations. Key challenges for implementing prevention services were identified as partnerships, provider-promotion of services and participant uptake of services. Practices deviated most from guidelines with regard to the description of prevention plans in informed consent forms. Recommendations are made for both practices and ethics guidelines. (shrink)

Until recently, any sex or sexual activity with a person under the age of 16 was criminalised, regardless of consent. All such incidents were considered criminal offences and needed to be reported to the police. This paper explores the knowledge, practices and perspectives of seventeen social workers in KwaZulu-Natal in relation to their mandatory reporting responsibilities on consensual underage sex. All social workers were clear about their reporting responsibilities regarding child abuse and non-consensual underage sex. However, findings suggest that social (...) workers were less clear on the exact circumstances in which they ought to report consensual underage sex. Most participants indicated that they would make individual assessments about when to report underage consensual sex and sexual activity. Such decisions would be influenced by structural factors, the personal circumstances of affected children and the availability of other interventions to address early sexual activity. This study has shown that social workers are struggling to comply with mandatory reporting responsibilities involving underage consensual sex. Most social workers approach reporting of consensual sex and sexual activity differently to other reporting responsibilities and use a case-by-case approach. Given these findings, it is argued that parliament should consider reforming mandatory reporting provisions so that there is a distinction between the obligation to report consensual and non-consensual sexual offences against children. The mandatory obligation to report non-consensual sexual offences against children should remain but the obligation to report consensual sex or sexual activity should be discretionary and depend on the facts of each case. (shrink)

Background The South African legal framework requires mandatory parental/legal guardian consent for all research with children. Ethics guidelines provide some reprieve by allowing RECs to grant waivers of parental or guardianship consent in certain defined circumstances. In the first instance, consent may be provided by a proxy when parents or guardians are unavailable, for example with orphaned children. In the second instance, guidelines permit adolescent self-consent when the nature of the study justifies this approach, for example, research on sensitive issues (...) like sexual behaviour or substance use. Discussion South African guidelines set several conditions that must be met for waivers to be granted. These norms overlap with those in international guidelines. However, the ethical norms, especially related to self-consent are sometimes vague. This article critically evaluates the consent norms in the national ethics guidelines and makes recommendations for reform to ethics guidelines in a way that recognises the value of child participation in research, their evolving decision-making capacity and their best interests. Conclusion Recommendations are made to harmonise ethics guidelines and law in a way that promotes child participation in research, to ensure additional protections for adolescents when self-consent is allowed, and to withdraw procedural requirements for the community endorsement of self-consent strategies. (shrink)

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. (shrink)