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South African law provides that children under 18 years old can self-consent to medical treatments and terminations of pregnancy. An article published by van Heerden et al. in the South African Journal of Child Health in 2020 found that children 12 years and older were able to give informed consent to medical procedures because they were able to make a treatment choice, comprehend information, weigh options and provide reasons for their decision. However, only children older than 14 years possessed actual understanding of more abstract concepts. This paper considers whether the law is consistent with empirical data on child capacity. It does so by examining the evolution of laws regarding child capacity, interrogating current legal standards on capacity and ultimately evaluating whether the law reflects current empirical knowledge. We conclude that the law on medical treatment is not in conflict with the findings of van Heerden et al. However, there is less synergy between law and empirical data regarding terminations of pregnancy for children under 14 years old. Parliament placed an emphasis on access to health services and did not want age or parental consent to act as a barrier to adolescents getting medical assistance; however, data show that children younger than 14 years old struggle with more complex and abstract medical choices. We suggest that the recommendations in the Choice Act for counselling in terminations of pregnancy by children under the age of 14 years need to be more fully operationalised through the issuing of regulations or a national policy. [ABSTRACT FROM AUTHOR]

In April 2019, Nieuwoudt et al. published an article on the impact of age and education on cognitive functioning among coloured women in the Western Cape Province, South Africa (SA). The study reported that coloured women in SA have increased risk for low cognitive functioning, as a result of limited education and unhealthy lifestyles. The article was widely criticised, and the journal subsequently withdrew the piece. It was argued that the study was unethical as it perpetuated racial stereotypes through its failure to recognise the distinction between race and ethnicity when undertaking biological research on a race group. The study had received ethical approval, which raised pertinent questions about the ethics review process. This article looks at (i) the role of research ethics committees (RECs); and (ii) the normative framework within which ethics committees operate. It avers that an understanding of the ethical issues of scientific validity, fair subject selection and minimising harms must be viewed in the light of the complex social issues surrounding the construction of coloured identity in SA. The article finds that the REC should have considered this study unapprovable, because its methodology was based on racist assumptions, and its focus on one race or ethnic group posed social risks for that community. The REC ought to have interrogated why researchers were unclear in their distinction between race and ethnicity, and have been mindful of race being a social rather than a biological construct. [ABSTRACT FROM AUTHOR]

Adolescence and young adulthood are important periods of transition and therefore for action and intervention to ensure future sexual and reproductive health (SRH). Caregiver-adolescent communication about sex and sexuality is a protective factor for SRH, but there are often barriers to this. Adults' perspectives are limited within the literature but important as they should lead this process. This paper uses exploratory qualitative data from in-depth interviews with 40 purposively sampled community stakeholders and key informants to explore their insights into the perceived, experienced or expected challenges adults' experience when having these conversations within a high HIV prevalence, South African context. Findings suggest that respondents recognised the value of communication and were generally willing to try it. However, they identified barriers such as fear, discomfort and limited knowledge and perceived capacity to do so. They show that in high prevalence contexts adults grapple with their own personal risks, behaviours and fears that may affect their ability to have these conversations. This demonstrates the need to equip caregivers with the confidence and ability to communicate about sex and HIV, alongside managing their own complex risks and situations to overcome barriers. It is also necessary to shift the negative framing of adolescents and sex.

Background: The 2021 World Health Organization study on the impact of COVID-19 on older people (≥60 years) in the African region highlighted the difficulties they faced as the virus spread across borders and dominated the way of life. These difficulties included disruptions to both essential health care services and social support, as well as disconnections from family and friends. Among those who contracted COVID-19, the risks of severe illness, complications, and mortality were highest among near-old and older persons., Objective: Recognizing that older persons are a diverse group including younger- and older-aged individuals, a study was conducted to track the epidemic among near-old (50-59 years) and older persons (≥60 years) in South Africa covering the 2 years since the epidemic emerged., Methods: Using a quantitative secondary research approach, data for near-old and older persons were extracted for comparative purposes. COVID-19 surveillance outcomes (confirmed cases, hospitalizations, and deaths) and vaccination data were compiled up to March 5th, 2022. COVID-19 surveillance outcomes were plotted by epidemiological week and epidemic waves to visualize the overall growth and trajectory of the epidemic. Means for each age-group and by COVID-19 waves, together with age-specific rates, were calculated., Results: Average numbers of new COVID-19 confirmed cases and hospitalizations were highest among people aged 50-59- and 60-69-years. However, average age-specific infection rates showed that people aged 50-59 years and ≥80 years were most vulnerable to contracting COVID-19. Age-specific hospitalization and death rates increased, with people aged ≥ 70 years most affected. The number of people vaccinated was slightly higher among people aged 50-59 years before Wave Three and during Wave Four, but higher among people aged ≥ 60 years during Wave Three. The findings suggest that uptake of vaccinations stagnated prior to and during Wave Four for both age groups., Discussion: Health promotion messages and COVID-19 epidemiological surveillance and monitoring are still needed, particularly for older persons living in congregate residential and care facilities. Prompt health-seeking should be encouraged, including testing and diagnosis as well as taking up vaccines and boosters, particularly for high-risk older persons., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Abdelatif, Naidoo, Dunn, Mazinu, Essack, Groenewald, Maharaj, Msomi, Reddy, Roberts and Zuma.)

Background: South African women experience high levels of alcohol use and HIV infection during the perinatal period. Oral pre-exposure prophylaxis (PrEP) is highly effective at reducing HIV risk. We examined associations between alcohol use and PrEP use during pregnancy and postpartum., Methods: The PrEP in Pregnant and Postpartum women study is a prospective observational cohort of 1200 HIV-negative pregnant women enrolled at first antenatal care visit and followed through 12 months' postpartum in Cape Town, South Africa. The analytic sample comprised pregnant women who initiated PrEP at baseline and were not censored from study follow-up before 3-month follow-up. We examined associations between any or hazardous alcohol use (Alcohol Use Disorders Identification Test-Consumption score ≥3) in the year before pregnancy and PrEP continuation and adherence during pregnancy (self-report of missing <2 doses in past 7 days and biomarker-confirmed with tenofovir diphosphate in dried blood spots)., Results: Of 943 women on PrEP (median age of 26 years), 50% reported alcohol use before pregnancy, and 33% reported hazardous use. At 3-month follow-up, 58% of women were still using PrEP; 41% reported recent adherence, and 23% were biomarker-confirmed adherent. In multivariable models, hazardous alcohol use was associated with increased odds of continuing PrEP [adjusted odds ratio (aOR) = 1.54, 95% confidence interval (CI): 1.16-2.06], self-reported PrEP adherence (aOR = 1.41, 95% CI: 1.07-1.87), and biomarker-confirmed PrEP adherence (aOR = 1.35 95% CI: 0.98, 1.87). Associations were similar in models of any alcohol use and PrEP continuation/adherence., Conclusions: Pregnant and postpartum women who reported recent alcohol use had increased odds of continuing to take PrEP, indicating that higher risk women may continue on oral PrEP., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Of the 8 million people in South Africa living with HIV, 74% of persons living with HIV are on antiretroviral therapy (ART) and 65% are virally suppressed. Detectable viral load results in HIV-associated morbidity and mortality and HIV transmission. Patient barriers to care, such as missed wages, transport costs, and long wait times for clinic visits and ART refills, are associated with detectable viral load. HIV differentiated service delivery (DSD) has simplified ART delivery for clients who achieve viral suppression and engage in care. However, DSD needs adaptation to serve clients who are not engaged in care., Methods: A Sequential Multiple Assignment Randomized Trial will be undertaken in KwaZulu-Natal, South Africa, to test adaptive ART delivery for persons with detectable viral load and/or who are not engaged in care. The types of differentiated service delivery (DSD) which will be examined in this study are clinic-based incentives, community-based smart lockers, and home delivery. The study plans to enroll up to 900 participants-people living with HIV, eligible for ART, and who are not engaged in care. The study aims to assess the proportion of ART-eligible persons living with HIV who achieve viral suppression at 18 months. The study will also evaluate the preferences of clients and providers for differentiated service delivery and evaluate the cost-effectiveness of adaptive HIV treatment for those who are not engaged in care., Discussion: To increase population-level viral suppression, persons with detectable viral load need responsive DSD interventions. A Sequential Multiple Assignment Randomized Trial (SMART) design facilitates the evaluation of a stepped, adaptive approach to achieving viral suppression with "right-sized" interventions for patients most in need of effective and efficient HIV care delivery strategies., Trial Registration: ClinicalTrials.gov NCT05090150. Registered on October 22, 2021., (© 2023. The Author(s).)

This study examines baseline associations between alcohol use and HIV sexual risk among a cohort of HIV-uninfected pregnant women (n = 1201) residing in a high HIV burdened community in Cape Town, South Africa. Alcohol use was measured using a modified version of the Alcohol Use Disorder Identification Test (AUDIT). HIV sexual risk was measured through a composite variable of four risk factors: diagnosis with a STI, self-report of > 1 recent sex partners, partner HIV serostatus (unknown or HIV+) and condomless sex at last sex. Any past year alcohol use prior to pregnancy was reported by half of participants (50%); 6.0% reported alcohol use during pregnancy. Alcohol use prior to pregnancy was associated with increased odds of being at high risk of HIV (aOR = 1.33, 95% CI 1.05-1.68, for 2 risks and aOR = 1.47, 95% CI 0.95-2.27 for 3 risks). In addition to reducing alcohol use, several other strategies to address HIV sexual risk were identified. Evidence-based interventions to address alcohol use and other HIV sexual risk behaviors during pregnancy in South Africa are desperately needed. Qualitative work exploring individual and community level drivers of alcohol use among pregnant and breastfeeding women in this setting could support development of a culturally tailored intervention to address these issues in this population., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

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., (© 2022. The Author(s).)

Despite having some of the world's highest rates of HIV, there is a lack of knowledge on correlates of transmission risk among gay, bisexual and other men who have sex with men in Southern Africa. There is even less known about the factors that shape HIV risk in male-male couples. Using data from Together Tomorrow, a study of partnered GBMSM in South Africa and Namibia, this study assessed the individual and dyadic correlates of three major HIV risk factors in this population: substance misuse, transactional sex, and depressive symptomatology. Data were collected during November 2016-March 2017 via a quantitative survey conducted with 140 partnered MSM (70 couples) in Windohoek, Keetmanshoop, Walvis Bay, and Swakopmund, Namibia and 300 partnered MSM (150 couples) in Pietermaritzburg and Durban, KwaZulu-Natal, South Africa for a total sample size of 440 partnered MSM (220 couples). Results of multilevel modeling analyses show several significant factors present in partnered GBMSM that differ from studies of single GBMSM, with intimate partner violence being a significant correlate across all three risk factors. Future interventions should consider dyadic approaches and integrate IPV prevention and mitigation efforts to reduce HIV in this population as part of a multisectoral approach. To reduce rates of HIV in partnered GBMSM in Namibia and South Africa multilevel, multisectoral work is needed in policy, social norms change, and relationship-focused dyadic interventions to reduce the social and structural stigma facing male couples., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

The abduction and sexual violation of adolescents, especially in township contexts, has increasingly made headlines in South Africa. These incidents are evocative of jackrolling, a phenomenon that plagued townships during the apartheid upheavals in the late 1980s. The abduction of adolescents on their school journeys has been reported in several South African townships. In this paper, we report on a study in which we used participatory visual methods (i.e., cellphilms: short videos made with cellphones) to explore how 19 adolescent girls and boys living in the Inanda, Ntuzuma, and KwaMashu (INK) township precinct, outside Durban reflected on their vulnerability to sexual violence. Although the question was broad, our analysis of the visual data suggests that adolescents believed that their vulnerability to abduction and rape was almost inevitable. As such, in their cellphilms, they chose to portray their risk and vulnerability to abduction, rape, and even murder on their daily journeys to and from school. We found that through this methodology, adolescents were able to illustrate and/or articulate their fear of sexual violence. For them, violence was an inescapable reality that created fear and helplessness. This underscores the need for interventions, including the provision of safe scholar transport and visible policing in the community., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

There is strong evidence that gay, bisexual and other men who have sex with men (GBMSM) in African countries experience high prevalence of HIV. However, missing from the literature is an understanding of the HIV risk behaviors and prevention needs of partnered GBMSM in African countries. The Together Tomorrow project sampled 440 partnered GBMSM (220 couples) in South Africa and Namibia. Prevalence of HIV was high at 42%, with 33% of men in sero-discordant relationships. Despite high levels of HIV testing in the past 6 months (65%), condom use with main and outside sex partners was low. Men reported low levels of willingness to use pre-exposure prophylaxis (PrEP) (16%). HIV testing in the past 12 months and willingness to use PrEP were significantly associated with recent binge drinking and substance use. Men in sero-discordant relationships, those with sexual agreements and those who had experienced any form of IPV were all less likely to report that they had recently tested for HIV. There is a need to develop interventions that meet the unique needs of African partnered GBMSM and tackle stigma and discrimination as drivers of HIV risk in these settings.

Purpose: One third of people newly living with HIV/AIDS are adolescents. Research on adolescent HIV prevention is critical owing to differences between adolescents and adults. Parental permission requirements are often considered a barrier to adolescent enrollment in research, but whether adolescents view this barrier as the most important one is unclear., Methods: Adolescents were approached in schools in KwaZulu-Natal, South Africa, and at a sexually transmitted infection clinic at the Children's Hospital of Aurora, Colorado. Surveys with a hypothetical vignette about participation in a pre-exposure prophylaxis trial were conducted on smartphones or tablets with 75 adolescents at each site. We calculated descriptive statistics for all variables, using 2-sample tests for equality of proportions with continuity correction. Statistical significance was calculated at p < 0.05. Multivariate analyses were also conducted., Results: Most adolescents thought side effects (77%) and parental consent requirements (69%) were very important barriers to research participation. When asked to rank barriers, adolescents did not agree on a single barrier as most important, but the largest group of adolescents ranked parental consent requirements as most important (29.5%). Parental consent was seen as more of a barrier for adolescents in South Africa than in the United States. Concerns about being experimented on or researchers' mandatory reporting to authorities were ranked much lower. Finally, most (71%, n = 106) adolescents said they would want to extra support from another adult if parental permission was not required., Conclusion: Adolescents consider both parental permission requirements and side effects important barriers to their enrollment in HIV prevention research. Legal reform and better communication strategies may help address these barriers., (Copyright © 2020 Society for Adolescent Health and Medicine. All rights reserved.)

Background: South Africa (SA) has one of the highest rates of intimate partner violence (IPV) in the world. It is also in the midst of a demographic transition in which the number of people aged &gt;60 years is expected to double by mid-century. Despite the confluence of these two public health issues, there are no published studies on the epidemiology and risk factors for IPV in older SA women., Objectives: To provide a foundational understanding of IPV among women aged ≥50 years in SA., Methods: This study used the first-ever nationally representative sample of women aged &gt;49 (N=2 265) that includes data on physical, sexual, and emotional IPV. Both lifetime experience of IPV and IPV within the past 12 months were reported, as was the presence of controlling behaviours by the partner. Four multilevel logistic models and one multilevel linear regression model were fit to examine the demographic, developmental and structural correlates of IPV in women aged 50 - 95., Results: The lifetime prevalence rates for all types of IPV were slightly higher among older women than among women aged 15 - 49. Nine percent of respondents reported IPV in the past 12 months, and 35% reported at least one persistent controlling behaviour. Divorced/separated women and those who had witnessed IPV as a child had greater odds of reporting IPV. In contrast to the literature on younger women, education, race and wealth were not strong predictors of IPV in this sample of older women., Conclusions: This study is the first of its kind in the SA context, and shows that IPV is a persistent threat for women across the lifespan. It suggests that IPV may manifest differently in older women compared with women of reproductive age, necessitating future qualitative and quantitative studies that examine the correlates, causes and points of intervention unique to this growing population.

Conducting formative research is a scientific, ethical, and community engagement imperative. This article describes how formative research refined ethical processes for a family-based home-based counseling and testing (FBCT) intervention in KwaZulu-Natal. In-depth interviews were conducted to explore community ( n = 20) and key stakeholders' ( n = 20) needs, concerns, and perspectives on the FBCT model, including ethical issues for working with children and families. Data were analyzed thematically using NVivo software. Four key ethical considerations emerged, namely, respect for community norms and cultural practices; confidentiality, privacy, and forced disclosure; identifying potential risks and benefits; and voluntariness and capacity to consent. Data were used to refine the intervention and address participants' concerns by engaging the community, providing ethics training for intervention staff, and incorporating independent consent mechanisms for adolescent HIV testing that supported opportunities for family-based testing and disclosure.

There has been a recent increase in debates on the ethics of social media research, passive sensor data collection, and big data analytics. However, little evidence exists to describe how people experience and understand these applications of technology. This study aimed to passively collect data from mobile phone sensors, lapel cameras, and Bluetooth beacons to assess people's understanding and acceptance of these technologies. Seven households were purposefully sampled and data collected for 10 days. The study generated 48 hr of audio data and 30,000 images. After participant review, the data were destroyed and in-depth interviews conducted. Participants found the data collected acceptable and reported willingness to participate in similar studies. Key risks included that the camera could capture nudity and sex acts, but family review of footage before sharing helped reduce concerns. The Emanuel et al. ethics framework was found to accommodate the concerns and perspectives of study participants.

HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prevention research. For this reason, it is critical to study the implementation of relevant ethical-legal frameworks for such research in South Africa. This qualitative study used in-depth interviews to explore the practices and perspectives of eight members of South African research ethics committees (RECs) who have reviewed protocols for HIV vaccine trials. Their practices and perspectives are compared with ethics guideline requirements for standards of prevention.

South Africa (SA) has progressive legislation enabling adolescents to access various sexual- and reproductive-health services (SRH) independently, without consent from parents or legal guardians. This article reviews the SA legislative framework for adolescent access to SRH interventions. It outlines the five approaches adopted in current legislation to address adolescents' capacity to independently consent to specified health interventions, based on age, capacity and public policy requirements, or combinations thereof. Rather than subsume various health interventions under the umbrella of medical treatment, SA has separately legislated on many SRH interventions (e.g. HIV testing, contraceptives and terminations of pregnancy, among others). We identify strengths and weaknesses of the SA approach, and conclude with lessons learned from the SA experience which could inform discussion and debate on the most appropriate ways for countries to consider law reform that facilitates adolescent access to SRH services.

In terms of the Sexual Offences and Related Matters Amendment Act, consensual sex or sexual activity with children aged 12 - 15 was a crime, and as such had to be reported to the police. This was challenged in court in the Teddy Bear case, which held that it was unconstitutional and caused more harm than good. In June 2015, the Amendment Act was accepted by both the National Assembly and the National Council of Provinces, and came into operation on the 3 July 2015. This article looks at the amendments to sections 15 and 16 of the Act and what the reporting obligations for medical professionals and researchers are in light of the amendments, as well as the duty to provide medical services and advice to adolescents.

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., (© 2012 John Wiley & Sons Ltd.)

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., (Copyright © 2012 Reproductive Health Matters. Published by Elsevier Ltd. All rights reserved.)

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.

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.

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.

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.