The 'over-researched community': An ethics analysis of stakeholder views at two South African HIV prevention research sites.

Health research in resource-limited, multi-cultural contexts raises complex ethical concerns. The term 'over-researched community' (ORC) has been raised as an ethical concern and potential barrier to community participation in research. However, the term lacks conceptual clarity and is absent from established ethics guidelines and academic literature. In light of the concern being raised in relation to research in low- and middle-income countries (LMICs), a critical and empirical exploration of the meaning of ORC was undertaken. Guided by Emanuel et al.'s (2004) eight principles for ethically sound research in LMICs, this study examines the relevance and meaning of the terms 'over-research' and 'over-researched community' through an analysis of key stakeholder perspectives at two South African research sites. Data were collected between August 2007 and October 2008. 'Over-research' was found to represent a conglomeration of ethical concerns often used as a proxy for standard research ethics concepts. 'Over-research' seemed fundamentally linked to disparate positions and perspectives between different stakeholders in the research interaction, arising from challenges in inter-stakeholder relationships. 'Over-research' might be interpreted to mean exploitation. However, exploitation itself could mean different things. Using the term may lead to obscured understanding of real or perceived ethical concerns, making it difficult to identify and address the underlying concerns. It is recommended that the term be carefully and critically interrogated for clarity when used in research ethics discourse. Because it represents other legitimate concerns, it should not be dismissed without careful exploration.

Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study.

Obtaining voluntary informed consent for research participation is an ethical imperative, yet there appears to be little consensus regarding what constitutes a voluntary consent decision. An instrument to assess influences on participants' consent decision and perceived voluntariness was developed and piloted in two South African HIV clinical trials. The pilot study found high levels of perceived voluntariness. The feeling of having no choice but to participate was significantly associated with lower perceived voluntariness. Overall the data suggest that it is possible to obtain voluntary and valid consent for research participants in ethically complex HIV clinical trials in a developing country context.

Measuring voluntariness of consent to research: an instrument review.

The conceptual complexity of the term voluntariness has resulted in relatively few empirical studies of the voluntariness component of consent to research. As the call for a formal assessment of voluntariness to be incorporated into the consent process intensifies, more researchers are responding to the challenge of developing a valid and reliable measure of voluntariness. The purpose of this article was to summarize and describe the empirical literature on voluntariness of consent. As part of a broader study on the voluntariness of consent to research, existing empirical studies of voluntariness of consent to research were reviewed to establish how voluntariness of consent to research has been assessed to date. Fifteen studies using different voluntariness assessment instruments were identified and included in the review. The review found that little attempt has been made to systematically collect data on the reliability and validity of voluntariness assessment instruments. No two instruments reviewed were found to be based on a shared conceptualization of voluntary consent to research.

Compensation for research-related injury in NIH-sponsored HIV/AIDS clinical trials in Africa.

Concern has been voiced in the research ethics literature that under U.S. federal regulations U.S. sponsors, particularly the NIH, are not required to provide compensation for the treatment of research-related injury for trial participants or to allow grant funds to be used by investigators for appropriate insurance. This is problematic in developing country contexts because most participants are unlikely to have health insurance, resulting in overburdened and under-resourced health systems in many developing countries being responsible for providing care and treatment for research-related injury. This study provides preliminary insight into how respondent principal investigators of NIH-sponsored HIV/AIDS clinical trials in Africa and African research ethics committees deal with compensation for research-related injury. The majority of PIs surveyed provided free treatment for research-related injury, but few provided other forms of financial reparation to participants. The study also found that half of the PIs surveyed indicated that NIH funds were used for compensation, highlighting a contradiction between literature and practice. The majority of REC chairs surveyed indicated that their RECs routinely reviewed compensation plans for research-related injury and that their ethics application forms specifically requested information on compensation. Findings from one southern African country revealed that NIH funds were not used to provide treatment and/or financial reparation for research-related injury. Instead, PIs from this country relied on the government or the individual research participant (and/or their medical aid/health insurer) to cover the costs of research-related injury. The findings are discussed in the light of the recent (December 2011) U.S. Presidential Commission for the Study of Bioethics report which recommends that research participants are morally entitled to compensation for research-related injury.

The use of students as participants in a study of eating disorders in a developing country: case study in the ethics of mental health research.

This article describes the ethical analysis of an eating disorder study in which a university-based researcher in South Africa set out to establish the cross-cultural validity of the Eating Disorders Inventory. The following ethical issues are considered in the analysis: study design, social value, study population, risks and benefits, oversight, informed consent, and posttrial obligations. The ethics analysis is based on an adaptation of the structured framework proposed by Emanuel et al. (The Oxford textbook of clinical research ethics; pp. 123-133, 2008) for ethical research in developing countries. The analysis reveals that research that, on superficial analysis, seems to be low risk and noninterventional can result in adverse psychosocial effects and complexities for research participants and researchers alike. The study underlines the need for special ethics scrutiny of mental health-related research proposals involving students as research participants, especially when conducted by their own teachers.

The ethics of HIV research with people who inject drugs in Africa: a desk review.

Injecting drug use is a growing problem in Africa and a growing risk factor for contracting HIV in the region. It is imperative that HIV research includes injecting drug users so that they too are able to benefit from safe and effective behavioural interventions and biomedical HIV prevention and treatment products. This article relates a critical review of the findings of a desk review of previously published literature. The article examines injecting drug use in relation to HIV-related risk and research in Kenya, Mauritius, Nigeria, South Africa and Tanzania. The ethical challenges of including people who inject drugs in HIV research in Africa are also presented. The review found injecting drug use to be on the increase in all the countries reviewed. HIV-risk behaviour among people who inject drugs, such as needle-sharing and higher-risk sexual behaviour, was also found to be widespread. Furthermore, criminalisation of drug use and strict anti-drug laws are common in the countries reviewed, while harm-reduction programmes for people who inject drugs were found to be limited. The review identified a number of ethical challenges to the involvement of people who inject drugs in HIV research in Africa. This includes the illegal status and stigma surrounding injecting drug use, which may complicate participant recruitment, enrolment and retention. In addition, a lack of funding for supportive programmes to help injecting drug users may hinder the provision of appropriate standards of prevention and care and treatment for those who seroconvert.

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.

BACKGROUND: Africa 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. METHODS: In 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. RESULTS: Key cross cutting ethical issues were prioritized during the consultation as community engagement; ancillary care obligations; care and treatment; informed consent; and resource sharing. CONCLUSION: The 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.

Ethics review in a developing country: a survey of South African social scientists' experiences.

We report the findings of a preliminary study of social science researchers' experiences of ethics review from a developing country perspective. Social science researchers' experiences of ethics review were coded as negative (42.6%), positive (21.3%), or mixed (36.2%). Ethics review was primarily experienced as negative for pragmatic reasons such as slow turnaround time, inadequate review and problems with the centralization of review. Our finding that South African researchers experience the same problems and frustrations with RECs as developed country researchers affirms that South Africa's problems with ethics review are not due to it being a less developed system, but to general review practices as they arise naturally in institutions. Developing countries thus have a unique opportunity to learn from the reported dissatisfactions and mistakes of developed countries, to avoid procedures that have hindered ethics review of much social science research in developed countries, and to fashion their own review procedures in ways that are more appropriate to key ethical issues arising in social science research and local conditions and resources.

WITHDRAWN: Ethical issues and ethics reviews in social science research.

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