Nicole Mamotte

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.

African AIDS Vaccine Programme for a Coordinated and Collaborative Vaccine Development Effort on the Continent

The African AIDS Vaccine Programme, formed in 2000, is a network of African HIV vaccine stakeholders, led by Africans across the continent, with a vision of an African continent without AIDS.

The Effect of Relationships on Decision-Making Processes of Women in Harare, Zimbabwe

A preliminary study aimed at investigating the potential impact of relationships on decision-making process and autonomy of women was conducted in Harare, Zimbabwe. The majority of women surveyed (87.6%) were prepared to consult their husbands, whereas only 46.6% said they would consult their relatives prior to participation in health research. Only 6.2% and 11.3% were prepared to keep their participation secret from their husbands their relatives, respectively. Overall, 58.6% were rated as autonomous, 22.5% partially autonomous, and 18.9% were rated as not autonomous. Age, educational level, employment status, and marital status of respondents were significantly associated with autonomous decision-making process.

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.

Abstract 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.

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.

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.

WITHDRAWN: Ethical issues and ethics reviews in social science research.

This article has been withdrawn consistent with Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy). The Publisher apologizes for any inconvenience this may cause.