Macqueen KM, Namey E, Chilongozi DA, Mtweve SP, Mlingo M, Morar N, Reid C, Ristow A, Sahay S, Hptn T, Team SO. Community perspectives on care options for HIV prevention trial participants. AIDS Care 2007;19:554-60.
There is on-going global debate and policy-setting concerning researchers’ obligations to meet the health needs of people participating in HIV prevention trials in resource-poor settings. The perspectives of local community stakeholders on this issue are poorly understood as most of what is presented on behalf of communities where research takes place is anecdotal commentary. Using qualitative methods (130 in-depth interviews and 20 focus groups) MacQueen and colleagues assessed perceived fairness of different strategies to meet the health needs of women who become HIV-infected during a hypothetical vaginal microbicide trial. Respondents included HIV prevention research participants, community stakeholders and health-care service providers in ten sites in seven countries (South Africa, Malawi, Tanzania, Zimbabwe, Zambia, India, US). Many respondents perceived referrals to be a potentially fair way to address care and treatment needs but concerns were also voiced about the adequacy of local health-care options and the ability of trial participants to access options. Most respondents viewed the provision of antiretroviral treatment by researchers to HIV-infected trial participants as unfair if treatment was not sustained beyond the end of the trial. The results underscore the importance of effectively linking trial participants to sustainable, community-based treatment and care.
Editors’ note: This formative research with women in ten communities in Africa, India and the USA informed policy, not only at Family Health International, but among other research and community partners around the world. More information on the issues of standard of prevention and access to care is available from UNAIDS through two publications: Ethical considerations for biomedical HIV prevention trials and Good Participatory Practices in biomedical HIV prevention trials.
Tarantola D, Macklin R, Reed ZH, Kieny MP, Osmanov S, Stobie M, Hankins C. Ethical considerations related to the provision of care and treatment in vaccine trials. Vaccine 2007 Jun 21;25(26):4863-74.
Ethical principles of beneficence and justice combined with international human rights norms and standards create certain obligations on researchers, sponsors and public health authorities. These include treatment provision for participants enrolled in clinical trials of vaccines, drugs and other new preventive and curative technologies and methods. However, these obligations are poorly defined in practical terms, inconsistently understood or inadequately applied. Vaccine clinical trial designs normally define standards of prevention applicable to the population where the trial is to take place. The present document addresses specifically the setting of standards applicable to care and treatment in vaccine trials. The lack of clear guidance on how to achieve the optimal synergy between the development of new health technologies, on the one hand, and the promotion and protection of ethical and human rights principles, on the other, is a barrier to the progress of health research and therefore to the advancement of public health. The World Health Organization and UNAIDS have engaged in a series of consultations in Africa, the Americas, Asia and Europe to reflect on how this aim could best be achieved. This document highlights the outcome of these consultations. It proposes a structured approach to consensual decision making in the context of the clinical trial of vaccines against such public health challenges as HIV and newly emerging or threatening epidemics. A structured approach involving investigators and sponsors in a consultative process with trial communities and other stakeholders in research will ensure that the needs and legitimate expectations of trial participants are appropriately met, obligations towards them are delivered and, as a result, ethical research is facilitated in the interest of public health.
Editors’ note: Who will provide and who will pay for the treatment and care of people who become infected during a biomedical HIV prevention trial has been hotly debated now for ten years. UNAIDS in collaboration with WHO has revised Ethical considerations for biomedical HIV prevention trials and in collaboration with the AIDS Vaccine Advocacy Coalition, and a Working Group with diverse membership, has created Good Participatory Practices in biomedical HIV prevention trials. Both of these documents make it clear that providing access to antiretroviral treatment for those who seroconvert in an HIV prevention trial is the accepted standard.
February 26th, 2008 at 1:22 pm