South African AIDS Vaccine Initiative (SAAVI):
Research on Community Readiness and the Role of Community Advisory Boards
Goals: The goals of this research are: to assess the extent to which community members are adequately prepared to make informed decisions about whether they want to participate in new experimental HIV vaccine prevention trials; and to examine the role of Community Advisory in insuring that adequate protection are in place. Since the conduct of the controversial HIV-perinatal transmission trials in the early 1990s, debates have raged about the ethics of international health studies. In response to these controversies, a number of bioethicists have recently issued calls to mandate community involvement in decision-making about the conduct of health research. One major concern raised by these analyses is whether Research Ethics Committee (REC) reviews and individual informed consent provide sufficient ethical safeguards in all contexts. To advance the development of sound context-appropriate ethical standards, the purpose of this research is to develop a principled justification for the ethical assessment of international health research protocols by community representatives and to make practical recommendations regarding a feasible process for achieving community oversight. This research is being conducted in collaboration with the Medical Research Council in South Africa.
Methods: The study is proceeding in three stages: (1) semi-structured, open-ended interviews with the major stakeholders involved in such research; (2) the development, validation and administration of a questionnaire designed to assess perceptions of (a) current activities and responsibilities of CABs; (b) their success in carrying out these activities; and (c) normative preferences regarding the scope of CAB operations; and (3) the development, validation and administration of a questionnaire to assess community readiness for participation in AIDS vaccine trials.
In the first stage of this research, we use a qualitative research design based on individual and focus group interviews. The research is based on a theoretical sampling process, identifying potential interviewees on the basis of their involvement with HIV/AIDS vaccine trials in South Africa. The research aims to interview 2-3 people occupying each of the following positions: CAB members, principal investigators, research site staff, community educators/recruiters, research ethics committee members, trial participants and senior South African AIDS Vaccine Initiative (SAAVI) staff members. (SAAVI is a program of the Medical Research Council responsible for overseeing the conduct of all HIV vaccines trials in South Africa.) The interviews are open-ended, focusing on issues identified in the literature, including: 1) current involvement in HIV prevention research, 2) perceptions of community participation, 3) CAB operations, 4) perceptions of research in South Africa, 5) recruitment strategies, 6) community education, 7) perceptions the Masikhulisane Programme (a national vaccine education program run by SAAVI), and 8 ) adolescent participation in vaccine trials.
In the second stage of the research, based on the interview results, we are developing and implementing a validated questionnaire designed to assess the range and impact of current CAB activities and to determine normative preferences (what CABs should be doing) from the perspective of different stakeholder groups. Topics to be addressed in the interviews and questionnaire include: the perceived purpose of the CAB; their role in research protocol development and modification; in community education; in the informed consent process; in assuring community members’ knowledge of the risks and benefits of participation in HIV vaccine trials; in recruitment; in preventing exploitation at the individual and community level; in disseminating the research results; in securing access to the experimental therapies (if found to be effective); the process of determining CAB membership; CAB operations (e.g., administrative structure, trainings, decision-making procedures, compensation, etc.); their power and authority; interactions between the CAB and the PI and IRB (or REC); operational independence and sources of support; motivations for joining CABs; and trust and perceptions of the ethical conduct of HIV clinical research in their country.
In the third stage of the research, also based on the interview results, we are developing and validating a questionnaire designed to assess community readiness for participating in AIDS vaccine trials. This survey instrument is being used for three purposes: as an evaluation tool for pre-post measure of community education programs; to compare the levels of readiness of communities that have been exposed to vaccine trials with those that have not; and to compare the relative effectiveness of research site-run education program with government-run community education programs. Topics to be addressed include: knowledge about the purposes and conduct research, clinical trials, vaccine trials and HIV; the risks and benefits of research; confidentiality; compensation, incentives and undue inducement; voluntary participation; trust in adequate protections; therapeutic misconception; participation selection; auxiliary duties of researchers; and the perceived quality of different sources of information.
Principal Investigators: This research is being led by Dr. Priscilla Reddy at the Medical Research Council and her colleagues, Dr. Sibusiso Sifunda and Dr. Shamagonam James in collaborations with Dr. David Buchanan at the UMass Institute for Global Health.