|UNAIDS-Sponsored Regional Workshops to Discuss Ethical Issues in Preventive HIV Vaccine Trials (UNAIDS, 2000, 52 p.)|
In September 1997, UNAIDS convened a meeting of experts in ethics, vaccine research, and social sciences in Geneva to discuss the ethical issues arising from the anticipated conduct of HIV vaccine trials in developing countries. It was apparent that this area of research had begun to highlight ethical dilemmas requiring special attention, and that a better understanding of these issues might facilitate the progress of HIV vaccine trials.
This meeting resulted in the identification of specific areas in which further discussion was deemed necessary, and the participants recognized the importance of these discussions occurring at the regional level. In addition, three background documents were written to further expand on the ethical theory underlying the issues that were identified.
The three regional workshops were organized to facilitate discussion on the ethical issues surrounding preventive HIV vaccine research. The outcome of these discussions is reported here, and was used to formulate a draft guidance document on ethics in HIV vaccine research. This draft document was discussed further at a meeting in Geneva on 24-26 June 1998, which included, among others, representatives of each of the regional workshops. In addition, this meeting addressed possible revisions and additions to current international guidelines on biomedical research, and recommendations for future involvement of UNAIDS in HIV vaccine research.
Participants were invited by both UNAIDS and the regional planning committees. In each region, the majority of participants was from the country which hosted the meeting, and a minority represented other countries in the region. Countries in the region surrounding the hosting country were represented by a single participant. Regional participants included lawyers, activists, social scientists, ethicists, vaccine scientists, epidemiologists, people working in nongovernmental organizations (NGOs), people living with HIV/AIDS, and people working in health policy. Each meeting included two individuals involved in vaccine trial advocacy in the United States. In addition, there were three to six members of the secretariat, some of whom varied between workshops. This included an expert in ethics, a vaccine scientist, and a rapporteur. The same rapporteur reported each of the three workshops.
In Brazil, 20 participants attended the workshop, in addition to three members of the UNAIDS secretariat. The majority was based in Brazil, with representation from Cuba, Barbados, Honduras, Trinidad, and the United States.
In Thailand, 17 participants attended the workshop, in addition to six members of the UNAIDS secretariat. The majority was based in Thailand, with one participant each from Australia, Cambodia, China, India, the Philippines, and Viet Nam, and two from the United States of America.
In Uganda, 16 participants attended the workshop, in addition to four members of the UNAIDS secretariat. The majority was based in Uganda, with one participant each from Ethiopia, Senegal, South Africa, and Zambia. In addition, at this workshop there was one participant from the National Institutes of Health in the United States.
Workshop participants did not receive the workshop materials in advance, and thus were introduced to the issues on the first day of sessions. Each workshop began with a half day of background presentations and open discussion on the basic science of preventive HIV vaccines, principles of conducting clinical trials, ethical analysis in biomedical research, and community involvement in design and conduct of research.
The remainder of the three-day workshop was dedicated to intensive discourse on the ethical issues arising from the possible conduct of preventive HIV vaccine trials in developing countries. The tool that was used to guide these discussions was a hypothetical research proposal for a phase III preventive HIV vaccine efficacy trial, accompanied by study questions to assist in focusing the discussion on specific issues. The participants were divided into three small groups of approximately equal size. In Brazil, this division was based on language preference, and one group was conducted in Portuguese, one in Spanish and one in English. In the other regions, all groups worked in English. In all cases, groups were pre-assigned with an attempt to ensure a mix of regional representation and professional expertise. None of the participants of the regional workshops was made aware of the outcomes of previous workshops prior to discussions.
An attempt was made for all of the discussion groups to cover all of the topics included in the scenario (although in practice, time did not always allow for this). For each topical area, the small group discussion was followed by a plenary session, where the small groups reported on major issues covered, and where the items were opened to discussion by all participants. An attempt was made to identify opinion on which the entire group could agree, and to identify where there remained disagreement when the discussion was closed.
On completing the workshop, a draft summary was reviewed in a final plenary session by the entire group, and was extensively modified through further discussion in order to ensure adequate representation of the groups conclusions. In Brazil, the draft summary, which was reviewed by the group, consisted of brief consensus statements and outlined areas of conflict. By contrast, in the other two regions the draft summary consisted of a nearly complete report (the final items discussed on the day of the review were not included in the report that the group reviewed). The draft was modified according to group input, and then reviewed by members of the UNAIDS secretariat who were present at the specific workshop. The author of this final document and all of the draft documents also served as rapporteur for all of the regional workshops.
Finally, evaluation questionnaires were distributed to the group in order to assess the effectiveness of the workshop.
The preliminary background discussions on ethics, science and community as they pertain to HIV vaccine research are not summarized here. Only the outcomes of the group discussions on the specific ethical issues are reported. In addition, language and terminology used to describe similar concepts often differs between regional reports. This is a reflection of the suggestions that came from participants in each region for how a concept should be described.
The intent of this report is to accurately reflect the discussion and conclusions that arose from each of the plenary sessions. It is important to note that the discussions that arose were facilitated by a specific case scenario (included in Annex 1) and questions related to this scenario. However, this report describes generalized concepts, opinions, and principles that came out of the discussions, in a manner that might be applied to any form of HIV vaccine research. Some participants expressed concern that this process of generalization from a specific case to broader statements may not be valid for some of the topics, and that other specific cases may have given rise to different ethical principles being described.
For this report, an attempt was made to condense the plenary discussions into topical areas. These topical areas do not necessarily coincide with the numerical divisions made in the study questions. Within each topical area, the level at which consensus was reached is identified by the title consensus. There were no votes taken on these issues, and consensus here does not necessarily reflect unanimity, but rather a general sense of agreement without major resistance from any participants. Where there was significant disagreement or controversy on a topical area, this is identified by the title Controversy. Finally, where there was general discussion that added detail to the consensus statement, or describes specific regional experiences, this is identified by the title discussion.