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Preliminary report of project "Strengthening ethical review capacity of developing countries in the planning and conduct of HIV vaccine trials".
UNAIDS has commissioned the University of Bergen to plan and conduct four training workshops in research ethics for members of research ethics committees in countries where HIV vaccine trials are being carried out or where there are plans for such trials. As of December 1, 1999 three workshops have been conducted:
Geneva, March 1999
Stellenbosch, South Africa, July 1999
Rio de Janeiro, Brazil, October 1999
A total of 67 attended these workshops from countries in the respective regions where HIV vaccine trials are carried out or are being planned. The Geneva workshop lasted two days and was a pilot workshop. The two others built on the experiences of the Geneva workshop with added topics and lasted three days. A fourth workshop is being planned for Asia in Bangkok during the Spring of 2000.
Rather than simply presenting overviews of topics related to research ethics, the program was designed to enable participants to discuss controversial cases in HIV-related research during the past few years. By discussing real cases, the participants would obtain training in handling future controversial cases of a similar nature.They included persons from countries currently preparing for HIV vaccine trials, or where HIV vaccine trials are underway. The participants included people with extensive backgrounds in research ethics as well as people with limited experience, which presented a challenge in terms of preparation of course materials. Topics covered included, how to balance the interests of research subjects against society's interest in obtaining reliable knowledge when initiating and terminating clinical trials, when it is legitimate to carry out clinical trials that take advantage of different economic and other types of conditions between countries, and the responsibilities of sponsors for participants in trials in terms of treatment outside the trial protocol. These are issues where there is no agreement, but it is necessary for committee members to have some understanding of these issues as they will remain as important issues in the design of future HIV vaccine trials. Based on the experience and evaluations from these three workshops, the approach has been largely sucessful. One should also note that there has been a steady increase in the mean scores in the evaluations of the workshops, from 4.1 in Geneva to 4.5 in Stellenbosch to 4.6 in Rio, on a scale from 1-5. In spite of this, one should consider the following recommendations for modifications in the workshop format based on the experience so far:
Program UNAIDS training workshop in research ethics
Rio de Janeiro, Brazil, October 13-15, 1999
Wednesday, October 13
9:00 Welcome. Presentation of participants
9:30 Reidar K. Lie Introduction to workshop
9:40 Saladin Osmanov Current status of HIV vaccine development
10:30 Coffee/Tea
11:00 Ruth Macklin Overview of ethical principles
11.45 Brief country presentations on research ethics
Each participant is requested to bring with them information about the current status of Research Ethics Review in their country, and an overview of what they see as major challenges for appropriate development of review procedures. One person from each country will be asked to present the situation in their countries.
13:00 Lunch
14:00 Reidar K. Lie Responsibilities composition and functions of Research Ethics Committees: International Standards and Local/National situations
What documents should be submitted to an REC and how should they be reviewed; How should standard operating procedures be established that are in accordance with international guidelines and sensitive to local/national considerations; How can RECs and REC organizations implement systems of quality assurance.
14:30 Ruth Macklin: Informed consent
Elements of informed consent; Continued challenges to implementation of Informed Consent Guidelines
15:15 Coffee/Tea
15:30 Group work: Informed consent. Case. Perinatal transmission studies (only this aspect). VaxGen's Phase Vaccine III trial.
The first case is supposed to illustrate the challenges of implementing informed consent guidelines. Groups should discuss how much understanding one should aim at; procedures that might facilitate understanding and the role of RECs, if any, in monitoring informed consent procedures. The second case is supposed to illustrate controversies over whether information about scientific disagreements should be provided to trial participants.
17:00 Plenary: Presentation of Group work
17:30 End of day one
Thursday, October 14
9:30 Reidar K. Lie Evaluation of Risks and Benefits When Deciding When to Initiate or Terminate a Clinical Trial
Disagreements among scientists. Role of Data and Safety Monitoring Boards in terminating clinical trials prematurely. The inherent conflict between benefit to individual and benefit to society. Proposals to solve this conflict. Role of informed consent.
10:15 Coffee/Tea
10:30 Group Work: The Merck Study in Brazil
This case is supposed to illustrate problems concerning at what time there is sufficient evidence of benefit, and the conflicts of interest that may occur (company needing data to satisfy regulatory requirements).The groups should focus on how a REC should handle this type of disagreements among scientists. Can one suggest substantive or procedural guidelines?
12:00 Plenary: Presentation of Group Work
12:30 Lunch
13:30 Solly Benatar: Justice and medical research: a global perspective
14:00 Group work. The South African Controversy over continuation of treatment. The Thai natural history of perinatal transmission study.
Both of these cases are supposed to illustrate the problem of different economic conditions between countries. They also raise the question of whether one has special obligations to research subjects, and the question of inducement.
15:30 Coffee/Tea (Served during group work)
16:00 Plenary Presentation of Group Work
16:30 End of day two
Friday, October 15
9:00 Reidar K. Lie Ethical issues in behavioral research
Issues of informed consent, confidentiality, psychological and social harm. Stigmatisation.
9:30 Group work Ethical issues in behavioral research and epidemiological research
10:30 Coffee/Tea
11:30 Presentation of Group work
12:00 Evaluation of workshop
12:30 Lunch and departure