SUMMARY

The outcomes of the three regional workshops were very different on some topics and similar on others. The following is a brief outline of issues on which the three regions held similar perspectives and those on which they did not.

Vulnerability to Harm or Exploitation: The current terminology of ‘developed’ and ‘developing’ is not adequate for comparing the characteristics of a population, community or country which lead to vulnerability in relation to vaccine trials. Rather, there are specific conditions that contribute to vulnerability that should be recognized and addressed in these discussions. These were defined, with minor differences, by the three regions.

Collaboration in Phase I, II and III Trials: There was agreement that repeating phase I and II trials in a host country that have already been conducted in a sponsor country is useful for familiarizing the public, government, and scientific community and for building capacity. However, there was disagreement among regions on whether phase I and II trials should be conducted in a host country if they were not already completed in the sponsor country. There was also disagreement as to whether it is always necessary to repeat a phase I and II trial in a host country that has already been completed in a sponsor country, and whether it is always necessary to conduct a phase III trial in the sponsor country prior to or simultaneously with conducting a phase III trial in the host country. Scientific and Ethical Review Process: There were some differences in how each region thought this should be conducted. However, there was agreement that scientific and ethical review capacity must both be available and effective in the host country before an HIV vaccine trial is considered. There was also agreement that this is an area where international organizations such as UNAIDS have an important role to play. This role was defined by all groups as including capacity-building, but by some groups also as including conducting a complementary ethical review of trials and providing guidelines for representation on ethical review committees. Other issues discussed included how to ensure independence of the review process, what would constitute appropriate ethical review in the sponsor country, how capacity can be built, and the role of the community and government.

Community: Members of the community (including at a minimum the people who are likely to participate in trials, but usually also other groups) should be part of the process of development, approval and conduct of HIV vaccine trials. Defining ‘community’, mechanisms for ensuring active participation and approaches to addressing disagreement within a community were discussed.

Control Arm in Trials: The use of a substance in the control arm of an HIV vaccine trial that is not active in preventing HIV is ethical as long as an effective vaccine is not known. However, there was not agreement on whether a vaccine that is known to be effective against another disease should be offered to participants, nor what level of effectiveness of a proven HIV vaccine would warrant that it be used in a control arm.

Informed Consent: Individual informed consent is required for all HIV vaccine trials. However, it was acknowledged that this is often difficult to accomplish, and many problems specific to the regions were described, with some potential solutions being offered.

Special Populations: Women of childbearing age, pregnant women, children, and persons with mental disabilities were discussed. There was a variety of opinions on these issues, both within and between regions, and in most cases there was not agreement. Controversy arose over whether paternalism on the part of the scientific community is justified; whether individuals should have the right to decide for themselves to participate in trials or not, given the data available; and whether the ‘traditional’ approach of excluding some of these groups places them at an unreasonable disadvantage because data on vaccine effectiveness and access to the vaccine will be delayed.

Counselling: Participants in an HIV vaccine trial must have access to high-quality risk-behaviour counselling and to condoms and syringes. There was discussion and some difference of opinion on what this counselling should include, what ‘standard’ should be applied, how to ensure quality and how to ensure independence from the investigators. However, there was agreement that counselling should never be compromised in any country.

Treatment and Care: The regions differed widely between one another on whether participants who become infected during the course of a trial should be provided with HIV treatment if it is not generally available in the host country. However, on this issue, there was generally agreement within each of the regions. One region felt that treatment should be available at the level of the sponsor country, another that it should be available at the level of the host country, and the third took a position somewhere between these two.

Undue Inducement and Coercion: This was discussed only briefly in most regions. It arose in the context of providing a known public health vaccine to participants in the control arm of a trial, and in the context of providing treatment to those who become infected in the trial. Opinion differed widely on the significance of undue inducement in HIV vaccine trials.

Compensation: Regions varied on the aspects of compensation for harm that were discussed. Intellectual Property: The contribution of host countries to the success of HIV vaccine trials is substantial, and thus requires that discussion on claim to intellectual property for a specific trial be carried out prior to the trial and be specified in the contract. There was discussion on who in a host country might have claim to intellectual property and how negotiation of intellectual property could be combined with negotiation of other benefits to the host country that might arise from discovery of an effective product.

Access to Vaccine: All regions agreed that historical examples of ‘developing country’ participation in vaccine research where access to the final product has not occurred must not be repeated in HIV vaccine research. Effective vaccine must be free and available at least to those who participated in the trial and to other high-risk groups in the host country. Potentially, the product should also be available to other developing countries. It was agreed that a discussion on availability should take place prior to the trial beginning, but it was not agreed what level of assurance, and what level of detail should or could be included in the agreement prior to knowing results of the trial.