3. Ethical and Scientific Review

Consensus:

There must always be both an effective ethical review and scientific review mechanism available in the host country before a vaccine trial may proceed in that country, and these must review all HIV vaccine studies proposed for conduct in that country.

Discussion:

The conduct of vaccine research is not a one-time event but a long-term process of development. The sponsoring country and independent bodies such as UNAIDS should provide support in this area. This support may include formulating guidelines and assistance on how to develop ethical and scientific review capability, developing guidelines on the composition of an ethical review committee, or conducting its own complementary ethical review of a study after it has been evaluated locally. The community should be involved in the ethical review process.

The distinction of sponsor and host on the basis of nation-states may not be appropriate for this kind of review of research. Sponsors are often multinational corporations, and their country of affiliation may not be clear. In addition, the host may not be adequately defined by nation-state boundaries, but more appropriately as certain populations or communities, hospitals or cities. Use of sponsor and host countries implies developed and developing attributes, and this may be inappropriate. There may be a need to develop a form of international review process.

What ethical review bodies in the country of a sponsor should review proposed research, especially in countries where many bodies at many different levels area available? It was agreed that this process must be independent of the sponsor, but the question of which is the appropriate body was left unresolved. Final approval of a study in a host country, following ethical and scientific review, should follow existing regulations in that country.

It is difficult to determine what representation should exist on ethical review committees, but codifying this representation should occur at the local level with the assistance of international guidelines.

Controversy:

Representatives from the host country could be included on the ethical review body of the sponsoring country, or on the data and safety monitoring board. Some participants shared the opinion that representation on the ethical review committee of the sponsor would be valuable in educating the sponsor on the issues relevant to the host. However, others felt this would not be productive.

In practice, the ethical review mechanism of the host country might be formed immediately prior to the study protocol being reviewed. There was disagreement on whether or not this is adequate for reviewing HIV vaccine trials.

There was considerable controversy concerning the assurance of independence of the ethical review process, both within the host country and the sponsor country. It was generally agreed that ethical review needs to be free of outside influence on the decision-making process (such as from the sponsor company). However, the mechanism for assuring independence, and the bodies that pose the greatest threat to independent decision-making was controversial.