Book 5: Research protocols and study populations

To conduct HIV vaccine research in an ethical manner the research protocol should be scientifically appropriate, and the desired outcome of the proposed research should potentially benefit the population from which research participants are drawn.

4.1 To be ethical, HIV vaccine trials should be based on scientifically valid research protocols. The scientific questions posed should be rigorously formulated in a research protocol that is capable of providing reliable responses.

4.2 Valid scientific questions relevant to HIV vaccine development are those that seek to:

1. Gain scientific information on the safety, immunogenicity (ability to induce immune responses against HIV) and efficacy (degree of protection) of candidate vaccines;
2. Assess safety in groups likely to be exposed in mass immunisation campaigns (e. g. HIV-infected persons) and in groups who would be targeted for immunisation (e. g. youth);
3. Determine immunological correlates or surrogates in order to identify the protective mechanisms and how they can be elicited;
4. Compare different candidate vaccines; and
5. Test whether vaccines effective in one population are effective in other populations.

4.3 The selection of the research population should be based on the fact that its characteristics are relevant to the scientific issues raised, and the results of the research should potentially benefit the selected population.

4.4 The research protocol should:

1. Justify the selection of the research population from a scientific point of view (see also Point 7);
2. Specify referral processes for those persons excluded from the trial, where relevant;
3. Outline how the risks undertaken by the participants from that population are balanced by the potential benefits to that population (see Points 9, 10, 14 and 16);
4. Describe the vulnerability factors of potential participants, where relevant (see Point 7);
5. Establish safeguards for the protection of research participants from potential harm arising from the research (see Points 7 and 9);
6. Demonstrate how the candidate vaccine being tested is expected to benefit the population in which testing occurs; and
7. Address particular needs of the proposed research population.

4.5 Those who plan and conduct HIV vaccine research should have a good understanding of the social, political, health and cultural context of the specific community or population where the research will occur. This should be based on competent appropriate social science data (see Book 1, 11.4.3. iv; and Points 5 ,7, 9, 12.11, 13, 14.5 and 16).

4.6 The research endeavour should actively benefit the community being researched (see Book 1, 11.4.3. iii).