Book 5: Vulnerable populations

The social context of a proposed research population that creates conditions for possible exploitation or increased vulnerability among potential research participants should be assessed, where this is relevant. Steps must be taken to overcome these conditions, and to promote and protect the dignity, safety and welfare of participants. The vulnerability factors and steps that will be taken to offset these should be described in the research protocol.

7.1 Some communities, described as 'developing' or 'underdeveloped', may be considered as inappropriate participants for some phases of trials, due to a real or perceived increased level of vulnerability to exploitation or harm. These terms tend to refer primarily to economic considerations, whereas there are other relevant factors that affect risk.

7.2. Those who plan and conduct HIV vaccine research should explore and identify aspects of the social context that create conditions for exploitation or increased vulnerability to harm, for the selected pool of participants.

7.3 Vulnerability factors affecting potential participants should be described in the research protocol, where relevant.

7.4 Those who plan to conduct HIV vaccine research in vulnerable communities should justify this, and describe reasons why the research could not be conducted in less vulnerable communities (see Book 1, 7.1.3.8).

7.5 Measures should be taken to overcome vulnerability factors, and these should be described in the research protocol.

7.5.1 Strategies to offset vulnerability include capacity building for, and the early involvement of, participating communities (see Point 5), the development of advocacy processes and meaningful and ongoing informed consent procedures (see Points 12 and 13).

7.6 In some potential research populations the conditions affecting vulnerability or exploitation may be severe. Where excluding such communities from the benefits associated with research seems inappropriate, every effort should be made to afford adequate protection. If ensuring adequate safeguards is not possible, HIV preventive vaccine research should not be conducted in that community, and a less vulnerable community should be chosen (see Book 1, 9.12.4.2.1).

7.7 Strategies to offset vulnerability should be rigorously evaluated. Trial counsellors, community structures and advocacy groups could play a useful role in this regard.

7.8 General characteristics of vulnerable communities are described in Book 1, 7.1.3.8.

7.8.1 Factors of particular reference to HIV vaccine research (see Point 13) include:

1. Social marginalisation of groups from which participants might be drawn, such as men who have sex with men and residents of informal settlements;
2. Legal marginalisation of groups from which participants might be drawn, such as commercial sex workers and intravenous drug users;
3. Junior or subordinate membership in hierarchical structures;
4. Prevailing gender or class factors that limit ability to give free informed consent;
5. Limited availability and sustainability of health care and treatment options;
6. Limited community structures, such as community-based organisations or forums; and
7. Stigma or discrimination (social, institutional, governmental) on the basis of HIV status, or inadequate ability to protect HIV-related human rights, and to prevent HIV-related discrimination, including that arising from participation in an HIV vaccine trial.

7.9 In South Africa many individuals at high risk of HIV infection (one eligibility criterion for participation in efficacy trials of HIV vaccines) may be simultaneously vulnerable to exploitation because of socio-historical factors, such as oppression and economic impoverishment.