Book 5: Informed consent: Special measures

Special measures should be taken to protect persons who are, or who may be, limited in their ability to provide informed consent.

13.1 There are several categories of persons who are legally competent to consent to participate in research, and who have sufficient cognitive capacity to consent, but who may be limited in their freedom to make independent choices.

13.2 Those who plan, review, and conduct HIV vaccine trials should be alert to the problems presented by the involvement of such vulnerable persons. Appropriate steps must be taken to identify and offset their vulnerability. If it is not possible to address the vulnerability of such persons, they should be excluded from participation in trials. The involvement of vulnerable participants should be subject to the conditions outlined in Point 7.

13.3 Categories of vulnerable persons are described in Book 1, 5.3 and 7.1.3. For HIV preventive vaccine trials such persons may also include:

1. Persons who engage in illegal activities, such as commercial sex workers, or intravenous drug users. Such persons are vulnerable to undue influence and threats presented by possible breaches of confidentiality and action by legal forces. Persons engaging in socially stigmatised activities may be vulnerable to similar pressures; for example, men who have sex with men (see Point 7);
2. Persons who are junior or subordinate members of hierarchical structures, including members of the armed forces, students, employees and prisoners. Such persons are in dependent relationships (see Book 1, 7.1.3.7) and may be vulnerable to undue influence or coercion in that they may fear retaliation if they refuse co-operation with authorities (see Point 7);
3. Women living in cultures where their autonomy as individuals is not sufficiently recognised. They might be vulnerable to coercion from male partners, family, community members or traditional leaders (see Points 7 and 12.11); and
4. Persons from resource-poor communities or those dependent on welfare programmes. Such persons may be vulnerable to undue influence through offers of what others may consider modest material inducements (see Point 7).

13.4 Those who plan and conduct HIV vaccine trials should ensure meaningful, independent, ongoing informed consent of vulnerable persons, should respect their rights, foster their well-being, and protect them from harm (see Points 9 and 12). Extra efforts that should be taken to ensure this include:

1. Counselling to facilitate decision-making and to explore the impact of participation on such persons;
2. Evaluation of consent processes by an independent advocate, ombudsperson or group, or trial monitor;
3. Ongoing evaluation of potentially negative consequences related to trial participation; and
4. Access to supportive counselling and psychological and legal support services for trial-related harmful consequences, where necessary.