| Book
5: Benefits |
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Efforts must be made to maximise the potential benefits of HIV preventive vaccine research. The research protocol should outline the benefits that participants in HIV preventive vaccine trials should experience as a result of their participation.
10.1 Some of the activities related to the conduct of HIV vaccine trials should benefit participants.
10.1.1 At a minimum, participants should:
- Have regular and supportive contact with health-care workers and counsellors throughout the course of the trial (see Point 12);
- Receive comprehensive information regarding HIV transmission and how it can be prevented, and access to appropriate HIV prevention methods, including barrier methods (see Point 14);
- Have access to treatment and care for HIV/ AIDS if they become HIV-infected while enrolled in the trial (see Point 16); and
- Receive compensation for travel, time and inconvenience relating to trial participation.
10.1.2 If the vaccine is effective, recipients may develop protective immunity to HIV infection or disease. 10.2 Expected benefits should be described in the research protocol presented to research ethics committees, and in the informed consent process.
10.3 Care should be taken that benefits, such as superior attention and improved treatment and care (see Point 16), are not presented in a way that unduly influences freedom of choice regarding participation (see Book 1, 9.13.2.1/ 2 and Point 12.8.3).
10.3.1 Community representatives should be consulted to assist investigators to distinguish between benefits and undue inducements for participants and participating communities, taking into account local conditions (see Point 12.8.3)
10.4 Where participants incur expenses as a consequence of their participation, it is proper that they should be reimbursed for that expenditure (see Book 1, 9.13.2.4). Some payment for inconvenience or discomfort may also be considered reasonable (see Book 1, 9.13.1).
10.4.1 All payments to participants should be declared to and approved by local research ethics committees.
10.5 Investigators should communicate the results of the research to participants and participating communities, and the mechanism by which this will be done should be specified in the protocol.
10.6 Some benefit should accrue to the participating community as a result of HIV vaccine development activities, such as capacity building initiatives (see Book 1, 11.4.4; Points 2 and 3). |
