Book 5: Scientific and ethical review

HIV preventive vaccine trials should be carried out in South Africa only if the capacity exists to conduct appropriate, competent and independent scientific and ethical review.

6.1 Regulatory bodies and research ethics committees based in South Africa should review HIV vaccine protocols for such research to be conducted in South Africa.

6.2 Where possible, committees that review HIV vaccine trial protocols should include appropriate representative membership from the community where the research will take place (see Point 5.8.1).

6.3 These processes should ensure that the research is analysed from the viewpoints of individuals who are familiar with the conditions prevailing in the potential research population (see Point 4.5).

6.4 Efforts should be made to build the capacity of community representatives to contribute to the development and review of HIV vaccine trial protocols (see Points 3 and 5).

6.5 If capacity to conduct scientific and ethical review in South Africa is inadequate, the sponsor should be responsible for ensuring that adequate structures are developed for scientific and ethical review prior to the start of the research.

6.5.1 Care should be taken to minimise the potential for conflicts of interest, while providing assistance in capacity building for scientific and ethical review.

6.5.2 Capacity building may also be developed in collaboration with international agencies, or with South African organisations and parties.

6.6 In the event of a dispute between review bodies, this dispute should be referred to appropriate national structures, such as the National Health Research Ethics Committee, for a process of resolution.

6.7 Guidelines related to ethical review in Book 1, Points 9 and 10 apply.