15. Compensation for Injury or Harm

Consensus:

The circumstances under which compensation will be provided, and the type and level of compensation, must be described in the study protocol and in the information for consent.

Discussion:

Discussion centred primarily on harm of a social nature. Socially adverse events will generally result from discrimination based on perceived or actual HIV status. There needs to be adequate individual counselling and sensitization of the community to issues that may arise through involvement in HIV vaccine trials.

Where social harm results from apparent breach of confidentiality, it would be important to determine whether there was negligence on the part of the research team. Although this may be very difficult to accomplish, attempts should be made to do so, and compensation should be provided for cases where negligence was involved.

It was suggested that a Data and Safety Monitoring Board might take the responsibility of determining whether negligence was involved in a specific case or not, though it was acknowledged that this would be a new practice for such a body.

It was suggested that there needs to be a mechanism to ensure exclusion of those individuals who do not have an adequate understanding of the potential risks of participation in the trial.