/ 26 May 2000

Body to monitor Aids vaccine trials

Khadija Magardie

A new initiative, spearheaded by the Medical Research Council (MRC) and various Aids advocacy bodies, has been established to monitor potential human rights violations in clinical trials for HIV/Aids vaccines.

The project is entitled South African human rights and community mobilisation intervention for HIV/Aids vaccine development and clinical trials, and is funded by the South African Aids Vaccine Initiative and the European Commission, which has given R11-million towards the total budget.

The pilot project is expected to run over four years, with the aim of developing a model to be used in other countries, particularly in Africa.

According to organisers, the initiative will promote “informed decision-making” about vaccine development and potential clinical trials to be carried out in the country.

Head of the MRC Professor Malegapuru Makgoba said: “The lessons of human rights transgressions throughout history should serve as a stark reminder in dealing with the complexity of public health, human rights, ethical and legal issues in HIV/Aids clinical trials.”

There are several issues surrounding HIV/Aids clinical trials that would warrant the need for the community, and those who choose to participate, to make informed choices.

The ultimate outcome of the project would be to provide individuals and communities with “enough knowledge to be able to comprehend the complexities of HIV/Aids vaccine interventions and to make informed decisions on their involvement”. This would include monitoring and protecting the human and legal rights of potential participants.

The project would need to iron out the complications surrounding participants in clinical trials that exist globally, but particularly those in developing countries. This because of the widespread application of “relativity in standards of care” – a prescription that affords clinical trial participants the guarantee of adequate care, provided it conforms with the generally available standard of care in that country.

The implications of the trials in terms of employment-related issues will also require a detailed explanation to the community and participants.