Cover Image
close this bookUNAIDS-Sponsored Regional Workshops to Discuss Ethical Issues in Preventive HIV Vaccine Trials (UNAIDS, 2000, 52 p.)
close this folderWORKSHOP REPORTS
close this folderENTEBBE, UGANDA, 27-29 APRIL, 1998
View the document1. Phase I/II (Safety and Immunogenicity) Trials
View the document2. Phase III Trials
View the document3. Vulnerability to Harm and Exploitation
View the document4. Community
View the document5. Ethical Review
View the document6. Intellectual Property
View the document7. Control Arm in Trials
View the document8. Informed Consent
View the document9. Counselling
View the document10. Gender, Pregnancy and Breast-Feeding
View the document11. Children
View the document12. Discrimination
View the document13. Treatment and Care
View the document14. Endpoints in Vaccine Trials
View the document15. Compensation for Injury or Harm
View the document16. Access and Availability of Vaccine

5. Ethical Review

Consensus:

A host country that is considering conducting any phase of an HIV vaccine trial must have the capability to conduct its own ethical and scientific review of the proposed protocol. This review must be independent of parties that may have potential to gain from the outcome of the trial (such as investigators, those who may benefit financially, and those who may benefit politically).

Discussion:

Although governments will justifiably have an interest in the outcome of HIV vaccine research (unlike some other forms of scientific research), there is a need to ensure that the ethical and scientific review process can be conducted without influence from government. This may be accomplished through formation of independent government commissions or through legislation that defines the role and independence of the review bodies. Potential for political interference must be minimized. Various current government arrangements were described for the African region. In some, the head of government must sign the protocol before it proceeds, and the correctness of this practice was challenged by the group.

Ethical review should include representation from the community, as described above. Guidelines on the composition of ethical review committees for HIV vaccine trials should be developed and followed.

International organizations have an important role to play in the development of ethical review guidelines and in assisting countries to build ethical review capacity.

There is currently no mechanism for quality assurance of the ethical review process, or for enforcing adherence to guidelines. Should this be developed?

Where ethical and scientific review capacity does not exist, it should be established prior to conducting HIV vaccine trials. The role of international bodies in the review process requires examination. Where applicable, international review bodies may review protocols that are to be conducted in ‘developing’ countries. As a matter of principle, the final decision on whether to participate in a trial must rest with the host country, provided that the requisite capacity is in place, as outlined above.