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close this bookUNAIDS-Sponsored Regional Workshops to Discuss Ethical Issues in Preventive HIV Vaccine Trials (UNAIDS, 2000, 52 p.)
View the document(introduction...)
close this folderINTRODUCTION
View the documentPurpose of the Workshops
View the documentParticipants
View the documentWorkshop Methodology
View the documentReading this Report
View the documentSUMMARY
close this folderWORKSHOP REPORTS
close this folderOURO PRETO, BRAZIL, 1-3 APRIL, 1998
View the document1. Vulnerability to Harm or Exploitation
View the document2. Collaboration in Phase I/II (Safety and Immunogenicity) Trials
View the document3. Phase III (efficacy) Trials
View the document4. Review of Vaccine Trials
View the document5. Candidate Vaccine Choice
View the document6. Community
View the document7. Intellectual Property
View the document8. Control Arm in Trials
View the document9. Informed Consent
View the document10. Gender, Pregnancy and Breast-Feeding
View the document11. Counselling, Treatment and Care
View the document12. Access and Availability of Vaccine
View the document13. Items Not Discussed
close this folderBANGKOK, THAILAND, 20-22 APRIL, 1998
View the document1. Collaboration in Phase I, II and III Trials
View the document2. Community
View the document3. Ethical and Scientific Review
View the document4. Intellectual Property
View the document5. Control Arm in Trials
View the document6. Informed Consent
View the document7. Gender, Pregnancy and Breast-Feeding
View the document8. Children
View the document9. Protection from Discrimination
View the document10. Vaccine-Induced HIV-Seropositivity
View the document11. Counselling
View the document12. Post-Exposure Prophylaxis (PEP)
View the document13. Treatment and Care
View the document14. Compensation
View the document15. Availability of Vaccine
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
close this folderANNEX 1: CASE SCENARIO AND DISCUSSION QUESTIONS
View the documentCase Scenario
View the documentDiscussion Questions
close this folderANNEX 2: WORKSHOP EVALUATIONS
View the documentWorkshop Evaluation, Brazil
View the documentWorkshop Evaluation, Thailand
View the documentWorkshop Evaluation, Uganda
close this folderANNEX 3: LIST OF PARTICIPANTS
View the documentList of Participants, Brazil
View the documentList of Participants, Thailand
View the documentList of Participants, Uganda

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.