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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

9. Counselling

Consensus:

High-quality risk reduction counselling must be offered to all participants in an HIV vaccine efficacy trial, and should be provided independently of the investigator. Counselling capability should be part of the initial capacity-building process prior to a trial being conducted.

Discussion:

Independent monitoring of the quality of the counselling should be considered.

There should be standardization of counselling in some way. It must also be specific to cultural diversity and social norms. A country such as Uganda has extensive experience with this, but many others do not. They may need such international guidelines as standard formats, questionnaires, and training.