UNAIDS-Sponsored Regional Workshops to Discuss Ethical Issues in Preventive HIV Vaccine Trials (UNAIDS, 2000, 52 p.)

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INTRODUCTION

Purpose of the Workshops

Participants

Workshop Methodology

Reading this Report

SUMMARY

WORKSHOP REPORTS

OURO PRETO, BRAZIL, 1-3 APRIL, 1998

1. Vulnerability to Harm or Exploitation

2. Collaboration in Phase I/II (Safety and Immunogenicity) Trials

3. Phase III (efficacy) Trials

4. Review of Vaccine Trials

5. Candidate Vaccine Choice

6. Community

7. Intellectual Property

8. Control Arm in Trials

9. Informed Consent

10. Gender, Pregnancy and Breast-Feeding

11. Counselling, Treatment and Care

12. Access and Availability of Vaccine

13. Items Not Discussed

BANGKOK, THAILAND, 20-22 APRIL, 1998

1. Collaboration in Phase I, II and III Trials

2. Community

3. Ethical and Scientific Review

4. Intellectual Property

5. Control Arm in Trials

6. Informed Consent

7. Gender, Pregnancy and Breast-Feeding

8. Children

9. Protection from Discrimination

10. Vaccine-Induced HIV-Seropositivity

11. Counselling

12. Post-Exposure Prophylaxis (PEP)

13. Treatment and Care

14. Compensation

15. Availability of Vaccine

ENTEBBE, UGANDA, 27-29 APRIL, 1998

1. Phase I/II (Safety and Immunogenicity) Trials

2. Phase III Trials

3. Vulnerability to Harm and Exploitation

4. Community

5. Ethical Review

6. Intellectual Property

7. Control Arm in Trials

8. Informed Consent

9. Counselling

10. Gender, Pregnancy and Breast-Feeding

11. Children

12. Discrimination

13. Treatment and Care

14. Endpoints in Vaccine Trials

15. Compensation for Injury or Harm

16. Access and Availability of Vaccine

ANNEX 1: CASE SCENARIO AND DISCUSSION QUESTIONS

Case Scenario

Discussion Questions

ANNEX 2: WORKSHOP EVALUATIONS

Workshop Evaluation, Brazil

Workshop Evaluation, Thailand

Workshop Evaluation, Uganda

ANNEX 3: LIST OF PARTICIPANTS

List of Participants, Brazil

List of Participants, Thailand

List of Participants, Uganda