Ethical Issues in HIV Vaccine Trials

Thomas Kerns, PhD

St Martin's Press (Macmillan Ltd. in UK countries), 1997

 

Click here for a review of this book that appeared in The Lancet in 1998.

 

(Click on selected chapters below to see sample chapters)

 

Table of Contents

 

Preface

Introduction

1. Where stands the pandemic now?

2. It's not just another disease.


2.1 High morbidity and mortality

2.2 Lifelong infectiousness

2.3 Lengthy asymptomatic stage

2.4 Highly mutable

2.5 Effective modes of transmission

2.6 Destroys the immune system

2.7 Viral reservoir expanding

3. Will it ever slow down?

3.1 A cure?

3.2 Behavior Change?

3.2.1 Sex, drugs and human rights

3.2.2 Quarantine?

3.3 A weaker virus?

3.4 A preventive vaccine?

4. Is a vaccine possible?

4.1 Economic disincentives

4.1.1 Costs

4.1.2 Legal liabilities

4.1.3 Financial return

4.2 Scientific challenges

5. The human immunodeficiency virus

5.1 Etiologicity

5.2 Alive?

5.3 Virology and mutability

6. How the immune system works

7. How vaccines work

7.1 Cell-associated transmission

7.2 Animal models

8. Human trials

9. Criteria of Effectiveness

9.1 What does "vaccine success" mean?

9.2 Percent efficacy

9.3 Could a vaccine worsen the epidemic?

9.4 Standards for vaccine licensure

9.5 Urgency: a double-edged sword

10. Ethical principles

11. Real risks

A preliminary disquisition on The Other

11.1 No future protocols

11.2 Immediate systemic reactions

11.3 Potential immune tolerance

11.4 Enhanced infectivity

11.5 Discrimination

11.5.1 The problem

11.5.2 Confidentiality: relativism vs essentialism

11.5.3 Weak protections for confidentiality

11.6 Whole virus vaccines

11.6.1 Inactivated virus vaccines

11.6.2 Live, attenuated virus vaccines

11.6.3 Subunit vaccines

11.7 Being monitored

11.8 Feeling safe

11.9 Immunosuppression

11.10 Autoimmunity

11.11 Malignancies

11.12 Neurological disease of unknown origin

11.13 Learning your antibody status

11.14 Unknown and unanticipated risks

12. Whom do you want for volunteers?

13. Compensating volunteers for injury

14. Informed consent (1)

15. Assessing comprehension

16. Informed consent (2)

17. Ethics review committees

18. Protecting Individual Subjects

18.1 Individual volunteers are protected

18.2 Two levels of ethical review

18.3 High-risk/low-benefit protocols

19. Proxy consent?

20. Undue inducement

21. Motivations to volunteer

21.1 Altruism

21.2 Money

21.3 Medical care

21.4 The chance of protection

21.5 Other motives

21.6 Quitting

22. Still more questions

23. Data from unethical experiments?

24. The great simple solution

25. Thesis / Antithesis : Synthesis?

26. Smallpox and Guinea Worm Disease as metaphors

27. So . . .

Appendices

Selected Bibliography

 

 

Curriculum Vita | TK homepage | Public lectures | Jenner homepage |

Philosophy homepage | EVT homepage | EVT Introduction | EVT chapter 11

EVT chapter 14 | Lancet Review