Ethical Quandaries in Human Efficacy Trials for AIDS Vaccines

Ethical predicaments emerge from every quarter when we try to test HIV vaccines in human beings. These ethical complexities multiply, like the Hydra's head, and become even more challenging the more closely we examine them.

The purpose of this presentation is to lay out the details of some of these ethical complexities so they can become part of the public discourse. These trials, just now being planned and approved in developing nations and in the US, raise ethical problems at least as complex as (perhaps more complex than) any ethical problems we have yet had to deal with in human subjects research. Policymakers can expect to be faced with some extremely difficult choices in the months and years just ahead.

Ethicists convened at the World Health Organization in Geneva have already been discussing these issues but many of the issues are still undecided and quite controversial. Educated citizen will want to be aware of the enormity of the decisions being made.

This presentation includes the following:

I. State of the epidemic globally: epidemiology, new infections, and economic impact.

II. The dramatic uniqueness of AIDS: biologically, ecologically, sociologically.

III. The need for a preventive vaccine, and human trials to test it.

IV. Ethical principles to be applied: beneficence; justice; respect for persons.

V. The Nuremberg Code (1947) and human experiments in the concentration camps.

VI. The new International Ethical Guidelines for Biomedical Research Involving Human Subjects. (1993)

VII. The principle of informed consent:
a.) "the nature, duration and purpose of the experiment,
b.) the method and means by which it is to be conducted,
c.) all inconveniences and hazards reasonably to be expected."

VIII. Real risks to volunteer subjects.

IX. A preliminary disquisition on The Other.

X. An equitable balance of potential harms and potential benefits?

XI. The question of compensation for trial-related injuries (physical, social, psychological).

XII. Who do you want for volunteers?

XIII. The problem of "counselling with dual intent."

XIV. Motivations to volunteer (altruism, money, medical care, chance for protection, etc).

XV. Two more problems: Undue inducement, and coercion.

XVI. Quitting.

The Nuremberg Code, formulated as a result of the 1947 Nuremberg trials of the Nazi doctors, was the world's first clearly articulated statement of the ethics of human subjects research. It served as the conceptual groundwork for virtually all subsequent formulations. The most recent and most fully accepted statement of such guidelines, the International Ethical Guidelines for Biomedical Research Involving Human Subjects, was formulated by 150 representatives from 35 very diverse countries after seven years of research and consultation. In the short time since its promulgation by WHO in November 1993, it has already become the international standard for human subjects research.

In sum, this presentation

• Looks at some basic facts about the HIV/AIDS pandemic.
  
• Looks at the history (especially Nuremberg) of ethical guidelines for human subjects research.
  
• Presents some of the ethical complexities and quandaries in one of the more pressing medical urgencies on the planet.
  
• Asks the audience to consider and respond to some of these ethical predicaments.

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