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  • The Search for an AIDS Vaccine: Ethical Issues in the Development and Testing of a Preventive HIV Vaccine
  • Holly Taylor
Christine Grady. The Search for an AIDS Vaccine: Ethical Issues in the Development and Testing of a Preventive HIV Vaccine. Medical Ethics Series. Bloomington: Indiana University Press, 1995. vii + 193 pp. $25.00.

Although there have been two major breakthroughs in HIV research since this book was published—the discovery that AZT reduces the perinatal transmission of HIV, and the advent of combination therapy and its dramatic impact on AIDS mortality rates—the development of a preventive vaccine for HIV remains an urgent but elusive goal. The author’s cataloging of the scientific challenges of developing a preventive vaccine is not only timely, it leaves no doubt as to why an effective vaccine has not yet been developed and why careful attention will be needed when future efficacy trials are designed.

The book opens with two background chapters that familiarize the reader with the history and mechanics of vaccine development and human subject research. Though both chapters are comprehensive and provide essential background for the remainder of the book, chapter 2 is often repetitive rather than reflective of information presented in chapter 1. The “heart” of this book lies in chapter 3, “Human Subjects Research and HIV Vaccines.” Grady first argues that [End Page 819] the principle of “respect for persons,” as described in the Belmont Report, should be expanded to “include respect for the communities to which [autonomous] individuals belong” (p. 71). This expansion makes way for the concept of “community consultation and consent” to remedy the inadequacies of current guidelines regulating the conduct of clinical research as applied to vaccine research. Grady rightly notes that vaccine research is neither purely “therapeutic” nor “nontherapeutic,” as defined by the Declaration of Helsinki, and falls instead into a third category of research in which the community with which the individual research subject identifies stands to benefit. She argues, therefore, that for any vaccine research to be ethically sound, investigators must seek out the consent of the “community” as well as the consent of individual subjects.

At the conclusion of the book, Grady states that the introduction of the concept of “community consultation consent” is “a radical departure from the way in which vaccine research is generally undertaken” (p. 149). Given her own discussion of the influence of AIDS treatment advocates on the way that both the FDA and NIH currently conduct business, her advocacy for “community consultation and consent” prior to the implementation of HIV preventive vaccine trials seems less “radical” in the context of HIV. The shift in the epidemic’s impact, from gay men to injection drug users and their sexual partners, clearly requires a shift in who is invited to the table to represent the community of people who will be approached to enroll in vaccine trials. But our experience to date with the HIV epidemic makes this departure more “natural” than “radical.”

With the first three chapters as background, chapter 4 eloquently describes the state of HIV vaccine research through the early 1990s. Chapter 5 is both a detailed account of the planning and implementation of large-scale efficacy trials for an HIV vaccine, and an ethical guide to those who will conduct these trials. With the current federal regulations as her guide, Grady describes what information the investigator is obligated to provide each potential subject who is considering enrollment in an HIV vaccine trial. She does not, however, provide the same amount of detail regarding the “community consultation and consent” process. The process of identifying the appropriate “community” from which consent will be solicited, and the process by which the community consent will be obtained, need to be further elaborated. Also, an important question raised by the author’s requirement of community consent is what happens when a “community” does not provide its consent but there are enough individual community members willing to provide their consent to enroll in a well-designed and otherwise ethically sound trial. Yet Grady has made an important contribution to the considerations necessary before embarking on vaccine trials, and there will no doubt be many opportunities to refine these...

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