Overview

Efforts to halt the spread of AIDS have failed so far, and the creation of a vaccine now seems the best hope for controlling the disease. Yet developing and testing an HIV vaccine raises a host of difficult ethical issues. These concerns are the focus of this timely and important book. Christine Grady traces the history of vaccine research and surveys the guidelines, regulations, and attitudes concerning human subjects research. There is current information on the state of HIV research and the challenges facing scientists. Vaccine research differs considerably from drug research, and Grady explores the current wisdom governing research with human subjects. Proposing a model for the ethical conduct of vaccine research in general, this book applies it to the complex case of an HIV vaccine. Clinical trials are already ongoing, and the next step, field trials to determine efficacy, involve another set of issuesNand call for new strategies for ethical conduct. The Search for an AIDS Vaccine is essential reading for everyone interested in ethics and the conduct of HIV vaccine research.

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9780253326195

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Painstaking analysis of the knotty ethical problems involved in human-subjects research, and a well-thought-out proposal for a community approach to conducting field trials for an HIV vaccine. Grady's credentials include ten years of work with HIV-infected people in clinical trials of experimental therapies, participation in the Phase I trial of an HIV vaccine, and staff membership on the President's Commission on the HIV Epidemic (1987 - 88). Here she reviews the often disturbing history of vaccine development and early testing - which was non-regulated and frequently performed without the subjects' informed consent - and the evolution of codes and attitudes concerning human-subjects research, especially the recent regulatory changes brought about as a result of AIDS activism. She outlines the considerable scientific challenges that face researchers working on a preventive HIV vaccine and explains what has been accomplished so far: Phase I trials (to test short-term safety and the capacity of a vaccine to generate an immune response) and Phase II trials (to continue the Phase I evaluation and to determine the optimal dose) are already underway, the next phase being controlled field trials with human subjects to determine how effective the vaccine is in preventing infection or disease. Grady recommends a three-way partnership among communities (defined by geography, culture, behavior, or organizations), their individual members, and scientists to develop a common purpose. Grady considers such issues as when field trials should begin, who should be included as subjects, how their rights can be protected, the design and logistics of studies, and how their scientific and ethical aspects should be reviewed. Although not inaccessibly technical - there's a helpful glossary - this study is a bit textbookish for the casual reader. But it is highly recommended for medical ethicists and anyone concerned about the AIDS epidemic and how HIV research is conducted. (Kirkus Reviews)

Author Information

CHRISTINE GRADY, R.N., Ph.D., is Acting Clinical Director and Research Associate at the National Institute of Nursing Research, the National Institutes of Health and has served as a member of the staff of the President's Commission on the HIV Epidemic.

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