The Search for an AIDS Vaccine: Ethical Issues in the Development And Testing of a Preventive HIV Vaccine (Medical Ethics Series): Christine Grady
From Booklist
Grady has worked with HIV patients for 10 years and served on the President’s Commission on the HIV Epidemic and as a participant in the phase one trial of a preventive HIV vaccine in the U.S., as well. Much of her report is a carefully reasoned account of how research for and trial of a preventive vaccine differ from the methods used to discover a therapy. Grady writes clearly and logically, providing laypersons with useful information about and approaches to a major current ethical dilemma. She makes a good case for adding the community as a third party (the individual and the group are the first two) in HIV vaccine research and trials. Her work should not be too quickly dismissed as merely a dry academic report. William Beatty
Review
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)