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Protecting Human Research Subjects: Institutionalized Review Board Guidebook.

At last! Institutional Review Boards (IRBs) have a high-quality, comprehensive guidebook. The newly published Protecting Human Research Subjects: Institutionalized Review Board Guidebook is complete, well organized, clearly written, and reliable. Robin Levin Penslar, a research associate at Indiana University's Poynter Center for the Study of Ethics and American Institutions, produced the volume in conjunction with the Office for Protection from Research Risks, particularly project officer Joan Porter. They were assisted by consultants, contributors, reviewers, and editors far too numerous to list here.

The guidebook, published in loose-leaf form so that sections can be updated whenever appropriate, is organized into six chapters: "Institutional Administration"; "Regulations and Policies"; "IRB Review"; "Considerations of Research Design"; "Biomedical and Behavioral Research: An Overview"; and "Special Classes of Subjects."

Virtually every question that one can raise concerning protections of the rights and the welfare of human research subjects is addressed in a crisp style that illuminates the central issues. Selected references to additional readings are provided for each section of the guidebook, and a general bibliography is appended for those who wish to learn more. Armed with a copy of the guidebook, even the newest member of an IRB should feel comfortable in reviewing proposed or ongoing research protocols. Relevant laws, policies, codes, and regulations are all cited, and most useful documents are included in the appendix. The mystery is removed from arcane nomenclature of clinical studies. Tortuous FDA approval processes are described in simple declaratory sentences.

A glossary of terms (with cross references) should make it feasible for nonscientists and scientists not trained in ethics to understand and contribute to IRB deliberations. Nettlesome regulatory questions pertaining to such issues as epidemiological studies, vaccine trials, and research involving traumatized and comatose patients are thoroughly addressed. Each section dealing with a special kind of research includes "points to consider" so that an IRB can check to make sure that issues for which they are responsible have not been overlooked.

New sections deal with AIDS research; genetics research (including gene therapy); use of radioactive materials, and research utilizing X rays. Perennial regulatory questions relating to research involving fetuses, prisoners, children, minors, terminally ill patients, cognitively impaired persons, students, employees, and normal volunteers are addressed in ways that should make it less onerous for IRBs to recognize their responsibilities and to address fundamental ethical issues associated with studies in these areas.

Behavioral research is not neglected. There are sections dealing with alcohol and drug abuse studies and the tricky matters pertaining to preservation and limitations of privacy and confidentiality, including a lucid description of certificates of confidentiality.

Researchers and IRBs will be pleased to discover that issues of justice and policies relating to the inclusion of women in research are made as clear as possible.

One area that receives too little attention is foreign research, although this partial omission is offset by the inclusion of a useful set of references to the ethical conduct of international research. More attention could be given to questions relating to inclusion or exclusion of minorities in research studies. In this area the bibliography is not as helpful.

The guidebook includes practical guidance for obtaining informed consent; for assessing risks and expected benefits associated with research; and for inclusion or exclusion of women and minorities. The ethical principles behind these practices are scarcely mentioned, but the Belmont Report is fully reprinted. If IRB members wish to learn more about the ethical underpinnings of IRB requirements, they will need to search beyond the pages of the guidebook. A reading list is appended to help such inquirers.

A salute to OPRR and to the Poynter Center is appropriate. The IRB guidebook has not reached perfection, but it comes pretty close.
COPYRIGHT 1993 Hastings Center
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

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Author:McCarthy, Charles R.
Publication:The Hastings Center Report
Article Type:Book Review
Date:Nov 1, 1993
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