How to use the IRB Guidebook

The Guidebook is divided into the following chapters:
Introduction. Provides a basic understanding of the background and purposes of the IRB review system. It should be particularly useful for new IRB members and investigators just beginning their clinical research. The Introduction includes a description of The Belmont Report, providing a summary of the principles set forth in this seminal policy statement on the protection of human subjects of research.

Institutional Administration. Directed primarily at institutional administrators and IRB chairpersons. It will also be of interest to others on the IRB, clinical investigators, and sponsors of research who wish to consider how the IRB relates to other institutional offices.

Regulations and Policies. Assists in resolving uncertainties about the intent or interpretation of regulatory provisions. It should also be a useful reference for initial reviewers of research proposals.

Basic IRB Review. Presents the major focal points of IRB review: informed consent, risk/benefit analysis, privacy and confidentiality, selection of subjects, and incentives for participation. It goes beyond the regulations in suggesting how the regulations might be applied in various situations.

Considerations of Research Design. Provides descriptions of, and information on, the reasons for using certain experimental designs. The ethical issues raised by such uses are also explored.

Biomedical and Behavioral Research: An Overview. Describes certain kinds of research by subject matter and their various goals and methods in a general, introductory way, pointing out the ethical concerns each raises and providing references for further reading. This chapter will be of most benefit to nonscientists on the IRB and to scientist-reviewers confronting a research proposal in an unfamiliar discipline.

Special Classes of Subjects. Provides an analysis of the ethical issues that arise in research involving classes of particularly vulnerable research subjects. Regulations exist for some classes of subjects; for others, no regulations are in place.