The IRB Guidebook was last updated in 1993. Developments over the intervening years have made portions of the Guidebook information obsolete, while portions of the information remain valid. There is no errata document to indicate which information has been superseded. OHRP cautions users to verify the current validity of any Guidebook information before relying on the information in a program of human subjects protection.

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Institutional Review Board
Guidebook

* FOREWORD *



The impetus for developing this Guidebook for Institutional Review Boards (IRBs) was a finding of need by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. In its 1981 report, Protecting Human Subjects: The Adequacy and Uniformity of Federal Rules and their Implementation, the Commission stated that it "is clear that researchers and IRB members desire help both in understanding the policies and principles that underlie the regulations governing research with human subjects, and in identifying the issues to which one should be sensitive in designing or reviewing research proposals".

A first edition of the Guidebook was produced in the early 1980s under contract for the President's Commission by Public Responsibility in Medicine and Research (PRIM&R). PRIM&R is a Boston-based, nonprofit organization that sponsors annual conferences on topics related to the protection of human subjects.

The present Guidebook is a revised, updated, and expanded second edition, prepared under contract by Robin Levin Penslar, Research Associate at the Poynter Center for the Study of Ethics and American Institutions, in consultation with the Office for Protection from Research Risks and its numerous advisors. The Poynter Center is an independent ethics center housed at Indiana University.

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