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 There is no errata document to indicate which information has been superseded.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

* PREFACE *


A. Purpose of the Guidebook || B. Intended Audience || C. How to Use the Guidebook
D. Citation Form || E. Suggested Reading Materials || F. Abbreviations


A. PURPOSE OF THE GUIDEBOOK

It is hoped that the Guidebook will provide precisely what its title is intended to denote: guidance. The Guidebook does not itself constitute regulations but rather has been prepared for the convenience and reference of IRB members and administrators. The issues with which IRBs must concern themselves are many and complex. Simply becoming familiar with the regulations is difficult enough; understanding the concepts involved, how they relate to human subjects research, and how one might go about applying those concepts are complex matters, matters on which many talented and highly respected authors have written a great deal. (The bibliographies cite many materials that IRBs should find useful.) The Guidebook is not designed to tell IRBs whether or not specific protocols should be approved (unless the regulations specifically prohibit the proposed activity or method). It does point out issues to which IRBs should pay attention and presents, wherever possible, areas where ethicists and others concerned with these issues have arrived at a consensus on the ethical acceptability of a particular activity or method (e.g., in clinical trials, the use of placebo arms where a standard therapy is available).

The Guidebook is also intended to be a resource that will serve as the focal point of IRB administrators' and members' human subjects work. Constructed in a loose leaf format, the Guidebook holds the regulations, relevant institutional documents (e.g., the institution's assurance and operating policies and procedures), and relevant forms. In addition to the text dealing with specific topics, the Guidebook contains a glossary of terms and a bibliography of sources. The loose leaf format will permit the Office for Protection from Research Risks (OPRR) to distribute updated chapters as new areas of research emerge that have implications for human subjects research or as regulations are revised.

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B. INTENDED AUDIENCE

The Guidebook is addressed to new and continuing IRB members, researchers, and institutional administrators. Some will find portions of the material too simplistic; for others, these same portions will be an indispensable primer. Even the more advanced reader should find the Guidebook a useful reference.

The Guidebook, as a product of OPRR, deals primarily with the human subjects protection regulations promulgated by the Department of Health and Human Services (DHHS). Because a significant amount of the research subject to the DHHS regulations is also subject to parallel FDA regulations, the Guidebook also discusses the issues raised by similarities and differences between the two sets of regulations.

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C. HOW TO USE THE 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.

Chapter 1.

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.

Chapter 2.

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.

Chapter 3.

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.

Chapter 4.

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.

Chapter 5.

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.

Chapter 6.

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.

Appendices.

Glossary of Terms. Explains terms as they are used in the context of reviewing biomedical and behavioral research. Words that are printed in the text in boldface appear in the Glossary.

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D. CITATION FORM

When referring to federal regulations pertaining to the protection of human subjects, the Federal Policy citations are given, unless a particular department or agency's regulations are being discussed. Although the Guidebook deals primarily with DHHS human subjects regulations, the Federal Policy citation is used to indicate that the discussion applies to research conducted, supported, or otherwise regulated by any of the sixteen federal departments and agencies that have adopted the Federal Policy. Where DHHS regulations are being discussed specifically, the Code of Federal Regulations (CFR) citation is given. Thus, 45 CFR 46 Subpart A is generally referred to as Federal Policy '___.101-124, while 45 CFR 46 Subparts B, C, and D are referred to as 45 CFR 46.201-211, 45 CFR 46.301-306, and 45 CFR 46.401-409, respectively.

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E. SUGGESTED READING MATERIALS

The ideas and opinions expressed in the materials listed in the General Bibliography (Appendix 1) and in the Suggestions for Further Reading sections of each chapter of the Guidebook are those of their authors alone, and do not necessarily, with the exception of official government statements, represent the views or policies of the Department of Health and Human Services. These references are intended to provide IRBs with a wide range of perspectives to assist them in their understanding of the many complex issues presented by research involving human subjects.

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F. ABBREVIATIONS

The following is a list of the most common abbreviations used in the Guidebook. Definitions for these terms appear in the Glossary of Terms.

ADAMHA Alcohol, Drug Abuse and Mental Health Administration
CDC Centers for Disease Control and Prevention
DHEW Department of Health, Education and Welfare
DHHS Department of Health and Human Services
FDA Food and Drug Administration
IDE Investigational Device Exemption
IND Investigational New Drug
IRBInstitutional Review Board
NDA New Drug Application
NIAAA National Institute on Alcohol Abuse and Alcoholism
NIDA National Institute on Drug Abuse
NIH National Institutes of Health
NIMH National Institute of Mental Health
OPRR Office for Protection from Research Risks
PHS Public Health Service
SAMHSA Substance Abuse and Mental Health Services Administration

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Preface