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Human Subjects Protection Resource Book

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Human Subjects Protection Resource Book Human Subjects Protection Resource Book Preface Purpose of This Resource Book Although many federal organizations now have guide­ books, manuals, or handbooks in support of human sub­ Thus, this resource book was a joint project of several jects protection activities, the first major work developed with agencies: DOE, the U.S. Department of Defense, and the a broad perspective was the Guidebook for Institutional U.S. Department of Veterans Affairs. However, this manual Review Boards in the early 1980s by Public Responsibility in does not represent the official views or policies of any of Medicine and Research, a nonprofit organization. In 1992, these or any other agencies. Rather, it is an attempt to the year following the formal adoption by 16 federal agencies synthesize the information currently available on the protec­ of the Federal Policy for the Protection of Human Subjects tion of human subjects in research, the continuing applica­ (Common Rule), the U. S. Department of Energy (DOE) tion of such information to new areas of endeavor, and the published the Human Subjects Research Handbook ever-changing rules, regulations, and guidance involved in (Protecting Human Research Subjects). In 1993, the Office the hope that it might provide useful information for investiga­ for Protection from Research Risks, National Institutes of tors, Institutional Review Boards (IRBs), research organiza­ Health, issued Protecting Human Research Subjects, tions, research subjects, and others. Institutional Review Board Guidebook, a new work. In 1995, a revised second edition of the DOE Human Subjects This book does not constitute regulations or formal Research Handbook (Protecting Human Research Subjects) federal agency guidance but rather has been prepared for was published to address more current issues and con­ the convenience and reference of the many audiences noted cerns in the human research area. above. Regulations are cited when appropriate, as is federal guidance, but existing regulations and agency guidance may By 2000, it was evident that accelerating changes in not always provide clarity or relevancy in the real world of science, regulations, and practices would require that research review and conduct. Therefore, where relevant existing guidebooks and manuals be updated. Dr. Susan citations from national advisory bodies have been used, Rose, the DOE Human Subjects Research Program Man­ readers are encouraged to explore the work of these advisory ager, with the support of the National Science and Technol­ groups, as well as scholarly publications, to attain a greater ogy Council, proposed that major revisions to these guide­ appreciation of the complexity of the challenges at hand. books and manuals be undertaken to provide the human subjects research community with broader and more current Some readers will find portions of the resource book too information in the form of a resource manual. Dr. Rose was simplistic; and other readers will find these same portions to asked to take on the development of such a document as a be an important primer, while the more advanced reader will federalwide project and formed a multiagency Resource employ this book as a useful reference. The book contains Book Task Group to research and compile the information. chapters that provide background information on the history Some participating departments or agencies made volun­ and development of the federal regulations, chapters that teers available to the task group for the research, compila­ discuss procedural and substantive issues regarding the tion, and review efforts. Many others contributed their time review and conduct of human subjects research, and and energy to the review process. (The participants in this chapters that are specific to one type of research (e.g., project are identified in the Acknowledgments section of this genetics, biological samples) or research in specific manual.) This document is the result of several years of populations (e.g., international settings, children, and hard work by many dedicated individuals and the support of workers). their institutions. i 2006 The chapters in this book provide evidence that the This resource manual frequently refers to the policies issues with which IRBs, investigators, and research organi­ and guidance of all signatories to the Common Rule and zations must concern themselves are many and complex. often to the policies and guidance of the Office for Human We have tried to provide some expanded discussions of the Research Protections (OHRP) as the lead regulatory agency regulations and beyond, but we do not presume to offer the in this field. OHRP has been given permission by the Office definitive discussions of the many ways in which any of Management and Budget to negotiate Federalwide reasonable reader might interpret the language of the Assurances of Compliance, and, as such, many depart­ regulations. An important goal of the resource book is to help ments and agencies rely on OHRP’s assurance system to facilitate understanding of the concepts involved, how they implement their own systems of compliance oversight. relate to human subjects research, and how one might go However, departments or agencies might interpret the about applying those concepts. This resource book is not regulations differently or impose additional requirements for intended or designed to tell IRBs whether or not specific research they conduct or support. Readers are encouraged protocols should be approved (unless the regulations to find out whether their institutions or funding agencies have specifically prohibit the proposed activity or method). It does, different or additional requirements. Although this book however, describe the issues on which investigators, contains an Agency Chapter 27 for DOE, your agency may institutions, and IRBs should focus their attention. Further­ insert your human subjects chapter in its place. Each agency more, although the book is broad in scope, human subjects has the opportunity to add a Chapter 27 to this resource issues change. Thus, this document focuses on what are manual that will include agency-specific additional sections considered to be the most important issues and concerns to or references covering its pertinent research regulations, the human subjects community, rather than on attempting to policies, and procedures. be comprehensive or complete. ii 2006 Acknowledgements The following individuals contributed thoughts, comments, written materials, and expertise to the development of this resource manual. Susan Rose , University of Southern California, formerly of the U.S. Department of Energy’s Human Subjects Research Program Kathi E. Hanna , Writer and Editorial Consultant Roger Aamodt, formerly National Institutes of Health Bonnie Lee, Food and Drug Administration Leslie Biesecker, National Institutes of Health Mark Longmire, Oak Ridge Institute for Science and Robert Bistline, U.S. Department of Energy Education Marianna Bledsoe, National Institutes of Health Sara D. Maddox, Editor and Consultant Jeffrey Cohen, Cornell University Darcy Mallon, Brookhaven National Laboratory Michael Colligan, Centers for Disease Control and Charles Pietri, HITECH Consultants Prevention Joan P. Porter, Department of Veterans Affairs Priscilla Craig, Department of Veterans Affairs Tom Puglisi, Department of Veterans Affairs Sherry Davis, Pacific Northwest National Laboratory Laura Lyman Rodriguez, National Institutes of Health Patty Decot, U.S. Department of Defense Michelle Russell-Einhorn, Consultant Marvin Frazier, formerly U.S. Department of Energy Allan Shipp, National Institutes of Health Rina Hakimian, formerly National Institutes of Health Denise Viator, Oak Ridge Institute for Science and Education Karen Hofman, National Institutes of Health Michael Viola, U.S. Department of Energy Kim Laing, U.S. Department of Energy Paula S. Waterman, Department of Veterans Affairs James Lavery, University of Toronto iii 2006 Table of Contents Chapter 1 Roles and Responsibilities for Protecting Human Subjects A. Introduction ................................................................................................................................ 1-1 B. The Institution Conducting Research .......................................................................................... 1-2 C. The Principal Investigator ........................................................................................................... 1-4 D. Other Members of the Research Team ....................................................................................... 1-5 E. The Institutional Review Board.................................................................................................... 1-6 F. The Institutional Review Board Administrator/Director, Support Staff, and Institutional Review Board Office .................................................................... 1-6 G. The Research Sponsor ............................................................................................................... 1-7 H. Research Subjects .................................................................................................................... 1-7 I. Communities.............................................................................................................................. 1-8 Key Concepts ........................................................................................................................... 1-9 References ..............................................................................................................................
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