RESPONSIBLE RESEARCH

A Systems Approach to Protecting Research Participants

Daniel D. Federman, Kathi E. Hanna, and Laura Lyman Rodriguez, Editors

Committee on Assessing the System for Protecting Human Research Participants

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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Responsible Research: A Systems Approach to Protecting Research Participants RESPONSIBLE RESEARCH A Systems Approach to Protecting Research Participants Daniel D. Federman, Kathi E. Hanna, and Laura Lyman Rodriguez, Editors Committee on Assessing the System for Protecting Human Research Participants INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Responsible Research: A Systems Approach to Protecting Research Participants THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. Support for this project was provided by N01-OD-4-2139, Task Order No. 80, received support from the evaluation of set-aside Section 513, Public Health Service Act. The views presented in this report are those of the Institute of Medicine Committee on Assessing the System for Protecting Human Research Participants and are not necessarily those of the funding agencies. Library of Congress Cataloging-in-Publication Data Responsible research : a systems approach to protecting research participants / Daniel D. Federman, Kathi E. Hanna, and Laura Lyman Rodriguez, editors ; Committee on Assessing the System for Protecting Human Research Participants. p. ; cm. Includes bibliographical references and index. ISBN 0-309-08488-1 (hardcover) 1. Human experimentation in medicine—Moral and ethical aspects. 2. Medical ethics. 3. Medical protocols. 4. Patients—Legal status, laws, etc. [DNLM: 1. Clinical Protocols. 2. Human Experimentation. 3. Patient Rights. 4. Safety. W 20.55.H9 R475 2002] I. Federman, Daniel D., 1928- II. Hanna, Kathi E. III. Rodriguez, Laura Lyman. IV. Institute of Medicine (U.S.). Committee on Assessing the System for Protecting Human Research Participants. R853.H8 R476 2002 174′.28—dc21 2002015090 Additional copies of this report are available for sale from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2003 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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Responsible Research: A Systems Approach to Protecting Research Participants “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Shaping the Future for Health

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Responsible Research: A Systems Approach to Protecting Research Participants THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Responsible Research: A Systems Approach to Protecting Research Participants COMMITTEE ON ASSESSING THE SYSTEM FOR PROTECTING HUMAN RESEARCH PARTICIPANTS DANIEL D. FEDERMAN (Chair), Carl W. Walter Distinguished Professor of Medicine and Medical Education, Harvard University, Boston, MA DANIEL L. AZARNOFF, President, D.L. Azarnoff Associates and Senior Vice President of Clinical and Regulatory Affairs, Cellegy Pharmaceuticals, San Francisco, CA TOM BEAUCHAMP, Professor, Kennedy Institute of Ethics, Georgetown University, Washington, DC TIMOTHY STOLTZFUS JOST, Robert L. Willett Family Professor of Law, Washington and Lee University School of Law, Lexington, VA PATRICIA A. KING, Carmack Waterhouse Professor of Law, Medicine, Ethics, and Public Policy, Georgetown University Law Center, Washington, DC RODERICK J.A. LITTLE, Richard D. Remington Collegiate Professor of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI JAMES McNULTY, President, Board of Directors, National Alliance for the Mentally Ill, and President, Depressive/Manic Depressive Association of Rhode Island, Bristol, RI ANNE PETERSEN, Senior Vice President-Programs, Kellogg Foundation, Battle Creek, MI BONNIE W. RAMSEY, Professor, Department of Pediatrics, University of Washington School of Medicine, Seattle, WA LYDIA VILLA-KOMAROFF, Vice President for Research, Northwestern University, Evanston, IL FRANCES M. VISCO, President, The National Breast Cancer Coalition, Washington, DC Expert Advisers KAY DICKERSIN, Associate Professor, Department of Community Health, Brown University School of Medicine, Providence, RI ALBERTO GRIGNOLO, Senior Vice President and General Manager for Worldwide Regulatory Affairs, PAREXEL International, Waltham, MA MARY FAITH MARSHALL, Professor of Medicine and Bioethics, School of Medicine, Kansas University Medical Center, Kansas City, KS CAROL SAUNDERS, President and Chief Executive Officer, Center for Clinical Research Practice, Wellesley, MA

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Responsible Research: A Systems Approach to Protecting Research Participants DENNIS TOLSMA, Associate Director, Clinical Affairs and Director of Research, Kaiser Permanente, Atlanta, GA Liaisons RICHARD J. BONNIE, John S. Battle Professor of Law and Director, Institute of Law, Psychiatry, and Public Policy, Charlottesville, VA NANCY NEVELOFF DUBLER, Director, Division of Bioethics, Montefiore Medical Center; Professor of Epidemiology & Social Medicine, Albert Einstein College of Medicine, Bronx, NY ELENA OTTOLENGHI NIGHTINGALE, Scholar-in-Residence, Institute of Medicine and National Research Council, Washington, DC PILAR OSSORIO, Assistant Professor of Law and Bioethics, Associate Director of the Center for the Study of Race and Ethnicity in Medicine, University of Wisconsin, Madison Law School, Madison, WI Study Staff LAURA LYMAN RODRIGUEZ, Study Director ROBERT COOK-DEEGAN, Senior Program Officer JESSICA AUNGST, Research Assistant NATASHA DICKSON, Senior Project Assistant IOM Board on Health Sciences Policy Staff ANDREW M. POPE, Board Director CHARLES H. EVANS, JR., Scholar-in-Residence ALDEN CHANG, Administrative Assistant CARLOS GABRIEL, Financial Associate Consultant KATHI E. HANNA Copy Editors JILL SHUMAN SARA MADDOX

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Responsible Research: A Systems Approach to Protecting Research Participants Preface The current extraordinary advances in basic biomedical and social sciences have unprecedented potential to improve the human condition. These insights, together with the human genome project and its successor proteomics, will require an enormous commitment to translational research to harvest their applications for medicine and public health. The progress in political and social theory, linguistics, statistics, psychology, and behavioral sciences generally deserves a similarly broad application of human research to reach full expression. These endeavors will require individuals to accept possible risk to themselves, benefiting the greater good with uncertain (or no) benefit accrued in return. Thus, those performing and overseeing research are obligated to provide the most reasonable assurances of safety possible. Events in recent years have evoked considerable public concern about the safety of human studies and the measures in place to protect subject-participants. Isolated cases of unknown representativeness capture enormous public attention. The death of a subject during bronchoscopy, the death of a patient in a gene transfer experiment, the death of a healthy volunteer in an asthma study—these and similar occurrences are stridently announced and exhaustively analyzed for their heuristic guidance. As individual human tragedies they deserve all the attention they receive, including minute analysis as sentinel events from which to draw preventive guidance for future studies. But at this time, there is no way to know how representative these terrible events are and therefore no way to know what general lessons to infer from them for the uniquely human endeavor of studying

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Responsible Research: A Systems Approach to Protecting Research Participants some humans for the possible benefit of others. And, without quantification of the problem, there is no way to assess the appropriateness of new protections and their inevitable costs. I believe any thinking person could be forgiven for assuming that there exists a reliable quantitative picture of the number of people harmed or injured each year as a result of their participation in research (let us call it the numerator)—and for assuming that there must similarly exist a comprehensive if not exhaustive registry of all individuals participating as “subjects” in biomedical or social science research (the denominator). Relating these to each other, society could reckon both the absolute magnitude of the problem and the fractional risk of harm confronting individuals considering participation. Frustratingly, neither figure is available, nor, without considerable effort, will they be forthcoming in the near future. This collective uncertainty has huge consequences. An awareness of these problems led the Secretary of the Department of Health and Human Services to engage the Institute of Medicine for this study. We were asked to conduct an expeditious analysis of the possible value of accreditation of human research protection programs, which was published in April 2001. In addition, we were asked for a more comprehensive review of the present system for protecting human participants and to make suggestions for strengthening it. The latter is now offered. Given the paradox of both the enormous potential and the uncertain reality in this area, what do we propose? We suggest that we address our current uncertainty by national data collection that in a few years should quantify and delimit the problem. However, until evidence is available, we believe it is necessary to pursue every promising mechanism to maximize the protection of individuals participating in research. In order to accomplish this goal, we recommend that all research involving humans take place in settings or through organizational affiliations where the culture, announced and exemplified by the leadership, emphasizes the highest ethical standards and dedication to the welfare of every study participant. We further urge that all individuals responsible for the conceptualization and conduct of research be specifically trained in research ethics as well as techniques. We believe that the complexity of current science and, in the instance of clinical trials, the biological high stakes, require a review that begins with the scientific quality of the proposed research and a parallel examination of potential conflict of interest. These results would then lead into an explicit review of the ethical dimensions of the study. We urge a new approach to informed consent, one in which legal disclaimer and institutional self-protection are second to clear, simple, unclouded, unhurried, and sensitive disclosure that gives the potential participant all the information a reasonable person would need to make a well-informed decision, and the time to do so. Financial conflicts of

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Responsible Research: A Systems Approach to Protecting Research Participants interest at any stage or level of the process must be disclosed and managed so that the objectivity of research is preserved and the public trust is upheld. We believe that the necessary efforts to accomplish these tasks are currently under-resourced, and we urge that that need for sufficient support be recognized and provided as a cost of the responsible conduct of research. And we believe that accreditation of programs should be explored as a means of achieving excellence, for it anneals two core mechanisms for improvement: self-assessment and the sharing of best practices. We do not, however, urge a permanent accretion of new regulations and bureaucracy. Rather, we believe the protection system should be reexamined at a time when the steps described above can be accomplished, probably about five years from now. We strongly urge that a new look be taken when the magnitude of the problems and challenges facing the system can be appreciated and the appropriateness of protective mechanisms assessed. To do no harm is impossible. But to minimize harm while enabling the benefits of progress to emerge should be an attainable ideal. Daniel D. Federman, M.D., Chair

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Responsible Research: A Systems Approach to Protecting Research Participants Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Steven Black, Kaiser Permanente Richard T. Campbell, University of Illinois at Chicago Gary T. Chiodo, Oregon Health & Science University Evan Gaines DeRenzo, The Johns Hopkins University Gary Ellis, Silver Spring, Maryland Michael Friedman, Pharmacia Corporation John Gallin, National Institutes of Health Paul L. Gelsinger, Citizens for Responsible Care and Research Paul W. Goebel, Chesapeake Research Review, Inc. Shirley M. Tilghman, Princeton University Kathy Zeitz, Methodist Health System Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions

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Responsible Research: A Systems Approach to Protecting Research Participants or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Daniel R. Masys of the University of California, San Diego, and Mary Osborn, University of Connecticut Health Center. Appointed by the National Research Council and Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Responsible Research: A Systems Approach to Protecting Research Participants Acknowledgments The committee is grateful to the many administrators, investigators, policy makers, professional societies, and in particular, the research participants, their representatives, and their families that contributed their time, energy, and insight to the work and deliberations of this group throughout its two-year course (see Appendix A for listing of contributors to phase 2 activities). Many thanks to Jeffrey Kahn and Robert J. Levine for their technical review of sections within the report and to Paul S. Appelbaum for his input to the committee’s discussion regarding the informed consent process. The committee also wishes to thank Lee Zwanziger, formerly of the Institute of Medicine, for her assistance and contribution to this project during the transition between Phases 1 and 2. Special gratitude is extended to Virginia deWolf, Constance Citro, and Andrew White of the Committee on National Statistics at the National Research Council and the entire CNSTAT/BBCSS Panel on IRBs, Surveys, and Social Science Research for their efforts to provide specialized insight into the questions facing this committee from the perspective of the social and behavioral sciences. Thanks also to Kenneth Shine, former President of the Institute of Medicine; Susanne Stoiber, Executive Officer of the Institute of Medicine; Clyde Behney, Deputy Director of the Institute of Medicine; and Andrew Pope, Director of the Institute of Medicine Board on Health Sciences Policy, for ongoing advice and guidance as this project progressed. This report was made possible by the support of the U.S. Department of Health and Human Services (including the National Institutes of Health, the Office for Human Research Protections, the Food and Drug Administration, the Agency for Healthcare Research and Quality and the Centers for Disease Control) and The Greenwall Foundation. Special thanks to Greg Koski, Belinda Seto, and Irene Stith-Coleman for their extra efforts and repeated attention to the ongoing information needs and support of this study.

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Responsible Research: A Systems Approach to Protecting Research Participants Acronyms AAHRPP Association for the Accreditation of Human Research Protection Programs, Inc. AAMC Association of American Medical Colleges AAU Association of American Universities ACHRE Advisory Committee on Human Radiation Experiments ARENA Applied Research Ethics National Association BLA Biologic License Application CBER Center for Biologics Evaluation and Research (FDA) CDER Center for Drug Evaluation and Research (FDA) CEO Chief Executive Officer CIOMS Council for International Organizations of Medical Sciences CQI continuous quality improvement CRO contract research organization DHEW (former) U.S. Department of Health, Education, and Welfare DHHS U.S. Department of Health and Human Services DRB Drug Research Board (NRC) DSMB/DMC data and safety monitoring board/data monitoring committee DSMP data and safety monitoring plan FDA Food and Drug Administration FWA Federalwide Assurance document (OHRP) GAO General Accounting Office

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Responsible Research: A Systems Approach to Protecting Research Participants GCP Good Clinical Practice (ICH) HIPAA Health Insurance Portability and Accountability Act of 1996 HRPPP human research participant protection program ICH International Conference on Harmonisation IND Investigational New Drug Application (FDA) IOM Institute of Medicine IRB Institutional Review Board MPA Multiple Project Assurance document NBAC National Bioethics Advisory Commission NCQA National Committee for Quality Assurance NDA New Drug Application (FDA) NHRPAC National Human Research Protections Advisory Committee NHS National Health Service (Britain) NIH National Institutes of Health NSF National Science Foundation OHRP Office for Human Research Protections OIG Office of the Inspector General (DHHS) OPRR (former) Office for Protection from Research Risks ORCA Office of Research Compliance and Assurance (VA) ORI Office of Research Integrity (DHHS) PHS U.S. Public Health Service PI Principal Investigator PLA Product License Application (FDA) PMA Premarket Approval (FDA) PRIM&R Public Responsibility in Medicine & Research QA quality assurance QI quality improvement Research ERB Research Ethics Review Board RFA Request for Applications SOP standard operating procedure SPA Single Project Assurance document SRC Scientific Review Committee VA U.S. Department of Veterans Affairs

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Responsible Research: A Systems Approach to Protecting Research Participants Contents     EXECUTIVE SUMMARY   1 1   INTRODUCTION   29     Context for This Report,   30     Basic Tenets of Ethical Human Research,   31     The Range of Human Research,   32     Recent Events,   36     Themes and Organization of This Report,   40     Summary,   44 2   A SYSTEMIC APPROACH TO HUMAN RESEARCH PARTICIPANT PROTECTION PROGRAMS   45     The Need for a Systemic Approach,   45     Defining Protection Programs,   48     Establishing a Balanced Program,   52     Functions Integral to the Protection System,   66     Summary,   69 3   BACK TO BASICS: SCIENTIFIC, CONFLICT OF INTEREST, AND ETHICAL REVIEW OF RESEARCH PROTOCOLS   70     The Need for Research Ethics Review Boards,   70     Three-Pronged Review,   72     Ensuring Discrete Scientific Review of Protocols,   75     Financial Conflicts of Interest and Protocol Review,   82

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Responsible Research: A Systems Approach to Protecting Research Participants     Ethics Review: Clarifying the Roles and Responsibilities of Research ERBs,   86     Organizing and Integrating the Review Processes,   101     Resource Needs,   105     Summary,   107 4   THE PARTICIPANT-INVESTIGATOR INTERFACE   108     Preparation of the Investigator and Protocol Design,   109     The Informed Consent Process,   119     Roles and Expectations of Research Participants,   129     Summary,   134 5   IMPROVING PROTECTION THROUGH OVERSIGHT AND DATA AND SAFETY MONITORING   136     Government Regulation of Research,   138     Oversight by Federal Research Agencies,   150     Data and Safety Monitoring by the Program,   152     Data and Safety Monitoring by an Independent Body,   154     Communicating the Results of Data and Safety Monitoring,   157     Data Security: Protecting Confidentiality,   159     Summary,   160 6   IMPROVING HUMAN RESEARCH PARTICIPANT PROTECTION PROGRAM PERFORMANCE AND CLARIFYING ROLES   162     Continuous Quality Improvement,   163     Status of Accreditation,   171     Role Differentiation Within the HRPPP,   177     Managing Conflicts of Interest,   182     Compensation for Research-Related Injury,   188     Personal Liability of Research ERB Members,   194     Summary,   195 7   IMPROVING AN EVOLVING NATIONAL HUMAN RESEARCH PARTICIPANT PROTECTION SYSTEM   197     The Need for Better Advice and Guidance at the Federal Level,   198     The Need for Public Information Regarding Ongoing Clinical Research,   200     Communicating Research Results: A Role for Publishers,   205     The Impact of the Health Insurance Portability and Accountability Act of 1996 Requirements and Privacy Issues on HRPPPs,   205     Research Efforts to Counter Terrorism,   211     Summary,   215

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Responsible Research: A Systems Approach to Protecting Research Participants     REFERENCES   217     APPENDIXES     A   Data Sources and Methods   231 B   Protecting Participants in Social, Behavioral, and Economic Science Research: Issues, Current Problems, and Potential Solutions, Report from the Panel on IRBs, Surveys, and Social Science Research   236 C   Clarifying Protocol Accountability   249 D   Committee Biographies   263     INDEX   277

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Responsible Research: A Systems Approach to Protecting Research Participants List of Tables, Figures, and Boxes Tables ES.1   Recommendations That Require Direct Government Action,   20 ES.2   Recommendations That Can Be Implemented in the Absence of Direct Government Action,   23 Figures ES.1   The Confluence of the Research Review Process,   12 1.1   The Phases of Human Research,   41 2.1   A Schematic Illustration of Roles and Interactions of HRPPPs in a Typical, Multisite Clinical Trial,   51 2.2   Accountability for Human Research Activities,   53 2.3   Effective Human Research Participant Protection Programs Require Four Necessary Conditions,   54 2.4   The Essential Functions of a Human Research Participant Protection Program,   67 3.1   The Confluence of the Research Review Process,   75 3.2   Content Knowledge Intrinsic to Human Research Ethics,   97 5.1   Form FDA 483 Deficiencies Issued by CDER Since 1990,   146

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Responsible Research: A Systems Approach to Protecting Research Participants Boxes 1.1   The Imperative Within Professional Ethics Codes Regarding the Importance of Scientific Questions,   33 2.1   Descriptions of HRPPPs at Various Levels Within the Research Environment,   50 2.2   Necessary Education Requirements for Organizational Leadership,   62 3.1   Elements of Scientific Review,   77 3.2   Possible Mechanisms for Scientific Review,   79 3.3   Research ERB Functions Within the Protection Program,   87 3.4   Basic Knowledge for Research ERB Members,   100 4.1   Responsibilities of the Investigator,   110 4.2   Requirements and Regulations for Education,   114 4.3   Informed Consent as a Structured Conversation,   122 4.4   What a Participant Might Want to Know,   132 5.1   Terms Commonly Used in This Chapter,   139 5.2   Results of Food and Drug Administration Inspections,   145 6.1   Potential Data Inputs to Develop Federal Baseline Information on a Protection System,   165 6.2   Quality Assurance Versus Quality Improvement,   167 6.3   Examples of What a Quality Assurance Database Might Contain,   170 6.4   Association for the Accreditation of Human Research Protection Programs: Principles for Accreditation of Human Research Protection Programs,   174 6.5   Compliance Offices,   180 6.6   Professional Societies’ Policies on Conflicts of Interest,   183 6.7   Federal Policies and Guidance on Conflicts of Interest,   184 6.8   International Experience in Compensation for Research-Related Injury,   189 7.1   Sample Journal Policies Regarding Research Participant Protections,   206 7.2   Health Insurance Portability and Accountability Act of 1996 (HIPAA) Waiver Criteria (under modifications to the HIPAA Privacy Rule),   210 7.3   Advisory Committee on Human Radiation Experiments Recommendations for Balancing National Security Interests and the Rights of the Public,   214

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Responsible Research: A Systems Approach to Protecting Research Participants RESPONSIBLE RESEARCH

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