Appendixes



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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs Appendixes

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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs This page in the original is blank.

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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs APPENDIX A Data Sources and Methods In an effort to comprehensively address the task of recommending accreditation standards for Human Research Participant Protection Programs (HRPPPs), the committee reviewed and considered various data sources in a concerted effort to cast a broad net for the collection and assessment of information. These sources included presentations before the committee from interested organizations, individuals, and federal agencies as well as formal public comments; a review of relevant literature; and commissioned draft standards for accreditation. A summary description of the committee's evidence-gathering methods follows. PRESENTATIONS AND PUBLIC COMMENT Over the course of the study, the committee requested and received written responses and presentations from organizations and individuals representing many perspectives of accreditation and human subjects protections in general. The committee felt it was important to receive as much input as possible from public and private groups involved with or seeking involvement in the accreditation process and human subjects protections, as well as from health professional and other organizations. To accomplish this, the committee held public meetings on December 18, 2000, and February 21, 2001, and convened a larger public forum on January 22, 2001, to gather information and hear from groups and individuals. The speakers at these meetings are listed in Box A-1.

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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs BOX A-1 Organizations and Individuals Appearing Before the Committee December 18, 2000 Sanford Chodosh, Public Responsibility in Medicine and Research Michael Hamm, Michael Hamm and Associates David Korn, Association of American Medical Colleges Greg Koski, HHS Office for Human Research Protections Charles McCarthy, Kennedy Institute of Ethics Richard Rettig, RAND Corporation Marjorie Speers, National Bioethics Advisory Commission Mark Yessian, HHS Office of Inspector General January 22, 2001 Jessica Briefer French, National Committee for Quality Assurance Jim Burris, Department of Veterans Affairs Marie M. Cassidy, Citizens for Responsible Care and Research Steve Erickson, Boston College William L Freeman, Indian Health Service Edward F. Gabriele, Naval Medical Research Center Peter Goldschmidt, Medical Care Management Corporation Vera Hassner Sharav, Citizens for Responsible Care and Research John Isidor, Shulman and Associates IRB, Inc. Jonathan Knight, American Association of University Professors David Lepay, Food and Drug Administration Felice Levine, American Sociological Association/Consortium of Social Science Associations John R, Livengood, Centers for Disease Control and Prevention Barbara J. LoDico, University of Medicine and Dentistry of New Jersey Dan Masys, University of California, San Diego Cherlyn Mathias, Private citizen Nick Reuter, Substance Abuse and Mental Health Services Administration Philip Rubin, National Science Foundation John Smith, Morehouse School of Medicine David P. Stevens, Association of American Medical Colleges Irene Stith-Coleman, Department of Health and Human Services Margaret VanAmringe, Joint Commission on Accreditation of Health Organizations Myrl Weinberg, National Health Council February 21, 2001 Greg Koski, HHS Office for Human Research Protections Belinda Seto, NIH Office of Extramural Research During the first committee meeting, a number of speakers addressed the history of human subjects protections and the industrialization of clinical research and provided overviews of the HHS Office of Inspector General activities, the HHS Office of Human Research Protections (OHRP), and accreditation processes among other topics.

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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs At the second meeting, the committee convened a public forum in order to hear a variety of perspectives on the preliminary draft accreditation standards formulated by Public Responsibility in Medicine and Research (PRIM&R), the accreditation process, and the protection of human research subjects. Over 125 people attended the meeting. Representatives of government and regulatory organizations, private accrediting groups, associations, institutions, IRBs, social science groups, research participants, and investigators made short presentations that were subject to comment and questioning from the committee and audience. In order to include as many people and groups as possible, the committee sent out a mailing that included an announcement of the public forum, a one-page description of the study, the committee roster, and a cover letter explaining the committee's purpose for requesting the information. The letter was sent to a variety of interested people and groups via fax, e-mail, and listservs, and asked those interested to send or fax comments pertinent to the committee's task and to respond to the PRIM&R draft standards for accreditation. The committee also used the project website [www.iom.edu/hrrp] to elicit comments on the project and the draft standards by providing project details, contacts, and links to pertinent information. The materials submitted to the committee supplemented those obtained by the committee through the literature review and public meetings. A small portion of the third committee meeting was held in open session to hear additional comments from project sponsors. In addition to the participants listed in Box A-1, many other individuals attended and participated in the public meetings, and/or provided written information to the committee. All registered participants for the January 2001 forum are listed below: Aronson, Debra Private citizen Ashe, Warren K. Howard University School of Medicine Bailey, Veronica Children's Hospital, Washington, D.C. IRB Berger, Douglas National Bioethics Advisory Commission Brooks, Tricia Capitol Associates, Inc. Brown, Rachel Association of Independent Research Institutes Bruinooge, Suanna S. American Society of Clinical Oncology Burkom, Diane Battelle Centers for Public Health Research and Evaluation Byerly, Wesley G. Wake Forest University School of Medicine

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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs Caia, Matt Committee on National Statistics, National Academy of Sciences Cantor, Michael Veterans Health Administration National Center for Ethics Carley, John M. U.S. Environmental Protection Agency Carpentier, Richard National Council on Ethics in Human Research Chesley, Francis D., Jr. Agency for Healthcare Research and Quality Chodosh, Sanford Public Responsibility in Medicine and Research Cohen, Jeffrey Office for Human Research Protections Coleman, Laura Eli Lilly and Co. Cuccherini, Brenda A. Veterans Health Administration Daly, Nancy American Society of Therapeutic Radiology and Oncology DeCrappeo, Anthony Council on Governmental Relations DeRenzo, Evan G Washington Hospital Center Dessaint, Danelle Division of Behavioral and Social Sciences and Education, NAS deWolf, Virginia A. NRC Committee on National Statistics Dinsdale, Henry National Council on Ethics in Human Research Dong, Bertha U.S. General Accounting Office Dunn, Cindy M. University of Rochester Dustira, Alicia K. Office of Research Integrity Eaglen, Robert Liaison Committee on Medical Education Eckenwiler, Lisa A. Old Dominion University Erickson, Stephen Boston College Feldman, Laura S. National Association of Children's Hospitals Fish, Bob U.S. Army Medical Research and Materiel Command

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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs Fleming, Yolanda A. National Medical Association Foote, Donna Newsweek Magazine Furtek, Edward University of California, San Diego Gallegos, Alice SUNY Stony Brook Gasparis, George Office of Human Research Protections Gelb, Romy U.S. General Accounting Office Gemski, Liz Capitol Associates Goebel, Paul W., Jr. Office of Human Research Protections Gordon, Daniel M. Walter Reed Army Institute of Research Gordon, Valery M. Office of Extramural Programs, OER, OD, NIH Gottfried, Kate Office for Human Research Protections Graziano, Alfred S., Jr. U.S. Air Force Gross, Lauren G. American Association of Immunologists Hamm, Michael Michael Hamm and Associates/PRIM&R Han, Sang National Association of State Universities and Land-Grant Colleges Harpel, Richard National Association of State Universities and Land-Grant Colleges Hartnett, Terry Clinical Trials Advisor Hauck, Robert J. P. American Political Science Association Higgins, Yvonne K. U.S. Air Force Hurt, Valerie Private citizen Kalf, George F. Thomas Jefferson University Kaneshiro, Julie Office of Science Policy, NIH Kester, Kent E. Walter Reed Institute of Research Khin-Maung-Gyi, Felix Chesapeake Research Review, Inc.

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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs Kohn, Adam M. Shaw Pittman Kuehl, Patricia PAREXEL International Kulakowski, Elliott C. Society of Research Administrators International/ Albert Einstein Healthcare Network Lechter, Karen Food and Drug Administration Lee, Bonnie M. Food and Drug Administration Levine, Jen Washington Drug Letter Linde-Serge, Marian Food and Drug Administration Lorden, Joan F. University of Alabama at Birmingham Macko, Gail Tactical Research, LLC McFarland, Jeff Society of Research Administrators International Meyer, Roger E. Association of American Medical Colleges Milstein, Alan Sherman, Silverstein, Kohl, Rose & Podolsky Mitchell, Marcus Glaxo-SmithKline Mitchell, Mary H. Harvard University Morgan, Charlene Department of the Navy, Bureau of Medicine and Surgery Nightingale, Stuart Department of Health and Human Services Noble, Gary R. Johnson & Johnson Noble, John H., Jr. Catholic University of America Okie, Susan Washington Post Overbey, Mary Margaret American Anthropological Association Panicker, Sangeeta American Psychological Association Papagni, Paul Columbia University/New York Presbyterian Medical Center Patel, Nilam Agency for Healthcare Research and Quality Patterson, Wayne The University of Texas Medical Branch at Galveston

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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs Paulsen, Cindy University of Chicago Perricord, Douglas Quintiles Transnational Polmar, Suzanne K. Yale University Pospisil, George C. National Institute of Neurological Disorders and Stroke, NIH Powell, James H. National Medical Association Puglisi, Tom PricewaterhouseCoopers Radcliffe, Sara PhRMA Reid, Ken Bioresearch Monitoring Report Russel-Einhorn, Michele PricewaterhouseCoopers Sanford, Sandra NCQA Scanley, Anne National Institute of Allergy and Infectious Diseases Scharke, Cliff Office for Human Research Protections Schrode, Kristi Bennet, Turner & Coleman, LLP Schwartz, Harvey A. Agency for Healthcare Research and Quality Seto, Belinda National Institutes of Health Shamoo, Adil E. University of Maryland School of Medicine Sharpe, Angela Consortium of Social Science Associations Shawver, Mary N. Diamond Healthcare Corporation Sherwin, Joseph R. University of Pennsylvania Siang, Sanyin American Association for the Advancement of Science Silver, Howard J. Consortium of Social Science Associations Simonson, Kristin American Society of Therapeutic Radiology and Oncology Skedvold, Paula National Institutes of Health Office of Behavioral and Social Sciences Research Skelton, Margaret Ann School of Medicine and Health Sciences, George Washington University

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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs Smedberg, Paul National Health Council Spilker, Bert PhRMA Stith-Coleman, Irene Department of Health and Human Services Straf, Miron L. Directorate for Social, Behavioral, and Economic Sciences, National Science Foundation Studer, Evelyn Research Triangle Institute Swanson, Dennis University of Pittsburgh Institutional Review Board Turman, Richard J. Association of American Universities Vincent, Angela National Medical Association Waterman, Paula Department of Veterans Affairs, Office of Research Compliance and Assurance Weiner, Susan L. The Children's Cause, Inc. Wenner, Karen A. McKesson HBOC Pharmaceutical Partners Group Wichman, Alison NIH Office of Human Subjects Research Wingard, Jennifer National Association of State Universities and Land Grant Colleges Zarin, Deborah Agency for Healthcare Research and Quality Zimmerman, Janet F. IMPACT Consulting Group The following people and organizations submitted written comments to the committee about accreditation programs and/or the PRIM&R Standards: American Political Science Association Association of American Universities/Council on Governmental Relations/National Association of State Universities and Land Grant Colleges Citizens for Responsible Care & Research Cornblath, David R. Johns Hopkins Medicine Eckenwiler, Lisa A. Old Dominion University Erickson, Stephen Boston College

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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs Feussner, John R. Department of Veterans Affairs, Veterans Health Administration Freeman, William Indian Health Service Gabriele, Edward F. Naval Medical Research Center Kulakowski, Elliott C. Society of Research Administrators International Levine, Felice J. American Sociological Association/Consortium of Social Science Associations National Medical Association Oakes, David D. Stanford University Overbey, Mary Margaret American Anthropological Association Patterson, Wayne The University of Texas Medical Branch at Galveston Richards, R. Henry American Academy of Pharmaceutical Physicians Rubin, Phillip National Science Foundation Ryan, Stephen J. University of Southern California Swanson, Dennis University of Pittsburgh Shopes, Linda Pennsylvania Historical & Museum Commission Townsend, Ardis Noreen Private citizen Vasgird, Daniel R. Research Foundation of the City University of New York Weinberg, Myrl National Health Council All written materials presented to the committee were reviewed and considered with respect to the task. This material can be examined by the public. The public access files are maintained by the National Research Council Library at 2001 Wisconsin Avenue, N.W., Harris Building, Room HA 152, Washington, DC 20007; tel: (202) 334-3543. LITERATURE REVIEW In order to be thorough in their review, the committee conducted multiple literature searches and read numerous articles, book chapters, and reports concerning the protection of human subjects of research and its components during the course of the study. The materials provided addressed topics including the

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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs history of human subjects protections; the laws, processes, and groups that regulate human research; critiques of the current system for protecting human research subjects; sample accreditation programs; and ethical issues surrounding human research. DRAFT STANDARDS FOR ACCREDITATION Due to the fast-track nature of this study, the Institute of Medicine sought to assist the committee in completing its task in a timely manner. For this reason, the IOM funded the completion of a two-year effort by PRIM&R to establish accreditation standards. The resulting standards were intended to assist the committee in its deliberations about accreditation strategies and their strengths and weaknesses. In addition, in the course of the committee's analysis, the draft standards developed by NCQA under contract with the Department of Veterans Affairs were provided to the committee for inclusion in their assessment of accreditation standards.