Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)
Chapter: PRESENTATIONS AND PUBLIC COMMENT
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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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.
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
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
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.
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
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
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
