Appendix A
Data Sources and Methods

In order to comprehensively assess the system for protecting human research participants, the committee reviewed and considered a variety of data sources and inputs in a concerted effort to collect and evaluate a broad array of information. These sources included a review of relevant literature; presentations before the committee from interested organizations, individuals, and federal agencies; data collected from organizations and people; and materials collected for the committee’s first report, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. A summary description of the committee’s evidence-gathering methods follows.

THE FIRST PHASE

The committee undertook its task in two phases. The first phase of the committee’s work, exploring accreditation of human research participant protection programs (HRPPPs), resulted in the publication of Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (IOM, 2001a). In order to gather information for that report, the committee held several open meetings and invited public comment on the draft accreditation standards presented to the committee by Public Responsibility in Medicine and Research (PRIM&R) and the National Committee for Quality Assurance (NCQA). A thorough description of the methods used in the first phase of the committee’s task can be found in Appendix A of Preserving Public Trust.



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Responsible Research: A Systems Approach to Protecting Research Participants Appendix A Data Sources and Methods In order to comprehensively assess the system for protecting human research participants, the committee reviewed and considered a variety of data sources and inputs in a concerted effort to collect and evaluate a broad array of information. These sources included a review of relevant literature; presentations before the committee from interested organizations, individuals, and federal agencies; data collected from organizations and people; and materials collected for the committee’s first report, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. A summary description of the committee’s evidence-gathering methods follows. THE FIRST PHASE The committee undertook its task in two phases. The first phase of the committee’s work, exploring accreditation of human research participant protection programs (HRPPPs), resulted in the publication of Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (IOM, 2001a). In order to gather information for that report, the committee held several open meetings and invited public comment on the draft accreditation standards presented to the committee by Public Responsibility in Medicine and Research (PRIM&R) and the National Committee for Quality Assurance (NCQA). A thorough description of the methods used in the first phase of the committee’s task can be found in Appendix A of Preserving Public Trust.

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Responsible Research: A Systems Approach to Protecting Research Participants PUBLIC MEETINGS AND FEEDBACK Over the course of the second phase of this study, the committee requested and received written responses and presentations from organizations and individuals concerned with human research participant protections. The first meeting of the committee’s second phase of work took place on May 14-15, 2001. Subsequent public meetings were held on August 21-22 and November 1-2, 2001, and March 25-26, 2002. The committee’s meetings on January 17-18 and May 20-21, 2002, were held entirely in executive session, and therefore, were closed to the public. The speakers at the various public meetings during phase 2 are listed in Box A.1. At the May 2001 meeting, presenters addressed the committee’s task, the Department of Health and Human Services (DHHS) draft interim guidance on conflicts of interest, and the activities of the National Human Research Protections Advisory Committee. Presenters also provided information regarding NIH insights from proactive compliance site visits, the Food and Drug Administration’s (FDA’s) bioresearch monitoring data, and common compliance problems observed by the Office for Protection from Research Risks (OPRR)/Office for Human Research Protections (OHRP). During the August meeting, the presentations covered a variety of topics including the HRPPP system, the role of the pharmaceutical industry and of contract research organizations in protecting human research participants, federal regulations and their legal implications, informed consent processes, international research trials, National Bioethics Advisory Committee recommendations, Institutional Review Board (IRB) administration, and FDA policies and procedures. The November public meeting was convened to explore the perspectives of human research participants. At that meeting, the committee heard from public members of regional, independent, and academic Institutional Review Boards; representatives of public support organizations, including Project LEAD, Citizen Advocacy Center, and PXE International; and research trial participants. During the January meeting, the committee focused on report content and recommendation development. In addition, the committee reviewed information compiled at its request by OHRP—OHRP Compliance Data by Institution, by Determination Letters Issues, and by Site-Visited Institution October 1998 to December 2001. In addition to evaluating the report contents and recommendations, the committee gathered information about the ongoing accreditation processes of the Association for the Accreditation of Human Research Protection Programs and the National Committee for Quality Assurance at its March meeting. Representatives from the National Institutes of Health (NIH) and

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Responsible Research: A Systems Approach to Protecting Research Participants BOX A.1 Individuals and Organizations Appearing Before the Committee During Phase 2 Open Sessions May 14-15, 2001 Michael Carome, DHHS Office for Human Research Protections Dennis Dixon, NIAID Biostatistics Research Branch Kate-Louise Gottfried, National Human Research Protections Advisory Committee Greg Koski, DHHS Office for Human Research Protections Stuart Nightingale, DHHS Office of the Assistant Secretary for Evaluation and Planning Belinda Seto, NIH Office of Extramural Research Stan Woollen, FDA Office of Medical Policy August 21-22, 2001 Helen Wyn Davies, Quintiles, Inc. Nancy Kass, Johns Hopkins University Bloomberg School of Public Health David Lepay, FDA Office of the Commissioner Robert Levine, Yale University School of Medicine James Phelps, Hyman, Phelps & McNamara Tom Puglisi, Pricewaterhouse Coopers Marjorie Speers, National Bioethics Advisory Commission Bert Spilker, Pharmaceutical Research and Manufacturers of America Jeremy Sugarman, Duke University Medical Center November 2, 2001 Pat Barr, IRB Member, community setting Perry Cohen, Trial Participant Rex Cowdry, National Alliance for the Mentally Ill Gregg Gonsalvez, Trial Participant Carolina Hinestrosa, Project LEAD William C. Jacobs, IRB member, independent IRB setting Libby Pedrazzani, Trial Participant Kathleen Rand Reed, IRB member, academic setting David Swankin, Citizen Advocacy Center Sharon Terry, PXE International Claudia Wayne, Trial Participant March 26, 2002 Jessica Briefer French, National Committee on Quality Assurance Greg Koski, DHHS Office for Human Research Protections Belinda Seto, NIH Office of Extramural Research Marjorie Speers, Association for the Accreditation of Human Research Protection Programs

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Responsible Research: A Systems Approach to Protecting Research Participants BOX A.2 Individuals Participating in Conference Calls with Committee Members January 10, 2002: IRB Community Perspective Arthur O. Anderson, U.S. Army Medical Research Institute of Infectious Diseases Jeffrey A. Cooper, Albany Medical Center Susan J. Delano, Research Foundation for Mental Hygiene, Inc. Felix Gyi, Chesapeake Research Review, Inc. Karen Hansen, Fred Hutchinson Cancer Research Center Steven Heeringa, University of Michigan Nancy Hibser-Davis, University of Illinois College of Medicine at Peoria Kathryn Madden, Oregon Research Institute Helen McGough, University of Washington Celia S. Walker, Colorado State University March 18, 2002: Research Investigator Perspective William F. Crowley, Massachusetts General Hospital Steven C. Schachter, Beth Israel Deaconess Medical Center Susan Weller, University of Texas Medical Branch at Galveston OHRP also updated the committee about activities at their respective organizations. The final committee meeting in May 2002 focused solely on the report contents and recommendations. In order to supplement the information gathered during the formal meetings, members of the committee conducted two conference calls to access perspectives from two additional areas of importance to the committee. The first call, held in January 2002, involved members of the IRB community, including IRB administrators and board members. The individual call participants were identified largely in consultation with the Applied Research Ethics National Association in order to gather a group representative of a variety of research organizations and disciplines. The second call, held in March 2002, focused on the investigator perspective. Participating investigators included biomedical and social science researchers who were identified in consultation with relevant professional associations. The participants in both conference calls are listed in Box A.2. During these meetings and throughout the course of the study, a number of people and organizations shared written materials with the committee. These materials were reviewed and considered with respect to the committee’s task and can be examined by the public. The public access files

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Responsible Research: A Systems Approach to Protecting Research Participants are maintained by the Public Access Records Office, 2101 Constitution Avenue, NAS 171, Washington, DC 20418; tel: (202) 334-3543. LITERATURE REVIEW In order to conduct a thorough review, the committee conducted multiple literature searches and read numerous articles, books, policies, and reports concerning the protection of human participants in research. The committee maintained information about the materials in a database that allowed the committee to search for items by keywords or other criteria. The materials provided to the committee addressed a large variety of topics including information about IRBs; informed consent procedures; federal regulations and compliance problems; the roles of industry, contract research organizations, participants, and other stakeholders in the research enterprise; the problems within the current protection system; the ethics of research involving humans; conflicts of interest; accreditation; regulatory costs; safety monitoring; multisite research; and a number of other topics.