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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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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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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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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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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.
Representative terms from entire chapter:
protection programs