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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