Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
INTRODUCTION, BACKGROUND, AND DEFINITIONS 32 the federal regulations and relevant international guidelines are sufficient. These observers argue that what is needed are more resources devoted to IRBs and regulatory agencies to ensure that protections are in place (Amdur, 2000; Snyderman and Holmes, 2000; Sugarman, 2000). In 1999 and 2000, several groups moved forward with plans to develop standards for accreditation of IRBs and human research protection programs. These initiatives have come forward largely from two groups: one spawned from the PRIM&R effort and the other developed through a contract between NCQA and the VA. The origins of both are discussed in Chapter 2. STATEMENT OF TASK In October 2000, the Secretary of HHS asked the IOM to conduct a two-phase study to address three interrelated topics involved in the protection of human research subjects. The three topics are (1) accreditation standards for HRPPPs8, (2) the overall structure and functioning of activities for the protection of human research subjects, including but not restricted to IRBs, and (3) criteria for evaluation of the performance of activities for the protection of human research subjects. The IOM response is being conducted in two phases. Phase 1, the subject of this report, focuses on accreditation standards for HRPPPs. The specific tasks for phase 1 are to 1. review and consider proposed HRPPP performance standards; 2. recommend standards for accreditation of HRPPPs, considering measures of structure, process, and performance, as well as resource sufficiency; and 3. recommend steps that the organizations and institutions conducting research and the federal government should take to collect and analyze data to monitor and evaluate how well the system for protecting human subjects is operating. Phase 2 will continue the 24-month study of the structure, function, and performance of activities for the protection of human research subjects.9 The results of this future work will be presented as a separate report. DEFINITIONS In this section on definitions, the committee wishes to clarify its choice of terms to avoid confusion within this report and also to signal its awareness of the 8 In the course of committee deliberations, the term âhuman research participant protection programâ was substituted for âhuman research review programâ as the former term better reflected the system of oversight that the committee hopes will result from its recommendations. 9 For more information see http://www.iom.edu/hrrp.