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INTRODUCTION, BACKGROUND, AND DEFINITIONS 40 (AAUP, forthcoming), and the Committee on National Statistics, collaborating with the Board on Behavioral, Cognitive, and Sensory Sciences (National Research Council), is commencing a study of research oversight for the social and behavioral sciences that should inform the present IOM committee's subsequent report. The committee believes that in the meantime it will be important that emerging accreditation standards and the accreditation bodies that use them take this diversity of research into account and clearly indicate those mainly or solely applicable to clinical research (see further discussion in Chapter 2 and Recommendation 5). Independent IRBs The mandates and functions of independent IRBs are similar in scope to those of IRBs housed within an institution. Both types of review bodies and their administrative staffs function within a prescribed set of FDA regulations and according to guidance documents requiring initial review and protocol approval. Thereafter, ongoing review activities include monitoring of adverse events, oversight of recruitment activities, and review and approval of protocol amendments. The trend over the past decade has been for industry sponsors to conduct more multicenter studies outside of the institutional framework, thereby shifting the jurisdictional locus from the IRBs of individual institutions to independent (central) IRBs. Such boards review a growing fraction of research both in the United States and abroad. Thus, accreditation bodies need to develop standards or a subset of standards that embrace the independent IRB model. Independent IRBs can stop a trial, but they do not employ investigators or have authority over them in the same way that the faculty at an academic health center does. The sections of the NCQA and PRIM&R draft standards on âresearch institutionsâ and âinvestigatorsâ therefore do not apply directly to independent IRBs (Isidor, 2001). The operations of IRBs could, however, be accredited, and given their growing importance, independent IRBs should be included in any credible accreditation system. An independent IRB or group of IRBs administered by a single organization might be accredited, perhaps by using the subset of standards applicable to IRBs only, with oversight of investigators and the actual conduct of research performed through mechanisms other than accreditation (e.g., by FDA or OHRP review of sponsors and investigators). Accreditation of independent IRBs could be made contingent, for example, on ensuring that the sponsors from whom they accept work meet specific criteria. Sponsors should disclose whether a protocol has previously been disapproved by any IRB. Most research reviewed by independent IRBs consists of clinical trials for drugs, devices, and biologics. Guidelines for the ethical conduct of such clinical trials already exist, however. These are the International Conference on Harmonisation Guidelines for Good Clinical Practice (ICH-GCP) which apply to
