U.S. Department of Health & Human Services
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What are the requirements for providing information on the number of protocols being reviewed by the IRB?
The HHS regulations at 45 CFR 46.502 (e) require institutions or organizations to provide the approximate number of all active protocols and approximate number of active protocols conducted or supported by HHS when registering an IRB. For the purpose of these requirements, an “active protocol” is any protocol for which the IRB conducted an initial or a continuing review at a convened meeting or under an expedited review procedure during the preceding twelve months.
If the IRB reviews protocols regulated by both OHRP and the Food and Drug Administration (FDA), the institution or organization also must provide the approximate number of active protocols involving FDA-regulated products and a description of the types of FDA-regulated products (such as biological products, color additives, food additives, human drugs, or medical devices) involved in the protocols that the IRB reviews.
Last Reviewed: 12/02/2010
Related Questions:
- What are the requirements for providing information on the number of full time equivalent positions?
- What are the requirements for IRB membership?
- How do I determine the various categories of members for the IRB roster?
- Does a FWA have to be updated if an institution later relies on an IRB not included in the original FWA submission?
- Does registration mean that an IRB is in full compliance with the HHS regulations, 45 CFR part 46, or is otherwise meeting a particular standard of competence or expertise?
