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On June 7, 2006, OHRP issued a guidance document titled Applicability of 45 CFR part 46 to Clinical Investigations Conducted Under FDA's Interim Final Rule at 21 CFR 50.23(e). This document addressed how to determine whether HHS regulations at 45 CFR Part 46 apply to the activities covered by FDA's interim final rule. The document provides guidance on:
* The determination of when institutions conducting activities covered by 21 CFR 50.23(e) would be engaged in non-exempt human subjects research, specifically:
--Clarifying that institutions whose employees or agents use an investigational device only to (1) identify a potentially life-threatening chemical, biological, radiological, or nuclear agent, (2) facilitate the treatment of individuals exposed to such an agent, and/or (3) report test results to a public health authority would not be engaged in human subjects research under 45 CFR part 46
--Clarifying that institutions whose employees or agents obtain or analyze identifiable private information derived from an investigational IVD device in order to evaluate the safety and effectiveness of the IVD device would be engaged in human subjects research under Part 46
* The requirements for obtaining or waiving informed consent under 45 CFR 46.116
--Clarifying the OHRP expectation that the IRB often …