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100. Food and Drug Administration (FDA) Research: Overview

The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction including drugs, biological products, and medical devices. FDA regulations are published in title 21 of the CFR. The following FDA human subject research regulations apply to the IRB:

21 CFR 50, Protection of Human Subjects

21 CFR 56, Institutional Review Boards

21 CFR 312, Investigational New Drug Application (IND)

21 CFR 812, Investigational Device Exemptions (IDE)

IRB Review of FDA Research

  • The IRB requires additional investigator forms for FDA research conducted under an IND or IDE to verify that investigators address IRB-relevant elements specific to FDA regulations.
  • Research conducted under IND or IDE is reviewed at convened Biomedical IRB meetings, with the exception of continuing reviews that meet the criteria for expedited review under Categories 8(a), 8(b), or 8(c) or reviews of minor modifications (see policy manual definitions) to previously approved research.
  • In presenting the protocol to the IRB, the primary reviewer will address the additional FDA regulatory requirements.

FDA also regulates the use of investigational articles outside of the research setting by a clinician for emergency use (drugs or devices), and compassionate use (devices only). See the relevant sections in the policy manual for approval requirements for emergency and compassionate (devices only) uses.

NOTE: FDA and DHHS human research protection regulations differ. For research subject to review under FDA and DHHS human subject regulations, both sets of regulations apply and the requirements for both sets of regulations must be met. An overview of these differences may be accessed through the following link: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/EducationalMaterials/ucm112910.htm

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