Institutional Review Boards (IRBs)

IRBs must approve proposed non-exempt research before involvement of human subjects may begin.

• IRBs that are designated on an FWA, and IRBs in the United States reviewing clinical investigations regulated by FDA, must register with OHRP electronically at 
  • http://ohrp.cit.nih.gov/efile/IrbStart.aspx for an initial registration and at
  • http://ohrp.cit.nih.gov/efile/IrbRnwStart.aspx for a registration update or renewal,
    (if technically feasible).
• Regulatory requirements for IRBs designated on FWAs are at 45 CFR part 46
• Under 45 CFR part 46, subpart E, IRBs must be registered with OHRP before the IRB may be designated on an FWA as reviewing proposed research for the FWA-holding institution.
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• Registration requirements for IRBs, in the United States,  reviewing clinical investigations regulated by FDA are at 21 CFR part 56.
• Under 21 CFR part 56, subpart B, each IRB in the United States (U.S.) that reviews clinical investigations regulated by FDA and each IRB in the U.S. that reviews clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products must register at
  • http://ohrp.cit.nih.gov/efile/IrbStart.aspx for an initial registration and at
  • http://ohrp.cit.nih.gov/efile/IrbRnwStart.aspx for a registration update or renewal,
    (if technically feasible).