It is incumbent on the institution to advise investigators and others involved in the conduct and administration of research involving human subjects of the institutional policies for reviewing exempt research.Įxpedited review procedures are described in. An institution with a Multiple Project Assurance (MPA) or Cooperative Project Assurance (CPA) should indicate in its Assurance if and how exempt research is reviewed. Institutions may elect to review all research under the auspices of the institution even if the research qualifies for exemption under. OPRR advises that investigators should not have the authority to make an independent determination that research involving human subjects is exempt and should be cautioned to check with the IRB or other designated authorities concerning the status of proposed research or changes in ongoing research. In addition, the institution should be prepared to reinforce and review, as necessary, the method of determining what is exempt. Those persons who have authority to make adetermination of what research is exempt are expected to be well-acquainted with interpretation of the regulations and the exemptions.
(Institutions and IRBs may not create new categories of exempt researchunder 45 CFR Part 46.) Institutions should have a clear policy in place on who shall determinewhat research is exempt under. Research activities involving human subjects that are exempt from IRB review are identified in 45CFR 46.101(b)(1)-(6). The purpose of this letter is to assist Institutional Officials and Institutional Review Board (IRB) Chairs in interpreting the term "exempt" research and identifying research for which "expedited review" is appropriate. Subject: Exempt Research and Research That May Undergo Expedited Review THE GUIDANCE INFORMATION IN THIS DOCUMENT RELATED TO EXEMPT RESEARCH REMAINS IN EFFECT. NOTE: THE INFORMATION IN THIS DOCUMENT RELATED TO EXPEDITED REVIEW IS OUTDATED AND HAS BEEN REPLACED BY OHRP’S AUGGUIDANCE ENTITLED, "GUIDANCE ON THE USE OF EXPEDITED REVIEW PROCEDURES." CLICK HERE FOR THE AUGGUIDANCE. Regulations & Policy Archived Materials.Subpart C Certification Request to OHRP.Single IRB Exception Determinations has sub items, about Single IRB Exception Determinations.OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements.
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