The Secretary’s Advisory Committee on Human Research Protections (SACHRP) is “pleased” that the HHS Office for Human Research Protections (OHRP) tried its hand at writing guidance related to limited review of studies. Nonetheless, SACHRP wants the agency to make numerous additions and revisions before finalizing the document—particularly changes that would help institutions operationalize such reviews using best practices.

Published June 16, OHRP’s draft guidance “Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions,” is open for feedback until Aug. 15, so regulated organizations may want to review SACHRP’s comments if they are considering submitting their own responses.^[1] The comment document, approved at SACHRP’s July 20 meeting, uses some variation of the word “recommend” 14 times.^[2] Three new SACHRP members participated in the two-day meeting.^[3]

As SACHRP’s comment letter explained, a limited institutional review board (IRB) review is a “new type of review introduced in the 2018 revisions to the 45 C.F.R. § 46 and is intended for the review of certain research in which the primary risks relate to privacy and confidentiality. The [OHRP] draft guidance discusses the concept of limited IRB review and provides information about how a limited review may be conducted.”