News Flash:  IRBs must continue to determine that research within the expedited categories is minimal risk

OHRP released 8 new FAQs regarding the revised Common Rule on March 15th.  Importantly, among these is the following clarification that because the Federal Register list of expedited review categories has not yet been updated, IRBs must still actively determine that research that falls within the expedited categories is minimal risk regardless of the revised Common Rule presumption that such research is minimal risk unless an IRB determines and documents otherwise.

[NEW!] After January 21, 2019 (the general compliance date for the revised Common Rule), is the 1998 Expedited Review List still in effect for studies subject to the revised Common Rule?

Yes. Until HHS finalizes a revised expedited review list, the 1998 Expedited Review List (63 FR 60364) is still in effect for research subject to the revised Common Rule. This means that until a new list is finalized, the entire 1998 list, including the “Applicability” section, remains in effect for studies subject to the revised Common Rule. Under the 1998 List, in order for research to qualify for expedited review, a determination must still be made that the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

HHS must publish any proposed revision to the expedited review list in the Federal Register and solicit public comment on the proposal before a revised expedited review list can be finalized.

The “Applicability” section of the 1998 Federal Register notice also stipulates that that the expedited review procedure may not be used:

  • For classified research; and
  • Where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

IRBs that have modified their expedited review procedures in response to the revised Common Rule may need to revisit their procedures to ensure compliance with all of the requirements noted in the 1998 Federal Register notice.

The other new OHRP FAQs address:

  • The general compliance date of the revised Common Rule
  • Which rule applies:
    • When studies were reviewed but not approved by the IRB before January 21, 2019
    • When studies were approved with conditions before January 21, 2019
  • Whether FWAs must be revised because of the revised Common Rule
  • Whether studies that qualify for either exemption or expedited review may be considered exempt
  • Whether IRBs must continue to monitor studies that no longer require continuing review
  • Where clinical trial consent forms must be posted