Elimination of Continuing Review

THESE CHANGES APPLY TO NON-EXEMPT RESEARCH.

The requirement for continuing review has been eliminated for certain kinds of non-exempt research studies.

• Circumstances Where Continuing Review is Not Required

  "(1) Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances:

  (i) Research eligible for expedited review in accordance with §46.110;

  (ii) Research reviewed by the IRB in accordance with the limited IRB review described in §46.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8);

  (iii) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:

  (A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or

  (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

  (2) [Reserved]" 45 CFR 46.109(f)(2018 requirements)

• Summary of Changes
  • Eliminates continuing review for research eligible for expedited review or research that has progressed to the point it involves data analysis or accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
  • Requires that IRBs document decisions to require continuing review or full board review in circumstances when such review is not required.
  • Investigators still have the current obligations to report various developments (such as unanticipated problems or proposed changes to the study) to the IRB. This includes study closure.
  • Proposed modifications would still require IRB review and approval.