On 1/18/19 OHRP issued a FAQ recommending that IRBs continue to conduct continuing review of research that is eligible for expedited review under the current categories 8(b) or 9 of the OHRP Federal Register list even though continuing review is not required for such studies under the revised Common Rule.
The revised Common Rule eliminates the requirement for continuing review for research eligible for expedited review unless and IRB determines otherwise and documents its rationale. However, the list of research eligible for expedited review has not been updated yet. OHRP is recommending that IRBs use their discretion to determine that continuing review of studies eligible for expedited review under the current categories 8 & 9 is required at the same frequency as would have been required under the pre-2018 Common Rule (i.e., at intervals appropriate to the degree of risk, but not less than once per year). The IRB’s documented rationale could simply be that the IRB is following OHRP’s guidance.
Research eligible for expedited review under the current categories 8(b) and 9 includes:
- Continuing review of research previously approved by the convened IRB where no
subjects have been enrolled and no additional risks have been identified (Category 8(b))
- Continuing review of research not conducted under an IND or IDE where categories two
through 8 do not apply but the IRB has determined and documented at a convened
meeting that the research involves no greater than minimal risk and no additional risks
have been identified.
OHRP explicitly reminds organizations that this recommendation is not applicable to:
- Research that is subject to the pre-2018 Common Rule
- Research that is subject to FDA regulations
- Research that meets the conditions for expedited review under categories 8(a) or (c)
- Research that has progressed to the point that it meets the conditions of 46.109(f)(1)(iii):
- Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
- Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.