Per federal regulations, an IRB must conduct continuing review of previously approved research at intervals appropriate to the degree of risk, but not less than once per year [21 CFR 56.108(a)(1) and 56.109(f)].
Depending on the type of research, continuing review may be performed by expedited review or by full IRB review.
The regulations (45 C.F.R. 46.110(b)(1)) limit the use of expedited review procedures to specific research categories published in the Federal Register at 63 FR 60364-60367, and to the review of minor changes in previously approved research during the period (of not more that one year) for which approval is authorized. An IRB is permitted to use expedited review for the continuing review of research that involves solely one or more of the activities published at 63 FR 60364-60367.
As a rule, if research did not qualify for expedited review at the time of initial review, it will not qualify for expedited review at the time of continuing review, except in limited circumstances described by expedited review categories (8) and (9) at 63 FR 60364-60367. It is also possible that research that previously qualified for expedited review in accordance with Section 46.110, has changed, such that expedited IRB review would no longer be permitted for continuing review.
Please also see recent OHRP guidance about continuing review.
Expedited Review Category (8)
Under Category (8), an expedited review procedure may be used for the continuing review of research previously approved by the convened IRB as follows:
Where
- The research is permanently closed to the enrollment of new subjects; all subjects have completed all research-related interventions; and the research remains active only for long-term follow-up of subjects;
OR- No subjects have been enrolled and no additional risks have been identified;
OR- The remaining research activities are limited to data analysis.
Of note, category (8) identifies three situations in which research that is greater than minimal risk and has been initially reviewed by a convened IRB may undergo subsequent continuing review by the expedited review procedure.
For a multi-center protocol, an expedited review procedure may be used by the IRB at a particular site whenever the conditions of category (8)(a), (b), or (c) are satisfied for that site. However, with respect to category 8(b), while the criterion that "no subjects have been enrolled" is interpreted to mean that no subjects have ever been enrolled at a particular site, the criterion that "no additional risks have been identified" is interpreted to mean that neither the investigator nor the IRB at a particular site has identified any additional risks from any site or other relevant source.
Expedited Review Category (9)
Under Category (9), an expedited review procedure may be used for continuing review of research not conducted under an investigational new drug application or investigational device exemption where categories (2) 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.
The determination that "no additional risks have been identified" does not need to be made by the convened IRB.
