10.7 Expedited Review

In general, if research did not qualify for expedited review at the time of initial review, it does not qualify for expedited review at the time of continuing review. However, according to the HHS guidelines for expedited review, continuing review of a protocol that was originally approved by the full board may be eligible for expedited review if it falls within one of the following categories:

• oContinuing review of research previously approved by the convened IRB as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.
• oContinuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (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.

It is also possible that research activities that previously qualified for expedited review have changed or will change, such that expedited IRB review may not be appropriate for continuing review. Changes may include, for example, a modification to the protocol in which the previous risk to subjects was minimal but, as a result of the modification, now places them at more than minimal risk. Researchers may contact OSP staff for guidance as to whether they should apply for expedited or full continuing review.

Researchers seeking expedited review will submit an application package to the OSP. The application package will include a completed continuing review application form and all applicable supporting documents, such as recruitment materials, informed consent documents, and any test or survey instruments to be used. In the application, as with the application for continuing review by the full Board, the researcher will address any changes in the protocol or any developments affecting the research and risks for human subjects that have occurred since the initial approval of the research.

Once OSP has received the application package, OSP staff will conduct a preliminary screening of the application package, and once the screening has been completed, OSP staff will consult with the IRB Chair to determine who will be responsible for the expedited review. The expedited review may be carried out by the Chair, another IRB member, or the HRPP specialist serving as an alternate IRB member. All other procedures outlined for the initial review via the expedited process in section 9 apply for the expedited continuing review, including procedures regarding conflict of interest.

The expedited reviewer will make one of the following recommendations: APPROVED, REVISIONS and/or ADDITIONAL INFORMATION REQUIRED, or FULL REVIEW