submission to the investigator, outlining the reasons for tabling the protocol, and includes a description of the revisions or clarifications requested.
DISAPPROVED. OSP staff generates a letter describing the reasons for disapproving the protocol and provides it to the researcher. A study is not approved if the IRB has enough information to make the necessary determinations of approval but believes the continuation of research does meet the criteria for approval.
OSP staff will include in the letter approving the continuation of a project the beginning and end date of approval. During the convened meeting, the IRB determines the approval period as appropriate to the degree of risk but not less frequently than once per year for research retaining full Board review status. The date when a protocol is approved by the full Board, or by the primary reviewer following the completion of requested minor revisions to a protocol, determines the latest permissible date of approval and, therefore, the latest permissible date for the next continuing 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:
Continuing 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.
Continuing 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.