new determination. Barring extenuating circumstances, if a researcher does not respond to requested revisions in the 90-day time period, the application is withdrawn, and a new protocol submission is required.
FULL REVIEW REQUIRED. The primary expedited reviewer may determine the protocol requires full review by the IRB at a convened meeting.
The primary expedited reviewer may also determine that the project is eligible for exemption or the activities do not fall under the purview of the IRB. If the protocol is determined to be eligible for exemption, the researcher will withdraw their application and submit a new application for determination of exempt status.
OSP staff will include in the approval letter the beginning and end date of approval. The date the primary expedited reviewer approves the study is the date the approval period starts. The approval period will last no more than one year. In some cases, the expedited reviewer may require continuing review of the project more frequently than once per year. In these cases, the reviewer must write a justification for this requirement and provide the explanation to OSP staff.
An expedited review does not mean that the review will be concluded quickly, although it will usually be faster than a full Board review. An expedited review simply means that a review can occur without a convening of the IRB.
In cases where a full Board review is needed quickly, and the urgency is not a result of negligence or delay on the part of researchers to submit human subject applications in a timely fashion, researchers should contact the OSP, and the IRB Chair and OSP staff will determine if a quick turnaround is possible. If the IRB Chair agrees to the urgent full review of a protocol, and it is administratively feasible, the application materials will be distributed as soon as possible to IRB members to allow sufficient time for review prior to a meeting. In these cases, the researcher may also be asked to attend the meeting to answer any questions that arise.
Continuing review of research is for protocols that were previously approved by the IRB and must be completed before the current period of approval ends. The period of approval is usually one year but may be less, depending on the project.
In most cases, if a protocol was reviewed and approved by the full board, the IRB must review the continuation of research at a convened meeting at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For certain categories of research, however, HHS guidelines