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 allow for continuing review through the expedited process of a protocol that was originally approved by the full Board. Projects originally approved through expedited review will, in most cases, be eligible for continuing review through the expedited process.

Researchers requiring continuing review of their research should contact the OSP for the continuing review application form. Applications will require signatures or endorsements by all researchers involved in the project. For students submitting an application, a signature by a faculty sponsor or advisor is required.

Before submitting the application to the OSP, researchers should ensure that the application is complete and accurate, and they thoroughly address all items and questions on the application. In the application, the researcher will provide an updated summary of the protocol and provide justification for any proposed amendments to the protocol; a status report on the progress of the research, including the number of participants involved in the research and a description of participants; a summary of any adverse events that have occurred and/or any unanticipated problems involving risks to