Reviews

Expedited Review

The IRB will decide if an application is eligible for Expedited Review. If so, the application will be delivered to two members of the Committee who will review the application. Expedited review is conducted by the Chairperson or members of the Committee designated for the task. The designated members will review and return any concerns to the IRB usually within 2-3 weeks. The PI is contacted and responsible for addressing each reviewer's concerns before approval is granted by the IRB.

Exempt Studies

Certain classes of research may be judged exempt from the requirement for IRB review. To be classified as "exempt" the research must meet the specific criteria. The decision whether a specific project qualifies for exemption must be made by the IRB not the investigator. The IRB may require review of studies even though they qualify for exemption in the federal regulations; however, neither the IRB nor the institution may exempt a study that does not meet the federal criteria.

Order of Procedure

There are two full IRB meetings each month; one at 4:00 P.M. on the first Tuesday and the other at 4:00 P.M. on the third Tuesday of each month (except for the months of July and August which only have one meeting per month on the third Tuesday). Applications should be submitted to the Research Subjects Office by the deadline dateslisted. This is necessary to make sure the application is in an acceptable form and to allow time for the review process. Please refer to the IRB Guidelines for complete details. Applications are then distributed to the members of the Committee for their review and for any preliminary discussions between the investigator and primary reviewers.

Some of these procedures are subject to change, please contact the Research Subjects Office for current information.

Continuing Surveillance (Reapproval Process)

All protocols must be reapproved at least annually until they are terminated. For some protocols more frequent reapproval will be required, this would be specified at the time of initial approval. Investigators will be notified by the IRB when their protocols are due for reapproval, and will be sent the IRB reapproval application. Studies which are not reapproved by the expiration date are no longer in compliance with IRB regulations and will be terminated. Subjects may not be recruited into studies that have expired due to lack of reapproval.

Reporting Serious Adverse Events

Minor adverse consequences of investigational therapy should be reported only if they were either unanticipated in the consent form or if the original description in the protocol substantially underestimated their probability or magnitude.

 Anticipated adverse consequences of research procedures must be reported if they are of sufficient magnitude to require medical therapy or if they prolong hospitalization.

Upon receipt of an adverse event report, the IRB will decide if further investigation of the event is required. In some cases investigators may be required to discontinue a study pending the outcome of IRB review. The IRB is required to report to NIH or to FDA (if either agency has jurisdiction) any "unanticipated problems involving risks to subjects or others." In many studies, investigators have additional obligations to report adverse events to funding agencies or industrial sponsors.

  Any reports sent to the funding agency about the event should also be included in your report to the IRB.

 If your study is part of a multicenter trial any Adverse Event/Safety Reports you receive from other sites should be sent to the IRB within 5 days of when they are received. The investigator should evaluate these reports and explain what action she or he feels is appropriate for informing the subjects.

 The Research Subjects Office provides a form letter that should be used to report both in‑house and off‑site adverse events to the Committee. Copies of any reports made to funding agencies should be included with the form letter; and, if the adverse event occurred at another site, a copy of the notification you received should be included with the form letter. This form letter contains the information that the Committee requires for the initial review of the adverse event. If the adverse event is serious enough to warrant informing subjects of its risk, a revised consent form will be required for future subjects and, when appropriate, an addendum consent form for subjects currently participating. Copies of these consent forms should be included with the adverse event report. Further information may be requested by the IRBduring the review process.

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