IRB Timelines

General expectations for IRB turnaround times as well as quarterly data on submission volume and IRB timelines are posted on the IRB's @CHOP page.

Submissions that are incomplete or do not adhere to IRB submission guidelines may require additional time. Please submit early whenever practicable. Please note that the time to when the IRB review is complete is not the same as time to approve (stipulations may be issued). Final approval is dependent on meeting the regulatory criteria, the cooperation of the investigator(s) to respond to the IRB's requests for modifications in a timely manner. It may also be affected by outside factors such as the Conflict of Interest Committee, other Ancillary Committees, or the FDA.

Investigators frequently request that the IRB expedite a review. However, in general, studies are reviewed in the order in which they are received. The volume of submissions generally precludes pulling items out of the queue unless it is a true emergency that will adversely affect study subjects or grant funding. Reviewing studies out of order means that other investigators' submissions will not receive timely review. Investigators who believe that their submission requires immediate processing, should contact the IRB Office or the IRB Chair and provide justification and a description of the specific circumstances.

New Study

Studies that require full board review and approval are placed on the next available agenda. The IRB receives approximately 12 new studies each month that require full board review. The full board meets weekly; the interval between submission and review depends on the timing of the submission relative to the next scheduled meeting.

Studies eligible for expedited review make up approximately 75% of the IRB's new volume (excluding exempt determinations). The expedited studies are reviewed by the chair, one of the vice-chairs or (less frequently) by another designated member.

NIH Grants: Submissions Requiring Just-In-Time Review

To ensure that the NIH's timelines are met, the IRB encourages investigators to start working on the study submission in eIRB as soon as a fundable score is received. Investigators should alert the IRB as soon as possible when a just-in-time review will be needed.

Amendments

Full Amendment

Amendments make up the largest proportion of all submissions received by the IRB Office. The large number is due to studies that are amended multiple times in a single year. All amendments should be accompanied by a cover letter that outlines the justification(s) for each requested change.

Changes to the Study Team

Amendment that are limited to additions and/or removals of study team members (not the Principal Investigator) are typically reviewed within 2 business days. To facilitate processing, all study team members must be current on their required training. For more information, see the CHOP Human Research Protection Program Training.

Continuing Review

The IRB instructs researchers to submit the information required for continuing review at least 45 days prior to expiration. With the current submission volume experienced by the IRB office, this generally allows for sufficient time for IRB review and correspondence with the research team. The CHOP IRB's goal is to process each submission in a fair and efficient manner.

Response to Stipulations

The turnaround time for responses to the IRB's requests for modifications varies significantly depending on:

• the inclusion of a cover letter that summarizing the responses, item by item. (Example cover letter)
• the clarity, accuracy and completeness of the response (frequently cover letters indicate that changes have been made that are not reflected in actual changes to the protocol, consent form or eIRB application);
• the number and complexity of the requested modifications to the study; and
• the total volume of IRB submissions at the time of the submission.