I. Submitting Periodic Reports to the IRB

All protocols receiving IRB approval must be periodically reviewed. The IRB makes the determination of the frequency for continuing review for each protocol as part of the initial approval. The continuing review process periodically will occur at an interval not to exceed one year from the initial IRB approval. It is the responsibility of the Principal Investigator to comply with the continuing review requirements and must submit the required documentation on IRBNet in a timely manner in order to ensure that there will be no interruption in the research process. The IRBNet User Manual will help you with the submission process. The Principal Investigator must ensure that their protocol does not meet or exceed the expiration date that has been initially approved.

II. Requirements for Submission of Continuing Review

IRBNet will send a notification to all the principal investigator and co-investigator 60/30/7 days prior to expiration.  The Principal Investigator will have the total responsibility for the timely submission of their protocol information. The following documents must be completed and submitted to the ORI/IRB Office 30 days in advance of the next IRB meeting date that does not exceed the expiration of the protocol:

A. Protocols with Full Convened Initial Approval

Continuing reviews are conducted by the convened IRB unless the research falls into one  of the categories appropriate for expedited review as listed in 45CFR46.110(a)(8)(9). The following documentation is required for continuing reviews:

1. Completed Continuing Review Request Form

2. Completed Continuing Review Protocol Assessment Form

3. If there are new changes to be made to the informed consent, the new consent must be attached for review and approval. If no consent changes are necessary then the current consent must be attached in order to receive an updated approval stamp.

4. The current CITI refresher course completion certificate is required for the investigator and all co-investigators on the study. A copy of these certificates must be attached to the IRBNet submission.

5. Full convened Protocols that are now “closed to enrollment” and are in the “data analysis” portion of the study process may be eligible for Expedited Continuing Review. Please contact the appropriate IRB Coordinator (listed in Section IV below) for verification of when your protocol is qualified for this type of review.

B. Protocols with Expedited Initial Approval

Protocols that received Expedited IRB initial approval will receive Expedited IRB continuing review. The following documentation is required for continuing reviews:

1. Completed Continuing Review Request Form

2. Completed Continuing Review Protocol Assessment Form

3. If there are new changes to be made to the informed consent, the new consent must be submitted for review and approval. If no consent changes are necessary then the current consent must be attached in order to receive an updated approval stamp.

4. The current CITI refresher course completion certificate is required for the investigator and all co-investigators on the study. A copy of these certificates must be attached to the IRBNet submission.

C. Protocols with Exempt Approval

Protocols with Exempt IRB initial approval should also receive a continuing IRB review. The principal investigator should submit a new package (not new project) on IRBNet requesting a year continuance of the study. The IRBNet User Manual will help you with the submission process. This package must include the Continuing Review Request Form. If there are new changes to be made to the informed consent, the new consent must be submitted for review and approval. If no consent changes are necessary then the current consent must be attached in order to receive an updated approval stamp. The current CITI refresher course completion certificate is required for the investigator and all co-investigators on the study. A copy of these certificates must be attached to the IRBNet submission. It is not necessary to complete the Continuing Review Protocol Assessment Form for exempt continuing reviews. It is the responsibility of the principal investigator to notify the ORI/IRB of any changes (procedure, personnel, or closure) in the protocol.

III. Non-Compliance of Submission for Continuing Review

In the event that the protocol does not receive continuing review by the required date, the study will be FORCED CLOSED and must be submitted as a new protocol. If the study is forced closed then the investigator must confirm in writing that all research activities concerning that study have ceased.

IV. Contact Information and Needed Documentation  

All Continuing Review documents may be found in the IRBNet library or on this website. If you have additional questions, please contact:

IRB #1 – Trula Stanley, IRB #1 Coordinator, by phone at 304.696.7320 or by e-mail.

IRB #2 – Bruce Day, IRB #2 and Conflict of Interest Coordinator, by phone at 304.696.4303 or by e-mail.