CONTINUING REVIEW INSTRUCTIONS

　

　

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 insure 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 or more of the categories appropriate for expedited review, excluding categories (8)(b) and (9).  The following documentation is required for continuing reviews: 

1. Memorandum requesting continuing IRB review from the principal investigator.

2. Completed Continuing Assessment Form.

3. List of all active study subjects and addresses.

4. If there are new changes to be made to the informed consent, the new consent must be attached for review and approval.  In addition, the old original color-stamped consent form must be submitted back ORI/IRB to be kept on file.

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 ORI/IRB 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. 

1. Memorandum requesting continuing IRB review from the principal investigator.

2.   Completed Continuing Assessment Form.

3. List of all active study subjects and addresses.

4. If there are new changes to be made to the informed consent, the new consent must be submitted for review and approval. 

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 on IRBNet requesting a year continuance of the study.  It is not necessary to complete the Continuing 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 CLOSED and must be submitted as a new protocol. 

　

IV.       Contact Information and Needed Documentation

All Continuing Review documents may be found on the ORI/IRB website at www.marshall.edu/research/ori or if you have additional questions, please contact:

    IRB#1 - Trula Stanley, IRB#1 Coordinator at (304) 696-7320 or email her at stanley@marshall.edu.

    IRB#2 - Bruce Day, IRB #2 Coordinator at (304) 696-4303 or email him at day50@marshall.edu.