UCSD-CSUSM JOINT DOCTORAL PROGRAMS
COVER SHEET INSTRUCTIONS FOR CSUSM IRB APPLICATION

Overview

Students enrolled in a CSUSM/UCSD Joint Doctoral Program (JDP) who plan to involve human subjects in research are required to obtain approval from either the CSUSM or UCSD Institutional Review Boards in advance of initiating research. This document describes a cooperative review process (45 CFR 46.114) that allows the UCSD and CSUSM Institutional Review Boards (IRB) to rely upon each other to avoid duplication of effort and reduce burden for investigators, IRB members and staff. This agreement is limited to CSUSM/UCSD JDP students. The impact of this agreement will be evaluated during regularly scheduled doctoral program reviews at UCSD and CSUSM to determine whether the agreement may be expanded.  These instructions specifically apply to JDP student’s submitting a protocol to the CSUSM IRB. 

Procedures
1.Determination of Reviewing IRB
The Reviewing IRB is determined by the primary institutional affiliation of the faculty mentor responsible for oversight of the proposed research with consideration of the following:

a)Projects that involve VA facilities, use the UCSD MRI facility, or Rady Children’s Hospital will be reviewed by UCSD.

b)Research that involves the Center for Children and Families will be reviewed by CSUSM.


2. Submission
To initiate this review process, eligible students must provide a “UCSD-CSUSM Joint Doctoral Programs Cover Sheet for Application.” Applications will not be considered for review without this Cover Sheet. The JDP Cover Sheet can be obtained at http://www.csusm.edu/gsr/irb/forms.html.

a) When the CSUSM IRB is the Reviewing IRB: The student should submit their IRB application to their dissertation committee Chair.  Upon the chair’s approval, the application must be electronically forwarded by the CSUSM dissertation chair via the appropriate process to the CSUSM IRB committee.  Complete submission instructions can be found at: http://www.csusm.edu/irb.

3. IRB Review Process

a) The CSUSM IRB will review the protocol and upon approval of the application, will provide the UCSD IRB with an electronic copy of the Cover Sheet signed by a representative of the CSUSM IRB. 

b) The UCSD IRB will sign the Joint Doctoral Programs Cover Sheet for Application acknowledging their acceptance of the CSUSM IRB’s decision and return an electronic copy to the CSUSM IRB.

c) Upon receipt of the Cover Sheet signed by both institutions, the CSUSM IRB will send an approval letter, stamped consent form(s) (when applicable), and a copy of the signed JDP Cover Sheet to the investigator, and the research may then commence.

4. Modifications to an Approved Project

a)To initiate review of a request for modification/amendment of a CSUSM approved protocol, investigators will submit the request to only the CSUSM IRB.

1)The CSUSM IRB will review the modification/amendment request. Upon completion of review and approval of the modification/amendment request, the CSUSM IRB will provide the UCSD IRB with an electronic copy of the modification/amendment request approval letter.

b)Upon approval of the modification, the investigator will receive an approval letter and revised and re-stamped/approved consent forms (when applicable) from the Reviewing IRB. Upon receipt of the approval letter and approved consent forms (when applicable) from the Reviewing IRB, the requested changes may be implemented.

5. Continuing Review/Renewal of Approved Project

a)To initiate review of a request for renewal of a CSUSM approved protocol, the investigator will submit the request to only the CSUSM IRB.

1)The CSUSM IRB will review the renewal request. Upon completion of review and approval of the renewal request, the Reviewing IRB will provide the Relying IRB with an electronic copy of the renewal approval letter.

b)The investigator will receive an approval letter and approved consent forms (when applicable) from the CSUSM IRB and may continue research activities.