SDSU/UCSD Joint Review Agreement for Students
A. Overview
Students enrolled in a SDSU/UCSD Joint Doctoral Program (JDP) or master's degree program involving both SDSU and UCSD (e.g. master's in Public Health) who plan to involve human subjects in research are required to obtain approval from both the SDSU and 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 SDSU Institutional Review Boards (IRB) to rely upon each other to avoid duplication of effort and reduce burden for investigators, IRB members and staff. The JDP student investigator may submit an IRB application to either SDSU or UCSD to initiate the review process.
B. Regulatory Background
45 CFR 46.114 states: “Cooperative research projects are those projects covered by this policy which involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. With the approval of the department or agency head, an institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.”
The following standards apply where an institution holding an HRPP-approved Assurance wishes to avoid duplication of effort, in accordance with DHHS regulations at 45 CFR 46.114, by relying upon the IRB review of another Assurance-holding institution:
1. The review arrangement must be approved in writing by HRPP and by appropriate officials of the institutions involved.
2. The institution relying upon another institution's IRB has a responsibility to ensure that the particular characteristics of its local research context are considered, either (i) through knowledge of its local research context by the reviewing IRB; or (ii) through subsequent review by appropriate designated institutional officials, such as the Chairperson and/or other members of its local IRB.
C. Procedures
1. Eligibility Criteria
a) Only research that does not exceed minimal risk and meets criteria for exempt or expedited review can be reviewed under this agreement. Criteria for exempt review can be found here. Criteria for expedited review can be found here.
b) Projects that involve VA facilities, use the UCSD MRI facility, or Rady Children’s Hospital will receive review by UCSD.2. Determination of Reviewing IRB
a) The Reviewing IRB is determined by the primary institutional affiliation of the faculty mentor responsible for oversight of the proposed research with one exception: the UCSD IRB will be the Reviewing IRB for all eligible studies that involve the UCSD MRI facility, VA facilities, and Rady Children’s Hospital.
3. Submission
a) To initiate this review process, eligible students must provide a “UCSD-SDSU Joint Doctoral Programs Cover Sheet for Application.” Applications will not be considered for review without this Cover Sheet.
1) When the SDSU IRB is the Reviewing IRB: All IRB applications will be prepared and submitted (along with the Joint Doctoral Programs Cover Sheet for Application) using the SDSU vIRB web-based system.
2) When the UCSD IRB is the Reviewing IRB: All IRB submissions will be prepared and submitted using the UCSD web-based electronic submission process for biomedical applications or hardcopy when submitting an SBS application. UCSD requires that the PI sign the both the Joint Doctoral Programs Cover Sheet for Application and the Standard UCSD Application Face Sheet. Signed cover sheets can be faxed to the UCSD HRPP office at 858-455-9540 or submitted by mail to the UCSD HRPP Office, mail code, 0052.
4. IRB Review Process
a) Reviewing IRB: The Reviewing IRB will review the protocol. Upon completion of review and approval of the protocol application, the Reviewing IRB will provide the Relying IRB with access to the complete protocol and supporting documents. An electronic copy of the approved informed consent document(s), and the Cover Sheet signed by a representative of the Reviewing IRB will be sent to the Relying IRB. Note that all investigator communication with the IRB should be directed to the Reviewing IRB only.
b) Relying IRB: The Relying IRB will sign the Joint Doctoral Programs Cover Sheet for Application acknowledging their acceptance of the Reviewing IRB decision and retain copies of all documents received from the Reviewing IRB. The Relying IRB will then return the signed Cover Sheet for Application to the Reviewing IRB.
5. Approval of Project
a) Upon receipt of the Cover Sheet signed by both institutions, the Reviewing IRB will send an approval letter, stamped consent form(s) (when applicable) and a copy of the signed Cover Sheet to the investigator and the research may then commence.
6. Modifications to an Approved Project
a) To initiate review of a request for modification/amendment of an approved protocol, investigators will submit the request to only the Reviewing IRB.
1) Reviewing IRB: The Reviewing IRB will review the modification/amendment request. Upon completion of review and approval of the modification/amendment request, the Reviewing IRB will provide the Relying IRB with notification of the review and access to a copy of the request and revised supporting documents, including the revised informed consent document(s), and a copy of the modification/amendment request approval letter.
2) Relying IRB: The Relying IRB will have access to all documents used by the Reviewing IRB.
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.
7. Continuing Review/Renewal of Approved Project
a) To initiate review of a request for renewal of an approved protocol, the investigator will submit the request to only the Reviewing IRB.
1) Reviewing IRB: The Reviewing 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 request, the stamped consent document(s), and a copy of the renewal approval letter.
2) Relying IRB: The Relying IRB will have access to all documents used by the Reviewing IRB.
b) The investigator will receive an approval letter and approved consent forms (when applicable) from the Reviewing IRB and may continue research activities.