1. SDSU/UCSD Joint IRB Review Process Wendy Bracken Human Research Protection Program Coordinator /Educator Division of Research Affairs Graduate & Research Affairs San Diego State University

2. Main Points 4 When to submit to each IRB 4 Language for joint UCSD/SDSU Consent Forms 4 Important distinctions between the UCSD and SDSU IRB

3. Protocol Submission: 4 Which IRB should you contact for initial review? 4 This is determined by: –The primary location of the study Participant involvement at primarily one institution Research in the community or other site not affiliated with either SDSU or UCSD Research that is part of a larger approved study

4. Participant Involvement at Primarily One Institution 4 For example, if participants will be recruited from and/or study activities take place primarily on SDSU’s campus then: –Protocol submission should occur at SDSU prior to submission at UCSD –You should contact the secondary IRB to begin the review process using the protocol/supplementary documents approved by the primary IRB –Be sure to clearly identify yourself as a JDP student (Especially important if you submit to UCSD first)

5. Concurrent Review: 4 Concurrent review is appropriate if the research is conducted in the community or involves another institution not affiliated with either UCSD or SDSU: –Submit protocols to both institutions concurrently. –Once the protocol is received, SDSU and UCSD’s IRB will communicate with you (as well as any other IRBs as necessary) regarding any required revisions.

6. Research that is Part of a Larger Approved Study: 4 Student research that is a part of a larger study: –Example: You are working on a study at UCSD and would like to answer a specific question that complements the existing protocol for use in your thesis/dissertation. Your research can be reviewed as a modification to an existing protocol at UCSD. –The PI of record will submit a modification to UCSD’s IRB to include your procedures that are added to the research plan. –You would then submit a new protocol to SDSU that describes your research and references the larger parent protocol. Be sure to clearly state which activities are part of the larger project and which portions are specific to your research.

7. Content of joint consent forms: 4 Providing subjects with two consent forms (one from each institution), which contain similar information, is a burden to the participant. 4 Instead, a single consent form that represents requirements of each institution should be used.

8. Content of joint consent forms: 4 In the heading of the form, reference both SDSU and UCSD: Consent to Participate in Research University of California San Diego/San Diego State University Project Title

9. Content of joint consent forms: 4 In the ‘Voluntary Nature of Participation’ section, state that the choice whether or not to participate will not influence future relations with SDSU or UCSD: –“Participation in research is entirely voluntary. Your choice of whether or not to participate will not influence your future relations with San Diego State University or the University of California, San Diego. If you decide to participate, you are free to withdraw your consent and stop your participation at any time without penalty or loss of rights to which you are entitled.”

10. Content of joint consent forms: 4 In the ‘Questions about the Study’ section, include contact information for SDSU’s IRB as well as UCSD’s Human Research Protection Program: –“For questions about your rights as a research participant or to report research-related problems you may contact the Institutional Review Board at San Diego State University (619) 594-6622, irb@mail.sdsu.edu or the University of California, San Diego Human Research Protections Program at (858) 455-5050.”

11. Content of joint consent forms: 4 If it is necessary to include the UCSD injury statement within the ‘Questions About the Study’ section, include SDSU’s injury statement as well: –UCSD Harm Clause: “If you are injured as a direct result of participation in this research, the University of California will provide any medical care you need to treat those injuries. The University will not provide any other form of compensation to you if you are injured. The researchers for this study will assist you in obtaining appropriate medical treatment, but this study does not provide financial assistance for medical or other costs. You may call the Human Research Protections Program at (858) 455-5050 for more information about this, to inquire about your rights as a research subject or to report research-related problems.”

12. Content of joint consent forms: –SDSU Compensation for Injury: “If any complications arise as a direct result of participation in this research, we will assist you in obtaining appropriate attention. If you need treatment or hospitalization as a result of being in this study, you are responsible for payment of the cost for that care. If you have insurance, you may bill your insurance company. You will have to pay any costs not covered by your insurance. San Diego State University or the San Diego State University Foundation (if funds are managed through the SDSU Foundation) will not pay for any care, lost wages, or provide other financial compensation. If you feel you have a claim that you wish to file against the State or the Foundation (if funds are managed through the SDSU Foundation), please contact Graduate and Research Affairs - Division of Research Affairs at (619) 594-6622 to obtain the appropriate claim forms.”

13. Content of joint consent forms: 4 In the ‘Consent to Participate’ section, state that the SDSU Institutional Review Board and the Human Research Protection Program at UCSD has approved this consent form: –“The San Diego State University Institutional Review Board and the University of California, San Diego Human Research Protections Program have approved this consent form, as signified by both institution’s stamps.”

14. Important Distinctions Between SDSU and UCSD’s Review Process: 4 UCSD 4 Requires that the Research Subject’s Bill of Rights be given to participants. 4 Documents approved research flyers/other advertisements with a stamp. 4 Verifies the accuracy of translated consent forms. 4 SDSU 4 Does not require the Bill of Rights except in studies with medical experimentation. 4 Does not document approved research flyers/other advertisements with a stamp. 4 PI is responsible for providing accurately translated consent forms.