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Reliance Agreements

Collaborative Research and the Use of Reliance Agreements for Single-IRB Reviews

Under the U.S. Department of Health and Human Services鈥 2018 revisions to the , reliance agreements (agreements to rely on a single institution鈥檚 IRB review of a proposed study) are required for most human subjects research collaborations for federally funded research in the United States.

Exceptions to this rule include 鈥渃ooperative research for which more than a single IRB is required by law (including tribal law passed the official governing body of an American Indian or Alaska Native tribe); or 鈥渞esearch for which any Federal Department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context鈥 (45 CFR 46.114 (b)(2) (i-ii)).

If you are collaborating with co-investigators outside of 糖心原创 on a federally funded, non-exempt study, you will likely need to go through the reliance agreement process.  If you are collaborating with others outside of 糖心原创 on a study that falls into one of the exempt categories or your collaborative study is not federally funded, all parties will need to submit their separate IRB packages for review at their home institutions with similar supporting materials.

In all cases, you should prepare your IRB materials by referencing Co-PIs and their affiliations on recruitment materials, information and consent sheets, and data collection tools.

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  • Q: Which IRB reviews a 糖心原创-affiliated PI鈥檚 IRB application for their master鈥檚 or doctorate degree at another institution?

    For 糖心原创 administrators, staff, faculty, and other employees who are enrolled in a graduate program outside of 糖心原创, they should apply to the other university鈥檚 IRB in most cases. 

    • This is up to the discretion of the university鈥檚 IRBs Administrative Team (the Budget and Compliance Analyst, the IRB Chair, and the Dean of Graduate Studies & Research)
    • If the PI is the sole PI: and they want to recruit participants from our university for their thesis or dissertation, their IRB materials (e.g., consent form/info sheet and recruitment materials) must state their role at 糖心原创 and their role as a graduate student in a specific program at another university (e.g., I am an instructor in the Department of Computer Science at 糖心原创 and a doctoral student in the Department of Computer Science at UC Irvine.) 
      • They will need a letter of support from a 糖心原创 department chair/ program or college dean/ staff person/administrator to place in their IRB package if they are doing research that requires an expedited or full IRB review due to risk or that names 糖心原创 explicitly in the research (rather than using a pseudonym).
      • To streamline the process, we recommend that the PI has their recruitment and consent forms reviewed by the 糖心原创 IRB Chair prior to inclusion in the IRB package for their graduate school鈥檚 IRB.
    • If the PI has co-PIs at 糖心原创: they may apply through our IRB first. They need to share on relevant materials that they have dual roles as an employee at 糖心原创 and as a graduate student at another university.  They should contact their other university to see if they are also required to apply there for IRB approval.

    • If the PI has co-PIs from the college/university where they are enrolled in graduate studies: they should apply to the other university鈥檚 IRB.  If they are not recruiting participants from 糖心原创 nor attaching their research to 糖心原创 in any way, they do not need to apply to 糖心原创 separately. 

Pursuing a Single-IRB Determination for Collaborative Research

糖心原创 as the Reviewing Institution

糖心原创-affiliated researchers who have primary oversight of the collaborative study will apply to the 糖心原创 IRB using the Limited/Expedited/Full IRB application. This application requires you to list all collaborators, their institutions/affiliations, and the contact information for their IRB Office.  Upon approval by and signatures of the 糖心原创 Institutional Research Officer (the Dean of Graduate Studies and Research) and the IRB Chair, the IRB Office will route a reliance agreement to your colleagues鈥 IRB to review and sign via AdobeSign. After the agreement is signed by all parties, the study can begin.

糖心原创 as the Relying Institution

If an outside collaborator has primary oversight of the proposed study, their institution should be the reviewing institution and 糖心原创 will be the relying institution,

After the reviewing institution approves your study, their IRB Office should email the 糖心原创 IRB Admin Team the approval letter along with study materials to review (irb@csusm.edu).  If we agree with the procedures and protocol, the institutional representatives--the Dean of Graduate Studies and Research and the 糖心原创 IRB Chair will sign a reliance agreement for 糖心原创. (This is typically routed to our office through the other institution鈥檚 IRB Office.) After the agreement is signed by all parties, the study can begin.

If you have questions about this process, please contact irb@csusm.edu. This is especially helpful to do before you start the process so we can help you determine the right level of review for your proposed study.