document iconmyCSUSM
cougar courses logoCOUGAR COURSES
email iconEMAIL
email iconMS OFFICE APPS
password iconPASSWORD
MANAGEMENT
Your  Account:
document iconmyCSUSM
cougar courses logoCOUGAR COURSES
email iconEMAIL
office iconMS OFFICE APPS
password iconPASSWORD
MANAGEMENT
Research

Reliance Agreements

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

Under the U.S. Department of Health and Human Services’ 2018 revisions to the Office of Human Research Protection’s Common Rule, reliance agreements (agreements to rely on a single institution’s 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 “cooperative 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 “research 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” (45 CFR 46.114 (b)(2) (i-ii)).

If you are collaborating with co-investigators outside of CSUSM 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 CSUSM 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.

Show All
  • Q: Which IRB reviews a CSUSM-affiliated PI’s IRB application for their master’s or doctorate degree at another institution?

    For CSUSM administrators, staff, faculty, and other employees who are enrolled in a graduate program outside of CSUSM, they should apply to the other university’s IRB in most cases. 

    • This is up to the discretion of the university’s 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 CSUSM 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 CSUSM and a doctoral student in the Department of Computer Science at UC Irvine.) 
      • They will need a letter of support from a CSUSM 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 CSUSM 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 CSUSM IRB Chair prior to inclusion in the IRB package for their graduate school’s IRB.
    • If the PI has co-PIs at CSUSM: they may apply through our IRB first. They need to share on relevant materials that they have dual roles as an employee at CSUSM 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’s IRB.  If they are not recruiting participants from CSUSM nor attaching their research to CSUSM in any way, they do not need to apply to CSUSM separately. 

Pursuing a Single-IRB Determination for Collaborative Research

CSUSM as the Reviewing Institution

CSUSM-affiliated researchers who have primary oversight of the collaborative study will apply to the CSUSM 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 CSUSM 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’ IRB to review and sign via AdobeSign. After the agreement is signed by all parties, the study can begin.

CSUSM as the Relying Institution

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

After the reviewing institution approves your study, their IRB Office should email the CSUSM 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 CSUSM IRB Chair will sign a reliance agreement for CSUSM. (This is typically routed to our office through the other institution’s 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.