Understanding Reliance Agreements

 A human subject research reliance agreement is a signed authorization agreement between institutions engaged in human subject research that cedes review of the research activities to the Institutional Review Board (IRB) of one of the institutions.  Reliance agreements may be referred to by different names depending on an institution’s practice, e.g., IRB Authorization Agreement or Interagency Agreement. A reliance agreement is not required unless one institution agrees to rely upon another institution’s IRB for review of human subject research activities.

To Request a Reliance Agreement

 The Cal State East Bay PI should create an IRB protocol on Cayuse, providing basic details about the protocol, and indicating which institution will be the relying institution and which will be providing the IRB review and approval.

 

How to determine when a Reliance Agreement is viable.

 The Institutional Review Board (IRB) is charged with protecting the rights of human subject who participate in research on or through this campus. This includes research conducted by all CSUEB faculty, staff and student investigators, and also research by investigators from other institutions or agencies who are working in conjunction with CSUEB in any capacity. The IRB is responsible for ensuring that human subjects are informed about and protected from any unnecessary risks that may be associated with participating in research.

It is up to each institution to determine whether they will maintain an Institutional Review Board (IRB) to review and provide oversight of the institution’s human subject research.  An institution’s IRB may decide to review all of that institution’s research or to allow reliance agreements in certain scenarios to cede review to another IRB.  Cal State East Bay’s policy is that all research involving human subject, exempt and non-exempt, must be reviewed by the Cal State East Bay Review Board (IRB) or by the IRB Office.  The Cal State IRB supports the use of reliance agreements when circumstances allow and such use would be reasonable and prudent.

Prior to collecting human subject research data, each Principal Investigator (PI) must notify their institution of their research and data collection plans and follow the institution’s human subject research policy, which usually entails submitting a full IRB protocol for review. When the research involves collaboration with another institution, each Principal Investigator (PI) must notify their home institution of their plans and follow the institution’s human subject research “IRB” policy. If either collaborating party determines they would like to request a reliance agreement in order to rely on the other institution’s IRB for review and oversight of the human subject research, each PI should notify their home IRB office of that intention and follow the instructions of their respective institutions.

  • The standard approach is that each institution submits a full IRB protocol to their home institution’s IRB for review.
  • For a research project collaboration, depending on the activities and where they will occur, a full IRB protocol may need to include a copy of the collaborating PI’s IRB protocol and IRB approval letter.
  • For research project collaborations, when the situation warrants it or as prescribed by , one institution may be asked to be the IRB reviewer for one or more PIs at other institutions, and if so those institutions of the other PIs may request a signed reliance agreement be issued to confirm their reliance on the lead IRB.

Single IRB Plan

  • The NIH sIRB Policy requires that applicants/offerors include an sIRB plan in the application/proposal, respectively.
  • The sIRB plan describes the use of an sIRB that will be selected to serve as IRB of record for all study sites.
  • Per NIH Guide Notice , providing name of the sIRB of record at Just-in-Time (JIT) satisfies the NIH sIRB Policy requirement for a sIRB plan for NIH grant applicants.
  • Reminder- although applications/ proposals no longer require that the sIRB plan be included, when applicable, applicants/offerors still need to develop and carry out a plan for use of an sIRB.

 Examples:

Cal State East Bay PI

  • Cal State East Bay (CSUEB) PI plans to conduct human subject research. The CSUEB PI submits an IRB Protocol to the CSUEB IRB for review.

 

Cal State East Bay PI with Funding from Another Institution

  • Cal State East Bay (CSUEB) PI plans to conduct human subject research under a subaward, service agreement, or other form of funding, from an external agency or institution.
    • The CSUEB PI would plan to submit a full protocol to the CSUEB IRB. If there is a collaborating PI at the lead institution, then both PIs submit full protocols to their institutions.
    • If, however, the CSUEB faculty’s data will be collected at an awarding institution or there is another reason for the lead institution to have IRB review responsibility over all of the project’s Human Subject Research, then each PI involved might agree to request a reliance agreement if their institutions allow. If so, then each PI should notify their home institution of their intent to request the single Reliance Agreement.

 

Cal State East Bay Providing Funding to Another Institution

  • Cal State East Bay (CSUEB) provides a subaward to or otherwise funds another institution for a project that includes human subject research activities.
    • If the funding is from or related to a CSUEB PI’s project, then the CSUEB PI submits an IRB Protocol to the CSUEB IRB for review, and the PI of the awardee institution submits an IRB protocol to their institution’s IRB for review.
    • If the two PIs agree they would like one of the institutions to be the IRB reviewer over both the human subject activities of both PIs, then each PI should notify their home institution of their intent to request the single Reliance Agreement.

 

For all human subject research projects, review and approval by the IRB depends on many variables, including, but not limited to the specific human subject activities, study population, and where and how the activities will be conducted.

 If any questions, please contact the IRB.