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Execution of Reliance Agreements For Studies Subject to Single IRB Review

September 2020

A reliance agreement is a formal, written document that provides a mechanism for an institution engaged in research to delegate institutional review board (IRB) review to an independent IRB or an IRB of another institution. Institutions that are engaged in human subjects research, where one institution will rely on the other institution’s IRB, must agree to the terms of the Reliance Agreement before research can begin.

All requests for reliance agreements must be submitted via the Reliance Request survey. The information collected in the reliance request allows the JHM IRB reliance team to make an initial cede determination (e.g., whether JHM agrees to serve as a single IRB or rely on an external IRB). JHM IRB investigators cannot commit JHM IRB to serve as the sIRB without prior approval [e.g., a letter of support] nor do they have they authority to agree on behalf of the organization to rely on an external IRB

For studies subject to the NIH sIRB policy in the case where a participating site in a multi-site study granted an exception from the requirement for sIRB review it is the expectation that the participating site will obtain its own local IRB review/determination. A reliance agreement would not be executed with this site.

Use of the SMART IRB Agreement

For all federally-funded research, and where possible for all other research, the Office of Human Subjects Research requires that the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement be used as the basis of reliance for all studies where JHM serves as the sIRB. Consistent with the requirements set forth in the NIH sIRB policy and the Revised Common Rule, JHM IRB will consider requests to serve as the sIRB for all federally funded, cooperative, non-exempt human subjects research studies conducted within the United States.

In the case where the SMART IRB agreement may not be used as the basis for reliance an alternate agreement may be used to facilitate reliance.

Indemnification

When using SMART IRB as the basis for reliance, JHM requires execution of a separate Letter of Indemnification [LOI] as indemnification is not covered in the SMART IRB agreement. The LOI is specific to the role of the organization as either the Reviewing IRB institution or the Relying Institution. If an organization originally signs the LOI as a Relying Institution and wishes to also have these terms govern the reliance relationship when it is serving as the Reviewing IRB Institution using the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement, a second version of the SMART LOI must be executed between organizations where the roles of the organizations are reversed.

The Associate Director of the IRB Reliance Program maintains executed letters of indemnification.

Documentation of Reliance

Reliance agreements can cover a specific project or a broad scope of projects. Where JHM IRB is the reviewing IRB, participating sites are required to fully execute a reliance agreement with JHM IRB before research can begin at the participating site. Where JHU/JHHS is the relying organization, a cede decision must be finalized and local context review by the JHM HRPP completed before any research at the JHU/JHHS sites may begin.

Cede decisions for JHM/JHHS are made on a study-specific basis, requiring submission of a “Reliance Request Survey”. When JHM/JHHS agrees to enter into a reliance agreement using SMART IRB as the basis for reliance, a cede decision can be provided in the following ways:

  • IRB Reliance Exchange [IREx]
  • SMART IRB Letter of Acknowledgment

All of the above-referenced options constitute official documentation of reliance.

It is the preference of JHM/JHHS to use the “SMART IRB Letter of Acknowledgement” [LOA] to document reliance. Signature lines are not required, but can be added when appropriate [e.g., if requested by the Relying institution].

The Associate Director of the IRB Reliance Program maintains cede letter documentation.