Using Reliance Agreements (cede requests) for Multi-site Research Protocols
As a leader in pediatric care and research, Boston Children's Hospital (BCH) and its researchers often collaborate with others outside of BCH. When research protocols include researchers from multiple institutions, a reliance agreement may be used. This decision is made on a case by case basis.
In an effort to reduce duplicate submission and oversight by multiple IRBs for the same protocol, Boston Children's Hospital IRB offers reliance agreement opportunities. Reliance agreements are arrangements between institutions and IRBs in which one institution relies upon another institution’s IRB to approve and provide oversight for a protocol. With reliance agreements, multiple IRB reviews and approvals at all IRBs whose institutions are engaged in the research are not needed.
Types of Reliance Agreements
BCH IRB executes various types of reliance agreements:
Single Reliance Agreement: These agreements are executed for an individual protocol between two or more institutions.
Master Reliance Agreements: These agreements are executed for one or more protocols from the same consortium of researchers/institutions. Such agreements can be utilized to facilitate the review of any protocols from the same cohort of researchers across multiple institutions. Often master agreements are established so that any one of the signatory institutions/IRBs can review a protocol on behalf of others who signed the agreement.
Harvard Catalyst Master Agreement: This master agreement has been executed for all institutions affiliated with the Harvard Catalyst system, a collection of 30+ institutions who have already executed the terms of reliance among its members. This agreement is also being expanded to allow non-Harvard affiliated institutions to join. For the most current list of institutions please go to http://catalyst.harvard.edu/services/irbcede/institution_contacts.html
For IRBs/Institutions: Use of reliance agreements varies across institutions and is often dependent on the research protocol. It is recommended to inquire with each institution involved whether they will consider using a reliance agreement.
For Researchers: Agreements avoid duplicate IRB review across institutions, but do not lessen researchers’ oversight across those sites. The Reviewing Site’s PI must act as overall PI, collecting all regulatory information from all sites and informing the Reviewing IRB. The Relying Site’s PI must communicate all regulatory information from their site to the Reviewing Site’s PI and IRB.
Extent of reliance agreement: Agreements only cover IRB review: Institutional (ancillary) reviews (ancillary non-IRB reviews such as pharmacy reviews, radiation safety committee reviews, clinical trial agreement reviews, etc.) still need to be conducted at each institution.
For Other Institutions to Rely upon BCH:
When a request is made for another institution to rely on (cede review to) Boston Children's Hospital (BCH) IRB, the ‘Add Reliance on BCH’ activity must be completed in CHeRP in the approved protocol that will cover IRB review for the other site(s). The activity will collect information (such as investigators from the relying site, consent forms applicable to all participating institutions, site specific recruitment documents) to add to the main protocol thereby allowing the BCH IRB review to extend to other sites . This request can be submitted as long as a BCH protocol has been submitted. It can be entered when other activities (such as an Amendment or Continuing Review) are pending or under review. In addition, should multiple institutions wish to rely on BCH for the same protocol, multiple Reliance activities can be request simultaneously.
For BCH to Rely upon another Institution’s IRB:
When a request is made for BCH to rely on (cede review to) another institution’s IRB, the BCH PI must complete the CHeRP Form ‘Reliance on Another IRB’. The form will generate applicable questions (based on the categories selected for BCH’s involvement) and allow for study documents to be uploaded. The activity is not an IRB review process (since the IRB review will be ceded to another institution) but rather is a mechanism to review/approve the request to rely on another IRB , trigger applicable ancillary institutional reviews, and track research activities occurring at BCH.
Further information can be obtained by contacting Boston Children's Hospital IRB Specialist, Daniel Alderson at 617-919-1918 or by email.