Boston Children's Research Reliance Agreements

As a leader in pediatric care and research, Boston Children's Hospital (BCH) and its researchers often collaborate with others outside of Boston Children's Hospital. A single IRB (sIRB) is an Institutional Review Board that reviews and approves all sites participating in a multisite study. The purpose of an sIRB is to reduce the burden of multiple IRB reviews, encourage collaboration, and minimize duplicate submissions.

Reliance Agreements

When one institution relies on the review of another institution’s IRB, this arrangement is documented through an IRB reliance agreement. The reliance agreement outlines the responsibilities of each party and delegates review authority to the IRB of record. BCH IRB executes various types of reliance agreements to facilitate sIRB review efficiently:

• SMART IRB: Boston Children’s Hospital is a signatory to the SMART IRB master reliance agreement. It is the preference of BCH to use the SMART IRB agreement as the basis of reliance for all studies where we rely on an external IRB at an academic institution or hospital or serve as the sIRB. Where possible, the SMART IRB agreement will be used as the basis for reliance.
• Independent IRBs: IRB services contracts establish reliance arrangements between BCH and Independent IRBs. BCH currently has IRB services contracts with Advarra and WGC and can rely on them for review of research requiring use of a sIRB.
• Cooperative 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.
• Reliance Agreement with Dana-Farber/Harvard Cancer Center: Boston Children’s Hospital is one of the institutions participating with the Dana-Farber/Harvard Cancer Center (DF/HCC). As such, all cancer-relevant research will be reviewed through the DF/HCC IRB. The DF/HCC Protocol Review and Monitoring Requirements guidance document summarizes research which requires submission and review by the DF/HCC Scientific Review Committee and the DF/HCC IRB. The guidance document contains a chart which provides examples of research requiring DF/HCC review and research which can be reviewed by the BCH IRB.
• Single Reliance/IRB Authorization Agreement (IAA): In cases where an institution does not meet the eligibility criteria to sign onto the SMART IRB agreement, BCH may use an IRB Reliance/Authorization Agreement to establish a reliance relationship with an external institution.

sIRB Mandate

• All research that is funded by National Institutes of Health (NIH) falls under the NIH sIRB Policy must use a sIRB for the multi-site research conducted in the United States as designated in the funding application. For more information: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html
• All cooperative research that falls under the Department of Health and Human Service regulations must use a sIRB for the research that is conducted in the United States. This includes other agencies that have signed onto the Common Rule. For more information: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html
• BCH Single IRB Review Policy outlines procedures for compliance with federal mandates and other request for sIRB review.
• All requests for BCH IRB to serve as the sIRB must complete the BCH Single IRB (sIRB) Request Form

BCH IRB as sIRB 

• To initiate a request for BCH IRB to serve as the sIRB, the Single IRB Request Form must be completed.
• When the BCH IRB agrees to serve as the sIRB, the research team will be directed to create an "Add Reliance on BCH" within the approved protocol in CHeRP. Refer to specific instruction in BCH sIRB Process guidance.
• Please review the following important information on responsibilities, local context review and editing of the BCH consent for relying sites:
• Single IRB PI Responsibilities and Guidance
• Understanding Local context in Single IRB review
• Instructions for Relying Site Consent Form Changes

The following documents are provided as resources for BCH Lead PI/study team:

• Anticipated Relying Sites Spreadsheet
• IRB Continuing Review Summary Sheets for Relying Sites
• Example of Add Reliance on BCH form in CHeRP
• SMART IRB sample Communication Plan

BCH relying on an external sIRB

• When a request is made for BCH to rely on (cede review to) another institution’s IRB, the BCH PI must create a ‘New Research Activity’ with submission type "Reliance on Another IRB" application in CHeRP.  Refer to Reliance on Another IRB Submission guidance.
• The form will generate applicable questions (based on 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 a mechanism to review/accept (approve) the request to rely on another IRB. It will also trigger applicable ancillary institutional reviews, and track research activities conducted at BCH or elsewhere by BCH investigators.

Please review the following important information on responsibilities, local context review and editing of the BCH consent:

• Relying Investigator Responsibilities and Guidance
• Understanding Local Context in Single IRB review
• Reliance on Another IRB Amendment: When and how to submit an amendment on a "Reliance on Another IRB" in CHeRP
• Reliance on Another IRB Reportable Event: When and how to submit a reportable event on a "Reliance on Another IRB" in CHeRP
• The following documents are provided as resources for BCH PI/study team:
• Example of Reliance on Another IRB form in CHeRP (research procedures occurring at BCH)
• Example of Reliance on Another IRB form in CHeRP (research limited to data analysis)

Have questions?

• Email the reliance team
• For BCH staff/employees only- consider dropping in to the reliance team open office hour, every Thursday at 11 AM.  Email the reliance team for zoom link.