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: Boston Children’s has a master services agreement with Advarra and WCG.  Please refer to Instructions for Reliance on Independent IRB for details on how to request reliance on an Independent IRB. Please refer to Instructions for Reliance on Independent IRB.
• 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

• BCH Single IRB Review Policy outlines procedures for compliance with federal mandates for federally funded multisite research.
• Investigators should utilize the following instructions to request reliance on an external IRB:
  • Reliance on Another IRB Submission for general guidance on submission to an Academic or Hospital based sIRB.
  • Instructions for Reliance on Independent IRB for guidance on submitting to WCG/Advarra or other Independent IRBs.

Specific categories of non-federally funded research requiring IRB chair/vice chair review for reliance on external IRB before submission in CHeRP

IRB leadership has identified specific categories of research that require assessment by the IRB Chair/Vice Chairs to decide if the study can rely on an external IRB.   

• Non-federally funded studies involving vulnerable population (children, decisionally impaired adults) must be reviewed by the BCH IRB Chair/Vice Chair if they involve:
  • Placebo-controlled-studies that pose greater than minimal risk to participants assigned to the placebo arm (e.g., lumbar puncture, PIC line)
  • Genetic manipulation interventions (gene therapy, editing, CRISPR, ASO)
  • First-in-Human Trials (Phase 1)
  • Fetal therapies -  studies that involve surgical and non-surgical methods to treat diseases or abnormalities in the fetus, and range from fetal surgery to medications administered directly to the fetus or to the pregnant person that directly treat the fetus
• If research does NOT involve categories above, Investigator may create protocol and select Reliance on Another IRB (refer to Reliance on Another IRB instructions above).
• If research does involve categories above, before submission in CHeRP, please email name of proposed IRB, protocol & consent to reliance@childrens.harvard.edu.   

Decision of whether research may be reviewed by an external  sIRB will be provided within 1 week. Investigators may be told they may proceed with external sIRB reliance, or they may be told research must be reviewed by the BCH IRB.

Reliance on another IRB CHeRP submission process

When a request is made for BCH to rely on (cede review to) an external sIRB, 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 instructions above). 

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.

Information on responsibilities, local context review and editing of the BCH consent

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.