Single IRB Review 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. Both OHRP and the FDA permit an IRB the option to rely on the review of another IRB. When this is the intention, the two institutions enter into an agreement referred to variously as an IRB Reliance Agreement. These agreements are executed between a Reviewing IRB and one or more Relying Institutions and delineate the roles and responsibilities of the involved parties. The following information is provided to help investigators understand responsibilities and procedures when a single IRB is used for multiple sites participating in the same research.
NIH Policy: Effective January 25, 2018, the NIH requires use of a Single IRB [sIRB] for the review of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt "human subjects research," whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. This Policy applies to domestic sites only. Implementation of the NIH sIRB policy is expected to reduce unnecessary administrative burdens and systemic inefficiencies while maintaining appropriate human subjects protections. Under the policy, “multi-site” is defined as two or more sites.
For more information: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html
Revised Common Rule: The Common Rule is a federal policy regarding Human Subjects Protection that applies to 17 Federal agencies and offices. Under the new Final Rule governing human subjects protections approved by DHHS in January 2017, most U.S. government funded cooperative studies that meet the criteria for non-exempt “human subjects research,” and involve more than one site, will also require sIRB review. This requirement went into effect January 20, 2020.
Even when not funded by the federal government or by NIH, the BCH IRB will offer the ability to use a single IRB on a voluntary basis. These decisions are made on a case by case basis.
For IRBs/Institutions: Use of a single IRB varies across institutions and is often dependent on the research protocol and the funding agency for federally funded research the use of a single IRB is required. For other studies it is recommended to inquire with each institution involved whether they will consider using a single IRB.
For Researchers: Single IRB review avoids duplicate IRB review across institutions, but does not lessen researchers’ oversight across those sites. The Reviewing Site’s PI assumes significant additional responsibilities and must assume responsibilities on behalf of all sites .This includes but is not limited to developing and implementing communication plans to assure distribution of IRB review-associated materials to all sites, and continually collecting and submitting all regulatory information from all relying sites to the sIRB. The Relying Site’s PI must communicate all regulatory information from their site to the Reviewing Site’s PI and IRB and conduct their research under the terms and policies of the Reviewing site’s IRB.
Extent of Reliance Agreement: A Reliance Agreement will only cover IRB review. Other required Institutional reviews (such as pharmacy, radiation safety committee, clinical trial agreement, conflict of interest, etc.) still need to be conducted at each institution.
Types of Reliance Agreements
BCH IRB executes various types of reliance agreements.
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 or serve as the sIRB. Where possible, the SMART IRB agreement will be used as the basis for reliance.
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.
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 with Independent IRBs: There is a master agreement with WIRB/Copernicus and Advarra for when BCH determines it will rely on one of these independent IRBs. This was negotiated on behalf of many Harvard Catalyst affiliated 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.
Overview of the Reliance Process
When other Institutions want to rely upon BCH as the single reviewing IRB: 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. This activity will collect information (such as principal investigators from the relying sites, consent forms applicable to the participating institutions, site-specific recruitment documents) to be added 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 (and approved). It can be submitted when other activities such as a Continuing Review or Amendment are pending or under review. However, the acceptance of the site cannot be release until any other pending submissions for that protocol are approved. In addition, should multiple institutions wish to rely on BCH for the same protocol, an "Add Reliance on BCH" request must be submitted separately for each site; however, many can be submitted at the same time.
- Single IRB PI Responsibilities and Guidance
- Understanding Local context in Single IRB review
- Anticipated Relying Sites Spreadsheet
- IRB Continuing Review Summary Sheets for Relying Sites
- Example of Add Reliance on BCH form in CHeRP
- Application for Relying on BCH (full)
- Application for Relying on BCH (protocol specific information)
- Single IRB Request Form
When BCH Relies on 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 create a ‘New Research Activity’ with submission type "Reliance on Another IRB" application in CHeRP. 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.
- Relying Investigator Responsibilities and Guidance
- Understanding Local Context in Single IRB review
- 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)
- One page descriptions with instructions for:
- Reliance on Another IRB Submission: How to submit an initial request for "Reliance on Another IRB."
- 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
Further information can be obtained by contacting Boston Children's Hospital IRB Specialist Robleinscky Dominguez at 617-355-5935 or by email.