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The Office of Human Research Protections requires a single IRB (sIRB) for all domestic sites participating in non-exempt, cooperative research studies whereby two or more institutions coordinate to complete a portion of the research outlined in a specific protocol. 

Reliance on a single IRB typically occurs with:

  1. Multi-center, federally-funded research which requires use of a single IRB
  2. Industry-sponsored clinical trials
  3. Multi-center studies with New York Presbyterian (NYP) and Clinical and Translational Science Center (CTSC) partner institutions

Decisions about whether Weill Cornell Medicine will enter into an Authorization Agreement review, whereby the WCM IRB will rely on the IRB at another institution, or will review for other institutions, are handled on a protocol-specific, case-by-case basis once those requests have been submitted (see "Request for Single IRB Review" below).

Existing Reliance Agreements

WCM IRB has executed reliance agreements with the following institutions to serve as the IRB of Record for certain non-exempt research (described further below): 

Broad Reliance
  • Cornell University Ithaca campus
  • Memorial Sloan Kettering Cancer Center (MSKCC)
  • Rockefeller University 
WCM-NYP Oncology & COVID Research
  • NYP Brooklyn Methodist Hospital
  • NYP Queens 
WCM Clinical & Translational Science Center (CTSC) Supported Research
  • CUNY Hunter College 
  • Hospital for Special Surgery (HSS)
  • Cornell University Ithaca campus
  • Memorial Sloan Kettering Cancer Center (MSKCC) 

WCM IRB has executed broad reliance agreements with the following commercial IRBs to serve as the IRB of Record when necessary: 

  • Biomedical Research Alliance of New York (BRANY) IRB
  • Advarra IRB
  • Western IRB (WIRB) 

For trials not covered under these existing agreements, a request to establish reliance must be sought from the WCM IRB as early as feasible. 

What is an Authorization Agreement?

An authorization agreement refers to the formal written agreement that documents respective authorities, roles, responsibilities, and communication between an institution/organization serving as the IRB of Record (Reviewing IRB) and the institution relying on that IRB (Relying IRB). This term includes: reliance agreement, cooperative agreement, master services agreement (MSA), master joint agreement (MJA), or umbrella agreement. 

Researchers seeking to rely on the IRB of another institution or have the WCM IRB serve as the reviewing IRB for another institution must have an IRB authorization 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 agreements can be for a single research study or for multiple studies (e.g., a master reliance agreement). The authorization agreement is negotiated and finalized by the WCM IRB and reviewed by WCM's legal counsel, as needed.

Authorization  agreements do not replace the need for IRB approval.

Even with an authorization agreement, researchers must still obtain IRB approval from the reviewing IRB before beginning any study activities and before funds can be released. The WCM principal investigator remains responsible for ensuring all of WCM institutional requirements are met before beginning the research and throughout the course of the research activities.

Mutli-Site versus Cooperative Research

Multi-site ResearchCooperative Research

Multi-Site Studies

Multi-Site Studies use the same research procedure (i.e., protocol) outlined in a single protocol that is carried out at multiple institutions

Examples of Multi-Site Studies
  • Protocols implemented at multiple locations that address the same research questions, involve the same methodologies, and evaluate the same outcomes, such as clinical trials
  • Sites that are accruing research participants for studies that are identical except for variations due to local context considerations

Cooperative Studies

Cooperative or collaborative research is where two or more institutions coordinate to complete a portion of the research outlined in a protocol at their respective locations.

Examples of Cooperative Studies
  • A study where one institution gathers the data and another institution analyzes the data 
  • Protocols that are split between institutions, where one institution may collect a portion of the data, and another institution collects a different portion of the data

sIRB Review Process

sIRB review is more than just an IRB review.  It includes other components such as COI, state/local laws and institutional requirements, ancillary reviews, etc.

sIRB Review Process

sIRB vs. Local Review

The image below depicts the different responsibilities of the sIRB compared to the local institution.

sIRB vs. Local Review Process

Request for a Single IRB Review

When it has been established that a trial will utilize single IRB review, a determination must be made on which campus’s or institution’s IRB will oversee the trial conduct. To facilitate this process, both the WCM and External IRBs will collect and review basic information about the planned collaboration.   

The WCM Principal Investigator (PI) or designee must initiate a request for IRB reliance via the WCM Qualtrics Portal or via email to singleirb@med.cornell.edu.

It is suggested that the subject line indicate, “WCM-IRB Reliance Request, [Name of WCM PI/Name of External PI], [Study Title or Abbreviated Name].”

The body of the email should contain the following information: 

  • Study Title and Abbreviated Title (if applicable) 
  • WCM and/or External IRB number(s)
  • WCM and Overall PI Name(s)
  • Funding source(s) (e.g. Federal, Institutional, Industry)
  • Proposed lead IRB or participating sites if not yet known
  • Briefly describe the role/involvement of WCM investigators and subjects (Example: WCM investigators will receive and analyze the de-identified samples; WCM subjects will be approached for consent and blood draw.)
  • Availability for a brief follow up call or meeting 

Determination of IRB of Record

Once a request for reliance has been received, staff from the WCM and External IRB(s) will jointly determine who will serve as the IRB of record for any given collaboration. A response from the IRB office will be provided within two business days of reliance request receipt.   

The determination on which institution will serve as IRB of record for collaborative human subjects research will take into consideration the following: 

  • Awardee institution and/or PI for trial funding
  • Where research procedures are taking place, anticipated to recruit more, and/or anticipated to analyze data.
  • The ability of the site or institution to serve as a HIPAA-covered entity and/or privacy board.
  • Expressed preferences of the participating site investigators or IRBs.

Industry Sponsored multisite research will utilize a commercial IRB, unless an academic IRB has been identified and is in use. 

Resources

Institutional sIRB Resources

sIRB Reilance Procedure COMING SOON

NIH sIRB Resources

Single IRB for Multi-Site or Cooperative Research

Questions about sIRB?

Contact the sIRB Office:

(646) 962-8200
singleIRB@med.cornell.edu

German Jimenez
Human Research Compliance Specialist & Reliance Coordinator
Single IRB (sIRB) Administrator
BRANYplus Administrator


Lauren Blumberg

Assistant Director, Regulatory Compliance