*Effective January 25, 2018, the NIH has mandated that all domestic sites participating in a non-exempt multi-site research study (where study activities outlined in a single protocol are carried out at multiple institutions) use of single IRB (sIRB)
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*Effective January 20, 2020, OHRP will require a sIRB for all domestic sites participating in non-exempt, cooperative research study (two or more institutions coordinate to complete a portion of the research outlined in a specific protocol).
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Decisions about whether Albert Einstein College of Medicine, Inc. & Montefiore Medical Center will enter into a Authorization Agreement for IRB review, whereby the Einstein 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 via the Einstein IRB Reliance Request Portal.
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 Einstein 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 Einstein IRB and reviewed by Einstein's legal counsel, as needed.
Authorizations 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 Einstein principal investigator remains responsible for ensuring all of Einstein institutional requirements are met before beginning the research and throughout the course of the research activities.
Questions about the use of a single IRB (sIRB)?
Email us at SingleIRB@einsteinmed.org or call us at 718-430-2237 and ask to speak with the IRB Reliance Analyst about authorization agreements or the use of single IRBs.
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Cooperative Research |
Multi-site studies use the same research procedures (i.e., protocol) outlined in a single protocol that is carried out at multiple institutions.
Examples of Multi-site Research
- 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
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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 Research
- 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
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sIRB Resources
sIRB Review Process
sIRB review is more than just an IRB review. It includes other components, such as those depicted in the image below.
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sIRB vs Local Review
The image below depicts the different responsibilities of the sIRB compared to the local institution.
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NIH Single IRB Resources
SMART IRB
SMART IRB is an initiative developed under an award from the National Center for Advancing Translational Science (NCATS) of the National Institutes of Health (NIH) to support single IRB review in facilitation of multi-site human subjects research.
Both Einstein and Montefiore are signed on to the SMART IRB Agreement as Participating Institutions. Using the SMART IRB Agreement as the ‘Reliance Agreement’ is an option if the other Participating Institutions have signed on and also agree to use the SMART IRB Agreement for a given study. A decision to use the SMART IRB agreement is made on a study-by-study basis by each Participating Institution.
Using SMART IRB does NOT replace or negate the internal submission process at Einstein regardless of whether Einstein is the Reviewing IRB or relying on an external IRB. Investigators should never assume that the agreement can or will be used for a given study or convey to others, including a funding agency, that the agreement will be used, without explicit documented agreement from each Participating Institution.
