Single IRB (sIRB) Reliance Multiple policies/regulations require review by 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. These policies apply as follows: As of January 25, 2018, the NIH Policy on Single IRB for Multi-Site Research mandated sIRB review for NIH-funded studies. As of January 20, 2020, the Revised Common Rule’s Cooperative Research Provision (45 CFR 46.114) for most federally funded research. At Einstein/MMC, sIRB review is likely required if your project meets the following criteria: Federally Funded (federal agency list) Involves cooperative research (two or more institutions coordinate to complete a portion of the research outlined in a specific protocol) Does not fall into one of the exempt categories used by the Einstein IRB All studies intending to utilize Single IRB review are required to be submitted via the Einstein IRB Reliance Request Portal prior to receipt of grant deadlines. This includes both studies where the Einstein IRB is requested to be the Single IRB and cases where Einstein will cede review to an external IRB. For federally funded studies, a submission in the Reliance Request Portal is required at least 10 days in advance of any grant deadline. For non-federally-funded studies, a submission in the IRB Reliance Request Portal is required as soon as possible upon identification that sIRB review may be requested or required. Please note: PCORI is not a federal agency. However, they often require sIRB review of protocols, so a reliance request should be submitted at least 10 days in advance of any PCORI grant deadline. Decisions related to Single IRB review of research are made by OHRA on a protocol-specific, case-by-case basis. The portal allows OHRA management to assess a number of factors, including, but not limited to: The funding source Whether appropriate resources are available to support the plans for Single IRB review The number of sites participating in a study The complexity and risk level of the study protocol The submission in the IRB Reliance Request Portal also supports the assessment of fees related to Single IRB review processes. These fees will be specified by OHRA in an official Letter of Support and must be included in the budget as direct costs when submitting grant applications and negotiating contracts. 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. 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 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. Multi-Site versus Cooperative Research Multi-Site Research Click to enlarge 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 Research Click to enlarge 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 vs. Local Review The image below depicts the different responsibilities of the sIRB compared to the local institution. What Is 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. Resources Institutional sIRB Resources Single IRB Reliance Procedure IRB Reliance Request Form Single IRB (sIRB) Presentation NIH sIRB Resources Einstein NIH sIRB Request/Submission Guidance SMART IRB Communication Plan Form Questions about the use of a single IRB? Email SingleIRB@einsteinmed.edu or call 718.430.2237 and ask to speak with the IRB Reliance Analyst! × ×
