General Information
What is a Reliance Agreement
A Reliance Agreement is a formal, written document that provides a mechanism for an institution engaged in research to delegate institutional review board (IRB) review to an independent IRB or an IRB of another institution. Institutions may use different descriptive terms, e.g., reliance agreement, cooperative agreement or IRB authorization agreement (IAA). Agreements may cover single studies, categories of studies, or all human subjects research under an organization’s Federalwide Assurance (FWA).
What is sIRB and who is required to use it?
NIH defines sIRB as the selected IRB of record that conducts the ethical review for participating sites of a multi-site study.
Effective January 25, 2018, the National Institute of Health implemented a policy requiring the Use of a Single Institutional Review Board for Multi-Site Research. The goal of the sIRB policy is to reduce the burden of the IRB review process for multi-site research conducting the same protocol, allowing research to proceed effectively and expeditiously without compromising the protections of human subjects.
Who is required to use sIRB?
The sIRB policy mandates that all domestic sites participating in multisite studies under the same research protocol involving nonexempt human subjects research will use an sIRB to conduct the ethical reviews required by HHS for the protection of human subjects. The policy also applies to NIH’s intramural programs. It does not apply to career development, research training, or fellowship awards
See policy here: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html and an FAQ here.
Contact the UMass Chan IRB before submitting a grant that involves sIRB.
Is SMART IRB an IRB?
NO, SMART IRB is an initiative developed under an award from the National Center for Advancing Translational Sciences ("NCATS") of the National Institute of Health ("NIH") to support single Institutional Review Board review in the facilitation of multi-site human subjects research. SMART IRB includes:
- An IRB reliance agreement that permits eligible institutions that join it (“Participating Institutions”) to cede review of human subjects research to other Participating Institutions’ IRBs; and
- A set of standard operating procedures (SOPs) to guide implementation of the reliance relationship among Participating Institutions.
- A network of regional ambassador to support adoption and implementation of IRB reliance across the nation.
- An optional centralized online system to support sign-on, reliance determinations, and harmonization (ongoing development).
Investigators can use the online system to request, track, and document reliance agreements for studies among SMART IRB Participating Institutions.
Click here to see all participating sites
What if my research is Exempt?
UMass Chan typically restrict Reliance Agreements for use with Non-Exempt Human Subjects Research.
In most cases, IRBs will review exempt research in-house. If you are joining research that has already been deemed exempt elsewhere, call the IRB’s main number at 508-856-4261 to inquire about ways to streamline the eIRB application.
How do I initiate a reliance agreement?
Requests may be initiated directly from an investigator, a member of the study staff, or the external IRB. Determinations are made on a case-by-case basis by the UMass Chan IRB and appropriate Institutional Officials.
NOTE: The reliance agreement process varies depending on who is serving as the IRB of Record.
***First step:
Contact the IRB Liaisons, Allison Blodgett (508-856-4271) or Joann Jean-Baptiste (508-856-8092) with the information below.
UMass Chan to serve as Reviewing IRB
- UMass Chan IRB Docket # H------
- Description of how external personnel are involved in the research
- Their home Institution
- HRP-215
UMass Chan to serve as a Relying IRB
- Copy of the protocol
- Copy of the consent
- Description of how UMass Chan personnel are involved in the research
- HRP-508 pSite Supplement
Click on these links for NCI CIRB IRB & Western IRB submission instructions.