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Reliance Agreements

Definitions
Policies and Requirements
Reliance Agreements​​
Requesting a Reliance Agreement
JHM IRB Serving as the sIRB​
JHM Relying on an External IRB

Definitions

Reliance Agreement: 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 that are engaged in human subjects research, where one institution will rely on the other institution’s IRB, must agree to the terms of the Reliance Agreement before research can begin.

Single IRB [sIRB]: An Institutional Review Board that oversees all sites participating in a multisite study.

Multisite: Under the NIH Single IRB Review policy, policy, “multisite” is defined as two or more sites.

Participating Site [pSite]: A participating site in a multisite research study.

SMART IRB: The “SMART IRB” master reliance agreement was created in 2016 to harmonize and streamline the IRB review process for multisite studies. It enables reliance on a study-by-study basis, clearly defines roles and responsibilities of relying institutions and reviewing IRBs, and eliminates the need to sign reliance agreements for each study [e.g., a non-SMART IRB agreement]. 500+ institutions have already signed onto this agreement and are actively using it as the basis of reliance for multisite projects.

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Policies and Requirements

NIH Policy

Effective January 25, 2018, the NIH requires use of a Single IRB [sIRB] for the review of NIH-funded multisite 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 the 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 goes into effect January 20, 2020.

For more information: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html

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Reliance Agreements

  • SMART IRB
    • Johns Hopkins is a signatory to the SMART IRB master reliance agreement. It is the preference of Johns Hopkins 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. For all NIH-funded research and where possible for all other research, the SMART IRB agreement will be used as the basis for reliance.
  • IRB Authorization Agreement
    • In cases where an institution does not meet the eligibility criteria to sign onto the SMART IRB agreement, Johns Hopkins may use an IRB Authorization Agreement to establish a reliance relationship with an external institution.
  • Master Agreements
    • Johns Hopkins has executed broad reliance agreements with central IRBs and consortium groups. If you believe your study may fall under the scope of an existing master reliance agreement, or if you are interested in entering into a master reliance agreement with Johns Hopkins, please contact the IRB Reliance Team at JHMIRBReliance@jhmi.edu.

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Requesting a Reliance Agreement

JHM IRB will review requests to serve as a sIRB as well as requests to rely on an external IRB. Typically, requests for reliance are submitted to our IRB at two time points:

  1. when studies are in the planning stages [e.g., grant submission]
  2. when studies are ready to be submitted for IRB review

The first step in the reliance agreement process is to complete a Reliance Request. The JHM IRB reliance team will review the information provided in the reliance request survey and will contact you with next steps/instructions.

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JHM IRB Serving as the sIRB

All new (NIH) grant applications and competitive renewals for multi-site research require a plan for use of a single IRB.  For more information...

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JHM Relying on an External IRB

The JHM IRB routinely serves as the single IRB, but there are also cases where Johns Hopkins will be asked to rely on an external IRB. For more information...

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