IRB Reliance Agreements

This webpage is designed to serve as a resource for those interested in learning more about the Harvard Longwood Campus IRB reliance process. If you need additional information or have a protocol-specific reliance question, contact Julie Chamberlin at jchamberlin@hsph.harvard.edu.

HELPFUL DEFINITIONS
REGULATORY REQUIREMENTS
HLC IRB RELIANCE POLICY
RELIANCE ARRANGEMENTS (How Reliance is documented)
REQUESTING RELIANCE – HARVARD LMA SCHOOL as sIRB
REQUESTING RELIANCE – HARVARD LMA SCHOOL as PSITE

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HELPFUL DEFINITIONS

Reliance agreement: A formal, written document that provides a mechanism for an institution engaged in non-exempt human research to delegate institutional review board (IRB) review to an IRB affiliated with another institution or an independent IRB.  Reliance agreement, IRB Authorization Agreement (IAA), cede review, cede, or External IRB are all terms that refer to a situation where research is conducted at two (or more) institutions and one is designated to serve as the reviewing institution/IRB while the other(s) serves as the relying institution/IRB.

Single IRB (sIRB): An Institutional Review Board that has been designated as the IRB of record; responsible for overseeing all sites participating in a multisite study.

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

Participating Site (pSite): A participating site in a multisite research study.

SMARTIRB: The “SMARTIRB” master reliance agreement was established in 2016 to harmonize and streamline the IRB review process for multisite studies. It enables reliance on a study-by-study basis, defines roles and responsibilities of relying institutions and reviewing IRBs, and eliminates the need to sign reliance agreements for each study. The Harvard LMA Schools are SMARTIRB participating institutions. As such, when a reliance agreement involves SMARTIRB institutions, an application is required through the SMARTIRB Online Reliance System.

 

REGULATORY REQUIREMENTS

NIH Policy

Effective January 25, 2018, the NIH required the use of a Single IRB (sIRB) for the review of NIH-funded multi-site 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 revised Common Rule most U.S. government funded cooperative studies that meet the criteria for non-exempt “human subjects research,” and involve more than one site, will require sIRB review.  This requirement went into effect January 20, 2020.  For more information: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html

 

HLC IRB RELIANCE POLICY

When Harvard Longwood Campus School investigators are conducting collaborative, non-exempt human research (i.e., the human research requires expedited or full board review), it may be possible to establish an IRB Authorization Agreement (IAA) allowing one institution to rely on IRB review conducted by the other institution

Activities that do not constitute human subjects research or are determined to be exempt are ineligible for a reliance arrangement. Instead, the HLC IRB will perform IRB review, if required.  In addition, HLC IRB does not routinely execute reliance agreements with international institutions.

 

RELIANCE AGREEMENTS

SMART IRB

  • The HLC Schools are signatories to the SMARTIRB master reliance agreement. It is the preference of HLC IRB to use the SMARTIRB agreement as the basis of reliance for all studies where we rely on an external IRB or serve as the sIRB.

IRB Authorization Agreement (IAA)

  • In cases where an institution is not a SMARTIRB signatory or using its Online Reliance System, the HLC IRB may use its template IRB Authorization Agreement to establish a reliance relationship with an external institution.

Reliance arrangements with Independent IRBs

  • The HLC IRB does not routinely enter into reliance arrangements with independent/commercial IRBs. If you anticipate that your study will be reviewed by an independent IRB, contact Leslie Howes at lhowes@hsph.harvard.edu or 617-432-2153.

 

REQUESTING RELIANCE – Harvard LMA School as sIRB

To request that a Harvard LMA School review the proposed research project and serve as the IRB of Record, follow instructions on submitting an application in ESTR.  Your department-assigned IRB Review Specialist will facilitate the review process.

 

REQUESTING RELIANCE – Harvard LMA School as pSite

To request that a Harvard LMA School rely on another institution, submit an external IRB application in ESTR by following these instructions on the ESTR Support website.

When a Reliance Request involves a SmartIRB participating institution, an additional application is required through the SmartIRB Online Reliance System. Instructions and resources for using the SmartIRB reliance system are available here.  If you have not used the SmartIRB Online Reliance System, you must first Request Investigator Access.

When a Reliance Request involves a non-SmartIRB participating institution OR only Harvard University and its Schools, only the external IRB application in ESTR is necessary.