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Reliance

Reliance

An institution conducting research has the option to rely on the review of another institution’s IRB, per the Office of Human Research Protection (OHRP) and the Food and Drug Administration (FDA). The institution and outside IRB must enter into an agreement to delineate each party’s roles and responsibilities.

IRB Authorization Agreement (IAA)

Institutions that hold a Federalwide Assurance (FWA) use this document to agree to adhere to federal laws and regulations involving the protection of human subjects in research. Oversight provided by the IRB of record must satisfy the terms of the relying institution’s FWA.

IAAs can be signed on a study-by-study basis or they can take the form of a master reliance agreement, such as the SMART IRB Master Reciprocal Agreement, the Kaiser Permanente InterRegional agreement, and the OHSU Memorandum of Understanding (MOU).

Individual Investigator Agreement (IIA)

Outside investigators who are collaborating with KPNW and not acting as an employee or agent of their home institution (or do not have one) must sign an IIA.  This document extends KPNW’s FWA to cover the individual outside investigator.  The investigator must agree to follow KPNW’s human subject protection policies and IRB oversight.

Single IRB (sIRB) and Collaborative Research

The single IRB (sIRB) mandate is a set of complementary federal policies that require certain types of federally-funded studies that involve multiple institutions to use one designated IRB to accomplish oversight and approval.

SMART IRB

SMART IRB Online Reliance System

https://smartirb.org

The SMART IRB Online Reliance System was designed to simplify the single IRB process for multisite studies. Investigators and institutions can use the Online Reliance System to request, track, and document reliance arrangements on a study-by-study basis. The system also:

  • Manages communication between institutions and investigators
  • Tracks the status of requests
  • Clearly indicates what needs to be done next
  • Documents reliance arrangements for each study
  • Allows for the addition of sites to a reliance arrangement by creating an amendment

Investigator Benefit of Using the SMART IRB Agreement

  • Reduces hurdles for multisite collaborations
  • Supports small and large studies, regardless of funding
  • Helps obtain trial results faster
  • Investigators from participating institutions can use the Online Reliance System to request reliance arrangements for their studies from KPNW

How it works for Investigators

Review our Guidance Document

To submit a request for reliance for your study, the PI or a designee will:

  • Provide details about the study
  • List the engaged sites
  • Identify activities and personnel at each site
  • Upload research protocol and all consent templates
  • Upload SMART Letter of Acknowledgement filled out for the study

 If you would like to use SMART IRB for a collaborative project, contact the IRB Manager.

When must a study use an sIRB?
  • The sIRB Mandate applies to studies that are:
    • Non-exempt
    • Multi-site collaborative studies, and
    • Federally funded studies for which the sites are all using the same protocol
The policy does not apply to studies that are:
  • Funded to foreign awardees, or
  • Conducted at foreign sites (though domestic sites of the same study m ust be reviewed by an sIRB, or
  • Funded through career development, research training or fellowship awards, or
  • Where reviewer by the proposed sIRB would be prohibited by a federa, tribabl, or state law, regulation or policy, or
  • Collaborative projects in which multiple sites are involved but different sites may complete different parts of the study.

The funding agency may consider other requests for exceptions if there is a compelling justification, but expects these kinds of exceptions to be infrequent.

For additional informaiton on the sIRB Mandate, see the NIH Policy on use of a Single Institutional Review Board for Multi-site Research .

For additional information on the federal requirements, see the Revised Common Rule's Cooperative Research Provision.

What to Do: Pre-Approval Stage (if applicable)

Pre-award Reliance Request

In some situations, the IRB of record will require documentation from relying IRBs that they are willing to rely on the IRB of record prior to the final protocol’s approval and execution of an IRB Authorization Agreement (IAA). If the IRB of record requests this documentation, fill out the sIRB Request Form on our website and follow the instructions.

What to Do: IRB Review

When KPNW agrees to be the IRB of record

Once the study protocol is approved at KPNW IRB, submit the following through the IRBNet system to add external sites:
  • Local context information from each of the relying sites
  • Subject facing documents (consent, recruitment, etc.) tracked for use at relying sites
  • Applicable reliance agreement (IAA or IIA), if not a SMART or KP interregional reliance
 

When KPNW will rely on another IRB, submit the following in IRBNet:

Prior to submission to the IRB of record, submit the following through the IRBNet to add external sites:
  • Local context information for KPNW
  • Research Protocol from reviewing IRB (must be currently approved version)
  • Copy of the IRB approval letter agreeing to include KPNW IRB as a site
  • Any subject facing documents for KPNW subjects (consent, recruitment, etc.)
  • Applicable reliance agreement (IAA, IIA or SMART Letter of Acknowledgement), if not a KP interregional reliance

Reliance Flow Chart - KPNW Relying

Please note that the IRB team may require additional documentation to conduct the review.

For additional information, see our guidance ‘Establishing IRB Reliance at KPNW IRB’

Annual Report for Ceded Projects

Projects ceded to another IRB receive a ‘Next Report Due’ date in the IRBNet system. This date is the same as the expiration date at the reviewing IRB. Upon receipt of the continuing review approval letter from the reviewing IRB, prepare a package in IRBNet and upload the approval letter. If the protocol or any other locally relevant documents were also modified in the last year, include the most recent versions of the revised materials in the package.