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, the OHSU Memorandum of Understanding (MOU), and the HCSRN Reciprocal Reliance Agreement (RRA).

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.

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

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

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.

sIRB Mandate - NIH Policy, effective January 25, 2018

  • Applies to: NIH funded studies for which the sites are all using the same protocol. These will typically be clinical trials but can include observational studies.

Collaborative Research - Revised Common Rule sIRB requirement, effective January 19, 2020

  • Applies to: Federally funded cooperative research—studies that involve more than one institution.

Which studies must follow the single IRB NIH policy?

The NIH policy applies to all studies that are:

  • Funded through grants, cooperative agreements, or contracts submitted to NIH on or after January 25, 2018*, and
  • Involve non-exempt human subjects research, and
  • Involve multiple sites, all of which are using the same protocol. *This includes multi-site studies where most sites are using the same protocol, but one or more sites are solely responsible for overall study coordination, laboratory services, statistical services, or other study support functions.

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 must be reviewed by an sIRB), or
  • Funded through career development, research training or fellowship awards, or
  • Where review by the proposed sIRB would be prohibited by a federal, tribal, 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.

NIH will consider other requests for exceptions if there is a compelling justification, but expects these kinds of exceptions to be infrequent.

Pre-award/NIH Grant Application Requirements

All competing NIH grant applications (new, renewal, revision, or re-submission) for multi-site studies as defined above must include a plan describing the use of an sIRB for the study. See Section D “NIH Grant Application/Contract Proposal Preparation” of the NIH FAQ Single IRB Policy and Multi-site Research and Section 3.2 of the PHS Human Subjects and Clinical Trials Information Form Application Guide.

For multisite studies where KPNW is the prime awardee, you must identify who will be the IRB of record. Then, work with your Sponsored Projects Administrator (SPA) to write the sIRB Plan according to NIH instructions, and ensure that your budget reflects any additional costs associated with the sIRB.

Although this step is pre-IRB submission, consult with the IRB as early as possible to avoid complications, especially if requesting that KPNW IRB act as IRB of record for all sites.

Regardless of who will be the prime awardee and/or IRB of record, the KPNW IRB must acknowledge and agree to the sIRB plan. To request an acknowledgment, click on the link below to enter basic information regarding the proposal and upload the following documentation.

  • Copy of the sIRB Plan that will be included in the grant submission; and
  • Summary of proposed research as it relates to human subjects, including activities that will occur at KPNW.

Request IRB Acknowledgement

When KPNW agrees to be the IRB of record, submit the following through the IRBNet system:

  • Local context information from each of the relying sites
  • Copy of NIH Grant (if applicable)
  • Research Protocol using the applicable template located in the Forms and Templates section of IRBNet
  • All subject facing documents including those to be used at relying sites
  • Any other study documents you are prompted for when filling out the IRB submission in IRBNet system
  • Applicable reliance agreement

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

  • 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 other study documents you are prompted for when filling out the IRB submission in IRBNet
  • Any subject facing documents for KPNW subjects (see help text in eIRB-1st page or external IRB page)
  • sIRB reliance agreement

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.