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IRB Reliance (Authorization) Agreements

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Overview

A reliance agreement (aka IRB Authorization Agreement (IAA)) 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, IRB authorization agreement (IAA), or memorandum of understanding (MOU). Agreements may cover single studies, categories of studies, or all human subjects research under an organization’s Federal-wide Assurance (FWA). MOUs are generally used when covering an entire research program; reliance agreements are generally used to cover a designated protocol or protocols.

The type of agreement may be based on the nature of established financial, legal, or collaborative relationships between the entities. The HHS Office for Human Research Protections (OHRP) sample template uses the term “authorization agreement”; the Food and Drug Administration (FDA) uses the term “agreement.” The agreement should clearly identify the IRB of record for a protocol or program and the delineation of responsibilities.

Procedures For Collaboration/Single IRB at Rutgers

 
When Rutgers Is
the IRB of Record
When Rutgers Is
Relying On Another IRB For IRB Approval
Collaborating with Another PI
From Another Organization
  1. Confirm if Rutgers University is willing to be the IRB of Record by contacting the Rutgers IRB Administrator. 
  2. Use the Rutgers IRB Reliance Agreement Template.
  3. Submit your study for RU IRB Approval in the Rutgers eIRB system.
  1. Confirm if Rutgers University is will to rely on the Non-Rutgers IRB by contacting the Rutgers IRB Administrator.
  2. Use a template provided by the Non-Rutgers IRB.
  3. Submit your study for IRB approval in the Rutgers eIRB system requesting "Administrative Review".
Utilizing SMART IRB
 
***SMART IRB Does Not
Provide IRB Approval.
  1. Confirm if the Non-Rutgers Institution is a member of SMART IRB (required).
  2. Both IRBs will adhere to the SMART IRB Master Reliance Agreement (MRA) (already setup and agreed upon).
  3. Submit your reliance request study using the SMART IRB website.
  4. Rutgers IRB will complete a Pre-Check in the SMART IRB System confirming IRB of Record.
  5. Submit your study for IRB approval in the Rutgers eIRB system using the regular approval process.
  6. Attach RU IRB Approval in SMART IRB.
  7. When SMART IRB Reliance Approval is received, you may commence with study activities.
  1. Confirm if the Non-Rutgers Institution is a member of SMART IRB (required).
  2. Both IRBs will adhere to the SMART IRB Master Reliance Agreement (MRA) (already setup and agreed upon).
  3. Submit your study using the SMART IRB website.
  4. Rutgers IRB will complete a Pre-Check in the SMART IRB System confirming IRB of Record.
  5. Submit your study for IRB approval in the Rutgers eIRB system requesting "Administrative Review".
  6. Attach IRB Approval in SMART IRB.
  7. When SMART IRB Reliance Approval is received, you may commence with study activities.

***Rutgers University is a member of SMART IRB (Learn More).

Types of Reliance Agreements

  • IRB Authorization Agreement (IAA): An IAA is an agreement between Rutgers University and another institution that holds a Federal Wide Assurance (FWA) with the Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS). Any institution (e.g., university, medical centers, NGOs, community organization, survey research organization) receiving funds from HHS must have an FWA.  This agreement type is used to establish the IRB-of-Record (whether that's Rutgers University or the other institution).  The IAA is signed by the Institutional Officials or designee at each institution.
  • Individual Investigator Agreement (IIA): an agreement between Rutgers University and an individual collaborator who is unaffiliated with Rutgers University and is not covered under an institution with an FWA. It allows research which requires coverage under a FWA to be conducted, if the individual collaborator agrees to conduct their human subject research under the direction and supervision of a Rutgers Principal Investigator and coverage under Rutgers’ FWA. This form would be used in place of an IRB Authorization Agreement (IAA) for eligible individual collaborators. 
    • Common Situations Requiring The Use Of This Agreement Include:  when a researcher leaves Rutgers University but wishes to continue their research (and they did not move to new institute with a FWA) or a researcher who is part of a medical clinic/institution which does not have an FWA but will be conducting human subject research as part of a Rutgers study.
    • Common Types Of Investigators Using This Form Include: former student working after graduation with their faculty mentor, professional in the community with specific expertise, community partner, etc.
  • Master Reliance Agreements (MRA): can be utilized when multiple studies are ceding review to a specific external IRB.  Master Agreements may be reciprocal in that signatory institutions can act as the site providing IRB review and oversight or the site relying.  Master Reliance Agreements may be for a single protocol or a number of protocols and are negotiated on a case by case basis.
    • Common Examples: NCI-Designated Cancer Center - National Cancer Institute, Commercial IRBs.
  • Smart IRB (Master Reliance Agreements (MRA)):  an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multisite studies across the nation, regardless of funding status. SMART IRB is not an IRB; rather, it's a platform that offers a master IRB reliance agreement (the SMART IRB Agreement) and a web-based system (SMART IRB's Online Reliance System) that provides a central process for participating institutions and their investigators to request, track, and document study-specific reliance arrangements. Investigators and their study teams, together with institutional and HRPP/IRB offices, use the SMART IRB platform to initiate single IRB review of a study. May be used by two or more institutions. Rutgers University is a member of SMARTIRB (Learn More).

IRB Reliance Agreement Templates

Contact the Rutgers IRB Reliance Administrator if you need a reliance agreement template.

Help

Contact the IRB Reliance Administrator.