IRB Reliance Terms and Definitions

Version date: December 2017

Below please find a list of common IRB reliance terms and definitions. If you have questions about any of these or collaborative research generally, please contact the HS IRBs’ Reliance Team for assistance.

Ceding IRB Review: Describes when one institution cedes IRB review to another institution’s IRB. Also known as relying on another IRB.

Collaborating Investigator Summary: A document used when UW-Madison agrees to serve as IRB of record for external personnel or collaborators engaged in human subjects research who are not affiliated with an institution with its own IRB. This document is only used when studies are not federally funded. If a collaborating investigator summary is needed, the HS IRBs office facilitates the processing of such agreements. Also see Individual Investigator Agreement (IIA).

Engagement in Human Subjects Research: The term used in Federal guidance to determine whether IRB oversight is required for a site or personnel participating in a research study or project.

Federalwide Assurance (FWA): A formal, written, binding attestation in which a research institution commits to DHHS that it will comply with the Federal Policy governing human subjects research.

Individual (or Independent) Investigator Agreement (IIA): An agreement used when UW-Madison agrees to serve as IRB of record for external personnel or collaborators engaged in human subjects research who are not affiliated with an institution with its own IRB. This document is only used when studies are federally funded. If an individual investigator agreement is needed, the HS IRBs office facilitates the processing of such agreements. Also see Collaborating Investigator Summary.

Institutional Official (IO): The signatory on the federalwide assurance (FWA) filed with the Office of Human Research Protections (OHRP) to ensure compliance with regulations governing protection of human subjects. OHRP requires the IO to be a high-level official who has the authority to represent the institution named in the FWA. The IO is the UW-Madison official responsible for signing IAAs and IIAs on behalf of the institution.

IRB Authorization Agreement: A formal, written agreement in which one institution agrees to serve as the IRB of record for a relying Institution. Agreements are generally used to cover a single research study, categories of research studies or research studies within a research program. If an IRB authorization agreement is needed, the HS IRBs office facilitates the processing of such agreements.

IRB of Record (aka Reviewing IRB): An IRB that assumes IRB responsibilities for another institution or personnel not affiliated with an institution with an IRB. A formal agreement is typically required when an IRB agrees to serve as IRB of record for another institution or external personnel.

IRB Reliance and IRB Reliance Agreement: IRB reliance is a term to describe partnerships or agreements among different IRBs to rely on each other to provide IRB oversight for research studies. An IRB reliance agreement also may be referred to as an IRB authorization agreement (IAA).

Local Research Context (aka Local Considerations): Knowledge of the institution and community environment in which human subjects’ research will be conducted. In order for an IRB to agree to serve as IRB of record for another institution or external personnel, it must have adequate knowledge of local context (e.g., state laws, understanding of cultural context) in order to do so.

Multisite Research: Any research study or project involving sites or personnel outside UW-Madison, UW Health, or the Madison VA qualifies as multisite research. All multisite research projects raise questions about whether sites or personnel are engaged in research and if so, how IRB oversight will be provided.

Relying Institution or Organization: A relying institution or organization is one which is relying on or has ceded IRB review to another IRB for a specific study or set of studies. Relying on another IRB to provide IRB oversight also is referred to as ceding or deferring IRB review.

Reviewing IRB: A reviewing IRB is the IRB that serves as the IRB of record for institutions or personnel not affiliated with an organization with an IRB. Also referred to as IRB of record.

Single IRB (sIRB): A single IRB conducts reviews on behalf of all or some participating sites in a multicenter study.

SMART IRB: A nationwide NIH-funded initiative supporting IRB reliance through a master IRB agreement and other tools. It is not an actual IRB. SMART IRB stands for Streamlined, Multisite, Accelerated Resources for Trials. UW—Madison is a founding member of SMART IRB and the HS-IRBs actively encourage use of the SMART IRB agreement for eligible studies, including studies that are not clinical trials.



Keywords:cede collaborating engagement rely   Doc ID:49549
Owner:Monica E.Group:Health Sciences IRBs
Created:2015-03-25 12:34 CSTUpdated:2018-01-16 16:44 CST
Sites:Health Sciences IRBs
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