IRB Reliance Terms and Definitions

Version date: March 2015

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

BTCTC (Big Ten Cancer Research Consortium): A research partnership involving Big Ten institutions that is designed to advance cancer research through collaborative, hypothesis-driven, oncology trials.

Ceding IRB Review: Ceding IRB review is a term to describe one institution ceding or deferring IRB review to another institution’s 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 and 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).

Deferring IRB Review: Deferring IRB review is a term to describe one institution ceding or deferring IRB review to another institution’s IRB.

Engagement in research: Engagement in human subjects research in the terms used in the Federal regulations 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 an institution ensures to the Department of Health and Human Services (HHS) that it will comply with applicable regulations governing research with human subjects.

GPC (Greater Plains Collaborative): Network of ten medical centers focused on improving healthcare delivery through ongoing learning, adoption of evidence-based practices, and active research dissemination.

Individual 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 and 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: The institutional official (IO) is the signatory on the federalwide assurance (FWA) filed with OHRP to ensure compliance with regulations governing protection of human subjects. OHRP requires the institutional official 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 the reviewing IRB 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: A reviewing IRB that assumes IRB responsibilities for another institution or personnel not affiliated with an institution with an IRB. A formal agreement is often required when 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: 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.

MARCH (Midwest Area Research Consortium for Health): A research partnership among 6 Midwest-based institutions.

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.

MWPSC (Midwest Pediatrict Surgical Consortium): A research partnership involving pediatric surgeons at 10 children’s hospitals.

NCI CIRB (National Cancer Institute Central Institutional Review Board): The NCI CIRB provides centralized IRB oversight for institutions conducting certain cooperative group oncology studies.

NCATS (National Center for Advancing Translational Sciences): Established by NIH in December 2011 to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster.

Relying IRB or Organization: A relying IRB or organization is relying on or has ceded IRB review to another IRB to provide IRB oversight 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.

StrokeNet: Created by the NIH to conduct small and large clinical trials and research studies to advance acute stroke treatment, stroke prevention, and recovery and rehabilitation following a stroke. This network of 25 regional centers across the U.S., which involves more than 200 hospitals, is designed to serve as the infrastructure and pipeline for new potential treatments for patients with stroke and those at risk for stroke.

WIC (Wisconsin IRB Consortium): This agreement allows 4 institutions (Aurora Health Care, Marshfield Clinic, Medical College of Wisconsin, and UW-Madison) to defer IRB oversight to a single WIC member IRB for studies that involve 2 or more institutions.

WIRB (Western Institutional Review Board): Commercial IRB that UW-Madison has contracted with to review the majority of industry-sponsored research studies that are not investigator initiated.



Keywords:cede collaborating engagement rely   Doc ID:49549
Owner:Monica E.Group:Health Sciences IRBs
Created:2015-03-25 12:34 CSTUpdated:2015-10-13 14:12 CST
Sites:Health Sciences IRBs
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