Glossary

Cede Review

An institution agrees to transfer IRB review and oversight authority for specified research to another institution’institution's IRB (reviewing IRB).

cIRB

<<<<Application insertused definitionfor >>>multi-site research where UNMC is ceding review to another reviewing IRB.

Lead Site

<<<<Generally, insertthe definitionLead >>>Site is the study team at the reviewing IRB’s institution. The Lead Site is designated by the Overall PI (see below) and, working in collaboration with the Reviewing IRB, ensures coordination of communication to and from all Relying IRB (see below), routing all IRB submissions to the Reviewing IRB and communicating IRB determinations to Site Investigators.

Lead Principal Investigator (Lead Site PI)

The study wide lead Principal Investigator with ultimate responsibility for the conduct and integrity of multisite research.

Local Context

Unique legal requirements, cultural or religious values, or other site-specific variables that exist at a site where subjects are enrolled in research.

Overall PI

The lead multisite principal investigator with ultimate responsibility for the conduct and integrity of research (generally, the initiating principal investigator or funding principal investigator, as applicable).

Participating Site (pSite)

<<<<An insertinstitution definition(including >>>an IRB organization) that meets the eligibility requirements set forth in the Agreement and agrees to accept the terms and conditions of the Agreement.

Participating Site Principal Investigator (pSite PI)

The lead investigator at each institution participating in multisite research usually responsible for the conduct of the research at the participating institution.

Reliance

<<<< insert definition >>>

Reliance Agreement (also known as an Authorization Agreement)

An agreement between two Organizations engaged in human subject research that documents respective authorities, roles, responsibilities, and communication between the reviewing and relying IRBs.

Reliance Negotiation

<<<< insert definition >>>

Relying Institution

A participating Institution that cedes IRB review to the IRB of record (reviewing IRB) designated under a Reliance Agreement.

Relying IRB

<<<<see insertRelying definition >>>Insitution

Reviewing IRB

The IRB which is responsible for conducting IRB review and approval as described in 45 CFR 46.109 for cooperative human subject research.

sIRB

<<<<A insertmodel definitionof >>>IRB review for multisite studies where UNMC acts as the IRB of record.