Glossary of Terms

An unconfirmed report of noncompliance.

Also called a Reliance Agreement, is the agreement that documents respective authorities, roles, responsibilities, and communication between an institution/organization providing the ethical review and a participating institution relying on the ethical review.

The IACUC reviews protocols, reviews the animal care and use program, and monitors university animal facilities to ensure compliance with standards and regulatory requirements.

Failure (intentional or unintentional) to comply with applicable federal regulations, state or local law, requirements or determinations of the IACUC, or University policy regarding research or teaching involving animals.

An institution that participates in a Single IRB (sIRB) Study.

Applies to investigators who are delinquent in meeting IRB requirements.

Non-Compliance such that the failure to comply could adversely affect the rights, safety, or welfare of a human subject; place a human subject at increased risk of harm; cause harm to a human subject; affect a human subject’s willingness to participate in research; or damage or compromise the scientific integrity of research data.

A study in which two or more institutions (participating sites, or pSites) coordinate to complete the research activities, but all institutions rely on a single institution’s/organization’s IRB for ethical review. The reviewing IRB may or may not be affiliated with any of the pSites.

A study in which two or more institutions (participating sites, or pSites) coordinate to complete the research activities, but all institutions rely on a single institution’s/organization’s IRB for ethical review. The reviewing IRB may or may not be affiliated with any of the pSites.

An action of the IRB, IRB chairs, vice chairs, Institutional Official/Organizational Official, or designee of the Institutional Official/Organizational Official to temporarily or permanently withdraw IRB approval of some or all research procedures short of a Termination of IRB Approval. Suspended studies remain open and are subject to continuing review. Note: Similar actions taken by investigators or sponsors to stop research activities are not considered suspensions.

Having or involving a system, method, or plan.

An action of the convened IRB, Institutional Official/Organizational Official or designee of the Institutional Official/Organizational Official to permanently withdraw IRB approval of all research procedures (except for those follow-up procedures that may be necessary to protect the health and/or welfare of participants). Terminated studies are permanently closed and no longer require continuing review. Note: Similar actions taken by investigators or sponsors to stop research activities are not considered terminations.

Any information that is (1) unanticipated, (2) related to the research, and (3) indicates that subjects or others are at increased risk of harm. For Department of Defense (DOD) research the term Unanticipated Problem Involving Risks to Subjects or Others includes any incident, experience, or outcome that meets ALL three of the following conditions: -Is unexpected (in terms of nature, severity, or frequency) given the procedures described in the research protocol documents (e.g., the IRB-approved research protocol and informed consent document) and the characteristics of the human subject population being studied. -Is related or possibly related to participation in the research (in this Instruction, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research). -Suggests that the research places human subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized, even if no harm has actually occurred.