UW Research

Glossary of Terms and Acronyms

510K device

Regulatory term. A 510(k) is a pre-market submission made to the FDA for the purpose of demonstrating to the FDA that the device to be marketed…

administrative closure

Closure of an IRB-approved study or of an application for any type of HSD determination or UW IRB approval that is initiated by HSD (not the…

adverse event (AE)

Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), system, or disease temporally…

approved drug

Drug products approved by the FDA. See the FDA website at: https://www.fda.gov/drugs/drug-approvals-and-databases/resources-information-approved-drugs

assent

Regulatory term. Agreement to participate in research by an individual who is not competent to give legally valid informed consent (e.g., a child or cognitively impaired…

assurance

Regulatory term. A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research…

authorization agreement

See: reliance agreement

Authorized Institutional Official

Regulatory term. An official of an institution who has the authority to speak for and legally commit the institution to compliance with the requirements of the…

autonomy

An individual’s right to consider alternatives, make choices, and act without undue influence or interference of others. See: Belmont Report

Belmont Report

A report that sets out the basic ethical principles governing research involving human subjects, which are the ethical basis of the federal human subjects regulations. Issued…