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…

administrative closure

Closure of a study that no longer has IRB approval because the approval lapsed or…

adverse event (AE)

Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for…

approved drug

Drug products approved by the FDA. See the FDA website at: http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm

assent

Regulatory term. Agreement to participate in research by an individual who is not competent to…

assurance

Regulatory term. A formal written, binding commitment that is submitted to a federal agency in…

authorization agreement

See: reliance agreement

Authorized Institutional Official

Regulatory term. An official of an institution who has the authority to speak for and…

autonomy

An individual’s right to consider alternatives, make choices, and act without undue influence or interference…

Belmont Report

A report that sets out the basic ethical principles governing research involving human subjects, which…