UW Research

Glossary of Terms and Acronyms

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…

applicable clinical trial

This refers to the specific types of clinical trials that are required to comply with federal requirements about registration and results reporting at the federal website…

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 (IO)

Regulatory term [45 CFR 46.103(b)]. An official of an institution who has the authority to speak for and legally commit the institution to compliance with 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…

beneficence

An ethical principle discussed in the Belmont Report that entails an obligation to promote good (or benefits). It refers to the balance between the risks and…