Glossary of Terms and Acronyms
- administrative closure
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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)
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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
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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
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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
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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
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See: reliance agreement
- Authorized Institutional Official (IO)
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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
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An individual’s right to consider alternatives, make choices, and act without undue influence or interference of others. See: Belmont Report
- Belmont Report
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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
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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…
