Glossary of Terms and Acronyms
- respect for persons
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As discussed in the Belmont Report the principle that individual autonomy be respected and that persons with diminished autonomy be protected. See also: Belmont Report
- serious adverse event
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See: adverse event
- serious noncompliance
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Noncompliance which meets any of the following criteria: Significant increase of the risks to, or jeopardize the safety, welfare, and/or rights of, one or more subjects…
- short form consent process
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This is an alternative method of obtaining and documenting consent, when a researcher occasionally and unexpectedly encounters a non-English-speaking subject in a study for which no…
- significant risk device
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An investigational device that presents a potential for serious risk to the health, safety, or welfare of a subject and is: intended as an implant; purported…
- Single IRB
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This refers to a situation in which a single Institutional Review Board (IRB) is providing the review and oversight (i.e., is the IRB of record) for…
- split review
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This refers to a situation in which each engaged institution participating in a collaborative research study obtains its own Institutional Review Board (IRB) review for the…
- subject identifier
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Information that identifies the subject. Per federal human subjects regulations, any information that renders a person “readily identifiable” is a subject identifier. Under HIPAA regulations about…
- subject payment
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A term used broadly in the Human Subjects Division (HSD) documents referring to payment for study participation, for example: money, class credit, or gift cards.
- therapeutic misconception
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The purpose of a clinical trial is to evaluate an experimental therapy or intervention, not to provide therapy. Clinical trial participants, hoping for therapeutic benefits, may…