Glossary of Terms and Acronyms
- Common Rule
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A set of regulations governing research with human subjects that have been adopted by many federal agencies. Revised January 21, 2019. See: 45 CFR 46
- compassionate use
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One of several “expanded access” mechanisms established by the FDA to allow access to an investigational device for patients who cannot participate in a clinical trial…
- compensation
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See: payment
- competence
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A legal term denoting capacity to act on one’s own behalf, including: the ability to understand information presented, to understand the consequences of acting (or not…
- conditional approval
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IRB determination that the applicable criteria for IRB approval on an item have been met based on the assumption that specific conditions will be met by…
- consent form
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Document describing the risks, benefits, and study procedures so that potential subjects can make an informed decision about whether or not to participate in the research.
- continuing noncompliance
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A pattern of repeated noncompliance by the same investigator or the IRB that meets any of the following criteria: Suggests the likelihood that noncompliance will continue…
- controverted issues
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An issue discussed at an IRB meeting for which there is a disagreement between some IRB members, or there are opposing viewpoints among IRB members that…
- covered entity
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This refers to those individuals, organizations, and institutions that maintain or transmit PHI, and that are required to comply with HIPAA regulations. See: 101.G1 UW HIPAA…
- daisy-chaining
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This is also called triangulation. This is when one institution relies on another IRB but that other IRB doesn’t do the review because it is relying…