Glossary of Terms and Acronyms
- third party subjects
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An informal name for living individuals about whom researchers obtain individually identifiable private information from someone else but who themselves have no interaction with the researcher….
- unanticipated adverse device effect
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Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with a medical device (if that effect, problem…
- unanticipated problem
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A problem or event that meets all of the following criteria: Unexpected – The harm (or potential harm) is inconsistent with risk information previously reviewed and…
- undue influence
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Undue influence refers to the use of persuasion, authority figures, or the offer of an excessive or inappropriate reward or other overture in order to obtain…
- vulnerable populations
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Groups of subjects who may be at higher risk for effects of undue influence or coercion on their decision about whether to participate in a research…
- waiver of consent
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According to federal regulations, researchers may not involve a human being as a subject in research unless they have obtained the “legally effective informed consent of…
- waiver of documentation of consent
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Federal regulations require a researcher to document that the research participants have provided informed consent. This is typically accomplished by signing a consent form. However, the…
- waiver of HIPAA authorization
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A request for permission to access, obtain, use or disclose a research subject’s Protected Health Information (PHI) for research purposes without obtaining the subject’s specific authorization…