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
See: adverse event
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…
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…
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…
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…
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…
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…
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.
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…
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….
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…
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 refers to the use of persuasion, authority figures, or the offer of an excessive or inappropriate reward or other overture in order to obtain…
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…
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…
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…
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…