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
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…
See: payment
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…
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…
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.
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…
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…
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…
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…
Data Monitoring Committee See: Data Safety Monitoring Board
An independent group of experts who monitor a study for subject safety, study outcomes, and study progress while the research is ongoing.
The researcher’s plan to oversee subject safety, study outcomes, and study progress by monitoring research progress and quality, reporting problems, and assuring data accuracy and protocol…
Information is de-identified if there is no reasonable basis to believe that the data can be linked to specific individuals. When the data are Protected Health…
In the context of informed consent, the process of providing information to participants at the conclusion of study procedures. The intent of debriefing is to provide…
In the context of informed consent, the omission of relevant information and/or the presentation of misleading information about a study.
A code of ethics for clinical research developed by the World Medical Association. It is considered the original cornerstone document on human research ethics. See: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
The decision (vote) by an Institutional Review Board (IRB) that the IRB is unable to approve the research because the applicable criteria for IRB approval have…
This determination is granted by HSD (when requested by a research sponsor) to research that does not yet have definite plans for human subjects research. It…
This refers to a situation in which more than one Institutional Review Board (IRB) oversees and reviews the same parts of a study; i.e., there is…