Glossary of Terms and Acronyms
- Data Monitoring Committee (DMC)
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Data Monitoring Committee See: Data Safety Monitoring Board
- data safety monitoring board (DSMB)
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An independent group of experts who monitor a study for subject safety, study outcomes, and study progress while the research is ongoing.
- data safety monitoring plan (DSMP)
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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…
- de-identified data
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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…
- debriefing
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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…
- deception
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In the context of informed consent, the omission of relevant information and/or the presentation of misleading information about a study.
- Declaration of Helsinki
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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/
- deferral
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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…
- Delayed Onset Human Research (DOHR)
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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…
- dual review
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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…