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…
A legally binding agreement between two parties when data is being transferred from one party to the other. It describes any limitations on the use of…
See: Direct Costs
Defense Contract Audit Agency
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…
22 CFR 127.7 and AECA 38(g)(4) The persons (including entities and individuals) listed in documents linked below have been convicted of violating or conspiracy to violate…
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/
734.2(b)(2)(ii) Any release of technology or source code subject to the EAR to a foreign national. Such release is deemed to be an export to the…
22 CFR 120.3 Any item or technical data designated in 22 CFR 121.1. The policy described in 120.3 is applicable to designations of additional items. This…
22 CFR 120.9 The furnishing of assistance (including training) to foreign persons, whether in the United States or abroad in the design, development, engineering, manufacture, production,…
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…
Department of Health and Human Services (Sponsor)
Department of Homeland Security (Sponsor)
By definition in Uniform Guidance, “Direct costs are those costs that can be identified specifically with a particular final cost objective, such as a Federal award,…
22 CFR parts 120 through 130 The office at the Department of State responsible for reviewing applications to export and reexport items on the U.S. Munitions…