Glossary of Terms

Glossary of Human Subjects and IRB Related Terms

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There are currently 7 names in this directory beginning with the letter R.
Recruitment
an activity that seeks to enroll prospective subjects into a research study by presenting information about the research including a summary of eligibility requirements. All recruitment materials must be consistent with application and informed consent documents.

Related to the Research
A financial interests is Related to the Research when the interest is in: A sponsor of the research; A competitor of the sponsor of the research; A product or service being tested; or A competitor of the product or service being tested.

Research as Defined by DHHS
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Research as Defined by FDA
Any experiment that involves a test article and one or more Human Subjects, and that meets any one of the following: Must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act meaning any use of a drug other than the use of an approved drug in the course of medical practice; Must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act meaning any activity that evaluates the safety or effectiveness of a device; OR Any activity the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.

Research as Defined by Virginia Code
Virginia Code (§32.1-162.1) references the DHHS definitions of “research.”

Research Integrity & Assurance (RDIA)
The George Mason University office that serves as an administrative hub for the university’s oversight of human subjects research.

Risk
The probability and magnitude of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Risks include immediate risks of study participation as well as risks of long- term effects.
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