U.S. Department of Health & Human Services
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When is an institution considered to be “engaged in research”?
In general, an institution is considered to be engaged in human subjects research when its employees or agents:
(1) obtain data about living individuals for research purposes through intervention or interaction with them,
(2) obtain individually identifiable private information for research purposes (45 CFR 46.102(d),(f)) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102; or
(3) obtain the informed consent of human subjects.
Employees and agents, including students, are individuals performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility.
In general, an institution is considered to be engaged in human subjects research whenever it receives a direct HHS award to support such research, even if all of the human subjects activities will be performed by agents or employees of another institution. In general, simply informing potential subjects about a research study is not considered engagement in research. Also, providing written information about a research study, including how to contact the investigators for information and enrollment, and seeking and obtaining prospective subjects' permission for investigators to contact them are not considered engagement in research. However, obtaining informed consent from a research participant is considered engagement in research.
[For details, please see OHRP guidance on this topic at: http://www.hhs.gov/ohrp/policy/engage08.html, specifically, Section (B)(4).]
Last Reviewed: 06/17/2011
Related Questions:
- What assurance ofcompliance process for human subject protection is accepted by the Office for Human Research Protections (OHRP) and other Federal agencies?
- What is an assurance of compliance with human subject protection regulations?
- What research does the Federalwide Assurance (FWA) cover?
- What time period does the Federalwide Assurance (FWA) cover and when does it have to be updated?
