Section 1
Stony Brook University Definitions

A. Human Subject (for studies not under FDA jurisdiction) is a living individual about whom an investigator conducting research obtains data

a) directly, through intervention or interaction with the individual
OR
b) indirectly, through study of the individual's existing data and/or biological specimens

B. Human Subject (for studies under FDA jurisdiction): means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.

C. Minimal Risk: means that the probability and magnitude of harm or discomfort that is anticipated in a research activity are not greater, in and of themselves, than those ordinarily encountered in daily life or during performance of routine physical or psychological examinations or tests.

D. Quality Assurance/Quality Improvement (QA/QI) initiatives*: Part of the mandated functions of Stony Brook University Medical Center (SBUMC), implemented, e.g., after thorough evidenced-based best practices are identified, in response to an identified safety issue, or to improve the delivery of care and avoid potential safety issues.  The overarching intent of QA/QI initiatives is continuous monitoring of hospital operations and improved care of our patients at SBUMC.

E. Research*: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

* See Section 26 for policy and guidance on the distinction between research and quality assurance/quality improvement (QA/QI) activities.

Return to Human Subjects Research at SBU

Last Updated: 2007-06-28