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What is research?
The Department of Health and Human Services (DHHS) regulations (45 CFR 46.102(d)) define research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research even if they are a component of a larger non-research activity (e.g., instruction, demonstration).
Who is a human subject?
DHHS regulations (45 CFR 46.102(f)) define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains either (1) data through intervention or interaction
with the individual, or (2) identifiable private information.
University of Iowa IRB Policy Citations and Guidance
Human Subjects Research Determination Booklet
University of Iowa Operations Manual and Guidance
University of Iowa IRB ICD Template Wording
None
January 2014