<< Previous Section | < Previous Page | Next Page > | Next Section >> Definitions Research A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 45 CFR 46.102(d) Human Subject A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. 45 CFR 46.102(f) Intervention Physical procedures and manipulations of the subject's environment performed for research purposes. Interaction Interaction includes communication or interpersonal contact between investigator and subject. Private Information Private information is information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, as well as information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Definition of Human Research Data from living individuals Biological material from living individuals Interaction or intervention with a living individual Use of a non-FDA approved, drug, device or biological << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 2 Quick Links Research in Humans History of Rules About Research in Humans Definitions Federal Mandate Respect for Persons Beneficence Justice Common Rule IRB Mission Cases Bibliography Chapter 2 Download (PDF)