-CITE- 45 CFR Sec. 46.102 -EXPCITE- Title 45 SUBTITLE A PART 46 Subpart A -HEAD- Sec. 46.102 Definitions. -TEXT- (a) 'Secretary' means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has been delegated. (b) 'Department' or 'HHS' means the Department of Health and Human Services. (c) 'Institution' means any public or private entity or agency (including federal, state, and other agencies). (d) 'Legally authorized representative' means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. (e) 'Research' means a systematic investigation designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute 'research' for purposes of these regulations, whether or not they are supported or funded under a program which is considered research for other purposes. For example, some 'demonstration' and 'service' programs may include research activities. (f) 'Human subject' means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. 'Intervention' includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. 'Interaction' includes communication or interpersonal contact between investigator and subject. 'Private information' includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. (g) 'Minimal risk' means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (h) 'Certification' means the official notification by the institution to the Department in accordance with the requirements of this part that a research project or activity involving human subjects has been reviewed and approved by the Institutional Review Board (IRB) in accordance with the approved assurance on file at HHS. (Certification is required when the research is funded by the Department and not otherwise exempt in accordance with Sec. 46.101(b)). (46 FR 8386, Jan 26, 1981; 46 FR 19195, Mar. 27, 1981)