Information Sheets

Definitions

I. "Human Subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains (i) data through intervention or interaction with the individual or (ii) identifiable private information.

A. "Intervention" includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject's environment that are performed for research purposes.

B. "Interaction" includes communication or interpersonal contact between investigator and subject.

C. "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 that has been provided for specific purposes by an individual and that 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.

II. "Research" means a systematic investigation designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute "research" for purposes of human subjects policy, whether or not they are supported or funded under a program that is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities.

III. "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.

IV. "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.

V. "HSC" means Human Subjects Committee.

VI. "IRB" means Institutional Review Board, the Federal designation for human subjects review committees such as the HSC.

VII. "CFR" means the Code of Federal Regulations. 45 CFR refers to Title 45 of the Code of Federal Regulations. A number such as 45 CFR 46.116 refers to paragraph 116 of Part 46 of 45 CFR.

VIII. "Children" are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.

IX. "Parent" means a child's biological or adoptive parent.

X. "Guardian" means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.

XI. "Assent" means a child's affirmative agreement to participate in research. Mere failure to object should not be construed as assent.

XII. "Permission" means the agreement of parent(s) or guardian to the participation of their child or ward in research.