Definition of Terms

Research: systematic investigation designed to develop or contribute to generalizable knowledge. Under this definition some demonstration, service and training projects may be considered to include research activities.

Investigator: either a person affiliated withSacredHeartUniversity (faculty, staff, or student) conducting human subjects research on or off campus, or a person unaffiliated with the University who wishes to conduct research involving human subjects on campus

Human Subject: a living individual about whom an investigator (whether professional or student) conducting research obtains a) data through intervention or interaction with the individual or b) identifiable, private information

Intervention: 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: communication or interpersonal contact between investigator and subject

Private information: 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.

Minimal risk: risks of harm anticipated in the proposed research that 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

Informed consent: the knowing, legally effective consent of any individual or the individual's legally authorized representative. Such consent can be obtained only under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.

Legally Authorized Representative: an individual or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the research procedure(s)

Institutional Review Board: the committee at Sacred Heart University given the authority to approve or disapprove research projects involving human subjects (45 CFR 46.102)