Definitions & Common Terms

Common Terms/Concepts in Human Subjects Research

 

1. ADVERSE EVENT

Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (e.g., abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research (whether or not considered related to the subject’s participation in the research). Adverse events encompass both physical and psychological harms. They occur primarily in the context of biomedical research, although they may occur in the context of social and behavioral research.

2. DEBRIEFING:

Giving subjects previously undisclosed information about the research project following completion of their participation in research. (This usage, occurring within the behavioral sciences, departs from standard English, in which debriefing is obtaining rather than imparting information.)

3. DECEPTION:

Whenever information about an activity is deliberately withheld from subject participants. (In some research, fully informed consent may itself have injurious effects on the subject, or may invalidate the experiment, as in the use of placebos or double blind studies.) Studies involving deception always require full board review.

4. ENGAGED INSTITUTION:

An organization/institution is considered engaged in human research when its employees or agents, for the purposes of non-exempt research projects obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; (3) the informed consent of human subjects for the research; or (4) when the institution receives a direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by a subcontractor (i.e., employees or agents of another institution).

5. INVESTIGATOR (or PI, Principal Investigator):

The primary researcher who assumes the responsibility of the protection of human subjects. (When the PI is a master or doctoral student, the faculty adviser is ethically and legally responsible for all research activities.)

6. MINIMAL RISK:

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.

7. PERSONAL AND (POTENTIALLY) SENSITIVE:

Examples include, but are not limited to: information about sexual attitudes, preferences, practices; the use of alcohol, drugs, or other addictive products; information that could damage an individual’s financial standing, employability, or reputation within the community; information in a subject’s medical record that could lead to social stigmatization or discrimination; information about a subject’s psychological well-being or mental health; and/or other records, such as medical, academic, photographic, audio tapes, and videotapes. NOTE: According to Federal regulations, "sensitive" means that -- if disclosed and linked to the participant -- data could potentially cause economic, social, psychological, or other harm, or put the participant at risk for criminal or civil liability.