IRB Glossary of Terms

Anonymity – Subjects are not identifiable to anyone, including the researcher.

Benign behavioral interventions – are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the researcher has no reason to think the subjects will find the interventions offensive or embarrassing.

Children (Minors) – 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.

Confidentiality – The treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission. This may apply to either a research subject or some subset of information about the person who is a research subject. If confidentiality is promised to research subjects, they are identifiable to the researcher, but the researcher promises not to identify them publicly.

Consent Form – A letter to subjects outlining the elements of consent used to inform subjects about the research and explain exactly what their participation, if they choose to participate, consists of. A consent form contains contact information of the investigator and is signed by the subject.

Debriefing – Subjects receive previously undisclosed information about the research project following completion of their participation in the research.

Deception by omission – An important aspect of the research is withheld from the subject.

Deception by commission – The subject is misled about the true purpose of the research.

Human subject – means a living individual about whom an investigator conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.

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. Informed consent must be sought under circumstances that minimize the possibility of coercion of undue influence and must include the eight basic information elements described in the regulations (see below). Information must be presented in language understandable to the subject or the subject’s legally authorized representative.

Intervention – includes both physical procedures by which information or biospecimens are gathered 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.

Minimal Risk – means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Principal Investigator – The scientist or scholar with primary responsibility for the design and conduct of a research project.

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.

Research – means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Risk – The probability that physical, financial, emotional, and/or psychological harm may occur. In IRB review, probability and severity of possible pain or discomfort should be included in the concept of risk.

Subjects – Individuals whose physiological or behavioral characteristics and responses are the object of study in a research project. Human subjects are defined as living human beings.

Voluntary – Free of coercion, duress or undue inducement; used in research context to refer to a subject’s decision to participate (or continue to participate in a research activity).