IRB Definitions

anonymity
confidentiality
data collection
deception
human subject
human subject at risk
informed consent
interaction
intervention
minimal risk
private information
scholarly research
survey methodology
treatment/stimulus

Anonymity: The investigator(s) cannot associate the identity of a particular subject with her/his responses.

Confidentiality: The investigator(s) will not make unauthorized disclosure of identifying information and/or data that have been obtained from a respondent.

Data collection: Any research procedure, instrument, or device that is intended to elicit from or record the actions, reactions, attitudes, and/or other behavioral manifestations of subjects in conjunction with a research project.

Deception: In research, means that the subject/respondent, at the time of the data collection, is not fully informed of the nature and purpose of the research in which she/he is involved so as to prevent potentially biased reporting of data/information.

Human subject: A living individual about whom an investigator (whether professional or student) conducting research obtains:

Data through intervention or inteMay 31, 2007 Identifiable private information

Human subject at risk: Any individual who may be exposed to the possibility of injury including economic, legal, physical, psychological, or social injury as a consequence of participation as a subject in any research project or related activity that departs from the application of those established and accepted methods necessary to meet the person’s needs or that increase the ordinary risks of daily life, including the recognized risks inherent in a chosen occupation or field of service. Individuals who have received routine acceptable educational, medical, nursing, psychological, or social services that were in effect prior to the initiation of the research project in question are not considered human subjects at risk.

Informed consent: The voluntary, knowing consent of an individual or her/his legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion.

Interaction: Communication or interpersonal contact between investigator and subject.

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.

Minimal risk: 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 examination or tests.

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 stated or may readily be ascertained by the investigator or is associated with the information) in order to obtain the information to constitute research involving human subjects.

Scholarly research: Any activity generally associated with the acquisition and/or development of knowledge. It is assumed that any research data collected through scholarly research efforts is intended for presentation at professional meetings and/or possible publication. All master’s theses are considered to fall into the category of scholarly research.

Survey methodology: Includes, but is not limited to, mail questionnaires, telephone interviews, personal interviews, and group questionnaires that seek to collect data from any population or sample of individuals.

Treatment/stimulus: Any agent or technique that directly influences the attitudes, behavior, or body organism of the human subject.