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Definitions

Anonymity: The investigator(s) cannot associate the identity of a particular subject with any collected data.

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 that uses instruments, devices, or observations to record the actions, reactions, attitudes, and/or other behavioral manifestations of subjects during a research project.

Deception: In research, this means that the subject/respondent is not fully informed of the nature and purpose of the research at the time of the data collection in order to prevent biased behaviors or responses from the subject/respondent.

Human subject: a living individual about whom an investigator obtains data through interaction or identifiable private information.

Human subject at risk: Any individual who may be exposed to the possibility of economic, legal, physical, psychological, or social injury as a consequence of participating as a subject in a 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 and 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: A subject’s voluntary agreement to participate in research based upon the subjects adequate understanding of the research. The researcher must ensure that the person receives enough information to clearly understand any and all implications of participation. There are specific requirements for adequate informed consent.

Interaction: Communication or interpersonal contact between investigator and subject.

Intervention: Procedure during the experiment in which a treatment or manipulation of the environment occurs to elicit a change in behavior or physiological functioning.

Minimal risk: The probability and magnitude of harm or discomfort anticipated in the research is not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.

Private information: Any data that can reveal an individual’s identity or describe their behaviors or answers given during an experiment. In most daily situations, an individual expects that their behavior is not being observed or recorded (for example, at a park or in a restroom). Private information also includes information that is provided for a specific purpose (for example, medical care or social services).

Research: a systematic investigation designed to contribute to generalizable knowledge.

Risk: The probability that harm (including physical, psychological, social, legal, or economic) will occur as a result of participating in a research study.

Survey methodology: Includes, but is not limited to, mail and web-based 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 physiological processes of the human subject.

Sensitive, vulnerable, or protected populations: Includes minors (except as allowed under expedited review), prisoners, fetuses, cognitively disabled, test subjects for new drugs or clinical devices, pregnant women, legally incompetent persons. For more information, see the HHS Vulnerable Populations page.

Next: Guidelines for Using Deception

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