Glossary

Anonymity: Subjects are not identifiable to anyone, including the researcher. “Anonymity” and “confidentiality” do not have the same meaning and are not interchangeable.

Board review: Review of proposed research at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in nonscientific areas. All applications that are not granted exempt or expedited status must receive board review.

Children/Minors (under 18 years old): 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: Pertains to 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 without permission in ways that are inconsistent with the understanding of the original disclosure. If confidentiality is promised to research subjects, they are identifiable to the researcher, but the researcher promises not to identify them publicly. "Confidentiality" and "anonymity" do not have the same meaning and are not interchangeable.

Consent: See informed consent.

Exempt: Only the IRB can determine if a study is exempt. Certain types of research may qualify for exemption according to federal regulations contained in 45CFR46. Once the IRB determines that a study is exempt, informed consent is not required. All applications that are not granted exempt status must receive expedited review or board review.

Expedited review: Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.

Full board review: Full board review of proposed research is conducted at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in nonscientific areas. All proposals that are not granted exempt or expedited review and all projects which involve “vulnerable groups” (i.e., children/minors, institutionalized people, pregnant women, cognitively impaired individuals) require a full board review. Other projects that may involve more than minimal risk (e.g., sensitive questions, unusual interventions) to the subject also must have full board review.

Human research participant: See Human Subject.

Human subject: Means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Informed consent: A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence.

Informed consent form: A letter to subjects outlining the elements of consent, informing them about the research and explaining exactly what their participation, if they choose to participate, consists of. A consent form contains investigator contact information and is signed by the subject.

Institutional Review Board (IRB): A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.

Intervention: Includes both physical procedures by which data 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: 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.

Remuneration: Payment for participation in research.

Risk: The probability of harm or injury (physical, psychological, social or economic) occurring as a result of participation in a research study. In IRB review, probability and severity of possible pain or discomfort should be included in the concept of risk.

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

Vulnerable populations: Pregnant women, human fetuses, neonates of uncertain viability, or nonviable neonates, pregnant animals, institutionalized persons and minors (children under the age of 18 years old).