Institutional Review Board

IRB Definitions

Anonymity means that the identity of a subject is not identifiable with his or her responses.

Assent is an agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.

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.

Continuing Review is applicable if data gathering continues for more than twelve months, federal regulations require that the project be subject to a “continuing review.”

Data Collection refers to any research procedure that is intended to elicit from or record the actions, reactions, attitudes, and/or behavioral manifestations of subjects participating in a research project.

Debriefing gives subjects previously undisclosed information about the research project following completion of their participation in research.

Exempt Review means a research proposal where the subjects are at no more than minimal risk, the subjects' confidentiality is maintained, and the proposal meets one of the six criteria for exemption.

Expedited Review means a review by a subcommittee of the IRB for research that involves no more than minimal risk, or to review minor revisions in previously approved research, or review revisions for proposals that were approved with contingencies.

Full Review means a review of proposals by the entire IRB. This will be conducted for research that involves greater than minimal risk, or the research is of a psychologically sensitive nature.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data or private information. (45 CFR 46.102)

Informed consent means subjects' willingness to participate after the researcher communicates to subjects, in language they can understand, information that the subjects may reasonably be expected to desire in considering whether or not to participate, and that minimizes the possibility of coercion or undue influence.

Institutional Review Board is the 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.

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. (45 CFR 46.102)

Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.

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

Privacy is the control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

Protocol is the formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR 46.102)

Risk means the extent to which a human, subject to research procedures, may be exposed to physical, psychological, or other types of harm.

Voluntary refers to a subject's decision to participate (or to continue to participate) in a research activity.

Vulnerable Populations refers to subjects such as children, prisoners, pregnant women, persons with disabilities, economically or educationally disadvantaged persons, or any other population that may be relatively or absolutely incapable or protecting their interests through the informed consent process.