District Administrative Offices
 
IRB GLOSSARY

Glossary of commonly used IRB terminology

Beneficence
: The Belmont Report defines beneficence as an obligation to subjects that includes two aspects:
               1. do no harm
               2. minimize potential harm while maximizing benefit
(also see “Ethical principles”)

Ethical principles: Three basic ethical principles for research involving human subjects are outlined in The Belmont Report:
               1. Respect for persons
               2. Beneficence
               3. Justice

Exempt: Some research may be eligible for exemption from IRB review if it meets one or more criteria detailed in 45 CFR §46.101(b). Many studies that are conducted in educational settings, involving normal educational practices, may be deemed exempt. For example, research involving educational tests (cognitive, diagnostic, aptitude, or achievement), surveys, interviews or observations of public behavior where no individual subjects can be identified, directly or indirectly, may be exempt. Collection of data that is publicly available, such as that found on the website of the office of Institutional Research & Grants, also is exempt. However, only the IRB can make this determination.

Expedited: Some research may be reviewed by the IRB chairperson or designee (in the absence of the chairperson). Additional consultation with one or more IRB members or content experts may be sought without convening the full IRB. These research studies would involve no more than minimal risk to subjects.

Full review: Research that is neither exempt nor meets the criteria for expedited review must be reviewed by the full IRB. Research involving more risk than a subject might encounter in daily life or studies that focus on vulnerable populations must be reviewed by the full IRB. If the full IRB is called to meet in person, a majority of members must be present. At the discretion of the chairperson, the full IRB may be convened by telephone or video conference.

Human subject: “. . . a living individual about whom an investigator (whether professional or student) conducting research obtains
               1) Data through intervention or interaction with the individual, or
               2) Identifiable private information.” 45 CFR §102(f)

Justice: The Belmont Report defines justice as “fairness in distribution.” It also states that justice involves the question of, “Who ought to receive the benefits of research and bear its burdens?”
(also see “Ethical principles”)

Research: “. . . a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.” 45 CFR 46 §46.102(d)


Respect for persons: The Belmont Report defines respect for persons as incorporating two components:
               1. individuals are autonomous agents
               2. there must be special protections afforded to persons with diminished autonomy
(also see “Ethical principles”)

Vulnerable populations: The Office of Human Research Protections (OHRP) has identified classes of subjects who must be afforded special protections. These include, but are not limited to, children, prisoners, pregnant women, fetuses, and neonates. Research involving students or employees, often populations of convenience, also must be reviewed to ensure that there is no undue pressure to participate.

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