6-IRB

Institutional Review Board (IRB)

A committee responsible for the review and oversight of human subject research.

Federal Regulations (46 CFR 46.111 and 21 CFR 56)

Guidelines that IRBs follow in their review of research involving human subjects.

Conflict of Interest (COI)

A situation in which a researcher may have competing interests that could affect the integrity of the research.

Belmont Principles

Ethical guidelines that include respect for persons, beneficence, and justice in research involving human subjects.

Human Research Protection Program

A system that encompasses the role of IRBs in safeguarding the rights and welfare of human research subjects.

Informed Consent

A process through which research subjects are fully informed about the research and voluntarily agree to participate.

Expedited Review

A type of IRB review process for research with no more than minimal risk, which can be reviewed by the chairperson or an experienced reviewer.

Full Committee Review

A comprehensive IRB review process that involves the entire committee assessing the research proposal.

Vulnerable Subjects

Individuals who may be at a greater risk of coercion or undue influence and require additional protection in research.

Systematic Investigation

A planned and structured approach to gather data for research purposes, aiming to contribute to generalizable knowledge.