IRB & Clinical Research Glossary

FDA regulations governing IRBs that review clinical investigations of products regulated by the FDA.

Any untoward medical occurrence in a research participant, whether or not considered related to the study intervention.

A child's affirmative agreement to participate in research; required in addition to parental permission when appropriate.

The 1979 report that articulated the three core ethical principles for human-subjects research: respect for persons, beneficence, and justice.

The federal policy for the protection of human subjects, codified at 45 CFR 46 and adopted by most federal departments and agencies.

Periodic re-review of an ongoing study by the IRB to confirm that risks remain minimized and protections remain adequate.

A company that provides clinical research services to sponsors on a contract basis, such as monitoring, data management, or regulatory submissions.

Human-subjects activities that meet one of eight exemption categories in 45 CFR 46.104 and are exempt from most IRB requirements.

A faster IRB review process used for minimal-risk research that fits into pre-approved categories under 45 CFR 46.110.

The U.S. agency that regulates drugs, biologics, and medical devices, including clinical investigations of these products.

An institution's written commitment to OHRP to comply with 45 CFR 46 for federally supported human-subjects research.

Review of a study at a convened meeting of the IRB, required for more-than-minimal-risk research.

An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human subjects.

A subject's signed permission to use or disclose their protected health information (PHI) for research under the HIPAA Privacy Rule.

The Institutional Organization (IORG) identifier OHRP assigns to the organization that operates one or more registered IRBs.

The process by which a prospective participant voluntarily confirms willingness to participate in a study after being informed of all aspects relevant to the decision.

An independent committee that reviews and approves human-subjects research to protect participants' rights, welfare, and well-being.

An FDA mechanism that allows an investigational medical device to be used in a clinical study to collect safety and effectiveness data.

An application submitted to FDA that allows an unapproved drug or biologic to be shipped and used in clinical investigations.

The probability and magnitude of harm or discomfort in a study are not greater than those ordinarily encountered in daily life or during routine examinations.

The HHS office that oversees compliance with 45 CFR 46 and provides guidance to IRBs and institutions.

The individual responsible for the conduct of a research study at a given site, including protection of subjects and regulatory compliance.

Any departure from the IRB-approved protocol, whether intentional or unintentional.

A formal agreement by which one institution cedes IRB review to another institution's IRB (the IRB of record).

An arrangement in which one IRB serves as the IRB of record for all participating sites in a multi-site study.

The person or entity that initiates a clinical investigation and takes responsibility for its conduct.

Groups of research subjects who require additional protections because they may have limited ability to give voluntary informed consent or be at increased risk.