IRB & Clinical Research Glossary

FDA regulations governing investigational new drug (IND) applications and the conduct of drug clinical investigations.

FDA regulations governing the protection of human subjects, including informed consent and additional safeguards for children.

FDA regulations requiring disclosure of clinical investigator financial interests in studies submitted to support FDA marketing applications.

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

FDA regulations governing investigational device exemption (IDE) studies of medical devices.

2016 U.S. law that, among many other provisions, authorized single-IRB review for cooperative research and expanded the use of real-world evidence.

Additional protections for pregnant women, human fetuses, and neonates involved in research.

Additional protections for biomedical and behavioral research involving prisoners as subjects.

Additional protections for children involved in research, including parental permission and assent requirements.

Voluntary accreditation by the Association for the Accreditation of Human Research Protection Programs, signaling that a research organization meets recognized human-protection standards.

A trial design that allows pre-planned modifications based on accumulating data, such as dose adjustment, sample size re-estimation, or dropping arms.

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

An IRB determination that a study is approvable contingent on specific changes the investigator must implement.

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

A secure, computer-generated, time-stamped electronic record that allows reconstruction of the events relating to the creation, modification, or deletion of an electronic record.

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

Human-subjects research training provided by the Collaborative Institutional Training Initiative; commonly required for investigators and study staff.

A printed, optical, or electronic document designed to record protocol-required information on each trial subject.

An IRB serving multiple unaffiliated sites or sponsors as a single review body, often used in industry-sponsored research.

The sponsor or CRO representative responsible for monitoring trial sites to verify compliance, data accuracy, and subject protection.

The site staff member responsible for day-to-day coordination of a clinical study under the PI's supervision.

A trial in which groups (clusters) such as clinics or communities are randomized to study arms rather than individual participants.

Threats or excessive incentives that could compromise a subject's voluntary decision to participate in research.

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

A financial, professional, or personal interest that could bias an investigator's or IRB member's judgment in conducting or reviewing research.

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.

A study in which each participant receives two or more interventions in sequence, with each participant serving as their own control.

The degree to which trial data are complete, consistent, accurate, and trustworthy throughout their lifecycle.

A question raised — usually by the sponsor, CRA, or EDC edit check — about apparent inconsistencies or missing data in the CRF.

A contract between a covered entity and a recipient governing the use and disclosure of a HIPAA limited data set for research.

An independent committee that monitors accumulating safety and efficacy data in an ongoing trial and can recommend modification, continuation, or termination.

The written plan describing how a study will monitor safety data, report adverse events, and act on safety signals.

A clinical trial that uses telemedicine, mobile/local providers, or digital tools to conduct some or all study activities at locations other than a traditional site.

Adults whose ability to give informed consent is compromised by acute or chronic conditions and who require additional protections.

An IRB action to postpone an approval decision until the investigator addresses substantive issues that cannot be resolved with minor modifications.

A site record documenting which study tasks the PI has delegated to which qualified staff members and the dates of those delegations.

The U.S. cabinet department under which OHRP and FDA operate; HHS issues the Common Rule at 45 CFR 46.

A formal IRB determination that a study cannot be approved as submitted; the investigator must be informed in writing of the reasons.

Software used to collect, manage, and store clinical trial data electronically.

The Belmont principle of justice applied to subject selection: research burdens and benefits must be fairly distributed.

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.

The Statement of Investigator that an investigator signs to commit to conduct an IND study according to FDA regulations.

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 federal rule governing the use and disclosure of protected health information (PHI) by covered entities, including for research.

The International Council for Harmonisation's Good Clinical Practice guideline, the global standard for ethical and scientific quality in clinical trials.

A sponsor report to FDA of serious, unexpected, suspected adverse reactions and certain other safety findings in an IND study.

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

The voting IRB member who presides over convened meetings and is often delegated authority to perform expedited review.

The official membership list of an IRB, identifying each member's role, qualifications, and representation requirements.

The IRB that has agreed to provide ethical review for a study or institution under a reliance arrangement.

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.

A compilation of clinical and non-clinical data on the investigational product that informs investigators of expected safety and efficacy.

An NIH process in which final IRB approval, human-subjects assurances, and certain other documents are submitted only after a grant is likely to be funded.

An individual authorized under applicable law to consent to participation in research on behalf of a prospective subject who cannot consent for themselves.

The relying institution's review of state and local laws, institutional policies, and community considerations that the central IRB cannot reasonably evaluate.

A contract governing the transfer of tangible research materials (biospecimens, reagents, cell lines) between organizations.

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.

An IRB member whose primary concerns are in non-scientific areas; required for quorum at convened board meetings.

An activity that does not meet the regulatory definition of research with human subjects, so no IRB oversight is required.

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

A study in which investigators observe outcomes without assigning interventions, including cohort, case-control, and cross-sectional designs.

An early-phase clinical study, usually first-in-human, that evaluates safety, tolerability, and pharmacokinetics in a small group of subjects.

A clinical study that evaluates efficacy signals and further characterizes safety in a target patient population.

A large, often pivotal study designed to confirm efficacy and safety for regulatory approval.

A post-marketing study conducted after regulatory approval to gather additional safety, effectiveness, or comparative data.

A trial designed to evaluate interventions under conditions close to routine clinical practice rather than tightly controlled efficacy settings.

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 study design in which participants are randomly assigned to an intervention or control arm to evaluate efficacy or effectiveness.

The process of obtaining renewed informed consent from already-enrolled subjects when significant new information would affect their willingness to continue.

Clinical evidence about the use, benefits, or risks of a medical product derived from analysis of real-world data sources such as EHRs and claims.

A prospective collection of data on participants with a particular disease, exposure, or treatment, often used for long-term outcomes research.

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

The Secretary's Advisory Committee on Human Research Protections, which advises HHS on the protection of human subjects.

Suspected Unexpected Serious Adverse Reaction — a serious adverse reaction whose nature or severity is not consistent with the reference safety information.

An adverse event that results in death, is life-threatening, requires hospitalization, causes persistent disability, or is otherwise medically important.

A material failure to follow regulations, IRB requirements, or the approved protocol that increases risk to subjects or affects their rights or welfare.

An abbreviated written consent statement, used with an oral presentation of the IRB-approved long form, often to consent non-English-speaking participants.

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

A clinical study in which all participants receive the same intervention, without a comparison group.

Original records of clinical findings, observations, and other activities in a trial, used for reconstructing and evaluating the trial.

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

The document that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial.

The physical or virtual location where a clinical investigation is conducted under the direction of a principal investigator.

Any individual member of the study team designated by and supervised by the PI to perform critical trial-related procedures.

An IRB action that halts some or all study activities, typically due to unexpected risk or serious or continuing non-compliance.

An IRB member with no other ties to the institution operating the IRB, intended to bring an independent community perspective.

Any incident, experience, or outcome that is unexpected, related or possibly related to participation, and suggests greater risk of harm than was previously known.

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

An IRB determination that the requirement for a signed written consent form may be waived, while the consent process itself still takes place.

An IRB determination that informed consent is not required for the research because all four regulatory criteria are met.