Glossary of Terms

Per 45 CFR 46.102(e)(1), research involves a human subject when the investigator obtains information or biospecimens about the person through intervention or interaction and uses, studies, or analyzes them.

This includes:

  • Opinions or experiences expressed interviews or surveys
  • Biological samples collected for health assessment
  • Any private information used in a way that links back to the individual

A condition in which the identity of research participants is entirely unknown and cannot be reasonably ascertained by anyone, including the investigators. No identifiers, including indirect ones, are collected or maintained that would all re-identification.

Refers to how sensitive information about research participants is collected, stored, and shared to protect their identity. While the researchers may know participant identities, they commit not to disclose this information outside of the study.

A conflict of interest exists when a researcher's personal, financial, or professional interests may compromise--or appear to compromise--their objectivity in conducting or reporting research. This includes roles or relationships that could bias study design, conduct, or outcomes. 

For more information regarding conflict of interest, please see the Research Integrity and Compliance Conflict of Interest page.

Refers to measures taken to safeguard research data against unauthorized access, loss, or disclosure. This includes appropriate file storage, encryption, and access controls, as well as adherence to policies such as FERPA, HIPAA, and institutional data stewardship standards.

Used by NIH and other federal sponsors when human subjects research is anticipated during the grant period, but specific plans are not finalized at the time of submission. IRB approval must be obtained before involving human subjects.

Per 45 CFR 46.104, certain types of human subjects research may be exempt from IRB review if they fall into one of eight categories (e.g., normal education practices, anonymous surveys, benign behavioral interventions). Exempt research must still be submitted to the IRB for a determination.

Research that poses no more than minimal risk and includes procedures listed in OHRP's expedited review categories. Per 45 CFR 46.110, it may be reviewed by the IRB Chair or designated reviewers, not the full committee. Local policy may impose additional requirements.

A federal law that protects student education records. It provides students (or parents, if minors) the right to access, amend, and control disclosure of their records. Researchers must obtain appropriate consent to access education records unless a FERPA exemption applies.

Please see FERPA in Research for additional information.

Required for research involving more than minimal risk or vulnerable populations not covered by exempt or expedited categories. FCR is conducted during a convened IRB meeting with a quorum and majority approval.

Knowledge intended to apply beyond the study sample or setting, such as through publication or informing policy or theory. It reflects an intent to contribute to a field of scholarly or scientific understanding.

Federal law that includes the Privacy Rule and Security Rule to protect individuals' health information. HIPAA applies to covered entities and sets conditions for access, use, and disclosure of Protected Health Information (PHI) in research.

Defined in 45 CFR 46.102(e)(1) as research involving a living individual about whom an investigator obtains (1) information or biospecimens through interaction/intervention or (2) identifiable private information or biospecimens for research purposes.

A biospecimen for which the identity of the subject is—or may readily be—ascertained by the investigator or is associated with the specimen. (45 CFR 46.102(e)(6))

A committee established under 45 CFR 46 to review and oversee research involving human subjects. The IRB ensures that research complies with ethical standards and regulatory requirements and protects participants' rights and welfare.

Defined under 45 CFR 46.102(e)(3) as communication or interpersonal contact between the investigator and the subject. Includes surveys, interviews, phone calls, emails, and virtual contact.

Per 45 CFR 46.102(e)(2), includes both physical procedures (e.g., blood draws) and manipulations of the subject or environment performed for research. Can include use of devices, administration of substances, or behavioral tasks.

A data set that excludes direct identifiers but may contain certain indirect identifiers (e.g., dates, city, ZIP code). Use of a limited data set requires a data use agreement per HIPAA regulations but does not require individual authorization.

Defined by OHRP as individuals who are alive at the time data or biospecimens are obtained. Research involving decedents may not constitute human subjects research under 45 CFR 46.

Defined at 45 CFR 46.102(j) as the probability and magnitude of harm or discomfort anticipated in the research not being greater than those ordinarily encountered in daily life or during routine physical or psychological exams.

In the context of HSR (45 CFR 46.102(b)(1)), "obtain" means to acquire information or biospecimens through interaction/intervention or to access identifiable private information or identifiable biospecimens for research purposes.

Information that permits the identification of an individual either directly (e.g., name, SSN) or indirectly (e.g., combination of age, race, and location). The sensitivity of PII increases in small populations or when combined with other data.

Individually identifiable health information held or transmitted by a covered entity or its business associate. Includes demographic data, health status, services received, or payment for healthcare. Subject to HIPAA rules.

A detailed research plan submitted for IRB review, including study objectives, design, methodology, participant details, consent process, and data management plans. It provides the basis for IRB determinations.

All individuals responsible for design, conduct, or reporting of the research. Includes PIs, Co-PIs, and team members who interact with participants or access identifiable data. Must complete human subjects training prior to IRB approval.

Systematic activities intended to improve practice or processes in a specific setting. If not designed to contribute to generalizable knowledge, QI/QA may not constitute human subjects research. Intent and dissemination determine IRB requirements.

Per 45 CFR 46.102(l), a systematic investigation designed to develop or contribute to generalizable knowledge. Includes development, testing, and evaluation.

The IRB assesses whether risks are minimized, reasonable in relation to benefits, and equitably distributed. Adequate privacy/confidentiality protections and informed consent procedures are also required per 45 CFR 46.111.

A prospective plan incorporating data collection and analysis to answer a research question or test a hypothesis. Includes clinical studies, surveys, interviews, and observational research.

Groups that may be at increased risk of coercion or undue influence. Per 45 CFR 46 Subparts B-D, this includes pregnant women, prisoners, and children. Other groups may include individuals with impaired decision-making, economically disadvantaged, or socially marginalized individuals.