Human Participant Definitions

As defined by the Code of Federal Regulation 45 CFR 46.102
As defined by the U.S. Food and Drug Administration (FDA)

As defined by the Code of Federal Regulation 45 CFR 46.102

Department or Agency head means the head of any Federal Department or Agency and any other officer or employee of any Department or Agency to whom authority has been delegated.

Institution means any public or private entity or Agency (including Federal, State, and other agencies).

Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective participant to the participant's participation in the procedure(s) involved in the research.

Research means 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.

Research subject to regulation, and similar terms, are intended to encompass those research activities for which a Federal Department or Agency has specific responsibility for regulating as a research activity (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a Federal Department or Agency solely as part of the Department's or Agency's broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor).

Human participant means 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.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the participant or the participant's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and participant. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., identity of the participant is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human participants.

IRB means an Institutional Review Board established in accord with and for the purposes expressed in this policy.

IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Certification means the official notification by the institution to the supporting Department or Agency, in accordance with the requirements of this policy, that a research project or activity involving human participants has been reviewed and approved by an IRB in accordance with an approved assurance.

For further information, please see the Code of Federal Regulation 45 CFR 46.102.

As defined by the U.S. Food and Drug Administration (FDA)

"Research" under the Food and Drug Administration (FDA) regulations means any experiment that involves a test article and one or more human participants and that either is subject to requirements for prior submission to the FDA under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study and clinical investigation are deemed to be synonymous for purposes of the FDA regulations. In practice, all uses of drugs or medical devices constitute "research" under this definition unless the drug or device is both approved and being used in the course of medical practice. In addition, all uses of FDA-regulated test articles in which the results will be submitted to the FDA or held for inspection by the FDA constitute "research" under this definition.

"Human participant" under the FDA regulations means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A participant may be either a healthy human or a patient. For medical device studies in which data will be submitted to the FDA or held for inspection by the FDA, a human participant includes a human on whose specimen an investigational device is used.

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