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Human Subjects: Definitions and Resources

Refer to this page for definitions and additional resources related to payments to human subjects.

Clinical Trial: Any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of 21 CFR 58, regarding nonclinical laboratory studies. The terms clinical study, clinical trial, and clinical investigation are deemed to be synonymous for purposes of this Manual.

Confidentiality: Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity (ICH 1.16).

Conflict of Interest: A convergence of an investigator's private interests with his or her research interests, such that an independent observer might reasonably question whether the investigator's professional actions or decisions are improperly influenced by considerations of personal financial gain.

Human Research Protection Program (HRPP): The department which serves as the administrative home for the Institutional Review Board (IRB).

Human subject: As defined by DHHS regulations 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. [45 CFR 46.102(f)]. As defined by FDA regulations, “human subject” means an individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient [21 CFR 50.3(g), 21 CFR 56.102(e)]. A human subject includes an individual on whose specimen a medical device is used [21 CFR 812.3(p)].

Institutional Review Board (IRB): Research at UCSD using a human subject must be approved by the Institutional Review Board (IRB. ) which is an independent committee that protects the rights and well-being of research subjects. As part of the protocol and informed consent process, the IRB reviews all aspects of compensation and reimbursement made to a human subject including amount, proposed distribution method, timing, and if a human subject is either a UCSD student or employee.

IRB approval: The determination of the IRB that the human subjects 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.

Investigator:  An individual who actually conducts human subjects research, i.e., under whose immediate direction the test article or research procedure is administered or performed upon, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team (21 CFR).

Participants: Participants" are often confused with "human subjects." "Participants" are people who are taking part in sponsor-defined training or sponsor-supported conferences, who are eligible to receive expense reimbursement under the terms of the sponsored project agreement. Participants cannot be paid for their participation in these events, but can be reimbursed for legitimate and justifiable expenses.

Protocol: Plan of Study approved by IRB.

Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized 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.

Sponsored Project: For purposes of this policy, an externally funded activity governed by specific terms and conditions. Sponsored projects must be separately budgeted and accounted for subject to terms of the sponsoring organization. Sponsored projects may include grants, contracts, and cooperative agreements for research, training, and other public service activities.

HRPP Guidelines

HRPP Contacts

Health Sciences Research Polices, Compliance & Ethics