Clinical Investigation: “Involves use of a test article (i.e., drug, device, food substance or biologic), one or more human subjects, meets requirements for prior submission to FDA (involves drugs or medical devices other than the use of FDA-approved drugs or medical devices in the course of the medical practice), or results are intended to be part of an application for a research or marketing permit” [21 CFR 56.102(c)]
Human Subjects (FDA): “An individual who is or becomes a participant in research, either as a recipient of a test article or as a control or as an individual on whose specimen a device is used. A subject may be either a healthy individual or a patient” [21 CFR
(e)] (Drug, Food, Biologic)
Human Subjects (FDA for medical devices): “A human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or who participates as a control. A subject may be in normal health or may have a medical condition or disease” [21 CFR 812.3(p)] (Medical Devices)
In cases in which VA regulations or those of any other federal agency apply, institutional oversight of the activity follows the definitions for “research” and “human subjects” as defined by VA regulations [VA Handbook 1200.05] or the relevant agency as appropriate.
For Department of Defense-supported research, institutional oversight of the activity follows the definitions of “research” and “experimental subject” as defined by Department of Defense regulations [DoD Directive 3216.02].
The term research encompasses basic and applied investigations such as bench work, clinical research, other work and product development, and other forms of creative activity. Research involving human subjects typically applies to behavioral and social sciences research including surveys, interviews, observations, and studies of existing records; clinical trials; epidemiological research, including surveillance, monitoring, and reporting programs; pilot studies; thesis and dissertation research involving human subjects; repository research, tissue banking, and databases from individually identifiable living persons; and human genetic research. In addition, certain quality assurance or quality improvement activities designed to measure the effectiveness of programs or services may constitute human research. Human subjects typically covered by the UK HRPP include the following categories: normal volunteers, patients, students, employees, children, non-English speaking or non-native volunteers, pregnant women, prisoners, and individuals with limited decision-making or impaired consent capacity, including those who are institutionalized.
The IRB or the Office of Research Integrity (ORI) determines whether an activity meets the pertinent definitions and, thus, is subject to the HRPP. In the case of class projects involving data collection from human subjects, the instructor is responsible for making the decision on whether the activity is subject to the HRPP and is encouraged to contact ORI for assistance in making this determination.
Investigators/researchers may not determine whether research to be conducted is exempt from the federal regulations, including IRB review. The ORI is responsible for communicating written policies and procedures for the University community to follow in determining whether activities need IRB review or are exempt from review.