Human Subject Research Determination
Determination of Human Subject Research as an Agent of UVa
It is the responsibility of each investigator to seek IRB review and approval prior to initiation of any research involving human subjects or before conducting any clinical investigation.
The investigator is responsible for making a preliminary decision regarding whether his/her activities meet either (a) the Department of Health and Human Services (DHHS) definitions of both “research” and “human subjects” and/or (b) the FDA definitions of both "clinical investigations" and "human subjects." The Determination of UVa Agent Form and the Determination of Human Subjects Research Form are available to guide the investigator in making this decision.
The investigator may contact IRB-HSR staff or IRB Chair/Vice Chairs for advice on the applicability of the federal regulations and UVa policies.
If the research is not being done as an agent of UVa, the researcher must submit the completed Determination of UVa Agent Form to the IRB-HSR. The IRB-HSR will return the determination to the researcher in writing.
In cases where it is not clear whether the study requires IRB-HSR review, the researcher should submit either the Determination of Human Subjects Research Form to the IRB-HSR. The Director or IRB Chair or their designees make the final determination whether the activities meet the federal definitions using, as a guide, the documents, Determination of Human Subjects Research Form and applicable federal guidance, policy or regulation. The IRB-HSR may require the investigator to contact the applicable regulatory agency to assist in making the determination. The IRB-HSR will return the determination to the researcher in writing.
For more information regarding the types of projects that include research with human subjects as conducted by an agent of UVa see the IRB-HSR Learning Shot: SOM Salient Issue: When do you need IRB review?
Department of Health and Human Services (DHHS)/Common Rule
Research: A systematic investigation designed to develop or contribute to generalizable knowledge [45CFR 46.102(d)]. Activities which meet this definition constitute research, 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. Some research development or testing and evaluation may also meet this definition.
Human subjects (DHHS): A living individual about whom an investigator 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 subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
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., the identity of the subject 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 subjects.
Food and Drug Administration (FDA)
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 the FDA (involves drugs or medical devices other than the use of FDA approved drugs or medical devices in the course of medical practice), or results are intended to be part of an application for research or a marketing permit.
If the activities involve use of an FDA regulated test article (i.e., drug, device, food substance, or biologic under the purview of the FDA), UK applies the FDA definitions of “human subjects.”
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 56.102(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 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). This definition includes the use of tissue specimens even if they are unidentified.
If the research involves any of the following, FDA regulations 21 CFR 50 & 56 apply and require IRB approval prior to implementation:
- Any use of a drug in research other than the use of an FDA approved drug in the course of medical practice;
- Any use of a medical device in studies where the purpose is to determine the safety or effectiveness of the device; or
- Data will be submitted to or held for inspection by FDA as part of a marketing permit.
The definition of human subject typically means only “living individuals”; however, at UVa, research involving fetal tissue or newborn blood spots requires IRB review. Other exceptions involving collection of human specimens in FDA regulated device research may apply- see FDA definition of Human Subject above.