Human Subject Agreements
Determining what constitutes human subjects research can be difficult, and unfortunately, there is no definitive description for this type of research. The Common Rule offers the following definitions as guidance for determining human subjects research. The definitions are intentionally broad to include a wide range of research for capturing both the biomedical and humanities spectrums. Use these definitions as a starting point for determining whether a research project requires review by the Institutional Review Board (IRB).
Question 1: Is the project actually research as defined by the common rule?
“Research” as defined by the Department of Health and Human Services is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
“Research” as defined by the Food and Drug Administration (FDA) means any experiment that involves a test article and one or more human subjects, and either a) meet the requirements for prior submission to the FDA under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or b) need not meet the requirements for prior submission to the FDA under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted 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 synonymous for purposes of FDA regulations. [21 CFR 50.3(c), 21 CFR 56.102(c)]
- “Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act” means any use of a drug other than the use of an approved drug in the course of medical practice. [21 CFR 312.3(b)]
- “Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act” means any activity that evaluates the safety or effectiveness of a device. [21 CFR 812.2(a)]
Question 2: Does the project involve human subjects?
A human subject is defined by DHHS as a living individual about whom a research investigator obtains data through intervention or interaction with the individual or from individually identifiable information.
- “Intervention” as defined by DHHS regulations means 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. [45 CFR 46.102(f)]
- “Interaction” as defined by DHHS regulations means communication or interpersonal contact between investigator and subject. [45 CFR 46.102(f)]
- “Private information” as defined by DHHS regulations means 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). [45 CFR 46.102(f)]
- “Identifiable information” as defined by DHHS means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).
Additional information can be obtained from the Office of Research Support and Compliance (RSC). If the answer to both questions is yes, then IRB approval is required to conduct research. Otherwise, ask these additional questions:
- Does the activity involve the use of a drug (including an approved drug or an over-the-counter drug), other than the use of an approved drug in the course of medical practice?
- Does the activity involve the use of a medical device (including an approved medical device), other than the use of an approved medical device in the course of medical practice? (Note that medical devices generally include devices intended for the use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals, and devices intended to affect the structure or any function of the body of humans or other animals.)
- Will data be submitted to the FDA or held for their inspection?
If the answer to one of the above questions is “yes,” then IRB approval is needed to proceed.
In making such a determination it is best to consult a faculty supervisor or advisor, DRC, department head, or consult RSC. However, before contacting RSC, review its list of FAQs addressing past determinations of what is human subjects research and UT IRB Policies and Procedures manual.
For more information on human subjects research, visit the RSC website.