What is Human Subjects Research
It can be very difficult to determine what constitutes human subjects research. Unfortunately, there is no clear line in the sand. 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 in hopes of capturing both the biomedical and humanities spectrums. These definitions are the starting point for anyone attempting to determine whether their research requires IRB review.
The first question is if your project is actually research as defined by the common rule:
“Research” as defined by DHHS is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
“Research” as defined by FDA is means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration 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 Food and Drug Administration 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)]
The second question to ask is if your project involves human subjects:
A human subject is defined by DHHS as a living individual about whom a research investigator (whether a professional or a student) 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).
If the answer to both questions is yes, then you need IRB approval to conduct research. Otherwise you need to ask these 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 you will need IRB approval to proceed.
In making such a determination it is best to consult your faculty supervisor or advisor, DRC, department head, or consult our office. However, before contacting RSC, review our FAQs addressing past determinations of what is human subjects research and our UT IRB Policies and Procedures manual.
- Examples of Activities that May or May Not be Human Subjects Research
- Exempt categories Listing (exempt studies must be submitted for review)
- Expedited categories List
- Human Subject Regulations Decision Charts (PDF)