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 to ask is if your project involves human subjects:
Human Subject means a living individual about whom the investigator conducting research obtains (a) data through intervention or interaction with the individual or (b) identifiable private information (45 CFR 46.102F). 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.
The second question is if your project is actually research as defined by the common rule:
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities meeting 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 (45 CFR 46.102d).
For more information see the Office for Human Research Protections.
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 ORS please review our FAQs addressing past determinations of what is human subjects research and our UT IRB Policies and Procedures manual.
Exempt categories Listing (exempt studies must be submitted for review)
