WHEN DO THE FDA REGULATIONS APPLY?
The FDA regulates research that involves food, dietary supplements, drugs, medical devices as well as electronic products to ensure that the data collected from these investigations was done so in an ethical, compliant, and sound manner before any product developed from the research is marketed and readily available to anyone.
HOW DOES THE FDA DEFINE RESEARCH?
FDA uses the term “Clinical Investigation” instead of “research”. This is different than the standard human subject regulations, also known as the Common Rule. A Clinical Investigation involves any experiment that involves a test article and one or more human subjects.
TEST ARTICLE? WHAT’S THAT?
Very simply put, a test article is the “thing” under investigation. This might be a drug, device, or health app, for example. The defining factor is the reason behind why you are doing the research - Is the intent of your investigation to develop a thing that will “cure, treat, mitigate, diagnose, or prevent disease in humans?” If so, then the FDA regulations will most likely apply to your research.
NOT YOUR TYPICAL HUMAN SUBJECT...
Our standard human subject regulations define a human subject as a person that the researcher interacts or intervenes with. A human subject can also be private, identifiable data from a living person.
FDA regulations do not define a human subject in the same way. According to the FDA, a human subject is “an individual who is or becomes a participant in research, either as a recipient of a test article or control. A subject may be either a healthy human or a patient.” Notice that there is no mention of intervention or interaction or identifiable data, for that matter. That is because the FDA definition of a human subject is much more broad.
For example, if you are using non-identifiable human blood to test a new diagnostic assay or test, that is a human subject according to the FDA.
THINGS TO THINK ABOUT…
- Is the intent of your research to develop a “thing” (for example, a drug, device, or biologic) that will cure, treat, mitigate, diagnose, or prevent disease in humans?
- Will you be using people – either in person or something that came from a human, whether it is identifiable or not?
- Do you plan on submitting data to the FDA at some time in the future?
WHAT TO DO NEXT...
The FDA regulations are quite complex and this is merely a simple overview to determine whether these regulations might apply to your research. The FDA regulations also differ whether your research involves a drug, biologic, or device.
THE HUA IRB office is here to help with any question that you may have. Don’t hesitate to give us a call, email, or just stop by!
Additional Resources
You can also check out the following documents in the ESTR Library:
- HUA Investigator Manual
- HRP-306—WORKSHEET—DRUGS
- HRP-307-WORKSHEET-DEVICES
- HRP-310-WORKSHEET-HUMAN RESEARCH