The difference between a “patient” and a “subject”

You may have gotten an IRB contingency asking you to change the word “patient” to “subject” in an informed consent form. Is the IRB just being picky here? After all, a clinician may both see someone as a patient and also be an investigator on a study that person is considering joining. So what’s the big deal about using “patient” or “subject”?

There’s a pretty important difference between the two terms, in fact.  When a person is a “patient,” the goal of the their care is to improve their health, and the care will be individualized to their particular case. Enroll them in a study, however, and they become a “subject.” The care they receive is designed to create information. Instead of being tailored to the subject’s individual case, all subjects on the study will receive the treatment as spelled out in the protocol, and providing individualized care is not the goal. The goal is to create data that can later be analyzed.   An investigator’s primary interest is not improving that particular person’s health. Instead, the investigator wants to collect data from this and many other subjects’ care to prove/disprove a hypothesis. So the words “patient” and “subject” are not interchangeable, even when they are referring to the same person.

This can get confusing in a few situations, such as when the treating physician is also a research investigator. The clinical/investigator may be seeing the person as both a patient and a subject. And when you do get that contingency to change “patient” to “subject” in a consent form, don’t just use the search-and-replace function to change all instances of “patient,” because sometimes “patient” is the right term to use. For example, you screen your patients to find out if they are eligible to become subjects on your study. And while it is unknown if a particularly study regimen will help that individual subject, we hope that what we learn from the research will help future patients (not future subjects).

And one more thing — sometimes we hear doctors say that they want to make research available in their practice because they think the research will help their patients. We at the IRB wince a little inside when we hear this. The whole point of research is to find out if something works. If we already knew it would be beneficial, we would just make it routinely available instead of doing research on it. So, when discussing the possibility of joining a study with a patient, please be careful to remember that once enrolled, the person will be a subject upon whom something new is being tested with outcomes unknown, and not a patient upon which a known therapy will be used.