Is It Research? Is It Human Subjects Research?

Part of Human Subjects Protection for Clinical Research Staff: What Counts as Human Subjects Research.

About 5 minutes. Free, in your language, no account needed.

Why this matters

The first question for any project is whether it is research, and whether it involves human subjects as the regulations define them. Staff are often asked to "just pull some data" or "just add a few questions." Whether that is research is not a casual call.

The definitions below are the US Common Rule's (45 CFR 46.102), used as the worked example. Belmont's distinction between practice and research is an ethics principle, not a regulation. Outside the United States, follow your national law and ethics committee on what needs review.

Start with Belmont: practice versus research

Belmont separates two things. Practice means interventions designed solely to enhance the well-being of an individual patient or client, with a reasonable expectation of success. Research means an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby contribute to generalizable knowledge. For studies within the Common Rule's coverage, this boundary is where the question of review starts.

Step one: is it research?

The Common Rule (45 CFR 46.102(l)) defines research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Three words do the work: systematic, designed and generalizable. Whether results will be published is not what decides it. OHRP's training notes that much published work is not research under this definition, and some research is never published.

Activities deemed not to be research include:

Step two: does it involve a human subject?

A human subject (46.102(e)(1)) is a living individual about whom an investigator conducting research does one of two things:

  1. obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes them; or
  2. obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.

Key terms:

So a person can be a human subject without anyone touching them: identifiable private information is enough. The definition covers living individuals only. "Identifiable" here turns on whether the identity is or may readily be ascertained by the investigator, not on the HIPAA identifier list taught in Module 6.

Two more definitions you will hear

A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects on biomedical or behavioral health-related outcomes.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Both definitions come back in later lessons.

A simple way to sort a request

A CRLN habit, not a regulatory test: ask four questions in order.

  1. Is the activity a systematic investigation designed to contribute to generalizable knowledge?
  2. If yes, will the investigator obtain information or biospecimens through intervention or interaction?
  3. Or will the investigator use identifiable private information or identifiable biospecimens?
  4. If you are unsure at any step, who at our institution makes this determination?

If the answer is anything but an obvious "no," pause and ask.

In practice

A physician asks a research nurse to collect blood pressure readings from every patient on a unit for six months, record them with initials and birth dates, and present the results at a conference. The nurse notices two signals: structured collection designed to draw conclusions beyond these patients, and identifiable information from care. The conference plan is not what makes it research, but it prompted the question. She writes to the IRB office, describes the plan and asks for a determination, and she does not start collecting until she hears back.

What this looks like when it goes wrong

A coordinator is told that a project is "just a chart review" and pulls records with names and diagnoses for a colleague who plans to publish. Nobody asks whether the project is research or whether the records are identifiable private information.

When the colleague submits an abstract, the conference asks whether an IRB was involved. It was not, and the records have already been used. The problem began with a casual label on a request that deserved a real question.

Key takeaways