IRB 101: What is (and isn’t) human subjects research?

In my first post in this IRB 101 series, I described what IRBs are and why they exist (i.e., to protect research participants). In the second post, I focused on describing potential risks to research participants.  This third post defines criteria for human subjects research by breaking down the term “human subjects research.”

Who are human subjects?

The Common Rule, which provides guidelines for research and evaluation, defines a human subject as “a living individual about whom an investigator (whether professional or student) conducting research:

  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable

In layman’s terms, human subjects are living individuals who are participating in a research study.  The more complicated part of this definition, the bulleted items, actually deals with defining “research” with human subjects.

What is research?

Generally, research is defined as a systematic investigation or study.  The bullets in the Common Rule definition above break down specifically what is human subjects research.  The first bullet focuses on the conditions in which data is collected, while the second bullet focuses on whether the data is identifiable.

Data Collection Conditions

The first bullet in the definition contains two technical research terms: (1) intervention; and (2) interaction. Interventions are any manipulation of the research participant or their environment for research purposes.  Interventions happen when you are setting up an experiment.  For example, a researcher wants to investigate whether visitors prefer an exhibition space with low light versus bright light.  They study research participants in both light conditions.  Interactions involve the researcher or another person communicating with a person for purposes of research (experimental or otherwise).  Interactions can include interviewing visitors about their experience in an exhibition, sending an email survey to members about their satisfaction with the museum and member benefits, or focus groups to explore non-visitors’ perceptions of a museum.  From my experience, visitor studies research typically involves interactions, but less often interventions.

Identifiable Data

The second bullet focuses on identifiable information.  Identifiable means the researcher can identify the research participant, so the data is not anonymous.  Information is clearly identifiable if it is linked to a person’s name, email address, social security number, etc.  Information may also be identifiable if the researcher can discern the identity of a person based on research conditions.  For example, if you are interviewing participants in a teacher cohort that is small and has worked closely with museum education staff for a long period of time, it would be easy to identify research participants based on their feedback.  Please note that this bullet specifically about whether you collect and study identifiable data.  You may opt to keep the identifiable information confidential by not reporting names or other identifiable information, but you are still conducting human subjects research if the data is identifiable to the researcher.

What is not human subjects research? 

There are a few activities similar to research that are not considered human subjects research.  For example, journalistic activities are not human subjects research.  So, if your institution wants to publish a personal interest story about a staff member, it is not human subjects research.  In this scenario, you are beholden to ethical guidelines for journalistic activities but not human subjects research.

Why does this all matter?

If you are doing human subjects research, you need to consider whether IRB is required.  There are some exceptions as to whether human subjects research requires IRB, which I will describe in my next post.  However, determining whether you are conducting human subjects research is the first step in determining whether you need IRB review.

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