Once Upon a Time, There Was a Human Research Subject . . . or Was There?

Human subjects research plays an important role in many of the medical and social advancements we enjoy today, but as a result of the horrifying and unethical experiments of the past (e.g., Nazi experiments, Tuskegee Syphilis study, Willowbrook State School experiments) human subjects research is now highly regulated and closely monitored.  Federal regulations require that research involving human subjects be prospectively reviewed and approved by an Institutional Review Board (IRB) before ANY research activities take place.  Failure to do so can have serious consequences including, but not limited to: disciplinary action, notification to participants, inability to publish, notification to federal agencies/funding agencies, and restriction or revocation of funding for the specific project, and in especially egregious cases, an entire organization.  So it’s important to understand whether a research project qualifies as human subjects research.

Consider this: a student plans to study the wedding customs of a remote Mexican village by interviewing local people about their values and practices around marriage, attending local weddings, and taking pictures of the ceremonies.  All the information will be presented in a final scholarly paper.

Does this qualify as human subjects research? 

While this may seem like a straightforward question, what constitutes human subjects research is complicated. The regulatory definitions provide a framework to begin the assessment, but they aren’t always helpful when addressing real-life scenarios like the one above.

What qualifies as human subjects research?

For this article, we will focus on the federal regulations known as the Common Rule.  The Common Rule applies to all federally funded human subjects research (excluding FDA-regulated research).  The federal Office for Human Research Protections (OHRP) enforces the Common Rule.

To determine whether an activity is human subjects research under the Common Rule, you must answer the following questions:

  1. Is the activity research?
  2. If yes, does the activity involve human subjects?
  3. If yes to both of the above, does the activity fall under one of the categories of Exempt research? Exempt research categories are described at 45 CFR 46.104 and will be discussed in future blog posts.

Of course, we must first understand how the Common Rule defines “research” and “human subjects.”

Research

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

When analyzing whether the activity in question meets this definition, it is important to consider whether the project involves a hypothesis and a detailed plan to verify that hypothesis. In other words, if the investigator will analyze the data they collect and use it  to draw new conclusions that will be applied broadly to other scenarios then the activity is likely research.  Additionally, if the findings will be published or presented this is a good indication that the activity may be research

 Human Subject  

Human subject is defined in the Common Rule as “a living individual about whom an investigator (whether professional or student) conducting research:

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

45 CFR 46.102(e)(1)

Importantly, a human subject isn’t just a living individual; it is any identifiable information about a living individual.  This includes activities that use physical procedures to gather information or biospecimens.

Let’s go back to our example.

If you haven’t already guessed, I was the student in the scenario above.  As described already, I went to the village and somehow finagled an invite to 3 upcoming weddings.  I interviewed the participants, took pictures, ate some of the best turkey mole I’ve ever had, and may or may not have indulged in questionable amounts of tequila.  Then, I wrote a 63-page paper describing the customs, ceremonies, and values of this unique group of people.

At the time, I had no idea what human subjects research was or that Institutional Review Boards (IRBs) even existed.

Fortunately for me, my Mexican wedding customs study was not human subjects research.

Why not?  I clearly interacted with living individuals and obtained a large amount of identifiable data, so my activities involved human participants.

However, my activity did not meet the definition of research under the regulations.  I was collecting data about existing customs and summarizing the information.  I wasn’t conducting a systematic investigation.  I wasn’t testing a hypothesis or answering a question that could develop or contribute to generalizable knowledge.  I was doing this so I could graduate college.

Below are other examples that can serve as a guide for what is and is not human subjects research.

Common examples of human subjects research:

  • Trials that use living individuals to test new drugs, devices, or products
  • Projects that collect bodily materials such as blood, urine, or hair that are linked to any kind of identifiable information
  • Identifiable data obtained from medical records, surveys, and observations

Common examples that are generally NOT human subjects research[1]:

  • Case studies (specific facts/circumstances around one or two individuals, often in a medical care setting, used as examples for training or educational purposes)
  • Quality Assurance/Quality Improvement activities
  • Data from deceased individuals, even if it is identifiable[2]
  • Biographies or oral histories
  • Service surveys (e.g., surveys issued after a training session for the purpose of improving the program)

If the activity in question does not meet the definitions above, then it is not human subjects research and the requirements under the Common Rule do not apply.  Generally, IRBs determine whether an activity is research involving human subjects.  Individuals are advised not to make that determination themselves as any misclassification can have serious consequences for the individual and their organization as noted above.

Of course, when you are unsure whether your project qualifies as human subjects research, it’s always best to ask someone with experience in the area.

[1] While case studies and quality assurance/quality improvement (QA/QI) projects are generally not considered research they can become research if, for example, the clinician attempts to answer a specific question rather than using the cases for educational instruction.

[2] HIPAA may still apply so be sure to check with the privacy board or privacy officer.

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