In “human subject research,” what is “research,” and what is “a human subject?”
Is any research “research”? No. Not in “human subject research,” as it is used in ethical guidelines and informed consent procedures central to the biomedical and social sciences. These terms have very specific meanings that do not comprise all we might think of as “research” or “humans,” so it can be confusing.
The University of California (Irvine) website explains it as follows, in keeping with US federal government guidelines. “Research” is:
a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
A “systematic investigation” is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.
-Examples of systematic investigations include:
-surveys and questionnaires
-interviews and focus groups
-analyses of existing data or biological specimens
-evaluations of social or educational programs
-cognitive and perceptual experiments
-medical chart review studies
That’s “research.” What about a “human subject,” then? A human being you interact with in the course of any academic activity to learn something from them? No.
A human subject is as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.
Does humanities research constitute “human subject research?” Very rarely. Why? It is not collecting data to make generalizable or predictive conclusions.
But what about when you interact with an individual or individuals to find our their opinions about something?
Let’s turn to NYU, which posts some helpful guidelines:
When are Humanities or Oral History projects considered to be human subjects research requiring IRB review?
If the proposed project will involve collecting identifiable information about a livingindividual AND will be used to reach conclusions, inform policy or generalize findings,
then the project must be submitted to the IRB for review.
The following examples are projects which would not require IRB review:
• The goals of the project are to document a specific issue or event or the experiences of individuals and will not be used for further analysis for commonalities predictive of
• The project will compare and contrast policies, procedures or events to identify general
commonalities or inform policy decisions without collection of information about
What about classroom activities? NO (unless you are conducting biomedical experiments in your class, in which case, yes)
What about chatting with actual human beings who have feelings? NO, unless “chatting” is part of your data collection methodology for research as defined above.
What about finding out about what happened during a historical event or period in which actual human subjects were involved, and you find out by interacting with them? NO, unless your questions and procedures fall under the definition of “research” above.
What about telling an individual your opinions? NO, but it’s a good idea to be polite and consider if they want your opinions. If it turns out they don’t, consider not offering your opinions to those people. You could ask, but on the other hand, if someone has said or done something you find dangerous or offensive, you might offer your opinion anyway. Is that research? NO.
Are researchers allowed to interact with other humans informally outside of project guidelines, even in ways that might contribute to their overall understanding of a topic? YES, but such information or knowledge gained informally cannot contribute to data collection or the publication of “research” as defined in “human subject research" above.
Do humanities scholars use "data”? NOT USUALLY, NOT TRADITIONALLY but this is changing with the rise of “digital humanities,” and methodologies, fields, and definitions are shifting and being debated.
How does internet research affect these guidelines and procedures? NO ONE KNOWS, we are in a huge seismic redefinition of the key terms public/private, data, text, and human.
Are there specific guidelines for internet research? NO There are people working on this, but no, there are no official government-sponsored guidelines anywhere, as of 2012. Basically, the most current guidance documents tend to say, and I paraphrase, “Holy Hell is this complicated. Chances are really good you’re going to mess up. Do your best, think really carefully, and try not to hurt people, but honestly, none of us really know what’s going on with online lives."
My department says all my projects need to go through review. Then they do. If you need to go through review or exemption and you blow it off, you won’t be able to use your research data.