by Michael (Mike) Kraten, PhD, CPA, IRB chair at Providence College
As the chair of our college's institutional review board (IRB), you can only imagine how frequently I am asked questions about the 45 CFR Part 46 federal regulations regarding the requirements of human subjects research.
What types of questions? For instance:
- I'm not sure whether my study is contributing to "generalizable knowledge." How can I tell whether it's doing so?
- How can I possibly know whether I'm potentially damaging someone's "financial standing, employability, or reputation" with my work?
- When does a "practicable" study become impracticable?
These questions, though tricky, are certainly not impossible to answer. Occasionally, though, a quirky query leaves me searching for an appropriate response. For instance, a colleague recently asked me:
- How can I learn about the OHRP regulations without reading them?
Huh? How can any one possibly expect to learn about information without reading it? It would have been easy to dismiss his query as a facetious one, but I understood my colleague's dilemma.
You see, if English is not a researcher's native language, the OHRP regulations can represent a daunting "wall of text" that is extremely difficult to decipher. Heck, even monolingual English speakers (like me) can struggle to understand the dense verbiage.
Indeed, even our IRB's explanatory guidance relies on long English sentences and paragraphs to communicate our policies. Any native speaker of an Arabic, Cyrillic, or Hebrew language would naturally prefer some other means to master the information.
At first, though, I couldn't think of a more accessible resource for my colleague. And then...aha! I remembered a passing anecdote by a 2014 Advancing Ethical Research (AER) Conference presenter that later generated some animated discussion at a networking event.
The anecdote involved the communication of informed consent terms to illiterate human subjects in an emerging nation. The researchers chose to explain the relevant principles by role-playing through a theatrical skit. (Could I find an online video that captured their guidance? Alas, despite my web searches, I could not do so.)
But while searching for this video, I discovered a set of OHRP Decision Charts that explains the regulations in a visual context. I forwarded the set to my colleague, who found them far more comprehensible than the traditionally presented "wall of text."
Thus, my most recent "useful AER Conference recollection" wasn't gleaned from a handout or a PowerPoint slide. It was, instead, an anecdote that I heard from a session presenter and then discussed with colleagues.
In other words, it was knowledge that only persisted in my memory because I first absorbed the information while meeting within a community of researchers. Indeed, it is the very persistence of that community that helps to generate such immense value at the AER Conference.
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