Bioethics Blogs

The Persistence Of Community

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.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.