What do we know about interview research under the NPRM?
Whatever its final provisions, the new Common Rule seems bound to be much harder to follow than, say, Canada’s TCPS2. The proposed rule is full of cross references from one section to the next, and often to other documents, such as Subpart D or the Belmont Report. This makes it hard to figure out what it says about any given form of research.
Here’s what I’ve been able to figure out about one form: interview research. My sense is that the NPRM proposes to eliminate IRB review for the vast majority of conversations between consenting adults, but it may unintentionally impose review on projects that do not merit it.
The NPRM proposed rule would exclude:
- “Oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected.” [§_.101(b)(1)(ii).]
- Interviews with adults where the “information is recorded by the investigator in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects.” [§_.101(b)(2)(i)(A).]
- Interviews with adults where “disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.” [§_.101(b)(2)(i)(B).]
Note that §_.101(b)(2) excludes the second and third exclusions for subpart D, which governs research with children, which is why I’ve inserted “with adults.” I wish the proposed rule relied less on difficult-to-follow cross references and more on plain English.
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.