Essay Giving Guidance on Research Ignores Impending Rules Changes

To The Editor:

The premise in “Don’t Let Your Misunderstanding of the Rules Hinder Your Research (The Chronicle, April 19), by Richard A. Shweder and Richard E. Nisbett, is inaccurate. The revised Common Rule actually does require limited IRB review for some exemption categories. The FAQ guidance the authors point to in their opinion piece is only for the current iteration of the law; the new Common Rule, effective in 2018, has different requirements that are not present in the current law. The new requirements for some of the expanded exempt categories are in the final rule: See here.

Search for “limited IRB review” in the main text of the revised rule (note, there is a lot of discussion and explanation prior to the actual revised rule) to find that the expanded exemption categories at 45 CFR 46 include a handful that actually require IRB review. I will not list all the text of the specific examples, but this excerpt from the revised version of 45 CFR 46 lists the applicable sections:

“§ .109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under § ll.104 for which limited IRB review is a condition of exemption (under§ ll.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7), and (8)).”

This is not a matter of interpretation for research that will be subject to the revised Common Rule. The revised rule presents an opportunity for all parties to come together to examine policy, improve review efficiency, reduce burden, and facilitate ethical human subjects research. Disregard for the facts only fuels frustrations and misunderstandings.

Cheri Pettey
Columbus, Ohio

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