Detouring Around the IRB: New Regulations from HHS

The Department of Health and Human Services proposed revisions this week to modernize regulations protecting the safety of research participants. One of the most important results of the proposed changes is that some studies that currently must undergo IRB review would become exempt, and those that normally request an exemption wouldn’t need any review at all.

“Some that are currently exempt would specifically be declared as outside the scope of the regulations (‘excluded’), and thus would not require any administrative or IRB review,” according to page 23 of the document outlining the proposed changes. “Further, in terms of determining when a study is exempt, a web-based ‘decision tool’ will be created….it is expected that in many instances the tool would be used by the investigators themselves,” unlike the current process requiring IRB approval of a request for exemption.

Celia B. Fisher, PhD, professor of psychology and director of the Center for Ethics Education at Fordham University, points out the potential problems with the new regulations. She writes, “[I]n an effort to streamline the process, proposed changes that exclude some research from institutional oversight, shift the burden of evaluating participant protections from Institutional Review Boards (IRBs) to individual researchers—some of whom are not well versed in research ethics, or have a clear conflict of interest in lessening participant protections to facilitate their research.”

What do you think about the new decision tool? Will the proposed changes affect how you conduct research?