One goal for the revised Common Rule, according to its developers, was to streamline oversight requirements based on the risk level of proposed research. IRB oversight has caused its share of grousing among researchers here and elsewhere about overreach (a.k.a. mission creep) and focus on irrelevant details. Social and behavioral researchers are now weighing in in print about what they hope the revised Common Rule, slated to take effect in January, will mean for them.
The New York Times had a recent piece titled “Some Social Scientists Are Tired of Asking for Permission.” Per the article, “The revision exempts from oversight studies involving “benign behavioral interventions.” This was welcome news to economists, psychologists and sociologists who have long complained that they need not receive as much scrutiny as, say, a medical researcher.“
The Times piece included a link to a separate essay in The Chronicle of Higher Education, in which the authors indicate institutions should not squander the opportunity to deregulate research. “Happily, we are now in a position to fix the system. University research administrators are at liberty to exempt all low-risk research (including government-supported projects) from IRB review. The ball is in their court,” these authors write.
A few words of caution before you go tossing all of your protocol templates and informed consent information sheets into the recycling, however. While the UAMS IRB is still reviewing what changes it will make in response to the new regulations, please note that just about all of the low-risk behavioral research currently reviewed here does NOT have to go before the convened IRB. Projects that meet the current exempt criteria just get a quick look-see in the office to ensure we have enough information to confirm an “exempt” determination and that some basic informed consent and human subject protection requirements are met. Many more low risk studies qualify for expedited status review and are handled by a reviewer in the IRB office — no need to wait to make it onto the convened IRB’s agenda. These kinds of studies can be turned around in a matter of days once they arrive at the IRB office. (Please note that they may be reviewed by other offices prior to coming to the IRB; the nature and length of those reviews are entirely outside the IRB’s purview.) We also note here that the authors of the Chronicle of Higher Education piece make mention of researchers being able to determine their projects exemption status “presumably using a plainly defined, self-administered exemption tool.” That exemption tool did not make it into the final rule, and there also may be some concerns about PIs making their own exemption decisions. Note also that federal regulations are not the only requirements governing human subject research. Our accrediting agency has certain requirements we must meet (although those may also change with the new regulations). Lastly, given the nature of the research done here and our population, UAMS has also adopted additional requirements that are outside the scope of the Common Rule. For example, the IRB typically does not allow faculty to require their students or staffers to participate in a research project, even if the project meets exempt criteria. These details mean that there will likely remain some level of institutional and/or IRB oversight for these very low risk projects, even as we implement the flexibility allowed under the new Common Rule.