Don’t Let Your Misunderstanding of the Rules Hinder Your Research
Read the full article at The Chronicle of Higher Education.
Do the new regulations for institutional review boards permit universities to develop a self-exemption tool for investigators conducting low-risk research in the social sciences and humanities? We promoted that option in our essay in The Chronicle last month. A few research administrators around the country responded by telling their faculty members and suggesting in print that such a self-exemption option is not actually available under the new rules. They seem to believe we misread the regulations.
Clarity on this issue is important given this opportunity for IRB reform. So it is useful to turn to the Office for Human Research Protections website, where the following frequently asked question is posed: "Must there be review by someone other than the investigator before a research study is determined to be exempt?" The answer: "No, the regulations do not require that someone other than the investigator be involved in making a determination that a research study is exempt."
It is true that in September 2015, in a Notice of Proposed Rulemaking, the affected agencies floated the idea of a federally developed and universally required self-exemption tool for federally funded research projects, but this was not incorporated into the new regulations published in the Federal Register on January 19. And perhaps that has created some confusion.
Some of the confusion may also be traced to the habit of risk-averse strategizing that often leads academic administrators to overlook the distinction between regulations and statutes (legally enforceable duties and obligations) on the one hand and nonbinding recommendations and opinions ("guidance") on the other.
The old regulations left the door open for a self-exemption process to go forward at any academic institution that elects to have one, and the new regulations continue to allow that. And according to the new regulations, the so-called final rule "continues to permit flexibility in how exemption determinations are made." They do not require exemption determinations to be made by an IRB or even by an IRB administrator, though they do recommend some kind of administrative review. They permit universities and colleges to create a self-exemption tool or an organized self-exemption process for federally funded research if it can be shown to reliably distinguish exempt from nonexempt projects.