Don’t Let Your Misunderstanding of the Rules Hinder Your Research

April 19, 2017

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 relevant granting 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.

For example, here is a proposal from the OHRP website, which strikes us as eminently reasonable as a starting point for discussions between researchers and research administrators.

"An institution might craft a checklist for certain exemption categories, with questions that are easily answered ‘yes’ or ‘no’ by an investigator, with certain answers leading to a clear conclusion that the study is exempt. The institution might allow a researcher to immediately begin a study after having completed such a checklist and filed it, together with accompanying documents, with an appropriate institutional office, without waiting for or requiring any prior review of that filing."

In our view, the "appropriate institutional office" might be the investigator’s home department.

Over the next nine months, thoughtful research administrators in academe will be undertaking IRB reform. We encourage faculty members from the social sciences and humanities to get involved as well. This is an ideal time to give serious thought to the creation of a reliable self-exemption tool for low-risk research projects. We believe exemption decisions should be taken out of the hands of research administrators; otherwise mission creep of the sort endemic to many IRBs will continue to be a problem.

Universities and colleges experimenting with different models of reform should be creative, keeping in mind all legally available options. One of the best-kept secrets in academic research is that OHRP jurisdiction applies only to federally funded projects. In other words, any extension of the review system beyond federally funded projects is discretionary, and it has been for a very long time.

In fact, the vast majority of research projects in the social sciences and humanities are not federally funded. That fact and the restricted legal scope of the application of IRB regulations are highly relevant to any future discussions about regulatory limits on free inquiry and about the scope of IRB reform in general.

The Office for Human Research Protections has made it clear that it has no interest in overseeing research not funded by agencies bound by the Common Rule, the federal government regulations for human-subject research, or in applying the new regulations to such projects." The office has encouraged universities to decrease inappropriate administrative burdens and given its blessing to those who wish to experiment in new ways of managing low-risk research that is not federally funded. This is welcome guidance — now it is time for us to move forward with reform.

Richard A. Shweder is a professor in the department of comparative human development at the University of Chicago. Richard E. Nisbett is a professor in the department of psychology at the University of Michigan at Ann Arbor.