Long-Sought Research Deregulation Is Upon Us. Don’t Squander the Moment.
Read the full article at The Chronicle of Higher Education.
It has been a 40-year labor: Regulatory systems are not easy to undo. Nevertheless, in January the federal government opened the door for universities to deregulate vast portions of research in the social sciences, law, and the humanities. This long-sought and welcome reform of the regulations requiring administrative oversight of federally funded human-subject research on college campuses limits the scope of institutional review board, or IRB, management by exempting low-risk research with human subjects from the board’s review.
The new regulations state: "We acknowledge that guidance may be useful for interpreting some of the terms in this exemption, and that some cases will be debatable. However, we also believe that a substantial number of research activities will plainly fit this exemption, and should be allowed to proceed without IRB review."
The exempted research activities include surveys, interviews, and other forms of free communication between researchers and human adults, aptitude testing, the observation and recording of verbal and nonverbal behavior in schools and public places (for example, courtrooms), benign behavioral interventions (including ordinary psychology experiments), secondary-data analysis, and other low-risk projects and research procedures.
The decision as to whether a project should be exempt is left to the researcher, presumably using a plainly defined, self-administered exemption tool. The overhauled policy — which holds that exempted research activities should be excused from board review with no requirement of IRB approval of the exemption — aligns with a longstanding recommendation for reform proposed by a special committee of the American Association of University Professors and is consistent with the recommendations of a special panel of the National Research Council. That’s the good news.
The bad news is that the new regulations don’t take effect until next January. University research administrators have 10 months to decide how to interpret and put them in place, via the local institutional review boards, which are made up of faculty members and nonacademic professionals. Will they do the right thing and walk through the door? Will the delivery of a new and improved review-board system prove to have been worth the wait?