Omri Ben-Shahar on Reducing the Time and Cost of Securing Approval for Human Subject Research

Reforming the IRB in Experimental Fashion

Ask researchers about one of the biggest impediments to experimental research, and they will point to the federal law that requires all federally funded human subject research to get preapproval from an ethics committee known as an institutional review board (IRB).

Over the decades, IRBs—regulated by the Office for Human Research Protections in the U.S. Department of Health and Human Services—have increased their jurisdiction to cover any interaction of scholars with human beings, including oral histories, ethnography, studies by students, and more. All have to be preapproved. A researcher wants to pay internet users to assess visual images? Get IRB approval. Interview lawyers about their practice? Get IRB approval. Poll students about their experiences? Get IRB approval.

It is widely recognized that IRBs have exercised “mission creep,” continuously expanding the de facto scope of their oversight. Some might describe this trajectory charitably as the advance of ethical norms, but the cost of IRB expansion is undeniable: more burden on researchers, slowdown of research, fewer studies, and inevitably less progress.

Can this burden be reduced without increasing risks to subjects? The University of Chicago is about to launch a pilot reform to test this question. The reform will address the great majority of social science experiments that are classified as minimum risk—by my own count well over 95 percent of the protocols received by the social science IRBs are treated as either “exempt” or “expedited.”

Read more at The Regulatory Review