Tuesday, August 14, 2012

Elliott Decries IRB Opacity

Writing for the Chronicle of Higher Education's Brainstorm Blog, Carl Elliott argues that the "by any reasonable estimate [the IRB] oversight system has been a failure . . . yet so many people are professionally invested in the current oversight system that they cannot imagine replacing it, only tinkering with it." He particularly condemns the secrecy of the system.

[Carl Elliott, “When Medical Muckraking FailsChronicle of Higher Education, Brainstorm, August 2, 2012.]

Elliott argues that a system designed to oversee federally funded research is "no match for the power and influence of today’s globalized, multi-billion-dollar research industry." Moreover,

Of the many flaws in the current oversight system, perhaps the most dangerous is its secrecy. IRB meetings are closed to the public, and their proceedings are confidential. Many IRB’s are private, for-profit businesses, and thus not even subject to federal or state Freedom of Information Act requests. Often it is difficult even to find out which IRB has approved a research study. In fact, the very existence of some research studies is secret; research sponsors are not required to register Phase I clinical trials on Clinicaltrials.gov, the federal registry. So if you are an investigative reporter and want to see a potentially troubling research protocol – what the consent form looks like, how much the subjects were paid, whether the investigators had any financial conflicts of interest, how risky the study is – chances are that you will be denied.

The problem with an oversight system that is both unreliable and secretive is that the public has no idea what is happening beneath the surface. If there is no mechanism for making oversight failures public, and barriers are erected to prevent journalists from investigating, how can we judge whether the oversight system is working? How certain are we that there are not many more hidden abuses, waiting to be uncovered?

One potential comparison would be with our transportation system. When a civil aviation or other major transportation accident occurs, the National Transportation Safety Board investigates and makes public the results of those investigations. The process has not eliminated transportation accidents, but it allows transportation operators around the country to learn from each other's mistakes, and for the public to hold them accountable.

A system of shared information can also put lapses in perspective. Elliott lists a dozen "widely reported episodes" from the past twenty years as examples of "scandals" in human subjects research. As the comments on the Chronicle site note, these not everyone regards these episodes with the same outrage as does Elliott, and--according to the Presidential Commission for the Study of Bioethical Issues--these are a dozen cases among the tens of thousands of studies conducted annually. A better reporting system might leave us thinking that human subjects research is indeed like aviation. Any crash is bad, but the system as a whole is pretty safe.

Greg Koski, who served as the first director of OHRP, has suggested using the aviation industry as a model for clinical research. Perhaps Elliott could join that effort.

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