This week marks the publication of my book, From Oversight to Overkill: Inside the Broken System That Blocks Medical Breakthroughs—And How We Can Fix It. It also marks the launch of my campaign to force reform on a reluctant system.
The campaign faces a daunting challenge. Over the years, thousands of individuals have complained about dysfunctional research oversight. The usual response has been silence. Fredric Coe writes an impassioned essay about how the University of Chicago’s IRB makes him waste hours and dollars on risks that do not exist and forms that nobody will read. In response, nothing happened.
The same is true for institutions. The American Association of University Professors charged a panel of thoughtful scholars to examine IRB oversight. It recommended sweeping changes. Nothing happened. The National Academy of Medicine spent substantial effort on a critique of the application of the HIPAA privacy rules to health research. The Academy begged for relief from overly restrictive oversight. Nothing happened.
I am a retired family doctor with no connections to the higher reaches of academic medicine and even less connection to the political stage, which is the place where change must happen. So how can I imagine that I can make a difference?
My theory of change is that From Oversight to Overkill will act as an accelerant for a demand for change that has been accumulating in the pent-up frustration of scientists. The book specifically addresses most of scientists’ major concerns about the burden of IRB review. First, it encourages them that they are not alone—that scientists in other fields, in other institutions, even in other countries, are all burdened alike, that every form of medical investigation is damaged or delayed. That means that their problem, which may seem small, is part of a larger pattern whose impact is substantial.
Second, scientists are hesitant to attack a system that claims to be ethics. What do they know of ethics? In most cases, only what they have been forced to learn through online tutorials about how IRB review is ethics in action. From Oversight to Overkill fills them in on a secret—that any ethics the IRB system once possessed have long since been expelled, and that what remains is a bureaucracy that carefully checks boxes that don’t matter to protect subjects from risks that are either trivial or entirely absent by looking at forms they have no interest in reading.
I exempt from this criticism review of studies that do in fact pose real dangers; they are the reason the system was created and they will always need oversight. But the vast majority—probably in the high ninety percents—of protocols that IRBs review are safer than walking down the steps to get the mail on a sunny April day.
So the first part of my theory is that the scientists, liberated from their feeling of isolation and their fear of ethics, will speak up about the treatments they can’t develop and the diseases they can’t cure. If enough scientists speak up, everyone will be shocked and amazed—and this will include the public and Congress.
The second part of my theory is grounded in the conviction that although I do not know when or how it will happen, fundamental change is bound to come. In fact, this is a matter of law, so to speak. Herb Stein was Chairman of the Council of Economic Advisers under Nixon and Ford. Stein’s law states, “If something cannot go on forever, it will stop.” The IRB system cannot go on as it is forever. I’m hoping that now is the time for change.