“The Misregulation of Human-Subject Research”

That is the subtitle to a new book, The Censor’s Hand, by Carl Schneider, a Professor of Law and Medicine at University of Michigan. It’s an assault against the state of Institutional Review Boards (IRBs) that supervise research on human subjects.

From an interview with Inside Higher Ed:

Good regulation is accountable, but IRBs are effectively answerable to nobody. Good regulation has clearly defined jurisdictional limits, but IRBs may intervene as they wish. Good regulation is guided by clear rules, but IRBs have little more than empty principles. Good regulation is disciplined by fair procedures, but IRBs can ignore every fundamental precept of due process. Good regulation is transparent, but IRBs need not even explain — much less justify — their decisions. Good regulation is staffed by experts, but IRB members cannot be competent in all the specialties they regulate. Good regulation has manageable workloads, but IRBs regulate more details of more research in more ways than they can review responsibly, and they have steadily broadened and intensified their hold over research.

In short, the IRB system makes unreliable decisions because it is lawless and unaccountable, because its organization, procedures, membership and imperialism are so inappropriate. The problem is not regulation, it is bad regulation.

They are good points. The fact that I thought twice about posting this, for fear it could offend the authorities, might be evidence  in favor of his argument. “Keep your IRB happy” is one of the main things I teach my students, because your career can depend on it.

Even so, Schneider goes much too far when, later, he says, “Nor is there good evidence that IRBs actually improve research or protect its subjects.”

I agree that my human subject experiences seem more and more like lawsuit protection, focusing on risk mitigation for the University rather than the research subjects. At the same time, I see colleagues and students intent on ethical infractions, usually minor, all the time. Colleagues of mine have also had their computers seized by autocratic police, and the encryption pushed on them by the IRB was the only thing that saved their subjects’ privacy and safety.

Nonetheless, I agree: the bureaucracy is broken. A couple of weeks ago I was getting my haircut a few blocks away from campus. The daunting prospect of getting a simple human subjects approval and a data collection contract in two months had weighed on me all day, and I’d spent the afternoon banging my head against a bureaucratic wall. Purchasing, lawyers, and project management at Columbia are like nothing I’ve ever seen before. When my haircutter asked how I was doing, I replied honestly: the Columbia bureaucracy was getting me down. He started laughing. “You’re the third person to say that to me this week!” he replied.

So some places are worse than others.

7 thoughts on ““The Misregulation of Human-Subject Research”