Review: Carl Schneider and Censorship

The Censor’s Hand: The Misregulation of Human-Subject Research

Carl E Schneider

The MIT Press

(NB: I was commissioned to review this book for Pacific Standard in September; what's published here is the first draft, from early October.  After some suggestions from the editor, I submitted a revised second draft a couple of days later.  Neither draft has been published there yet, and I've no idea if and when that will change.  If anything does appear there, I'll provide a link.)

Not so long ago, Stephen Pinker provoked the ire of many bioethicists by appearing to launch an attack on institutional ethical review boards (IRBs).  Accusing them of hindering important work in science, he wrote that they should “get out of the way”.  Bioethicists responded by pointing out that there is a history of researchers behaving abominably – the go-to example in recent years being the Tuskegee syphilis study, in which black men were deliberately left untreated so that the natural course of the disease could be studied.  Ethical review, the bioethicists’ response goes, will not guarantee that nothing bad will ever happen; but it does reduce the chance.

Yet Pinker’s broad claim is not without support from within the bioethics community.  Thoughtful commentators have been looking at the institutional review board system for some while now, and arguing that it needs significant reform.  Could it be, some have wondered, that “bioethics” has become an end in itself, claiming an authority with which even many bioethicists are uncomfortable?  And if, then, there is a decent case for reform, how far should it go?  Some think that the system needs re-tuning; some think that it needs something approaching a rebuild.  And some think that a rebuild is too conservative: that the system is, and cannot but be, so broken that the only option is to get rid of it all together.  In this camp, we find Carl Schneider.  The Censor’s Hand aims to present the case not against IRBs as they are, but against IRBs tout court.

Schneider presents seven basic charges.  IRBs, he posits, cannot be shown to do good; can be shown to do harm; are built to err; overtax and have unrealistically high expectations of their members; lack a “legible and convincing ethics”; overdo informed consent; and corrode free expression (p 185).  Throughout the book, he provides example after example that are meant to demonstrate that these posits are true.  And, indeed, some do have some merit.  Sometimes ethics committees are staffed by people who really don’t understand what they’re doing; they can get bogged down in the minutiae of informed consent; and so on.  More: the laws that set the terms within which ethics committees work have to be phrased fairly broadly in order to be workable; combine this with the fact that there is (in many countries) no overarching organisation to manage them, and the absence of a uniform ethic is unsurprising (though one man’s incoherence is another man’s flexibility and a third’s admirable diversity).

But we cannot leap from any of that to the conclusion that the IRB system should not be reformed or replaced but ditched; and some of the accusations are not well-founded anyway.  A failure to research some illness does not cause death – the illness  does that.  Sure, IRBs cannot easily be shown to do good; but happiness writes white: noone speaks publicly about IRBs making sensible suggestions and working efficiently, and it’s hard to know much about disasters that didn’t happen.  Sometimes, concerns about a given study may appear overwrought; but they may be defensible when seen as the application of a broad principle about protecting the vulnerable.  Schneider does a good enough job of providing a platform for complainants, but he does not (and I think does not seek to) provide an objective survey.

The complaint about censorship is – as far as I can make out – simply tendentious.  Bluntly: not to get ethics committee approval for a study is not being censored.  There’s no complex argument needed here: it just ain’t.  It’s perplexing, too, that one of the (unreferenced) quotations used to make the assertion that IRBs’ function is “offensive… to the values protected by the First Amendment [and] a free society” (p 183) actually refers to Watchtower v Stratton, a case concerning door-to-door advocacy.  Unless one thinks (implausibly, I’d suggest) that that and research are effectively the same thing, much more would have to be done to show that the point translates.

Schneider’s suggested alternatives to IRBs are bizarre.  For him, research funders can act as ethical gatekeepers (he doesn’t even acknowledge any conflicts of interest here); and if something does go wrong, “injured subjects may sue researchers for damages” or avail themselves of criminal sanctions (pp xxx, 195) – which is paper-thin protection, provided much too late in the game.

Schneider does himself no favours in his presentation of an already weak case.  His targets are personified as “regulationists”: a spooky band that seems to be comprised of meddling do-gooders of whom all right-thinking people naturally disapprove; but in this, he has done nothing more than to construct an Aunt Sally.  And a direct result of the prioritisation of complaint over balanced argument is that the book is, sadly, often almost unreadably boring.  Points are laboured rather than developed, and much of the book is a parade of quotations that bludgeons the reader.  There are 1084 references within this fairly short work; the effect is dizzying rather than illuminating.  Worse, not every quotation is clearly or accurately referenced: one passage (p 52) talks about research on adolescent sexuality and on drugs for childhood asthma, with quotations about both, though but no reference is provided for the former topic.  Elsewhere, a comment about the role of IRBs in the gene-therapy trial that killed Jesse Gelsinger (p 122) is supported by a quotation attributed to the Oxford bioethicist Julian Savulescu, but that is actually from a 2004 paper by Richard Saver, who gets no credit.  (The quotation, incidentally, seems to say the opposite of what Schneider thinks it does.)  This is a very poor show.

The Censor’s Hand is likely to appeal to True Believers in the abolitionist cause; but whether it would persuade anyone else is uncertain.  A more careful and measured presentation of the case would have helped with that.  As it is, it’s not at all obvious whether those whose minds people like Schneider would need to change would have the patience to finish the book.