By GEORGE J. ANNAS
Review of The Censor’s Hand: The Misregulation of Human-Subject Research, by Carl E. Schneider
Cambridge: MIT Press, 2015
There is a monster on American campuses—curtailing free speech of faculty and students, imposing high transaction costs through incoherent rules and procedures on researchers, and costing unknowing citizens their very lives. Who would not want to stop this monster from inflicting more pain and suffering? Carl Schneider, a professor of law at the University of Michigan, certainly does—and the case he makes for killing the monster, aka the IRB or Institutional Review Board, is simultaneously over-the-top and compelling.
His timing could not be better. His primary target, the federal Office for the Human Research Protections (OHRP), which oversees the IRB system, has just released (in the September 8th Federal Register) a detailed proposal to redefine the mandate of the IRBs and modify how they work. The comment period is open until mid-December, and many comments are likely to refer to Schneider’s book, both to agree with some of the proposed changes, and to suggest that more radical changes should be made. OHRP’s proposals are for reform of IRBs; Schneider is for their elimination.
Schneider’s case against IRBs, in a nutshell, is that they do much more harm than good. He believes they make sense only when seen as a response to major scandals in biomedical research such as the Nazi doctors and the US Public Health Service Tuskegee Syphilis Study. Scandals of this magnitude are rare, and can’t be stopped by IRBs in any event. The author argues that IRBs wrongly use “event licensing” as their primary tool: a “gruesomely inefficient” requirement that researchers obtain IRB approval before engaging in human subjects’ research. IRB costs are ignored—especially, he asserts, costs “in lives, health, and welfare” inflicted by delaying important research. Amateurs get together in the form of IRBs to judge professionals whose work they only superficially understand. The jurisdictional subject matter is vague, leading to uncontrollable IRB mission creep. IRBs are paternalism and inconsistent; characterized by lawlessness, rigidity and arrogance. Finally, IRBs over-rely on “mandated disclosure,” spending most of their effort on crafting frustratingly lengthy consent forms no one reads. Is the attempted regulation of research on human subjects really this bad? Schneider thinks it’s even worse.
The book’s title, The Censor’s Hand, highlights his core argument: government-academic review bodies should not have prior approval authority over what two adults (including students and faculty members) say to each other, whether by way of conversation or answering structured questions or surveys. OHRP’s new proposals to change current regulations take some important steps to reverse IRB mission creep into the social sciences, by proposing an entirely new category of research: research that is “excluded” from review altogether. For example, in the “free speech” realm, the proposal would exclude “oral history, journalism, biography, and historical scholarship activities that focus on specific individuals about whom the information is collected” from IRB review. In a more limited setting, surveys and interviews are excluded if conducted by national security or defense agencies—but both Schneider and I would exclude all surveys and interviews, at least those involving only adults, from IRB review.
Unlike Schneider, however, I find it difficult to characterize IRBs as government regulatory agencies, even those located in public institutions, since they are entirely made up of non-government workers, are appointed by their own institution, and are accountable, if at all, only to their local institution. To the extent that they have morphed into compliance committees, the blame rests with their own university’s management, and its view of risk management. More persuasive is Schneider’s generic argument that academic institutions should never impose prior restraints on speech, as a matter of academic freedom, rather than constitutional law.
OHRP’s new proposals also attempt to move IRBs away from wasting time on riskless or very low-risk research, to concentrate instead on potentially dangerous and risky research. That’s good, although the new emphasis on biorepositories, such as the president’s proposed precision medicine genomic bank, seem out of place in the IRB/human research world. I think it makes more sense to remove any authority IRBs have over biorepository research and medical record research, instead of expanding it. OHRP is also on shaky ground in continuing to rely on the Belmont Report as the major rationale for its new proposals. As Schneider notes, the Belmont Report has become a “Sacred Text” of IRBs, but is nonetheless “more invoked than read and more read than analyzed.” The report is vaguely worded, was hastily constructed, gives labels rather than principles, is internally inconsistent, and ultimately provides IRBs with “a kindergarten ethics.” OHRP would have been better off ignoring it in this round of proposed changes rather than torturing logic to drag it into their rationale for changes. But IRBs can continue to declare allegiance to the Belmont Report, since, Schneider argues, IRBs are unaccountable to any outside forces. He notes that even minimal due process would require an appeals mechanism whereby researchers could challenge IRB decisions.
The danger of writing a screed is that it will be dismissed and ignored as an extreme position that is based more on emotion than logic. This would be a mistake. Instead I hope this book will help persuade even supporters of IRBs that major reforms are needed if IRBs are to meet their own goal of protecting the human dignity of research subjects, and trying to minimize injury and exploitation. Although there is much I don’t agree with in this book, especially the author’s views on informed consent, I strongly recommend that IRBs around the country make this book required reading for their members, and set aside time to discuss it at a regular meeting. IRB members will not recognize themselves or their mission in this book; and it is their mandated mission rather than their membership that make IRBs so controversial. Nonetheless, reading and discussing it can help them re-think and encourage others toredefine their role—which was originally, and can be again, primarily practicing ethics, not compliance and risk-management.Schneider wants IRBs abolished, but reform seems more reasonable and certainly more likely. Continuing controversies over emergency research without consent, research on extremely premature newborns with drastically deficient consent, and research on people with mental disabilities (there is no agreement on regulating this category yet), also argue for reform rather than abolition. Since reform was not the author’s goal, he does not give us a blueprint. But if we are to reform instead of abolish IRB review of research, I suggest that the following steps should be taken (it seems at least plausible that Schneider could find them improvements over our current practice as well):
- OHRP’s regulatory authority should be expanded. It should become an independent federal agency (moved out of the Department of Health and Human Services) and its rule-making authority should be supplemented to include adjudicatory authority as well. (This was recommended by Jay Katz almost 40 years ago.) OHRP itself should act as a “national IRB” and be required to review all extreme and unusual procedures, including emergency research and risky research on children and mentally ill subjects. It should also have authority to hear appeals from local IRB decisions and be required to write opinions, developing a common law for IRBs that promotes fairness and uniformity. Rules regarding research should much clearer and designed primarily to protect research subjects against exploitation. For example, no research should ever be permitted on a subject who is in restraints (too close to torture).
- Informed consent must focus on voluntariness and understanding. It is not just a research rule, but is at the core of the doctor-patient relationship in therapy as well. Informed consent is not a formality, but it is still treated as if it is. Serious consideration should be given to eliminating written forms altogether (and videotaping the informed consent process as a substitute method of documentation). Alternatively, forms should be limited to one page of essential information. Nonessential information can be put in an appendix, ideally one that is posted on a website. OHRP’s new proposals take a step in this direction, but a weak and tentative one.
- IRBs themselves should be radically overhauled. A majority of the members should be public members -- ignorant to be sure, but if researchers can’t explain their proposals to non-medical, public IRB members, there is no hope that they will be able to explain it to prospective subjects. IRB meetings should be public, and announced to the public. Human experimentation is a public enterprise, done on members of the public for the benefit of the public and usually financed by the public as well, and should not be regulated in secret.
Researchers are not the enemy, but neither are IRBs irrational monsters set on destroying research projects. Serious reform rather than libertarian despair is in order, and IRB reform seems possible for the first time in 25 years.
Posted on 30 November 2015
GEORGE J. ANNAS is Warren Distinguished Professor at Boston University and Director of the Center for Health Law, Ethics & Human Rights at Boston University School of Public Health. His most recent book is Genomic Messages: How the Evolving Science of Genetics Affects our Health, Families, and Future (with Sherman Elias), (HarperOne, 2015).