The op-ed, which will appear in tomorrow’s print edition, is online here. It’s co-authored with Christopher Chabris (who happens to be my husband). Here—where I’m writing only for myself—I thought I’d say a bit about what motivated us and elaborate on a few points whose force may have been blunted by the process of condensing our thougts into our allottted 1,000 words.
The news hook for the article was an August memo leaked to Fox News in which the Obama administration announced that it is looking to hire behavioral scientists to help shape policy. Notwithstanding that the explicit model for this initiative is the U.K.’s “Behavioral Insights Team,” formed in 2010 by Conservative Prime Minister David Cameron, in the U.S., some on the right went completely off the rails about the Obama announcement.
A typical reaction was from Fox News’s Monica Crowley, who described the initiative as “really frightening,” “insane,” “outrageous,” “unconstitutional,” “an Orwellian horror show”—and all of the aforementioned mostly because, so far as I can tell, she believes that nudges constitute a form of “psychological warfare” akin to “what our military does to our enemies.” There are certainly legitimate criticisms of nudges to be made by both the right and the left, but that they are a form of Communist mind control is not among them. (For starters, even if nudges did rely on something like subliminal messages, those messages have been shown to have no effect on consumer behavior, much to the chagrin of marketers.)
The impetus for our piece, then, was to disabuse the Crowleys of the world (or at least that portion of them who are open to persuasion on this matter) of that notion, and then to offer some affirmative reasons why conservatives and libertarians should embrace the nudge (its preservation of all options in the choice set; its ability to incentivize personal responsibility; its efficiency), especially relative to its often perfectly viable alternative: the shove. (To that end, the piece was originally intended for a periodical with a right-of-center audience but wound up in the L.A. Times, where some of it may admittedly amount to preaching to the choir.)
In making our case…
Update: In other SUPPORT news today, a second group of bioethicists has written to the NEJM in, ahem, support of OHRP’s original criticisms of the SUPPORT trial. Readers may recall that another group of prominent bioethicists had previously published a letter in the NEJM in support of SUPPORT.
OHRP today announced details of the public meeting it previously said it would convene to address the SUPPORT trial and similar trials comparing two or more standard-of-care interventions in which subjects are randomized.
From an OHRP email:
On June 26, 2013, the Department of Health and Human Services (HHS) announced in the Federal Register an August 28, 2013 public meeting to seek public input and comment on how certain provisions of the Federal policy for the protection of human subjects should be applied to research studying one or more interventions which are used as standard of care treatment in the non-research context.
HHS specifically requests input regarding how an institutional review board (IRB) should assess the risks of research involving randomization to one or more treatments within the standard of care for particular interventions, and what reasonably foreseeable risks of the research should be disclosed to research subjects in the informed consent process.
HHS is seeking participation in the meeting and written comments from all interested parties, including, but not limited to, IRB members, IRB staff, institutional officials, research institutions, investigators, research subject advocacy groups, ethicists, and the regulated community at large. The meeting and the written comments are intended to assist HHS, through the Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), in developing guidance regarding what constitutes reasonably foreseeable risk in research involving standard of care interventions such that the risk is required to be disclosed to research subjects. HHS is seeking input on a number of specific questions but is interested in any other pertinent information participants in the public meeting would like to share.
More details and deadlines after the jump.
UPDATE: A class action lawsuit has been filed in federal court against UAB providers and IRB members on behalf of infants enrolled in the SUPPORT study (through their parents). The Amended Complaint, which was filed May 20, can be found here. In addition, here are two more sets of reactions to the SUPPORT study in the NEJM, both in defense of it, from a group of prominent bioethicists and from NIH. Here is a new post from John Lantos at the Hasting Center’s Bioethics Forum blog. And here is coverage of the most recent developments in the New York Times. I’ll continue to aggregate links as warranted.
Regular readers may recall that recently, OHRP sent a determination letter to one of multiple sites (the University of Alabama at Birmingham (UAB)) involved in an RCT (the SUPPORT study) of optimal oxygen levels for premature infants (prior coverage here, here, and here). OHRP’s criticism itself led to considerable criticism among many research ethicists and physician-researchers (see, e.g., here, here, and here), as well as the SUPPORT researchers themselves (here), while others defended OHRP to varying degrees (here, here, and here).
Now, in a new letter to UAB, OHRP clarified that it has no objections to the study design; its objections, instead, pertain to what parents were told in the informed consent documents. Then, in a remarkable move, it announced that it is suspending its compliance actions against UAB, and plans no further action vis-a-vis other SUPPORT sites, pending its issuance of new guidance to address the risks that must be disclosed when conducted clinical trials like SUPPORT. OHRP promises not only the usual notice and comment period following the draft guidance but also an open public meeting, presumably in advance of the draft.
As the OHRP letter itself suggests, the fight within the research ethics community over the SUPPORT study can be seen as part of a larger conversation about the future of human subjects research regulation in the learning healthcare system. OHRP’s guidance-making process in this matter will clearly be one to watch.
In my last post on Maryland v. King, I suggested that both proponents and opponents of King should find the philosophical case for a universal DNA database stronger than they might otherwise have thought. Obviously, moving in that direction — or even including mere suspects in a database — would raise legal questions that merit (and, one hopes, receive) further consideration by the Supreme Court. But how likely is it that the Court will have another opportunity to consider the constitutionality of a statute that continues to draw the line at arrestees?
The Supreme Court’s decision in King was necessarily limited to the fact pattern presented by Maryland’s particular statute authorizing the collection of DNA from arrestees. For instance, the Court repeatedly noted that the Maryland statute at issue limited DNA collection from arrestees to those who had been “charged” (not, in fact, merely arrested) with “serious crimes,” defined as crimes of violence or burglary, or attempts to commit these crimes. (Although Justice Scalia expressed skepticism that, under the Court’s analysis, it would or could find in any subsequent case a limiting principle preventing the collection of DNA from, say, those arrested for traffic violations, it is of course possible that the Court could find such a distinction.) The Court also noted that in Maryland, samples may not be processed or added to the database until after arraignment, when a judicial officer “ensures that there is probable cause to detain the arrestee.” The presence of probable cause, and the arrestee’s corresponding reduced expectation of privacy, were “fundamental” to the Court’s decision to uphold the collection of DNA from “arrestees.” The Court also noted that samples must be expunged if the arrestee is not convicted. Finally, the Maryland statute strictly limits use of the DNA database to solving cold cases and identifying remains and missing persons; use of the database for other purposes (research, to test for paternity, to analyze health or other traits) is criminalized. The Court explicitly said that a database that was not so limited would raise additional privacy concerns that would require a new analysis.
As usual, it’s more likely that the Court will have another opportunity to examine the constitutionality of DNA collection from arrestees if a circuit split arises regarding one or more of these or other practices. And that, in turn, depends, on how widely states and the federal government vary in their authorizing statutes. An Urban Institute report from May 2013 suggests that variation is, in fact, widespread on these potentially constitutionally relevant factors:
Seriousness of offense
Of the 28 arrestee DNA states, 13 collect DNA from those arrested or charged with any felony; 14 (like MD) collect only from a subset of felonies, typically involving violence, sexual assault, or property crimes; 7 collect from anyone arrested or charged with select misdemeanors; 1 (OK) collects from “any alien unlawfully present under federal immigration law”; and the federal government accepts profiles of any arrestee and any non-US citizen detained by the US government. In addition, 2 states collect DNA immediately upon arrest only if the arrestee has been previously convicted of a felony (CT) or other qualifying crime (TX).
Disclaimer: I’m not a Fourth Amendment person. Rather, my interest in King is in its implications for policies for the use of DNA in the criminal justice system. I spent the better part of a year after my Ph.D and before beginning law school helping to research and edit a book on DNA and the criminal justice system and co-authoring its final chapter with the book’s editor, David Lazer. Although that was ten years ago now, most of the major policy issues in this area have not much changed over the last decade. So, with that caveat, and an invitation to readers to point out anything I say that is out of date or otherwise inaccurate, here are a few quick thoughts on King.
The majority and dissenting opinions spill most of their respective ink taking contrary positions on the primary purpose served by collecting DNA from arrestees. The majority somehow manages to argue with a straight face that the primary purpose (and indeed, to guess from its analysis, apparently the only purpose) of collecting DNA from arrestees is to identify the body of the arrested individual sitting in the booking room. As Justice Scalia wrote in dissent, this claim by the Court “taxes the credulity of the credulous” (slip op. dissent at 1). The clear primary purpose and actual use of statutes authorizing the routine collection of DNA from arrestees is to solve other cases than the one “at bar,” if you will, in the booking room.
One might have thought that the Court went out of its way to avoid finding that the primary purpose of the DNA collection at issue is “to detect evidence of ordinary criminal wrongdoing,” (Indianapolis v. Edmond, 531 U. S. 32, 38 (2000), in order to avail itself of the “special needs” exception to the Fourth Amendment’s usual requirement that searches be conducted pursuant to individualized suspicion. But no. The Court ultimately concludes that the special needs cases “do not have a direct bearing on the issues presented in this case, because unlike the search of a citizen who has not been suspected of a wrong, a detainee has a reduced expectation of privacy” (slip op. at 25). In upholding the state’s power to collect DNA from arrestees, then, the Court relied on — along with the minimally intrusive nature of the search — the arrestee’s reduced expectation of privacy. Indeed, the Court deemed the latter feature “fundamental” to its analysis (id. at 24).
Consider, then, that no such reduced expectation of privacy can be attributed to an even larger class of individuals who are indirectly included in DNA offender databases: the relatives of arrestees (and others who are directly included in offender databases).
The U.S. Supreme Court ruled this morning, in Maryland v. King, that it is constitutional under the Fourth Amendment’s protection against “unreasonable” searches and seizures for the state to compel collection of DNA from arrestees. The probable cause required to arrest someone under the Fourth Amendment permits fingerprinting and taking photographs during the booking process, and the Court held that collecting DNA (limited to 13 loci in supposed “junk DNA”) was not relevantly different. The decision was 5-4, with Kennedy writing for the Court and joined by Chief Justice Roberts and Justices Thomas, Alito, and Breyer. Justice Scalia dissented in his usual spirited way, joined by Justices Ginsburg, Sotomayor, and Kagan.
I suspect that one or more Bill of Health bloggers will have some analysis of this decision once they’ve had the chance to digest it. In the meantime, here is a still-relevant primer I co-authored in 2004 on legal and ethical debates involving DNA and the criminal justice system (including issues related to both offender DNA databases and post-conviction access to potentially exculpatory crime scene DNA). Note that Justice Breyer, in addition to being the Court’s resident patent expert (except him to play a large role in the upcoming Myriad gene patenting decision), has been following debates about DNA and the criminal justice system for some time. He authored Chapter 2 of the book I just linked to.
Although I promised that I was done commenting on the artist-cum-policy wonk who claims to make 3-D “masks” of unknown individuals from their discarded DNA, Matthew Herper of Forbes has taken the criticisms of her (and the media covering her project) articulated by me and others directly to the artist. I confess that her response does not make me feel any better. Even if you’re “only” engaging in art, it seems to me that when that art has an obvious science policy message — indeed, one that you invite — you have some obligation to be clear about how “speculative,” as she puts it, your art is. But when you decide to move from the world of art into the world of science, and to start leading policy discussions based on your speculative art and working with forensic examiners? Then you really have a strong duty to be very clear about what your work can and cannot do. That means, among other things, taking care when talking with the media, and correcting the media if they get it wrong.
Yesterday, the Social Science Genetic Association Consortium, an international consortium that pools and conducts social science research on existing genome-wide association study (GWAS) data, and on whose Advisory Board I sit, published (online ahead of print) the results of its first study in Science. That paper — “GWAS of 126,559 Individuals Identifies Genetic Variants Associated with Educational Attainment” (plus supplemental data) — like much human genetics research, has the potential to be misinterpreted in the lay, policy, and even science worlds. That’s why, in addition to taking care to accurately describe the results in the paper itself, including announcing the small effect sizes of the replicated SNPs in the abstract, being willing to talk to the media (many scientists are not), and engaging in increasingly important “post-publication peer review” conversations on Twitter (yes, really) and elsewhere — we put together this FAQ of what the study does — and, just as important, does not — show. So far, our efforts have been rewarded with responsible journalism that helps keep the study’s limits in the foreground. Perhaps the DNA artist should consider issuing a similar FAQ with her speculative art.
This post is part of Bill of Health‘s symposium on the Law, Ethics, and Science and Re-Identification Demonstrations. We’ll have more contributions throughout the week. Background on the symposium is here. You can call up all of the symposium contributions by clicking here. —MM
Daniel C. Barth-Jones, M.P.H., Ph.D., is a HIV and Infectious Disease Epidemiologist. His work in the area of statistical disclosure control and implementation under the HIPAA Privacy Rule provisions for de-identification is focused on the importance of properly balancing competing goals of protecting patient privacy and preserving the accuracy of scientific research and statistical analyses conducted with de-identified data. You can follow him on Twitter at @dbarthjones.
The media’s “re-identification rain-makers” have been hard at work in 2013 ceremoniously drumming up the latest anxiety-inducing media storms. In January, a new re-identification attack providing “surname inferences” from genomic data was unveiled and the popular press and bloggers thundered, rattled and raged with headlines ranging from the more staid and trusted voices of major newspapers (like the Wall Street Journal’s: “A Little Digging Unmasks DNA Donor Names. Experts Identify People by Matching Y-Chromosome Markers to Genealogy Sites, Obits; Researchers’ Privacy Promises ‘Empty’”) to near “the-sky-is-falling” hysteria in the blogosphere where headlines screamed: “Your Biggest Genetic Secrets Can Now Be Hacked, Stolen, and Used for Target Marketing” and “DNA hack could make medical privacy impossible”. (Now, we all know that editors will sometimes write sensational headlines in order to draw in readers, but I have to just say “Please, Editors… Take a deep breath and maybe a Xanax”.)
The more complicated reality is that, while this recent re-identification demonstration provided some important warning signals for future potential health privacy concerns, it was not likely to have been implemented by anyone other than an academic re-identification scientist; nor would it have been nearly so successful if it had not carefully selected targets who were particularly susceptible for re-identification.
As I’ve written elsewhere, from a public policy standpoint, it is essential that the re-identification scientists and the media accurately communicate re-identification risk research; because public opinion should, and does, play an important role in setting priorities for policy-makers. There is no “free lunch”. Considerable costs come with incorrectly evaluating the true risks of re-identification, because de-identification practice importantly impacts the scientific accuracy and quality of the healthcare decisions made based on research using de-identified data. Properly balancing disclosure risks and statistical accuracy is crucial because some popular de-identification methods can unnecessarily, and often undetectably, degrade the accuracy of de-identified data for multivariate statistical analyses. Poorly conducted de-identification may fail to protect privacy, and the overuse of de-identification methods in cases where they do not produce meaningful privacy protections can quickly lead to undetected and life threatening distortions in research and produce damaging health policy decisions.
So, what is the realistic magnitude of re-identification risk posed by the “Y-STR” surname inference re-identification attack methods developed by Yaniv Erlich’s lab? Should *everyone* really be fearful that this “DNA Hack” has now made their “medical privacy impossible”? Read More
This post is part of Bill of Health‘s symposium on the Law, Ethics, and Science of Re-Identification Demonstrations. You can call up all of the symposium contributions here. We’ll continue to post contributions throughout the week. —MM
In your open letter to me, you write:
No one is asking you to be silent, blasé or happy about being cloned (your clone, however, tells me she is “totally psyched”).
First things first: I have an ever-growing list of things I wish I had done differently in life, so let me know when my clone has learned how to read, and I’ll send it on over; perhaps her path in life will be sufficiently similar to mine that she’ll benefit from at least a few items on the list.
Moving on to substance, here’s the thing: some people did say that PGP participants have no right to complain about being re-identified (and, by logical extension, about any of the other risks we assumed, including the risk of being cloned). It was my intention, in that post, to articulate and respond to three arguments that I’ve encountered, each of which suggests that re-identification demonstrations raise few or no ethical issues, at least in certain cases. To review, those arguments are:
- Participants who are warned by data holders of the risk of re-identification thereby consent to be re-identified by third parties.
- Participants who agree to provide data in an open access format for anyone to do with it whatever they like thereby gave blanket consent that necessarily included consent to using their data (combined with other data) to re-identify them.
- Re-identification is benign in the hands of scholars, as opposed to commercial or criminal actors.
I feel confident in rejecting the first and third arguments. (As you’ll see from the comments I left on your post, however, I struggled, and continue to struggle, with how to respond to the second argument; Madeleine also has some great thoughts.) Note, however, two things. First, none of my responses to these arguments was meant to suggest that I or anyone else had been “sold a bill of goods” by the PGP. I’m sorry that I must have written my post in such a way that it leant itself to that interpretation. All I intended to say was that, in acknowledging the PGP’s warning that re-identification by third parties is possible, participants did not give third parties permission to re-identify them. I was addressing the relationship between re-identification researchers and data providers more than that between data providers and data holders.
Second, even as to re-identification researchers, it doesn’t follow from my rejection of these three arguments that re-identification demonstrations are necessarily unethical, even when conducted without participant consent. Exploring that question is the aim, in part, of my next post. What I tried to do in the first post was clear some brush and push back against the idea that under the PGP model — a model that I think we both would like to see expand — participants have given permission to be re-identified, “end of [ethical] story.” Read More