Whose Business Is It If You Want To Induce a Bee To Sting Your Penis?

Photo source: WikiMedia Commons

You might think that the answer to this question is obvious. Clearly, it’s your business, and yours alone, right? I mean, sure, maybe it would be considerate to discuss the potential ramifications of this activity with your partner. And you might want to consider the welfare of the bee. But other than that, whose business could it possibly be?

Well, as academic empiricists know, what others can do freely, they often require permission to do. Journalists, for instance, can ask potentially traumatizing questions to children without having to ask whether the risk to these children of interviewing them is justified by the expected knowledge to be gained; academics, by contrast, have to get permission from their institution’s IRB first (and often that permission never comes).

So, too, with potentially traumatizing yourself — at least if you’re an academic who’s trying to induce a bee to sting your penis in order to produce generalizable knowledge, rather than for some, um, other purpose.

Yesterday, science writer Ed Yong reported a fascinating self-experiment conducted by Michael Smith, a Cornell graduate student in the Department of Neurobiology and Behavior who studies the behavior and evolution of honeybees. As Ed explains, when, while doing his other research, a honeybee flew up Smith’s shorts and stung his testicles, Smith was surprised to find that it didn’t hurt as much as he expected. He began to wonder which body parts would really smart if they were stung by a bee and was again surprised to learn that there was a gap in the literature on this point. So he decided to conduct an experiment on himself. (In addition to writing about the science of bee stings to the human penis, Ed is also your go-to guy for bat fellatio and cunnilingus, the spiky penises of beetles and spiders, and coral orgies.)

As Ed notes, Smith explains in his recently published paper reporting the results of his experiment, Honey bee sting pain index by body location, that

Cornell University’s Human Research Protection Program does not have a policy regarding researcher self-experimentation, so this research was not subject to review from their offices. The methods do not conflict with the Helsinki Declaration of 1975, revised in 1983. The author was the only person stung, was aware of all associated risks therein, gave his consent, and is aware that these results will be made public.

As Ed says, Smith’s paper is “deadpan gold.” But on this point, it’s also wrong. Continue reading

Update on Litigation in Looney v. Moore (SUPPORT Trial Class Action)

For those closely following the litigation over this clinical trial, a few updates. On January 22, the district court ruled on defendants’ motions to dismiss plaintiffs’ third amended complaint. That complaint named as defendants the director of the IRB, the chair of the IRB, the other members of the IRB (“the IRB defendants”)—all in their individual capacities; the PI of the trial, in his individual capacity; Masimo Corporation, the manufacturer of the oximeter used in the trial; and fictitious defendants (ABC Health Care Providers #1-100; ABC Individuals #1-100; and XYZ Entities #1-100). The complaint stated seven counts: products liability and negligence against Masimo; negligence, negligence per se, lack of informed consent, and breach of fiduciary duty against the IRB defendants and the PI; and wrongful death against all defendants.

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Would Marlise Munoz’s Fetus Have Survived? Should It Have?

This is post is part of The Bioethics Program’s ongoing Online Symposium on the Munoz and McMath cases, which I’ve organized, and is cross-posted from the symposium. To see all symposium contributions, in reverse chronological order, click here.

Had the hospital not relented and removed the ventilator from Marlise Munoz’s body, could the Munoz fetus have been brought to term, or at least to viability? And if so, would the resulting child have experienced any temporary or permanent adverse health outcomes? Despite some overly confident commentary on both “sides” of this case suggesting a clear answer one way or the other—i.e., that there was no point in retaining the ventilator because the fetus could never be viable or was doomed to be born with catastrophic abnormalities; or, on the other hand, that but for the removal of the ventilator, the “unborn baby” was clearly on track to being born healthy—the truth is that we simply don’t know.

Before getting into the limited available data about fetal outcomes in these relatively rare cases, a bit of brush clearing. The New York Times juxtaposed reports about possible abnormalities in the Munoz fetus with the hospital’s stipulation about the fetus’s non-viability in ways that are likely to confuse, rather than clarify:

Lawyers for Ms. Muñoz’s husband, Erick Muñoz, said they were provided with medical records that showed the fetus was “distinctly abnormal” and suffered from hydrocephalus — an accumulation of fluid in the cavities of the brain — as well as a possible heart problem.

The hospital acknowledged in court documents that the fetus was not viable.

Whether intentionally or not, the nation’s newspaper of record implies — wrongly, I think — that the hospital conceded that the fetus would never be viable because of these reported abnormalities. In court, the hospital and Erick Munoz stipulated to a series of facts, including that Marlise was then 22 weeks pregnant and that “[a]t the time of this hearing, the fetus gestating inside Mrs. Munoz is not viable” (emphasis added). The hospital conceded nothing at all about any fetal abnormalities. In short, the Times, and many other commentors, have conflated “non-viability” as a function of gestational age with “non-viability” as a way of characterizing disabilities that are incompatible with life. As I read this stipulation, the hospital was not at all conceding that the fetus would never have been viable, had the ventilator remained in place. Rather, given the constitutional relevance of fetal viability, the hospital was merely conceding the banal scientific fact that the Munoz fetus was, at 22 weeks, not currently viable. There is nothing surprising in the least about the hospital’s “concession” about “viability” in the first sense, above: 22-week fetuses are generally not considered viable. Continue reading

Online Symposium on Munoz and McMath Cases

UPDATE: Following Friday’s court order (discussed below), the hospital today (Sunday, Jan. 26, 2014) removed the ventilator from Marlise Munoz, who has met the criteria for brain death since Nov. 28, 2013.

Two high-profile, rapidly evolving cases involving death by neurological criteria — better known as “brain death” — raise vexing and sometimes novel legal, ethical, and medical questions at the edges of life and death. I’m organizing an online symposium on these cases over at The Bioethics Program Blog, and will be cross-posting my contributions here, beginning with this introduction to the symposium, which brings readers up to date with legal developments through today. Please contact me if you’re interested in participating.

The Marlise Munoz Case

On November 26, 2013, Erick Munoz found his wife, Marlise, unconscious on their kitchen floor. She was then 14 weeks pregnant with their second child. Erick resuscitated her and she was transported, alive, to John Peter Smith Hospital, where she was placed on a ventilator to assist her breathing and given other life-sustaining treatment. Not long thereafter, however, Erick says that the hospital told him that Marlise was brain dead.

Although Marlise did not have a written advance directive, according to Erick, both he and Marlise had

worked as paramedics during their marriage, and thus were knowledgeable of and had personally witnessed injuries that resulted in death, including brain death. Erick and Marlise frequently discussed their requests, beliefs and desires with each other, and expressed clearly to each other, family members and friends, their respective desires not to be resuscitated should either of them become brain dead.

Erick requested, with the “full support” of Marlise’s parents, that the ventilator be removed from her body and that he be given possession of it for burial.

The hospital refused. It argued that § 166.049 of the Texas Advance Directives Act (TADA) — which provides that “a person may not withdraw or withhold life-sustaining treatment under this subchapter from a pregnant patient” — prohibits it from removing the ventilator. It was not entirely clear whether the hospital believed that Marlise was in fact dead or not. The media was reporting as late as December 24 that the hospital had said that Marlise was in “serious condition,” and the hospital had not released Marlise’s medical records, which Erick said would show a diagnosis of brain death, to him.

After the jump, this week’s developments in the Munoz case, the McMath case, and a list of symposium participants.

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My Comments on HHS’s Proposed Rule Criminalizing Trade in Blood Stem Cells

Professor Nalini Ambady (1959-2013)

Professor Nalini Ambady (1959-2013)

Bonjour de Toulouse, where I’m visiting this month at the Institute for Advanced Study (IAST), which is hosted by the Université de Toulouse Capitole and physically (and in many senses conceptually) situated inside the Toulouse School of Economics. That setting is a particularly good one for this post on markets in human tissue.

In early October, I wrote about a rule that the Department of Health and Human Services has proposed that would amend the National Organ Transplant Act (NOTA) to criminalize compensation for providing peripheral blood stem cells (PBSCs) given through apheresis. Compensating those who allow their bone marrow to be aspirated — the other major source of hematopoietic stem cells (HSCs) — is already explicitly criminalized under the statute. At the end of the post, I promised to follow up with a second post on why I’m skeptical about this rule, as a matter of policy. This is that post.

But before discussing appropriate policy for addressing the problem of the 3,000 Americans who die each year for want of a bone marrow transplant, and for reasons I’ll explain near the end of my post, I want to say something about one particular person: Professor Nalini Ambady, a Stanford social psychologist who, about one year ago, began an international search for a compatible, willing HSC donor to treat her leukemia.

Because she is South Asian, and because few Asians and other racial and ethnic minorities are listed in the U.S. bone marrow registry — South Asians comprise only 2% of the U.S. registry — she had a difficult time finding a match. She nevertheless found 12 potential matches in the U.S. bone marrow registry, and apparently at one point had scheduled the transplant. In the end, however, half were ruled out as imperfect matches — and each of the remaining six matches declined to donate.

Having exhausted the U.S. registry, Ambady and her supporters sought a match in South Asia registries — but even fewer people are registered in that region than in the U.S. Of India’s 1.2 billion people, for example, only about 45,000 are registered. Nevertheless, a potential thirteenth match was found in an Indian registry. He matched at least 6 of 10 HLA markers; he would need a blood test to determine whether he was a complete match. Unfortunately, after a worrisome week of silence about whether he was indeed a complete match, Ambady and her family learned that the potential donor had backed out.

And then a potential fourteenth match:

Weeks later, it happened with another potential match for Nalini, this time an 8/10 and so an even likelier match. This man wanted to watch someone else donate their bone marrow before making up his mind. A registry chief actually arranged this for him in early May. Somehow, it wasn’t persuasive enough. He, too, decided not to donate.

Professor Ambady died on October 28 after eight compatible or potentially compatible registered donors ultimately declined to donate.

Apparently, declining to donate after agreeing to be listed in a registry and being found to be a match is quite common. According to one registry chief, the attrition rate is 50% in the U.S., Europe, and India. Would a financial incentive have tipped any of these vaccillating prospective donors towards a decision to donate? Although we can’t say, this is an eminently answerable question. Unfortunately, the Department seems uninterested in learning whether a compensation scheme would save lives — or have ill or counterproductive effects — or not.

In its Notice, the Department lists the following policy reasons for expanding NOTA’s list of “organs,” the exchange of which for valuable consideration is prohibited, to include PBSCs: (1) preventing commodification; (2) curbing opportunities for coercion of PBSC providers and (3) exploitation of PBSC recipients; (4) encouraging altruistic donations, and (5) decreasing the likelihood of disease transmission resulting from paid donations. My responses to these arguments are after the jump. I end with some thoughts about alternative policy tools for increasing the supply of PBSCs in the absence of a legal compensation scheme.

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In Memoriam: Adrienne Asch

I’m sorry to report that Adrienne Asch, director of the Center for Ethics at Yeshiva University and the Edward and Robin Milstein Professor of Bioethics, died yesterday of cancer. A social psychologist by training (but no relation to Solomon Asch), Professor Asch’s scholarly focus was the ethical, legal, and social implications of human reproduction, especially as it intersects with disability studies. An interdisciplinary scholar (as most bioethicists are), she taught courses at Wurzweiler School of Social Work, Cardozo School of Law, and Albert Einstein College of Medicine.

I didn’t always agree wth Adrienne, but she was an important scholar. As Sam Bagenstos noted, her death is “a huge loss for the disability world.” Among other things, she challenged pro-choice scholars and activists to rethink the implications of some of their policies and theories for people with disabilities in present and future generations. Here is one example of many.

Adrienne was also a lovely person. Some years ago, I picked her up from Wellesley (where she then taught) and drove her to Dartmouth (where I was a college senior) for a brief visit. It was, from start to finish, an epic fail on my part. In my defense, her assistant gave me terrible directions, I was then unfamiliar with the joy that is Boston rush “hour” traffic (including the fact that it begins at 3pm and lasts until 7pm), and this was before either cell phones or GPS. Nevertheless, what was supposed to be a three-hour drive that left time for her to change clothes at the hotel before her first talk became a four-hour tour during which I grew increasingly anxious about the prospects of getting her to the church on time, as it were. Adrienne was blind (hence my driving her), and this raised the additional issue of what to tell her, and when, about our travels. Ever the intellectual and mentor, as soon as she got into the car, she wanted to hear about the honors thesis I was writing. Alas, I turned out to be utterly incapable of navigating Boston’s traffic and discussing French existentialism at the same time, and soon we were hopelessly lost. I stopped at a gas station for directions (remember when you had to do that?), but by then we had hit rush hour traffic. We finally reached the highway and I managed to make up some time. As we discussed all manner of topics bioethical, I did the math and figured that if I, ahem, flirted with the speed limit, I could just have her to her talk on time.

The New Hampshire state police were not accommodating of this plan, however. Mere yards from our final exit I saw flashing lights in my rearview mirror. Feeling the car slowing down as I pulled over, Adrienne asked brightly, “Oh, are we there?” Mortified, I told her that no, in fact, I was being pulled over for speeding and that we would now certainly be at least a few minutes late for her talk. She would have been well within her rights to be furious with me, but was instead remarkably understanding. (The administrative director of Dartmouth’s Ethics Institute, by contrast, chided me for acting unethically by speeding.) Here‘s a great interview with Adrienne that captures some of her personality, as well as her views about disability and her experiences living with a disability.

Yeshiva University’s notice of Adrienne’s death, along with funeral and shiva details, is here. Tributes are being collected here. She will be missed.

[Cross-posted at The Faculty Lounge]

New Blog, “ACA Death Spiral,” by Houston Law’s Seth Chandler

In case the title of the blog doesn’t make its thrust clear, here’s a snippet from Seth’s opening post:

This blog is going to chronicle what I believe will be the implosion of the Affordable Care Act.  I do not believe the Exchange based system of providing health insurance without medical underwriting is likely to work or that, if it does, it will not need far more massive propping up from federal taxes than is conventionally recognized. We’ll be looking at current events, the history of the Act, important court cases, and regulatory developments. Our tools will be a careful review of primary documents, some graphical and mathematical analyses, and references to important and insightful articles written by others.

Also, there is more to the Affordable Care Act than the Exchanges.  There is more than the individual mandate. There is the employer mandate, the complex systems of federal reinsurance needed to backstop the Act, the reintroduction of medical underwriting under the “wellness label” and so much more.  We’ll try as time permits to take a look at developments in these important areas too.

Seth — who is an insurance law expert — notes the “need for some hard and at least somewhat scientific look at what is going on.” So far, since beginning the blog some 48 hours ago, he has tackled the Upton Bill intended to address the “if you like your health care plan you can keep it” issue (which passed the House this afternoon with the help of 39 Democrats and now heads to the Senate); yesterday’s announced “Obamafix,” intended to address the same issue; whether the ACA’s little-known reinsurance and risk adjustment provisions could make exchanges more resilient to the underenrollment that many, including Seth, anticipate; and five questions journalists should be asking about the ACA (hint: fewer questions about how the rollout is likely to affect the careers of pols; more questions about the winners and losers under the ACA among the rest of us).

Welcome to the blawgosphere, Seth.

[Cross-posted at The Faculty Lounge]

HHS Proposes Rule to Amend NOTA, Nullify Flynn v. Holder

On October 2, in the midst of the government shutdown—either HHS somehow managed to convince itself that the rule was “necessary for the protection of life” or, more likely, it had already been scheduled for printing—HHS quietly published a Notice of Proposed Rulemaking. The proposed rule would effectively moot the recent Ninth Circuit case of Flynn v. Holder by criminalizing the compensation of bone marrow donors, even when the life-saving stem cells are extracted through a newer, minimal risk procedure. In this post, I’ll explain the medicine, the Ninth Circuit’s decision, and what HHS proposes to do in response. In my next post, I’ll have some reaction to HHS’s policy arguments, about which I’m skeptical, and perhaps a few thoughts about where plaintiffs might go from here.

Section 301 of the National Organ Transplant Act (NOTA) of 1984 criminalizes the transfer of “human organs” for “valuable consideration.” Reimbursement of reasonable out-of-pocket expenses associated with travel and lost wages are okay—as are, since the 2008 amendment of NOTA, paired living donor chains—but any other “valuable consideration” that might incentivize sources of organs is not. Under NOTA, as amended,

‘human organ’ means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation

(emphases added). HHS has since added to this list “intestine, including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract.”

So-called “bone marrow transplants”—in reality, infusions of hematopoietic (blood) stem cells (HSCs)—are often life-saving procedures for those with, for example, leukemia or aplastic anemia. (See these sobering statistics compiled by the Institute for Justice, which represented the plaintiffs in Flynn.) When NOTA was passed, the only way to obtain HSCs was through bone marrow aspiration using a long needle thick enough to suck liquid marrow directly from the donor’s pelvic bone. HSCs are then harvested from the marrow. The procedure is done under general anesthesia and so the donor is subject to the usual risks of anesthesia. Although the donor can return to usual activities in two to seven days, discomfort may linger for up to two weeks. Continue reading

The Troubled Peer Review System, the Open Access Wars, & the Blurry Line Between Human Subjects Research & Investigative Journalism

Legal academics who work across disciplines sometimes find themselves in the uncomfortable position of explaining to their stunned colleagues the process by which second- and third-year law students, armed with author c.v.s, decide what gets published and where.

Well, get ready to get your schadenfreude on. For the past 10 months, John Bohannon, a contributing correspondent for Science magazine, has been conducting a sting of (other) science journals and their peer review processes. Much like the famed Sokal hoax, Science submitted to 304 journals a bogus paper written by a fictitious researcher from a nonexistent institution. The paper described “the anticancer properties of a chemical that [the fictitious researcher] had extracted from a lichen,” and according to Bohannon, “[a]ny reviewer with more than a high-school knowledge of chemistry and the ability to understand a basic data plot should have spotted the paper’s short-comings immediately” and rejected it promptly. And yet, over half of the journals accepted the paper. Recall that the bogus paper purports to report on the discovery of the anticancer properties of lichen. Let the prospect of bogus cancer research published in peer reviewed medical journals sink in.  Continue reading

(Taboo) Science, Policy & the Importance of Good Science Communication: Redux

In late May, I wrote the following:

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” — 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.

I had no role in the GWAS itself; that credit goes to SSGAC’s extraordinarily meticulous scientists. I did, however, have a strong hand in the FAQs. And so I am really pleased that in a new editorial, the editors of Nature (not for nothing, Science’s main competitor) highlighted our FAQ as an example of best practices in behavioral genetics research and science communication. They write:

For clarity, scientists would do well to follow the example of the Social Science Genetic Association Consortium. In June, this group published a paper on genetic variants associated with educational attainment (C. A. Rietveld et al. Science 340, 1467–1471; 2013). Accompanying this was a nine-page Frequently Asked Questions document that, in plain, easy-to-understand language, addressed such questions as why the researchers did the study, what they found and what the implications of the work are — and are not (see go.nature.com/7mov2j). The document spelled out that the consortium had not found ‘the gene’ for educational attainment, that each genetic marker found has only a very small effect on length of schooling, and that any policy response based on that single study would be premature.

Scientists cannot be held responsible every time someone misinterprets their work. But simple steps such as these could help to prevent and address some of the potential distortions of behavioural genetics — and could help to ensure that society continues to support the work.

For more on taboo science—including IQ, race, violence, and sexuality—see Erika Check Hayden’s accompanying article, which discusses our Science GWAS in the IQ category and (elsewhere in the article) quotes Duke lawprof (and new Conspirator!) Nita Farahany and Bill of Health guest contributor Yaniv Erlich. Now if we could only get popularizers of science to understand that their lay audience will rarely know that they are “oversimplifying” that science.

[Cross-posted at The Faculty Lounge]

Ethical Concerns, Conduct and Public Policy for Re-Identification and De-identification Practice: Part 3 (Re-Identification Symposium)

This post is part of Bill of Health‘s symposium on the Law, Ethics, and Science of Re-Identification Demonstrations. Background on the symposium is here. You can call up all of the symposium contributions by clicking here. —MM

By Daniel C. Barth-Jones

In Part 1, and Part 2 of this symposium contribution I wrote about a number of re-identification demonstrations and their reporting, both by the popular press and in scientific communications. However, even beyond the ethical considerations that I’ve raised about the accuracy of some of these communications, there are additional ethical, “scientific ethos”, and pragmatic public policy considerations involved in the conduct of re-identification research and de-identification practice that warrant some more thorough discussion and debate.

First Do No Harm

Unless we believe that the ends always justify the means, even obtaining useful results for guiding public policy (as was the case with the PGP demonstration attack’s validation of “perfect population register” issues) doesn’t necessarily mean that the conduct of re-identification research is on solid ethical footing. Yaniv Erlich’s admonition in his “A Short Ethical Manifesto for the Privacy Researcher blog post contributed as part of this symposium provides this wise advice: “Do no harm to the individuals in your study. If you can prove your point by a simulation on artificial data – do it.” This is very sound ethical advice in my opinion. I would argue that the re-identification risks for those individuals in the PGP study who had supplied 5-digit Zip Code and full date of birth were already understood to be unacceptably high (if these persons were concerned about being identified) and that no additional research whatsoever was needed to demonstrate this point. However, if additional arguments needed to be made about the precise levels of the risks, this could have been adequately addressed through the use of probability models. I’d also argue that “data intrusion scenario” uncertainty analyses which I discussed in Part 1 of this symposium contribution already accurately predicted the very small re-identification risks found for the sort of journalist and “nosy neighbor” attacks directed at the Washington hospital data. When strong probabilistic arguments can be made regarding potential re-identification risks, there is little possible purpose for undertaking actual re-identifications that can impact specific persons.

Looking more broadly, it seems more reasonably debatable whether the earlier January re-identification attacks by the Erlich lab on the CEPH – Utah Residents with Northern and Western European Ancestry (CEU) participants could have been warranted by virtue of the attack having exposed a previously underappreciated risk. However, I think an argument could likely be made that, given the prior work by Gitschier which had already revealed the re-identification vulnerabilities of CEU participants, the CEU portion of the Science paper also might not have served any additional purpose in directly advancing the science needed for development of good public policy. Without the CEU re-identifications though, it is unclear whether the surname inference paper would have been published (at least by a prominent journal like Science) and it also seems quite unlikely that it would have sustained nearly the level of media attention.

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Press and Reporting Considerations for Recent Re-Identification Demonstration Attacks: Part 2 (Re-Identification Symposium)

This post is part of Bill of Health‘s symposium on the Law, Ethics, and Science of Re-Identification Demonstrations. 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.

Forecast for Re-identification: Media Storms Continue…

In Part 1 of this symposium contribution, I wrote about the re-identification “media storm” started in January by the Erlich lab’s “Y-STR” re-identifications which made use of the relationship between Short Tandem Repeats (STRs) on the Y chromosome and paternally inherited surnames. Within months of that attack, April and June brought additional re-identification media storms; this time surrounding re-identification of Personal Genome Project (PGP) participants and a separate attack matching 40 persons within the Washington State hospital discharge database to news reports. However, as I have written has sometimes been the case with past reporting on other re-identification risks, accurate and legitimate characterization of re-identification risks has, unfortunately, once again been over-shadowed by distortive and exaggerated reporting on some aspects of these re-identification attacks. Unfortunately, a careful review of both the popular press coverage and scientific communications for these recent re-identification demonstrations displays some highly misleading communications, the most egregious of which incorrectly informs more than 112 million persons (more than one third of the U.S. population) that they are at potential risk of re-identification when they would not actually be unique and, therefore, re-identifiable. While each separate reporting concern that I’ve addressed here is important in and of itself, the broader pattern that can be observed for these communications about re-identification demonstrations raises some serious concerns about the impact that such distortive reporting could have on the development of sound and prudent public policy for the use of de-identified data.

Reporting Fail (and after-Fails)

University of Arizona law professor Jane Yakowitz Bambauer was the first to call out the distortive “reporting fail” for the PGP “re-identifications” in her blog post on the Harvard Law School Info/Law website. Bambauer pointed out that a Forbes article (written by Adam Tanner, a fellow at Harvard University’s Department of Government, and colleague of the re-identification scientist) covering the PGP re-identification demonstration was misleading with regard to a number of aspects of the actual research report released by Harvard’s Data Privacy Lab. The PGP re-identification study attempted to re-identify 579 persons in the PGP study by linking their “quasi-identifiers” {5-digit Zip Code, date of birth and gender} to both voter registration lists and an online public records database. The Forbes article led with the statement that “more than 40% of a sample of anonymous participants” had been re-identified. (This dubious claim was also repeated in subsequent reporting by the same author in spite of Bambauer’s “call out” of the inaccuracy explained below.) However, the mischaracterization of this data as “anonymous” really should not have fooled anyone beyond the most casual readers. In fact, approximately 80 individuals among the 579 were “re-identified” only because they had their actual names included within file names of the publically available PGP data. Some two dozen additional persons had their names embedded within the PGP file names, but were also “re-identifiable” by matching to voter and online public records data. Bambauer points out that the inclusion of the named individuals was “not relevant to an assessment of re-identification risk because the participants were not de-identified,” and quite correctly adds that “Including these participants in the re-identification number inflates both the re-identification risk and the accuracy rate.

As one observer humorously tweeted after reading Bambauer’s blog piece,

It’s like claiming you “reidentified” people from their high school yearbook”.

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My L.A. Times Op-Ed: In Defense of the Evidence-Based Nudge

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…

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OHRP Announces Details of August 28 Public Meeting About SUPPORT and Similar Trials

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.

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OHRP Suspends Compliance Action Against SUPPORT Study Sites Pending Public Hearing & Guidance

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.

Looking for the Next Maryland v. King

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).

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Maryland v. King, Low-Stringency DNA Database Searches, and the Case for a Universal Database

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).

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U.S. Supreme Court Upholds Constitutionality of DNA Collection Upon Arrest (Maryland v. King)

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.

Science, Art, Policy, and the Importance of Good Science Communication

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.