NPRM Symposium: How Should We Think About Whether To Donate Our Leftover, Non-Identified Tissue to Research?

By Michelle Meyer

Proposed changes to the federal Common Rule would ask patients for the first time to decide whether to allow their non-identified, leftover tissue to be used for research or thrown away. For that choice to be meaningful, the public needs to be aware of the nature, risks, and benefits of biospecimens research, and of what the proposed changes will—and will not—do. In my latest Forbes essay, “No, Donating Your Leftover Tissue To Research Is Not Like Letting Someone Rifle Through Your Phone,” I consider the power of analogies and other reflections on Rebecca Skloot’s recent New York Times op-ed on the NPRM.

Call for Papers: Designing Ethical Review Processes for Big Data Research

By Michelle Meyer 

The Future of Privacy Forum is hosting an academic workshop supported by the National Science Foundation to discuss ethical, legal, and technical guidance for organizations conducting research on personal information. Authors are invited to submit papers for presentation at a full-day program to take place on December 10, 2015. Papers for presentation will be selected by an academic advisory board and published in the online edition of the Washington and Lee Law Review. Four papers will be selected to serve as “firestarters” for the December workshop, awarding each author with a $1000 stipend. Submissions, which are due by October 25, 2015, at 11:59 PM ET, must be 2,500 to 3,500 words, with minimal footnotes and in a readable style accessible to a wide audience. Publication decisions and workshop invitations will be sent in November. Details here.

(UPDATED) Defendants’ Motion for Summary Judgment Granted in Looney v. Moore (SUPPORT trial lawsuit)

By Michelle Meyer

UPDATE: Plaintiffs have filed an appeal in the U.S. Court of Appeals for the Eleventh Circuit. Their brief is due on October 19.

The district court has granted summary judgment (opinion pdf) for all remaining defendants as to all of plaintiffs’ remaining claims in Looney v. Moore, the lawsuit arising out of the controversial SUPPORT trial, which I last discussed here. This therefore ends the lawsuit, pending possible appeal by the plaintiffs.

Plaintiff infants include two who were randomized to the low oxygen group and survived, but suffer from “neurological issues,” and one who was randomized to the high oxygen group who developed ROP, but not permanent vision loss. In their Fifth Amended Complaint (pdf), plaintiffs alleged negligence, lack of informed consent, breach of fiduciary duty, and product liability claims against, variously, individual IRB members, the P.I., and the pulse oximeter manufacturer. What unites all of these claims is the burden on plaintiffs to show (among other things) that their injuries were caused by their participation in the trial. Read More

Interpreting Fiorina’s Comments on Vaccination Law

By Michelle Meyer

I’ve started writing for Forbes as a regular contributor. My first piece, Carly Fiorina Says Her Views On Vaccines Are Unremarkable; For Better Or Worse, She’s Right, analyzes GOP presidential candidate Carly Fiorina’s recent ad hoc remarks on the relative rights of parents and schools with respect to vaccinations and to some of the hyperbolic reactions to those remarks. Fiorina’s remarks are ambiguous, in ways that I discuss. But, as the title of the article suggests, and for better or worse, I think that the best interpretation of them places her stance squarely in the mainstream of current U.S. vaccination law. I end with a call for minimally charitable interpretations of others’ views, especially on contentious issues like vaccination.

New York Times Op-Ed on the A/B Illusion & the Virtues of Data-Driven Innovation

By Michelle Meyer

I have an op-ed with Christopher Chabris that appeared in this past Sunday’s New York Times. It focuses on one theme in my recent law review article on corporate experimentation: the A/B illusion. Despite the rather provocative headline that the Times gave it, our basic argument, made as clearly as we could in 800 words, is this: sometimes, it is more ethical to conduct a nonconsensual A/B experiment than to simply go with one’s intuition and impose A on everyone. Our contrary tendency to see experiments—but not untested innovations foisted on us by powerful people—as involving risk, uncertainty, and power asymmetries is what I call the A/B illusion in my law review article. Here is how the op-ed begins:

Can it ever be ethical for companies or governments to experiment on their employees, customers or citizens without their consent? The conventional answer — of course not! — animated public outrage last year after Facebook published a study in which it manipulated how much emotional content more than half a million of its users saw. Similar indignation followed the revelation by the dating site OkCupid that, as an experiment, it briefly told some pairs of users that they were good matches when its algorithm had predicted otherwise. But this outrage is misguided. Indeed, we believe that it is based on a kind of moral illusion.

After the jump, some clarifications and further thoughts.

Read More

The Ethics of Punking the Diet-Research Media Complex (and Millions of Readers)

Scale

By Michelle Meyer

A remarkable new “sting” of the “diet research-media complex” was just revealed. It tells us little we didn’t already know and has potentially caused a fair amount of damage, spread across millions of people. It does, however, offer an opportunity to explore the importance of prospective group review of non-consensual human subjects research—and the limits of IRBs applying the Common Rule in serving that function in contexts like this.

Journalist John Bohannon, two German reporters, a doctor and a statistician recruited 16 German subjects through Facebook into a three-week randomized controlled trial of diet and weight loss. One-third were told to follow a low-carb diet, one-third were told to cut carbs but add 1.5 ounces of dark chocolate (about 230 calories) per day, and one-third served as control subjects and were told to make no changes to their current diet. They were all given questionnaires and blood tests in advance to ensure they didn’t have diabetes, eating disorders, or other conditions that would make the study dangerous for them, and these tests were repeated after the study. They were each paid 150 Euros (~$163) for their trouble.

But it turns out that Bohannon, the good doctor (who had written a book about dietary pseudoscience), and their colleagues were not at all interested in studying diet. Instead, they wanted to show how easy it is for bad science to be published and reported by the media. The design of the diet trial was deliberately poor. It involved only a handful of subjects, had a poor balance of age and of men and women, and so on. But, through the magic of p-hacking, they managed several statistically significant results: eating chocolate accelerates weight loss and leads to healthier cholesterol levels and increased well-being. Read More

Two Cheers for Corporate Experimentation

Rubin's vase2By Michelle Meyer

I have a new law review article out, Two Cheers for Corporate Experimentation: The A/B Illusion and the Virtues of Data-Driven Innovation, arising out of last year’s terrific Silicon Flatirons annual tech/privacy conference at Colorado Law, the theme of which was “When Companies Study Their Customers.”

This article builds on, but goes well beyond, my prior work on the Facebook experiment in Wired (mostly a wonky regulatory explainer of the Common Rule and OHRP engagement guidance as applied to the Facebook-Cornell experiment, albeit with hints of things to come in later work) and Nature (a brief mostly-defense of the ethics of the experiment co-authored with 5 ethicists and signed by an additional 28, which was necessarily limited in breadth and depth by both space constraints and the need to achieve overlapping consensus).

Although I once again turn to the Facebook experiment as a case study (and also to new discussions of the OkCupid matching algorithm experiment and of 401(k) experiments), the new article aims at answering a much broader question than whether any particular experiment was legal or ethical. Read More

Call for Abstracts: Constitutional Challenges to the Regulation of Food, Drugs, Medical Devices, Cosmetics & Tobacco Products

The Food and Drug Law Journal is pleased to announce a forthcoming symposium—Constitutional Challenges to the Regulation of Food, Drugs, Medical Devices, Cosmetics, and Tobacco Products—to be held at the Georgetown University Law Center (GULC) on Friday, October 30, 2015, and co-sponsored by the Food and Drug Law Institute and GULC’s O’Neill Institute for National and Global Health Law.

The deadline for submitting abstracts is June 1, 2015. Download more information about the symposium here.

In Memoriam: John D. Arras (1945-2015)

By Michelle Meyer

I am deeply saddened to report that bioethicist John D. Arras died on March 9, 2015.Arras John was the Porterfield Professor of Bioethics and Professor of Philosophy at the University of Virginia, where he directed the undergraduate bioethics program, held an additional appointment at the School of Medicine’s Center for Biomedical Ethics and Humanities, and over the years co-taught multiple courses at the Law School. He was a leading figure in the field of bioethics, and held several prestigious appointments beyond UVa including, at the time of his death, as a Fellow of The Hastings Center and a commissioner of the Presidential Commission for the Study of Bioethical Issues (whose recent report on Ebola he spoke to a journalist about just days ago). He also consulted regularly at the National Institutes of Health and was a founding member of the ethics advisory board of the Centers for Disease Control and Prevention.

John’s scholarly focus in bioethics was two-fold. First, like most bioethicists, John tackled concrete practical ethical problems involving medicine, public health, and the biosciences. His interests in this regard were fairly broad, but he focused on physician-assisted suicide, public health, human subjects research, and what justice requires in the way of access to health care. Read More