PILAC Report on Wartime Medical Care for Terrorists

Special Guest Post By Dustin A. Lewis, Senior Researcher, Harvard Law School Program on International Law and Armed Conflict

In armed conflicts involving terrorists, should we consider medical assistance to those terrorists a form of impermissible support to the enemy? Or should we consider impartial medical care “above” the conflict? Does the rationale first established in international humanitarian law (IHL) in 1864—that once hors de combat (out of the battle) all wounded fighters, even (indeed, especially) the enemy, should be provided all feasible medical care based on medical need—still hold for contemporary conflicts involving terrorists? Where the IHL protections for medical care are predicated (at least in part) on the caregiver complying with “medical ethics,” what exactly are those ethics? And should “medical ethics”—whether concerning the treatment of terrorists in particular or of the population in general—be the same in wartime as in (relative) peacetime?

In a recent research briefing for the Harvard Law School Program on International Law and Armed Conflict (HLS PILAC), my co-authors (Professor Gabriella Blum and Naz K. Modirzadeh) and I raise these and other issues. Titled “Medical Care in Armed Conflict: International Humanitarian Law and State Responses to Terrorism,” the report evaluates IHL protections for wartime medical assistance concerning terrorists. In addition, we examine how the United Nations Security Council has imposed numerous binding counterterrorism measures, but, in doing so, the Council has not fully exempted medical care, even where those counterterrorism measures may implicate medical care protected under IHL. We also analyze the practice of three states—Colombia, Peru, and the United States—regarding domestic prosecutions of wartime medical treatment for terrorists. Continue reading

REGISTER NOW! Specimen Science: Ethics and Policy Implications Symposium, with NEW Lunchtime Talk on “Biospecimens and the NPRM”

testtube_hand_bw_slideSpecimen Science: Ethics and Policy Implications
NEW Lunchtime Talk on “Biospecimens & the NPRM”
Monday,  November 16, 2015, 8:00 AM – 5:00 PM
8-11:45am: Austin Hall North (100);
11:45am-5:30pm, Langdell Hall South, Room 272

Harvard Law School, Cambridge, MA [Map]

Many important advances in human health depend on the effective collection, storage, use, and sharing of biological specimens and their associated data.   However, recent controversies involving specimen-based research have raised important questions about ownership, data-sharing, privacy considerations, group harms, and standards for responsible specimen stewardship.

Please join us for a symposium to discuss the key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery.  The experts at this day-long event will cover key topics, such as historical, legal, and international perspectives; donor attitudes, researcher perspectives, and institutional considerations; broad vs. specific informed consent; privacy, ownership, and control; use of specimens collected through mandatory newborn screening; research with discrete and insular populations; and others.  Conference papers eventually will be published as an edited volume with a major academic press.


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Panel: Is Professional Football Safe? Could We Make It Safer? Perspectives from Neuroscience, Law, and Ethics

Join us for a panel discussion as part of the 2015 Annual Meeting of the International Neuroethics Society!
October 15, 2015 Panel: 5:00 – 6:30 PM, Reception: 6:30 – 7:15 PM
Northwestern University Hughes Auditorium
303 E. Superior Street, Chicago, IL

Professional football has come under significant scrutiny in recent years, particularly because of concerns over player health and safety.  While concussions are most often discussed, players also face a variety of other health risks, from joint and muscle problems to cardiac malfunction to issues with chronic pain. But health risks are just one part of story. So, too, are the potential short and long-term benefits these exceptional athletes may reap from the game.

Come learn more about the debate, and about The Football Players Health Study at Harvard University, which seeks to understand and improve the health and wellbeing of former NFL players. This study looks at the risks and benefits of playing football at the professional level over the life of the player, supports novel discoveries and new therapies, and seeks to improve the systems and organizational structures that may affect player health.

Panelists: Continue reading

NPRM Symposium: More Resources, Now from OHRP

The Office for Human Research Protections (HHS) has released a series of 6 webinars to help the public better understand the goals and impact of the NPRM.  Happy viewing:

  1. Overview of the NPRM (approx. 34 mins.), Jerry Menikoff, Director, OHRP
  2. Exclusions and Exemptions (approx. 30 mins.), Jerry Menikoff, Director, OHRP
  3. Informed Consent (approx. 28 mins.), Jerry Menikoff, Director, OHRP
  4. IRB Review and Operations (approx. 18 mins.), Julia Gorey, Policy Analyst, Division of Policy and Assurances, OHRP
  5. Research with Biospecimens (approx. 22 mins.), Julie Kaneshiro, Deputy Director, OHRP
  6. Secondary Research Use of Data (approx. 21 mins.), Ivor Pritchard, Senior Advisor to the Director, OHRP

Research Ethics Extravaganza: New Draft CIOMS Guidelines

As if the proposed revisions to the Common Rule weren’t enough to process, the Council for International Organizations of Medical Sciences (CIOMS) just released its proposed changes to the current CIOMS Ethical Guidelines for Biomedical Research (last revised in 2002).  CIOMS invites public comments until March 1, 2016, at which point the CIOMS Working Group will process and review them and submit the final document to the CIOMS Executive Committee for approval.

According to CIOMS, most guidelines have been substantially revised in this draft, several have been merged, and new guidelines have been added.  The proposal also merges the guidelines for biomedical research with those for epidemiological research, and the scope has been broadened from biomedical research to health-related research with humans.

A busy and exciting time in research ethics!

NPRM Symposium: Resources from PRIM&R

Our colleagues at PRIM&R (Public Responsibility in Medicine & Research) have compiled several resources to help those interested in the proposed changes to the Federal Policy for the Protection of Human Subjects, or the Common Rule.  These include an NPRM Resources page, with a chart comparing the current Common Rule with the proposed changes by section, and other materials.  PRIM&R has also recently released a freely available (till December 11, when it becomes available only to members) annotated version of the current Common Rule, which provides the regulatory text, hyperlinked to further information in the form of guidance, frequently asked questions, and regulatory resources from the Office for Human Research Protections.

PRIM&R will be blogging about the NPRM in the coming weeks, and we will cross-post here.  Stay tuned.

NPRM Symposium: Helpful Resources to Understand What the NPRM Proposes to Change

For those trying to make sense of the NPRM, the Academic and Clinical Research Group at Verrill Dana has issued two very helpful resources: 

  1. A redline of HHS’s current Common Rule regulations at 45 C.F.R Part 46, Subpart A against the proposed regulations in the NPRM.
  2. Several decision charts walking through the following issues: 
  • the scope of covered human subject research and clinical trials,
  • the key definitions of “human subject” and “research,”
  • the exclusions (and conditions for exclusion) from the proposed regulations, and
  • the exemptions (and associated requirements) from the proposed regulations.

For those interested, the firm’s full client advisories on the NPRM are available here

[Posted with Verrill Dana’s permission]

TOMORROW (9/30): Non-Human Primates in Research – Legal and Ethical Considerations


Non-Human Primates in Research: Legal and Ethical Considerations
September 30, 2015, 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]


Please join us for a discussion of critical legal, ethical, scientific, and social issues raised by research involving non-human primates, and the research centers that house them.  What does the current regulatory structure require and permit, what gaps exist, what enforcement problems have arisen, and how are they being addressed at Harvard and elsewhere?  How should scientific and medical interests be balanced against the interests of the animals, and how might the ethical and/or regulatory analysis differ depending on the type of primate involved?  What trends are emerging with regard to funding, scientific approaches, and public opinion?  Our panelists will address these questions and others in the course of a lively debate.

Panelists: Continue reading

Big Data, Genetics, and Re-Identification

by Zachary Shapiro

While all scientific research produces data, genomic analysis is somewhat unique in that it inherently produces vast quantities of data. Every human genome contains roughly 20,000-25,000 genes, so that even the most routine genomic sequencing or mapping will generate enormous amounts of data. Furthermore, next-generation sequencing techniques are being pioneered to allow researchers to quickly sequence genomes. These advances have resulted in both a dramatic reduction in the time needed to sequence a given genome, while also triggering a substantial reduction in cost. Along with novel methods of sequencing genomes, there have been improvements in storing and sharing genomic data, particularly using computer and internet based databases, giving rise to Big Data in the field of genetics.

While big data has proven useful for genomic research, there is a possibility that the aggregation of so much data could give rise to new ethical concerns. One concern is that promises of privacy made to individual participants might be undermined, if there exists a possibility of subject re-identification.

Re-identification of individual participants, from de-identified data contained in genetic databases, can occur when researchers apply unique algorithms that are able to cross-reference numerous data sets with the available genetic information. This can enable diligent researchers to re-identify specific individuals, even from data sets that are thought to be anonymized. Such re-identification represents a genuine threat to the privacy of the individual, as a researcher could learn about genetic risk factors for diseases, or other sensitive health and personal information, from combing through an individual’s genetic information.

Continue reading

What’s the Difference Between Anorexia Nervosa and Hunger Strike?

My last post presented the debate over force feeding hunger striking prisoners in Israel. This post will discuss another group subjected to the dramatic means of force feeding in extreme circumstances, Anorexia Nervosa patients (AN).

Although ethical justifications for force-feeding are similar for both Anorexics and Hunger strikers (save life), the legal framework is completely different in each context. Whereas hunger striking prisoners were dealt with via ad-hoc legislation meant to answer national security threats, AN patients are handled within the framework of mental health law.  In the U.S., compulsory hospitalization of mental patients occurs through the state’s Civil Commitment Laws, which require dangerousness resulting from a mental illness to be evaluated by a psychiatrist.

Is the different legal attitude justified? How is it that the same act performed by prisoners is viewed as a political assertion but when done predominantly by adolescent middle-upper class girls, it is considered mental illness?

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Texas, Abortion, and the Supreme Court – Part II

[cross-posted at Prawfsblawg]

By Jessie Hill

In this second post on the certiorari petition in Whole Women’s Health v. Cole, I want to consider the likelihood that the Supreme Court will take this case, and if it does, what it is likely to do with it.

I think it’s a very good bet that the Supreme Court will decide to hear this case this Term, perhaps in conjunction with one of the other cases that deals with admitting privileges laws – either Currier v. Jackson Women’s Health Organization, another admitting privileges case, in which the Fifth Circuit actually enjoined an admitting-privileges requirement that would have shut down the last remaining abortion clinic in Mississippi, or Planned Parenthood v. Van Hollen, in which the Seventh Circuit enjoined an admitting-privileges law. However, both of those cases are still at the preliminary-injunction stage, unlike Whole Women’s Health, which was rushed to trial on an expedited schedule. Still, SCOTUS has been holding onto the petition in Jackson Women’s Health Organization since the spring and may well decide to consolidate it with Whole Women’s Health. (No petition has yet been filed in Van Hollen, as that case is back in front of the district court and scheduled for trial.)

There are a lot of reasons for the Court to grant cert in at least one of these cases.

Continue reading

Bioethicist Art Caplan: Science Anyone?

Bill of Health Contributor Arthur Caplan has a new piece up on bioethics.net. From the piece:

Plenty of pundits are analyzing the Wednesday night GOP debate in terms of who won and who lost. They are missing the point. There was a huge loser in the back and forth among the contenders—the public health of the American people. Why?–the resurrection in the debate of the heinous canard that vaccination causes autism.

Donald Trump led the assault on the health of our children by proclaiming that “”We’ve had so many instances … a child went to have the vaccine, got very, very sick, and now is autistic.” Really? Donald produce your evidence or get your racist, misogynist, birther, comb-over tushy out of the race. There is no evidence that vaccines cause autism. None. No one should tolerate outright lying that puts vulnerable kids at risk from a would-be President. So Donald show us your proof or leave Americas kids alone. […]

Read more here.

A Circuit Split on Contraceptives Coverage

Perhaps foreshadowed by the dissent in the 10th Circuit that I wrote about here, the 8th Circuit has now officially launched a circuit split regarding the legal validity of the accommodation that allows modified compliance/objection to the contraceptives coverage mandate.  Unlike the seven other circuits to have considered the question since Hobby Lobby, the 8th Circuit yesterday issued opinions upholding preliminary injunctions in two cases (here and here), thereby preventing the mandate+accommodation from being enforced against the objecting non-profits.

First, the 8th Circuit determined that the accommodation still substantially burdens objectors’ religious beliefs because it imposes significant financial penalties if they refuse to comply with a requirement that they view as violative of those religious beliefs. As I explained previously, I do think the court was right to focus on the monetary consequences of objection, rather than assuming that merely filing the required paperwork for an accommodation does not or cannot actually make objectors complicit in the way they claim it does.

Like SCOTUS in Hobby Lobby, the 8th Circuit then went on to assume that the contraceptives coverage mandate advances a compelling government interest, which is the next step in the analysis under the Religious Freedom Restoration Act once the substantial burden test is met.  So far, so good.  But that’s the end of my agreement.

Continue reading

Texas, Abortion, and the Supreme Court

[cross-posted at Prawfsblawg]

By Jessie Hill

Several Texas abortion providers have filed a petition for certiorari in Whole Women’s Health v. Cole, asking the U.S. Supreme Court to decide on the constitutionality of a Texas state law requiring abortion providers to have admitting privileges at a local hospital and requiring all abortion clinics to qualify as ambulatory surgical centers (ASCs), including requirements that are more demanding than those that apply to other, similar facilities that do not provide abortions. Here is my brief analysis of the legal issues in that case. (Note that this analysis is only of the “undue-burden” issues; there is also a res judicata issue in that case, which I will not analyze.)

The plaintiffs in Whole Women’s Health claim that the admitting-privileges and ASC requirements are unconstitutional because, under the standard identified in Planned Parenthood v. Casey, they impose an undue burden on the right to abortion. There are basically two ways in which these requirements can be seen to impose an undue burden.

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Monday, 9/21, HLS Health Law Workshop with Jessica Roberts

HLS Health Law Workshop: Jessica Roberts

September 21, 2015 5:00 PM
Hauser Hall, Room 102
Harvard Law School, 1575 Massachusetts Ave, Cambridge MA

Download the paper: “Theories of Genetic Ownership”

Jessica L. Roberts is the Director of the Health Law and Policy Institute and an Associate Professor of Law at the University of Houston Law Center. She specializes in health law, disability law, and genetics and the law. Prior to UH, Professor Roberts was an Associate-in-Law at Columbia Law School and an Adjunct Professor of Disability Studies at the City University of New York. Immediately after law school, she clerked for the Honorable Dale Wainwright of the Texas Supreme Court and the Honorable Roger L. Gregory of the Fourth Circuit Court of Appeals.

Professor Roberts’ research operates at the intersection of health law and antidiscrimination law. Her scholarship has appeared, or is forthcoming, in the Indiana Law Journal, the William and Mary Law Review, the Iowa Law Review, the Minnesota Law Review, the University of Illinois Law Review, the Notre Dame Law Review, the Vanderbilt Law Review, the University of Colorado Law Review, the American Journal of Law and Medicine and the Journal of Law and the Biosciences, among others. Professor Roberts teaches, or has taught, Contracts, Disabilities and the Law, Genetics and the Law, and Health Law Survey. In 2015, she received the university-wide Teaching Excellence Award and the Provost’s Certificate of Excellence. Professor Roberts was named a 2018 Greenwall Faculty Scholar in Bioethics.

Introducing New Contributor Jessie Hill

jessie_hill_peopleJessie Hill is joining Bill of Health as a regular contributor.

Jessie Hill is the Judge Ben C. Green Professor of Law and Associate Dean for Academic Affairs at Case Western Reserve University School of Law. She teaches and writes in the fields of constitutional law, health law, and law and religion. Her scholarship has been published in the Michigan Law Review, Duke Law Journal, Columbia Journal of Gender and Law, and the Texas Law Review, among others. Prior to teaching, Professor Hill worked at the Reproductive Freedom Project of the national ACLU office in New York, litigating challenges to state-law restrictions on reproductive rights, and then practiced First Amendment and civil rights law with a small law firm in Cleveland. She is a member of the Academic Advisory Board of Law Students for Reproductive Justice and is a frequent lecturer and consultant on reproductive rights issues.