When you Can Shed Blood for your Country but not Donate it

Portsmouth, Va. (Jan. 5, 2005) - A hospital corpsman assigned to USS Bataan (LHD 5), donates a pint of blood during the blood drive held by the Blood Donor Team. The Blood Donor Team stationed at Portsmouth Naval Hospital visits multiple commands throughout the area in efforts to boost the blood supply for the U.S. Armed Forces around the world. U.S. Navy photo by Photographer’s Mate 3rd Class Jeremy L. Grisham (Image from Wikimedia Commons).

A hospital corpsman donates a pint of blood. U.S. Navy photo by Photographer’s Mate 3rd Class Jeremy L. Grisham (Image from Wikimedia Commons).

I have a new article in JAMA this week, “Reconsideration of the Lifetime Ban on Blood Donation by Men Who Have Sex With Men,” co-authored with my former student Jeremy Feigenbaum and my frequent co-author Dr. Eli Adashi (former Dean of Medicine at Brown). In the article we show that FDA’s current policy is morally, ethically, and legally problematic. We are out of step with our peer countries (including the UK, Canada, South Africa) who do delay when men who have sex with men can give blood but not for a lifetime, the way the U.S. does. It is remarkable that if you have sex with a female prostitute or a woman who is HIV+ you face only a 12-month deferral in the U.S. but if you have had sex with a man, just once, ever, no matter his HIV status you face a lifetime delay.

We are in a world where the Defense of Marriage Act was struck down as unconstitutional, where Don’t Ask Don’t Tell has been struck down so that gay men and lesbians can proudly serve their country and shed blood (their own, others) on the battlefield. It is time to change a 30-yr old policy prohibiting them giving blood. What’s more, given the the Windsor decision and the recent Ninth Circuit application of heightened scrutiny to the exclusion of gay jurors for jury duty, we think there are serious constitutional questions about FDA’s policy as well.

My preferred approach, and the one I think FDA should move towards, is the Italian “test and assess” which has no blanket classification of MSM but instead does individualized risk assessment. As we describe in our paper thus far has not increased the risk of HIV+ blood making its way into the blood supply.

The Williams Institute in 2010 estimated that 6% of men had at least once had sex with another man, meaning there are potentially 7.2 million men who could become blood donors but are excluded by FDA’s rule. We owe it not only to these men, but also to all those who could benefit from their blood donations to revisit this rule.

Michelle Meyer: Misjudgements Will Drive Social Trials Underground

Michelle Meyer has a new piece in Nature – an open letter on the Facebook study signed by a group of bioethicists (including PFC’s Executive Director Holly Fernandez Lynch) in which she argues that a Facebook study that manipulated news feeds was not definitively unethical and offered valuable insight into social behavior.

From the piece:

“Some bioethicists have said that Facebook’s recent study of user behavior is “scandalous”, “violates accepted research ethics” and “should never have been performed”. I write with 5 co-authors, on behalf of 27 other ethicists, to disagree with these sweeping condemnations (see go.nature.com/XI7szI).

We are making this stand because the vitriolic criticism of this study could have a chilling effect on valuable research. Worse, it perpetuates the presumption that research is dangerous.”

Read the full article.

Petrie-Flom Center Launches New Book on Human Subjects Research Regulation

Human Subjects Research Regulations Book CoverThe Petrie-Flom Center is pleased to announce publication of Human Subjects Research Regulation: Perspectives on the Future (MIT Press 2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive Director, Holly Fernandez Lynch.  This edited volume stems from the Center’s 2012 annual conference, which brought together leading experts in a conversation about whether and how the current system of human subjects research regulation in the U.S. ought to change to fit evolving trends, fill substantial gaps, and respond to identified shortcomings.

The book is currently available from MIT Press and Amazon, in hardcover and paperback.  We will be hosting a book discussion at Harvard Law School on October 22, and in Baltimore on December 5 at Public Responsibility in Medicine and Research (PRIMR)’s annual Advancing Ethical Research Conference.  Details will be announced shortly.

 From the book jacket:

 The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. Invigorated by the U.S. government’s first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protection.

After reviewing the history of U.S. research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts.

Contributors
 Adam Braddock, Alexander Morgan Capron, Ellen Wright Clayton, I. Glenn Cohen, Susan Cox, Amy L. Davis, Hilary Eckert, Barbara J. Evans, Nir Eyal, Heidi Li Feldman, Benjamin Fombonne, Elisa A. Hurley, Ana S. Iltis, Gail H. Javitt, Greg Koski, Nicole Lockhart, Holly Fernandez Lynch, Michael McDonald, Michelle N. Meyer, Osagie K. Obasogie, Efthimios Parasidis, Govind Persad, Rosamond Rhodes, Suzanne M. Rivera, Zachary M. Schrag, Seema K. Shah, Jeffrey Skopek, Laura Stark, Patrick Taylor, Anne Townsend, Carol Weil, Brett A. Williams, Leslie E. Wolf

For a more information, including the full table of contents, check out the book on the MIT Press website

Art Caplan New Op-Ed: When Does Human Life Begin?

Art Caplan has a new Op-Ed on The Council for Secular Humanism about when human life begin.

From the piece:

“When does human life begin? For those in the “personhood” movement in the United States, there is no doubt about when that happens—it is at conception, when the sperm meets the egg. The personhood movement has gained a foothold among antiabortion activists who are looking to pass laws that define embryos as people with full rights. Personhood advocates aim to outlaw all abortions, along with in vitro fertilization, embryonic stem-cell research, and emergency contraception. Granting embryos personhood would also mean that someone who killed a pregnant woman at any stage in her pregnancy would be at risk of prosecution for a double homicide. And in those states that restrict a woman’s right to utilize a living will if she is pregnant, no living will could apply from the moment of conception..”

Read the full article.

Translating “ELSI” into Policy

by Guest Blogger Wylie Burke MD, PhD.

When the Human Genome Project began in 1990, the National Center for Human Genome Research – now the National Human Genome Research Institute (NHGRI) – created a research funding program for evaluation of the ethical, legal, and social implications (ELSI) of genomics. ELSI scholars study a wide range of issues, from the responsible conduct of genomic research, to implementation and outcomes of genetic testing programs, to intellectual property challenges.  But how should this research be evaluated? In particular, what impact should we expect for this kind of research? These questions are particularly challenging for those of us who work in the multidisciplinary Centers of Excellence in ELSI Research (CEERs) funded by the NHGRI, because these centers have been given a programmatic charge to consider policy-relevant questions and help to inform the policy-making process. A group of ELSI researchers, representing seven CEERs, have been deliberating these questions and recently published a paper with recommendations.

We noted, first of all, that policy-making occurs in many venues. Although discussions often focus on governmental policies, policy-making in other venues often influences genomic translation, including actions as diverse as Institutional Review Board (IRB) decisions about consent and return of results; guidelines promulgated by professional organizations; funding decisions of health insurers; and investment decisions of venture capital.   In addition, policy-making in one arena may influence the need for policies in another. For example, practice guidelines influence the use of genetic testing and may in turn influence how clinical data are accessed to evaluate test outcomes, or how IRBs decide what genetic results should be returned to research participants. Continue reading

Call for Submissions: Journal of Law and the Biosciences

JLB coverCall for Submissions: Journal of Law and the Biosciences

Deadline: Rolling.

The Journal of Law and the Biosciences (JLB) is actively soliciting original manuscripts, responses, essays, and book reviews devoted to the examination of issues related to the intersection of law and biosciences, including bioethics, neuroethics, genetics, reproductive technologies, stem cells, enhancement, patent law, and food and drug regulation. JLB welcomes submissions of varying length, with a theoretical, empirical, practical, or policy oriented focus.

JLB is the first fully open access peer-reviewed legal journal focused on the advances at the intersection of law and the biosciences. A co-venture between Duke University, Harvard Law School, and Stanford University, and published by Oxford University Press, this open access, online, and interdisciplinary academic journal publishes cutting-edge scholarship in this important new field. JLB is published as one volume with three issues per year with new articles posted online on an ongoing basis.

For more information about JLB, click here. To submit a manuscript, click here.

Art Caplan: Facebook Experiment Used Silicon Valley Trickery

Art Caplan has a new opinion piece on NBCNews about a recently published study in The Proceedings of the National Academy of Sciences, where a  Facebook scientist teamed up with two academics to subtly tweak the news feeds of nearly 700,000 Facebook users.

From the piece:

“The question of whether or not an experiment is ethical hinges upon the question of “informed consent.” Generally, this means that a subject in a study needs to have basic information about the study he’s participating in, understand the nature of the experiment and its risks and benefits, and have the ability to withhold his consent without fear of harm or retribution.

The authors of the study argue that they obtained subject consent: Their manipulation of Facebook users’ emotions was “… consistent with Facebook’s Data Use Policy, to which all users agree prior to creating an account on Facebook, constituting informed consent for this research.” This is nonsense; it’s not informed consent. It is an old Silicon Valley trick for systematically eliminating the legal rights of its customers.”

Read the full article.

Informed consent in social media research

Guest post by Winston Chiong, MD, PhD

Cross-posted from Geripal

facebook research ethics

I’m simultaneously a behavioral researcher, an ethicist, and a hopeless Facebook addict, so I’ve been thinking a lot about last week’s controversial study (Kramer et al, PNAS 2014) in which researchers manipulated the emotional content of 689,003 Facebook users’ News Feeds. In summary, users who saw fewer of their friends’ posts expressing negative emotions went on to express more positive and fewer negative emotions in their own posts, while users who saw fewer posts expressing positive emotions went on to express more negative and fewer positive emotions in their posts.

This provides evidence for “emotional contagion” through online social networks—that we feel better when exposed to other people’s positive emotions, and worse when exposed to negative emotions. This finding isn’t obvious, since some have suggested that seeing other people’s positive posts might make us feel worse if our own lives seem duller or sadder in comparison.

The journal and authors clearly did not anticipate a wave of online criticism condemning the study as unethical. (Full disclosure: one of the authors is also a researcher at UCSF, though I don’t think I’ve ever met her.) In particular, the authors claimed that participants agreed to Facebook’s Data Use Policy when they created their Facebook accounts, and this constituted informed consent to research. Looking at the Common Rule governing research on human subjects, it’s clear that the requirements of informed consent (including a description of the purposes of the research, expected duration, risks/benefits, compensation for harms…) are not met just because subjects click “Agree” to this sort of blanket terms of use. There are exceptions to these requirements, and some people have suggested that the research could have qualified for a waiver of informed consent if the researchers had applied for one. I’m not so sure about that argument, and in any case the researchers hadn’t.

While the online discussion about this study has been fascinating, I think there are a few points that haven’t received as much attention as I think they deserve:  Continue reading

In the Aftermath of Hobby Lobby

By Gregory Curfman and Holly Fernandez Lynch

[A quick follow up to our recent NEJM Perspective on the case, with I. Glenn Cohen]

Immediately after Justice Samuel Alito’s announcement on June 30 of the majority opinion in Burwell v. Hobby Lobby, the Supreme Court took further actions on the contraceptive mandate, and both supporters and opponents of the opinion were furiously assessing the implications and impact of what has proved to be a wild week for women’s access to contraception.

A report from the IMS Institute last April found that 24 million more prescriptions for oral contraceptives without a copayment were written in 2013 (when the contraceptive mandate was in full effect) than in 2012 (when it was not). This translates into a savings of $483 million for women (on average $269 per person). The percentage of women with no out-of-pocket costs for contraceptives increased from 14% to 56%. What will be the impact of the Supreme Court’s decision in Hobby Lobby on these trends?

The Hobby Lobby opinion is quite clear that the contraceptive mandate, spawned by the Affordable Care Act, may not be enforced against closely held, for-profit companies with religious objections to paying for contraceptives coverage. In other words, such companies will not face the hefty fines for noncompliance that would otherwise be imposed by the Department of Health and Human Services.

Nonprofit Organizations

The opinion does not, however, apply to religious-affiliated, nonprofit organizations, such as Catholic schools or religious charities. For such organizations that object to paying for contraceptives coverage, the applicable regulation provided an accommodation by which the entities themselves were off the hook, but instead their insurers (or in the case of self-insured organizations, a third party administrator) would be required to provide free contraceptives coverage without cost to either the employee or the employer.  In order to be eligible for this accommodation, the nonprofit entity must complete a form designating its objection and provide a copy to its health insurance issuer or a third party administrator. A number of nonprofits filed lawsuits asking that they be exempt from even this requirement, on the grounds that they were still being required to violate their religious beliefs by deputizing someone else to provide the objectionable services. One such group, the Little Sisters of the Poor in Colorado, a group of nuns who perform charity work, was granted an injunction by the Supreme Court last January.

Continue reading

Religious Freedom and Access to Health Care

SCOTUSfrontCheck out the “hot off the press” New England Journal of Medicine Perspectives piece “When Religious Freedom Clashes with Access to Care” by Petrie-Flom Faculty Director I. Glenn Cohen, Executive Director Holly Fernandez Lynch, and NEJM Executive Editor (and PFC Faculty Affiliate), Gregory Curfman.  We review the legal background for SCOTUS’ Hobby Lobby decision, summarize the majority and dissenting opinions, and clarify some key implications of the case, including further problematization of the employer-based health insurance system, reduced likelihood of future attempts to offer religious exemptions to health care mandates, and expanded religious challenges in the health care space.  We close by noting that although the public’s ire and praise has been directed at the Justices, they were applying Congress’ statute – and Congress could (but is very unlikely to) amend the Religious Freedom Restoration Act to be less stringent, or otherwise intervene to ensure that women have affordable access to contraceptive services regardless of their employer’s beliefs.

Take a look and let us know what you think!

Open Clinical Ethics Positions at Boston Children’s Hospital

Interested candidates should apply at www.childrenshospital.jobs.

 Temporary Clinical Ethicist

The Clinical Ethicist provides formal and informal ethics consultations and collaborates with clinical teams, patients and families, managers, and consultants to address ethical issues in pediatric health care and research. Documents ethics activities. May participate in clinical ethics rounds and other educational activities.

Requires working knowledge of theories, principles and concepts typically acquired through completion of a graduate degree in ethics, bioethics, or moral philosophy; a working knowledge of health care and hospitals or clinical degree in a health professional field; and extensive experience in clinical bioethics, preferably in hospital or health delivery systems. Work requires excellent interpersonal, organizational, oral and written communication skills in order to mediate moral disagreements or concerns and develop consensus, compromises, or other ethically acceptable resolutions. Work requires sensitivity in speaking with parents, patients, staff and others in stressful circumstances, in discussing ethical decisions regarding life support, dying and death, disclosure of bad news, participation in research, organ donation and transplantation, and other potential conflicts of interest and values. Work requires demonstrated ability in multidisciplinary collaboration and the ability to initiate, prioritize, and manage multiple projects, working across multiple departmental lines of authority and accountability and under pressure to meet deadlines.

 Clinical Ethicist

Provides formal and informal ethics consultations.  Organizes and participates in clinical ethics rounds, and collaborates with clinical teams, patients and families, to address ethical issues in pediatric health care and research. Develops ethics resources and education and serves as a facilitator for change directed toward strengthening the Hospital staff’s sense of moral responsibility and moral community.

Work requires at least 5 years clinical inpatient experience in a staff physician or nursing role with substantial prior ethics education and experience derived from completion of an ethics fellowship or other advanced ethics training and/or significant ethics consultation experience.  Preference for a clinical degree in a health professional field and graduate level preparation in this discipline, clinical ethics fellowship completion, graduate degree in bioethics or related field, a strong understanding of acute care pediatric health care, and five or more years of experience in clinical bioethics, preferably in a pediatric hospital or health delivery system. Significant focus on inpatient pediatric ethics consultations with active collaboration with nursing, social work, medical staff, and other internal and external individuals and groups.

Continue reading

Using Big Data To Transform Care: A Briefing on the July 2014 Special Issue of Health Affairs

HealthAffairsJournal

Register online now!

The application of big data to transform health care delivery, health research, and health policy is underway, and its potential is limitless.  The July 2014 issue of Health Affairs, “Using Big Data To Transform Care,” examines this new era for research and patient care from every angle.

You are invited to join Health Affairs Editor-in-Chief Alan Weil on Wednesday, July 9, for an event at the National Press Club, when the issue will be unveiled and authors will present their work.  Panels will cover:

  • Using Big Data At The Point Of Care
  • Research Issues
  • The Role Of The Federal Government
  • Obstacles/Challenges Of Using Big Data

Among the confirmed speakers are:  Continue reading

REGISTRATION OPEN: 9/18 conference on post-trial access

pills_genericvariety_slidePost-Trial Responsibilities: Ethics and Implementation

Thursday, September 18, 2014

Harvard Law School, Wasserstein Hall, Milstein East AB, 1585 Massachusetts Ave.

This event is free and open to the public, but due to limited seating registration is required. Please register online.

Law, policy, and guidance are vague, sometimes conflicting, and generally lacking in concrete solutions for questions regarding post-trial responsibilities. The issues are complex and demand thoughtful discourse to move the clinical trial enterprise towards meaningful solutions.  Areas that currently lack clarity include:

  • What types of interventions or resources should be included within post-trial responsibilities?
  • What is a reasonable duration for post-trial responsibilities to extend?
  • What is the mission and purpose of various stakeholders in the conduct of clinical research and how do these roles intersect with post-trial access responsibilities?

This conference will bring together diverse stakeholders to address and develop consensus around some of these questions.

Continue reading

“Isn’t Incarceration Better than Death?”

Katherine L. Record, JD, MPH, MA

Shortly after criticizing Massachusetts for incarcerating innocent individuals with substance use disorder (SUD) when drug rehab facilities are full, I received an email from a woman who lost her son to a heroin overdose just four months ago.

“Is preventing an overdose by detaining the SUD sufferer not a better alternative than leaving them to languish?” she asked.

She had found her 24 year-old son cold and blue, just hours after kissing him goodnight. He had been evicted from his sober living home for testing positive for drugs, but his mother did not know he had relapsed when he arrived at her front door. He was, in hindsight, a clear danger to himself – so why did his step-down house let him wander away? Why didn’t anyone call the authorities? Is jail not better than death?

Continue reading

Sunstein Keynote at Petrie-Flom Annual Conference featured in Harvard Law Today

sunstein-atlanticHarvard Law Today has posted a feature on Cass Sunstein’s keynote address at the 2014 Petrie-Flom Center Annual Conference, “Behavioral Economics, Law, and Health Policy.” Sunstein, who is the Robert Walmsley University Professor at Harvard Law School and the co-author of Nudge: Improving Decisions About Health, Wealth, and Happiness, addressed the opening day of the conference on May 2, 2014, on the subject of “Choosing Not to Choose.”

Full video of the conference will be available soon via the Petrie-Flom Center’s website. In the meantime, you can read about and view Sunstein’s keynote address here.

I. Glenn Cohen Discusses Ethics of Medical Personnel Involvement in Executions

cohen_talking_peoplePetrie-Flom Faculty Director I. Glenn Cohen appeared on The Rachel Maddow Show last night to discuss his recent opinion piece in JAMA, coauthored with Robert D. Truog and Mark A. Rockoff (both of Harvard Medical School), on “Physicians, Medical Ethics, and Execution by Lethal Injection.” In the piece, Cohen et al. argue that medical specialty boards should withdraw board certification from members who participate in executions.

From the interview:

…we think it [execution] is totally incompatible with the role of the doctor. A doctor is about healing. A doctor is about soothing pain. A doctor is not meant to be conscripted by the state to make what is the involuntary killing of another person look as though it’s a medical procedure, like getting your teeth pulled or putting your dog to sleep. It’s kabuki theater, Rachel, and we think doctors should stand up. Whatever your position is on capital punishment, it’s wrong to make this procedure look like medicine. That’s not what it is. [...]

Watch the full interview.

Petrie-Flom Center Hiring Interns to start August 2014

PFC_Logo_300x300The Petrie-Flom Center PFC_Logo_300x300for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

Student Internship Program

 

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is seeking student interns for the fall 2014 semester.   Availability to start by August 4, 2014 is preferred, but later start dates will be considered on an individual basis; please indicate your availability in your application materials. We may consider extension through Spring 2015 if there is mutual interest.

Who is eligible?

Harvard undergraduate and graduate students with an interest in the Center’s work are eligible to apply. More information about the Center is available at our website. The internship is open to students in all disciplines, but we particularly welcome applications from students studying health policy, philosophy, bioethics, law, medicine, business economics, and the sciences.  We are also interested in receiving applications from students interested in technology and communications.

What will the internship entail?
Continue reading

Direct-to-Patient Laboratory Test Reporting

MJYPetrie-Flom Student Fellow Michael Young has coauthored a new piece with Ethan Scheinberg (Harvard Law School) and Harold Bursztajn (Harvard Medical School) now available through JAMA, “Direct-to-Patient Laboratory Test Reporting: Balancing Access With Effective Clinical Communication” The article discusses ethical and clinical implications of a 2014 HHS ruling allowing patients direct access to completed medical laboratory reports.

From the article:

Continue reading

A Drug Epidemic’s Silver Lining

By Katherine L. Record

Can there be a silver lining to a drug epidemic that is so extreme it is deemed a public health emergency? As prescription opioid (painkiller) addictions drive individuals to heroin, there just might be.

Heroin use has surged recently – seizures of supply increased by nearly 70% over the last few years in New York (the epicenter for imports into the United States). In Boston, overdoses increased by nearly 80% between 2010 and 2012. This has followed a rising trend in prescription opioid addictions – 4 out of 5 users are addicted to prescription painkillers when they first try heroin. Turning to the street opioid is often a move of desperation; prescription opioids are now harder to abuse, more expensive, and harder to obtain than heroin. In other words, heroin provides a cheaper, easier to score, and stronger high.

This surge in use is changing the face of heroin; the Office of National Drug Control Policy’s director recently described the drug as a former “inner city problem” that has become classless, affecting “all populations and all ages.” To be blunt, white people – many with high paying jobs and fancy apartments – are now doing 8 to 10 bags a day.

Continue reading