DNA Donors Must Demand Stronger Privacy Protection

By Mason Marks and Tiffany Li

An earlier version of this article was published in STAT.

The National Institutes of Health wants your DNA, and the DNA of one million other Americans, for an ambitious project called All of Us. Its goal — to “uncover paths toward delivering precision medicine” — is a good one. But until it can safeguard participants’ sensitive genetic information, you should decline the invitation to join unless you fully understand and accept the risks.

DNA databases like All of Us could provide valuable medical breakthroughs such as identifying new disease risk factors and potential drug targets. But these benefits could come with a high price: increased risk to individuals’ genetic data privacy, something that current U.S. laws do not adequately protect. Continue reading

State-Level Solutions to Discrimination in Organ Transplants 

By Emily Largent

organ transplant

Doctors in North Dakota perform a kidney transplant. (Photo by ndguard/Flickr)

In recent years, alleged instances of discrimination against people with disabilities in organ transplantation have captured public attention.

In 2012, for example, the parents of Amelia Rivera, a child with Wolf-Hirschhorn syndrome, alleged that they were told their daughter was not a candidate for a kidney transplant because of her “mental retardation.” The Children’s Hospital of Philadelphia denied “disqualify[ing] transplant patients on the basis of intellectual ability.” Nevertheless, more than 51,000 individuals signed a change.org petition demanding that the hospital “allow the life saving [sic] transplant four-year-old Amelia Rivera needs to survive.”  Ultimately, Rivera received a living donor kidney transplant from her mother.

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Beyond Disadvantage: Photos from the Petrie-Flom Annual Conference

At last week’s Petrie-Flom Center Annual Conference, “Beyond Disadvantage: Disability, Law, and Bioethics,” discussed a number of topics related to the “mere difference” vs. “bad difference” disability theory debate.

Over the course of the day, six panels of experts shared their research and views on topics ranging from health care as eugenics to epistemic injustice to organ donation.

We will have the videos of the event soon, but in the meantime, enjoy the tweets from #rethinkingdisability and some photos from throughout the day by photographer Martha Stewart.

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Medical Professionals with Disabilities Workforce and their Associated Challenges

By Paulchris Okpala

person wearing medical scrubs

Do the provisions of the 2008 Americans with Disabilities Act Amendments Act (ADAAA) address challenges faced by medical professionals with disabilities (MPD)?

A 2012 report on Americans with disabilities from the US Census Bureau suggests that it is highly unlikely. There is every reason to be alarmed by the increasing number of medical professionals with disabilities who leave their jobs, or express the intention to quit employment. There is also a rapidly decreasing number of MPD who express the desire to seek employment. Could this trend be attributed to the challenges faced by the MPD in the workplace?

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Dementia, Disability, and Advance Medical Directives

By Rebecca Dresser

pencil drawing of a brain Anyone fortunate enough to live beyond middle age faces a risk of developing dementia. Dementia is a widely feared disability. People often say they wouldn’t want to live if they developed the condition.  

Experts in law and ethics praise advance directives, or instructions to follow on behalf of patients, as a tool giving people control over the life-sustaining medical care they later receive as mentally impaired dementia patients. Some advance directive supporters also want the law to recognize advance requests to withhold ordinary food and water in the late stages of dementia. And some argue that the U.S. should follow the Netherlands in allowing doctors to give lethal drugs to people who made advance directives asking for assisted death if dementia makes them unable to live at home or to recognize their loved ones.  

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Epistemic Injustice, Disability Stigma and Public Health Law

long staircase

By Daniel Goldberg

Public health law can integrate medical and social understandings of disability in ways that promise to reduce disability stigma and enhance epistemic justice.

However, models of disability currently embedded in public health law do precisely the opposite, at least partly due to the fact that public health laws have historically assimilated medicalized models of disability.

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2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics
June 1, 2018 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1987).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood.

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Making “Meaningful Access” Meaningful: Equitable Healthcare for Divisive Times

By Leslie Francis

Another anniversary of President Bush’s signing of the Americans with Disabilities Act (ADA) is coming up in late July, yet the nation remains far from offering even a semblance of equitable societal opportunity to most individuals with disabilities.

For them, full social participation is dismissed as merely an idealistic dream. With its focus on restoration of full functioning for patients, the health care delivery system might be supposed an exception, but a closer look shows the opposite is true.

Physicians’ offices, clinics, and hospitals too often have not been made accessible. Too frequently, these facilities have diagnostic or treatment equipment that some people, due to disability, cannot use. Health care provider staff are not trained to interact with or assess disabled individuals, and may be swayed by implicit biases that target disability, just as are non-medical personnel or laypersons in the population.

disability rights protest sign

Photo by The Leadership Conference on Civil and Human Rights/Flickr

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Bill of Health Blog Symposium: Research Integrity and Trustworthy Science: Challenges & Solutions

We are pleased to host this symposium featuring commentary from participants in the University of Minnesota’s Consortium on Law and Values in Health, Environment & the Life Sciences event, “Research Integrity and Trustworthy Science: Challenges and Solutions.”  Below, Susan M. Wolf tees up the issues.  All posts in the series will be available here.

By Susan M. Wolf, JD (Chair, Consortium on Law and Values in Health, Environment & the Life Sciences; McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine, University of Minnesota)

Trustworthy science is crucial to progress in scientific understanding, patient care, and product development. Yet threats to the integrity of science and to public confidence loom large. Researcher misconduct, inadequate education of new researchers, concerns over the reproducibility and rigor of scientific research, predatory journals that fail to perform thorough peer review, and oversight lapses all constitute significant threats to sound science and public trust.

A 2017 report from the National Academies on Fostering Integrity in Research carefully analyzed “detrimental research practices.” The report called for significant changes in the policies and practices of journals, research institutions, and researchers. Among the proposals was creation of a Research Integrity Advisory Board (RIAB) as an independent nonprofit. Further recommendations called for changes to allow researchers to reproduce results, including archiving datasets and code.

In March 2018, the University of Minnesota responded to the emerging research challenges and solutions by sponsoring a conference on “Research Integrity and Trustworthy Science: Challenges and Solutions.” We invited leading analysts to address the challenges for researchers, journals, and research institutions. In this blog symposium, plenary speakers from the conference examine three foundational elements of credible research:

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Challenges for Investigators—Generating Reproducible Research Results

This post is part of a series on emerging research challenges and solutions. The introduction to the series is available here, and all posts in the series are available here.

By John P.A. Ioannidis, MD, DSc, C.F. Rehnborg Chair in Disease Prevention, Professor of Medicine, of Health Research and Policy, of Biomedical Data Science, and of Statistics, and Co-Director, Meta-Research Innovation Center at Stanford (METRICS), Stanford University

Generating reproducible research results is not an easy task. As discussions about a reproducibility crisis become more common and occasionally heated, investigators may feel intimidated or even threatened, caught in the middle of the reproducibility wars. Some feel that the mounting pressure to deliver (both quantity and quality) may be threatening the joy of doing science and even the momentum to explore bold ideas. However, this is a gross misunderstanding. The effort to understand the shortcomings of reproducibility in our work and to find ways to improve our research standards is not some sort of externally imposed police auditing. It is a grassroots movement that stems from scientists themselves who want to improve their work, including its validity, relevance, and utility.

As it has been clarified before, reproducibility of results is just one of many aspects of reproducibility. It is difficult to deal with it in isolation, without also considering reproducibility of methods and reproducibility of inferences. Reproducibility of methods is usually impossible to assess, because unfortunately the triplet of software, script/code, and complete raw data is hardly ever available in a complete functional form. Lack of reproducibility of inferences leads to debates, even when the evidence seems strong and well-rounded. Reproducibility of results, when considered in the context of these other two reproducibility components, is unevenly pursued across disciplines. Some fields like genetic epidemiology have long understood the importance of routinely incorporating replication as a sine qua non in their efforts. Others still consider replication as second-class, “me too” research. Nevertheless, it can be shown (see Ioannidis, Behavioral and Brain Sciences, in press), that in most circumstances replication has at least the same value—and often more value—than original discovery. However, this leads to the question: how do we reward and incentivize investigators to follow a reproducible research path?

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Challenges for Journals—Encouraging Sound Science

This post is part of a series on emerging research challenges and solutions. The introduction to the series is available here, and all posts in the series are available here.

By Barbara A. Spellman, Professor of Law and Professor of Psychology, University of Virginia School of Law

Journals and scientists should be BFFs. But currently they are frenemies. Or, in adult-speak:

Journals play an important role in ensuring that the scientific enterprise is sound. Their most obvious function is to publish science—good science, science that has been peer-reviewed by experts and is of interest to a journal’s readership. But in fulfilling that mission, journals may provide incentives to scientists that undermine the quality of published science and distort the scientific record.

Journal policies certainly contributed to the replication crisis. As businesses, publishers (appropriately) want to make money; to do so they need people to buy, read, and cite their journals. To make that happen, editors seek articles that are novel, that confirm some new hypothesis, and that have clear results. Scientists know that editors want articles with these qualities. Accordingly, scientists may (knowingly or not) bias the scientific process to produce that type of result.

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Systems Matter: Research Environments and Institutional Integrity

This post is part of a series on emerging research challenges and solutions. The introduction to the series is available here, and all posts in the series are available here.

By CK Gunsalus, Director, National Center for Professional and Research Ethics (NCPRE), University of Illinois Urbana-Champaign

We know what it takes for institutions and scholars to produce high-quality, high-integrity research, and yet we do not always act upon that knowledge. As far back as 1988, Paul J. Friedman described both the roots of systemic shortcoming and approaches for conducting trustworthy research. Despite a clear understanding of the issues and steps that would improve our research and educational environments, the academy continues to be dogged by those same systemic issues. A recent National Academies of Sciences, Engineering and Medicine consensus study, Fostering Integrity in Research, in which I participated as a panel member, explores that same disconnect and makes recommendations. The bottom line is this: we must shift our attention and energy away from individual bad actors—though they exist and must be addressed—and toward the highly complex ecosystem within which research is conducted.

An update of an earlier appraisal published 1992, the 2017 NASEM report describes the transformation of research through advances in technology, globalization, increased interdisciplinarity, growing competition, and multiplying policy applications. It identifies six core values underlying research integrity—objectivity, openness, accountability, honesty, fairness and stewardship—and outlines best practices, including checklists, for all aspects of the research enterprise. I encourage you to read it and use these tools in your own work.

All the reports in the world won’t improve research integrity, however, if we don’t do the work in our institutions, departments, and research groups. There are many components to this effort, some of which are discussed in separate posts by my colleagues John P.A. Ioannidis and Barbara A. Spellman elsewhere in this symposium. Let’s focus here on institutional infrastructure.

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Vicarious Traumatization in the Wake of Community Violence: Healing the Helpers

This post is part of a series “Healing in the Wake of Community Violence: Lessons from Newtown and Beyond,” based on an event of the same name hosted at Harvard Law School in April 2017. Background on the series and links to other blog posts are here.

By Michelle Bosquet Enlow, PhD

depression_slideWhen a horrific violent event occurs, the community’s thoughts and efforts to help naturally extend out to the injured and traumatized survivors and the loved ones of those killed. However, the effects of such traumatic events ripple out beyond those so directly impacted. According to the Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association, 2013), the definition of trauma includes not only direct exposure to actual or threatened death or serious injury, but also witnessing such an event or experiencing repeated or extreme exposure to aversive details of such an event. Under this more comprehensive definition, the circle of affected individuals in the wake of community violence widens to include professionals and community leaders who are tasked with tending to the safety, medical, emotional, instrumental, and spiritual needs of those wounded. These “helpers” include first responders (e.g., police officers, emergency medical technicians), medical and mental health professionals, case workers, and religious leaders. Continue reading

Newtown: A Public Health Law Perspective

This post is part of a series “Healing in the Wake of Community Violence: Lessons from Newtown and Beyond,” based on an event of the same name hosted at Harvard Law School in April 2017. Background on the series and links to other blog posts are here.

By Wendy E. Parmet

No man is an island

Entire of itself,

Every man is a piece of the continent,

A part of the main

—John Donne, 1624

Like John Donne’s famous Meditation XVII, Newtown, Kim Snyder’s documentary about the aftermath of the 2012 massacre at the Sandy Hook elementary school in Connecticut, forces us to reflect on the inter-connectedness of human life. As Newtown shows with power and poignancy, the victims of that awful massacre were not islands. They were a part of a continent comprised of their families, friends, community, and indeed, all who recall the awful day they were killed.

parmet-chartThis inescapable reality, that our lives and deaths can affect and even traumatize others, is perhaps sufficient to proclaim that gun violence is a public health problem. None of the over 30,000 Americans who die each year from gun violence (most by suicide), are islands. Nor are any of the over 78,000 Americans who are injured by firearms. All are part of the continent. Gun violence affects us all.

But gun violence is a public health problem for another, equally important reason. As with other public health problems, from obesity to HIV/AIDS, the risk that individuals face with respect to firearms is influenced significantly by factors that lie outside their own control. This is not simply because the victims of the Sandy Hook massacre did nothing, and could do nothing, to cause their own death. It is also because different populations face different levels of risk. Race, age, income, gender, geography and a host of other variables determine one’s risk of dying or being injured by firearms.  Continue reading

Newtown: A Story of Collective Grief and Trauma

This post is part of a series “Healing in the Wake of Community Violence: Lessons from Newtown and Beyond,” based on an event of the same name hosted at Harvard Law School in April 2017. Background on the series and links to other blog posts are here

By Kim Snyder, Director and Producer of Newtown

We believe we must be the family of America, recognizing that at the heart of the matter we are bound one to another. – Mario M. Cuomo

newtown_sign_flags_webWhen I first landed in Newtown over four years ago following the horrific tragedy at the Sandy Hook Elementary School, I was drawn first and foremost to a story of collective grief and trauma. Seeing the story in the larger context of commentary on America’s problem with gun violence came later. My producing partner, Maria Cuomo Cole, and I both felt we hadn’t seen a documentary that chronicled the long tail of collective trauma for years out, after the cameras had left. We also hadn’t seen this story told from the perspective of an entire town. It is important to note that Newtown is a community of 28,000 people, and the vision of the film sought to represent a sample of voices from various sub-communities. Over the course of the next three to four years, we built trust with members of the Newtown community and explored the trajectory of collective trauma and resilience as it reverberated throughout Newtown and beyond. Not surprisingly, survival guilt was a pervasive theme that emerged. Through the perspectives of multiple sub-communities of the town—the educators, first responders, medical providers, clergy, neighbors, and youth—we came to observe a journey of fracture, isolation, and repair as this courageous community struggled to survive in the aftermath of the unthinkable.  Continue reading

Healing in the Wake of Community Violence: Lessons from Newtown and Beyond

This post is part of a series “Healing in the Wake of Community Violence: Lessons from Newtown and Beyond,” based on an event of the same name hosted at Harvard Law School in April 2017. Background on the series and links to other blog posts are here.

By Cristine Hutchison-Jones, PhD

Community members gather at a memorial service after the Sandy Hook school shooting. Still from the documentary Newtown.

Community members gather at a memorial service after the Sandy Hook school shooting. Still from the documentary Newtown.

On June 12, 2016, an armed man walked into the Pulse night club—a gay bar in Orlando, Florida, packed with patrons enjoying Latin night—and opened fire. By the time the police shot the gunman three hours later, he had killed 49 people and wounded more than 50 others in the deadliest mass shooting by a single shooter in American history.

As we mark today’s anniversary, the news is awash with stories of the way the shooting continues to impact people a year later. Much of the coverage—then and now—has rightfully focused on those most directly affected: the victims and their loved ones, and the LGBTQ and Latinx communities who were targeted and disproportionately impacted by the attack. But amidst the coverage of survivors and their loved ones, some stories are taking a step back to look at the broader impact. This is in keeping with a recent trend to discuss the lasting effects of incidents of mass violence on the wider community. Today’s coverage of the Pulse night club shooting includes stories that focus on the EMTs, police officers, and health care workers who were first on the scene and treated victims in the immediate aftermath of the attack, and on the impact of secondary trauma in their lives. Continue reading

The Global Virome Project: Understanding Our Viral Enemies to Create a Safer World

We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. 

By Ana S. Ayala

There is no doubt that viruses, emerging and re-emerging, have become an imminent global health threat. Starting in 2014, we saw the decimation of West African countries as a result of the Ebola epidemic. Soon after came the Zika outbreak that continues to pose a threat to countries in the Americas and around the world. Since December 2016, Brazil has been experiencing a rise in yellow fever cases , and deaths, among humans and monkeys alike. Colombia and Peru have already reported probable cases. As a response to rising human cases of the H7N9 bird flu, China just ordered the closure of all poultry markets in the eastern province of Zhejiang to stop the trade of live poultry.

Experts warn that the question is not whether but when a pandemic will hit. Unknown or little-known viruses currently looming in animal populations undetected pose a especially dangerous risk–we have little to no experience with them, we do not know whether or when they will spill over to humans, and we do not know where they will emerge next. Continue reading

Emergency Preparedness: Is Quarantine All We Have to Offer?

We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Stay tuned for more posts!

By Wendy K. Mariner

On August 1, 2014, while Ebola raged in Guinea, Liberia, and Sierra Leone, Donald Trump tweeted: “The U.S. cannot allow Ebola infected people back! People that go to faraway places to help out are great-but must suffer the consequences.”  Most experts agree that epidemics are best avoided where the population is educated, well-nourished, and resilient, with access to effective medical and public health resources. Yet, too often, the first response to the threat of an epidemic is to keep people out of the country or quarantine them. It is worth considering why this is so, and how we can do better.

A New Foreign and Interstate Quarantine Rule

On January 19, 2017, the day before Trump’s inauguration as President, the Centers for Disease Control and Prevention (CDC) issued final regulations for detaining individuals suspected of harboring a “quarantinable” communicable disease (QCD). Why would the Obama Administration issue new rules? The explanation in the Federal Register offers 2 reasons: (1) responding to the Ebola epidemic and outbreaks like MERS and measles; and (2) clarifying and codifying “current practice” “to make the public aware of their use.” Continue reading

When a Nurse Needs an Attorney: US Quarantine Policy

We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Stay tuned for more posts!

By Kaci Hickox, MPH, MSN, RN

As new cases of Ebola in the Democratic Republic of Congo (DRC) are announced, I am reminded of the importance of applying lessons learned from U.S. quarantine policies during the 2014 West Africa Ebola outbreak. I watched the suffering of entire families and communities facing the largest Ebola outbreak in history. During my Ebola training in Brussels, I will never forget hearing an Ebola expert explain, “Remember to have compassion because this disease turns peoples’ loved ones into a biological hazard.” I remember the moment I understood Ebola with my heart, not merely my head, when a young woman admitted to the Doctors Without Borders/Médecins Sans Frontières (MSF) Ebola Treatment Unit in Bo, Sierra Leone, explained, “Nineteen of my family members have died of Ebola.”

Yet, in the midst of extreme fear and suffering, I also witnessed the profound courage of the staff responding to stop the outbreak. On my last day in the unit we had celebrated the discharge of 39 Ebola survivors. Offering isolation, testing, and treatment for persons who developed symptoms of Ebola was necessary to stop disease transmission and finally, after two years of response, the outbreak was declared over in December 2015! In this globalized world, we must be prepared to react not only to Ebola, but to any infectious disease threat with courage instead of fear, science instead of politics.

How do we ensure courageous responses to infectious disease threats? Continue reading

New Blog Symposium: Between Complacency and Panic – Legal, Ethical and Policy Responses to Emerging Infectious Diseases

We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Stay tuned for more posts!

By Wendy E. Parmet and Jennifer L. Huer

Public health is often invisible. In contrast to health services, public health interventions usually operate behind the scenes, reducing risks to broad populations. No one can say who was saved, what deaths were prevented.

For public health, this invisibility presents political and budgetary challenges. Without clear beneficiaries, public health has lacked the political support and dollars allocated to health services. This challenge may be even more formidable today as the Trump Administration seeks enormous cuts to public health programs, while questioning settled public health science.

In the face of such challenges, it may be tempting for public health advocates to emphasize the dangers of emerging infectious diseases. Over the last forty years, a multitude of new or previously tamed infectious diseases such as HIV/AIDS, SARS, Ebola, and Zika have emerged, wrecking morbidity and mortality, and causing panic around the globe. During these outbreaks, public health’s importance becomes, at least briefly, all-too-apparent. Continue reading