Box of Hydroxychloroquine Tablets

Human Subjects Research in Emergencies: The Texas Nursing Home “Study” (Part II)

By Jennifer S. Bard

This post is the second in a series about conducting human subjects research in emergencies. These posts are being written in response to a rapidly evolving situation and will reflect the state of knowledge at the time of writing.

In April 2020, Dr. Robin Armstrong, medical director of the Resort, a nursing home in Texas City, Texas, reported “signs of improvement” after he gave hydroxychloroquine, a drug approved by the FDA to treat malaria, to 39 of his nursing home patients who were diagnosed with COVID-19.

At about the same time, information was emerging that now represents the current understanding that hydoxychloroquine isn’t only ineffective in treating COVID-19, but also may cause serious harm to patients. Tensions were raised even higher by the seemingly inexplicable enthusiasm for this treatment by the President and some media outlets.

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Busy Nurse's Station In Modern Hospital

Medical Licensure Law Suspensions During COVID-19 Present Opportunity for Change

By Alexa Richardson

As the coronavirus pandemic threatens to overwhelm the health care system, states have responded by broadly suspending licensure laws for health care providers.

The collective rollback of licensure laws is an opportunity for states to reexamine their priorities around provider licensing, and to pursue values like access to care and evidence-based scope of practice over protection of provider interest groups.

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covid-19 virus.

New COVID-19 Resources from the Petrie-Flom Center

The COVID-19 pandemic has raised many health law, policy, and bioethical questions. The Petrie-Flom Center is working hard to address many of the issues raised by the pandemic through our scholarship, events, and commentary in the news.

In the interest of sharing this knowledge, the Petrie-Flom Center has collected these resources on a new page on our website. In addition to a list of featured resources is a broader collection of our work on COVID-19. The page is dynamic and frequently updated. Check it out here.

Doctors hold blood sample wearing ppe suit and face mask in hospital.

New Stark Law Waiver Opens Opportunity for Creative Physician Compensation and Benefits

By Carmel Shachar

On March 30, 2020 the Department of Health and Human Services (HHS) announced a partial waiver of some key elements of the Stark Law, a health care fraud and abuse law. The purpose of this waiver is to relax some of the fraud and abuse requirements around physician compensation during the COVID-19 pandemic to allow hospitals and physician groups to think creatively about meeting the needs of an overworked and stressed workforce. It also provides us an opportunity to consider the post-pandemic future of the Stark Law, long thought to be an impediment to innovative payment and delivery models.

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person typing at computer

Social Workers and Chaplains at the Front Lines During COVID-19

By Adriana Krasniansky

Like doctors and nurses, chaplains and social workers are critical members of hospital care teams who are adapting their workflow and adopting telehealth platforms during the COVID-19 pandemic. 

However, much of their work requires navigating difficult and vulnerable conversions not well-suited for a video screen. This article investigates the unique approaches chaplains and social workers are taking to serve patients digitally in their times of need. Read More

a crowd of people shuffling through a sidewalk

Reopening the Country During COVID-19: Legal and Policy Issues 

By Mark A. Hall and David M. Studdert

Every public health crisis poses unique legal and ethical challenges, but none more so in modern times than the novel coronavirus pandemic. Urgent responses to the pandemic have halted movement and work and dramatically changed daily routines for most of our population in ways entirely unprecedented. As we wrote recently, this sweeping response challenges a host of civil liberties that state and federal statutes and constitutions protect. It should come as no surprise, then, that we are starting to hear widespread grumbling. There are even reports of some initial “protest” lawsuits. But even without overt legal challenges, public health officials are well attuned to the need to respect civil liberties in setting appropriate policies. And, if those officials are not well-attuned, politicians, who are concerned about widespread economic fallout, will forcefully remind them.

It follows that there is a pressing need for a set of principles to guide not just the imposing of COVID-type restrictions, but also relaxing or lifting them.

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A doctor holding a paper that reads "stay at home"

Ethical Duties of Health Care Providers and the Public in the Time of COVID-19

By Jonathan M. Marron, Louise P. King, and Paul C. McLean

In medical ethics, we often speak of duties, such as the duty one has to patients, to society, to our families, to ourselves. In fact, deontology is a moral theory often cited in medical ethics based primarily on the consideration and application of such duties.

But we typically speak of duties under “normal” circumstances, and normal certainly does not describe the current COVID-19 pandemic. It is unclear whether and how our typical conceptualization of duties – the duty of clinicians, of health care institutions, and of the public – apply under these unprecedented conditions. These questions are being considered in our hospitals, living rooms, the lay press, and on social media.

What follows is an edited version of a Twitter dialogue between surgeon Louise P. King and pediatric oncologist Jonathan Marron, both faculty members at the Harvard Medical School Center for Bioethics. Drs. King and Marron were responding to a tweet by Paul McLean, social media editor at the Center for Bioethics, on his personal account.

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hospital equipment

How Triage During COVID-19 Can be Fair to Patients with Disabilities

By Govind Persad

On March 28, 2020, the Department of Health and Human Services issued guidance regarding the application of antidiscrimination law to triage policies — that is, policies for fairly allocating scarce medical treatments, like ventilators, in the COVID-19 pandemic.

Many news outlets incorrectly portrayed HHS as prohibiting triage guidelines from considering disability. But the guidance is more nuanced.

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Researcher works at a lab bench

Human Subjects Research in Emergencies: An Ethical and Legal Guide (Part I)

By Jennifer S. Bard

This post is the first in a series about conducting human subjects research in emergencies. These posts are being written in response to a rapidly evolving situation and will reflect the state of knowledge at the time of writing.

The world is facing a medical emergency in the form of the rapid spread of a new virus, COVID-19, for which there is no known effective treatment and no preventive vaccine.

Without minimizing the need for haste or the significance of the threat, it is still important to remain aware of the risks inherent in rushing to treat patients with anything that might work and simultaneously conducting the research necessary to identify safety and effective interventions.

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