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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New TWIHL 182: Abortion Exceptionalism During COVID-19

By Nicolas Terry

I welcome three excellent guests this week. Our discussion centers around new abortion restrictions issued as part of state responses to COVID-19. For example, in Texas, Gov. Greg Abbott issued an executive order banning nonessential medical services. Subsequently, his attorney general interpreted that order as applying to all abortions. Planned Parenthood successfully applied for a temporary restraining order in the district court, only for the Fifth Circuit to lift the stay.

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The COVID-19 Pandemic and Efforts to Release People in Custody

By Phebe Hong

The first death of a federal inmate from COVID-19 occurred on March 28, at a prison in Oakdale, Louisiana. The inmate had been incarcerated for 13 years for a nonviolent drug charge. At least four other infected inmates have died at the same institution.

The COVID-19 pandemic is wreaking havoc on prisons and jails, where proper social distancing is nearly impossible to maintain.

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Social Justice in COVID-19 Response: The Legal Issues We Have to Talk About

By Scott Burris and Wendy E. Parmet

As the United States attempts to mitigate COVID-19 through social distancing, quarantines and isolation measures, we enter uncharted territory, and face pressing social, epidemiological, and legal questions.

Although the law is not fully settled, extreme measures that shutter businesses and limit social interactions outside of the home are likely constitutional if and when they are reasonably necessary, based on scientific evidence and knowledge, and are the least restrictive means available to stop a significant risk to the public. But adherence to those principles is not the only constitutional issue to consider during this pandemic.

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Pile of colorful pills in blister packs

How Can the US Address Coronavirus Drug Shortages?

Cross-posted from Written Description, where it originally appeared on April 7, 2020. 

By Lisa Larrimore OuelletteNicholson PriceRachel Sachs, and Jacob Sherkow

The escalating pandemic has caused devastating shortages not only of ventilators and personal protective equipment like masks, but also of essential medicines needed to treat COVID-19 patients. As detailed by STAT and the New York Times, prescriptions for painkillers, sedatives, anesthetics, and antibiotics are up, but the rate at which prescriptions are filled and shipped to hospitals is down. The FDA helpfully tracks drug shortages, but this doesn’t solve the problem. With the sudden spike in hospitalized patients with COVID-19 symptoms, physicians are using these drugs faster than manufacturers are making them.

What is causing these drug shortages?

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woman with iv in her hand in hospital. Labor and delivery preparation. Intravenious therapy infusion. shallow depth of field. selective focus

The Ethical Argument Against Allowing Birth Partners in All New York Hospitals

By Louise P. King and Neel Shah

Among pregnant people and those who love them, the past few weeks have been especially confusing and anxiety-provoking.

As the new epicenter of the COVID-19 pandemic, New York City hospitals temporarily restricted pregnant people from having a birth partner present during labor, a move that stoked international outcry and a vocal community response. Following a Change.org petition that rapidly amassed more than 600,000 protesting signatures, Governor Cuomo responded with an executive order, stating via a spokesperson, “[i]n no hospital in New York will a woman be forced to be alone when she gives birth. Not now, not ever.”

Both of us are obstetrician/gynecologists who have dedicated our careers to supporting the reproductive health and rights of those we are entrusted to care for. We are trained in health law policy and bioethics. And while we support the strong show of support for laboring women and their rights, we believe the Governor’s decision to mandate all New York hospitals allow birth partners — irrespective of the local case rate of COVID-19 or hospital capacity to test for infection or protect health care workers — is uninformed and unethical.

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hospital equipment, including heart rate monitor and oxygen monitor functioning at bedside.

Why COVID-19 is a Chronic Health Concern for the US

By Daniel Aaron

The U.S. government has ratified a record-breaking $2 trillion stimulus package just as it has soared past 100,000 coronavirus cases and 1,500 deaths (as of March 27). The U.S. now has the most cases of any country—this despite undercounting due to continuing problems in testing Americans on account of various scientific and policy failures.

Coronavirus has scared Americans. Public health officials and physicians are urging people to stay at home because this disease kills. Many have invoked the language of war, implying a temporary battle against a foreign foe. This framing, though it may galvanize quick support, disregards our own systematic policy failures to prevent, test, and trace coronavirus, and the more general need to solve important policy problems.

Coronavirus is an acute problem at the individual level, but nationally it represents a chronic concern. No doubt, developing innovative ways to increase the number of ventilators, recruit health care workers, and improve hospital capacity will save lives in the short-term — despite mixed messages from the federal government. But a long-term perspective is needed to address the serious problems underlying our country’s systemic failures across public health.

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The Long-Term Harm of Favoritism in COVID-19 Testing

By Jonathan M. Marron and Paul C. McLean

One of us is a sports fan, childhood cancer doctor, and bioethicist. The other is a former sportswriter drawn to medical ethics since the cure of his only child. If sports and ethics have something in common, it’s the value of a level playing field. Fairness matters. There’s a coin toss: heads or tails. Fairness, not favoritism.

We view the doctor-patient relationship through slightly different lenses, but it’s precious either way. It’s a relationship — above all else — built on trust. And that relationship, a cornerstone of healthcare, is suddenly like an already vulnerable person facing an uncertain prognosis. If the doctor-patient relationship is to survive the novel coronavirus (COVID-19) pandemic, it will require a unified team, trust, and a level playing field, regardless of how much money or influence you have.

What does sports have to do with this?

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Staying Sane and Hopeful During the COVID-19 Pandemic

By Sarah Alawi

March was a month full of stress and anxiety around the uncertainties of the COVID-19 pandemic and the disruption of normal life.

Following Harvard Law School’s decision to evacuate campus in early March, most students – myself included – had to hurriedly pack our lives into suitcases and return home in the space of days.

For some of us, getting home (for me, New Zealand) meant having to travel internationally  through airports and transit hubs amid a global pandemic. We landed on the other side to a new normal as the rest of the world caught on; we now live in quarantine “bubbles” while continuing to learn, meet and even socialize via Zoom. Our days are shadowed by restraint and a desperate hope to return to normalcy.

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