an ambulance parked at the entrance of an emergency department

Racial Disparities Persist in Human Subjects Research

By Beatrice Brown

Human subjects research has long been plagued by racial inequality. While flagrant abuses have been curtailed, disparities have, unfortunately, persisted.

One area ripe for scrutiny is clinical trial enrollment. A 2018 study by William Feldman, Spencer Hey, and Aaron Kesselheim in Health Affairs documents racial disparities in trials that are exempt from typical requirements for informed consent from study participants.

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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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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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Medicine law concept. Gavel and stethoscope on book close up

Free Online Ethics Resources Available from the Perelman School of Medicine

By Holly Fernandez Lynch

One of the silver linings of the COVID-19 pandemic has been seeing communities come together to offer support in ways big and small. Individuals are organizing drives to collect personal protective equipment for health care workers, media outlets are making pandemic content available for free, and children’s book authors are hosting online story times to offer a brief respite for parents suddenly thrust into homeschooling.

In that same spirit, the Department of Medical Ethics and Health Policy at the Perelman School of Medicine, University of Pennsylvania is hoping to ease the burden for bioethics faculty and bioethics and health professions students who may be in search of online content as their learning experiences have moved out of the brick-and-mortar classroom. We’re offering a variety of recorded video content in clinical and research ethics at no charge through at least June 30 – with lectures from two Petrie-Flom alums, Holly Fernandez Lynch and Emily A. Largent, as well as other faculty experts.

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Black Lives Matter To Human Research–Lessons From ‘On The Run’

On-the-Run-w-Goffman

By Michele Goodwin

In her recent publication, On The Run, University of Wisconsin sociology professor, Alice Goffman writes about embedded research from 2002-2007 in a “ghetto” community she names 6th Street (located in Philadelphia).  The African American residents of this community are mostly poor and tethered to the  criminal justice system as parolees, on probation, and in and out of jail.  Goffman’s human research subjects comprised the jailed, imprisoned, and minors–IRBs generally describe these populations as “vulnerable.”

On The Run is hailed as original, creative, and transgressive because of Goffman’s lengthy stay in such a descriptively chilling, dangerous, and Black neighborhood–where frequent gun battles teach kids to dive for cover, the women are teen mothers or crack addicted, and law enforcement incessantly polices the community. Indeed, she moves into the neighborhood and lives with three of the 6th Street boys.  Much could be gained from documenting the challenges in such a community, particularly given the troubling patterns of mass incarceration in the U.S.  However, the book raises questions about what represents credibility, quality, and rigor in social science research; the book lacks an index, bibliography, and meaningful citations.  I write about these concerns and more in a forthcoming Texas Law Review essay, which can be found here.

Reviewers lauded the rigor and ignored ethics of the book, agreeing with Goffman’s Princeton advisor, Professor Mitchell Duneier, and his NY Times assessment that  “[t]he level of immersion is really unusual,” because “[s]he got access to the life of the ghetto and came to understand aspects of it we don’t ever get to see.”  Yet, therein resides a significant problem. Fascination with the ghetto and perceptions that life in inner-cities is so bad that researchers can’t possibly expose those human subjects to risks and harms may have blinded the book’s many reviewers to the fact that Black lives matter, including in human research.  It might have also implied a lower standard for rigor; it is rare that an academic book lacks a bibliography and index.  Goffman also destroyed her field notes. These concerns becomes starkly relevant when she writes about her desire and collaboration with “Mike” to kill a man from the neighboring 4th Street.

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