By Jennifer S. Bard
Until more is known about how to mitigate the threat of AI-fueled persuasion in human subject research, a ban on its use is the only reasonable way to keep the promise that we, as a country, made to those harmed while participating in research.
A judge in Ohio ruled on Monday that a hospital in the region must administer ivermectin to a patient very sick with COVID-19 in their ICU, despite the decision by the medical staff, in agreement with recent statements by the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), that ivermectin is not an appropriate treatment, as it has been shown not to work against COVID.
The patient’s prescription came from a doctor who has no authority to treat patients at this particular hospital, although he is licensed to prescribe medicine in Ohio.
This case tracks a swelling interest, which some ascribe to the efforts of a group called America’s Front Line Doctors, among people for the anti-parasitic medication as both a treatment and prophylactic for COVID-19 — despite warnings from the medical establishment that it doesn’t work, and, if taken in the form normally given to farm animals or at the dosages being suggested, can be harmful.
The Ohio ruling is just the latest of several successful law suits (see similar cases in New York and Illinois) to order hospitals to administer ivermectin to hospitalized COVID-19 patients, despite the objections of the treating physicians.
There is also evidence of a global trend, as evidenced by the order of a court in South Africa to allow the prescription of ivermectin for COVID-19, something that was previously not permitted by the country’s drug regulatory agency.
This trend of courts ordering that treatments requested by hospitalized patients be made available by that hospital — so long as they are prescribed by a physician — opens the door to substantial administrative, legal, and ethical chaos. This post analyzes some of the most pressing legal, regulatory, and ethical concerns.
By Amanda Kim, M.D., J.D.‡, Michael Hsu, M.D. ‡, Amanda Koire, M.D., Ph.D. ‡, Matthew L. Baum, M.D., Ph.D., D.Phil. ‡
What obligations do researchers have to disclose potentially life-altering incidental findings (IFs) as they happen in real time?
Deep phenotyping research in psychiatry integrates an individual’s real-time digital footprint (e.g., texts, GPS, wearable data) with their biomedical data (e.g., genetic, imaging, other biomarkers) to discover clinically relevant patterns, usually with the aid of machine learning. Findings that are incidental to the study’s objectives, but that may be of great importance to participants, will inevitably arise in deep phenotyping research.
The legal and ethical questions these IFs introduce are fraught. Consider three hypothetical cases below of individuals who enroll in a deep phenotyping research study designed to identify factors affecting risk of substance use relapse or overdose:
A 51-year-old woman with alcohol use disorder (AUD) is six months into sobriety. She is intrigued to learn that the study algorithm will track her proximity to some of her known triggers for alcohol relapse (e.g., bars, liquor stores), and asks to be warned with a text message when nearby so she can take an alternative route. Should the researchers share that data?
A 26-year-old man with AUD is two years into sobriety. Three weeks into the study, he relapses. He begins arriving to work inebriated and loses his job. After the study is over, he realizes the researchers may have been able to see from his alcohol use surveys, disorganized text messages, GPS tracking, and sensor data that he may have been inebriated at work, and wishes someone had reached out to him before he lost his job. Should they have?
A 35-year-old man with severe opioid use disorder experiences a near-fatal overdose and is discharged from the hospital. Two weeks later, his smartphone GPS is in the same location as his last overdose, and his wearable detects that his respiratory rate has plummeted. Should researchers call EMS? Read More
By Benjamin C. Silverman
Deep phenotyping research procedures pose unique challenges to the informed consent process, particularly because of the passive and boundless nature of the data being collected and how this data collection overlaps with our everyday use of technology.
As detailed elsewhere in this symposium, deep phenotyping in research involves the collection and analysis of multiple streams of behavioral (e.g., location, movement, communications, etc.) and biological (e.g., imaging, clinical assessments, etc.) data with the goal to better characterize, and eventually predict or intervene upon, a number of clinical conditions.
Obtaining voluntary competent informed consent is a critical aspect to conducting ethical deep phenotyping research. We will address here several challenges to obtaining informed consent in deep phenotyping research, and describe some best practices and relevant questions to consider.
By Patrick Monette
To what end does a physician have a responsibility toward a research participant? Specifically, what data may be considered “actionable” for the physician to disclose to the patient, and when and how might this be done?
In the clinical setting, contemporary medical ethics address a physician’s “fiduciary responsibility.” That is, there is a well-established professional expectation that the physician will place the patient’s interests above their own and advocate for their welfare. This post focuses on an alternative dyad, that of physician and research participant, to explore how the field has broached the topic of actionability in the setting of clinical research. Read More
By Matiangai Sirleaf
Two French doctors recently appeared on television and discussed using African subjects in experimental trials for an antidote to the novel coronavirus (COVID-19).
“Shouldn’t we do this study in Africa, where there are no masks, no treatment, no resuscitation, a bit like some studies on AIDS, where among prostitutes, we try things, because they are exposed, and they don’t protect themselves. What do you think?” asked Jean-Paul Mira, head of the intensive care unit at the Cochin Hospital in Paris on April 1, 2020.
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.
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.
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.
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.