The Petrie-Flom Center Staff - Bill of Health

Incidental Findings in Deep Phenotyping Research: Legal and Ethical Considerations

February 10, 2021February 18, 2021 The Petrie-Flom Center Staff Leave a comment

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

Pen hovering over words "I agree" with check box next to it.

Unique Challenges to Informed Consent in Deep Phenotyping Research

February 10, 2021February 18, 2021 The Petrie-Flom Center Staff Leave a comment

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.

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Farmworker Protection during COVID-19: Will New Jersey learn its lesson?

February 8, 2021July 15, 2022 The Petrie-Flom Center Staff Leave a comment

By Marcus Mitchell, J.D.

New Jersey was hit particularly hard by COVID-19 in spring of 2020. There were several factors contributing to its high case rate and death toll in the state, including sometimes shifting and unclear directives from leadership and high population density. Communities of color experienced disproportionate death rates, due to institutional discrimination manifesting in the form of disparate and inequitable access to health care and an increased likelihood of pre-existing co-morbidities.

Doctor or surgeon with organ transport after organ donation for surgery in front of the clinic in protective clothing.

Recent Organ Procurement Organization Regulations Will Save Lives

February 5, 2021February 5, 2021 The Petrie-Flom Center Staff Leave a comment

By Matthew Wadsworth

Thirty-three Americans die every day for lack of an organ transplant. As the CEO of an organ procurement organization (OPO) — one of the network of 57 government contractors responsible for organ recovery across the country — this is what I think about every day: how to help the 3,000 people waiting in my home state of Ohio and the more than 100,000 others around the country who wake up each morning hoping they get a call that a transplant is available.

Fortunately, the U.S Department of Health and Human Services (HHS) recently published new, pro-patient regulations to bring baseline accountability to OPOs. While some of my peers have opposed the reform effort, I see it as long overdue.

Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Weaknesses in Medical Device Regulation Worsened by Trump Administration

February 5, 2021February 5, 2021 The Petrie-Flom Center Staff Leave a comment

By Jacob Howard

In the waning days of the Trump administration, a final push was made to fundamentally weaken regulation of medical devices.

Lambasted as a “full frontal assault on public health” by U.S. Food and Drug Administration (FDA) officials, key policy changes include proposed emergency exemptions to bring a multitude of devices to market without the necessary scientific backing. Justified as a strategy to expedite the delivery of life-saving products, this speed comes at a risk to millions of patients.

As the third most prevalent cause of death in the U.S., medical error continues to be a critical issue that is exacerbated by weakening integrity of the regulatory process. This issue is further compounded by the fact that past regulatory failures in the medical device sphere have not been adequately addressed. The surgical stapler offers an illustrative example.

Lessons Learned from Deep Phenotyping Patients with Rare Psychiatric Disorders

February 3, 2021February 18, 2021 The Petrie-Flom Center Staff Leave a comment

By Catherine A Brownstein and Joseph Gonzalez-Heydrich

Given the potential sensitivities associated with describing (i.e., phenotyping) patients with potentially stigmatizing psychiatric diagnoses, it is important to acknowledge and respect the wishes of the various parties involved.

The phenotypic description and depiction of a patient in the literature, although deidentified, may still be of great impact to a family.

By way of example, a novel genetic variant was identified as a likely explanation for the clinical presentation of a patient in a large cohort of individuals with neurodevelopmental and/or psychiatric phenotypes, a finding of great medical interest. The research team elected to further study this candidate and collected samples for functional evaluation of the gene variant and preparation of a case report.

Because the patient had a complicated phenotype, several physicians from various specialties were involved in the patient’s care. The paper draft was circulated amongst the collaborating clinicians and researchers and ultimately shared with the patient’s family by one of their involved caregivers. This is typically not a requirement of such studies, as the informed consent process includes the subjects’ understanding and consent for dissemination of deidentified results in the scientific literature. But as a general practice, families are informed about manuscripts in process, and in this case the family had requested to be kept abreast of ongoing developments.

“Actionability” and the Ethics of Communicating Results to Study Participants

February 3, 2021February 18, 2021 The Petrie-Flom Center Staff Leave a comment

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

Telemedicine or telehealth virtual visit / video visit between doctor and patient on laptop computer and mobile phone device.

The Petrie-Flom Center Launches New Project: Diagnosing in the Home

February 2, 2021February 1, 2021 The Petrie-Flom Center Staff Leave a comment

Diagnosing in the Home will seek to examine the ethical, social, and legal challenges of digital home health products, with a focus on home diagnosis of infectious and chronic conditions.

January 27, 2021 – The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School today announced a new research initiative, Diagnosing in the Home: The Ethical, Legal, and Regulatory Challenges and Opportunities of Digital Home Health. This three-year project will seek to promote the translation of diagnostic medical services into home health care through regulatory and ethical frameworks. This initiative is generously supported by a grant from the Gordon and Betty Moore Foundation.

What Can Policymakers Learn from the Slow COVID-19 Vaccine Rollout?

January 29, 2021January 29, 2021 The Petrie-Flom Center Staff Leave a comment

Cross-posted from Written Description, where it originally appeared on January 12, 2021.

By Lisa Larrimore Ouellette, Nicholson Price, Rachel Sachs, and Jacob S. Sherkow

In the middle of a record number of COVID-19 infections and deaths—and continued evidence of racial disparities in the pandemic’s effects—December brought some good news to the fight against the pandemic: the FDA’s emergency use authorizations (EUAs) for the Pfizer-BioNTech and Moderna vaccines and the ensuing nationwide rollouts. The record-breaking vaccine development timeline and the videos of healthcare workers receiving early vaccines are worth celebrating.

But the subsequent distribution has been tragically slow—echoing distribution challenges for COVID-related goods ranging from PPE to diagnostics. On Dec. 29, Dr. Leana Wen noted that at the initial vaccination rate, it would take 10 years to vaccinate the roughly 80% of Americans needed to achieve herd immunity. According to Bloomberg’s vaccine tracker, as of today, fewer than 10 million vaccines have been administered in the United States. States are still sitting on nearly two-thirds of the doses they have received, and the federal government is holding half the U.S. supply in reserve. In this post we explain what went wrong and how policymakers can correct course for COVID-19 and avoid such disasters in the future.

Syringe being filled from a vial. Vaccine concept illustration.

From 9/11 to COVID-19: A Brief History of FDA Emergency Use Authorization

January 28, 2021May 6, 2021 The Petrie-Flom Center Staff Leave a comment

Cross-posted from COVID-19 and The Law, where it originally appeared on January 14, 2021.

By Jonathan Iwry

The ongoing fight against COVID-19 has thrown a spotlight on the Food and Drug Administration (FDA) and its power to grant emergency use authorizations (EUAs). EUA authority permits FDA to authorize formally unapproved products for temporary use as emergency countermeasures against threats to public health and safety.

Under § 564 of the Food, Drug, and Cosmetic Act (FD&C Act), use of FDA’s EUA authority requires a determination that an emergency exists by secretaries of the Department of Homeland Security, the Department of Defense, or the Department of Health and Human Services (HHS), as well as a declaration by the HHS Secretary that emergency circumstances exist warranting the issuance of EUAs. Each issuance of an EUA requires that FDA conclude that:

it is reasonable to believe that a given product “may be effective” as an emergency countermeasure,

the known and potential benefits of authorization outweigh the known and potential risks, and

no formally approved alternatives are available at the time.

Annie Kapnick’s post on COVID-19 and FDA’s EUA authority provides a helpful overview of FDA’s emergency powers and their use in response to the pandemic. A brief look at the history of FDA’s emergency powers, including key events leading up to their enactment — Thalidomide, swine flu, AIDS, and 9/11 — offers perspective on the situation facing FDA today and its implications for the future. The history of EUA illustrates how its use today against COVID-19 involves fundamental questions about the role of public officials, scientific expertise, and administrative norms in times of crisis.

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