COVID-19 Trial Enrollment for Those Who Cannot Consent: Ethical Challenges Posed by a Pandemic.
Document Type
Article
Publication Date
11-2020
Identifier
DOI: 10.1542/peds.2020-010728
Abstract
The current coronavirus disease 2019 (COVID-19) pandemic has triggered an intense global research effort to inform the life-saving work of frontline clinicians who need reliable information as soon as possible. Yet research done in pressured circumstances can lead to ethical dilemmas, especially for vulnerable research subjects. We present the case of a child with neurocognitive impairment who is diagnosed with COVID-19 infection after presenting with fever and a seizure. The child lives in a group home and is in the custody of the state; her parents lost parental rights many years ago. Some members of the health care team want to enroll her in a randomized clinical trial evaluating an experimental treatment of COVID-19. For minor patients to enroll in this clinical trial, the institutional review board requires assent of patients and consent of guardians. An ethics consult is called to help identify relevant concerns in enrollment. In the accompanying case discussion, we address historical perspectives on research involving people with disabilities; proper management of research participation for people with disabilities including consent by proxy, therapeutic misconception, and other threats to the ethical validity of clinical trials; and the potentially conflicting obligations of researchers and clinicians.
Journal Title
Pediatrics
Volume
146
Issue
5
MeSH Keywords
Antiviral Agents; Betacoronavirus; Child; Coronavirus Infections; Female; Humans; Mental Competency; Neurocognitive Disorders; Pandemics; Pneumonia, Viral; Randomized Controlled Trials as Topic; Third-Party Consent
Keywords
Antiviral Agents; Betacoronavirus; Child; Coronavirus Infections; Female; Humans; Mental Competency; Neurocognitive Disorders; Pandemics; Pneumonia, Viral; Randomized Controlled Trials as Topic; Third-Party Consent
Recommended Citation
House SA, Shubkin CD, Lahey T, Brosco JP, Lantos J. COVID-19 Trial Enrollment for Those Who Cannot Consent: Ethical Challenges Posed by a Pandemic. Pediatrics. 2020;146(5):e2020010728. doi:10.1542/peds.2020-010728
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