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February 01, 2021

Medical and Public Health Practices in a Post-COVID-19 World: A Bioethical Perspective

By Janet Dolgin, Ph.D., J.D., Dicker Distinguished Professor of Law, Maurice A. Deane School of Law at Hofstra University, Professor of Science Education, Zucker School of Medicine at Hofstra/Northwell, Nassau County, NY

The emergence of COVID-19 in early 2020 occasioned significant shifts in patient care and in human subject research.  These shifts have led to bioethical quandaries.  Among the shifts, some may be abandoned once the pandemic fades.  Others may become more permanent components of society's responses to healthcare and to research. It is thus essential to consider the implications of the changes for healthcare and research in future years.

This article focuses on two such shifts:  (1) increased reliance on triage and rationing which privilege the needs of the public's health over both patient autonomy and clinician beneficence regarding individual patients; and (2) increased interest in challenge studies which involve intentionally infecting human volunteers with SARS-CoV-2 (the virus that causes COVID-19) in order to expedite vaccine development.  Each is considered in turn.

Rationing and Triage

The terms "rationing" and "triage" are often, though not always, used as synonyms in medical settings.  But the notion of "triage" may encompass that of "rationing," identified as a form of triage.  One author noted that "lotteries, rationing, and queuing" are three tools that affect the goals of triage.1  Others distinguished rationing and triage with regard to clinical medicine, defining the first to suggest that a clinician "has access to resources but choose[s] not to provide them," while in the second situation (that of triage), medical resources are not available for all of those who need them.2  Clinicians rely on triage in situations characterized by insufficient resources to meet the medical needs of a group of patients (as in a pandemic or pursuant to terrorism and natural disasters).3

In the early months of the COVID-19 pandemic, there were not enough ventilators, surgical masks, and hospital beds to meet demand.4  Medical, legal, and public health associations offered guidelines for triaging scarce resources for patients with COVID-19. Some relevant guidelines already existed,5 but each pandemic – each disaster – presents unique challenges.  Broad guidelines may survive over time, but the specifics of how best to respond in particular situations must be contemplated in light of the demands of that situation.

Perceptions of a looming shortage of ventilators occasioned particular concern in the early months of the COVID-19 pandemic.  Although it became clear later that the need for ventilators was less pressing than had been thought initially, during the spring of 2020, medical clinicians, lawyers, public health professionals and ethicists focused on determining fair rules for ventilator allocation.6  One study of ventilator allocation policies carried out in the early months of the COVID-19 pandemic surveyed responses from 67 members of the Association of Bioethics Program Directors at hospitals offering critical care.7  Five triage criteria were noted most often by survey respondents:  "benefit . . . , need. . ., age . . ., conservation of resources . . ., and lottery."  In reaching conclusions about patient need for and benefit from ventilatory assistance, the majority of respondents described their hospitals' triage policies as relying heavily on scoring systems (e.g., Sequential Organ Failure Assessment (SOFA) scores)8 that assessed patients' physiological status.  This approach supported the presumption – though not always the reality – of objectivity; in that, it provided some comfort to clinicians and bioethicists being asked to make extraordinarily difficult moral choices in April and May of 2020.9

Before the COVID-19 pandemic, triage decisions were unusual, though not unprecedented in healthcare settings.  Planning for and sometimes implementing triage has seemed virtually inevitable in the face of COVID-19.  Yet, some ethicists contend that triage should be implemented cautiously, if at all, even in crisis situations.10  Correlatively, the pandemic altered the conditions under which family members of hospitalized patients learned that clinicians planned to withdraw life-sustaining care from their loved one.11  As a general matter during the COVID-19 pandemic, hospital visitors, including family members and surrogates, were not allowed at the bedside of patients.12  Thus, family members were likely to learn through telephone conversations that a loved one's life-sustaining care was to be withdrawn.  This largely precluded the sort of sustained discussion and debate that such decisions often engendered before the pandemic.

That clinicians and bioethicists appreciated the presumptive objectivity offered by assessment tools, such as SOFA,13 during the pandemic is not difficult to understand.  But that appreciation raises concern about continuing reliance on such tools in future years. Hospital ethicists, in particular, have relied productively on patient narratives in helping to resolve bioethical conundrums. Eliciting and comprehending those narratives takes time and focus – luxuries precluded by the surge of COVID-19 patients that overwhelmed hospitals. An approach grounded on patient and family narratives facilitates identifying nuances that often lie at the center of successful responses to bioethical conundrums.  That was largely absent in the face of large patient surges both in the early months of the pandemic (e.g., in New York) and in late 2020 and early 2021 (e.g., in Los Angeles).

Challenge Studies

Challenge Studies (also known as "controlled human infection trials”) have generally involved exposing subjects to a particular pathogen to expedite vaccine development.14  Such studies have almost always involved infections for which cures or treatments were available.15  In the late spring of 2020, several proposals suggested conducting challenge studies to test the efficacy and safety of a vaccine against SARS-CoV-2.  These studies are more controversial than those that have been conducted with other pathogens16 because COVID-19 can be fatal, even in healthy young people.17

Moreover, the presumption that the morality of human subject research depends on consent from subjects cannot be satisfied in a COVID-19 challenge study. Too much remains unknown about the condition.  That was even more the case in the spring of 2020 when COVID-19 challenge studies were first suggested.18  Originally assumed to affect lung function, it became clear over time that COVID-19 can damage many bodily organs, including the heart and kidneys.19  Originally assumed to affect elderly people and people with certain co-morbidities, the disease proved capable of rendering people of all ages seriously ill.20  Moreover, even now, a year after SARS-CoV-2 emerged, its long-term consequences for health remain opaque.  COVID-19 symptoms usually resolve within two weeks.  However, many thousands of patients globally have experienced symptoms for significantly longer than two weeks.21  At this time (February 2020), it is known that long-term sequelae can include symptoms ranging from cough and shortness of breath to depression and intermittent fever, and even very serious symptoms, including lung abnormalities and heart inflammation.22  For how long such symptoms will last and whether other long-term complications will emerge over time is unknown.  Such uncertainties render informed consent problematic23 because researchers cannot provide the sort of information about research risks that is usually expected, even in challenge studies of vaccine safety and efficacy.

Nevertheless, there have been significant efforts to encourage challenge studies for a COVID-19 vaccine.  In April 2020, 35 members of Congress signed a letter to Alex Azar, Secretary of the Department of Health and Human Services (HHS) and Stephen Hahn, Commissioner of the Food and Drug Administration (FDA), asking them to support accelerated trials (moving more rapidly from one trial phase to the next than is generally allowed) and to support challenge studies.24  The letter's 35 signatories premised challenge studies on "informed consent of truly voluntary subjects."25  However, the presumption that informed consent could be obtained was misplaced.26

In the United Kingdom (UK), a group of experts was asked to consider developing COVID-19 challenge trials.  The government promised significant funding for the project.27  Further, 1 Day Sooner, an advocacy group that has sought volunteers for challenge trials of a COVID-19 vaccine,28 had recruited over 25,000 volunteers, representing more than 100 countries, by May 2020.29

Even as 1 Day Sooner still seeks challenge study volunteers, calls for challenge studies of COVID-19 vaccines have become less pressing.  That reflects the success of more traditional vaccine trials.  Several vaccines have now received approval in the United States and elsewhere.  The FDA granted Emergency Use Authorization (EUA) for immediate use of the Pfizer-BioNTech mRNA vaccine in early December 202030 and for Moderna's mRNA vaccine a week later.31  Additional vaccines seem likely to become available in early 2021.32

Triage, Futility, Challenge Studies and the Routinization of Care and Research

Before the appearance of COVID-19, triage was invoked in various places in the United States in response to local and regional disasters.  Moreover, rationing (more often implicit than explicit in the U.S. healthcare system) preceded the appearance of COVID-19.  These responses have, however, been reshaped and intensified by the remarkable and unexpected pressures brought by surges in hospitalized COVID-19 patients.  It is incumbent on hospitals, clinicians, and bioethicists to refrain from assuming that presumptions about triage and rationing accepted during the pandemic should be safeguarded once the pandemic ends.

Clinicians' decisions to withdraw life-sustaining care during the pandemic often resembled similar decisions about so-called "futile" care before the pandemic.33  However, before the pandemic patients and, more often, patients' surrogates were able to participate in conversations about the continuation or withdrawal of care, even when they objected to hospital and clinician decisions to terminate care on the grounds that its continuation was considered futile.34  Such conversations were often impossible to arrange during the pandemic.  At the same time, the exigencies of hospital care context offered justification for quick decisions about the withdrawal of life-sustaining care.35  No longer viewed as "giving up" on a particular patient, such decisions were justified as part of an effort to serve the public's health.

Challenge studies are generally deemed acceptable if they involve infections that are "self-limiting" or "that can be easily and fully treated."36  Arguably, they can also be justified even when providing less protection for subjects in the context of an infection posed to kill millions of people and sicken many more.37  Yet, science and medicine must guard against appropriating rules for challenge studies created in emergency settings for application in less troubled times.

Guidelines for ethical challenge studies were delineated in 2016 by a group of public health professionals in Australia and the UK.  The authors justified relying on challenge studies but set an "upper limit of reasonable risk:"38

We propose the following risk threshold for challenge studies, namely that:  under no circumstances the research exposes volunteers to risks of irreversible, incurable or possibly fatal infections.  This standard protects volunteers from serious risk, but is more permissive than a minimal risk standard and allows important and ethical research to go forward.39

These guidelines expanded the limit that had been defined by the Academy of Medical Science for challenge studies – that "the risk of harm can be no more than 'minimal.'"[i]40  Still, the guidelines'  suggested limits are clear and would preclude challenge studies of COVID-19, absent an effective cure, at least outside the context of a pandemic when guidelines created for more typical times might be reshaped.

More specifically, response developed for a pandemic should be limited to the sorts of situations for which they were created and should not become a new model for use in other contexts.  This could become a pressing concern.  For instance, 1 Day Sooner continues to recruit for a challenge study of a COVID-19 vaccine, even as vaccines tested pursuant to the rules that apply to traditional trials are being approved throughout the world.[ii]41  Continued recruitment after the pandemic subsides but before the development of an effective, accessible cure would occasion significant ethical questions in that these trials involve intentionally infecting healthy subjects with SARS-CoV-2.


Responses to the exigencies occasioned by COVID-19 are shaping an ethic of clinical care and an ethic of public health.  In whatever manner stakeholders will distinguish each ethic from the other or, even, merge their central concerns over time, it is important that the demands of clinical care and the ethic of autonomy and beneficence crafted in response to those demands not displace public health and welfare.  Equally, it is important that a focus on safeguarding public health not eclipse the clinician-patient relationship and the principles of autonomy and beneficence that largely define that relationship.

Thus, increasingly, shaping an ethic of clinical care requires an understanding of health as a "common good"42 even as it focuses on the health and well-being of individual patients and on the relationship between them and their healthcare providers.  Widespread acceptance of such a perspective would facilitate a workable balance between clinical ethics and public health ethics.  That balance would offer the most felicitous set of responses to the demands of everyday health and healthcare and to remarkable events such as pandemics, horrific storms, terrorism, and other disasters. 


  1. Sachs, N.M., Climate Change Triage, 44 Envtl L. 993, 1013 (2017).
  2. Mehlman, M.J., Can Law Save Medicine?, 36 J. Leg. Med. 121, n.33 (2015) (citing  Schwappach, D.L.B. &  Koeck, C.M., Preferences for Disclosure:  The Case of Bedside Rationing, 59 Soc. Sci. & Med. 1891 (2004)).
  3. Id.
  4. Truog, R.D.,  Mitchell, C., &  Daley, G.Q., The Toughest Triage Allocating Ventilators in a Pandemic, N. Eng. J. Med. (Mar. 23, 2020).
  5. See, e.g., N.Y.S. Task Force on Life and the Law (NYS Dep't Health), Ventilator Allocation Guidelines (Nov. 2015), 
  6. See, e.g.,  Antonmaria, A.H.M. et al., Ventilator Triage Policies During the COVID-19 Pandemic at U.S. Hospitals Associated with Members of the Association of Bioethics Program Directors, 173 Annals Intern. Med. 188 (Apr. 24, 2020). 
  7. Id.
  8. Id. The Sequential Organ Failure Assessment (SOFA) was employed most often to assess need and benefit. Other triage policies relied on specific exclusion of patients with particular diagnoses (e.g., cardiac arrest).  See Sequential Organ Failure Assessment (SOFA) score, Calculated Decisions, (last visited Jan. 19, 2021).
  9. Dolgin, J. et al., A Novel Ethical Approach to Moral Distress During COVID 19 in New York, Clinical Ethics (Dec. 1, 2020),  Over time, clinicians realized that the best responses to seriously ill COVID patients required understanding subjective factors (the patient's "story") as well as being able to assess SOFA scores and other presumptively objective criteria.  Id. at 5.
    Disability rights activists requested that the Office for Civil Rights investigate discriminatory consequences of reliance on SOFA scores, especially for people with disabilities.  See  Cowherd, S.,  Murray, A. &  O'Donnell, K.,  Question to Ask for Next Coronavirus Surge:  Are Your Triage Protocols in Compliance with OCR Guidance?, Pullman & Comley (Sept. 10, 2020), (last visited Jan. 19, 2021.
  10. Wirth, M. et al., The Meaning of Care and Ethics to Mitigate the Harshness of Triage in Second-Wave Scenario Planning During the COVID-19 Pandemic, 20 Am. J. Bioethics (2020), (reporting that 41% of 49 Michigan hospitals studied provided for no exceptions to a "no visitor" policy),
  11. See Dolgin et al., supra n. 9.
  12. Siddiqi, H., To Suffer Alone:  Hospital Visitation Policies During COVID-19, 15 J. Hosp. Med. 694 (2020).
  13. See supra n. 8 and accompanying text.
  14. Jao, I. et al., Deliberately Infecting Healthy Volunteers with Malaria Parasites:  Perceptions and Experiences of Participants and Other Stakeholders in a Kenyan-based Malaria Infection Study, 34 Bioethics 819 (Special Issue:  Ethics of Human Challenge Trials) (2020); 1 Day Sooner, (last visited Dec. 17, 2020).  Challenge studies differ from traditional vaccine trials precisely in that challenge studies involve intentionally infecting healthy volunteers with the disease against which a vaccine is targeted.
  15. Eyal, N., Why Challenge Trials of SARS-CoV-2 Vaccines Could Be Ethical Despite Risk of Severe Adverse Events, Ethics & Human Research (May 22, 2020), 
  16. See, e.g., Shirley, D.-A.T. & McArthur, M.A., The Utility of Human Challenge Studies in Vaccine Development:  Lessons Learned from Cholera, 2011 (1) Vaccine 3 (Auckl.) (October 2011),
  17. Several proposals for studying COVID-19 vaccine development were presented in the spring of 2020.  Eyal, supra n. 15;  Eyal, N., Lipsitch, M. & Smith, P.G., Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure, 251 The J. of Infectious Diseases 1752 (2020).  Further, the UK government planned to pay for a challenge study in Britain aimed at developing a vaccine for COVID-19.  Kirby, T., COVID-19 Human Challenge Studies in the UK, 8 The Lancet:  Respiratory Medicine (October 2020),  
  18. See supra nn. 14-17 and accompanying text.
  19. Rosenblatt, M., Human Challenge Trials with Live Coronavirus Aren't the Answer to a Covid-19 Vaccine, STAT (June 23, 2020),
  20. Id.
  21. Drillinger, M., Long-Haul COVID-19 May Be a Public Health Crisis After the Pandemic, Healthline (Dec. 14, 2020),
  22. Id.
  23. Increased understanding of, and novel treatments for, virtually any medical condition may appear over time.   Uncertainties about COVID-19 are of a different, more worrisome, order.  Scientists and clinicians can point to many parameters of the condition that are still unknown.  See, e.g., Rosenberg, supra n.  19; Drillinger, supra n. 21.
  24. Letter from 35 members of the Congress of the United States to Alex M. Azar II, Sec. Dept Health and Human Services &  & Stephen Hahn, Commissioner Food and Drug Administration (Apr. 20, 2020), available at
    In July 2020, Sidney Wolfe and George Annas, for Public Citizen, wrote to Alex Azar, Stephen Hahn and two others asking that HHS announce that human challenge studies involving infecting healthy volunteers with SARS-CoV-2 would not be allowed or supported.  Letter from Sidney M. Wolfe & George Annas (for Public Citizen) to Alex M. Azar, Sec. Dept Health and Human Services, et al. (July 6, 2020),
  25. Id.
  26. See Rosenblatt, supra n. 19; Drillinger, supra n. 21.  In light of the significant gaps in medicine and science's knowledge of COVID-19, anyone who agrees to be vaccinated with the virus that causes the illness cannot know the implications of that agreement and, in particular, cannot know the risks faced by such agreement.
  27. The UK Science Media Centre at the Wellcome Trust announced potential funding of £33 million.  Kirby, supra n. 17.
  28. Josh Morrison, who created an organization aimed at increasing access to organs for transplantation, co-founded 1 Day Sooner.  Rubin, R., Challenge Trials – Could Deliberate Coronavirus Exposure Hasten Vaccine Development?, 324 JAMA 12 (2020),
  29. 1 Day Sooner,  As of December 2020, 1Day Sooner's website continued to seek recruits "to participate in a human challenge trial for COVID-19 and, potentially, advocate for safe and rapid vaccine development."  See
  30. Letter from FDA to Pfizer (att'n, Ms. Alisa Harkins) (Dec. 11, 2020) (granting EUA),; see also FDA,  Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum (Dec. 2020),
  31. Letter from FDA to Moderna (att'n Ms. Carlota Vinals) (Dec. 18, 2020) (granting EUA),
  32. Oxford/AstraZeneca Vaccine Set to Get Clearance by Year-End:  Report, Business Standard (Dec. 19, 2020), (noting approval likely in UK by end of 2020);  Saperstone, J., Johnson & Johnson Takes Big Step Forward With Its Vaccine Trial, Has Potential to Be Single Shot (Dec. 19, 2020), (noting that Johnson & Johnson expects to apply to the FDA for EUA for its one-shot vaccine in February 2021).
  33. Alternative terms are increasingly used in place of the term "futility."  These include "medically ineffective treatment," MD. Code Ann., Health-Gen. Sec. 5-611(b)(2)(1) (West 2020) and "medically or ethically inappropriate" care.  Va. Code Ann. Sec. 54.1-2990 (West 2020).  See generally, Dolgin, J.L.,  Remaking the "Right to Die":  Give Me Liberty But Do Not Give Me Death, 73 SMU L. Rev. 47 (2020) (hereinafter Dolgin, Give Me Liberty).  See also Truog, supra n. 4 (suggesting that identifying patient care as "futile" "could ultimately undermine public trust and confidence").  For a recent case involving a dispute between a patient's family and clinicians about the "futility" of care see Alexander v. Scripps Mem'l Hosp. La Jolla, 232 Cal. Rptr.3d 733 (Cal. Ct. App. 2018).
  34. See Dolgin, Give Me Liberty, supra n. 33; Truog, supra n. 33.
  35. See Dolgin et al., supra n. 9. 
  36. See Shirley & McArthur, supra n. 16.
  37. In the view of this author, such studies should not be permitted unless informed consent is possible.  See supra nn 21-23  (contending that informed consent for COVID-19 vaccine challenge studies cannot be obtained at this time).
  38. Bambery, B., et al., Ethical Criteria for Human Challenge Studies in Infectious Diseases, 9 Public Health Ethics 92, 97 (2016),
  39. Id. at 98.
  40. Id. at 97 (citing Acad. Of Med. Sciences, Microbial Challenge Studies of Human Volunteers (2005)).
  41. 1 Day Sooner, (last visited Dec.22, 2020).  A preliminary questionnaire asks potential volunteers to indicate interest or not in "being exposed to coronavirus to speed vaccine development" (question 3) and  asks if 1 Day Sooner can "share your contact information with other organizations who may want to ask you to participate in related research."  Id.
  42. Jennings, B., Beyond the Covid Crisis – A New Social Contract with Public Health, Hastings Bioethics Forum (Pandemic Planning, Public Health) (May 19, 2020), The Academy of Medical Sciences is an "independent body in the UK representing the diversity of medical science."  The Academy of Medical Science, (last visited Jan. 19, 2021).
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About the Author

Janet Dolgin (B.A. in philosophy, Barnard College; Ph.D. in anthropology, Princeton University; J.D., Yale University) is the Jack and Freda Dicker Professor of Health Care Law at the Maurice A. Deane School of Law at Hofstra and Professor, Science Education at the Zucker School of Medicine at Hofstra/Northwell.  She is co-Director of the Hofstra Bioethics Center and Director of the Gitenstein Institute for Health Law and Policy (the "Institute").  Professor Dolgin and her colleagues at the Institute have implemented many public policy and legal service projects, including the Hofstra-Northwell Medical-Legal Partnership.

Professor Dolgin has written several books and scores of articles, focusing on family law and on shifts in the structure of healthcare in the United States.  The fourth edition of Bioethics and the Law (co-authored with Professor Lois Shepherd) was published by Wolters-Kluwer in 2019.  Professor Dolgin lectures widely in the United States and abroad about healthcare law, bioethics, and family law.  She may be reached at [email protected].