Ethics of controlled human infection to address COVID-19

Shah, Seema K.; Miller, Franklin G.; Darton, Thomas C.; Duenas, Devan M.; Emerson, Claudia; Lynch, Holly Fernandez; Jamrozik, Euzebiusz; Jecker, Nancy S.; Kamuya, Dorcas; Kapulu, Melissa; Kimmelman, Jonathan; MacKay, Douglas; Memoli, Matthew J.; Murphy, Sean C.; Palácios, Ricardo; Richie, Thomas L.; Roestenberg, Meta; Saxena, Abha; Saylor, Katherine W.; Selgelid, Michael J.; Vaswani, Vina; Rid, Annette

doi:10.1126/science.abc1076

Cited by 109 publications

(124 citation statements)

References 12 publications

(11 reference statements)

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“…SARS-CoV-2 CHIMs could minimize the uncertainty about exposure or disease acquisition inherent in field trials, thereby reducing the number of participants needed to establish the desired end point, and elucidate the duration of immunity conferred by vaccines undergoing field trials [108]. Importantly, ethical considerations related to SARS-CoV-2 CHIMs have been raised as to whether the societal benefits are sufficient to justify the risks posed by deliberately exposing humans to SARS-CoV-2 [109][110][111].…”

Section: Generating More Reliable Data Under Time Constraintsmentioning

confidence: 99%

Obesity and COVID-19: A Perspective from the European Association for the Study of Obesity on Immunological Perturbations, Therapeutic Challenges, and Opportunities in Obesity

et al. 2020

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Accumulating evidence suggests that obesity is a major risk factor for the initiation, progression, and outcomes of coronavirus disease 2019 (COVID-19). The European Association for the Study of Obesity (EASO), as a scientific and medical society dedicated to the promotion of health and well-being, is greatly concerned about the concomitant obesity and COVID-19 pandemics and their impact on health and society at large. In this perspective, we will address the inherent immunological perturbations and alterations in the renin-angiotensin-aldosterone system in patients with obesity and COVID-19, and discuss how these impairments may underlie the increased susceptibility and more detrimental outcomes of COVID-19 in people with obesity. Clearly, this has important implications for preventive measures, vaccination, and future therapeutic strategies to combat COVID-19. Furthermore, we will highlight important knowledge gaps and provide suggestions for future research and recommendations for policy actions. Since many new reports on COVID-19 rapidly appear, the present perspective should be seen as a focus for discussion to drive forward further understanding, research initiatives, and clinical management of COVID-19.

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Section: Generating More Reliable Data Under Time Constraintsmentioning

confidence: 99%

Obesity and COVID-19: A Perspective from the European Association for the Study of Obesity on Immunological Perturbations, Therapeutic Challenges, and Opportunities in Obesity

et al. 2020

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“…Due to its design, the controlled nature of CHIM limits the possibility of generalizing to predict the effectiveness of a candidate vaccine against natural exposure. However, in order to justify this model, the first step is to demonstrate its high social value, since it generates not only great uncertainty but also controversy [6,11].…”

Section: Resultsmentioning

confidence: 99%

“…CHIM ethics are little explored, and the COVID-19 ethical processes have largely focused on whether the risks are acceptable and participants could give high-quality informed consent, using rigorous procedures to maximize understanding of the participants. In this informed consent process, the individual rights of the participants cannot be violated under the guise of an emergency response, but special attention must be paid to both individual rights and the global public health emergency [6,10,11].…”

Section: Resultsmentioning

confidence: 99%

Bioethical Implications in Vaccine Development, a COVID-19 Challenge

Ospina‐Henao¹,

Mora²,

Solano³

et al. 2020

Cureus

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In the last 18 years, on three occasions, coronavirus has represented a challenge for global health. Between 2002 and 2003 with Severe Acute Respiratory Syndrome, in 2012 with Middle East Respiratory Syndrome, and since the end of 2019 with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing the coronavirus disease 2019 (COVID-19) pandemic, which has challenged health care models and the way of doing research, placing bioethics at the center of discussion. Methods On August 19, 2020, a webinar organized by the Research Institute of Medical Science (IICIMED, for its acronym in Spanish), entitled 'Bioethical Implications in Vaccine Development, a COVID-19 Challenge' took place. Three experts spoke about the importance of bioethics in the race to develop a COVID-19 vaccine, the risk involved in shortening the terms of the clinical trial phases, and how the associated risks can be minimized, in order to expedite research results. Conclusion With the novel SARS-CoV-2 coronavirus, critical challenges have been posed not only for public health but for research and the scientific community. A safe and effective vaccine is urgently needed to prevent COVID-19 transmission, complications, and deaths; the adherence to ethical principles required by clinical research is mandatory and closer supervision is also essential.

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“…Second, the global scale of the pandemic and associated morbidity and mortality may render even quite risky research objectively reasonable on the basis of high social value. For example, we have already seen vaccine trials proceed without the usual animal trials, and there is increasing discussion of using challenge trial design to speed vaccine development, a design far riskier for SARS-CoV-2 than for viruses used in other recent challenge trials given the lack of a proven cure [22][23][24][25]. It is widely accepted that trials can be justified on the basis of benefits to society; in the absence of direct benefits, it may be desirable to offer larger incentive payments similar to hazard pay offered to emergency workers or others performing dangerous work-as noted above, this can help make participation attractive across a wider socioeconomic swath [26].…”

Section: Incentivesmentioning

confidence: 99%

Paying Participants in COVID-19 Trials

Largent

Lynch

2020

The Journal of Infectious Diseases

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Abstract Trials are in development and underway to examine potential interventions for treatment and prophylaxis of coronavirus disease 2019 (COVID-19). How should we think about offering payment to participants in these trials? Payment for research participation is ethically contentious even under ideal circumstances. Here, we review 3 functions of research payment—reimbursement, compensation, and incentive—and identify heightened and novel ethical concerns in the context of a global pandemic. We argue that COVID-19 trial participants should usually be offered reimbursement for research-related expenses, and compensation for their time and effort, as for other types of research under usual circumstances. Given increased risk of undue influence against pandemic background conditions, incentive payment should be avoided unless essential to recruitment and retention in important trials whose social value outweighs this risk. Where essential, however, incentives can be ethically permissible, so long as reasonable efforts are made to minimize the possibility of undue influence.

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Ethics of controlled human infection to address COVID-19

Abstract: High social value is fundamental to justifying these studies

Cited by 109 publications

References 12 publications

Obesity and COVID-19: A Perspective from the European Association for the Study of Obesity on Immunological Perturbations, Therapeutic Challenges, and Opportunities in Obesity

Obesity and COVID-19: A Perspective from the European Association for the Study of Obesity on Immunological Perturbations, Therapeutic Challenges, and Opportunities in Obesity

Bioethical Implications in Vaccine Development, a COVID-19 Challenge

Paying Participants in COVID-19 Trials

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