For now, it’s unethical to use human challenge studies for SARS-CoV-2 vaccine development

Kahn, Jeffrey; Henry, Leslie Meltzer; Mastroianni, Anna C.; Chen, Wilbur H.; Macklin, Ruth

doi:10.1073/pnas.2021189117

Cited by 37 publications

(38 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Another reason sometimes supporting efforts to improve diverse recruitment is to encourage broader trust in research and research outcomes. Yet although trust in vaccines and vaccine trials is proving to be a serious concern in the context of COVID-19, especially among communities of color (Boodman 2020a(Boodman , 2020b, it is not clear that trust will be improved by the intentional inclusion of these communities in SARS-CoV-2 HICS, especially if that enrollment is achieved through financial incentives (Kahn et al 2020). To the contrary, it is reasonable to worry that financial incentives to encourage people of color to enroll in these studies may exacerbate worries of some that they are being "used as a guinea pig for white people" (Hoffman 2020).…”

Section: Diverse Recruitmentmentioning

confidence: 99%

“…Much of the discussion about HICS to combat COVID-19 has centered on whether trials that would intentionally infect healthy individuals with a pathogen for which we lack a proven cure could meet basic ethical requirements regarding risk and social value (Bull et al 2020;Dawson, Earl, and Livezey 2020;Eyal 2020;Eyal, Lipsitch, and Smith 2020;Kahn et al 2020;; Singer and Martinez 2020; WHO Working Group for Guidance on Human Challenge Studies in COVID-19 2020). Yet even skeptics have acknowledged that changed circumstances could alter the ethical equation.…”

mentioning

confidence: 99%

See 1 more Smart Citation

Promoting Ethical Payment in Human Infection Challenge Studies

Lynch

Darton

Levy³

et al. 2021

The American Journal of Bioethics

View full text Add to dashboard Cite

To prepare for potential human infection challenge studies (HICS) involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SARS-CoV-2 HICS participants should be paid. Because the goals of paying HICS participants, as well as the relevant ethical concerns, are the same as those arising for other types of clinical research, the same basic framework for ethical payment can apply. This framework divides payment into reimbursement, compensation, and incentives, focusing on fairness and promoting adequate recruitment and retention as counterweights to concerns about undue inducement. Within the basic framework, several factors are especially salient for HICS, and for SARS-CoV-2 HICS in particular, including the nature of participant confinement, anticipated discomfort, risks and uncertainty, participant motivations, and trust. These factors are reflected in a payment worksheet created to help sponsors, researchers, and ethics reviewers systematically develop and assess ethically justifiable payment amounts.

show abstract

Section: Diverse Recruitmentmentioning

confidence: 99%

mentioning

confidence: 99%

Promoting Ethical Payment in Human Infection Challenge Studies

Lynch

Darton

Levy³

et al. 2021

The American Journal of Bioethics

View full text Add to dashboard Cite

show abstract

“…By contrast, the risks and burdens of challenge trials—including infection-related risks, prolonged period of biocontainment and possible trial vaccine or treatment side effects—fall largely on volunteers 9 . These risks and burdens (which are heightened by uncertainty about COVID-19 disease outcomes) coupled with the absence of obvious direct benefits for volunteers have led some bioethicists to suggest that challenge trials using the novel coronavirus may be unethical 10,11,12 . Some commentators worry that challenge trials might attract volunteers who are vulnerable to undue inducement or problems understanding relevant risks, which might invalidate volunteers’ consent or result in their exploitation 13,14 .…”

Section: Tablementioning

confidence: 99%

Characterizing altruistic motivation in potential volunteers for SARS-CoV-2 challenge trials

Schmit²,

Darton

et al. 2021

Preprint

View full text Add to dashboard Cite

In human challenge trials, volunteers are deliberately infected with a pathogen to accelerate vaccine development and answer key scientific questions. In the U.S., preparations for challenge trials with the novel coronavirus are complete, and in the U.K., challenge trials have recently begun. However, ethical concerns have been raised about the potential for invalid consent or exploitation. These concerns largely reflect worries that challenge trial volunteers may be unusually risk-seeking or too economically vulnerable to refuse the payments these trials provide, rather than being motivated primarily by altruistic goals. We conducted the first large-scale survey of intended human challenge trial volunteers and found that SARS-CoV-2 challenge trial volunteers exhibit high levels of altruistic motivations without any special indication of poor risk perception or economic vulnerability. Findings indicate that challenge trials with the novel coronavirus can attract volunteers with background conditions, attitudes, and motivations that should allay key ethical concerns.

show abstract

“…A third option would be a challenge trial, in which an infectious dose of SARS-CoV-2 is administered intranasally. This design raises a slew of obvious ethical concerns of its own (19), the consideration of which is beyond the scope of this article.…”

Section: Availability Of Alternative Study Designsmentioning

confidence: 99%

Trials for second generation Covid-19 vaccines: Revisiting the debate over placebo use in developing country clinical trials

Lurie¹

2021

IJME

View full text Add to dashboard Cite

This article compares the current debate over the use of placebos in developing country clinical trials of second generation Covid-19 vaccines with the debates over previous paradigmatic cases raising similar issues. Compared to the earlier zidovudine and Surfaxin trials, Covid-19 vaccine trials are likely to confer lower risk to placebo groups and to offer a greater number and variety of alternative study designs. However, turning to the developing world to conduct studies that would be unacceptable in developed countries, simply on the ground that Covid-19 vaccines are generally unavailable in developing countries, is not ethically justifiable. This is so whether the justification is rooted in total absence of vaccine in a given country or in developing country vaccine prioritisation practices, because at root both derive from economic, not scientific conditions. However, the advent of variants that may create genuine uncertainty as to comparator vaccine effectiveness could justify a placebo control, depending on vaccine characteristics, variant prevalence, the degree of variant resistance, and the acceptability of immune-bridging studies. These factors must be considered together in the necessary case-by-case assessment of the ethical justification for any proposed trial.

show abstract

For now, it’s unethical to use human challenge studies for SARS-CoV-2 vaccine development

Cited by 37 publications

References 19 publications

Promoting Ethical Payment in Human Infection Challenge Studies

Promoting Ethical Payment in Human Infection Challenge Studies

Characterizing altruistic motivation in potential volunteers for SARS-CoV-2 challenge trials

Trials for second generation Covid-19 vaccines: Revisiting the debate over placebo use in developing country clinical trials

Contact Info

Product

Resources

About