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Challenge Trials: What Are the Ethical Problems?

Daniel M Hausman1

  • 1Rutgers University, New Brunswick, New Jersey, USA.

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|November 25, 2020
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Summary
This summary is machine-generated.

Human challenge trials for COVID-19 vaccines offer immense benefits with low risks. Philosophical objections are unlikely to outweigh the potential to save lives and reduce pandemic harms, provided claims about safety and efficacy hold true.

Keywords:
COVID-19SARS-CoV-2challenge trialshuman subjectsvaccine trials

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Area of Science:

  • Medical Ethics
  • Infectious Disease Research
  • Vaccinology

Background:

  • COVID-19 pandemic has caused significant global health, economic, and social disruption.
  • Vaccine development is crucial for controlling the pandemic.
  • Human challenge trials (HCTs) are being considered for accelerating vaccine evaluation.

Purpose of the Study:

  • To explore the philosophical ethical arguments for and against COVID-19 vaccine challenge trials.
  • To assess whether ethical objections remain valid if HCTs offer substantial benefits and low risks.

Main Methods:

  • Philosophical analysis of ethical principles related to research risks and benefits.
  • Examination of researcher obligations to participants versus societal benefit.
  • Hypothetical scenario evaluation assuming claimed benefits and risks of COVID-19 HCTs.

Main Results:

  • Potential objections to HCTs exist, particularly concerning the balance of harm to individuals versus the benefit to society.
  • However, if COVID-19 vaccine challenge trials indeed offer immense benefits and pose risks comparable to established procedures like kidney donation, ethical objections lose their compelling force.
  • The core of any ethical objection hinges on the veracity of the claimed low risks and high benefits.

Conclusions:

  • There is no insurmountable philosophical objection to conducting human challenge trials for COVID-19 vaccines, provided the purported benefits are realized and risks are demonstrably low.
  • Ethical scrutiny must focus on the empirical claims of safety and efficacy rather than a categorical rejection of the trial design.
  • The ethical permissibility of COVID-19 vaccine HCTs is contingent on their actual risk-benefit profile.