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Research Ethics during Pandemics: How IRBs Can Prepare.

Jacob M Appel1, Ilene Wilets2

  • 1Associate professor of psychiatry and medical education, the director of ethics education in psychiatry, and the assistant director of the Academy for Medicine & the Humanities at the Icahn School of Medicine at Mount Sinai and an attending physician at Mount Sinai Health System.

Ethics & Human Research
|March 28, 2023
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The Covid-19 pandemic presents ethical challenges for research. This includes discussing pandemic risks during informed consent and considering vaccination status for non-pandemic study enrollment.

Keywords:
Covid-19human research ethicsinformed consentpandemic risksresearch participants

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Area of Science:

  • Bioethics
  • Public Health Ethics
  • Clinical Research Ethics

Background:

  • The Covid-19 pandemic created unprecedented ethical dilemmas for researchers in the United States.
  • Existing ethics literature has not fully addressed key pandemic-related research challenges.
  • The pandemic necessitates re-evaluation of standard research protocols and ethical guidelines.

Purpose of the Study:

  • To explore the ethical implications of including pandemic risks in the informed consent process for clinical research.
  • To examine the ethical considerations surrounding the use of vaccination status in participant selection for non-pandemic studies during a pandemic.

Main Methods:

  • This essay utilizes the Covid-19 pandemic as a case study to analyze complex ethical issues.
  • It involves a critical review of current bioethical principles and their application in pandemic research scenarios.
  • The analysis focuses on two specific, underexplored ethical questions in the literature.

Main Results:

  • The informed consent process requires careful consideration of how to effectively communicate pandemic-specific risks to potential participants.
  • Determining the ethical permissibility and practical implementation of using vaccination status in enrollment for unrelated studies is complex.
  • There is a need for updated ethical frameworks to guide research conduct during global health crises.

Conclusions:

  • Ethical guidelines must adapt to address unique challenges posed by pandemics, such as informed consent modifications and participant selection criteria.
  • Further scholarly discussion is needed to establish clear protocols for navigating these ethical complexities in future public health emergencies.
  • Ensuring participant safety and research integrity requires proactive ethical deliberation during pandemics.