Elsevier

Mayo Clinic Proceedings

Volume 96, Issue 1, January 2021, Pages 165-173
Mayo Clinic Proceedings

Special article
Ethical Challenges in COVID-19 Biospecimen Research: Perspectives From Institutional Review Board Members and Bioethicists

https://doi.org/10.1016/j.mayocp.2020.10.021Get rights and content

Abstract

Biospecimen research is a prominent investigative strategy that aims to provide novel insights into coronavirus disease 2019 (COVID-19), inform clinical trials, and develop effective, life-saving treatments. However, COVID-19 biospecimen research raises accompanying ethical concerns and practical challenges for investigators and participants. In this special article, we discuss the ethical issues that are associated with autonomy, beneficence, and justice in COVID-19 biospecimen research and describe strategies to manage the practical challenges, with an emphasis on protecting the rights and welfare of human research participants during a pandemic response. Appropriate institutional review board oversight and bioethics guidance for COVID-19 biospecimen research must maintain their focus on protecting the rights and welfare of research participants, despite the urgent need for more knowledge about the virus and the threat it poses to communities and nations.

Section snippets

Respect for Persons

The basic ethical principle of respect for persons, otherwise known as respect for an individual’s autonomy, is to ensure that individuals are truly informed about their research participation. This principle is divided into two moral requirements: 1) the requirement to acknowledge autonomy, and 2) the requirement to protect those with diminished autonomy.6, 7, 8 Thus, autonomy refers to the right of a person to decide freely and independently whether they wish to participate in research, and

Beneficence and Its Corollary, Non-Maleficence

Beneficence is an ethical principle in research that requires protection of research participants from harm and exploitation, as well as maximizing possible benefits from participating in research.6 Given that COVID-19 biospecimen research typically requires biospecimen collection as the only research intervention, oftentimes with medical record review, it may be designated as minimal risk research. However, if collection of biospecimens is established without proper disclosure or consent,

Justice

Every pandemic evokes new questions about what justice requires, even as the pandemic also potentially worsens existing inequalities. In applying the principle of justice as conceived in the Belmont Report, IRBs have traditionally focused on the equitable selection of subjects. The Belmont Report also points out that the benefits of publicly funded research ought to be fairly available to all; however, there is no specific guidance on how to actually make the benefits of research available to

Recommendations for IRB Members and Bioethicists

Specialists in human subject protections, such as IRB members, should work collaboratively with bioethicists and investigators to ensure that the principles of respect for persons, beneficence, and justice are met prior to research approval. Formal institutional policies and study-specific approaches must strive to balance the need to conduct biomedical research with the need to preserve the rights and autonomy of research participants. These strategies should include consideration of creative

Conclusion

Ethical concerns about autonomy, beneficence, and justice are evident in COVID-19 biospecimen research. Appropriate IRB oversight and bioethics guidance must center on protecting the rights and welfare of research participants, despite the urgent need for more knowledge about the virus and its impact. Institutional review boards must continue their essential role in protecting human research participants, especially those who are now more vulnerable because of the impact of COVID-19−related

Acknowledgments

The opinions expressed by the authors are personal and do not necessarily reflect the official position of the Mayo Clinic Institutional Review Board, the Mayo Clinic Human Research Protection Program, or the Mayo Clinic Center for Individualized Medicine.

Editing, proofreading, and reference verification were provided by Scientific Publications, Mayo Clinic. Assistance with manuscript preparation was provided by Angie Lam and Vicki M. Schmidt.

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  • Potential Competing Interests: The authors report no potential competing interests.

    Grant Support: The research to prepare this manuscript was partly supported by the Mayo Clinic Center for Individualized Medicine. The sponsor had no role in the writing of the report or the decision to submit the article for publication.

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