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Case 3.1 : Self-Experimentation in the Development of COVID-19 Vaccines


Manriquez Roa, Tania; Biller-Andorno, Nikola (2024). Case 3.1 : Self-Experimentation in the Development of COVID-19 Vaccines. In: Bull, Susan; Parker, Michael; Ali, Joseph; Jonas, Monique; Muthuswamy, Vasantha; Saenz, Carla; Smith, Maxwell J; Voo, Teck Chuan; Wright, Katharine; de Vries, Jantina. Research Ethics in Epidemics and Pandemics : A Casebook. Cham: Springer, 49-50.

Abstract

This chapter focuses on issues relating to the rigour and quality of research in pandemic contexts, and the dissemination and publication of research findings. Research is indispensable to inform pandemic responses, including the development of new vaccines and therapeutic possibilities. While these studies are badly needed, public health emergencies present profound ethical challenges for the conduct of research. Key questions arise about whether and to what extent research designs should be adapted to pandemic contexts, including which adaptions may be necessary and which are unjustifiable. Where adaptions are needed, their implications for multiple aspects of research require careful consideration, including the quality of research, participant protections, and potential barriers to recruitment and participation. Challenges may also arise with ensuring that consent to research is informed, and that participants can distinguish between research and the early rollout of interventions in rapidly evolving pandemic contexts. Questions also arise about appropriate responses to studies with smaller sample sizes or other methodological flaws, which are proposed to address urgently pandemic priorities. Pressures to urgently contribute to pandemic evidence bases, including issuing pre-publications and press releases about research results prior to peer review, and dramatically accelerating peer-review processes, raise ethical issues about the dissemination and responses to research findings. The publication of poor quality research, including fraudulent research, contributed to the infodemic in COVID-19, and posed significant challenges for researchers, regulators, and policy makers seeking to develop evidence-informed pandemic responses. Accelerated dissemination of research findings prompts consideration of how to promote research integrity and detect research misconduct, and responsibilities to uphold research quality standards and ensure that publications make constructive contributions in challenging pandemic contexts. The five cases in this chapter promote reflection on citizen-scientists undertaking self-experimentation to develop COVID-19 vaccines outside frameworks for ethical and regulatory review of research; researchers proposing and undertaking research of questionable value and quality with vulnerable populations; and responsibilities of researchers, reviewers, journals and other research during accelerated pre-publication and peer-review processes.

Abstract

This chapter focuses on issues relating to the rigour and quality of research in pandemic contexts, and the dissemination and publication of research findings. Research is indispensable to inform pandemic responses, including the development of new vaccines and therapeutic possibilities. While these studies are badly needed, public health emergencies present profound ethical challenges for the conduct of research. Key questions arise about whether and to what extent research designs should be adapted to pandemic contexts, including which adaptions may be necessary and which are unjustifiable. Where adaptions are needed, their implications for multiple aspects of research require careful consideration, including the quality of research, participant protections, and potential barriers to recruitment and participation. Challenges may also arise with ensuring that consent to research is informed, and that participants can distinguish between research and the early rollout of interventions in rapidly evolving pandemic contexts. Questions also arise about appropriate responses to studies with smaller sample sizes or other methodological flaws, which are proposed to address urgently pandemic priorities. Pressures to urgently contribute to pandemic evidence bases, including issuing pre-publications and press releases about research results prior to peer review, and dramatically accelerating peer-review processes, raise ethical issues about the dissemination and responses to research findings. The publication of poor quality research, including fraudulent research, contributed to the infodemic in COVID-19, and posed significant challenges for researchers, regulators, and policy makers seeking to develop evidence-informed pandemic responses. Accelerated dissemination of research findings prompts consideration of how to promote research integrity and detect research misconduct, and responsibilities to uphold research quality standards and ensure that publications make constructive contributions in challenging pandemic contexts. The five cases in this chapter promote reflection on citizen-scientists undertaking self-experimentation to develop COVID-19 vaccines outside frameworks for ethical and regulatory review of research; researchers proposing and undertaking research of questionable value and quality with vulnerable populations; and responsibilities of researchers, reviewers, journals and other research during accelerated pre-publication and peer-review processes.

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Additional indexing

Item Type:Book Section, not_refereed, original work
Communities & Collections:04 Faculty of Medicine > Institute of Biomedical Ethics and History of Medicine
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:24 April 2024
Deposited On:28 May 2024 10:30
Last Modified:03 Jun 2024 09:25
Publisher:Springer
ISBN:9783031418037
Additional Information:Case included in chapter 3 "Research Quality and Dissemination"
OA Status:Gold
Publisher DOI:https://doi.org/10.1007/978-3-031-41804-4_3
  • Content: Published Version
  • Language: English
  • Licence: Creative Commons: Attribution 4.0 International (CC BY 4.0)