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

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 ...