Acquiescence and submission to COVID-19 vaccination: ethics considerations

Abstract

Compelling individuals to be vaccinated with candidate vaccines that have been granted emergency use approval based on limited data, and penalising non-compliance, raises challenging ethics issues. For instance, some individuals may wish to be vaccinated, but may be hesitant to be vaccinated with particular vaccine candidates. On the other hand, some individuals may be averse to vaccination of any sort but may find themselves being forced to submit to vaccination in certain situational contexts to gain access to benefits or services. In all such instances, acquiescence and submission runs counter to the notion of voluntariness, which is a central pillar of the doctrine of informed consent.

Ethical priorities for international collaborative adaptive platform trials for public health emergencies

“…Funding such major networks inevitably involves opportunity costs—for other kinds of research, and for research institutions not involved in those networks. Here, and in the five WHO-commissioned reviews,2 9–12 we draw attention to how all parts of the research ecosystem need to keep in view these key ethical questions of power, equity and respect for local contexts and needs, as they take forward these effective models of research.…”

“…The success of adaptive platform trial designs in responding to COVID-19, and the endorsement by the WHA of major clinical trial networks, highlights the need to review experience to date so that trials can be conducted even quicker and better in future emergencies: driven by scientific rigour, and underpinned by sound ethical practice. Drawing on five reviews commissioned by the WHO Health Ethics and Governance Unit,2 9–12 that subsequently formed the basis for an expert round table held in Geneva in July 2022, we offer the following ethics-related key considerations to support the further development of international collaborative adaptive platform trials. Priority questions for future research and practice identified at the round table are set out in box 1.…”

“…Research ethics committees have struggled at times with the complexity and novel ethical questions raised by adaptive design methodologies 9. This raises specific questions of capacity strengthening, separate from existing well-recognised resourcing and capacity issues for ethical review systems in many parts of the world.…”