Ethical acceptability of human challenge trials: Consultation with the US public and with research personnel.

Human challenge trials (HCTs) may accelerate the development of treatments and vaccines, and deliver novel insights into the course and consequences of infection. However, HCTs are contentious because they involve purposely exposing volunteers to infection. Consultation with the public and other stakeholders is essential for understanding how HCTs can be most ethically and acceptably pursued.

Managing the Transition to Widespread Metagenomic Monitoring: Policy Considerations for Future Biosurveillance.

The technological possibilities and future public health importance of metagenomic sequencing have received extensive attention, but there has been little discussion about the policy and regulatory issues that need to be addressed if metagenomic sequencing is adopted as a key technology for biosurveillance. In this article, we introduce metagenomic monitoring as a possible path to eventually replacing current infectious disease monitoring models. Many key enablers are technological, whereas others are not.

Characterizing altruistic motivation in potential volunteers for SARS-CoV-2 challenge trials.

In human challenge trials (HCTs), volunteers are deliberately infected with an infectious agent. Such trials can be used to accelerate vaccine development and answer important scientific questions. Starting early in the COVID-19 pandemic, ethical concerns were raised about using HCTs to accelerate development and approval of a vaccine.

A Systematic Review of Human Challenge Trials, Designs, and Safety.

Background: Few studies have assessed participant safety in human challenge trials (HCTs). Key questions regarding HCTs include how risky such trials have been, how often adverse events (AEs) and serious adverse events (SAEs) occur, and whether risk mitigation measures have been effective.

Methods: A systematic search of PubMed and PubMed Central for articles reporting on results of HCTs published between 1980 and 2021 was performed and completed by 7 October 2021.