Overview

The COVID-19 pandemic has had a devastating effect globally. Hundreds of millions of people have been infected with the SARS-CoV-2 virus and, according to the Economist Intelligence Unit, between 7 and 15 million people have died globally. The pandemic has highlighted difficult research ethics issues, including ethical issues in human challenge studies, cluster trials to evaluate public health measures, and reporting randomized controlled trials impacted by the pandemic. My research and public outreach explore each of these issues.

Human challenge studies. From the start of the pandemic, it was clear that a vaccine was urgently needed. But traditional vaccine development can take 10 to 15 years. Human challenge studies with the novel coronavirus were proposed to speed the development of a vaccine and save lives. But are such studies justifiable in terms of social value, risks to participants, and the potential impact on public trust in vaccines? In 2020, I was a member of a World Health Organization working group exploring the ethics of SARS-CoV-2 human challenge studies and our report, released on May 6, 2020, attracted international attention.

Cluster trials to evaluate public health measures. As cases of COVID-19 grew exponentially, people were locked down in their houses, non-essential businesses were closed, schools were shuttered, and travel was prohibited. While these precautionary measures were understandable, could rigorous evaluations of the de-implementation of these public health policies be ethically conducted. We explored the ethical issues in conducting a cluster randomized trial of school reopening, including the timing of the study, impact on vulnerable people, the role of gatekeepers, and the need for informed consent.

Reporting RCTs impacted by the pandemic. Thousands of clinical trials globally were terminated, paused or modified during the pandemic. These changes impact hundreds of thousands of trial participants and put the enrollment of millions on hold. But how should trials impacted by the pandemic be reported? I was part of an international team writing reporting guidelines (CONSERVE 2021) for trials modified by the COVID-19 pandemic and other extenuating circumstances.