A week after the world’s first COVID-19 human challenge trial began in London, UK, in which volunteers are deliberately exposed to the SARS-CoV-2 virus, Dr. Charles Weijer, professor and bioethicist at Western University, and Josh Morrison, Executive Director of 1Day Sooner are calling for the publication of the trial’s protocol.
In an opinion piece published in the British Medical Journal, Weijer and Morrison highlight the importance of research transparency, especially for trials of this kind.
The co-authors publicly disagree about whether these studies should be conducted; Weijer has consistently opposed COVID-19 human challenge studies based on the ethical implications, while Morrison advocates for COVID-19 human challenge trial volunteers and is publicly supportive of the UK human challenge trial.
“What we do agree on is that the full study protocol for any SARS-CoV-2 challenge study should be published now,” they write in the joint opinion piece. “The early publication of study protocols is a verifiable public commitment to conduct the study as planned and thus evinces trustworthiness. It also provides an opportunity for the scientific community to better understand and digest these studies, which will, in turn, allow for better communication with the public.”
The institutions leading the current human challenge study have committed publicly to publishing the protocol at some point, said Weijer. He hopes this opinion piece will motivate them to publish it immediately.
“The COVID-19 pandemic has made clear how fragile public trust is,” said Weijer, professor in the Faculty of Arts and Humanities and the Schulich School of Medicine & Dentistry. “Whether it is for a challenge study or a traditional clinical trial, the early publication of the protocol is a verifiably public declaration by researchers to conduct the study as planned. It provides evidence that researchers are trustworthy, and deserving of the public’s trust.”
Despite the fact that the co-authors disagree about the ethics of human challenge studies, they are both committed to free and open debate about ethical issues and have collaborated on previous projects, including a debate in the British Medical Journal and a live-streamed video debate at University College London.
“Greater engagement between academics and advocates is critical for the future of health research,” said Weijer.
Commentary reflects the perspective and scholarly interest of Western faculty members and is not an articulation of official university policy on issues being addressed.