Publish the protocol for the UK SARS-CoV-2 human challenge study now

Publishing protocols while a trial is being conducted rather than afterward has unique value, particularly for SARS-CoV-2 challenge studies, say Josh Morrison and Charles Weijer

On 17 February, the British government announced that the first SARS-CoV-2 human challenge study had received approval from a research ethics committee. The challenge study, it said, was “due to begin in the next few weeks.” We, as co-authors, disagree on whether these studies should be conducted, but what we do agree on is that the full study protocol for any SARS-CoV-2 challenge study should be published now. 

Support for publishing scientific protocols has broad consensus: a review of high impact studies reveals that 82% of those reviewed eventually made their protocols available. Science is a collaborative endeavor, and sharing methods makes future research easier to conduct. Moreover, access to protocols finalized before a study begins helps to improve the end result by specifying hypotheses, design, outcome measures, and analysis plans in advance to avoid unwarranted changes to design or analysis and selective reporting of outcomes.

Real time transparency—publishing protocols while a trial is being conducted rather than afterward—has unique value, particularly for SARS-CoV-2 challenge studies. The philosopher Onora O’Neill argues that trustworthiness is more important than trust. David Spiegelhalter believes her view is key to fostering public trust during the covid-19 pandemic. He says, “trust happens when people show honesty, reliability and competence, presenting evidence in ways that make it accessible, intelligible, useful and easily assessed (meaning you can check the workings for yourself, if you so wish).” 

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. Openness with the protocol may allow experts to spot potential gaps and areas for improvement in the study plan, and thus improve safety for healthy volunteers. Seeing the plan for the study ahead of time may reduce the opportunity for sensationalist coverage if something goes wrong. 

The publication of protocols for randomized controlled trials of SARS-CoV-2 vaccines bears this out. Pressure for publication of study protocols increased after the poor public communication of a pause in a trial to investigate a serious adverse event. Unfortunately, in this instance, protocol publication as a response to public criticism seemed defensive. The World Health Organization’s 7 December meeting on SARS-CoV-2 challenge studies emphasized the importance of preventing these studies from contributing to vaccine hesitancy. This makes it imperative to think carefully about how an adverse event in the trial would be managed and communicated to the public. Given that the hVIVO and Imperial College London study team has publicly committed to publishing the protocol at some point, it makes sense to do it beforehand rather than as a response to any potential issue that may arise. 

Human challenge studies can advance the frontiers of medicine, but they raise the specter of past abuses such as wartime experiments involving the exposure of prisoners to infectious agents. Evading public scrutiny is not a solution. Instead, these studies should be treated as an opportunity to enact and publicly demonstrate our highest moral standards. This is best achieved by aiming to conduct challenge research not as an exercise in meeting the necessary requirements to receive ethics committee approval, but, rather, as a chance to think carefully about what the ideal policies for medical research should be and then attempt to make these studies models of such behavior.

By all accounts, the volunteers who wish to participate in these studies are doing so out of a sincere desire to help humanity. We, as a scientific community, owe it to them to do the same. Publishing scientific protocols for SARS-CoV-2 challenge studies in advance is one meaningful way of meeting that moral commitment.

Josh Morrison is the executive director of 1Day Sooner, an advocacy group for research participants, including those in covid-19 challenge studies. @1daysooner

Charles Weijer is a bioethicist and professor at Western University in London, Canada. @charlesweijer

Competing interests: JM is employed as the executive director of 1Day Sooner, a nonprofit organization that advocates on behalf of volunteers for a covid-19 human challenge trial. CW receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute International.