This meeting, held on 6 February 2018 and hosted by the Academy of Medical Sciences and funded by HIC-Vac, the MRC and Wellcome Trust, was a fantastic opportunity for the research community to come together and discuss the regulatory and ethical challenges around carrying out human challenge studies.
Dr Charlie Weller (Wellcome Trust), brought up the subject of what they should be called. The different terms that researchers use to describe them (human infection challenge (as in HIC-Vac), controlled human infection models (CHIM), or human infection studies but to name a few) is both problematic and confusing. After carrying out some public involvement work, the Wellcome Trust has a preference for referring to them as Volunteer Infection Studies as an alternative to HIC/CHIM studies. There isn’t yet agreement among researchers that this term is the best to use in literature; but for now, we’ll also refer to them as Volunteer Infection Studies (VIS) in public communications to try and make the research more accessible.
The meeting was opened by Professor Andy Pollard and Richard Moxon, who both agreed that now was a good time to pause and refresh the guidelines for VIS. They both said that UK is very strong is carrying out these type of studies, and so what we need is a framework that will ensure high standards are kept as the field grows, but without hampering the excellent research that’s on-going.
The meeting sponsors, including our Director Professor Peter Openshaw, gave their perspectives on the importance of continuing to support VIS and the value they add to health research. During the sessions, speakers and audience members raised the point that as well as focussing on the UK, we need to keep global bodies involved too, especially when it comes to the acceptability and framework around running studies in low and middle income countries (LMICs).
Professor Helen McShane gave an overview of her research into mycobacterial vaccines using BCG as a challenge agent, which illustrated early on how some of these issues directly impact on a research project. It was helpful to give tangible examples to some of the issues that were raised throughout the day.
The report from the meeting will be available in the coming months, and it was an excellent point to start discussions on what the specific ethical and regulatory issues are, and how we might go about solving them.