The Academy, HIC-Vac network, MRC and Wellcome today published a meeting report on Controlled Human Infection Model (CHIM) studies. This meeting looked at the existing oversight of the materials used in these studies, and how to ensure the safety of the research volunteers involved in them.
On 6 February 2018, the Academy of Medical Sciences, supported by the Human Infection Challenge Vaccine network, the Medical Research Council and Wellcome, held a workshop to discuss the current environment for CHIM studies in the UK and whether there was a need for additional measures to ensure appropriate oversight of this research.
In a CHIM study, a well-characterised strain of an infectious agent is given to carefully selected adult volunteers in order to better understand human diseases, how they spread, and find new ways to prevent and treat them.
The Academy had previously examined this issue in 2005 with its report ‘Microbial Challenge Studies of Human Volunteers’, which had highlighted the need for additional guidance and oversight of CHIM studies.
During the workshop, which was co-Chaired by Professor Andrew Pollard FMedSci and Professor Maria Zambon FMedSci, participants raised a number of points that they felt were pertinent to the current landscape for CHIM studies:
- There continues to be significant investment in CHIM studies as part of a wider goal of tackling endemic, pandemic and emergent infectious diseases.
- There is a need to build the capacity and capabilities of low- and middle-income countries for conducting CHIM research locally.
- There is a need for an ethical framework that guides the use of CHIM studies.
- CHIM studies are not without their risks, and high quality standards of manufacturing challenge agents and conducting CHIM studies should be adhered to as far as possible.
- Increasing numbers of collaborations between sectors, both within the UK and internationally, are allowing an exchange of knowledge and expertise that can expand the use of CHIM studies and accelerate the benefits derived from them.
- Establishing an archive of challenge agents would be of great benefit to the research community.
- Registration of CHIM studies is essential to knowledge sharing and open innovation in this area of research.
- The research community should engage with regulators to ensure that regulation remains proportionate and fit for purpose in light of any developments in CHIM studies.
The report of this workshop can be found on the right hand side of this page. As next steps, the co-Chairs have recommended a number of activities including the development of a set of guiding principles for ethics committees considering CHIM studies, and further engagement with regulators to discuss the need for, and appropriateness of, any further regulatory oversight.
Professor Andrew Pollard FMedSci, co-Chair of the workshop, said:
“Controlled human infection models are important tools in accelerating vaccine development, an area of vital research for combatting infectious diseases, many of which are deadly.
“The UK is uniquely positioned to be a leader in this field. We must take steps to ensure this continues, starting with developing a set of guiding principles for research ethics committees and encouraging further engagement between the research community and regulators.”
“This new joint report provides an essential framework for researchers to conduct CHIM studies with the aim of improving the health of vulnerable populations with life-saving vaccines.”
Professor Maria Zambon FMedSci, co-Chair of the workshop, said:
“Controlled human infection models rely on the participation of healthy volunteers and we have a duty to ensure the safety and quality of materials used in these studies.
“There are a number of processes already established for clinical trials involving medicines that CHIM studies should adopt as best practice to help strengthen this field, in particular on reporting and transparency.
“As funding bodies consider additional resources for these studies, they should also consider the creation of an archive for the banking of characterised challenge agents and their associated studies, methodologies and results.”
To see our current ptroject page on this topic click here