UCL publishes independent report into regenerative medicine research
29 September 2017
The outcome of the independent special inquiry into regenerative medicine research at UCL, instigated by the UCL Vice-Provost (Research), has been published today.
It investigated UCL’s involvement in regenerative medicine research with a particular focus on UCL’s relationship to Professor Paolo Macchiarini and the Karolinska Institute.
The inquiry has made a series of recommendations and UCL will act upon all of them. We are grateful to the panel for their work. The recommendations include:
- reporting the inquiry findings to the Medicines and Healthcare products Regulatory Agency (MHRA) and the Karolinska Institute, and collaborating with relevant bodies in further investigations.
- improving the training and support of our staff and students to ensure compliance with regulations pertaining to the clinical use of biomedical devices, and taking steps to clarify and standardise our policies and practices.
- ensuring that research misconduct investigations are completed in a timely manner and that we are transparent in communicating allegations and findings of investigations, including the assurance that funders are well-informed and that studies are not subject to unnecessary delays.
- reviewing the honorary appointment process to ensure that candidates are vetted in a consistent manner.
- working with our partners to seek to standardise oversight and approval processes for products with clinical applications and assist patients interacting with researchers at the interface between academic research and clinical medicine.
We deeply regret that materials (known as POSS-PCU constructs), that had not undergone rigorous pre-clinical assessment and which were not made to GMP standards, were manufactured and supplied by Professor Alexander Seifalian's research laboratory for direct clinical use. Our governance systems should have prevented that. We also regret the wider, negative impact that this work had on the field of regenerative medicine research.
Professor Seifalian was dismissed from UCL on 15 July 2016. Two UCL research misconduct investigations of Professor Seifalian are ongoing. The inquiry has made no recommendation that any additional research misconduct investigations are required into any current UCL staff.
Professor David Price, UCL Vice-Provost (Research), said: “On behalf of UCL, I would like to express my gratitude to the panel and to everyone who contributed evidence to the inquiry.
“As a world-leading university, UCL takes the integrity of its research very seriously, and we are always seeking to improve our processes and raise our standards.
“We are committed to supporting our staff as they continue a wide range of excellent research into regenerative medicine, which has tremendous potential to improve patient outcomes with proper support and governance.
“The recommendations of the inquiry will help us to continue building on our culture of research excellence and innovation, to address global health challenges in a responsible and ethical manner.”
Tel: +44 (0)20 7679 9222
Email: chris.lane [at] ucl.ac.uk