Implementation of the requirements of the Act and HTA licensing activities at UCL
Who are the UCL HTA Governance leads?
Dr Mark Lowdell, Deputy Chair & Director of Laboratory of Cellular Therapeutics (Hampstead Campus) and Designated Individual.
Professor Frackowiak, former Vice-Provost (Special Projects), and Chair of the UCL HTA Governance Committee and Dr Lowdell executed and managed the implementation of the HT Act and HTA licensing requirements on behalf of UCL. The UCL HTA Policy and SOP Working Parties were established to ensure that appropriate policies and procedure are established to help UCL staff (including those who hold honorary contracts) work in accordance with the provisions of the HT Act, and the HTA's regulatory remit.
UCL HTA Governance structure and key responsibilities is available is being updated.
Licenses and UCL & UCL-affiliated NHS Trust Designated Individuals
The approach taken by UCL in regard to the HTA licenses needed to cover our actitivites was made following discussion with Dr Sandy Mather (Head of Regulation, HTA). UCL was advised to act as the Corporate License Holder and to have in place a number Designated Individuals at premises to supervise applicable activities under the applicable license.
A message providing guidance and detailing UCL's arrangements under the HT Act and the HTA’s regulatory framework was sent to ALL UCL staff in preparation for implementing the requirements of the HT Act and the HTA’s licensing activities at UCL. UCL staff unable to access copy this message for reference can contact the UCLH/UCL Biomedical Research (R&D) Unit.
UCL and affiliated-Trusts
UCL, UCL Institutes and affiliated and collaborating Trusts including GOSH, MEH, RFH, RNOH, UCLH coordinated closely to ensure that licensable activities undertaken at the aforementioned organisations are covered by applicable HTA licences.
UCL holds a Corporate License. Currently, 10 HTA licenses are held by several UCL Designated Individuals. The licenses cover research, anatomy and the storage and use of human tissue or cells for human application. The UCLH Designated Individual (Dr Mary Falzon) holds a licence that covers the storage and use of relevant material for Pathology activities at UCLH. Designated Individuals at other UCL-affiliated NHS Trusts, including the Royal Free Hospital and the Royal National Orthopaedic Hospital, hold licenses that cover Pathology activities and for the storage of human tissue and cells for human application.
Designated Individuals and the UCL HTA Governance Committee
A Designated Individual is the person who is responsible for supervising the activities under a license and for ensuring compliance with any conditions attached to a licence. If you are involved in any of the activities listed under activities governed by the HT Act on UCL, NHS Trust premises, or at third party sites, you must ensure that an applicable HTA license is in place. Please contact the Joint UCLH/UCL Biomedical Research (R&D) Unit if you would like a list and the contact details of UCL-affiliated NHS Trust Designated Individuals and the type of HTA license held.
UCL and UCL-affiliated NHS Trust Designated Individuals and Persons Designated form part of the UCL HTA Research Governance Committee and are automatically included in the UCL_HTA email distribution list, which enables up-to-date information, guidance and queries to be shared from both internal and external sources.
