UCL Research Ethics Committee
All research proposals involving living human participants and the collection and/or
study of data derived from living human participants undertaken by UCL staff or
students on the UCL premises and/or by UCL staff or students elsewhere → requires
ethical approval to ensure that the research conforms with general ethical principles and standards
UNLESS the only involvement of human participants in particular research activities will be in one or more
of categories a – f (→ exemptions), in which case the research will be exempt from ethics approval unless approval is specifically required by an external funding body or other external body in order to obtain research permission.
It is the responsibility of the Head of Department as outlined in 'Part 8: Management and Organisational Framework' of the Academic Manual: Duties and Responsibilities of Heads Of Department to ensure that staff and students of the Department are apprised of UCL's arrangements for research governance and the associated procedures, the main components of which include UCL's research ethics framework and the UCL REC: constitution, terms of reference and guidelines.
Research which falls under the remit of the NHS, must be referred to the appropriate Department of Health approved ethics committee. Further details and information on how to apply is available from the National Research Ethics Service.
Research involving → human tissue and research involving participants who lack → mental capacity must be reviewed by a Research Ethics Committee operating under the National Research Ethics Framework (NRES).
Human Tissue Act
In line with the Human Tissue Authority Code of Practice on Research, the majority of UCL-led research projects involving the storage and/or use of 'relevant material' (i.e. human tissue such as human tissue or cells with intact cell membranes) must be considered by a Research Ethics Committee operating under the National Research Ethics Service (NRES) or, where the research is a clinical trial which also uses human tissue, by a UK Ethics Committee Authority approved committee.
As the UCL Research Ethics Committee is not registered with the UKECA and does not operate under the NRES, if you propose to conduct a research project that will use 'relevant material' from healthy volunteers you will need to obtain ethical approval from an NHS Research Ethics Committee.
If your research involves human tissue please contact the UCLH/UCL Biomedical Research Unit or refer to the NRES webpages for further guidance.
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The Mental Capacity Act 2005 (MCA) provides a statutory framework for people who may not be able to make their own decisions, for example, because of learning difficulties, brain injury or mental health problems. It sets out who can take decisions, in which situations, and how they should go about this.
If you propose to conduct a research project that comes within the remit of the MCA:
• It applies to 16-17 year olds and adults (18 years and over) who lack capacity to make a particular decision or take a particular action for themselves at the time the decision or action needs to be taken.
• Guidance on the Act notes that lack of capacity may be permanent or temporary. It could be state-related (e.g. due to drug or alcohol use) or the person concerned could gain capacity for decision-making or action (within the legal definition) with appropriate support/training. The key point is whether they have capacity at the time.
then approval from a REC operating under the National Research Ethics Service will be required. You should note that research projects can be approved under the Mental Capacity Act only if the research cannot be carried out without the participation of individuals with the 'impairing condition' and the research is specifically connected to that impairing condition.
Please contact the UCLH/UCL Biomedical Research Unit or refer to the NRES webpages for guidance.
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For all UCLH, RFH and Institute of Neurology staff undertaking medical research the website www.ucl.ac.uk/jro/ provides all the information for i) R and D approval at UCLH; ii) Research contracts with UCLH both commericial and non commercial; iii) for research governance and keeping your study legal; iv) training and education in research governance; v) collaborations with statisticians.
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