SLaM/IoPPN Sponsorship Guidance v14
APPENDIX E - LOCAL RESOURCES
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Clinical Research Facility (Denmark Hill)
South London and Maudsley NHS Foundation Trust ‘Consent for Contact c4c’ initiative
IMANOVA
Bioresource
IOPPN Centre for Neuroimaging Sciences (CNS)
Clinical Research Facility (Denmark Hill)
Our £20m Clinical Research Facility on the Denmark Hill Campus of King's College London (KCL) opened in
Summer 2012. Funded primarily by the Wellcome Trust, three (KCL, South London and Maudsley and King's
College Hospital NHS Foundation Trusts) of the four partners of our King's Health Partners Academic Health
Sciences Centre, NIHR BRC for Mental Health infrastructure funding, and locally-attracted charitable
income, this facility is the first public-sector CRF in the UK and possibly the world, designed to
accommodate patients with psychiatric and neurological disorders. Additionally, it will facilitate research in
general medicine including haemato-oncology, cardiology and liver diseases, making it uniquely placed to
deliver experimental medicine at the mental and physical health interface. Providing neuroimaging, EEG
and virtual-reality facilities, an intensive care unit, a Cell Therapy Unit for gene- and cell-based therapies,
and a Clinical Trials Facility for commercially-sponsored trials, the CRF will seek to take full advantage of the
excellence of clinical and academic activity within KHP and provide an environment in which experimental
medicine thrives and ensures that the translation “from the bench to the bedside” improves patient care.
The CRF features state-of-the-art, in-built, neuroimaging suites, multiple dedicated neurocognitive testing
suites, two EEG suites (prone and sitting, for use with computer stimuli), a virtual-reality suite, a bedded
area for sampling and monitoring, an intensive care unit facility for critically-ill patients, a large Cell Therapy
Unit for gene- and cell-based therapies, and a Clinical Trial Facility to support commercially-sponsored
studies. The facility has been designed to serve as a `research hotel' accessible to all King's Health Partnerassociated clinical researchers undertaking appropriately approved research projects. Accordingly, it
maximises research space by supporting minimal storage facilities to avoid “silt up” of unwanted
equipment and documentation.
The CRF has been located alongside King's College Hospital in order to provide suitable access for the study
of critically-ill or brain-injured patients, and to ensure that all study subjects have easy and immediate
access to the emergency resuscitation expertise within KCH. The building has been constructed in
accordance with the Disability Discrimination Act (DDA) to allow access and utilisation by disabled
individuals; and SLaM Clinical Services Estates advice to ensure the CRF design as a whole minimises risk to
patients with mental ill health.
The establishment of the Denmark Hill CRF represents a key development in the forward strategy of KHP.
For further information please contact: Elka Giemza, Clinical Research Facility Manager - Tel: 020 3299
1850, email elka.giemza@kcl.ac.uk or King's CRF Administrator: Ade Shopade email:
adebukola.shopade@nhs.net; Tel: 020 3299 1851/1852
For guidance on how to include use of the CRF in your ethics application please contact the R&D office
Governance and NHS R&D approval: Where a study using the CRF involves SLaM patients the research
governance of the study will come under the SLaM/IoPPN R&D office (it will not need to be listed as a
separate site at Part C of the IRAS form). Where a study uses the facilities of the CRF and involves both
SLaM and KCH patients, it will need R&D approval from both Trusts.
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South London and Maudsley NHS Foundation Trust ‘Consent for Contact c4c’ initiative
‘Consent for Contact (c4c)’ is a Trust-wide initiative to increase our service users awareness of
opportunities for taking part in research. Clinical staff ask their patients whether they would be willing to
be approached for possible participation in research that may be of interest to them. Responses are
logged on a Research Consent form held in a service user’s electronic medical record.
The aim is to allow approved researchers to use a computerised retrieval system developed by the
Biomedical Research Centre to rapidly screen very large numbers of casenotes of service users who have
agreed that researchers can access their contact details and limited clinical information to identify if they fit
inclusion criteria and invite them to participate in research projects. The computerised retrieval system is
called SLaM Clinical Research Interactive Search (CRIS). CRIS has NHS ethics and National Information
Governance Board (NIGB) approvals to be used as a recruitment tool for research within SLaM.
For further information and guidance on how to include C4C in your ethics application please contact the
R&D office
IMANOVA
If you are using the facilities at IMANOVA please note the following:
A King’s College London - IMANOVA project specific agreement will be required for each study, the key
points that will need to be included in the agreement are:
1.
The total number of scans – and ligand, duration , arterial cannulation or not
2.
The details of the procedures that will be carried out at Imanova – this is so Imanova can put together
the Roles and Responsibilities section
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Timelines – to ensure they have the capacity
IMANOVA will need to see a fairly advanced protocol at the earliest stage possible – please include the
above in your study protocol and email it to the following people:
IMANOVA: Ilan.Rabiner@Imanova.co.uk, Andy.Brown@Imanova.co.uk
King’s College London: Andrew.webb@kcl.ac.uk
Anyone using the facilities at IMANOVA will be required to have up to date GCP training in place. KHP CTO
are responsible for providing GCP training for KCL staff undertaking studies at Imanova. To organise this
please email Sarah Ruiz (KHP CTO training officer sarah.ruiz@kcl.ac.uk) and advise her that you require GCP
training in order to conduct your research study in IMANOVA. (see also Appendix F – Training and
resources)
Consent to register participants at Hammersmith Hospital
As participants being seen at IMANOVA will be scanned in an imaging facility in the grounds of the
Hammersmith Hospital, in order for participants to receive medical cover in the event of a medical
emergency, they will need to be registered as ‘patients’ at the Hammersmith Hospital. This should be
included on the information sheet and consent form as follows:
Participant Information Sheet
In section “Will my taking part in this study be kept confidential?”
We will need to register you as a patient with the Hammersmith Hospital. This will allow us to use the
services provided by Hammersmith Hospital in case of a medical emergency when you attend Imanova for
your PET scan.
Consent form
I agree that my details can be passed to the Hammersmith Hospital,
so that I can be registered as a patient at that hospital
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NIHR BRC Bioresource
NIHR Bioresource for Mental Health is a SLaM/IoP BRC ethically approved initiative that aims to collect
samples and clinical information from individuals using SLaM services. Information about the Bioresrouce
can be found here: http://www.slam.nhs.uk/research/patient-involvement/currentopportunities/bioresource
If you are interested in collaborating with the Bioresource please contact them directly to discuss, and then
include details of the collaboration in your protocol and IRAS form.
IOPPN Centre for Neuroimaging Sciences (CNS)
Some of the research performed on MRI scanners run by the KCL Department of Neuroimaging (including
the scanner in the Wellcome CRF building) involves using the scanners outside their CE marking. If this
applies to your study it will need to be recorded on the IRAS application form. Please check this link and
seek advice from the CNS if needed
https://mri.iop.kcl.ac.uk/index.php/MRIforResearchers#CE_Marking If it does apply, an example of
how to complete the relevant section of the IRAS form is here:
https://mri.iop.kcl.ac.uk/images/4/4f/PartBSection2IRAS_Example.pdf .
No further action is required beyond completing the IRAS form correctly; in particular, note that as these
studies use, but are not studies of, the scanner, no reporting to the MHRA devices division is required.
The Department of Neuroimaging runs scanners both within the Centre for Neuroimaging Sciences (CNS)
and at the Denmark Hill CRF. The scanners are essentially identical, and it can therefore sometimes be
advantageous (e.g. in terms of scanner availability on particular days, or at particular times) to use the CRF
scanner even if the study does not directly involve other CRF resources. If you plan to use the CNS for your
scanning, but think that this might apply, please contact the CNS to discuss, and if needed adjust the
wording in your protocol, IRAS form and consent documents to reflect that participants might be seen at
either the CNS or CRF. The R&D office can help you with the wording if needed.
You will also need to apply to the CRF, see section on the CRF above for how to do this.
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