R&D Annual Report SLaM Board, Sept 2004 Graham Thornicroft Gill Dale

Who’s Who in R&D Institute of Psychiatry (King’s College London) Dean: George Szmukler South London and Maudsley NHS Trust: Graham Thornicroft, Director of R&D Gill Dale Assistant Director of R&D Head of Joint IoP / SLaM R&D Office Jo Piper Research Governance Facilitator Nicole Detre R&D Administrator Caroline Moran R&D Web Editor

Key Issues Maintaining our R&D income Impact of our research on the NHS Research Governance Clinical Trials Management Research Sponsorship Building research capacity Keeping staff informed

R&D Income SLaM’s R&D income for : £24.5m Approximately 10% of SLaM’s income

R&D Context National context: Financial flows – national review of R&D levy allocations: publications and research grant income used as drivers to determine ‘appropriate’ R&D levy. Risk: future re-basing of R&D levy. Local context: 97% ‘support for science’; 3% ‘priorities and needs’ Accountability for R&D spend, how the funds are distributed to the Directorates.

Increasingly Detailed Reporting Requirements to DH R&D Annual Report Reporting on ‘Priorities & Needs’ Programmes National Research Register quarterly Research Governance new this year: Controls Assurance Standard return

R&D Annual Report to DH Report on R&D portfolio by ‘priorities and needs’ programmes (SLaM leads on 19) Financial reporting of R&D spend by programme Information requirement focuses on outputs for each programme: Key research findings How research impacts on the NHS Publications (peer reviewed journals) Written agreements with research partners

SLaM Research Impact on the NHS July 2004 Document now available (based on R&D Annual Report to DH) [tabled] being distributed widely on Intranet and R&D website ( available from R&D Office

Maintaining our R&D Income Maintain high quality research – all of our 19 ‘priorities and needs’ research programmes currently rated as strong Be accountable for R&D spend – a clearer idea of how to use R&D funds Be aware of external risks (e.g. financial flows project)

Research Governance Reporting In 2004, compliance with the Research Governance Framework was reported through a Controls Assurance Standard (previously through R&D annual reporting process) Strategic Health Authority responsible for Research Governance performance management

Research Governance Challenges Honorary contracts - Anyone undertaking research in NHS requires a substantive or honorary contract - Difficulties with multicentre studies – many organisations require separate contracts Sponsorship - which organisation(s) to take the role? Written Agreements with collaborators

New Clinical Trials Regulations New management systems to ensure that we are fully compliant with the Medicines for Human Use (Clinical Trials) Regulations 2004: - Clinical Trials Authorisation (CTA) - all trials have a Sponsor - all trials have ethical approval - Good Clinical Practice - Monitoring - Adverse event reporting

Clinical Trials Extending existing Research Governance systems to meet clinical trials specific requirements: Introduced a formal risk assessment process* Extending monitoring systems Extending adverse events reporting systems Extending Research Governance talks to staff to cover Good Clinical Practice *national dissemination of our approach through DH/MRC Joint Project and R&D Forum conference

Joint Clinical Trials Co-ordinating Committee Reviews and monitors clinical trials portfolio Risk assesses new clinical trials in terms of organisational risk and reputation Keep abreast of clinical trials legislation It doesn’t do the job of the ethics committee which is about protecting participants

Research Sponsorship Research Governance Clinical Trials Regulations, 2004 SLaM position statement (tabled)

Building Capacity Under-represented professional groups: Research conferences for nurses and O.T.s Service user involvement in research SURE clinic and training courses National role in Mental Health Research Network Partnership of IoP/SLaM & U. of Manchester SLaM leads South London Hub

Mentalhealthcare.org.uk web site for carers, friends and relatives of people with mental illness Collaboration SLaM, IoP and Rethink coverage in local press, national periodicals and high profile web sites site receives around 10,000 visits per month information and advice on schizophrenia, bipolar disorder, eating disorders, autism, young people and mental health

Help to Researchers Regular, accessible, up to date advice and support: One to one advice circulars - funding opportunities - procedural advice Staff Research Handbook, advice leaflets R&D Update Newsletter Comprehensive website