The Pathway of Project Approvals. Charlotte Davies- Research and Development Operations Manager

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1 The Pathway of Project Approvals Charlotte Davies- Research and Development Operations Manager

2 What do R&D do? Advises on relevant regulations and legislation Advises on planning and conduct of research Supports researchers with their application for Trust approval and offers advice and guidance on carrying out research in the Trust Ensures that appropriate standards for research governance are in place with regards to monitoring, risk, capacity, finance, information systems and management. Coordinates the review, monitoring and dissemination of all research. All underpinned by Research Governance Framework for Health & Social Care : Second Edition.

3 Structure of R&D

4 NIHR Clinical Research Network (NIHR CRN) Studies adopted onto NIHR research portfolio Adoption dependent on source of funding- has to be from an NIHR partner Industry studies can elect to be adopted NHS Clinical Research Networks Cancer Dementia and Neurodegenerative Diseases (DENDRON) Diabetes (DRN) Medicines for Children Mental Health (MHRN) Primary Care (PCRN) Stroke (SRN) Comprehensive Clinical Research Network (CLRN) CLRNs were created to provide support for clinical trials and other well designed studies NUH hosts Trent CLRN

5 Project Pathway RESEARCH PROPOSAL Grant Application/Funding Research Design Service Sponsorship Application to regulatory bodies -MHRA -Ethics Portfolio Adopted Study/Non Adopted study NHS permission

6 Grant Applications/Funding Contact R&D at earliest opportunity Consider Public & Patient Involvement (co-applicants) Studies must either be profitable or cost neutral

7 Research Design Service for the East Midlands National Institute for Health Research Research Design Services' (NIHR RDSs) aim is to increase the volume and quality of successful grant applications for NIHR funding. To do this they provide expert advice to help local researchers to develop and design high quality research proposals for submission to national, peer-reviewed funding competitions for applied health or social care research. Nottingham Base (Nottinghamshire, Derbyshire and Lincolnshire) Information and Bookings

8 Sponsorship All research projects must have an identified sponsor The Research Governance Framework for Health and Social Care. The Sponsor is the organisation which accepts and takes on the legal responsibility for the research; taking the lead in confirming there are proper arrangements for the initiation, management and monitoring, and financing of a study. This includes overseeing the management of the project in participating sites.

9 REC The National Research Ethics Service (NRES) reviews; research proposals to protect the rights and safety of research participants and enables ethical research which is of potential benefit to science and society. There are different types of NHS Research Ethics Committees (RECs) across the UK, reviewing different kinds of studies. Need to book a review slot with REC

10 MHRA When is an authorisation (CTA) required? Trials of medicinal products- substances or combinations of substances which either prevent or treat disease in human beings or are administered to human beings with a view to making a medical diagnosis or to restore, correct or modify physiological functions in humans. Studies involving non-ce marked medical devices carried out in the UK may be regulated as clinical investigations under the Medical Devices Regulations 2002 and require approval from the UK Competent Authority. The Regulations do not apply to non-interventional trials

11 Ethics & MHRA Application forms generated through Project Filter Page CAF; Coordinated System for gaining NHS Permissions Adoption Form (For portfolio projects only) REC; Research Ethics Committee form R&D; Research and Development form SSI; Site Specific Information

12 Application Routes-Adopted Studies CAF form to be completed- generated by ticking 5a on project filter page in IRAS CSP Coordinated System for gaining NHS Permission The National Institute for Health Research (NIHR) - system that standardises and streamline the process for gaining NHS permission for clinical research studies in England. Coordinated through a central NIHR CSP Unit and locally through the 25 Comprehensive Local Research Networks (CLRNs). Research Governance checks divided into global (completed once only) and local (completed for each site) Trusts to give the final permission for research to go ahead

13 Application Route- Non Adopted Studies Checklist of required documents from R&D office; - IRAS application - Confirmation of Sponsorship - Confirmation of funding - Participants Documents ie PIS/Consent form (with local details and header) - Protocol - Regulatory Approvals REC/MHRA - CVs & GCP for research staff - Agreements CTA/MTA - Radiation Protection approvals

14 NUH R&D approval Governance Review in line with Research Governance Framework R&D IRAS form- listing NUH as a research site SSI IRAS form- Completed with local details Support Department Authorisations; -Pharmacy -Radiology -Medical Physics -Labs -Cardiology -Treatment Centre Sponsorship Letter- confirms sponsor

15 NUH R&D approval Regulatory Approvals- REC/MHRA Research Staff- Signed and dated CVs- adequately qualified to undertake the study Appropriate access to conduct the study- ie research passport scheme. GCP training for CTIMP/Medical Device studies Radiation Protection Approval- ARSAC licence in place site if administration of radioactive substances IRMER- Radiation element of study signed off by Chief Investigator site NUH MPE radiation assessment completed and signed off Study documents- Protocol, Participant Information Sheets, Consent forms, GP letters, Advertisements (with NUH header and local contact details) Finance- Confirmation of funding to enable a costing proforma to be formulated by R&D in conjunction with research team. This will be signed off by the R&D finance team.

16 Agreements Contract between Sponsor and Investigator- Clinical Trials Agreement Outlines; Responsibilities Indemnity/Insurance Regulations/Law relating to clinical trials- ICH GCP Finance Ownership of Intellectual Property

17 Agreements(2) Transfer of certain tissue requires a Human Tissue Transfer Agreement (HTTA) or Material Transfer Agreement (MTA) to comply with the Human Tissue Act (2008)

18 HTTA & MTA Commercially sponsored studies do not require an additional material transfer agreement (MTA) or human tissue transfer agreement (HTTA) Non-commercial studies require an MTA unless the following is in place:- The patient information sheet clearly states that any tissues or material they donate (or gift ) for research shall be used and stored by the receiving institution (i.e. there is no inference that the Trust is receiving the material) The patient consent form clearly states that the patient is consenting to the use and storage of their tissue/material by the receiving institution.

19 Public and Patient Involvement- PPI Becoming increasingly more important Already listed on ethics application PPI involvement in research design process Grant applications

20 Post Approval Accruals/recruitment Adverse Event reporting Annual reporting- MHRA/REC Monitoring Amendments

21 Aim of R&D The Department of Research and Development will play a central and strategic role in; Establishing NUH as the leading acute teaching Trust provider in the UK by 2016 Fostering of a culture in which research and innovation are embedded in routine clinical practice Creation of an environment in which research findings lead to sustained improvements in the quality of patient care.

22 Summary The first responsibility of R&D remains the provision of an excellent research support service. In addition, however, the Department has a new and complex range of resources, which will be strategically allocated and managed to support first class clinical research and to create sustainable research capacity in the organisation.

23 Questions? Research & Development Nottingham University Hospitals NHS Trust E11, Curie Court Queen s Medical Centre Derby Road Nottingham NG7 2UH R&D Direct Line : QMC Line : ext FAX : charlotte.davies@nuh.nhs.uk City Campus Satellite Office : Website;

24 Weblinks Research and Development NUH; MHRA; REC IRAS; NIHR Research Networks; NIHR list of funding partners %20_Version7%20January%202011_.pdf CSP guidance Research Design Service