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Research Governance

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    1. Research Governance Dr Lesley Hall Research Governance Manager Joint Research Office 28th November 2008

    2. 2 Outline Research Governance what does it mean? Overview of main research regulations and legislation Approval process for research the new Co-ordinated System for gaining NHS Permissions (CSP) Approvals in NUTH linking with CSP

    3. 3 Research Governance what does it mean? About reducing risks associated with research by: Ensuring scientific quality of the research through good design and review Addressing ethical issues (particularly proper informed consent) Ensuring safety of participants Maintaining confidentiality of participants Ensuring financial probity and appropriate use of NHS resources

    4. 4 Main regulations and legislation Department of Healths Research governance framework for health and social care 2nd Edition Sept 2005 EU Clinical Trials Directive implemented in the UK through the UK Medicines for Human Use (Clinical Trials) Regulations 2004 EU Medical Devices Directives implemented in the UK through the Medical Devices Regulations 2002 (SI No 618) (2002) Governance arrangements for NHS Research Ethics Committees - July 2001 (GAfREC) Human Tissue Act 2004 (implemented Sept 2006) Mental Capacity Act 2005 (partially implemented Apr 2007 to become law Oct 2007) Data Protection Act 1998 and more recently Freedom of Information Act 2000 (also Caldicott requirements)

    5. 5 Main principles of DHs Research Governance Framework (RGF) Framework to bring together general principles of good practice to ensure good quality research is undertaken. Applies to research in the NHS involving human participants (patients or staff), their organs, tissue or data/records All research in the NHS MUST have a research Sponsor responsible for management and monitoring of the research A person designated to take responsibility for the design, conduct and reporting of the study Chief Investigator

    6. 6 EU Clinical Trials Directive Transposed into UK law through Medicines for Human Use Regulations 2004 and Amendment regulations 2006 includes all interventional clinical trials of Investigational Medicinal Products (ctIMPs) where the aim is to test the safety or efficacy of the a product for human use Covers all kinds of medicinal products, including pharmaceutical and biological medicines, vaccines, herbal remedies and homeopathic products Also includes a pharmaceutical form of an active substances or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled in a way different from the authorised form, or when used in an unauthorised indication, or to gain further information about the authorised form

    7. 7 Requirements for ctIMPs Regulated in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) ctIMPs must be registered with European clinical trials database to obtain unique EudraCT number to be used on all correspondence Must obtain a Clinical Trial Authorisation (CTA) from Medicines and Healthcare Products Regulatory Agency (MHRA) Integrated application process Strict requirements for handling IMPs regarding labelling and dispensing

    8. Clinical Trials Toolkit -

    9. 9 Good Clinical Practice in ctIMPs (Amendment Regulations 2006) Commission Directive on Good Clinical Practice (GCP) 2006 - regulating that ctIMPs are conducted to GCP standards MHRA carry out site inspections Summary of main GCP Responsibilities: Trial documentation - Master Trial Files including responsibilities delegation logs Adequate resources (time, facilities, staff, training, potential to recruit) Recorded evidence of investigators qualifications (signed CV), GCP training etc Rights/well-being of trial subjects (ethical approval and medical care ensured) Must comply with protocol as set out in application or have amendments approved (MHRA and Ethics) this constitutes a serious breach in GCP if not adhered to IMPs stored, labelled and used only in accordance with protocol Data held and stored appropriately changes dated and initialled (no tippex) Informed consent is essential - patient MUST sign and DATE (dates cannot be added afterwards) also MUST follow the original protocol and ethics approval MUST show that all staff trained in obtaining informed consent Regular monitoring establishing committees and evidence of decisions made (minutes) Progress reports to Ethics and MHRA (copy to sponsor) yearly and end to trial Safety reporting very specific for ctIMPs regarding reporting of Serious Adverse Events (guidance available regarding legal requirements) Records retention and archiving patient confidentiality issues

    10. 10 EU Medical Devices Directive Devices are regulated in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) The devices legislation covers the placing on the market and putting into service medical devices This enables the device to obtain a CE mark which is a public representation of the manufacturer's claim that the device satisfies the relevant Essential Requirements in the Directives, is fit for its intended purpose and, where required, has been independently assessed by a Notified Body. If using CE marked devices then no need to register with MHRA Clinical devices developed and used within an NHS setting only (eg, medical physics) do not fall under the regulations CE mark not necessary unless placing on the market (looking for EN 60601-1 standard) GREY areas does it cross-over into medicinal products legislation (eg, device administers a medicinal product)

    11. 11 Research Ethics Governance Arrangements for NHS Research Ethics Committees (GAfREC) paragraph 3.1 states that ethical advice from the appropriate NHS REC is required for any research proposal involving: patients and users of the NHS. This includes all potential research participants recruited by virtue of the patient or user's past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above access to data, organs or other bodily material of past and present NHS patients fetal material and IVF involving NHS patients the recently dead in NHS premises the use of, or potential access to, NHS premises or facilities NHS staff - recruited as research participants by virtue of their professional role."

    12. 12 Research Ethics review National Research Ethics Service (NRES) Application form online accessed through IRAS website Has a section to be signed by the sponsor before submission One main REC for each study Before you can begin you must have a favourable opinion for the main site from the main REC If multi-centre study must have no objection at local level (if Site Specific Assessment necessary) for all sites. This is sent to the main REC and site approval list sent to Chief Investigator

    13. 13 Human Tissue Act 2004 Implemented Sept 2006 Regulated in the UK by The Human Tissue Authority (HTA) for the removal, storage, use and disposal of human bodies, organs and tissue from the living and deceased. What does the Act do? Identifies the range of activities for which a licence will be required Prohibits the conduct of certain activities without a licence Establishes penalties (including custodial sentences) Prohibits commercial dealing in human material

    14. 14 Overview of tissue use A licence is only required to store tissue Even where consent is not required a licence to store tissue is required Even where consent is not required ethics approval is always required - examples: Project specific Research Tissue Bank - can apply for generic ethics approval therefore facilitating programmes of research without a need for individual project based ethics approval as long as within established parameters If transferring to or from a Research Tissue Bank then a Material Transfer Agreement this clarifies issues of confidentiality, storage, handling and issues of liability Use the new data and tissue toolkit!

    16. 16 Mental Capacity Act 2005 Becomes law Oct 2007 The Act also sets out clear parameters for research Research involving, or in relation to, a person lacking capacity may be lawfully carried out if an appropriate body (normally a Research Ethics Committee) agrees that the research is safe, relates to the persons condition and cannot be done as effectively using people who have mental capacity. Carers or nominated third parties must be consulted and agree that the person would want to join an approved research project personal consultee (eg, family member) or if none available nominated consultee (eg, GP, or other health care professional not connected to research)

    17. 17 Data Protection/Caldicott Informed consent is key for use of data (although Section 60 of the Health and Social Care Act 2001 exemption via PIAG in some exceptional situations) If information is to be recorded on a new database in the Trust, the database must be registered and should be held on Trust server If patient identifiable information is to used or transferred out of the Trust e.g. to University computers, then Caldicott Guardian approval required

    18. 18 Gaining approvals for research Before research can begin in the NHS must have: Favourable ethical opinion MHRA approval (for ctIMPs) Any other relevant approvals (ARSAC, GTAC etc) Trust R&D approval from every NHS site involved in the study (following a full risk assessment and evidence of other approvals) All approvals should be processed in parallel eg, apply for REC, MHRA & R&D at the same time Centralised system for some projects.......

    19. 19 ...NIHR Co-ordinated System for gaining Permissions in the NHS NIHR CSP will be available for ALL studies which are eligible and adopted into the NIHR portfolio Non-commercial studies - award funding in open national competition across England, with high quality peer review, and with strategic direction Commercial studies decided via the industry adoption team A single system for processing applications for NHS permissions A single application point through the Integrated Research Application System (IRAS) for multi-site and single site studies Single, secure online databases (CSP ReDA) with an electronic document repository Ensures that specific checks are only conducted once for multi-centre studies, with clear distinction between local and national checks

    20. 20 NIHR CSP Contd NIHR CSP is co-ordinated by a national NIHR CSP Unit in London In collaboration with the 25 Comprehensive Local Research Networks (CLRN) in this area is Northumberland, Tyne and Wear CLRN (NTW CLRN) NIHR CSP went live 18 November 2008 and will be continuously developed Submitting to NIHR CSP through IRAS First thing you must do to gain access to CSP is to get the project adopted by the NIHR portfolio suggest at bid stage or at the latest as soon as funding confirmed Log onto IRAS at If you havent created an account follow instructions

    21. Entry page for IRAS

    22. 22 Once properly logged on takes you to the My Projects page and you need to create a new project

    23. 23 IRAS Filter Page

    24. 24 Access to CSP through filter form 3a (select England) brings up 5a (Yes for CSP)

    25. 25 Access to the Portfolio Adoption Form (PAF) From filter page press NAVIGATE form now in Project Forms

    26. 26 PAF completed click submission Follow instructions to select CLRN and submit PAF to CSP Adoption unit using SUBMIT key

    27. 27 Then what... Portfolio adoption team has 2 working days to decide if studies are potentially eligible and send CI a response (30 days to give final decision) Studies that are adopted will be uploaded to the CSP ReDA system awaiting all other documents from CI NOTE: For projects not adopted applications are processed directly through relevant R&D departments must contact R&D immediately

    28. Next step for CI CI or designee completes other forms in IRAS (REC form and NHS R&D and any other forms prompted through answers to filter questions) Core data set used to populate all forms CI adds NHS SSI Form for participating sites and transfers to PIs (see IRAS guidelines) Main REC form and SSI forms (for local RECs) still have to be printed and wet ink signed for submission All forms have to be submitted to CSP through IRAS for uploading on the CSP system for processing All NHS Organisations involved in the project will be notified about the project via the CSP system

    29. 29 CSP processing and NUTH Trust Once NUTH FT receives information about a study via the CSP system, someone from R&D will contact the investigator to obtain any additional information Trust R&D will use the NHS R&D app form from IRAS but will have a short supplementary form for local information required Any additional documents not already uploaded to CSP (if requested to supply information in your interests to pass on as quickly as possible for uploading to CSP - you should only be asked once - all NHS organisations will have access to documents once uploaded) Full costings for the study for the local site etc Once all the information necessary for processing has been received, the project will be placed on the agenda of the next available Trust R&D approvals committee

    30. 30 Trust R&D Approvals Committee Monthly meetings see Trust R&D website for dates - deadlines for applications 2 weeks before the meeting Committee membership: Clinical Director of R&D Research Operations Manager Research Governance Manager Assistant Finance Director Pharmacy Research Director Trust Research Finance Officer Information Governance Manager Director of Newcastle Clinical Trials Unit Outcome of the meeting: Recommend to approve Recommend to approve subject to further clarification of issues raised and/or final approvals from ethics/MHRA/Caldicott etc Recommend NOT to approve Insufficient information requires resubmission

    31. 31 R&D Risk assessments Patient/participant safety Evidence of ethical review Evidence of other appropriate approvals in place (eg, MHRA) Data protection/Caldicott approval Scientific risk positive independent peer review Investigator risk Organisational risk Financial risk (ensure fully costed) This risk assessment and governance checks forms the basis of the CSP approvals process and R&D will log all the information necessary on the CSP system As checks are all logged on the CSP system all NHS organisations can use these should not have to duplicate checks (except local issues eg, finance, pharmacy issues etc)

    32. 32 Final stages Once all governance checks are complete and verified, then R&D will arrange the necessary letter of approval from the Trust and upload this to the CSP system There is a 7 day clock for validation by the CLRN There is a 21 day clock for final Trust R&D letter of approval to be processed and issued Research CANNOT begin in the Trust without the final letter of approval signed by the Trust CEO All other NHS organisations should be able to approve using evidence and checks from the CSP system in addition to their local checks.

    33. 33 Useful websites Department of Health Research Governance Framework - NRES for ethics applications and guidance - applications must now be made through IRAS MHRA for Medical Devices and Medicinal Products EudraCT website for registering a ctIMP Clinical Trials Toolkit essential guide to ctIMPs Human Tissue Authority REC SOPs for use of Tissue version 3.4, Sept 2007 at: - Chapter 11 and Annex H

    34. Useful websites Mental Capacity Act information Department of Health Information about Research Passports IRAS Website: IRAS USER MANUAL NIHR Portfolio information: NIHR Portfolio information for Commercial projects

    35. 35 Contact details Dr Lesley Hall Research Governance Manager Joint Research Office 4th Floor, Leazes Wing Royal Victoria Infirmary Queen Victoria Road Newcastle upon Tyne NE1 4LP Trust R&D main office: 0191 2825959 or email Trust.R&