This policy supersedes the following which much now be destroyed:

Transcription

1 Document Title Reference Number Lead Officer Author(s) (name and designation) Ratified by Research Governance Policy NTW(O)47 Medical Director Simon Douglas, Senior Manager for Research Innovation and Clinical Effectiveness Trust Policy Group Date ratified November 2014 Implementation Date November 2014 Date of full implementation November 2014 Review Date November 2017 Version number V02 Review and Amendment Log Version Type of change Date V02 Review Nov 14 Description of change Rewrite of Policy and newly developed RGP-PGNs This policy supersedes the following which much now be destroyed: Document Number NTW(O)47 V01.10 Title Research and Development Policy

2 Research Governance (RG) Policy Section Contents Page No. 1 Introduction 1 2 Purpose 1 3 Duties, Accountability and Responsibilities 2 4 Definition of Terms 3 5 Guiding Principles of Research Governance in NTW 3 6 Other prerequisites for research in NTW 4 7 Research Approvals Process 6 8 Requirements for Honorary Research Contracts / Letters of Access 9 Audit and monitoring 7 10 Reporting adverse events / Protocol deviations 7 11 Identification of Stakeholders 7 12 Training 7 13 Implementation 7 14 Fair Blame 7 15 Fraud and Corruption 8 16 Monitoring 8 17 Associated documents 8 18 References 8 6 Standard Appendices included within policy document A Equality and Diversity Impact Assessment 9 B Training Checklist and Training Needs Analysis 11 C Audit Monitoring Tool 13 D Policy Notification Record Sheet - click here Appendices listed separate to policy Appendix No: Description Issue No: Issue Date Review Date 1 NTW RG Strategy 1 Dec 14 Nov 17 2 Committee Terms of Reference 1 Dec 14 Nov 17 3 Research approval by clinical service 1 Dec 14 Nov 17

3 Practice Guidance Notes listed separate to policy (if any) Ref No: Description Issue No: Issue Date Review Date RGP-PGN-01 Research governance approvals process 1 Dec 14 Nov 17 RGP-PGN-02 NTW Sponsorship 1 Dec 14 Nov 17 RGP-PGN-03 Audit and Monitoring 1 Dec 14 Nov 17 RGP-PGN-04 Honorary Research Contract Process 1 Dec 14 Nov 17 RGP-PGN-05 Protocol Deviation 1 Dec 14 Nov 17 RGP-PGN-06 Study Documentation and Archiving 1 Dec 14 Nov 17 RGP-PGN-07 Safety Reporting 1 Dec 14 Nov 17

4 1 Introduction 1.1. Health research and development (R&D) is core business for the NHS. It plays a vital role in improving health outcomes and the quality of care. It is therefore a core element of the NHS Operating Framework. Research studies enable clinicians and researchers to develop new treatments and resolve uncertainty about existing treatments. NHS organisations have to demonstrate their contribution to R&D in Quality Accounts Health research is highly regulated. Clinical trials, medical device studies, use of patient data, professional qualifications, access to and treatment of NHS patients and other aspects of research studies are regulated by EU directives, UK legislation and professional standards of good practice (DH, 2006). The Department of Health s Framework for Research Governance in Health and Social Care (2005) (RGF) describes the overarching framework within with research studies are delivered within the NHS NHS organisations are legally responsible for their research activity including the safety of their staff and patients The RGF requires all research active organisations to have systems in place to meet its requirements from 1st April Northumberland, Tyne and Wear NHS Foundation Trust, (the Trust/NTW) collaborates on research projects with a number of Higher Education Institutions, including Newcastle University and Northumbria University. Establishing a common set of principles provides a sound basis for collaboration in research across the NHS and academic boundaries, ensuring that researchers who are often active in both organisations can work to a largely consistent set of rules and regulations. 2 Purpose 2.1 This policy and associated practice guidance notes (PGNs) set out the Trusts Research Governance Policy As a research active NHS organisation, the Trust is required to demonstrate that it has in place effective systems to manage and administer that activity. The Trust is committed to a high standard of practice in the administration of its research activity and this policy is designed to ensure that those charged with achieving these standards have available to them a suitable operational framework This policy and associated PGNs are designed to ensure there is clear guidance for research managers and research active staff in relation to requirements issued in the following main documents: Department of Health (2000) Research & Development for a First Class Service Northumberland, Tyne and Wear NHS Foundation Trust 1

5 Department of Health (2001, revised 2005) Framework for Research Governance in Health and Social Care Department of Health (2006) Best Research for Best Health: A new national health research strategy Department of Health (2009): NHS : from good to great. Preventative, people-centred, productive Medicines for Human Use (Clinical Trials) Regulations 2004 National Institute for Health Research (2010) Research Support Services Framework 2.4. This policy has been designed to meet the research governance objectives set out in the Trust s Research Strategy (Appendix 1) This policy describes the governance requirements and responsibilities at each stage of a research project s lifecycle, from initiation to completion. 3 Duties, Accountability and Responsibilities 3.1 It is a requirement to establish a governance facility which will take responsibility for the implementation and monitoring of the Trust s Research Governance Policy Research and Development Committee The Trust Board established a Research and Development Committee (R&DC), reporting to the Quality and Performance sub-committee of the Board. The principal purpose of the R&DC is to oversee the implementation of the Trust Research Strategy including Research Governance. It has a role scrutinising research activities, monitoring RM&G, supporting effective dissemination and utilisation of research, and encouraging the collaboration of clinical services and researchers in the Trust (see Appendix 2 for Terms of reference (TOR)) The Trust Board has delegated responsibility to monitor and support the implementation of research management and governance processes both within the Trust and/or as outsourced to any external provider to the Research and Development Committee The Terms of reference of the R&D Committee includes having oversight both of the Trust s performance on research governance and of the processes for approvals For complex or high risk research projects the R&D Committee may be asked to provide additional expert input into the governance process. Northumberland, Tyne and Wear NHS Foundation Trust 2

6 3.3 Research and Clinical Effectiveness Department The Trust has established a Research and Clinical Effectiveness Department whose Director reports via the Medical Director to the Chief Executive. This principal purpose of the Research and Clinical Effectiveness Department is to: Develop and implement a research strategy2 specific to the Trust s needs, and Manage the research governance process according to the principles in the RGF Coordination and administration of the Research Governance Policy will take place through the Research and Clinical Effectiveness Department, working with other internal and external departments and personnel to achieve the objectives set out in this policy The Research and Clinical Effectiveness Department will ensure research undertaken in the Trust meets accepted standards of quality. 3.4 Trust Staff undertaking research It is the responsibility of the Trust s researchers to ensure that the quality of research carried out in the Trust is to an acceptable standard. 4 Definition of Terms 4.1 Research - The attempt to derive new knowledge by addressing clearly defined questions with systematic and rigorous methods 4.2 Research Governance - This applies to all research concerned with the protection and promotion of public health research undertaken in or by the Department of Health, its non Departmental Public Bodies and the NHS, and research undertaken by or within social care agencies. It includes clinical and non-clinical research; research undertaken by NHS or social care staff using the resources of health and social care organisations; and any research undertaken by industry, charities, research councils and universities within the health and social care systems that might have an impact on the quality f those services. 4.3 Researchers - those conducting the study. 4.4 Chief Investigator (CI) the person designated as taking overall responsibility within the team of researchers for the design, conduct and reporting of the study. 4.5 Principal Investigator (PI) the person designated at the Trust to take overall responsibility for the conduct of the trial at the Trust e.g. in a multi-centre trial where the CI is based elsewhere. 5 Guiding Principles of Research Governance in NTW 5.1 For detailed process for research governance approvals see practice guidance note, RGP-PGN-01 - Research Governance Approvals Process which sits with this policy. Northumberland, Tyne and Wear NHS Foundation Trust 3

7 5.2 All research undertaken by Trust employees or persons granted access to this organisation for the purpose of undertaking research; (see RGP-PGN-004 Honorary Research Contract Process, which sits with this policy) will be managed and administered by the Research and Development Department and its delegates according to this overall Research Governance Policy. 5.3 The Trust will promote the development of a multidisciplinary research-oriented workforce. 5.4 The Trust will encourage externally funded research and will strengthen its links with external collaborators through programmes which are complementary to the objectives of all organisation and the Trust s Research Strategy (Appendix 1) 5.5 The Trust will protect its Intellectual Property Rights and exploit the product of its research in collaboration with industry and commerce in return for a fair and reasonable share in the proceeds of such exploitation. (See Trust s policy NTW(O)38 - Intellectual Property Policy). 5.6 The Trust will develop standard agreements for contracting research projects with external organisations; such agreements will be used as a basis for protecting the Trust s financial position and as a means of minimising the Trust s risks and legal liabilities. 5.7 The Trust will ensure that all research projects are approved by a properly constituted ethics committee. 6 Other prerequisites for research in NTW 6.1 Use of Patient Information for Research The Data Protection Act, Caldicott Report, Research Governance Framework, the EU, funding and professional bodies have all issued guidance on how patient information for the purposes of research should be gathered, handled, stored and disclosed. The purpose of these guidelines is to ensure that Trust staff undertaking research are aware of their responsibilities with regard to use of existing medical records, as well as creation of new hard copy/electronic patient records for research. See intranet page for Caldicott Approvals process and form. 6.2 Agreements with External Organisations Relationships with external organisations can take several different forms. All significant external collaborations will be covered by an appropriate agreement. The final responsibility for wording of agreements will vest in the Research and Development Department and ultimately the NTW Director of Research Innovation and Clinical Effectiveness The Executive Director of Performance and Assurance will be the Trust s legal signatory for such agreements Where external funding is to be received to carry out research, documentation is required which clarifies the funding arrangements. Specifically it must be clear that the funding belongs to the Trust and not the individual researcher and all expenditure must be in line with standing trust procedures for pay/non-pay expenditure. Northumberland, Tyne and Wear NHS Foundation Trust 4

8 6.2.4 Applying for external funding any requests to external companies for funding into research, whether this be actual money or other items such as drugs, equipment etc. need to comply with current bribery legislation Offers of external funding again any offers from outside companies to supply funds etc. need to comply with bribery legislation. All offers should be unconditional and must not imply in any way the funding will result in orders being placed or dependent on a particular amount of other business being conducted, future orders, recommendations being made etc All funding received must be declared in line with Trust s NTW(F) Standards of Business Conduct and Conflict of Interest Policy. 6.3 Access to the Trust for research staff employed elsewhere It has been customary for HEI-employed staff and other individuals not employed by NTWFT, but who work on Trust premises or with Trust patients, records or employees, to hold honorary contracts. The Research Governance Framework makes the requirement for honorary contracts explicit. It states that researchers who do not have a contract with an NHS body but whose research involves contact with NHS patients must have an honorary contract with an NHS body (see practice guidance note, RGP-PGN-04 Research Contract Process for detailed guidance which sits with this policy) 6.4 Clinical Service Review of Research Services should comprehensively assess the suitability of local resources, equipment and facilities; the implications for support departments; the potential risks and arrangements for their mitigation; the ability of staff groups to support the study; whether the required number of participants/samples can be recruited; and the arrangements to cover costs. The standard form for Service Review is issued by the R&D Office (Appendix 3) It is crucial that the decision takes into consideration the impact on routine clinical work and related services such as Pharmacy, etc. Failure to address these issues at the outset may lead to problems when the research is underway. An important part of the decision making process will be the affordability of unfunded or part-funded research. 6.5 Peer Review of Research The Research Governance Framework for Health and Social Care (RGF) was issued to prevent poor practice in research. A key component of the framework is the need for all research to have been subject to independent peer review. Similarly, new UK law on the conduct of clinical trials requires host and sponsor organisations to ensure that research practice adheres to recognised international standards 8. If carried out appropriately, peer review addresses not only the scientific quality and relevance of the research, but also its financial implications and aspects of health and safety. It is therefore an important means of ensuring that the organisation knows about research being conducted which uses its staff, patients and facilities and is satisfied that it is safe, affordable and good quality. This is particularly important for research which is not externally funded and subject to review at that stage. Evidence of peer review is now required as part of the process of obtaining ethical approval for research. Northumberland, Tyne and Wear NHS Foundation Trust 5

9 6.5.2 The policy applies to all Trust staff conducting research or external staff using the Trust as a base for their research. This includes student research, although the primary responsibility for the quality of student research lies with the relevant Higher Education Institute (HEI). Failure to obtain Trust service review approval for research or falsely claiming that this is in place may constitute research misconduct. The Trust will not act as sponsor for any research which fails this requirement Which Research Needs Peer Review? The RGF states that all research should be subject to independent peer review. All research which uses Trust patients, patient samples, staff, facilities, or resources must therefore be subject to some form of review. However, this should be proportionate and take into account other review processes the research may have been subject to and the likely impact on the organisation. Where a study has already undergone a peer review of its scientific merit, the Trust will limit its examination to the implications to the local service Own account research The Department of Health wishes to reduce the amount of unfunded research which it regards as generally lower quality and lower priority. It is therefore extremely important that unfunded research is subject to a thorough review process in order to make sure the Trust can demonstrate that all its research meets standards of quality and probity. This should cover all the areas listed on the standard service review form and include an independent assessment of the scientific quality of the project Externally funded research - Research which requires external funding normally has peer review built into the process. However, this will consider the scientific value of the research and not the departmental resources required to conduct the research. While the Trust will not re-examine the scientific value to the proposal, whether a department can sustain the research from its available resources should be part of the Trust review Post-Graduate student research Post-Graduate student research and other projects which are short term and have minimal resource implications should be treated proportionately, with the emphasis on general appropriateness and the impact the research would have on the service and on patients. Services may wish to consider a fast track form of service review for these studies to ensure there is no unnecessary delay in them starting. Review of the scientific merit of the studies will be undertaken by the HEI. 7 The Research Approvals Process 7.1 See practice guidance note, RGP-PGN-01 Research Governance Approvals Process, which sits with this policy, for description of research approvals process and associated documentation. 8 Requirements for Honorary Research Contracts / Letters of Access 8.1 The requirements and processes for obtaining the necessary contracts/access for non- Trust employees to conduct research with the Trust are detailed in the practice guidance note - RGP-PGN Honorary Research Contract Process, which sits with this policy. Northumberland, Tyne and Wear NHS Foundation Trust 6

10 9 Audit and monitoring 9.1 The Trust s Research and Development Department will perform a series of in depth audit and monitoring on a minimum of 10% of approved projects annually (see practice guidance note, RGP-PGN-03 Audit and Monitoring, which sits with this policy). The results of this monitoring will be reported to the R&D Committee annually. 10 Reporting adverse events / Protocol deviations 10.1 The requirements for CIs and PIs to report adverse events and protocol deviations are detailed in practice guidance notes which sit with this policy, RGP-PGN-007 Safety Reporting and RGP-PGN-05 Protocol Deviation, respectively. 11 Identification of Stakeholders 11.1 This policy has been circulated within the R&D Team and Committee, as well as a Trust wide consultation period of 4 weeks to the following:- Senior Management Team Local Negotiating Committee Consultant Psychiatrists Planned Care Group Specialist Care Group Urgent Care Group Psychological Services Clinical Governance and Medical Directorate Safeguarding Trust Allied Health Profession Services Finance, IM&T, Estates and Performance Staff-side Trust Pharmacy Workforce Communications 12 Training 12.1 There is no Trust wide requirement for training in research governance but a range of bespoke training packages are available from the R&D Department and academic partners as required; see Appendix B 13 Implementation 13.1 The policy represents only minor changes from current processes so should be implemented Trustwide immediately, significant changes are for the operations of the R&D department and are captured in the associated PGNs listed with this policy. 14 Fair Blame 14.1 The Trust is committed to developing an open learning culture. It has endorsed the view that, wherever possible, disciplinary action will not be taken against members of staff who report near misses and adverse incidents, although there may be clearly defined occasions where disciplinary action will be taken. Northumberland, Tyne and Wear NHS Foundation Trust 7

11 15 Fraud, Bribery and Corruption 15.1 The Trust is committed to minimising the opportunities for fraud, bribery and corruption wherever they occur, and is committed to taking positive action to achieve this. All cases of suspected fraud, bribery and corruption must be reported to the Trust s Local Counter Fraud Specialist who will ensure the allegations are investigated and reported to NHS Protect as appropriate. Further information can be obtained from the Trust Counter Fraud Specialist on (See also Trust s NTW(O)23 Fraud, Bribery and Corruption Policy). 16 Monitoring 16.1 Monitoring requirements for this policy are stated in Appendix C 17 Associated documents NTW(F)07-01 Standards of Business Conduct and Conflict of Interest Policy for NTW Department of Health (2000) Research & Development for a First Class Service Department of Health (2001, revised 2005) Framework for Research Governance in Health and Social Care Department of Health (2006) Best Research for Best Health: A new national health research strategy Department of Health (2009): NHS : from good to great. Preventative, people-centred, productive Medicines for Human Use (Clinical Trials) Regulations 2004 National Institute for Health Research (2010) Research Support Services Framework 18 References Department of Health (2006) Best Research for Best Health: A new national health research strategy Northumberland, Tyne and Wear NHS Foundation Trust 8

12 Appendix A Names of Individuals involved in Review Equality Analysis Screening Toolkit Date of Initial Screening Review Date Christopher Rowlands August 2014 Trust-wide Service Area / Directorate Policy to be analysed Is this policy new or existing? Research Governance Policy NTW(O)47 What are the intended outcomes of this work? Include outline of objectives and function aims This policy and associated practice guidance notes (PGNs) set out the Trusts Research Governance Policy. As a research active NHS organisation, the Trust is required to demonstrate that it has in place effective systems to manage and administer that activity. The Trust is committed to a high standard of practice in the administration of its research activity and this policy is designed to ensure that those charged with achieving these standards have available to them a suitable operational framework. New Who will be affected? e.g. staff, service users, carers, wider public etc Research could potentially have wide ramifications for the improvement of health and wellbeing Protected Characteristics under the Equality Act The following characteristics have protection under the Act and therefore require further analysis of the potential impact that the policy may have upon them Disability Sex Race Age Gender reassignment (including transgender) Sexual orientation. Religion or belief Marriage and Civil Partnership Pregnancy and maternity Carers Other identified groups How have you engaged stakeholders in gathering evidence or testing the evidence available? Through standard policy consultation process Northumberland, Tyne and Wear NHS Foundation Trust 9

13 How have you engaged stakeholders in testing the policy or programme proposals? Through policy process For each engagement activity, please state who was involved, how and when they were engaged, and the key outputs: Proposed policies are circulated widely and there is the opportunity to make comments about proposals and these comments need to be addressed as part of the policy making process. Summary of Analysis Considering the evidence and engagement activity you listed above, please summarise the impact of your work. Consider whether the evidence shows potential for differential impact, if so state whether adverse or positive and for which groups. How you will mitigate any negative impacts. How you will include certain protected groups in services or expand their participation in public life. No impact Now consider and detail below how the proposals impact on elimination of discrimination, harassment and victimisation, advance the equality of opportunity and promote good relations between groups. Where there is evidence, address each protected characteristic Eliminate discrimination, harassment and victimisation NA Advance equality of opportunity Promote good relations between groups What is the overall impact? NA NA No negative impact Addressing the impact on equalities NA From the outcome of this Screening, have negative impacts been identified for any protected characteristics as defined by the Equality Act 2010? None If yes, has a Full Impact Assessment been recommended? If not, why not? Manager s signature: Chris Rowlands Date :August 2014 Northumberland, Tyne and Wear NHS Foundation Trust 10

14 Appendix B Communication and Training Check list for policies Key Questions for the accountable committees designing, reviewing or agreeing a new Trust policy Is this a new policy with new training requirements or a change to an existing policy? If it is a change to an existing policy are there changes to the existing model of training delivery? If yes specify below. Are the awareness/training needs required to deliver the changes by law, national or local standards or best practice? Please give specific evidence that identifies the training need, e.g. National Guidance, CQC, NHSLA etc. Please identify the risks if training does not occur. Change to existing No specific training required No major changes policy updated to reflect incremental changes to practice since policy last updated Please specify which staff groups need to undertake this awareness/training. Please be specific. It may well be the case that certain groups will require different levels e.g. staff group A requires awareness and staff group B requires training. Is there a staff group that should be prioritised for this training / awareness? Please outline how the training will be delivered. Include who will deliver it and by what method. The following may be useful to consider: Team brief/e bulletin of summary Management cascade Newsletter/leaflets/payslip attachment Focus groups for those concerned Local Induction Training Awareness sessions for those affected by the new policy Local demonstrations of techniques/equipment with reference documentation Staff Handbook Summary for easy reference Taught Session E Learning Please identify a link person who will liaise with the training department to arrange details for the Trust Training Prospectus, Administration needs etc. Formal training not required R&D team can assist individuals if required No See above Laura Frisby Northumberland, Tyne and Wear NHS Foundation Trust 11

15 Appendix B continued Training Needs Analysis Staff/Professional Group Any member of staff submitting an application for research approval Type of training Duration of Training bespoke Approx. 1 hour once Frequency of Training Copy of completed form to be sent to: Training and Development Department, St. Nicholas Hospital Should any advice be required, please contact: (internal Northumberland, Tyne and Wear NHS Foundation Trust 12

16 Statement Monitoring Tool Appendix C The Trust is working towards effective clinical governance and governance systems. To demonstrate effective care delivery and compliance, policy authors are required to include how monitoring of this policy is linked to auditable standards/key performance indicators will be undertaken using this framework. NTW(O)47 Research Governance Policy - Monitoring Framework Auditable Standard/Key Performance Indicators Approved projects will be monitored for compliance with this policy and associated PGNs Research projects will be approved within National Standard of 15 days Frequency/Method/Person Responsible In depth project audit and monitoring under RGP- PGN-003 (10% minimum of approved projects per annum) by research governance facilitator Quarterly report to DH / R&D Committee by Senior Manager for Research Where Results and Any Associate Action Plan Will Be Reported To Implemented and Monitored; (this will usually be via the relevant Governance Group). Reported annually to R&D Committee R&D Committee 3. Research projects will provide evidence of peer review Quarterly report to R&D Committee by Senior Manager for Research R&D Committee The Author(s) of each policy is required to complete this monitoring template and ensure that these results are taken to the appropriate Quality and Performance Governance Group in line with the frequency set out. Northumberland, Tyne and Wear NHS Foundation Trust 13