Research Governance Policy Version: Status: Title of originator/author: Name of responsible director: Developed/revised by group/committee and Date: Approved by group/committee and Date: Effective date of issue: (1 month after approval date) Next annual review date: 1 Final Research & Audit Manager/Research Facilitator Executive Medical Director Research & Development Group Quality Governance Committee, 25 February 25 March 2013 31 January 2016 Date Equality Impact Assessment Completed Regulatory Requirement:
Trust Policy Foreword South Western Ambulance Service NHS Foundation Trust (SWASFT) has a number of specific corporate responsibilities and obligations relating to patient safety and staff wellbeing. All Trust policies need to appropriately include these. Health and Safety - SWASFT will, so far as is reasonably practicable, act in accordance with the Health and Safety at Work etc. Act 1974, the Management of Health and Safety at Work Regulations 1999 and associated legislation and approved codes of practice. It will provide and maintain, so far as is reasonable, a working environment for employees which is safe, without risks to health, with adequate facilities and arrangements for health at work. SWASFT employees are expected to observe Trust policy and support the maintenance of a safe and healthy workplace. Risk Management - SWASFT will maintain good risk management arrangements by all managers and staff by encouraging the active identification of risks, and eliminating those risks or reducing them to the lowest level that is reasonably practicable through appropriate control mechanisms. This is to ensure harm, damage and potential losses are avoided or minimized, and the continuing provision of high quality services to patients, stakeholders, employees and the public. SWASFT employees are expected to support the identification of risk by reporting adverse incidents or near misses through the Trust webbased incident reporting system. Equality Act 2010 and the Public Sector Equality Duty - SWASFT will act in accordance with the Equality Act 2010, which bans unfair treatment and helps achieve equal opportunities in the workplace. The Equality Duty has three aims, requiring public bodies to have due regard to: eliminating unlawful discrimination, harassment, victimization and any other conduct prohibited by the Act; advancing equality of opportunity between people who share a protected characteristic and people who do not share it; and fostering good relations between people who share a protected characteristic and people who do not share it. SWASFT employees are expected to observe Trust policy and the maintenance of a fair and equitable workplace. NHS Constitution - SWASFT will adhere to the principles within the NHS Constitution including: the rights to which patients, public and staff are entitled; the pledges which the NHS is committed to uphold; and the duties which public, patients and staff owe to one another to ensure the NHS operates fairly and effectively. SWASFT employees are expected to understand and uphold the duties set out in the Constitution. Code of Conduct and Conflict of Interest Policy - The Trust Code of Conduct for Staff and its Conflict of Interest and Anti-Bribery policies set out the expectations of the Trust in respect of staff behavior. SWASFT employees are expected to observe the principles of the Code of Conduct and these policies by declaring any gifts received or potential conflicts of interest in a timely manner, and upholding the Trust zero-tolerance to bribery. Information Governance - SWASFT recognises that its records and information must managed, handled and protected in accordance with the requirements of the Data Protection Act 1998 and other legislation, not only to serve its business needs, but also to support the provision of highest quality patient care and ensure individual s rights in respect of their personal data are observed. SWASFT employees are expected to respect their contact with personal or sensitive information and protect it in line with Trust policy. Page 1 of 20
CONTENTS 1. INTRODUCTION... 3 2. PURPOSE... 3 3. SCOPE... 4 4. OBJECTIVES OF THE TRUST S RESEARCH AND DEVELOPMENT (R&D)... 4 5. FRAMEWORK AND GOVERNING PRINCIPLES... 5 6. RESEARCH FRAUD OR MISCONDUCT... 7 7. MANAGEMENT AND ACCOUNTABILITY... 8 8. STAFF TRAINING AND DEVELOPMENT... 9 9. PROCESS FOR GAINING TRUST MANAGEMENT PERMISSION... 10 10.AMENDMENTS... 11 11.MONITORING AND AUDITING... 11 12.ACTION FOLLOWING COMPLETION OF RESEARCH... 11 13.REVIEW... 12 14.REFERENCES... 13 15.ASSOCIATED DOCUMENTS... 13 16.GLOSSARY... 13 APPENDIX A... 16 APPENDIX B... 17 Page 2 of 20
1. Introduction Page 3 of 18 South Western Ambulance Service NHS Foundation Trust (hereafter referred to as the Trust ) acknowledges that research is essential to the successful promotion of health and is a key element of continuous improvement, underpinning the provision of safe and effective evidence-based care. In recognising this, the Trust is committed to developing and supporting a culture of research excellence by observing the requirements set out in legislation and NHS policy. A core standard for healthcare organisations is that they have systems in place to ensure that the principles set out in the Research Governance Framework for Health and Social Care (2nd edition, 2005) are consistently applied, to ensure safe systems of care when research is being undertaken. All research within the scope of the Governance Arrangements for Research Ethics Committees requires review by a Research Ethics Committee (REC). Additionally, to comply with the requirements of the Research Governance Framework, the Trust must formally approve all research activities in which it participates. This policy reflects the role that the Trust increasingly plays in delivering key services that are based not on historical precedent, scientific uncertainty or individual preference - but on sound evidence. It reinforces the importance of building high-quality, research-based practice that lays the foundation for our greater contribution to NHS priorities - with the goal of finding new, more effective techniques and eradicating unsafe or inefficient practices and interventions. 1.1 Definition of Research Research can be defined as the attempt to derive widely applicable new knowledge by addressing clearly defined questions with systematic and rigorous methods. 1.2 Today s Research May be Tomorrow s Practice Key characteristics of NHS Research and Development (R&D) projects include that they should be: 2. Purpose relevant to the NHS; generalisable; protocol-driven; valid; peer-reviewed. The purpose of this policy is to develop, support and sustain a culture of research excellence by: setting standards for the participation, operation and conduct of research;
3. Scope Page 4 of 20 defining the mechanisms to ensure that these standards are being met; establishing arrangements for the monitoring and assessment of all research; ensuring that research and development activity is an integral part of the Trust s Clinical Governance arrangements for quality care and evidencebased services, responsive to all needs and involving the users, carers and communities we serve. 3.1 This policy applies to all research activity within the Trust involving its premises; patients, carers, users and staff (including their tissues and data, both past and present); and to all studies where the Trust has agreed to act as the sponsor. In addition, it sets out processes for:- effective management and accountability of all research undertaken within the Trust; ensuring those undertaking research are appropriately guided, supported and supervised; ensuring that the appropriate approvals are in place before any research activity commences; progressing research projects from proposal to completion; reporting and disseminating research outcomes; the evaluation of individual research projects and the research and development programme as a whole. 3.2 Activities such as clinical audit, clinical innovations, service evaluations and local developments of existing research are not within the scope of this policy and will not be managed as research. Advice may be sought from the Research & Audit Department regarding the classification of individual projects. An algorithm differentiating research from audit and service evaluation is included in Appendix A. 4. Objectives of the Trust s Research and Development (R&D) Programme 4.1 The Trust is committed to developing a robust research programme through which it can discharge its duties in terms of research as set out in the Health and Social Care Act 2012. 4.2 The primary objectives of the R&D programme are to: develop the R&D capacity, culture and framework to assist the Trust in the delivery of evidence-based clinical practice, ensuring that decisions are based on sound facts drawn from managed and co-ordinated R&D activity; enable the Trust and its staff to influence national NHS R&D priorities and to actively encourage the Trust s own R&D activity, focusing on areas requiring improvement; promote a culture of learning that ensures staff have a contemporary and empirical understanding of evidence-based practice to support operational and clinical effectiveness; involve service users in the setting of the R&D agenda and explore
opportunities for the effective dissemination of research outcomes to participants, employees and the public; develop and manage a Trust-wide portfolio of quality, high-level R&D in association with health, education and social care partners, submitting joint applications to agencies where appropriate. 5. Framework and Governing Principles 5.1 Use of Patient Data The handling of personal information in research must be compliant with the Trust s Information Governance Policy and with the Data Protection Act 1998. All use of patient data for research purposes requires the consent of the patient. There are some exceptions where patient data can be used without consent under Section 60 of the Health and Social Care Act 2001. Requests for this use are now through the National Information Governance Board for Health and Social Care (NIGB). An application for approval to use identifiable patient data to the NIGB may be made simultaneously with the application to the REC and for Trust Permission. 5.2 Clinical Trials of Investigational Medicinal Products All Clinical Trials of Investigational Medicinal Products (CTIMPs) must be conducted in line with the EU Clinical Trials Directive 2004, transposed into UK law by the Medicines for Human Use (Clinical Trials) Regulations 2004. It is a statutory requirement that all CTIMP studies have in place a favourable opinion from a recognised REC and a notice of no objection from the Medicines and Healthcare Products Regulatory Agency (MHRA) prior to commencement. 5.3 Clinical Investigations of Medical Devices For clinical investigations of a non-ce Marked medical device (i.e. a new or substantially modified device, or an existing device with new function, feature or material) or a CE Marked device being used for a new intended purpose, a notice of no objection is required from the MHRA Devices Division in line with the Devices Regulations prior to commencement of the study. 5.4 Adults Lacking Capacity to Consent to Anyone carrying out research to which the requirements of the Mental Capacity Act 2005 (MCA) apply must act in accordance with the provisions of the Act in order for the research to be lawful. The MCA provides a statutory framework for people who may not be able to make their own decisions, for example because of learning difficulties, brain injury or mental health problems. It also covers temporary loss of capacity such as confusion, loss of consciousness, stroke, heart attack and delirium. It sets out who can take decisions, in which situations, and how they should go about this. Page 5 of 20
5.5 Ethics Page 6 of 20 The dignity, rights, safety and welfare of participants must be primary considerations in any research study. All research must be informed by due consideration of ethical responsibilities towards participants and patients. A favourable opinion from an appropriately recognised REC is required for all research projects involving NHS patients, users, relatives or carers (including their organs, tissue and data). RECs are not accountable in any way to NHS Trusts, and in particular are separate from Trust R&D Departments in respect of their decisionmaking. 5.6 Science Adequate background or preparatory work is essential before starting any research project. Research which duplicates other work unnecessarily is itself unethical, wastes resources, can have a negative impact on participants and could possibly bring the Trust into disrepute. All proposals for research must be subjected to review by experts in the relevant fields who are able to offer independent advice on its quality. A copy of the peer review report should be submitted for all research projects prior to the commencement of the application process for Trust Permission and/or REC approval. Research-related data should be retained for a period of five years to enable further analysis by the original, or other, research teams, subject to appropriate consent for its use being in place, or this not being a requirement. 5.7 Patient and Public Involvement 5.8 Information Participants or their representatives should be involved wherever possible in the design, conduct, analysis and reporting of research. Service users and members of the public shall have reasonable access to information about any research being undertaken by the Trust. Such information may be in the form of research reports, articles, or leaflets; made available through presentations and/or seminars, or via the Trust s website. All information should be presented in a format and language which is suitable for the intended audience. All research must be open to critical review and appropriate monitoring. Researchers must familiarise themselves with the requirements of the Data Protection Act and other legal provisions and guidance on handling information. 5.9 Health and Safety The safety of participants and of research and other staff must be given priority at all times. Researchers need to be aware of their responsibilities under Health and Safety Legislation both in respect of themselves, colleagues and research participants.
Page 7 of 20 Health and Safety considerations will be addressed through risk assessment of research activities where appropriate. The Trust policy procedure (and other legislative and policy requirements where appropriate), for the reporting of accidents, adverse and dangerous incidents must be followed and will be used to record any adverse events arising from the research process. 5.10 Finance and Intellectual Property 5.11 Sponsorship All researchers must comply with the procedures of the Trust s Finance Department in planning and accounting for all expenditure, together with audit processes and dealing with fraud. Arrangements for the management of intellectual property arising from R&D are dealt with under the Trust s Business Code of Conduct. All findings and intellectual property from research conducted by employees of the Trust will remain the property of the Trust, although it is recognised that statute provides copyright may be assigned to the author of work intended for publication in a professional or academic journal or electronically. The Trust however reserves the right to itself, at no cost, reproduce and use these publications for its own non-commercial purposes, including for further research and training. Research findings and intellectual property arising from research which is externally funded will be subject to contractual agreement with the research funder/sponsor and/or employing organisation. Funding for research activity must be identified and confirmed prior to an application for Trust Management Permission to conduct a research project. All research conducted within the NHS requires a research sponsor. The sponsor or sponsoring organisation is responsible for securing the arrangements for the initiation, management, monitoring and financing of a study. In addition, the research sponsor needs to be satisfied that: the proposal is worthwhile and of high scientific value; the quality of the research environment has passed appropriate quality assurance standards; and that the key researchers have adequate experience and expertise to conduct the research. Where it is the intention that the Trust be identified as the Sponsor for a project, early contact with the Research & Audit Department is essential in order for the necessary agreement to be obtained. 6. Research Fraud or Misconduct 6.1 Research fraud or misconduct has been defined as Falsification, plagiarism or deception in proposing, carrying out or reporting results of research. It also includes serious breaches of protocol of Good Clinical Practice (GCP). Research misconduct may include the following, whether deliberate, reckless or negligent: Fabrication, falsification or corruption of research data; Distortion of research outcomes by distortion or omission of data; Dishonest misinterpretation of results; Publication of data known or believed to be false or misleading;
Unauthorised use of information which was acquired confidentially; Plagiarism, or dishonest use of unacknowledged sources; Misquotation or misrepresentation of other authors; Inappropriate attribution of authorship; Misconduct in relation to grant applications and fund utilization; Failure to obtain appropriate permission to conduct research; Fraud or other misuse of research funds or research equipment; Unethical behaviour in the conduct of research, e.g. in relation to research subjects. All cases of suspected fraud or misconduct are to be reported in accordance with the Trust s procedures. The general principles are: Allegations should be in writing and should be made at the earliest opportunity; Allegations should be reported to the Research & Audit Department and to the Executive Medical Director; Allegations will be investigated and outcomes recorded by the Research & Audit Department; Allegations and investigation outcomes will be reported to the Quality Governance Committee (QGC); In the event of serious allegation or continuing non-compliance with terms of the project approval, the approving REC and the Strategic Health Authority will be informed; Where a healthcare professional (clinical or social work) is involved in research misconduct the matter will be reported to the appropriate professional body. 7.1 Management and Accountability Figure 1 illustrates the management and accountability structure for research and development activity. Individuals Working on Research Projects Principal Investigator for study Research & Development Group Clinical Effectiveness Group Quality Governance Committee Executive Medical Director Trust Board Page 8 of 20 Figure 1 - Accountability for Research and Development All organisations conducting, sponsoring, funding or hosting health and social All organisations conducting, sponsoring, funding or hosting health and social care research must have systems to ensure that they and their staff understand and follow the standards set out in the Research Governance Framework for Health and Social Care. The Chief Executive holds ultimate accountability on behalf of the Board for research and development activity, and delegates responsibility for the quality, management and delivery of the research programme to the Executive Medical Director. The Executive Medical Director is responsible for overseeing and monitoring research and development activity within the Trust. The Executive Medical Director is the authorised signatory for letters giving Management Permission for research to commence.
Page 9 of 20 The Research & Development Group is responsible for approving the annual Trust programme of research and development, and considering the approval of proposals for research and development generated from Trust staff and external organisations. The Clinical Effectiveness Group (CEG) will receive reports of all research projects receiving Trust Management Permission. The Quality Governance Committee (QGC) will receive reports from the Clinical Effectiveness Group and will in turn provide updates to the Board. The Research & Audit Manager will comprise the named contact for all outside links such as with Higher Education Institutions and other NHS organisations, NRES and research sponsors. The Research & Audit Department must be notified of, and submit to, the R&D Group for approval, all research conducted within the Trust, ensuring that all the relevant procedures are followed, monitored and reported to the R&D Group. In addition the Research & Audit Department will offer guidance and professional support to others undertaking research within the Trust and produce an annual review of research within the Trust. The Chief Investigator (CI) has overall responsibility for the conduct of the research. In multi-site studies, the CI has responsibility for co-ordinating the research across the sites. The Principal Investigator (PI) has overall responsibility for the research at a particular site. In single-site studies, the CI and the PI will usually be the same person. All Researchers/Investigators have a responsibility to adhere to this policy, the conditions of Trust Management Permission, current legislation and policy requirements relating to the research, other approvals in place for the study and to conduct all activity in line with the study protocol. Students should make contact with the Research & Audit Department before commencing any research activity involving Trust staff, patients (including their data), premises or resources, to ensure that the appropriate approvals and permissions are in place. Clinical Staff and Managers are encouraged to engage in the research and development process. This may take the form of contributing data to ongoing projects or initiating and carrying out projects individually or in teams. 8. Staff Training and Development 8.1 Appropriate staff training and development will be provided to improve knowledge of the research process, systems, guidance and support available so as to develop capacity, expertise and skills required to undertake research. 8.2 All staff working on Clinical Trials of Investigational Medicinal Products (CTIMPs) should hold a certificate of Good Clinical Practice (GCP). These staff are required to update their GCP training when legislation has changed, new policies or practice
Page 10 of 20 have been implemented, different research activities are to be undertaken, or a significant period of time has elapsed since research activities have been conducted. 8.3 Trust staff working on projects other than CTIMPs should ensure that they have received training appropriate to their role and the research tasks and responsibilities allocated. All staff working on research projects within the Trust are encouraged to attend GCP training and this is a requirement for those acting as PIs. Training should be updated as per 8.2 above. 8.4 Where researchers are employed by the Trust, compliance with this policy will be a condition of employment. All staff are encouraged to engage in the research process. This may include activities such as contributing data to on-going projects or initiating and carrying out their own research. Staff participation in research projects will be voluntary; additionally, they will have the right to opt out at any stage - in line with the approved project protocol. 9. Process for Gaining Trust Management Permission 9.1 Research activity involving Trust staff, patients (including their data), facilities or resources may not be initiated without formal Trust Management Permission, signed by the Executive Medical Director. Early contact with the Research & Audit Department for guidance regarding the process for obtaining this permission is recommended. 9.2 Applications will be reviewed and assessed by the Research & Development Group. Agreement in principle may be given following this review and the application may then be completed. 9.3 Applications should be made by the CI/PI and should be completed in the Integrated Research Application System (IRAS), accessed from https://www.myresearchproject.org.uk/ 9.4 The application pack for Trust Permission will comprise: the R&D form in IRAS, the Site Specific (SSI) form in IRAS & the supporting documentation as specified in the R&D submission checklist in IRAS. 9.5 Applications should be made through the Coordinated System for Gaining NHS Management Permission (CSP) where studies have been adopted into the National Institute for Health Research (NIHR) portfolio (once agreement in principle has been obtained); further details and guidance are provided in the submissions tab in IRAS. 9.6 Applications not eligible for inclusion in the NIHR portfolio should be made directly to the Research & Audit Department. 9.7 The application for Trust Management Permission and REC review may be made simultaneously, providing agreement in principle from the R&D Group has been obtained. 9.8 All applications should be completed in line with the guidance provided by the Research & Audit Department staff. A checklist of required documentation is
available in the submission tab in IRAS. 10. Amendments 10.1 The Trust SOP for amendments to research projects should be followed and the appropriate submission should be made prior to the amendment being implemented. Amendments defined as substantial will in most cases, also need to be submitted to the REC and/or the MHRA prior to implementation. 11. Monitoring and Auditing 11.1 All research activity will be routinely monitored. In addition, NHS organisations are required to conduct formal audit of a selection of research projects. The Department of Health s minimum standards for research governance state that at least 10% of projects should be routinely audited. 11.2 A project will also be audited if there is any suspicion of reduced research governance standards in a project. 11.3 It should be noted that this monitoring is in addition to summary reports of research progress that should be submitted to the Trust by the CI/PI on an annual basis. 12. Action Following Completion of Research 12.1 Following completion of any research project, the outcomes should be presented, as far as is reasonably practicable, to a meeting of the Trust s R&D Group. Further presentations may be required to other Trust committees or working groups or external stakeholder organisations. 12.3 The outcome of any research should be considered to improve Trust practice. 12.3 Research projects should normally be considered for publication in appropriate media. Particular consideration should be given to publication in peer-reviewed journals. 12.4 Guidance and support in preparing papers for publication will be available to researchers from the Research & Audit Department. 12.5 In circumstances where an author or co-author is a Trust employee and publication of research is likely to attract media attention, the Public Involvement and Relations Manager should be consulted and briefed in advance. In some circumstances, the Chief Executive should be informed. 12.6 The stages of the process from submitting an application for Trust Management Permission to conduct research, through to the dissemination of findings is illustrated in Figure 2. Page 11 of 20
1) Idea for research Research Design Services (RDS) assist with forming research proposals and funding applications 2) Preliminary work e.g. Literature search and methodology. Commence application process in IRAS SWAST Research and Audit Department assist with formulating research ideas, and with REC and Trust applications 3) Obtain agreement in principle from R&D Group 4) Complete application in IRAS and submit for Trust Permission and REC approval PenCLRN Can help CI with writing applications and chasingup delayed decisions. Also can monitor progress of approvals etc. at participating sites if we are the lead site 7) Project Commences Fig 3. 6) Notification of approval sent to PI 5) Governance checks completed by Research and Audit Department/CLRN 8) Ongoing monitoring by Trust and Regulatory bodies 9) Annual Reports to Trust and REC 10) Study completed Final report to Trust and REC Dissemination of findings Fig 2. Page 12 of 20
13. Review 13.1 The Research Governance Policy will be reviewed every three years, with the next review due in January 2015. 14. References 1. Comprehensive Clinical Research Network: http://www.crncc.nihr.ac.uk/about_us/ccrn Page 13 of 20 2. Coordinated System for Gaining NHS Permission overview, process and guidance: http://www.crncc.nihr.ac.uk/about_us/processes/csp 3. Governance arrangements for research ethics committees: a harmonised edition, May 2011: http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguida nce/dh_126474 4. Health Research Authority (HRA) : http://www.hra.nhs.uk/ 5. INVOLVE Patient and Public Involvement http://www.involve.org.uk/ 6. Medicines and Medical Devices Regulation what you need to know: http://www.mhra.gov.uk/howweregulate/medicines/index.htm 7. Medicines for Human Use (Clinical Trials) Regulations 2004 http://www.legislation.gov.uk/uksi/2004/1031/contents/made 8. Mental Capacity Act 2005, Code of Practice: http://www.legislation.gov.uk/ukpga/2005/9/pdfs/ukpgacop_20050009_en.pdf 9. National Information Governance Board for Health and Social Care (NIGB): http://www.nigb.nhs.uk/ 10. National Research Ethics Service Research or Audit?: http://www.nres.nhs.uk/applications/guidance/research-guidance/ 11. Research Governance Framework for Health and Social Care Second edition, 2005 http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguida nce/dh_4108962 12. Standard Operating Procedures for Research Ethics Committees, v 5.1, Mar 2012: http://www.nres.nhs.uk/nres-publications/publications/standard-operating-procedures/ 13. The UK Code of Practice for Research - Promoting good practice and preventing misconduct, September 2009: http://www.ukrio.org/ukr10htre/ukrio-code-of-practice-for-research1.pdf
15. Associated Documents This policy links to: Governance Strategy Incident Reporting Policy Information Governance Policy Protocol for Sharing and Disclosing Information Quality Strategy 16. Glossary Chief Investigator (CI): the investigator with overall responsibility for the design, conduct and reporting of a study. Comprehensive Clinical Research Network (CCRN): is made up of 25 Comprehensive Local Research Networks (CLRNs) which cover the whole of England by region. The Trust straddles two of these networks the Peninsula and Western CLRNs. The networks coordinate and facilitate the conduct of clinical research and provide a wide range of support to the local research community. http://www.crncc.nihr.ac.uk/about_us/ccrn Page 14 of 20 Good Clinical Pracice (GCP): The principles of Good Clinical Practice in Clinical Trials as set down in Articles 2-5 of the GCP Directive and implemented in the UK by Schedule 1 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I.2004/1031) as amended by S.I. 2006/1928. Good Clinical Practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Health Research Authority (HRA): is a newly formed NHS organisation established on 01 December 2011 as a Special Health Authority. The purpose of the HRA is to protect and promote the interests of patients and the public in health research. Indemnity: provides protection against any action by an individual, a group or an organisation that believe they received bad or negligent services, and incurred a loss as a result. Most professional bodies have professional indemnity cover; in some cases it is compulsory. The limit of an indemnity policy relates to the maximum amount of money that an individual or organisation will pay out in the event of a claim being made. Integrated Research Application System (IRAS): a single system for applying for the permission and approvals for health and social care research in the UK. See http://www.myresearchproject.org.uk International Conference on Harmonization of Good Clinical Practice (ICH GCP): an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected; consistent with the principles that have their origin in the Declaration of Helsinki, and that clinical trial data are credible. See http://www.emea.eu.int/pdfs/human/ich/013595en.pdf Medicines and Healthcare products Regulatory Agency (MHRA): the Executive Agency of the Department of Health protecting and promoting public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely. See
http://www.mhra.gov.uk/ Also encompassing the MHRA Devices Division: http://www.mhra.gov.uk/howweregulate/devices/index.htm Mental Capacity Act 2005: places clear responsibilities on researchers regarding the inclusion of participants lacking in capacity. (http://www.legislation.gov.uk/ukpga/2005/9/pdfs/ukpgacop_20050009_en.pdf Monitoring: the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s). The purposes of trial monitoring are to verify that: a) the rights and well- being of human subjects are protected. b) The reported trial data are accurate, complete and verifiable from source documents c) The conduct of the trial is in compliance with the currently approved protocol / amendments(s), with GCP, and with the applicable regulatory requirements. National Institute for Health Research (NIHR): undertakes to create a health research system in which the NHS supports leading edge research, providing the systems and infrastructure needed to support this. It also commissions and funds NHS and Social Care Research and provides systems to streamline and unify the activity. The role of the research strand of the NIHR is to develop the research evidence to support decision-making by professionals, policy-makers and patients, make this evidence available, and encourage its uptake and use. http://www.nihr.ac.uk/pages/default.aspx National Institute for Health Research Clinical Research Network Portfolio: the national database of research projects which have been accepted as meeting the minimum requirements for inclusion in the portfolio and are therefore eligible for NHS support via the NIHR. http://www.crncc.nihr.ac.uk/about_us/processes/portfolio/p_search National Institute for Health Research Coordinated System for Gaining NHS Management Permission (NIHR CSP): is a single point of entry for investigators wishing to apply for NHS Permission for single or multi site studies. It may only be used for studies which have been adopted into the UK Clinical Research Network Study Portfolio. http://www.crncc.nihr.ac.uk/about_us/processes/csp Principal Investigator: the investigator responsible for research at an individual site. Protocol: A document that describes the objective(s), design, methodology, statistical considerations, and organisation of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Research Ethics Committees (RECs): review research proposals which fall within their remit as defined in the Governance Arrangements for Research Ethics Committees and as required due to legislation. http://www.nres.nhs.uk/applications/approval-requirements/ethical-review-requirements/ Research Site: the single organisation responsible for hosting the research at a particular locality. One or more locations within a single organisation, such as an NHS Trust, will usually be considered as a single site. Page 15 of 20
Sponsor: The sponsor is the individual, or organisation (or group of organisations) that takes on responsibility for confirming there are proper arrangements to initiate, manage and monitor, and finance a study. All research taking place within the NHS requires that a Sponsor has agreed to take on these responsibilities prior to any research activity taking place. Trust Permission Letter: letter confirming that NHS Permission has been given and the study can commence. Page 16 of 20
Appendix A Differentiating Research, Audit & Service Evaluation* RESEARCH CLINICAL AUDIT SERVICE EVALUATION The attempt to derive generalisable new knowledge including studies that aim to generate hypotheses as well as studies that aim to test them. Quantitative research designed to test a hypothesis. Qualitative research identifies/explores themes following established methodology. Addresses clearly defined questions, aims and objectives. Quantitative research -may involve evaluating or comparing interventions, particularly new ones. Qualitative research usually involves studying how interventions and relationships are experienced. Usually involves collecting data that are additional to those for routine care but may include data collected routinely. May involve treatments, samples or investigations additional to routine care. Quantitative research - study design may involve allocating patients to intervention groups. Qualitative research uses a clearly defined sampling framework underpinned by conceptual or Designed and conducted to produce information to inform delivery of best care. Designed to answer the question: Does this service reach a predetermined standard? Measures against a standard. Involves an intervention in use ONLY. (The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference.) Usually involves analysis of existing data but may include administration of simple interview or questionnaire. No allocation to intervention groups: the health care professional and patient have chosen intervention before clinical audit. Designed and conducted solely to define or judge current care. Designed to answer the question: What standard does this service achieve? Measures current service without reference to a standard. Involves an intervention in use ONLY. (The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference.) Usually involves analysis of existing data but may include administration of simple interview or questionnaire. No allocation to intervention groups: the health care professional and patient have chosen intervention before service evaluation. theoretical justifications. May involve randomisation No randomisation No randomisation ALTHOUGH ANY OF THESE THREE MAY RAISE ETHICAL ISSUES, UNDER CURRENT GUIDANCE:- RESEARCH REQUIRES R.E.C. REVIEW AUDIT DOES NOT REQUIRE REC REVIEW SERVICE EVALUATION DOES NOT REQUIRE REC REVIEW *Table taken from NRES website Research or Audit Page 17 of 18
Appendix B Standard Conditions of Trust Management Approval for Research Conducted at South Western Ambulance Service NHS Trust ( the trust ). You may only conduct or participate in research involving the Trust s patients or using the Trust s staff, premises or equipment in accordance with the relevant protocol, terms and conditions of the approval of the relevant Research Ethics Committee (REC) and which has been authorised by the MHRA (if applicable). Permission is only granted for those activities for which a favourable opinion has been given by the REC. In addition to complying with all the Trust s Policies and Procedures generally, in carrying out research you must comply with the Trust s local reporting requirements, systems, policies, procedures, and protocols for implementation of the Research Governance Framework. The Trust manages all research in accordance with the Research Governance Framework for Health & Social Care and compliance by you, with this Framework, is a requirement of this Trust Permission. The Framework sets out the roles and responsibilities of individuals and organisations and standards that should be applied to work managed within the formal research context. A direct link to these standards is available on the Department of Health s website at: http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/dh_4108962 Data Protection & patient Confidentiality You should make a reasonable and appropriate effort to understand any project issues that may arise due to the Data Protection Act 1998 and other legal provisions and guidance on handling information, seeking expert advice where necessary and you should ensure that the agreed counter measures described in your SSI form and supporting documentation are kept in place in order that the project does not breach any of the principles outlined in the Data Protection Act 1998. Protocol Amendments All amendments (including changes to the local research team) need to be submitted in accordance with guidance in IRAS before the changes are implemented locally. Protocol Deviations/Urgent Safety Measures The research sponsor or the Chief Investigator, or the local Principal Investigator at a research site, may take appropriate urgent safety measures in order to protect research participants against any immediate hazard to their health or safety. The R&D office and Sponsor should be notified that such measures have been taken. The notification should also include the reasons why the measures were taken and the plan for further action. The Research and Audit Department, Sponsor, REC and any other regulatory bodies should be notified within the same time frame. Protocol Violation Any protocol violation resulting from error, fraud or misconduct should be notified to the Executive Medical Director and the Research and Audit Department as soon as you become aware of it. Notification of Adverse Events/Safety Reporting All adverse events/incidents are to be reported in accordance with the Trust s Incident Reporting Policy and Serious Incident Policy (and other legislative and policy requirements where appropriate) using the Trust s Incident Reporting Form stating clearly in the text box that the incident is research-related. Indemnity Trust Permission is given on the basis that indemnity arrangements are in place as detailed in the application and supporting information and that these remain in place for the duration of the study. Page 18 of 20
Research Audit, Monitoring & Reporting You should ensure that requests for reports on the progress and outcomes of the work required by those with a legitimate interest (such as the regulatory body, the Sponsor, the Funder(s), the Research Ethics Committee and the Trust) are produced on time and to an acceptable standard and that all data and documentation associated with the study are available for audit at the request of the appropriate authority. You should provide an annual progress report to the Research and Audit Department, the first being due one year after Trust Permission is given for the study. A summary of the final report on the research should be submitted within one year of the conclusion of the research. The report should detail whether the study achieved its objectives, the main findings, and arrangements for publication or dissemination of the research including any feedback to participants. All NHS organisations are required to monitor research to ensure compliance with the Research Governance Framework and other legal and regulatory requirements. This is achieved by a random audit of research projects. Finance You should ensure that any research income is managed in accordance with the agreed financial arrangements. Honorary Contracts/Letters of Access You should ensure that anyone engaged in the research involving the Trust s patients, users, carers or staff, who is not employed by the Trust has an honorary contract or Letter of Access to give them permission to attend the Trust s premises, or have access to records for the required purposes. If you have been advised that you should complete a Research Passport application (or any member of the local research team), then you are responsible for ensuring that this is done and submitted in accordance with Trust policy and the published Research Passport guidance. The relevant individuals must not commence any research activities involving the Trust until the appropriate contractual agreements are in place for them. The site Principal Investigator must ensure that they actively monitor professional registration of any HRC holders who are working under their supervision. Changes to the Project Status and to the Membership of the Research Team You should notify the Research & Audit Department immediately if you are no longer able to continue as Chief Investigator/site Principal Investigator/Local Collaborator and/or if there is a change to project status such as a temporary halt or early termination. Archiving The Principal Investigator is responsible for ensuring that there are suitable archiving arrangements in place at the end of the study that ensures the study s essential documents are safe and secure and are accessible on request by the sponsor, the Trust or any other authority with a legitimate interest. The minimum length of time that the study s essential documents should be kept for is 5 years after the study has closed. Review of Trust Management Permission Trust Permission may be reviewed at any time in the light of any relevant information received. Breach of Permission Conditions Failure to comply with these conditions may lead to suspension or termination of Trust Management Permission and the relevant Research Ethics Committee shall be informed. v3 2011 05 Page 19 of 20