Burton Hospitals NHS Foundation Trust. Committee On: 19 May Review Date: March Corporate / Directorate

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1 POLICY DOCUMENT Burton Hospitals NHS Foundation Trust RESEARCH GOVERNANCE AND INNOVATION POLICY Approved by: Executive Management Committee On: 19 May 2015 Review Date: March 2018 Corporate / Directorate Clinical / Non Clinical Department Responsible for Review: Distribution: Essential Reading for: Corporate Non-Clinical Research and Development All Staff Via Intranet All Divisional Managers All Divisional Medical Directors All Matrons and Head Nurses All Research Active Staff Information for: This Policy applies to all individuals and organisations involved in research, including contractors, for whom Burton Hospitals NHS Foundation Trust is the host authority. It also applies to anyone whose role may impact, directly or indirectly, on participants in research within the Trust. Policy Number: Version Number: 2 5 Signature: Chief Executive Date: 19 May 2015 Research Governance and Innovation Policy / Version 5 / March 2015

2 Burton Hospitals NHS Foundation Trust POLICY INDEX SHEET Title: Research Governance and Innovation Policy Original Issue Date: November 2005 Date of Last Review: August 2011 Reason for amendment: Review Responsibility: R&D Manager Stored: R&D Office R&D Intranet site Governance Support Intranet site Linked Trust Policies: E & D Impact assessed EIA 030 Consulted R&D Consumer Involvement in Research Policy Policy for Consent to Examination or Treatment Standing Financial Instructions Health & Safety Policy Risk Management Strategy Confidentiality Policy Data Protection Policy Complaints Policy and Procedure Disciplinary Policy and Procedure Whistleblowers Policy Pharmacy Policy for the Management of Clinical Trials Involving the use of Medicines Procedure for Acceptance of Sponsorship, Hospitality and Gifts from the Commercial Sector Policy for Reporting Adverse Incidents and Near Misses Trust Intellectual Property Policy Lone Worker Policy Deputy Divisional Accountant Director of Human Resources R&D Committee PPI Lead Senior Learning and Development Advisor Data Protection Officer Library Services Manager Research Governance and Innovation Policy / Version 5 / March 2015

3 REVIEW AND AMENDMENT LOG Version Type of change Date Description of Change 5 Review March 2015 Minor changes to internet links and to clarify content Compliance with BHFT Policy Framework Research Governance and Innovation Policy / Version 5 / March 2015

4 RESEARCH GOVERNANCE AND INNOVATION POLICY CONTENTS Paragraph Number Subject Page Number 1 Purpose of this document 1 2 Introduction The Benefits of Conducting Research Benefits of Research to the Researcher Benefits of Research to the Trust 2 3 Scope of this Policy Projects within the scope of this Policy Projects outside the scope of this Policy Who does the Policy apply to? Who is excluded from this Policy? 3 4 Management and Accountability Responsibilities of the Trust Responsibilities of Researchers Responsibilities of Staff 6 5 Standards Required by the Trust Research Misconduct and Fraud If Research Misconduct or Fraud are Suspected 8 6 Public and Patient Involvement 8 7 Obtaining Consent to participation in Research 9 8 Dissemination of Results 9 9 Finance 9-10 Research Governance and Innovation Policy / Version 5 / March 2015

5 10 Intellectual Property Definition of Intellectual Property Management and Accountability for Intellectual Property 11 Adverse Event Reporting External Links Pharmacy Policy Effectiveness Summary Relevant Legislation, Policies and Help Appendix 1: Good Clinical Practice 15 Appendix 2: Trust Research Approval Process Appendix 3: Provision of Information on Data Collected to Research Subjects Appendix 4: Adverse Event Reporting Appendix 5: Monitoring Compliance Research Governance and Innovation Policy / Version 5 / March 2015

6 Burton Hospitals NHS Foundation Trust RESEARCH GOVERNANCE INNOVATION POLICY 1. PURPOSE OF THIS DOCUMENT Burton Hospitals NHS Foundation Trust ( the Trust ) has a duty to provide proper Research Governance to ensure that patients have confidence in, and benefit from, quality research in health and social care 1. This means that the Trust has the responsibility for ensuring the proposed research is ethical and respects the dignity, rights, safety and well-being of participants, in accordance with the declaration of Helsinki on Good Clinical Practice (Appendix 1). As such, the purpose of the Policy is to: Clearly define the responsibilities of all those involved in the research process. Set standards of operations and conduct. Define the mechanisms to ensure standards are being met. In this way, the Trust aims to develop and maintain a research culture of excellence. 2. INTRODUCTION The aim of Research & Development (R&D) is to support a knowledge-based health service in which clinical, managerial and policy decisions are based on sound information about research findings and scientific developments. 2.1 The Benefits of Conducting Research: In recent years increasing emphasis has been placed on the importance of delivering health care to patients which is based on sound research evidence. Research & Development is the means for developing new approaches to health care delivery, as well as testing the efficacy of existing approaches. The purpose of this is to determine which approach will improve patient care by providing the greatest benefits. Burton Hospitals NHS Foundation Trust is committed to the development of a strong research culture throughout the Trust. 1 Research Governance Framework for Health and Social Care, DH Research Governance and Innovation Policy / Version 5 / March

7 2.2 Benefits of Research to the Researcher Research is a stimulating field providing staff with the opportunity to improve health care within their own speciality. In addition the skills required to conduct good quality research (e.g. critical appraisal of research evidence) can be useful in other aspects of health care delivery. The researcher is likely to benefit from: Improvement in their knowledge of best practice Acquiring / improving analytical and appraisal skills Improved professional standing by involvement in good quality research and journal publications 2.3 Benefits of Research to the Trust There are many benefits to Trusts which employ research-active individuals and who have a developed culture. These include: Better patient care Better informed and more highly skilled staff Potential for financial gains through intellectual property Attraction of a higher calibre of staff to research active organisations 3. SCOPE OF THIS POLICY 3.1 Projects within the Scope of this Policy Research within the NHS Research Governance Framework is defined as the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods. Research within this Trust can be defined as any systematic activity that provides new knowledge. It can involve: Direct intervention (drugs, devices, surgical procedures) Taking or using samples (tissues, fluids, organs), whether specifically for research or using material that would typically be discarded Additional diagnostic, physical or psychological tests Completing questionnaires Undertaking interviews Access to patient records Use of Trust resources Research Governance and Innovation Policy / Version 5 / March

8 Research may involve any of the following: Past or present patients Relatives of past or present patients The recently deceased Members of staff Healthy volunteers 3.2 Projects Outside the Scope of this Policy Research should be distinguished from: Clinical Audit: Monitoring clinical activity against established good practice guidelines, or developing guidelines from accepted research evidence. This includes routine data collection for monitoring of clinical performance. Patient Surveys: Patient satisfaction surveys that relate to aspects of the routine functioning of established services of the Trust. Service Evaluation: Measures current service without reference to a standard. Innovation: Introducing new techniques developed elsewhere. Clinical Audits, Patient Surveys, Service Evaluation and Innovation projects fulfilling the above criteria are therefore excluded from the procedures laid out in this Policy. It is the responsibility of the researcher to clarify whether or not their project falls within the scope of this Policy with the R&D Office. 3.3 Who does the Policy apply to? This Policy applies to all individuals and organisations involved in research, including contractors, for whom Burton Hospitals NHS Foundation Trust is the host authority. It applies to anyone who conducts, participates in, funds or manages healthcare research within the Trust. It also applies to anyone whose role may impact, directly or indirectly, on participants in research within the Trust. 3.4 Who is excluded from this Policy? This Policy does not apply to: Research carried out by practitioners in their private capacity outside of NHS premises. Research carried out in primary care involving the Primary Care Trust s patients. Research Governance and Innovation Policy / Version 5 / March

9 4. MANAGEMENT & ACCOUNTABILITY The Chief Executive of the Trust is the Accountable Officer and, as such, has responsibility for quality under duty of care and also takes ultimate responsibility for R&D. The Medical Director takes executive responsibility for the management for all research on behalf of the Trust. The R&D Committee is the main body overseeing R&D and is chaired by the R&D Clinical Lead. This Committee is responsible for overseeing and promoting the R&D strategy. The R&D Committee will undertake the following key activities: Ensure that all research undertaken has the necessary ethical approvals and indemnity. Ensure that all research projects are assessed to ensure the research protocol addresses health and safety, data protection, finance, responsibility and accountability agreements as laid down in the Research Governance Framework for Health and Social Care. This will be accomplished through the research project approval process (Appendix 2). Reviewing projects to identify Intellectual Property (IP) arising from research as appropriate. Cases with the potential for development will be referred to the West Midlands IP Hub for evaluation. Those considered viable for development will be referred to the Director of Finance. The ultimate decision as to whether to protect or exploit IP will be made by the board. Receive published research papers and ensure dissemination of research findings is achieved. 4.1 Responsibilities of Burton Hospitals NHS Foundation Trust To be aware, and maintain a record, of all research within the Trust. To ensure all research involving participants for whom they are responsible has ethical approval. To ensure that someone with the authority to do so has given permission for each research project to take place within the Trust. To ensure that informed consent is given in accordance with the research protocol and that procedures are in place to audit this. To ensure, in liaison with the lead officers within the Trust, that all legal requirements, such as those for Data Protection, Health and Safety, Financial Probity and Medicines for Human Use (Clinical Trials) Regulations, are followed. To facilitate capacity building in research skills to enhance the level of skill within the organisation and encourage participation by Trust personnel. Research Governance and Innovation Policy / Version 5 / March

10 4.2 Responsibilities of Researchers It is the responsibility of the researcher to ensure that the dignity, rights, safety and well being of participants are protected at all times. As such, they are responsible for: Notifying the Trust of any research proposed. Approval of each project by Research Ethics Committee and R&D Department is required before the project can commence. The approval process is detailed in Appendix 2. Carrying out all research in accordance with the Research Governance Framework. Maintaining research quality in accordance with Good Clinical Practice. Ensuring that all management procedures required by the Trust are followed at all times. Complying with the Trust s monitoring requirements, adverse event and incident reporting procedures in accordance with all relevant Trust Policies (Whistle Blowers Policy, Fraud & Illegal Acts Policy and Complaints procedures). Ensuring that they have adequate indemnity arrangements. Ensuring that agreements with other parties are fully documented and that responsibilities are clear. Ensuring that honorary contracts and/or research passports are held by any non- NHS researchers involved in the research. Terminating research when it is clear that the question has been answered or where significant risk would occur should the research continue. Ensuring results are published and disseminated appropriately. Ensuring that patients are clearly identified as being in a research study in both medical notes and on the electronic prescribing system. The purpose of this is to enable colleagues to liaise with researchers about any participants in trials where proposed new treatment, or changes to current treatment, may impact on, and potentially violate, the approved research protocol. Research Governance and Innovation Policy / Version 5 / March

11 4.3 Responsibilities of All Staff It is the responsibility of all staff to engage with the research process. This may take the form of contributing data to on-going projects or initiating and carrying out their own research. Staff should discuss with research teams any patients where proposed new treatment, or changes to current treatment, may impact on and potentially violate the approved research protocol for any participants in trials. Contracts for directly employed staff require that, should they carry out research, it is conducted in compliance with the Research Governance Framework. Externally employed NHS staff and non-nhs researchers who wish to carry out any type of research within the Trust are required to have appropriate arrangements in place as defined in the National Institute for Health Research guidance on research passports. The R&D Office will identify such individuals and ensure such contracts are in place. 5. STANDARDS REQUIRED BY THE TRUST The Trust requires all staff and students, and those who are authorised to conduct research in the Trust or use Trust facilities, to observe the highest standards in the conduct of their research. In pursuing high standards it is expected that they will: Follow the Research Governance Framework Maintain professional standards Follow the Trust's research project approval and monitoring processes Adhere to all relevant Trust policies Maintaining research quality in accordance with the International Conference on Harmonisation of Good Clinical Practice (ICH GCP) (Appendix 1) Accurately and comprehensively document results Attribute honestly the contribution of others Carry out literature searches to prevent duplication and wasting resources Ensure valid informed consent is taken from all participants recorded and stored appropriately Carry out research with reasonable care towards all risks, including risks to people and the environment Secure and store all data Report any conflicts of interest to the R&D Office and Local Ethics Committee Observe fairness and equality in the conduct and publication of the research Report any serious adverse events, expected or unexpected, to the R&D Office, and the responsible Trials Centre and report adverse incidents in accordance with the Trust s Adverse Incident Reporting Policy and procedures Research Governance and Innovation Policy / Version 5 / March

12 Those engaged in research should note that as a matter of course the Trust expects all its researchers to keep clear and accurate records of their research and of any procedures or documents associated with it. Such documentation is subject to audit. 5.1 Research Misconduct and Fraud The Trust does not tolerate fraud, or attempted fraud, by either its own employees or any others with whom the Trust has a relationship, be that contractual or not. Research misconduct and fraud includes, but is not limited to, the following: Piracy (the deliberate exploitation of ideas or work of others without acknowledgement) Fabrication Falsification Fraud (including the invention of data) Willful destruction of research materials Plagiarism (the copying of ideas, data or text, or any combinations of the three without permission or acknowledgement) Deception in proposing, carrying out or reporting the results of research Deliberate or negligent deviations from accepted practice in carrying out research Deliberate omission of data that does not fit expected results Publication of data known to be false or misleading Unauthorised use of information which was acquired confidentially Failure to obtain appropriate approval to conduct research, where this is required Fraud or other misuse of research funds or research equipment Failure to work in a way which adequately controls risks Deliberate maligning of a scientist's research reputation based on false information Colluding in, or concealing, the misconduct of others Misconduct also includes failure to follow any research protocols contained in any ethical consent that has been given for the research and/or any research protocols set out in the guidelines of appropriate recognised professional, academic, scientific and governmental bodies and/or procedures that avoid unreasonable risk or harm to humans, other living organisms or the environment. Research Governance and Innovation Policy / Version 5 / March

13 It also includes facilitating misconduct in research by collusion in, or concealment of, such actions by others, and any plan or conspiracy or attempt to do any of these things. Misconduct in research does not include honest and reasonable error, or honest and reasonable differences in interpretation or in judgment in evaluating research methods or results, or misconduct (including gross misconduct) unrelated to research activity. Suspicion of fraud should be reported promptly to the Trust Local Counter Fraud Specialist or Director of Finance in accordance with Trust policy. Reports can also be made to the R&D Office. Suspicion of research misconduct that does not involve fraud should be reported promptly to the R&D Office or the Director of Governance. All research misconduct will be managed in accordance with the Trust s Counterfraud Procedures. 5.2 If Research Misconduct or Fraud are Suspected Staff, including those holding honorary contracts with the Trust, have a responsibility to report any incident of fraud or misconduct, whether this has been witnessed or for which there are reasonable grounds for suspicion. In the first instance any incidents or suspicions of fraud or misconduct should be reported to the R&D Office. 6. PUBLIC AND PATIENT INVOLVEMENT Where there is an active partnership between researchers and consumers, it is argued that the research is often more relevant and of a higher quality. The Trust advocates that consumers are encouraged to become actively involved in the research process as early as possible, so that they are able to influence research priorities and the design of the research. It is the responsibility of the researcher to ensure that: All research is carried out in accordance with the Trust s Consumer Involvement in Research Policy. All information provided for patients or the public is presented in a format and language which is suitable for the intended audience. Research Governance and Innovation Policy / Version 5 / March

14 7. OBTAINING CONSENT TO PARTICIPATION IN RESEARCH In obtaining and documenting informed consent, the investigator should comply with the research protocol, the Trust s Consent Policy and the EU Clinical Trials Directive 20001/20/EC ( The decision to take part in a project, to have personal data used for research and to donate body fluids, tissues or organs must be based on adequate information. The information required is detailed in Appendix 3 (Provision of Information to Research Subjects). Further information should be supplied to the individual as may be necessary. Researchers must ensure that all individuals, or a legal representative, sign a Consent Form. Patients must be informed that participation in research (or not) does not in any way affect their entitlement to receive treatment, or adversely impact on the care and treatment they receive. Specific conditions for consent apply to research involving children, vulnerable subjects and to research on tissue. Guidance on these areas and sample consent forms are contained in the Patient Information Sheet and Consent Form Guidelines obtained from the NRES website ( 8. DISSEMINATION OF RESULTS All proposals for research must state how dissemination will take place. Papers and reports arising from studies for which the Trust is the Lead Centre should be sent to the R&D Committee in the first instance. The Committee will decide upon the appropriate action to take in order to implement any recommendations arising from a research study. 9. FINANCE All researchers must comply with the procedures of the Standing Financial Instructions in planning and accounting for all expenditure. As part of the approval process, researchers are required to provide detailed cost information as to the likely impact of the study to the Trust. Burton Hospitals NHS Foundation Trust will only agree to host projects that are not detrimental to the service currently provided to patients. Research Governance and Innovation Policy / Version 5 / March

15 All monies obtained from R&D activities must be paid into the R&D budget. Income will be demonstrated within the R&D budget for reporting/monitoring purposes and the R&D budget will be subject to financial audit. Additional costs of research for non-commercial studies, e.g. Pharmacy dispensing costs, can be claimed against appropriate projects where funding is available. Should costs be higher than initially calculated then R&D can approach the funder for additional money. If the trial is non-commercial then the R&D Committee may decide to compensate the relevant Department(s) using commercial overhead costs charged to other projects. At the end of the financial year, all monies associated with a legitimate trial will be carried forward upon discussion with the Director of Finance. In the case of commercial studies, Burton Hospitals NHS Foundation Trust will require a set up fee for hosting each project and the R&D office will negotiate additional overheads, to cover administration and associated costs. This will not infringe on the funding agreed by the Researcher and Commercial organisation. The R&D Committee has a Research Fund to provide staff with funding to support new research projects in Government priority areas and education or training courses related to research. The R&D Committee are responsible for deciding the allocation of monies not directly attributed to a project or additional monies charged for carrying out Commercial Research within the Trust. 10. INTELLECTUAL PROPERTY (IP) 10.1 Definition of Intellectual Property Intellectual Property can be defined as products of creativity, innovation or research and development (R&D) which can be given legal recognition of ownership as Intellectual Property Rights through patents, copyright, design rights, trademarks or know-how. The Trust s employees have the potential to generate significant valuable Intellectual Property from both within and outside research and development activities. The Trust s policy is to encourage and enable staff to participate in the generation of IP as part of its commitment to deliver the best possible patient care. However, the Trust is entitled to receive benefits from intellectual property rights (IPR) and must be able to protect and exploit these wherever possible. All matters relating to IP will be managed in accordance with the Trust IP Policy Management and Accountability for Intellectual Property All IP produced by employees of the Trust in the course of their normal duties will remain the property of the Trust. However, IP generated by an employee in his or her own time which is unconnected with their normal contracted course of duties, and Research Governance and Innovation Policy / Version 5 / March

16 uses none of the Trusts resources, will be owned by the employee. Ownership of IP is often unclear and may be shared between several parties. IP ownership can also be transferred between parties to expedite its commercialisation. Given the above, employees are advised to report any IP to the Trust Research and Development Committee to determine ownership and interests. The decision to protect IP by patenting rests with the Board of Directors. The Trust is the vehicle for holding patents and other Intellectual Property, but is free at its absolute discretion to engage another organisation to exploit its IP on its behalf. Research findings where research is externally funded will be subject to the contractual agreement with the research funder and / or employing organisation. The Trust will consider the payment of rewards to staff who, during the course of their employment, have produced innovative work of outstanding benefit to the Trust according to the Trust s IP Policy. The Board of Directors will consider each case on its individual merit. 11. ADVERSE EVENT REPORTING The Research Governance Framework specifically requires that Trusts have arrangements to ensure that any type of adverse event potentially relating to research is reported correctly. In order to ensure full compliance with the required regulations, researchers are responsible for reporting Adverse Events (AE), Serious Adverse Events (SAE) and Serious Unexpected Suspected Adverse Reactions (SUSARs) to the appropriate authorities including the Sponsor, the MHRA and the Trust. Full details as to the procedure to be followed are given in Appendix 4. The necessity for also following the hospital incident reporting system in conjunction with this should be considered at all times, as there will be occasions where both systems need to be utilised. Advice should be sought from the Risk Management Team where doubt arises. Where an Incident Report form is completed which involves a research participant, it should be ensured that the relevant tick-box is ticked, even if the event is not directly related to research activity. This will ensure that the R&D Office is informed of the incident and can make a decision about further action. 12. EXTERNAL LINKS Burton Hospitals NHS Foundation Trust aims to develop the research culture by forming outside collaborations. The Trust also intends to broaden the existing Research Governance and Innovation Policy / Version 5 / March

17 portfolio by collaboration with academic partners. When external links are formed, the following apply: The duties and responsibilities of all external bodies involved with research in the Trust will be defined in clear written service level agreements (with the exception of the Research Ethics Service) relating to each research study. The service level agreements will define the service parameters, monitoring of the agreement and contract negotiation and renewal where appropriate. All research agreements must be provided to the R&D Office, before going to the R&D Committee for approval. Where research is externally funded, the organisation that funds the research has a responsibility for ensuring that the work is a proper use of the funds they control. The employing organisation employs the researchers and will normally hold the contract with the funder of the study. Organisations holding contracts with funders are responsible for the management of the funds provided and the management of the researchers themselves. All research will require a research sponsor. The sponsor or sponsoring organisation is responsible for assessment of the quality of the research as proposed, the quality of the research environment, and the experience and expertise of key researchers and the monitoring of the research process. The Research Ethics Committee (REC) is the committee convened to provide independent advice on the extent to which research proposals comply with recognised ethical standards. The involvement of the REC is not subject to a written agreement, as is the case with the other organisations listed above. Individual researchers bear the day-to-day responsibility for the conduct of the research. Where more than one researcher is involved in a study, one of the team must be designated as the principal investigator for accountability to the Trust, the research sponsor and employing organisation. In accordance with the Research Governance Framework, a minimum of 10% of all projects will be subject to audit each year. Should the Trust utilise external contractors to carry out this work then appropriate agreements will be drawn up to protect researchers, participants and the Trust. 13. PHARMACY When setting up a new study involving medicines, Pharmacy must be contacted as soon as possible, preferably during the research protocol design stage. Research Governance and Innovation Policy / Version 5 / March

18 Researchers need to ensure that arrangements have been made for the procurement, storage and dispensing of all medicines to be used in a trial and for maintaining drug accountability records. The researcher needs to verify that Pharmacy can accommodate the work involved, particularly if the study drug requires any special manipulation in its preparation, e.g. aseptic manipulation, or other specialist facilities. On study completion, the researcher should have arrangements for the disposal of the medicines and for the archiving of Pharmacy data. Very few studies involving medicines are exempt from requiring a Clinical Trial Authorisation (CTA) from the Medicines and Healthcare Products Regulatory Agency ( /). It is the responsibility of the sponsor to ensure that all medicines used in trials have a CTA. Research audits will include Pharmacy processes and procedures. The Trust s Pharmacy Policy for the Management of Clinical Trials Involving the Use of Medicines can be found on the Pharmacy website or via a link on the R&D website. 14. POLICY EFFECTIVENESS The effectiveness of this Policy will be measured through adherence to the Policy Framework, which will be monitored: o On an ongoing basis by the R&D Lead o Independently by Internal and periodic External Audits o At a local level by Directors / Associate Directors In addition, the paperwork and minutes of the R&D Committee meetings will be disseminated to relevant individuals within the Trust, in order to provide a regular update on local R&D activity 15. SUMMARY All research undertaken within the Trust must conform to this Policy and all policies to which it refers. It is the responsibility of both those individuals conducting research within the Trust and those whose work might involve the generation of Intellectual Property to ensure that they comply with the requirements of this Policy and management & accountability procedures. 16. RELEVANT LEGISLATION, POLICIES AND HELP Health & Safety Act: Research Governance and Innovation Policy / Version 5 / March

19 Data Protection Act 1998: Department of Health Research and Development Information: 5D=department-of-health Human Tissue Act 2004: Health Research Authority Integrated Research Application System: ICH-GCP (Good Clinical Practice): http//: The EU Clinical Trials Directive 20001/20/EC: Useful Contacts Research Governance Facilitator Ext R&D Manager Ext R&D Clinical Lead Ext Research Governance and Innovation Policy / Version 5 / March

20 GOOD CLINICAL PRACTICE Appendix 1 Good Clinical Practice (GCP) produced 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 the clinical trial data are credible. The Principles of GCP: Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s). Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial and subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks. The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. The available non-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial. Clinical trials should be scientifically sound, and described in a clear, detailed research protocol. A trial should be conducted in compliance with the research protocol that has received prior institutional review board (IRB) / independent ethics Committee (IEC) approval / favourable opinion. The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s). Freely given informed consent should be obtained from every subject prior to clinical participation. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification. The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s). Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved research protocol. Systems with procedures that assure the quality of every aspect of the trial should be implemented. Further information is available from the official website: Research Governance and Innovation Policy / Version 5 / March

21 Appendix 2 BURTON HOSPITALS NHS FOUNDATION TRUST R&D APPLICATION PROCESS The Research and Development Committee has overall responsibility for approving all research projects prior to them commencing. Without R&D Approval for a project, then researchers do not have Trust indemnity. Carrying out research without Trust indemnity presents a serious risk to the Trust and, as such, is a disciplinary offence. What exactly is required? To obtain R&D management approval, the researcher must send all of the documents to be used in their project to the Research Governance Facilitator. These must include: Project-wide Documents may be provided centrally if the application is submitted through the Co-ordinated System for gaining NHS Permission for Research: R&D form from the IRAS (Integrated Research Application System) submission Copies of ethics approval letters Research Protocol with version number and date Finalised questionnaire(s) Relevant supporting information such as indemnity or funding information MHRA Clinical Trial Authorisation Local Documentation to be provided, where used, include: Site Specific Information form from the IRAS (Integrated Research Application System) submission ; Patient Information Sheet on headed paper with version number and date, and local contact details Consent form on headed paper with version number and date, and local contact details GP/Consultant Information Sheet / Letter on headed paper with version number and date, and local contact details Signed and dated summary CV for all members of the research team Evidence of ICH GCP training within the last two years Should the R&D Office consider that the paperwork is not of the standard required, then the application will be put on hold until outstanding documentation is provided. Paperwork will be rejected for the following reasons: Application form is not signed Trust headed paper is not used Documentation is of poor standard (incorrect / incomplete) Version numbers on documentation not the same as those for which ethics approval has been given Research Governance and Innovation Policy / Version 5 / March

22 Once the R&D Office receives the above paperwork, they will be reviewed by the Research Governance Facilitator within 5 days of receipt. Some low-risk projects are eligible for approval without formal submission to full committee. The R&D Facilitator will advise on a project-by-project basis using the relevant Standard Operating Procedure. Where submission to the full R&D committee is required, the researcher is usually invited to attend the meeting where all documentation relating to the project will be reviewed. This is a fairly informal process that gives the committee an opportunity to ask the researcher questions about the project. The R&D Committee meets monthly and typically reviews 4 studies a month. To prevent delays in the approval process, researchers are advised to contact the Research Governance Facilitator as early as possible so that she/he can help them through the process. The Research Governance Facilitator is based in Clock Tower Wing (ext ). Help and information on research and the application process, including dates of R&D meetings, are posted on the R&D Intranet site (accessible via the Information Library). Research Governance and Innovation Policy / Version 5 / March

23 Appendix 3 PROVISION OF INFORMATION ON DATA COLLECTION TO RESEARCH SUBJECTS Researchers are advised to consider the extent to which the use of personal data by them is obvious to the individual, and to the extent that it is not. In the case of data collected directly from individuals, the individual must be given an Information Sheet prior to giving consent for participation in research, and specific consent obtained for their personal data to be utilised. To liaise with the Data Protection Officer to ensure compliance with the Data Protection Act 1998 s principle of fair collection, Information Sheets must contain the following information: A description of what data will be collected (e.g. name, clinical data, genetic data, family history, etc) The purposes for which data will be collected and used including any proposed future uses Details of the organisation(s) who will collect, store/handle and process the data The name of the designated data owner responsible for security and access to the data (usually the principal investigator) Details of any person or organisation who will have access to the data or to whom any of the data will be disclosed and for what purposes? A description of steps to be taken to maintain data security, safety and confidentiality In what form will the data be disclosed, to whom and why If the data is to be passed outside the European Union, this must be stated What will happen to the data at the end of the study How long the data will be retained Whether the research subject will be identifiable Whether researchers wish to conduct further research and if they do, details of what this would involve. Research Governance and Innovation Policy / Version 5 / March

24 Appendix 4 ADVERSE EVENT REPORTING Adverse Event (AE) means any untoward medical occurrence in a subject to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. Adverse Reaction (AR) means any untoward and unintended response in a subject to an investigational medicinal product which is related to any dose administered to that subject. Serious Adverse Event (SAE) Serious Adverse Reaction, or Unexpected Serious Adverse Reaction means an adverse event, adverse reaction or unexpected adverse reaction respectively that: (a) (b) (c) (d) (e) results in death is life threatening requires hospitalisation or prolongation of existing hospitalisation results in persistent or significant disability or incapacity or consists of a congenital anomaly or birth defect Suspected Serious Adverse Reaction (SSAR) means an adverse reaction that is classed in nature as serious and which is consistent with the information about the medicinal product in question set out (a) (b) in the case of a licensed product, in the summary of product characteristics (SmPC) for that product in the case of any other investigational medicinal product, in the Investigator s Brochure (IB) relating to the trial in question Suspected Unexpected Serious Adverse Reaction (SUSAR) means an adverse reaction that is classed in nature as serious and which is not consistent with the information about the medicinal product in question set out (a) (b) in the case of a licensed product, in the summary of product characteristics (SmPC) for that product in the case of any other investigational medicinal product, in the IB relating to the trial in question Research Governance and Innovation Policy / Version 5 / March

25 REPORTING MECHANISM: PLEASE NOTE: The necessity for also following the hospital incident reporting system in conjunction with this should be considered at all times, as there will be occasions where both systems need to be utilised. Advice should be sought from the Risk Management Team where doubt arises. 1. Adverse Event The Investigators Brochure usually states that all adverse events should be routinely reported to the study Sponsor. A copy of the AE Form (below) should be filled in and sent to the R&D Office on a quarterly basis. 2. Serious Adverse Event If the AE is assessed as serious the CI/PI must report the event to the Sponsor immediately or within 24 hours of being made aware of the event. The initial report can be made verbally but must be promptly followed with a detailed, written report. The CI/PI must record the event with his assessment of seriousness, (along with causality, expectedness and severity) on a trial SAE form provided by the Sponsor (use SAE Reporting Form if no form is provided). Some information may not be available at the time of initial reporting and therefore every effort must be made by the CI/PI to ensure that all the required information for complete reports is made available. 3. Fatal/life threatening SUSARs The Sponsor must inform the Competent Authorities (CAs) and REC(s) of fatal or life threatening SUSARs as soon as possible, but no later than 7 calendar days after the Sponsor has first knowledge of the minimum criteria for expedited reporting. In each case, relevant follow-up information should be sought and a report completed as soon as possible. This should be sent within an additional 8 calendar days. 4. Non- fatal and non-life threatening SUSARs The Sponsor must report all other SUSARs and safety issues to the CA(s) and main REC(s), as soon as possible but no later than 15 calendar days after the Sponsor has first knowledge of the minimum criteria for expedited reporting. Further relevant information should be given as soon as possible. Research Governance and Innovation Policy / Version 5 / March

26 Any or all of the above Sponsor s responsibilities may be delegated for the purposes of the trial. Where the Trust is acting as Sponsor, this role is delegated to the Chief Investigator as stated in the Internal Sponsorship Agreement document signed by both parties. All correspondence to the Sponsor, competent authority (CA) and Research Ethics Committee (REC) must be copied to the R&D office. Record Keeping: The CI/PI must record all AEs in accordance with the study protocol. If the event is classed as serious, the CI/PI must record it (with their assessments of seriousness, causality and severity) onto the trial SAE recording form provided by the Sponsor. The Trust SAE Recording Form (below) should be used if no SAE form has been provided by the Sponsor. A copy of all forms must be filed in the subject s notes/medical records, the Site Master File and copies sent to the Sponsor within the specified time scales. The Research Ethics Service should be notified of: All unexpected adverse events, adverse reactions or serious adverse events occurring in patients recruited at the Trust. Any unexpected increase in the incidence of expected non-serious adverse events or reactions. Investigators must have a mechanism in place to monitor this. Research Governance and Innovation Policy / Version 5 / March

27 ADVERSE EVENT FLOWCHART Adverse Event observed Yes Is it serious? Is it expected from the disease state? Yes It is an SAE. Assess for severity and record on the appropriate SAE form. Report to Sponsor within 24 hours. (Those SAEs listed in the research protocol as not requiring immediate reporting must be reported to the Sponsor within the timeframes as defined in the protocol). It is an AR. Assess for severity and record on the appropriate SAE form. Report to Sponsor within 24 hours. Sponsor to assess for expectedness according to Investigator Brochure Is it expected from the known safety profile in the Investigator Brochure? Yes No No No It is an AE. Unless unexpected, keep a copy of AE Form in the Site File Is it reasonably, causally related to the study intervention or trial medication? No It is an SAE Assess for severity and record on appropriate SAE form. (Those SAEs listed in the protocol as not requiring immediate reporting must be reported to the Sponsor within the agreed timeframes as defined in the research protocol). Yes It is a SSAR. Assess for severity and record on appropriate SAE form Those listed as not requiring immediate reporting in the research protocol must be reported to the sponsor It is a SUSAR Assess for severity and record on appropriate SAE form. Must report to the sponsor within 24 hours of knowledge of the event. If life threatening / fatal event must be reported to CA and REC within 7 days. Follow up information must be provided within a further 8 days If event not life threatening / fatal event must be reported to CA and REC within 15 days. Follow up information must be provided as soon as possible Research Governance and Innovation Policy / Version 5 / March

28 BURTON HOSPITALS NHS FOUNDATION TRUST ADVERSE EVENT REPORTING FORM (1) Project and Subject Identifiers: (If applicable) (2) Project Title: EudraCT No: NTCRN No: Initials: Unique Study No: (3) Description of Event (include date and time of onset) (4) Causal relationship to Project/ Intervention/ Project Specific Action (Please tick one) Definite Probable Possible Unlikely Unrelated (5) Seriousness Mild Moderate Severe/Serious* (*Complete Serious Event Reporting Form ) (6) If serious, was the event: Suspected Unexpected Not applicable (6) Event/Reaction Outcome (7) Action taken/treatment Recovered Yes No If yes, date of recovery Improved Yes No If yes, date On-going Yes No If yes, details Worsened Yes No If yes, date (8) Reviewing of all events is the responsibility of the researcher and as such must ensure that the participants are not compromised. Any appropriate action must be taken to protect the participants, research team and Trust whilst ensuring validity of the results. If the action taken leads to suspension, cessation or amendment of the study, then the sponsor, R&D and the relevant ethics committee must be notified. (9) Completed by: Name and Job Title: Signature: Date:... Research Governance and Innovation Policy / Version 3 / November

29 BURTON HOSPITALS NHS FOUNDATION TRUST SERIOUS ADVERSE EVENT REPORTING FORM When completing this form please refer to Trust Research Governance and Innovation Policy 1. Project Identifiers: (where applicable) IRAS No. Ethics Number: EudraCT No. 2. Project Title: 3. Project Sponsor: 4. Subject Identifiers: Initials: Date of Birth: Age: Sex: Male Unique Study Identifier: Female 5. Does this event meet the definition of a SUSAR? Yes No 6. Event/Reaction Information: Date of Onset: Time of Onset: Research Governance and Innovation Policy / Version 5 / March

30 Description of Event: e.g. Lab Tests/Results, Signs & Symptoms related to Diagnosis 6.1. Result: (Please tick one) Death Involved/Prolonged Hospitalisation Involved/Persistent/Significant Disability or Incapacity Life Threatening 7. Suspected Medicinal Product Information (tick if not applicable) Name of Medicinal Product (s): Daily Dose (s): Research Governance and Innovation Policy / Version 5 / March

31 Indication(s) for use: Route of Administration: Start/End Date of Therapy: Was Medicinal Product Discontinued: Yes No What is the Causal Relationship of the Reaction to the Medicinal Product? (Please tick one below) Definite Probable Possible Unlikely Unrelated Has Unblinding Occurred? (Please tick one, if yes please provide details below) Yes No 8. Concomitant Medications and Relevant Medical History: Concomitant Meds: State Dose, Route and Start/End Dates (exclude those used to treat reaction) Research Governance and Innovation Policy / Version 5 / March