RESEARCH GOVERNANCE POLICY

Transcription

1 RESEARCH GOVERNANCE POLICY Controlled document This document is uncontrolled when downloaded or printed. Reference number Version 4 Author Name & Job Title Executive Lead WHHT: R011 Fiona Smith - Research and Development Manager Dr Justin Harrison Acting Director of R&D Approved b/ Date R&D Steering Group / 1 October 2015 Ratified b Qualit & Safet Group Date ratified 16 th vember 2015 Committee/individual responsible Issue date vember 2015 Review date October 2017 Target audience Ke Words Previous Polic Name Research & Development Steering Group Research & Development research, governance (if applicable) Author: Fiona Smith Review October 2017 Page 1 of 17

2 CONTRIBUTION LIST Ke individuals involved in developing this version of the document Name Fiona Smith Designation Research & Development Manager Approved b Committee QSG/ Change Histor Version Date Author Reason Version 1 Dec 2006 Fiona Smith Version 2 Sept 2008 Fiona Smith Review Version 3 Sept 2011 Fiona Smith Formal Review Author: Fiona Smith Review October 2017 Page 2 of 17

3 CONTENTS 1 Aim Objectives Definitions Scope Responsibilities Chief Investigator, Investigators, Other Researchers: Main Funder: Sponsor: Emploing Organisation: Organisation Providing Care / Responsible Care Professional: Procedure Legal requirements Registration of all research projects Ethical Practice Financial management and Costing of Research Data Protection Good Clinical Practice (GCP) Indemnit Partner organisations Research Personnel Peer Review Project Management Medical Devices Fraud & Misconduct in Research Involving Consumers in Research Intellectual Propert [IP] Rights Communication Strateg Evaluation measures Monitoring the effectiveness of R&D activit Monitoring the effectiveness of the polic Review Equalit Impact Assessment Statement References Research and Development Contact Details: Ethics Committee Contact Details Related Policies Equalit Impact Assessment Polic and Procedure Sign-off Sheet Author: Fiona Smith Review October 2017 Page 3 of 17

4 1 Aim The aim of this polic, alongside the R&D SOP s, is to provide guidance and support for those undertaking research and to promote high standards of qualit and ethics in all areas of research activit in line with the requirements of the Research Governance Framework [RGF] available at dguidance/dh_ Proper governance of research is essential to ensure that the public can have confidence in, and benefit from, qualit research in health and social care. The public has a right to expect high scientific, ethical and financial standards, transparent decision making processes, clear allocation of responsibilities and robust monitoring arrangements [RGF] 2 Objectives The requirements for management of R & D within the NHS are to ensure that research: Is for the benefit of patients, staff and the general public Is of high qualit Meets ethical standards Complies with legal requirements Is conducted in line with best practice guidance Compliance with the Research Governance Framework has to be demonstrated to the Department of Health through Trust Qualit Accounts. 3 Definitions Caldicott Guardian Caldicott Guardians are responsible for agreeing and reviewing internal protocols governing the protection and use of patient-identifiable information b the staff of their organisations. Chief Investigator The person who takes overall responsibilit for the design, conduct and reporting of a stud if it is at one site; or if the stud involves researchers at more than one site, the person who takes primar responsibilit for the design conduct and reporting of the stud whether or not that person is an Investigator at an particular site. In the case of a clinical trial the Chief Investigator:- Author: Fiona Smith Review October 2017 Page 4 of 17

5 Clinical trial Consent a) In relation to a clinical trial conducted at a single trial site, the Investigator for that site, or b) In relation to a clinical trial conducted at more than one trial site, the authorised health care professional, whether or not he is an Investigator at an particular site, who takes primar responsibilit for the conduct of the trial An investigation intended to discover or verif the clinical, pharmacological and / or other pharmacodnamic effects of one or more investigational medicinal product(s), and/or to identif an adverse reactions to one or more investigational medicinal product(s) and / or to stud absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safet and / or efficac. A process b which a subject voluntaril confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented b means of a written signed and dated informed consent form. Emploing organisation Organisation emploing the Chief Investigator, investigators or researchers. Emploers remain liable for the work of their emploees. Essential documents Essential Documents are those documents which individuall and collectivel permit evaluation of the conduct of a trial and the qualit of the data produced. These documents serve to demonstrate the compliance of the Investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulator requirements. Funder Organisation providing funding for a stud (through agreements, grants or donations to an authorised member of the emploing and/ or care organisation). Author: Fiona Smith Review October 2017 Page 5 of 17

6 Good Clinical Practice (GCP) Honorar research contract (HRC) Investigational Medicinal Product (IMP) Participant Sponsor Good Clinical Practice is a set of internationall recognised ethical and scientific qualit requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.principal Investigator The leader responsible for a team of individuals conducting a stud at a (participating) site. HRCs are required for researchers who are not emploees of the NHS and whose activities could have a foreseeable and direct impact on patient care. A pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a Clinical Trial. Patient, service user, carer, relative, professional carer, emploee, or member of the public, who consents to take part in a stud. Individual, organisation or group taking on responsibilit for securing arrangements to initiate, manage and finance a stud. 4 Scope This polic is available for all staff and is required reading in Induction Training for new staff involved in Research. All R&D policies and SOPs are available on the intranet. 5 Responsibilities Summar of Ke Responsibilities and Organisations Accountable for the Proper Conduct of a Stud 5.1 Chief Investigator, Investigators, Other Researchers: Developing proposals that are scientificall sound and ethical. Submitting the design for independent expert review. Submitting the stud (or proposal) for independent ethical review. Conducting a stud to the agreed protocol (or proposal), in accordance with legal requirements, guidance and accepted standards of good practice. Preparing and providing information for participants. Ensuring participants welfare while in the stud. Arranging to make findings and data accessible following expert review. Author: Fiona Smith Review October 2017 Page 6 of 17

7 Feeding back results of research to participants. 5.2 Main Funder: Assessing the scientific qualit of the research as proposed. Establishing the value for mone of the research as proposed. Considering the suitabilit of the research environment in which the research will be undertaken, particularl the experience and expertise of the chief investigator, principle investigator(s) and other ke researchers involved. Requiring that a sponsor takes on responsibilit before the research begins. 5.3 Sponsor: Confirming that everthing Is read for the research to begin: o Taking on responsibilit for putting and keeping in place arrangements to initiate, manage, and find the stud; o Satisfing itself the research protocol, research team and research environment have passed appropriate scientific qualit assurance; o Satisfing itself the stud has ethical approval before it begins; o For clinical trials involving medicines, seeking a clinical trial authorisation and making arrangements for investigational medicinal products. Satisfing itself that arrangements are kept in place for good practise in conducting the stud, and for monitoring and reporting, including prompt reporting of suspected unexpected serious adverse events or reactions. 5.4 Emploing Organisation: Promoting a qualit research culture. Ensuring researchers understand and discharge their responsibilities. Ensuring studies are properl designed and submitted for independent review. Ensuring studies are managed, monitored and reported as agreed according to the protocol. Providing written procedures, training and supervision. Taking action if misconduct or fraud is suspected. 5.5 Organisation Providing Care / Responsible Care Professional: Arranging for an appropriate person to give permission for research involving their patients, service users, carers or staff, before the research starts. Ensuring an such research is conducted to the standards set out in the research governance framework. Requiring evidence of ethical review before recruitment to an research that affects their dut of care. Before recruitment to trials with medicines, requiring evidence of a positive ethical opinion and a clinical trials authorisation. Retaining responsibilit for the care of participants to whom the have a dut. Author: Fiona Smith Review October 2017 Page 7 of 17

8 6 Procedure 6.1 Legal requirements The following items are legal requirements and are included in standing NHS procedures. Ensuring compliance is the responsibilit of general performance management. Sstems to ensure researchers are aware of the Data Protection Act and other legal provisions and guidance on handling information Sstems to ensure financial probit Arrangements to make researchers aware of their responsibilities under the Health and Safet Act both in respect of themselves and participants. Where tissue samples are involved, the stud must be carried out in accordance with the Human Tissue Act 2004 available at and the Codes of Practice from the Human Tissue Authorit available at fm The Briber Act 2010 came into effect on 1st Jul All commercial research agreements need to reflect the introduction of the Briber Act mcta available at Agreements/mCTA-Guidance_2011.pdf (ma need to cop address and paste into internet browser address bar Briber Act 2010 available at Registration of all research projects All research projects require Trust R&D approval before commencement All research projects [including pre-protocol and educational research projects] require regulator approvals, Trust R&D and ethical approval before the stud can commence. All relevant paperwork is available on the intranet/website or from the R&D offices (for contact information please see final page of this document). Clinical Directors are asked to examine the proposal and ensure that the project is compatible with the direction and workload of the directorate, sets out to answer a question of value and interest, and is adequatel supported financiall so that routine patient care funds are not jeopardised. All research requires a nominated sponsor. If there is no external sponsor, this can be the NHS Trust. Please contact the R&D Manager for advice about this requirement. Investigators with limited experience in research should obtain a supervisor, a senior member of staff with research experience, within the Trust who will oversee the running of the project. Author: Fiona Smith Review October 2017 Page 8 of 17

9 6.3 Ethical Practice All research requires approval of the relevant ethics committee prior to commencement All research involving patients, service users, health professionals, volunteers, organs, tissues or data requires independent ethical review from the relevant committee[s] prior to commencement. Informed consent from participants is essential and consent must be sought in the wa agreed during ethical review. This requirement is audited. Guidance is available at Financial management and Costing of Research Sstems to ensure financial probit are a legal requirement for all projects. Researchers are required to liaise with R&D to agree costing and budgetar management of projects. The research costs of all projects funded via external grant applications, commercial agreements or the internal funding sstem will be calculated according to a standardised and robust model. This is to ensure that the true costs to the Trusts are known, and there is no cross subsidisation between service budgets and research. An overhead is included in commercial research contracts to cover the cost of R&D management and general associated Trust costs. An surplus is available to support and promote high qualit research activit in the Trust. 6.5 Data Protection The Data Protection Act requires that confidential patient data is onl accessed b researchers who have obtained ethical and R&D approval for their stud and who understand their responsibilities with regard to data protection regulations, particularl ensuring patient anonmit and confidentialit. The SOP Management of source data is available for researchers. Researchers are required to have read the guidance and made arrangements for appropriate storage of research documentation. Researchers who need access to patients medical records will need authorisation from the R&D department. Approval from R&D should be supplied to the Medical Records Department before extraction of records can commence. The RGF requires that there are appropriate arrangements in place to archive the data when the research has finished and to make it accessible. Please see SOP gsop-17 Archiving of essential documents. Author: Fiona Smith Review October 2017 Page 9 of 17

10 6.6 Good Clinical Practice (GCP) All research staff are required to attend GCP training to ensure the understand the legal requirements and responsibilities associated with research activit. 6.7 Indemnit All commercial companies sponsoring research must have a contract in place including an indemnit agreement accepting responsibilit for an claims for compensation arising following inclusion in the stud. Approved non-commercial studies are generall covered b NHS indemnit for negligent harm. This does not provide cover for non-negligent harm. 6.8 Partner organisations Research cannot be carried out with partner organisations unless a documented agreement is in place allocating responsibilities. 6.9 Research Personnel All staff involved in research require a substantive or honorar contract of emploment with the Trust or must have a research passport / letter of access for the stud. Following guidance from the DH, undergraduate students should not be named as the lead researcher. We advise the following wording this work is being undertaken b, 3rd ear student at.., working under the supervision of..., (job title), who holds a substantive contract with NHS Trust. Staff supervising students are required to: Ensure students have adequate supervision, support and training Ensure that students compl with the RGF and Trust polic Ensure that responsibilities are agreed and documented 6.10 Peer Review All research should be subjected to review b independent recognised experts in the relevant fields All non-commercial research that is externall funded via grants from research councils or major charities will have alread been subject to peer review. All internall funded projects go through informal peer review b discussion with the head of department, Clinical Director, members of the R&D Steering Group as appropriate. Projects with funding in excess of 10,000 will require an external peer review if not provided b the external funding bod. This review must be: a) independent i.e. no conflicts of interest Author: Fiona Smith Review October 2017 Page 10 of 17

11 b) expert, in terms of understanding of the clinical and research methodologies and outcomes c) recorded 6.11 Project Management Guidance is available from the R & D offices regarding best practice in research project management. The lead researcher in each project is responsible for efficient and ethical management of all aspects of the project and is required to ensure all trial documentation is in order and available for internal and external audit and inspection Medical Devices An piece of electrical equipment supplied as part of the trial must be notified to Clinical Engineering (WGH ext 7558). Before placement on an ward/department the equipment must be checked for electrical safet b Clinical Engineering for the relevant site, and full documentation provided for its safe operation. An item of analtical electrical equipment or an screening kits (e.g. d-dimer, pregnanc testing, drugs of abuse etc) must be notified to the Point of Care Manager ( ) for suitabilit, and also to the Medical Devices Group. An item deemed unsuitable analticall will be referred back to the trials organiser with recommendations for suitable alternatives Fraud & Misconduct in Research A clinician or health professional are available at each hospital site to deal with an concerns. An issue can be discussed with these staff members in complete confidence. The Director of R & D, or deput, will then assess appropriate action, following discussion with the lead researcher of the project involved and the Caldicott Guardian if appropriate. The General Medical Council recommends that action should be taken promptl, including taking account of participants' safet, establishing the facts as far as possible, separating genuine concerns from those made mischievousl or maliciousl protecting the person who has made the allegations and the person about whom the allegation is made from harmful criticisms or actions having a sstem in place to deal fairl and promptl with complaints and allegations of fraud and misconduct. The R&D Steering Groups has the power to suspend projects while investigations are being made. If there is proven cause for concern, the sponsors of the stud would be informed and the disciplinar procedure for misconduct would be commenced. Author: Fiona Smith Review October 2017 Page 11 of 17

12 6.14 Involving Consumers in Research The Consumers in NHS Research Group recommends that major advisor bodies in NHS R&D programmes should have at least two consumer representatives. The R&D Steering group includes an active la member. This group promotes consumer involvement wherever possible in all aspects of the research process. The R&D department is activel encouraging researchers in the Trusts to involve consumers wherever it is appropriate. The R&D department provides information to patients information about ongoing research and the results of research in the Trust. Where necessar, translators can be provided and information can be made available in different formats Intellectual Propert [IP] Rights All projects are reviewed to consider the potential intellectual propert rights before ethical approval is given. The IP Polic outlines the principles of IP Management in the Trusts. At WHHT the IP Lead is the R&D Manager and the Trust has membership of Health Enterprise East, a regional IP organisation that offers independent advice to NHS Trusts Communication Strateg R&D will activel support and encourage dissemination of research findings at local, regional, national and international meetings. The R&D department has a web-site that is regularl updated. It contains all relevant information for researchers and can be accessed via the Trust Intranet or the Internet. [ 7 Evaluation measures 7.1 Monitoring the effectiveness of R&D activit It is paramount to the operational success of the Research and Development programme, and related outcomes, that its effectiveness is closel monitored. 7.2 Monitoring the effectiveness of the polic This polic s effectiveness will be monitored b the Research and Development Steering Group principall, and b the Qualit and Safet Committee in the second instance. Responsibilit for updating and maintaining this polic lies with the R&D Manager, and will be reviewed and/or revised on a regular basis accordingl. The effectiveness will be monitored through the following: Project review Annual R&D review Audit plans for Trust Sponsored projects Author: Fiona Smith Review October 2017 Page 12 of 17

13 Annual Report submitted to the Trust Board Involvement in external/internal audit/inspection. 8 Review The polic is reviewed b the RDSG Committee 9 Equalit Impact Assessment Statement This polic has been reviewed against the Equalit Impact Assessment (Section 12) and there is no potential discriminator impact 10 References For further information regarding policies mentioned in this document, please refer to: or contact the R&D department Research and Development Contact Details: WGH office info Tel: fiona.smith@whht.nhs.uk Website: Ethics Committee Contact Details For further information regarding Ethics Committee submissions please contact: Health Research Authorit Skipton House 80 London Road London SE1 6LH Tel: General enquiries: contact.hra@nhs.net RES/research queries: HRA.Queries@nhs.net 11 Related Policies Intellectual Propert Polic R&D SOP s Author: Fiona Smith Review October 2017 Page 13 of 17

14 12 Equalit Impact Assessment 1. Does the polic/guidance affect one group less or more favourabl than another on the basis of: Race Ethnic origins (including gpsies and travellers) Nationalit Gender Culture Religion or belief Sexual orientation including lesbian, ga and bisexual people Age Disabilit - learning disabilities, phsical disabilit, sensor impairment and mental health problems Marriage & Civil partnership Pregnanc & maternit 2. Is there an evidence that some groups are affected differentl? 3. If ou have identified potential discrimination, are an exceptions valid, legal and/or justifiable? 4. Is the impact of the polic/guidance likel to be negative? Yes/ 5. If so can the impact be avoided? n/a 6. What alternatives are there to achieving the polic/guidance without the impact? 7. Can we reduce the impact b taking different action? Comments If ou have identified a potential discriminator impact of this procedural document, please refer it to (Insert name and position) together with an suggestions as to the action required to avoid/reduce this impact. Author: Fiona Smith Review October 2017 Page 14 of 17

15 13 Polic and Procedure Sign-off Sheet Polic Name and Number: Version Number and Date: : Service Location: PLEASE INSERT SERVICE LOCATION All staff members must sign to confirm the have read and understood this polic. Name Signature Name Signature Author: Fiona Smith Review October 2017 Page 15 of 17

16 Polic Ratification Form Name of Document: Research Governance Polic Ratification Date: Name of Persons Job Title Date Divisional Support (Direct Line Manager / Matron / Consultant / Divisional Manager) Consultation Process (list of stakeholders consulted / staff groups presented to) Research & Development Steering Group Polic Review Group Endorsement B Panel/Group Name of Committee Chair of Committee Date Qualit and Safet Group Document Checklist 1. Stle & Format Is the title clear and unambiguous? Is the font in Arial? Is the format for the front sheet as per Appendix 1 of the polic framework Has the Trust Logo been added to the Front sheet of the polic? Is it clear whether the document is a guideline, polic, protocol or standard operating procedure? 2. Rationale Are reasons for development of the document stated? 3. Content Is there an introduction? Is the objective of the document clear? Does the polic describe how it will be implemented? Are the statements clear and unambiguous? Are definitions included? Are the responsibilities of individuals outlined? 4. Evidence Base Is the tpe of evidence to support the document identified explicitl? Are ke references cited? Are supporting documents referenced? Yes / Y Author: Fiona Smith Review October 2017 Page 16 of 17

17 Document Checklist 5. Approval Does the document identif which committee/group will approve it? 6. Review Date Is the review date identified? Is the frequenc of review identified? If so is it acceptable? 7. Process to Monitor Compliance and Effectiveness Are there measurable standards or Ke Performance Indicators to support the monitoring of compliance with and effectiveness of the document? Is there a plan to review or audit compliance with the document? Yes / Name of Person completing Ratification Form Fiona Smith Job Title Date Ratification Group/Committee Chair Signature Date Qualit and Safet Group Trace Carter Author: Fiona Smith Review October 2017 Page 17 of 17