ࡱ> i  7bjbj {b{b.S0 0 8ldd3j(2222222${518x2""22j22h/|0!A8/|2203/8V`8$08022B380 B r: UK Policy Framework for Health and Social Care Research (FORM 1) Responsibility of Sponsor organisation Confirmation of Compliance with UK Policy Framework for Health and Social Care Research In agreeing to act as a sponsor as defined in the UK Policy Framework for Health and Social Care Research, the gives a commitment to fulfil its responsibilities as sponsor. The definition of sponsor as defined in the UK Policy Framework for Health and Social Care Research is the organisation that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project.  HYPERLINK "http://www.nhsresearchscotland.org.uk/uploads/tinymce/uk-policy-framework-health-social-care-research%20v3.3.pdf" http://www.nhsresearchscotland.org.uk/uploads/tinymce/uk-policy-framework-health-social-care-research%20v3.3.pdf While the has sponsor responsibilities, the day-to-day local management and conduct of the research project rests with the principal investigator (PI) and/or academic supervisor from the University; and responsibility for the quality of the research and appropriate experience of the PI rests with the Dean of the host academic Faculty. Ensuring compliance with UK Policy Framework for Health and Social Care Research requirements and undertaking to safeguard the integrity of every aspect of the research are serious responsibilities. You are asked to read the following responsibilities and to confirm your agreement to undertaking this role by signing the declaration overleaf. Your Dean of Faculty (or designated representative) should then countersign. On receipt of the signed form, the Research Integrity and Governance Manager in Research and Innovation Services will issue a letter to the funding body or NHS partner(s), confirming the Universitys acceptance as a sponsor. Title of project The MND Diary Project - Investigating the coping, resilience and health literacy of people living with Motor Neurone Disease(MND): a longitudinal qualitative studyFunding BodyEconomic and Social Research CouncilChief Investigator for the UniversityNicola GlennieFacultyFaculty of Health Sciences and sportOther partnersProject Reference223Start dateOctober 2020End dateOctober 2023 Your responsibilities as Principal Investigator (PI) with respect to the project referenced in this form are: To ensure that adequate resources and support are in place to perform the activities which have been allocated to the local project team and that these resources are efficiently utilised. To set up systems to ensure that any adverse effects caused by the project are minimised, managed appropriately and reported to the sponsor and co-investigators, where appropriate. To ensure an adequate system is in place to record and review and to report significant developments pertaining to the project including safety of participants, scientific directions as well as ensuring timely reporting of the project progress and outcomes to the sponsor and funders when required and to co-investigators in an appropriate manner. To ensure that all procedures in the project proposal submitted to the NHS are adhered to, unless amendments, changes and deviations, in agreement with the Chief Investigator, have been submitted and approved through the appropriate ethics approval and local research and development review. To ensure financial information and data related to the research project will be available for audit and review by appropriate bodies. The PI must also be satisfied that: All arrangements are consistent with UK Policy Framework for Health and Social Care Research and current relevant legislation. The research proposal or protocol takes into account any relevant systematic reviews, other research evidence and research in progress that makes effective use of patient, service user and public involvement where appropriate and that it is scientifically sound, safe, ethical, legal and feasible and remains so for the duration of the research, taking account of developments while the research is ongoing. The research proposal or protocol has been submitted for appropriate independent expert (peer) review and revised in light of that review. To ensure the proposed division of the work and responsibilities for the work is agreed by all groups and individuals involved in the research project. Everyone involved in the conduct of the research is qualified by education, training and experience, or otherwise competent, to discharge their roles in the project. The information given to potential participants is in a suitable format and is clear and relevant to their participation in the research, and where consent is required, to their decision making about taking part in the research. The study is ethical and the project will be or has been reviewed and approved by a local research ethical review process prior to the commencement of the research project. If the research project is a clinical trial, the current legislation is complied with and that appropriate registration and notifications have been completed, including associated clinical trials in other sites. Appropriate insurance, financial arrangements and agreements are in place to compensate anyone harmed during the project. Students are appropriately supervised during the research project and students have received sufficient training and information to perform the tasks allocated including information contained in the UK Policy Framework for Health and Social Care Research. Systems are in place to ensure the best quality of data generated and the integrity and confidentiality of such data. Good practice is applied for the management and storage of research data in order to comply with the legislation, maximise resource use and protect sensitive data. The data analysis, outcomes and conclusions of the research project are open to critical review through the appropriate channels such as scientific journals without compromising outstanding commercial and intellectual property obligations. Arrangements, in accordance with confidentiality agreements, are in place for the conclusion of the study, publication and dissemination of findings (including information sent to study participants) as well as ownership of intellectual property. This must take into account obligations to funding bodies. There are written agreements/procedures for management and monitoring of the research project, in particular in the case of high-risk projects or if the direction of project changes significantly. Principal investigators must ensure that their activities are in line with the corporate responsibilities of the sponsor organisation (The ) Commitment to upholding and encouraging the principles of best practice governing the academic work and professional conduct of staff and students for which the sponsor is responsible. Compliance with current relevant legislation and ensuring that its research activities are carried out to fulfil legal obligations, including clinical trial regulations and the highest ethical and safety standards at all times and at all levels of the project. Fostering of an environment in which the dignity, safety and rights of human participants must be of the utmost importance. Ensuring that research conducted under the auspices of the sponsor organisation, by staff and students for which the sponsor has responsibility, complies with procedures and policies for good research practice, governance and ethics, including appropriate ethical review and approvals. Ensuring that adequate resources are in place to perform the activities which have been allocated to the local project team and that these resources are efficiently utilised. Monitoring of research progress and ensuring compliance, especially of external collaborators and subcontractors. Ensuring that complaints of misconduct are investigated with thoroughness and rigour, bearing in mind any legal requirements, including The Human Rights Act, Freedom of Information Act and Data Protection Act. Provision of adequate insurance cover to ensure compensation in the event of negligent and (where appropriate) non-negligent harm arising from the research. The sponsor has also responsibility for articulating and publicising applicable standards, training new and existing staff and students, acting as the accountable guarantor to external bodies and ensuring appropriate arrangements for the management of research are in place. Establishment of systems to ensure the respect of confidentiality and privacy agreements and ensuring that dissemination of research outputs is done in an appropriate manner. Establishment of systems to identify, protect and exploit intellectual property and provision of agreements covering ownership of intellectual property and partnership arrangements. Fair recruitment and selection of staff, access to training and continuous career development and provision of the best research environment which regards researchers as professionals. Cooperating with any investigation arising from complaints received in respect of actions taken by staff for which the sponsor has responsibility, including making financial information and data related to the research project available for audit and review by appropriate bodies.  DECLARATION OF ACCEPTANCE OF THE RESPONSIBILITIES OF THE ROLE OF SPONSOR ON A RESEARCH PROJECT CONDUCTED ON NHS PREMISES OR INVOLVING NHS PATIENTS, STAFF, DATA, ASSOCIATED CARERS, HUMAN ORGANS OR TISSUES. INTERNAL ETHICAL APPROVAL STATUS: To be sought/ Response awaited/ Granted EXTERNAL ETHICAL APPROVAL STATUS: To be sought/ Response awaited/ Granted I have read and understood the list of requirements and responsibilities detailed in the UK Policy Framework for Health and Social Care Research and wish to nominate the University as sponsor for this project, on which I will be Principal Investigator/ Lead Researcher/ Academic Supervisor for the Principal Investigator/ Academic Supervisor (delete as appropriate) Name____Fiona Harris_____________________ Signature _________________________________ Date __________________________ Student (If applicable) if the PI is a student, the academic supervisor must sign above and the student below. Name________Nicola Glennie_______________ Signature _________Nicola Glennie_____________________ Date ______24.11.21___________________ Countersigned by the Dean of Faculty/ Authorised Faculty Signatory Name__________________________________ Signature _________________________________ Date __________________________ Notes For student projects, these responsibilities rest with the academic supervisor Other models of sponsorship may be considered if a significant part of the work and responsibilities are attributed to other organisations: Joint sponsorship where all partners are equally responsible (and liable) for sponsorship requirements for the research taking place under their auspices, including external collaborators Co-sponsorship where specific responsibilities of sponsorship are divided amongst, and delegated to, partner organisations in the project If the single sponsorship model is adopted, as defined in the present agreement, and external collaborators and partners are involved in the project, PIs must obtain confirmation of their compliance to UK Policy Framework for Health and Social Care Research using the Responsibility of External Collaborators Confirmation of Compliance with UK Policy Framework for Health and Social Care Research form, available from the Universitys Research and Innovation Services. Guidance and advice on any aspect of UK Policy Framework for Health and Social Care Research procedures and requirements is available from the Universitys Research Innovation Services [Contact the Research Integrity and Governance Manager].      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