New Research Governance arrangements at the University of Sheffield

New Research Governance arrangements at the University of Sheffield

Foreword I am pleased to introduce this special edition on Research Governance, which demonstrates the University of Sheffield s commitment to high quality research through the integration of new policies and procedures for governing research into the University s research support infrastructure. Our success in research activity confirms the University s position as one of the UK s leading research institutions. Indeed, in the 2001 RAE, 73% of our departments were rated as having an international reputation for excellence. Success is due to the high calibre of the University s researchers and to the existence of a culture that is conducive to good research practice. But now, perhaps more than ever before, UK Universities and individual researchers are being expected to demonstrate and justify their research methodologies and outputs. In recent years researchers have begun to explore entirely new areas of research and this, together with some high profile events, has affected public confidence in research. In response to these recent developments, the UK Government and several research sponsors have announced new regulations to strengthen and ensure the quality of research processes. One such regulation is the Research Governance Framework for Health and Social Care. Over the past two years, a combination of factors has encouraged the University to improve its procedures for governing research. Improvements include the establishment of new University policies applicable to all research disciplines (e.g. Good Research Practice Standards; Ethics Policy for Research Involving Human Participants, Data and Tissue), and research governance procedures applied to narrower fields (.e.g. health and social care research activities). The aim of these policies and procedures is to affirm, codify and ensure the maintenance of standards for governing University research and, as a result, strengthen the quality of research methodologies and outputs. This will enhance the credibility and reputation of the University and its individual researchers. In recognition of the rich diversity of its research base, the University has developed policies and procedures in a context-sensitive way which will ensure that they are of value to and workable within the University s different research disciplines. Nationally and internationally, the University continues to make inroads at the frontier of research exploration. I am confident that the University is in a strong position to capitalise on its successes and that new University policies and procedures for governing research will add value to, and support the University in, its research mission. Professor Geof Tomlinson Pro-Vice Chancellor for Research ETHICS All projects should be independently scrutinised and approved on ethics grounds SCIENCE All projects should be independently reviewed and approved on scientific grounds (including internally funded) INFORMATION Researchers should be aware of the Research Governance Framework Partnership Agreements should be in place between research partner institutions Written Agreements should be in place between governance sponsors and research sponsors Research should be appropriately disseminated MONITORING Projects should be monitored Projects should adhere to informed consent and protocol procedures Projects should record any adverse events Projects should report research misconduct/fraud FINANCE AND INTELLECTUAL PROPERTY The project s governance sponsor has in place systems to ensure: Financial probity Access to research costing and financial management systems of research The identification of research-based intellectual property Access to systems for ownership, exploitation and income from intellectual property OTHER All projects must have a nominated governance sponsor The project s governance sponsor has in place systems to: Ensure all research is appropriately notified and approved Ensure links between research and clinical governance systems Approve all student research Researchers should be aware of legal provisions/guidance on handling information (e.g. the Data Protection Act) HEALTH, SAFETY AND EMPLOYMENT Researchers should be aware of their responsibilities under the Health and Safety Act Researchers are contractually bound to adhere to the research governance standards The project s governance sponsor has in place an honorary contracts system

Understanding Governance What does research governance mean? The phrase is taken from the Research Governance Framework for Health and Social Care (the Framework). According to the Framework, published in 2001 by the Department of Health, research governance: Sets national standards that all UK Universities undertaking health and / or social care research activities need to apply in respect of those activities Defines mechanisms to deliver the national standards (the University is establishing appropriate mechanisms) Describes arrangements to monitor and assess the national standards (the University is establishing appropriate monitoring arrangements) In the first instance, the University is collaborating with the local Sheffield Teaching Hospital NHS Trust to ensure that their respective research governance systems are compatible. In due course the University plans to explore extending this collaborative model with other NHS Trusts. The national standards are designed to improves research quality and safeguard the public by: Demonstrating enhanced ethical and scientific quality Promoting good practice Reducing adverse incidents and ensuring lessons are learned Preventing poor performance and misconduct Who do the research governance standards apply to? Within the higher education context research governance standards apply to University research that takes place within the UK s health care system and / or within the UK s social care system. Even if not directly engaged in health or social care research you may work in an area where such research is being conducted or with people who are participating in such research. Although you may not need to know research governance issues in detail, an understanding of research governance principles may be beneficial. Definition of health care research: Research concerned with the protection and promotion of public health Research undertaken in or by the Department of Health, its non- Departmental Public Bodies and the NHS Research undertaken by or within social care agencies This includes: Clinical and non-clinical research Research undertaken by NHS staff using NHS resources Research undertaken by industry, the charities, the research councils and universities within the health and social care systems that might have an impact on the quality of those services Latest definition of social care research: Research involving service users / carers, their data or care professionals for whom Directors of Social Services within local Councils have a duty of care, whether this care is provided directly by their organisation or contracted to other agencies in the statutory or independent sectors. Why was the Research Governance Framework for Health and Social Care introduced? New areas of exploration (e.g. stem cell research and nanotechnology), together with some high profile events (e.g. the enquiry into the use of organs at the Royal Liverpool Children s NHS Trust Alderhey Hospital), have affected public confidence in research. These developments have taken place against a climate in which businesses, governments, the media, public institutions and services are all expected to have in place transparent systems that stand up to public scrutiny in order to retain the general public s trust, goodwill and support. In recent years, within the context of UK based research, the UK Government, its departmental bodies, government funded and charitable funded research sponsors have announced new regulations to strengthen and assure the quality of research processes. One such regulation, the Research Governance Framework for Health and Social Care, was published in response to recent developments in research and changing legislation (e.g. the EU Clinical Trials Directive 2001/20/EC). The Framework seeks to retain the public s confidence in UK-based health and social care research by ensuring that all health and social care research is: (i). Conducted according to a framework of (research governance) standards which: Protect human participants in research Enhance the relevance, scientific value and accountability of research Clarify the responsibilities and accountabilities of institutions and individuals involved (ii). Governed by a Department of Health recognised research governance sponsor

The University s approach When do research governance standards become compulsory? From 1 April 2004 all UK-based health care needs to be governed: In accordance with the standards described by the Framework By a Department of Health recognised research governance sponsor In partnership with the Sheffield Teaching Hospital NHS Trust, for the period 1 April 1 September 2004 the University has in place provisional research governance procedures for its health care research projects. By 1 September 2004 the University s research governance procedures for health care research projects will be fully established. The 1 April 2004 deadline does not apply to social care research. It is expected that the Department of Health will announce a deadline for social care research in due course, from which point social care research will need to be conducted in accordance with research governance standards. The Framework recognised that the same standards should apply across health and social care research, but also that the procedures for achieving the standards in the field of social care research might need to be different from those established for health care research. As of February 2004 the Department of Health is exploring the development of guidance on research governance procedures for social care research. Becoming a research governance sponsor The Framework defines a sponsor as: the organisation that takes on overall responsibility before a study starts, for the initiation, management and financing of it (or for arranging the initiation, management or financing). The sponsor satisfies itself that the study meets the relevant standards, and makes sure arrangements are put and kept in place for management, monitoring and reporting Research-active NHS Trusts are required by the Department of Health to become sponsors. In early 2003 the University decided that it was in its best interests to also become a sponsor for health and social care research projects. This status carries with it official recognition, from the Department of Health, for having in place high quality assurance standards. Sponsor status will both enhance the University s competitive edge and help spread good practice across the diversity of the University s research disciplines. Sponsors will be responsible and accountable for ensuring that: Research projects that it sponsors are governed in accordance with the research governance standards Procedures are established to ensure that research governance standards are established, maintained and monitored In due course the University also plans to register as a sponsor for social care research. How have the University and the Sheffield Teaching Hospital NHS Trust approached the task of becoming sponsors? Due to the diverse nature of the University s research and broad scope of the Framework, the identification of sponsors may not always be straightforward. Both the Trust and the University however work very closely to ensure that their respective research governance procedures are clear and complementary. In late 2002 the University established the Research Governance Sub Committee to coordinate the task of becoming a sponsor. The Sheffield Teaching Hospital NHS Trust is represented on the Sub Committee. Transitional research governance procedures for University sponsored projects will be in place for the period 1 April 1 September 2004.

Reference Overview of research governance procedures at the University of Sheffield. Detailed guidance will be issued before 1 April 2004. Initial project idea University registration and departmental approval (URMS record or RGC2 form) Independent scientific review and approval Independent ethics scrutiny and approval Submission of relevant approvals and documentation for scrutiny by the Research Office. Issue of project authorisation letter to the Principal Investigator by the Research Office Authorisation of research project contract by the Research Office Research project commences and runs Sources of further guidance The Research Office has developed a specific reference area on its website at: www.shef.ac.uk/researchoffice/ro/governance.html This includes up-to-date information on: The University s approach to research governance Transitional research governance procedures for University sponsored projects for the period 1 April - 1 September 2004 Developments in respect of social care research within the research governance context Jargon buster to research governance Links to the Framework Links to information on the Sheffield Teaching Hospital NHS Trust s governance procedures The site also includes guidance on the University s policies on good research practice and research ethics. The issues of research ethics and good research practice each constitute discrete elements of research governance. However, whilst research governance is specifically concerned with health and social care research, research ethics and good research practice are issues of relevance to all research disciplines. Good Research Practice Standards The GRP Standards are published at: www.shef.ac.uk/staff/grpstandards.html The University s GRP Standards apply to all those who are conducting or participating in research activities at the University of Sheffield. This includes University members of staff, students and visitors. Ethics Policy for Research Involving Human Participants, Data and Tissue The Ethics Policy is published at: www.shef.ac.uk/staff/ethics.html The Ethics Policy applies to all University staff and students who are conducting research activities involving human participants, data and tissue (either within or outside the University), and all individuals who are not members of the University but who are conducting research activities involving human participants, data and tissue at the University. Research project is monitored (and might be audited) Project final reports and closure Archiving of project research evidence

Research Office 85 Wilkinson Street, Sheffield S10 2GJ Tel: 0114 222 1431 Fax: 0114 222 1452 Email: research.office@sheffield.ac.uk Web: www.shef.ac.uk/researchoffice/