• Remain responsible for the quality of all aspects of the care of our patients or users, whether or not they are involved in research and whoever that research may be conducted and funded by. • Ensure that researchers not employed by the PCT hold an NHS honorary contract. • Have systems to identify and learn from errors and failures. • Have systems to process, address and learn lessons from complaints arising from any research work being undertaken through or within the organisation. • Ensure that significant lessons learnt from complaints and from internal enquiries are communicated to funders, sponsors and other partners. • Permit and assist with any monitoring, auditing or inspection required by relevant authorities.
Recommended reading • Research Governance Framework in Health and Social Care (2005)
For further information please contact: PCT Research Governance Facilitators R&D Department, Room 310 Learning Centre, Huddersfield Royal Infirmary, Lindley, Huddersfield, HD3 3EA. Tel: 01484 347007 Or Airedale, Calderdale and Huddersfield Research Ethics Committee, Fleming House, Airedale General Hospital, Keighley, BD20 6TD. Tel: 01535 294657
Research governance framework leaflet series
Research governance an overview
Or for North Kirklees PCT: Wakefield District REC Wakefield West PCT, White Rose House, West Parade, Wakefield WF1 1LT. Tel: 01924 213110
http://www.dh.gov.uk/PolicyAndGuidance/ ResearchAndDevelopment/fs/en PCT Leaflet No. 1
This leaflet was created by Calderdale and Huddersfield NHS Trust on behalf of the 4 PCTs © Calderdale & Huddersfield NHS Trust 2005
Calderdale Primary Care Trust, Huddersfield Central Primary Care Trust, North Kirklees Primary Care Trust and South Huddersfield Primary Care Trust
Research governance framework leaflet series Research governance – an overview Research is essential to the successful promotion and protection of health and well being, and to modern and effective health and social care services. At the same time, research involves benefits and risks, both in terms of return on investment and sometimes for the safety and well-being of the research participants. Proper governance of research is therefore essential to ensure public confidence in, and benefit from, quality 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. The Research Governance Framework (RGF) was published by the Department of Health in 2001 and has recently been republished in 2005. It is of direct relevance to all those who host, conduct, participate and manage health and social care research. It seeks to promote improvements in research quality across the board and provides a context for the encouragement of creative and innovative research for effective transfer of learning, technology and best practice to improve care. The RGF aims to improve research quality and safeguard the public by: • Enhancing ethical and scientific quality • Promoting good practice • Reducing adverse incidents and ensuring lessons are learned
• Preventing poor performance and misconduct. This leaflet aims to provide an overview of the requirements and implications of the RGF.
Who does the RGF apply to? The RGF is not restricted to principal investigators, managers or to any one professional group. All service and academic staff (including student researchers), no matter how senior or junior, have a role to play in the proper conduct of research. Participants in research and the public in general can also help to ensure that standards are understood and met.
What type of research does the RGF cover? The RGF covers clinical and non-clinical research, research involving NHS patients, staff and premises. It also includes research undertaken by industry, the charities, the research councils and universities within the health and social care systems.
Key responsibilities of researchers • R&D approval of project – considering issues such as sponsorship and scientific rigor of the project • Research Ethics Committee Approval – All research involving patients and users of the NHS, including volunteers and NHS staff, or data, organs or other bodily material, NHS premises or facilities, must be reviewed independently to ensure that it meets ethical standards. This must be done before the research commences by a Local or Multi Centre Research Ethics Committee.
• NHS Organisational Approval – the relevant PCT(s) must give approval for the research to take place before it commences. Researchers and their teams must be aware and adhere to: • Informed Consent – All studies must have appropriate arrangements for obtaining and recording informed consent. • Data Protection Act – particular attention must be given to systems for ensuring confidentiality of personal information and the security of those systems. • Health & Safety Act – the safety of the participants and of research and other staff must be given priority at all times.
Key Responsibilities of the organisation As an organisation the PCT must: • Be aware of all research being undertaken in the organisation, or involving participants, organs, tissue or data obtained through the organisation. • Ensure that our patients, users, members of the public and care professionals are provided with information about any research which may have a direct impact on their care, their experience of care, or their work in the organisation. • Ensure that any research involving our patients, users, carers and members of the public or staff meet the RGF standards, in particular that it has an identified research sponsor willing and able to discharge its responsibilities, and that clear and documented agreements are in place about the allocation of responsibilities between all parties involved.