Research Ethics Committee Approval
For further information
If your study is involving patients or users of the NHS; patient data; NHS staff or NHS premises or facilities you will need to obtain Local Research Ethics Committee approval as well as R&D approval. Please contact the Calderdale and Huddersfield LREC Administrator for details on how to apply.
The PCT Research Governance Facilitators are more than happy to offer additional advice and help if this is required. Please contact:
Recommended Reading • Research Governance Framework in Health and Social Care (2005) http://www.dh.gov.uk/PolicyAndGuidance/ ResearchAndDevelopment/fs/en
• Central Office for Research Ethics Committees http://www.corec.org.uk
PCT Research Governance Facilitators R&D Department, Room 310, Learning Centre, Huddersfield Royal Infirmary, Lindley, Huddersfield, HD3 3EA.
Research governance framework leaflet series
Tel: 01484 347007 Or Airedale, Calderdale and Huddersfield Research Ethics Committee, Fleming House, Airedale General Hospital Keighley, BD20 6TD.
Tel: 01535 294657 Or for North Kirklees PCT:
• University of Huddersfield - School Research Ethics Panel, Systems for ethical approval / gaining advice of SREP http://www.hud.ac.uk/hhs/research/ general_r/srep.htm
Wakefield District REC Wakefield West PCT, White Rose House, West Parade, Wakefield WF1 1LT. Tel: 01924 213110
• Research Governance Framework Leaflet Series # 1-12
PCT Leaflet No. 4
Available from the R&D Dept.
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
A student project must therefore meet all of the same requirements as any other project under the RGF. This means: • Adequate and appropriate peer review
• R&D Approval
Training in research methodology and practice is an essential part of the education of many health professionals and others who have an interest in health care practice.
• Research Ethics Committee (REC) approval (If applicable)
Research Governance Framework and students The Research Governance Framework (RGF) (2005) aims to improve research quality and safeguards 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 explain the requirements and implications of the RGF with particular reference to student research.
Status of student projects Research projects undertaken by students, as part of their studies must be carried out under the standards of the RGF.
• Compliance with the Data Protection Act, 1998 • Compliance with PCT policies in general e.g. health and safety.
Roles and responsibilities When the lead applicant is inexperienced, the research supervisor will share the responsibility for the ethical and scientific conduct of the research. The research supervisor will usually take on the role of the principle investigator for inexperienced applicants. Supervisors please refer to the PCT leaflet ‘Research Governance – Information for Principal Investigators’. Students have the responsibility to work with their supervisor who will help them with the ethical and scientific quality of the proposal. Inadequate scientific review of the project will lead to delay in approval which may make the research impossible to complete within the time available.
The supervisor should also check forms for R&D and LREC approval before submission. As time is usually limited, the research question and methodology should be modest enough to produce valid data on a small scale within the limited time available.
R&D Approval Approvals by the R&D Department must be awarded before the research commences. Students should allow sufficient time (up to 60 days) for this process in planning for the study. Staff in the R&D office are happy to offer additional advice and help if this is required. In light of these timescales we recommend that for undergraduate students that the dissertation is a literature based study which can speed up the process (up to 30 days). This has the support of the University of Huddersfield. Please contact the Research Governance Facilitators for the necessary forms – contact details on back of leaflet.
Honorary contracts Any researcher who is not employed by the PCT, including students, must have an honorary contract before they begin their research, access patients, staff or data. Honorary contracts, if required, are routinely arranged through the PCT’s approvals process.