Research Governance has a number of components and Ethics is just one of them. Research Governance refers to the University’s responsibility for ensuring that staff are appropriately trained (e.g. Good Clinical Practice training); that research projects are scientifically sound (demonstrated through scientific review); that appropriate indemnity provision and ethical approval is in place; and that appropriate monitoring and reporting takes place. The University’s Research Governance Framework outlines in detail the University’s regulations for staff and students relating to research involving human participants.
The World Medical Association has published a new version of the Declaration of Helsinki. The 2008 version is now the only official one; all previous versions have been replaced and should not be used or cited except for historical purposes.
Compliance with research governance and ethical conditions is subject to audit.
Research involving the NHS must follow the NHS procedures
All research involving NHS patients, staff or records MUST be submitted to the NHS Research Ethics Committee. For a step by step guide click here. The following link will take you to the National Research Ethics Service (NRES) webapge - http://www.nres.npsa.nhs.uk/
All other research must follow the University & School procedures
For a step by step guide for all other research click here.The forms you will require for these steps are downloadable here.
1. Scientific peer review
The first thing you must do is ensure that you have written a detailed research proposal and that you have had it scientifically reviewed by experts in the area of your research. In the event that you are unable to secure someone to review your proposal, please contact Dr Mark Linden ext 6568 who will attempt to match your project to our bank of reviewers. Please read the attached Standard Operating Procedure for scientific review.
The forms you will need are:
2. School Research Ethics Committee (SREC) approval
When the proposal has been scientifically peer reviewed and you have addressed the reviewers required comments satisfactorily, you can then proceed to apply for ethical approval. Download and complete the ethics review checklist and application form.
School of Nursing SREC Meetings.
SREC Meetings will be chaired by Dr Marian Traynor. The meetings will be held on the following Tuesdays at 2.00pm (except Monday 1st October and Friday 16th November)
4th September, 1st October, 16th November, 4th December 5th February, 5th March, 26th March, 7th May, 4th June
All research projects require a ‘sponsor’. That is, an institution that will provide indemnity and insurance. In general, for non-NHS projects, the University will sponsor the project, but only if you inform the Research Governance Office of your project. To do this, download and complete the following form which the SREC will need to see when considering your application:
In summary, you should submit the following forms to SREC:
· Research Proposal
· SREC Application form
· Scientific Peer Review Report/s
· Scientific review form/GOV 1
· Ethics review checklist/GOV 2
· Request for sponsorship form /GOV 3
· Relevant information & consent forms
· Relevant data collection tools.
If you are unfamiliar with the ethical requirements for participant information and consent you should read this guidance (click here) prior to producing your participant information sheet and consent form. This format will be expected by the SREC. Once ethical approval has been granted, please ensure that you comply with the following governance processes.
3. Send protocol, copy of ethics approval letter & GOV 3 to Ms Ruth Erwin in the Research Governance Office
4. Insert study details into ‘My Research’ database on QOL.
5. Maintain a Study Management File
6. If there are amendments to be made to the proposal, complete and return a Protocol Amendment and Extension Form.
7. When the study ends complete and return a Declaration of End of Study Form.
Dates for SREC Meetings:
Tuesday 4 September 2012 at 2.00pm
Monday 1 October 2012 at 2.00pm
Monday 5 November 2012 at 10.00am
Tuesday 4 December 2012 at 2.00pm
Tuesday 5 February 2013 at 2.00pm
Tuesday 5 March 2013 at 2.00pm
Tuesday 26 March 2013 at 2.00pm
Tuesday 7 May 2013 at 2.00pm
Tuesday 4 June 2013 at 2.00pm
Proposals should be submitted 10 days before the date of the meeting
Governance Arrangements for Research Ethics Committees (GAFREC)
A revised version of GAFREC has been agreed by the four UK Health Departments and is available for information on the PHA website by clicking on the following link:
This document is the policy of the UK Health Departments describing what is expected from the research ethics committees that review research proposals relating to areas of the UK Health Departments’ responsibility. It also explains when review by these committees is required.
The policy covers the principles, requirements and standards for research committees, including their remit, composition, functions, management and accountability. It also describes the Research Ethics service in which the research committees operate and the review they provide.
This harmonised edition comes into effect on 1 September 2011. It revises and replaces editions of the policy previously issued separately in England and Scotland in 2001. It also applies to Wales and Northern Ireland.