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Preparing Research Proposals
How to Distinguish between Research & Audit
It is important to establish whether the activity you are about to undertake is research or audit. The Research Governance Framework and its requirements for R&D and Research Ethics Committee approvals applies for research and not audit projects.
Research can be defined as 'a structured activity which is intended to provide new knowledge which is generalisable (i.e. of value to others in a similar situation) and intended for wider dissemination' (Department of Health, 2002)
Clinical Audit:- '…a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, processes and outcomes of care are selected and systematically evaluated against explicit criteria. Where indicated, changes are implemented at an individual, team, or service level and further monitoring is used to confirm improvement in healthcare delivery.' (Principles for Best Practice in Clinical Audit, NICE, 2002)
The Clinical Effectiveness Department in conjunction with R&D has produced detailed guidance on distinguishing between research and audit and this can be found by following the link below
Quick Tips on Distinguishing between Research & Audit
The National Research
Ethics Service have useful guidance - Defining
Research 
All research projects require R&D approval before they can begin. If you are undertaking an audit project, please contact the Clinical Effectiveness Department for further guidance and information.
Clinical Audit Notification
Download
the notification form
How to Write a Research Protocol
A protocol is an essential starting point for high quality research and all research studies must be protocol based. R&D and Research Ethics Committee approval will only be granted to studies with a protocol.
A protocol gives written evidence for the necessity and feasibility of a research study and also provides a detailed plan of investigation. It also allows the peer reviewer, Research Ethics Committee or statistical advisor to make a judgement about the scientific aspects of the study. It can be used as a reference to answer any questions which are not immediately apparent from the R&D and REC application forms.
Detailed guidance on writing research protocols can be accessed here:
Writing
Research Protocols - Guidance for Researchers 
Planning a Research Project – Questions to Ask
How to get Statistics Support
Statistics Advice:
The R&D Department Medical Statisician is available to offer statistical advice to all Trust researchers.
If you require statistics support, please contact the Mr Phil McShane on 0113 343 1489 or
email p.mcshane@leeds.ac.uk who will be able to put you in contact with our statistician
Statistics guidance:
R&D Statistics support - useful information on Statistical analysis
Sample
Size Calculations and Analysis Plan
Further
guidance on the Statistical Information required by the Research Ethics Committee
Further web based guidance on statistics and health research can be accessed through RDDirect's Research Flowchart