Research Governance: guidance for researchers | Collaborations for Leadership in Applied Health Research and Care Cambridgeshire and Peterborough

Guidance for CLAHRC CP researchers

Step 1

It is important to establish from the outset whether a project is likely to be research or not, as projects NOT classed as research do NOT require ethical approval to be granted by a REC (Research and Ethics Committee).

Guidance from the National Research Ethics Service (NRES) on ‘what is research?’ can be found here, and this document ‘Defining Research‘, provides further guidance on distinguishing research from clinical audit and service evaluation, and indicates whether review by a REC is required.

If you think your project is research, then you should register on IRAS, the Integrated Research Application System (IRAS) which is a ‘one-stop shop’ for applying to multiple agencies such as the REC, R&D, MHRA etc. If your research involves NHS patients, staff and/or facilities, your research cannot proceed without formal approval from the R&D Office(s) at each of the NHS Trusts in which your research is to take place.

If the project is audit, service evaluation, public health surveillance, practice development, quality or service improvement, action research, service design or development, a case study or satisfaction survey, then this is not classed as research, but it still needs to be registered as a project on the CLAHRC CP KPI database and the Governance arrangements detailed as per the Governance data input tab; this should be completed in consultation with the peer reviewer.

You should also check with the clinical governance office for the NHS organisation where you will be conducting the study what other review arrangements or sources of advice apply to the project. For example, there may be standard guidelines on the conduct of clinical audit.

Step 2

If your project is research, contact the Lead Organisation’s Research & Development Department.

If your project is non-research, contact the Lead Organisation’s Clinical Audit or Service Evaluation/Development Department.

Step 3

Managing the research governance requirements:

Research Management and Governance guidance from the NIHR West Anglia CRLN can be found here which also explains about the Research Passport scheme. This flowchart is helpful in setting out the research passport requirements.

Guidance on research, audit, service development and Ethics Committees from CPFT can be found here, and there is an explanation of the research passport system here. This can be a very daunting procedure as this flowchart demonstrates, so please ensure that all steps are taken and if in doubt, contact the CLAHRC manager for assistance.

Guidance for research at Cambridge University Hospitals Partnerships can be found here on the Addenbrooke’s website.

Guidance from the University of Cambridge on research passports can be found here.

Step 4

If the project is an evaluation then the following links will be useful:

CLAHRC Evaluation Guide here.

CLAHRC Evaluation plan Template here.

CLAHRC Evaluation Report Template here.

CLAHRC Evaluation Workbook here.

NHS Cambridgeshire has a full evaluation toolkit which can be found here.

A short evaluation toolkit from NHS Cambridgeshire can be found here and here.

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Health Research Authority toolkits

Two new toolkits have just been released by the HRA which will be of use for researchers.

The first is a way of deciding whether or not your project is categorized as research rather than audit or service evaluation, and the second is for deciding whether or not NRES ethics approval is required. The links to the toolkits are below:

http://www.hra-decisiontools.org.uk/research/index.html

http://www.hra-decisiontools.org.uk/ethics/