There are a number of different kinds of projects involving data collection, research, audit, service evaluation, Quality Improvement (QI) initiatives, case notes studies, student thesis, etcetera. All of them require formal authorisation from the Trust before participants can be approached or data collected.
The first step is to determine what kind of project you propose to undertake, as different types of projects are subject to different regulations and routes to obtain the appropriate authorization. Please refer to the Guidance for projects involving data collection which gives guidance on distinguishing between research, audit, service evaluation and public health surveillance and how to apply for authorization for each; you can also refer to the HRA Decision tool.
Is Your Project Defined as Research?
Any research activity that takes place within the NHS is subject to the Department of Health's Framework for Research Governance in Health and Social Care which sets standards for the research process and formalises the responsibilities of all those involved. The governance approval process protects both participants and researchers. All our research activity needs to be covered by our insurance and that requires lots of information.
For projects meeting the definition of research,
you then need to determine whether your study requires NHS REC approval.
Once again, the Health Research Authority (HRA) has developed a Do I need NHS REC approval? on-line tool to assist you.
You must also bear in mind that all research taking place in the NHS must both be assessed by the HRA and receive confirmation from the R&D Office at each proposed NHS site that they have the capacity and capability to support the project before work, including the recruitment of participants, may begin. This applies to all research conducted in the NHS, including work undertaken by students, and there is currently no 'fast track' process for either HRA or Trust approval. There are, however, certain conditions ELFT applies to all student research projects.
As of March
2014, ELFT became a noclor
partner. The team at noclor can support research submissions.
They will review your draft and identify any areas which need to be amended.
There is a guide to the Research
Life Cycle which will assist you in all aspects of your project; mandatory training is also
provided. All applications to conduct a research project should be submitted through the noclor office and not to the research office at ELFT.
Applications to the HRA are prepared with the support of your research sponsor; if you wish ELFT to sponsor your project you must contact noclor to arrange this. Only the Trust R&D Office is authorised to sign IRAS forms on behalf of the sponsor.
For more information, see our page on HRA Approval.
What if it's not a 'research' project?
Where your project falls outside the definition of research, it still requires appropriate approval before participants are recruited and/or data is collected.
All audit undertaken in ELFT must be registered with the Trust’s Assurance Department. To do so, complete the Clinical Audit Project Registration Form, available on the intranet, and send this form to QOET@elft.nhs.uk . There is a separate process for the mandatory Trustwide, Service User-Led and Directorate Audits. For more information on these, contact QOET@elft.nhs.uk.
Quality Improvement (QI)
There is a process for formal authorisation of QI projects within each directorate – every project is approved by the directorate’s QI forum and has a named project sponsor who is accountable for the work. To engage with the QI team, complete the on-line form.
Service Evaluation / Development
Other types of data collection exercises, such as Service Evaluations / Developments, are reviewed by the Associate Medical Director, Frank Röhricht . For these projects, investigators should complete a Service Evaluation / Development Protocol template and submit it along with an email from your line manager endorsing the project to firstname.lastname@example.org copying in the Clinical Director of the service in which the data will be collected. Advice on completing the template is available here.