What do I do if I am interested in doing a piece of research?

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.

For projects meeting the definition of research, 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.  These conditions only apply to projects defined as 'research' - service evaluations, literature reviews and case studies are generally more appropriate designs for a student thesis. 

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.   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.

Where your project falls outside the definition of research, it still requires appropriate approval before participants are recruited and/or data is collected.

Audit

 

All audits undertaken at ELFT are aligned to Trust and directorate assurance priorities, and coordinated by the Trust’s Quality assurance team. We do not encourage or support individuals to undertake isolated audits, as our audit programme is linked to change planning processes in each directorate which are tracked and monitored. For any queries about audit, please contact qa@elft.nhs.uk.

 

Quality Improvement (QI)

 

We encourage all staff to be involved in improving the way their team works, through quality improvement. All QI work at ELFT takes place in teams, so we do not support individuals to undertake QI work on their own. 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 find out more about which projects are going on in your directorate/team, and who to contact for support, please visit https://qi.elft.nhs.uk or contact qi@elft.nhs.uk.

Service Evaluation / Development

A Service Evaluation provides practical information to help decide whether a development or service should be continued or not. Evaluation also involves making judgements about the value of what is being evaluated. Service evaluations must be submitted to the Trust’s Governance and Ethics Committee for Studies and Evaluations (GECSE).  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 elft.gecse@nhs.net copying in the Clinical Director of the service in which the data will be collected. Advice on completing the template is available here.

Literature Review

As a literature review does not contain any data from ELFT sources, it does not require any governance approval from the Trust. If it is linked to a case study, please follow guidance below.

Case Study/Review

Case reports are usually anonymised and there are rarely ethical issues to be considered as long as consent is obtained. However, some journals may require evidence of approval prior to publication. Case Studies which conform to the Trust’s standards (detailed in the Case Study Governance template) do not normally require assessment. However, where the author (or student supervisor) has question about the appropriateness of a proposal and specifically if an exception to Trust standard is being sought, the Case Study Governance template should be completed and submitted to the Trust’s Governance and Ethics Committee for Studies and Evaluations (GECSE) at elft.gecse@nhs.net

Can I meet with you to discuss my research?

The Research Design Service (RDS) London provides help to those preparing research proposals for submission to peer-reviewed funding competitions for applied health or social care research. The advice is provided free of charge and is available through use of online resource and consultations with experts.

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.

How can I get my research up and running to time and with minimal problems?

If you are new to research in the NHS, or have not set up a project for a while, you may find the thought of getting approvals and setting up you study daunting. The HRA has published information to assist with planning your application for HRA Approval and preparing study documentation

There are a number of training resources available to you providing help completing forms, dealing with ethical issues, and drafting information sheets, etc.

How do I apply for a research grant?

Our research partner noclor has a finance team, experienced in costing and pricing both commercial and non-commercial research. This team can also draft and review contracts between funding / sponsoring organisations and the research sites.

I have ethical approval and have been indemnified by my college/university; can I begin my research project?

No. In order to carry out research within this Trust, you must also obtain NHS Research Ethics Committee approval and the authorisation of the Trust in which the research will take place. As with all research undertaken within the Trust, a senior member of the Trust is required to take overall responsibility for the proper conduct of the study.

I am a student and wish to conduct my master's / doctoral thesis research in the Trust; is there a 'fast track' approval process for small-scale projects?

No. All research conducted in the NHS must conform to the requirements of the Department of Health's Research Governance Framework, including work undertaken by students, and there is currently no 'fast track' process for either ethical or NHS Trust approval.

There are, however, certain conditions the Trust applies to all student research projects.  

Whose contact details do I put in the Participant Information Sheet?

The Health Research Authority (HRA) has some excellent guidance on drafting information sheets and consent forms. These documents should always be amended where necessary to reflect local content at each research site. The local contact in our Trust for raising a complaint is the Patient Advice and Liaison Service (PALS)

Who should I name on the Participant Information Sheet as the independent contact point for general advice about taking part in research?

This should also not refer to either the ELFT research office, noclor, or (in this case) the Patient Advice and Liaison Service (PALS). Instead, we recommend INVOLVE, a national advisory group, which is funded by and part of the NIHR, supporting greater public involvement in NHS, public health and social care research.

Other contacts for IRAS forms now that ELFT has become a noclor partner:

Where ELFT is the sponsor of a study, the contact on behalf of the sponsor for all correspondence relating to applications for this project (IRAS A4), should be the specific noclor research governance facilitator with whom the study team is working. You should approach noclor at an early stage (before finalising your IRAS dataset).

     Name:
     Title:
     Address: 1st Floor, Bloomsbury Building 
     St Pancras Hospital, 
     4 St Pancras Way, London NW1 0PE. 
     Email: contact.noclor@nhs.net
     Phone:
     Fax: 020 7685 5788

At question A64-1, the Lead Sponsor's contact person (where ELFT is the sponsor) this should be

     Name: Mr Emmanuel Rollings-Kamara
     Organisation: East London Foundation Trust
     Address: 1st Floor, Bloomsbury Building 
     St Pancras Hospital, 
     4 St Pancras Way, London NW1 0PE. 
     Email: sponsor.noclor@nhs.net  
     Phone: 020 3317 3757
     Fax: 020 7685 5788

Regardless of the sponsor, where ELFT is the lead Trust/research site, the details of the lead NHS R&D contact for this research (IRAS A68-1) should also be the specific noclor research governance facilitator with whom the study team is working. You should approach noclor at an early stage (before finalising your IRAS dataset).

     Name:
     Title:
     Address: 1st Floor, Bloomsbury Building 
     St Pancras Hospital
     4 St Pancras Way, London NW1 0PE
     Email: contact.noclor@nhs.net
     Phone: 020 3317 5788
     Fax: 020 7685 5788

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