All projects that will involve Lancashire Teaching Hospital patients, their data or tissue, facilities or staff require NHS Permission in accordance with the NHS Research Governance Framework before they can be carried out on our site. Our Research Governance team can support you in the preparation and navigation of NHS approvals processes.
- The Research Process
The first question to ask when setting up a study is 'Is it research?'
The Health Research Authority (HRA) have issued guidance (Defining Research) on the categorising of research, clinical audit and service evaluation. Try their online decision tool: http://www.hra-decisiontools.org.uk/research/
All three types of study require the approval of host Trusts, however, systems for approval for each type of study vary and only research requires Health Research Authority (HRA) and REC (Research Ethics Committee) review.
- Research - is designed and conducted to generate new knowledge and should follow the systems for approval of NHS Research – see Research Governance section.
- Audit - is designed to answer the question "Does this service reach a predetermined standard?" Please contact the Clinical Effectiveness and Audit team.
- Service evaluation - is designed to answer the question "What standard does this service achieve?" – Service Evaluations can be registered with the Research Governance Team.
If your project is research then you will need to:
- write a protocol
- find funding
- obtain sponsorship and
- apply for approval to conduct your research
- gather the views of service users (patients and their relatives and / or carers)
- Developing your idea
Developing a new study idea, looking for collaborators, applying for funding and navigating the approvals process can be daunting so please contact us at the earliest opportunity so that we can support you with this process. Please note that grant applications require R&I sign off and to do this we need to ensure that, at the very least, the project is costed correctly and fully. Therefore if you are planning on submitting a grant through Lancashire Teaching Hospitals NHS Foundation Trust, or if the grant has Lancashire Teaching Hospitals NHS Foundation Trust costs associated with it, please contact us at an early stage and no later than 3 weeks in advance of the deadline.
The Centre for Research and Innovation can facilitate access to methodological expertise to support your project development and grant application including statistical support for the design and analysis of funded research studies along with health economics, qualitative and quantitative methodologies expertise.
- How to write a Research Protocol
A protocol is an essential starting point for high quality research.
The protocol often includes:
- The research idea
- Research Question
- Background information
- Sample population
- How the results will be put into practice
- Advice and support completing online ethics application (IRAS system)
The NHS Health Research Authority (HRA) has produced guidance to help you determine whether or not you require approved by an NHS Ethics Committee. Please note: Even if you do not require approval by an ethics committee you may still require HRA approval, and local Trust acknowlegement.
You will need to complete an online application using the IRAS (Integrated Research Application System)
For guidance on the use and completion IRAS, please contact the department. We are happy to review applications and provide feedback on your application prior to submission.
- Patient and Public Involvement
Increasingly, public involvement is a requirement of applying for research funding and is used by commissioners as an indicator of the quality of the research application. It is based on the view that members of the public can bring knowledge and experience of a particular condition or service relevant to:
- the research topic
- A public perspective
- Views about the best ways to involve other users and carers in research
Members of the public can help to:
- Improve the design and focus of the research
- Advise on ‘best practice’ for public involvement throughout research
- Advise on ethical issues.
Some links to further information about public and patient involvement can be found here:
- INVOLVE – Promoting public involvement in NHS, public health and social care research (http://www.invo.org.uk/)
- Training – Good Clinical Practice for Research (GCP)
Everyone involved in the conduct of clinical research must have training to ensure they are best prepared to carry out their duties. This is laid down in the Research Governance Framework for Health and Social Care 2005, covering all research in the NHS in England, and is law for those people working on clinical trials.
GCP training can be accessed as either a taught course or online through e-learning. It is the policy of the Trust that all staff involved in research must complete GCP training, every two years. A refresher course is available for those who have already attended the full Introduction to GCP course.
To access the courses, you can register online via:
https://learn.nihr.ac.uk/ or contact the department for further information.
Once you have finalised your course, you must send a copy of the certificates to:
Further advice can be found in the document