How to start research

When you first have an idea for a research project, you need to define:

• What you want to study?
• Why you want to study that?
• How potentially could the study be carried out?
• Who can help you?

It is essential to determine what information already exists on the topic.

Literature searches (such as NICE Healthcare Databases Advanced Search) can also be performed by the Trust librarians. In addition, a search of the databases of clinical trials will show if a similar study has been registered.

ClinicalTrials.gov, International Standard Randomised Controlled Trial Number (ISRCTN), EU Clinical Trials Register

Start with a small study and a limited number of participants, these are easier to run/manage and more likely to get funded. It will also allow you to help identify if the project is possible, what the problems are and potentially modify it before a larger study. This initial data can help with a future larger funding application.

The Health Research Authority provides and/or co-ordinates a number of approvals that are commonly required prior to undertaking research on NHS patients including research ethics committee (REC) reviews.

Using the Defining Research Table and the 2 HRA tools, “Is my study Research” and “Do I need NHS REC review” will help determine some of the approvals required.

If the answer to “Is my study Research?” is No, consider whether the work is audit and if it is, contact the audit department

If it is not research and not audit, contact the R&I department at ekhuft.researchandinnovation@nhs.uk and follow the process outlined for Grey Area Project (G.A.P.),as described in SOP 13. You will need the following documents Protocol, Researchers CV, G.A.P. Application Form.

EKHUFT Research Facilitator, to signpost through the process (Email jane.povey@nhs.net).

EKHUFT R&I Department (ekhuft.researchaninnovation@nhs.net), to register project, provide assistance and advice and act as final sign off for funding and ethics applications:

 If you are applying for funding contact Research Design Service South East (RDS SE) for help.

Once you have an initial idea of the background, aims and research question of your study, they can provide the following:

• Help with which funding stream to apply to and with the grant preparation.
• Access to statisticians, health economists and qualitative research experts
• A grant for PPI work
• A pre-submission panel (PSP) who can assess your application
• Ongoing help during the project.

Statistical help

Most projects will require some form of statistical input and there are a variety of ways that this can be accessed:

1.      Available from the RDS for projects applying for funding 
or
2.      R&I can arrange an appointment with a statistician through the Trust
or
3.      The program Stats Direct is available for use on computers in all 3 trust libraries

A protocol will be required for all types of project, the level of detail will depend on the classification of the project.

Help with writing protocols can be found from the following :

• R&I SOP 10 Developing a research protocol or proposal- available from the R&I central office     
• NHS Health Research Authority - protocol

Help with writing patient information sheets and the consent forms required for many projects:

• Health Research Authority consent form

There are various opportunities for funding, both small and large sums.

There are 2 in house funding schemes that can provide small funding pots, contact Research Facilitator for details and timings.

Research Professional - A search tool to help find funding opportunities. Contact Research Facilitator

Applied Research Collaboration- Kent, Surrey and Sussex (ARC-KSS)

A list of funding opportunities compiled by ARC- KSS can be found here

East Kent Hospitals Charity 

Relevant Registration/affiliation body

NIHR - for applied clinical research

UK Research and Innovation 

Charities, including:

Association of Medical Research Charities

Medical Research Council/UK Research and Innovation 

Wellcome

If the answer to “Is my study Research?” Is Yes, use the second tool to identify if REC review is required.

Register the project with R&I.

For this you will require the protocol.

The Integrated Research Application System (IRAS) is a single system for applying for the permissions and approvals for health and social care / community care research in the UK

Register at https://www.myresearchproject.org.uk/

IRAS captures the information needed for the relevant approvals from the following review bodies:

Administration of Radioactive Substances Advisory Committee (ARSAC)
Confidentiality Advisory Group (CAG)
Gene Therapy Advisory Committee (GTAC)
Health Research Authority (HRA) for projects seeking HRA Approval
Medicines and Healthcare products Regulatory Agency (MHRA
NHS / HSC R&D offices
NHS / HSC Research Ethics Committees
Her Majesty's Prison and Probation Service (HMPPS)
Social Care Research Ethics Committee

Contact Research Facilitator for further information (jane.povey@nhs.net)

NIHR CRN supported studies benefit from the following:

Access to the NIHR CRN Study Support Service

Provision of NHS support as defined by AcoRD Provision of Research Part B costs as defined by AcoRD (for studies funded by AMRC member charities only)

Access to relevant research delivery training 

ISRCTN registration

NIHR CRN support is available to all studies, regardless of location, study type, study size, therapy or research area, provided they meet the eligibility criteria.

A study is eligible for the NIHR portfolio if it:

Meets the HRA definition of research

Has appropriate ethical approval; and Health Research Authority (HRA) approval where required

Has full research funding through open and nationally competitive grant calls administered by the NIHR

Funded by other areas of central Government (including UK Research and Innovation and the Research Councils)

For further details of possible funding schemes:

National Institute of Health Research - Eligibility for clinical research network support

Apply through the IRAS form- Q 5a/b

Public Involvement is the active contribution of patients and members of the public to help shape research. It is expected that the public should be involved in all stages of research and both funding and HRA approval processes require evidence of PPI.

This can involve helping to develop research ideas and funding applications; contributing to the design of research; offering ongoing advice through membership of project steering groups or as grant co-applicants.

There can be support to researchers to develop clear, public facing, materials e.g. patient information sheets or questionnaires;conduct research e.g. interviewing participants and help to disseminate findings

For further information:

National Institute of Health Research - Public involvement

EKHUFT have a list of “Research Friends”, people who have been involved in trials who have expressed an interest in helping with future trials. https://www.ekhuft.nhs.uk/patients-and-visitors/research-and-innovation-vp0719wot/get-involved/ . If you would like to request help from this group, please contact Jill Baker, Tel 01227 766877, Ext: 722 5932, email: jillian.baker@nhs.net