Guidance for researchers
If you have an idea for mental health or dementia research and you need support with the development of your proposed research design, or support to write a strong application, we can help.
Dr Anna-Marie Bibby-Jones is a statistician jointly funded by Sussex Partnership and the Research Design Service. Her role is to enhance the collaboration between the two organisations and recommend how to strengthen future grant applications, based on critiquing past research designs.
Anna can offer ongoing help and advice, from idea development to application submission for those seeking funding for applied health and social care research.
The Research Design Service offers free, confidential and tailored advice for those seeking funding for applied health and social care research.
Please contact us as early as possible in the development of your grant application.
For grants where one or more applicant is based at either University of Brighton or University of Sussex, please also email the Brighton and Sussex Joint Clinical Research Office at: jcro
There are so many things to consider when you're starting out on your research project so we've answered some frequently asked questions and provided useful resources below to help you make sure you are on the right track.
For research advice, please get in touch: anna-marie.
We've developed a research protocol template [link to Research protocol.doc] which covers the core elements of what's needed in your research application. Work through the template, starting with the information you put in your funding application and build it up from there with a higher level of detail.
It's good practice to publish your research protocol - a quick and easy way to get a publication early on in your project is via Trials
A popular source for funding is the NHS research funding body, the National Institute of Health and Care Research (NIHR), who offer:
- A funding stream called Research for Patient Benefit (RfPB) which is for clinicians wanting to do research
- Other funding streams and alternative sources of funding including Wellcome Trust and the British Academy.
You can find a list of funders below or use a funding search engine such as RDInfo or ResearchProfessional.com. Sign up for their RSS news feeds to get regular updates on calls for applications.
Funding search engines
- ResearchProfessional.com (BSMS, Brighton University and Sussex University staff and students all have access)
- RDInfo (free!)
- University of Sussex
List of Funders
- Age UK
- Arts and Humanities Research Council (AHRC)
- Alzheimer’s Society
- Kent, Surrey & Sussex Applied Research Collaborative (ARC)
- British Academy
- British Heart Foundation
- Dunhill Medical Trust
- Economic and Social Research Council (ESRC)
- Leverhulme Trust
- Medical Research Council (MRC)
- Mental Health Research
- MQ Health
- NIHR (National Institute for Health and Care Research)
- Research Councils UK
- Royal Society*
- The Health Foundation
- UK Clinical Research Collaboration (UKCRC)
- UK Research & Innovation
- Wellcome Trust
Knowing where to begin on your research journey can be tricky, to simplify this stage, use resources such as the Kent, Surrey & Sussex Applied Research Collaboration (ARC), Research Design Service, Clinical Research Network Interactive Learning Resource. This resource covers three levels: understanding research, getting involved in research, and developing your research. Go at your own pace and discover the different research paths available to you.
Funders will only fund research studies that are answering a novel, important research question. Sometimes we think up research ideas and then find that someone else has done the study we wanted to do! It can be difficult to know for sure that your research idea is completely new but there are some simple steps and some resources available online to help you find out what you need to know.
A good place to start is by talking to other researchers, clinicians and experts in the field. Conducting a basic literature search using engines such as PubMed, Medline, Nice Evidence or Web of Science with keywords; ask for help from your librarian. Don’t forget to check the ‘grey literature’ including conference presentations and publications from relevant research groups.
To check if your research idea is novel, try using websites such as:
- Research Design Service and in particular this video on Identifying gaps in current research
- For NIHR funded projects try searching through the UKCRN portfolio
- NIHR Journals library comprises a suite of five open access journals providing an important and permanent archive of research funded by the National Institute for Health Research.
- Controlled trials which lets you search national and international clinical trial registration sites.
- WHO Trial Search: searches through a wide set of databases.
Contact R&D as soon as you start to put your proposal together.
You must get provisional R&D approval for your research before you start preparing your funding application.
This provisional approval is to say that the R&D department are willing, in principle, to support your study. It's not uncommon that R&D are unable to grant this, so, to avoid disappointment it is crucial that you seek provisional approval right from the start. Bear in mind that once your study is funded you will first need to obtain formal NHS research ethics and R&D approval before starting your study. The R&D department can provide you with guidance throughout the process.
For information about the support that is available to you, email Yvette Wagner (Research Governance Lead) at ResearchGovernance
You can start by:
- Seeking advice early on.
- Requesting support from the NIHR Research Design Service (RDS) SE which offers free advice and support to NHS researchers who are developing applications to suitable funders such as NIHR or Medical Research Council.
- Asking a lay review panel to assess your application through the NIHR RDS SE or one of SPFT’s Lived Experience Advisory Panels
- Applying for a patient and public involvement (PPI) grant to support PPI consultation on design.
- Attending an NIHR training workshop on preparing funding bids. A range of research information about training, workshops, news, funding deadlines or national and local events is available via the NIHR Research Design Service South East e-bulletin each month. Sign up for regular bulletins.
- Checking the funder's scope criteria – is your research topic relevant?
- Reading the funder's guidance notes for the specific competition to which you are applying very carefully
- Referring to the R&D checklist developed for preparing NIHR RfPB applications (but is fit for purpose with most funding applications)
PPI stands for Patient and Public Involvement and the answer is yes you do need to incorporate it into your study. PPI is about doing research 'with' and 'for' patients and service users rather than 'on' and 'to'. For NIHR grant applications PPI work will be expected. At Sussex Partnership we have our own PPI Team.
Get in touch via involvementinresearch
Research is developing to consider different elements of Equality, Diversity, and Inclusion (EDI). We have put together a series of resources to help researchers understand the issues and barriers faced by under-served groups in research, and how to start addressing them. In order to reduce inequalities in health and care outcomes, our research studies need to embrace EDI.
- No acronyms
- No jargon
- No technical terms
- Use of common English words
- Short sentences
- Active phrases.
A plain English summary must be submitted as part of an NIHR funded application. Here is some helpful guidance.
For help calculating the finances for your project contact our R&D Governance team: ResearchGovernance@spft.nhs.uk
A feasibility study is testing whether your main study can be done and you would conduct this if you had a lot of unknowns, e.g. no effect size on which to carry out a sample size calculation, no primary outcome, or if you are unsure whether people would be willing to be randomised to different arms in your study. Importantly, they do not evaluate the outcome of interest, this is left to the main study.
A pilot study is a mini version or test run of your main study to check you haven’t overlooked something in the process that could delay, disrupt, or prevent the full achievement of the research objective. So in, a pilot study you would assess whether your strategies for recruitment, randomisation, treatment, and follow-up assessments were robust.
Two helpful references:
Helpful documents to help you work out what questions to ask to when testing a new intervention:
The R&D team have developed a research protocol template, which covers the core elements of what is needed in a fully informative document. Work through the template and you will have a good recipe for your research project.
It is good practice to publish your research protocol and a quick and easy way to get a publication early on in your project. Use a site like http://www.trialsjournal.com/
These tools can help you write applications, plan and report your findings:
The Health Foundation also has this helpful resource which can be used to report service evaluation and quality improvement projects.
The Health Research Authority (HRA) have an excellent set of guidance on the ethical and legal principles of gaining consent in general, in a paediatric setting and in situations where adults lack capacity.
They also provide Consent and Participant Information Sheet Preparation Guidance as well as listing a number of HRA Examples and Templates for use in your study.
Our Clinical Research Co-ordinators also recommend the following top tips for preparing consent forms:
- Make sure it is concise; some trials can have very long consent forms with a lot of boxes to initial. Although sometimes this may be necessary, it can be hard to get a participant to concentrate if there are two pages of boxes to initial
- Use large fonts for the participant to read it clearly
- Explain the information sharing intentions and when you would share information e.g. if someone is at risk or if the clinical care team need to be informed; explain that no information will be fed back to the participant
- Reference the 2018 Data Protection Act
- Make sure you use lay terms.
- It’s handy to have a space for both the patient identification number and their local Trust ID at the top of the consent form. Although this is not compulsory, it means that if you are searching for their documents a while after you have consented them, you can find them easily and confirm that it is the correct person (e.g. If you consent John Smith and have 400 people on your study then you could have a duplicate and you then have to start searching through recruitment logs to confirm you have the right person).
- Explain that one copy (often the original) will be put in the investigator site file, one will go in the patient’s medical notes and one will be given to the patient. This is a Good Clinical Practice requirement but is often forgotten.
- If you plan to carry out future research based on samples you are taking for this study make this clear – the participant should sign a separate consent form for this.
- Date and include a version number
- You may find it helpful to look at some of the recently accepted other forms as a guide.
Before that can be answered, have you checked that you have got the right research design to answer your research question? If so, other questions will follow before you can attack the sample size calculation such as:
- Is this a feasibility, a pilot or a main study?
- Is this an exploratory study using qualitative methods?
- Are you doing clinical trial, an observational study or developing/refining an intervention for instance?
- Are you developing a new scale or outcome measure?
- What is your primary outcome and how is it distributed? Is there any information on the mean value or standard deviation for your population under similar test conditions?
- What is the minimum clinical difference on your primary outcome measure?
- What is your estimated attrition rate?
- What might the response rate look like?
- How will you analyse your data –simple data summary, compare two means, hypothesis testing?
- What power are you aiming for (most NIHR grants look for 90%)
In your application you must give a justification for your sample size, the reviewer needs to be able to follow your description to make the calculations for themselves.
See these guides:
For advice from a statistician contact anna-marie.
It depends on what type of study you're carrying out and what you're trying to achieve. A feasibility study or a pilot may not need to involve randomisation. But if you are trying to work out if your participants are willing to be randomised, or if your randomisation process will work in practice, then yes you need to randomise.
For a main study, randomised controlled trials are the most rigorous way of determining whether a cause-effect relation exists between treatment and outcome and for assessing the cost effectiveness of a treatment (Kendall, 2003). When you randomly allocate participants to different study arms you are effectively trying to minimise different sorts of bias (e.g. allocation, selection) and increase comparability among groups with various known and unknown confounding factors (WHO) so that, as best as possible, the difference between the treatment groups is the treatment they’ve received.
There's a range of different statistical analyses available to researchers but choosing an appropriate test for your data can be tricky. We have developed this resource map to guide you through your options by asking simple questions about what you want to do.
For statistical methodological support for your application email anna-marie.
Knowing how you'll analyse your data is an importance practice before starting research. It gives a direction and keeps researchers accountable to their methods when they conduct data analysis. To aid this process we have produced a statistical analysis plan (SAP) template and checklist from the most common elements of SAPs from our previous research.
National Institute for Health and Care Research (NIHR) has updated its open access publication policy guidance which applies to all peer-reviewed research articles submitted on or after 1 June 2022. The policy follows four principles:
- Articles must be immediately, freely and openly accessible to all
- There should be no barriers to the re-use and dissemination of NIHR funded articles
- Articles must be freely discoverable
- NIHR will pay reasonable fees to enable immediate open access.
NIHR have provided guides and checklists to support compliance.