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, please contact the national NIHR Research Support Service.

The King's College London and partners hub supports research in mental health and brain disorders, across a range of research designs including clinical trials and observational studies.

Research resources

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.

When should I let the research department know about my study plans?

Contact the SPFT research team as soon as you start to put your proposal together.

You must get provisional approval from the Research and Development department (R&D) 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 our Research Governance team at spft.ResearchGovernance@nhs.net.

All studies need to be reviewed by the Pre-Sponsorship Review Panel (PSRP) if they are developed by one of the following organisations: 

  • University of Sussex
  • University of Brighton
  • Sussex Partnership NHS Foundation Trust
  • Brighton and Sussex University Hospitals NHS Trust.

The PSRP will provide feedback and advice to researchers to meet the quality and safety criteria expected by sponsoring organisations. 

The panel will make recommendations of each application for sponsorship to the sponsoring organisation. 

For more information about the PSRP submission and review process see this link or contact psrp@sussex.ac.uk.

Sussex Partnership's Sponsorship Committee meet every six weeks to review and approve recommendations for sponsorship, and to monitor active, sponsored research projects.  

We've developed a research protocol template 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.

Participant information quality standards

In order to improve the quality of information given to people who are invited to take part in research, the Health Research Authority (HRA) have introduced Participant Information Quality Standards and Design and Review Principles which all studies must adhere to from 1st December 2023.

All researchers should familiarise themselves with the guidance available online:  

As part of the Participant Information Quality Standards, Sponsors are encouraged to provide template formats for Participant information sheets. Sussex Partnership NHS Foundation Trust (SPFT) has produced the following templates which can be adapted for use in SPFT sponsored studies.

Public contributors should be involved in the design process to ensure that participant information is relevant and understandable for the intended audience.

Please note: SPFT, in line with many other Trusts, have committed to drop the terms “borderline personality disorder” or “emotionally unstable personality disorder” in favour of using the term Complex Emotional Needs (CEN).

Filter questions and core study information

  • Ensure filter questions are completed correctly as this will impact the questions included further down the application
  • If you wish to apply for inclusion on the NIHR portfolio, please select yes to filter question 5B
  • Include as much practical detail as possible and ensure that this is clear and consistent throughout your application
  • Sponsor – you will need someone to authorise your forms as Sponsor. This is usually the employer of the chief investigator. If this is Sussex Partnership, you should contact the R&D office to discuss the sponsorship approval process.

Research procedures, risks and benefits

  • Obtaining informed consent constitutes a non-clinical intervention and should be listed in A18
  • Include local lone working procedures if researchers will meet participants unaccompanied
  • Consider whether breach of confidentiality may be required if a disclosure needs to be made relating to risk to the participant or others.

Recruitment and informed consent

  • Consider adding consent for contact schemes (such as SPFT’s Everyone Counts scheme and Research Network) as a recruitment strategy – please discuss this with research governance in the first place
  • Consider using the Join Dementia Research website to recruit to Dementia studies
  • Please consider the use of posters, social media and other recruitment routes for the study to reach as wider patient population as needed. Please discuss this with the SPFT Research Delivery team 
  • Medical records cannot be screened by individuals outside of the clinical care team without consent
  • Potential service user participants should always be contacted by the clinical care team in the first instance, unless consent has been provided for contact by another party.
  • Please think about whether it is suitable for your study to be open to participants who do not speak English as their first language and assess if provisions for an interpreter or translator could be utilised
  • Trial Forge has evidence-based resources about improving research design and increasing recruitment and retention to health research studies. Click here for more information about Trial Forge.

Confidentiality

  • Research data must be kept for 10 years in line with Trust policy
  • If you will be emailing personal data you must use secure pathways or encryption services. Please contact research governance if you need further advice on this
  • If you will need to share large amounts of information with other organisations, get in touch with research governance as soon as possible to implement a secure solution for sharing the information
  • Personal data should be kept only as long as is necessary and should be stored securely in a locked cabinet on secure premises or on a secure network.
  • Research data should be stored separately to personal data.

Publication and dissemination

  • Registering research – interventional research should be registered on ISRCTN. Non-interventional research can be registered free at clinicaltrials.gov
  • Dissemination plan – SPFT have produced a guidance document to support the development of your dissemination strategy. This should be considered early on and detailed in your IRAS application.

Management of the research

  • Be realistic about start and end dates, update these if you experience delays in set-up. This will reduce the needs for amendments once the study has commenced
  • Add the use of Participant Identification Centres by selecting yes to A73-1 even if you do not plan to use them from the outset. This will allow their set-up at a later time point if desired, without submission of an amendment. Please contact the governance team if you think that you will be using PIC sites.
  • Indemnity will be provided by the sponsoring organisation.

Supporting documents

  • There is a checklist on IRAS for the documents you need to submit with this form to the Health Research Authority.
  • Ensure all documents are dated, version controlled, and include the IRAS number. Documents should also include page numbers.

Participant Information sheet

  • The HRA has provided a template wording to include on Participant Information Sheets about the use of personal data. This can be found here 
  • Participant Information sheets for service users should include the details for the local Patient Advice and Liaison Service
  • Please use lay language in the Participant Information Sheet

Consent form

  • Please ensure the consent form includes the option to be contacted about further research opportunities and to be contacted with information about the findings of the study. 
  • Please Include consent for audio/video recording if this is being used.

Demographics questionnaire

  • SPFT collects anonymous demographic data about all research participants. The demographics questions can be included in your study materials if you would like to analyse the data. Otherwise the questionnaire can be provided separately to your research data collection and will not form part of your IRAS application.

If you would like to download our document listing these top tips, please click here.

Grant application and calculating finances

Please contact us as early as possible in the development of your grant application. We can help you to calculate the finances for your project. 

Email: spft.researchgovernance@nhs.net

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@sussex.ac.uk.

How to write a successful funding application

You can start by seeking advice early on: 

  • Contact the NIHR Research Support Service, which offers free advice and support to NHS researchers to develop competitive funding applications for health, public health and social care research.
  • Ask a lay review panel to assess your application through the NIHR Research Support Service or one of SPFT’s Lived Experience Advisory Panels
  • Apply for a patient and public involvement (PPI) grant to support PPI consultation on design.
  • Attend an NIHR training workshop on preparing funding bids. 
  • Check the funder's scope criteria – is your research topic relevant?
  • Read the funder's guidance notes for the specific competition to which you are applying very carefully
  • Refer to the R&D checklist developed for preparing NIHR RfPB applications (but is fit for purpose with most funding applications).

Sources of funding

A popular source for funding is the NHS research funding body, the National Institute of Health and Care Research (NIHR), who offer:

  • There are a broad range of research funding opportunities available. The National Institute of Health and Care Research (NIHR) funds a great deal of research we do in SPFT. They offer research fellowship opportunities for certain clinicians with salary backfill available here. This includes clinicians with little or no previous research training or experience through to clinicians with extensive research experience.
  • NIHR also offer an Associate Principal Investigator (PI) Scheme. This is a national initiative designed to support the development of Early Career Researchers in the field of clinical research. It provides healthcare professionals with the opportunity to gain hands-on research experience by working closely with a study’s Principal Investigator (PI) on NIHR portfolio studies. The scheme is particularly beneficial for those looking to understand the practicalities of trial delivery, with a structured six-month training period with includes defined learning outcomes. Participants are expected to take on responsibilities within a study, such as recruitment and data collection, under the supervision/mentorship of an experienced PI. Upon completion, individuals are awarded formal recognition from the NIHR, which can support future career progression in clinical research. If you would like to find out about SPFT studies that you could potentially join as an Associate PI please email spft.researchgovernance@nhs.net

You can find a list of funders below or use a funding search engine such as RDInfo or ResearchProfessional.com. Sign up for their news feeds to get regular updates on calls for applications.

Funding search engines

List of Funders

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. Conduct 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:

  1. NIHR Research Support Service and in particular this video on Identifying gaps in current research
  2. 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.
  3. Controlled trials which lets you search national and international clinical trial registration sites.
  4. WHO Trial Search: searches through a wide set of databases.

Helpful information to help you work out what questions to ask to when testing a new intervention:

Sussex Partnership is a leading mental health trust in the research we do. We are keen to support staff working in the Trust, with an interest in research, to develop their research skills, experience and activity. Support is available for all staff, regardless of previous research experience – no experience is necessary! Please read the following and scroll down to download

  • a useful guide on the processes for researching at Sussex Partnership and
  • a Research Proposal form for you to complete and return to us.

We want to ensure that research in Sussex Partnership is a positive experience for everyone – research participants and their friends/families, our staff and services and for the researchers themselves, including trainees, students and supervisors. We also want to ensure that findings from SPFT research make a meaningful difference to people who use services in SPFT but also more widely across the UK and potentially beyond, their friends/families and to staff and services. For this to happen, individual research studies need to be part of a larger research programme as it is unusual for a single research study to have a meaningful impact.

In practice, this means that if someone is keen to research in SPFT (that is, hoping to recruit SPFT service users, their friends/family or SPFT staff), either as a lead researcher or as a research supervisor (i.e. having a formal role of supervising a trainee or student to complete a research study as part of their course), they need to commit to developing a wider research programme around the topic area, or contributing further to an existing topic area, with a commitment to publish research findings and ensure they are disseminated widely to maximise impact. This could include, for example, committing to conducting a series of linked research studies or supervising a succession of linked student/trainee research projects (e.g. Major Research Projects for trainee clinical psychologists), the published findings from which can make a meaningful difference in the Trust and beyond. We also hope that this will provide preliminary data to support applications for research funding in future, that the research department can support. Researchers and research supervisors at an earlier stage of their research journey will also be asked to join our Early Career Researcher programme so that they can access relevant support and training as they develop and enhance their research skills.

If you are employed by SPFT and you are interested in finding out more about researching in the Trust, please read through the following:

Is my project research?

  • Here is a useful decision tool for deciding whether or not a project hoping to recruit SPFT service users, friends/families or staff is research and would therefore require NHS research approval and approval from the SPFT research team: https://www.hra-decisiontools.org.uk/research/
  • Further information on conducting service evaluation, audit or quality improvement projects in the trust can be found by contacting the Quality Improvement Team at email: spft.qist@nhs.net as these are not covered by the research department.
  • If you are planning a specific research study yourself that would involve recruiting SPFT service users, their friends/family or staff, or if you are hoping to supervise someone else (e.g. a trainee or student) it is vitally important that you contact the Research Governance team right at the start of the planning process at spft.researchgovernance@nhs.net with a completed copy of the proposal form (see below). This should be when you have a general idea for a research study (including a research study you are hoping to supervise) but well before you or others have invested time in the project or started applying for ethical or other approvals. 

Funding opportunities

There are a broad range of research funding opportunities available.

  • The National Institute of Health and Care Research (NIHR) funds a great deal of research we do in SPFT. They offer research fellowship opportunities for certain clinicians with salary backfill available.  This includes clinicians with little or no previous research training or experience through to clinicians with extensive research experience.
  • NIHR offer funding for specific research projects through a number of funding streams
  • NIHR also offer an Associate Principal Investigator (PI) Scheme. This is a national initiative designed to support the development of Early Career Researchers in the field of clinical research. It provides healthcare professionals with the opportunity to gain hands-on research experience by working closely with a study’s Principal Investigator on NIHR portfolio studies. The scheme is particularly beneficial for those looking to understand the practicalities of trial delivery, with a structured six-month training period with includes defined learning outcomes. Participants are expected to take on responsibilities within a study, such as recruitment and data collection, under the supervision/mentorship of an experienced PI. Upon completion, individuals are awarded formal recognition from the NIHR, which can support future career progression in clinical research. Click here for further information. If you would like to find out about SPFT studies that you could potentially join as an Associate Principal Investigator, please email spft.researchgovernance@nhs.net
  • The NIHR Principal Investigator Pipeline Programme (PIPP) is a similar programme to the one above but targeted specifically at developing Nurses & Allied Health Professionals to become Principal Investigators (PIs) within the NHS. It is designed to equip aspiring PIs from these professions with the knowledge, skills, and confidence needed to lead high-quality clinical research. Through a combination of structured training, support/mentorship, and practical experience, participants are guided through the key responsibilities of a PI, including study setup, regulatory compliance, team leadership, and patient recruitment. Please click here for further information. If you would like to find out about SPFT studies that you could potentially join as an Associate PI on the PIPP scheme please email spft.researchgovernance@nhs.net 
  • The NIHR Applied Research Collaboration in Kent, Surrey and Sussex (ARC KSS) has a learning academy to support the development of researchers, with a focus on Early Career Researchers. They have plenty of resources, training opportunities and information on their website which you can see here
  • You can also find out more guidance for researching in SPFT in our advice for research section: Research and Development web pages.

Process guide and research proposal form

PPI stands for Patient, Public and Carer 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 and our studies are shaped by our Lived Experience Advisory Panels, where people with lived experience work alongside the research team.

The impact of PPI on research

One of our researchers, Professor Kathryn Greenwood talks to Lucy Walsh, PPI coordinator, about the impact of 'PPI' on her research. Find our more on our YouTube channel.

Get in touch

Get in touch via email at: spft.involvementinresearch@nhs.net at an early stage for advice.

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:

Planning my analysis and deciding which statistical analysis to use on my data

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.

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.bibby-jones@nhs.net who is the R&D team statistician.

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.

Participant information quality standards

In order to improve the quality of information given to people who are invited to take part in research, the Health Research Authority (HRA) have introduced participant information quality standards and design and review principles, which all studies must adhere to.

All researchers should familiarise themselves with the guidance available online:  

As part of the Participant Information Quality Standards, Sponsors are encouraged to provide template formats for Participant information sheets. Sussex Partnership NHS Foundation Trust (SPFT) has produced the following templates which can be adapted for use in SPFT sponsored studies.

Public contributors should be involved in the design process to ensure that participant information is relevant and understandable for the intended audience

Top tips from our clinical research coordinators

Our clinical research coordinators 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 other recently accepted 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.bibby-jones@nhs.net.

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.

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:

  1. Articles must be immediately, freely and openly accessible to all
  2. There should be no barriers to the re-use and dissemination of NIHR funded articles
  3. Articles must be freely discoverable
  4. NIHR will pay reasonable fees to enable immediate open access.

NIHR have provided guides and checklists to support compliance.

Inclusion in research

Our vision for the research department is to facilitate an inclusive environment where everyone feels welcomed and supported to participate.

We embrace diversity and ensure all voices are heard in our research and our goal is to make research widely known, inclusive, and innovative research for everyone. By being warm, accessible, and proactive, we bring research directly to patients, carers, and families in every community. Led by Dr Anna-Marie Bibby-Jones, Research Inclusion Lead, our research department has a live, evolving, and co-produced Equality, Diversity & Inclusion (EDI) strategy that shapes our work. Our EDI research working group meets quarterly to review our progress in meeting our objectives.

Our objectives are to:

  1. Increase networking and strengthen connections

  2. Regularly monitor and evaluate our EDI activities

  3. Use and find appropriate resources to facilitate accessibility and inclusivity initiatives

  4. Improve communication and accessibility of our research information

  5. Improve the knowledge and confidence of the research team around EDI barriers and facilitators

  6. Achieve a more diverse R&D staff team

  7. Improve our community engagement

  8. Ensure EDI is more regularly integrated into R&D policies and protocols

  9. Raise awareness of research and reduce stigma of mental health research affecting different communities

  10. Be a leader for EDI in research.

Actions to meet these objectives include:

  • Championing inclusive research through accessible materials, diverse recruitment, inclusive study design, and meaningful community engagement.
  • Collaborating with advocacy and learning disability lived experience groups, co-produced outreach materials with LGBTQ+ communities and minoritised ethnic groups, and active participation in the Sussex Diversity in Research Engagement Network (REN).
  • Co-production of EDI training, which has been adapted and delivered across partner institutions.

Resources to support EDI in research

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. Start by using the National Institute for Health and Care Research (NIHR) EDI toolkit here.

There are a number of organisations who offer language support to enable research access and involvement.

Sussex Interpreting Services is a charity working with communities to ensure equitable access to health and social care and research. Resources include:

New guidance to improve inclusion of adults with a learning disability in research

Researchers and experts by experience have been working together to include adults with learning disabilities in their research studies. It was evident that comprehensive guidance was necessary to enhance the inclusion of individuals with learning disabilities.

Sussex Partnership worked alongside Kent and Medway NHS and Social Care Partnership Trust, Kent Community Health NHS Foundation Trust, University of Kent and Bemix. Together with insights from experts by experience, to produce three short films highlighting best practice. These valuable resources are now available to view and are accompanied by two sets of succinct guidance - one of which was created using Easy Read format. 

The project, led by Dr Anna-Marie Bibby-Jones, Equality, Diversity & Inclusion in Research Lead for Sussex Partnership, will increase awareness of how to include people with a learning disability (and also neurodiversity). The project was funded by the National Institute of Health and Care Research Clinical Research Network Kent, Surrey & Sussex (NIHR CRN KSS) who will share these resources nationwide.

The project explored what people with learning disabilities think are the barriers that stop them accessing research and how to overcome those barriers. 

Film resources

Written guidance

The group has also produced a guidance document, which is also available in easy read version:

Easy Read versions of participant information sheet

We recently completed some work with Team Springwell to develop easy read versions of a participant information sheet and consent form for the GIVE 3 study, which is testing if a short form of cognitive behavioural therapy helps people with psychosis . They are provided here as an example of good practice in co-producing easy-read participant documents.

5% of people in Sussex are LGBTQ+, but this isn't always represented in our research participants.

We've produced an animation to increase awareness of research opportunities in Sussex and to encourage people to sign up to our Research Network to find out more.

We would like to thank Be The Fox, who kindly created this artwork in support of the NHS.

Click here to see our short film.

We have created the PPI Youth Café, to give young people a space to have a real input within current mental health research that affects them. We try to meet once a month with researchers to discuss their projects. We have two cafes:

  • one for 16–25-year-olds and
  • one for 11-15 year-olds

Read more about the Youth PPI Cafe here

E: spft.involvementinresearch@nhs.net

Instagram: @theyouthppicafe

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