Research governance
Our Research Governance team support and advise researchers to meet the requirements of the UK Policy Framework for Health and Social Care Research as well as other relevant standards, policies and legislation.
We're also required to report to the National Institute of Health and Care Research on how we are performing in terms of setting up and recruiting to studies. See our performance data here.
In order to improve the quality of information given to people who are invited to take part in research, the HRA have introduced Participant Information Quality Standards and Design and Review Principles which all studies must adhere to from 1 December 2023.
All researchers should familiarise themselves with the guidance available online:
and
As part of the Participant Information Quality Standards, sponsors are encouraged to provide template formats for Participant information sheets. SPFT have produced the following templates which can be adapted for use in SPFT sponsored studies.
We use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it's in the public interest when we use personally-identifiable information from people who have agreed to take part in research.
This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate.
If you withdraw from the study, we'll keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.
If you have a complaint about how we've handled your personal data, you can contact our data protection officer who will investigate this for you. If you're not satisfied with our response or believe we're processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office.
Contact our Data Protection Team: spft.
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 Partnership's Sponsorship Committee meet every six weeks to review and approve recommendations for sponsorship, and to monitor active, sponsored research projects.
Please download our Research Protocol Template here
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
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