Protecting your data

Research and General Data Protection Regulations (GDPR)

Health and care research may be exploring prevention, diagnosis or treatment of disease, which includes health and social factors in any disease area.

All NHS organisations (including Health & Social Care in Northern Ireland) are expected to participate and support health and care research. The Health Research Authority (HRA) and government departments in Northern Ireland, Scotland and Wales set standards for NHS organisations to make sure they protect your privacy and comply with the law when they are involved in research. In addition, research ethics committees review research studies to make sure that the research uses of data about you are in the public interest, and meet ethical standards.

Find out how the Trust will collect and process your data for research purposes, plus the legal basis for collecting and using your information for research.

Managing Your Information - A Guide for Research Participants

The Health Research Authority has also produced guidance for the use of data for Research Purposes.

Information about Research Studies and Data

As an NHS organisation 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 is 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 will 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 wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).

Our Data Protection Officer is Richard Green and you can contact them at dataprotectionofficer@nsft.nhs.uk

Research may be sponsored by companies developing new medicines or medical devices, NHS organisations, universities or medical research charities. The Research Sponsor (the Data Controller) decides what information will be collected for the study and how it will be used.

Research Studies (Either recruiting new participants or in follow-up) for which NSFT is not the Research Sponsor/Data Controller but where NSFT Data is being directly or indirectly processed and shared for Research Purposes can be found below. 

To find out more about how your Data is being used in these studies, please contact the relevant Organisation listed in the below documents:

NSFT Research Operating Capability Statement

NSFT Research has an R&D Operational Capability Statement, endorsed by the Trust Board of Directors, which outlines our organisational capacity to undertake research:

NIHR B01 RnD Ops Capability May 2011

NIHR PID Reporting Data

The Government wishes to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical trials. In 2013 the NIHR requested that providers of NHS services publish outcomes of clinical trial research against certain benchmarks. From October 2014, the NIHR funding to providers of NHS services became conditional on the reporting of and meeting the two benchmarks of:

  • Recruiting the first patient within the 70 day time period from submission of the study
     
  • Delivery against the recruitment target agreed for the NSFT site.
     

The performance below reflects studies which are considered to be interventional or clinical trials only.

Performance in Initiating: Clinical Trials:

Performance in Delivering: Commercial Studies

MRC ethics guides

Research policies

At NSFT Research, we have developed the following policies about setting up and conducting clinical research in the Trust.

Policies are in PDF format, and contain templates for use by researchers. Editable version of templates are also available from research@nsft.nhs.uk.  Further guidance about conducting research in practice is available on the 'For Researchers' section of the website. 

  • Confirming research Capacity and Capability This standard operating procedure (SOP) was approved on 24 November 2016 and published on 1 January 2017. Download RD001
  • Research Integrity, Fraud and Misconduct This SOP was approved on 29 June 2017 and published on 1 July 2017.   Download RD003 
  • Conducting Clinical Trials of Investigational Medicinal Products This SOP was approved on 26 June 2017 and published on 1July 2017  Download RD005 
  • Research Trial Management: Trial Master Files and Site-Specific Files This SOP was approved on 27 April 2017 and published on 1 May 2017 DownloadRD008 
  • Research Auditing and Monitoring Procedures This SOP was approved on 29 July 2021 and published on 27 August 2021  Download RD009
  • Gaining Valid Informed Consent from Participants for the Purpose of Research Studies This SOP was approved on 28 June 2018 and published on 1July 2018  Download RD012
  • Research Study Close-down and Archiving Procedures This SOP was approved on 29 July 2021  and published on 27 August 2021  Download RD013
  • Research Adverse Event and Safety Reporting Procedures This SOP was approved on 28 June 2018  and published on 1 July 2018  Download RD016  SAE Form: SAEform SAE guidance: SAEguidance
  • Income Distribution from NIHR Adopted Industry Sponsored Studies This SOP was approved on 27 October 2016  and published on 1 November 2016  Download RD029 

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