Research and General Data Protection Regulations (25th May 2018)
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.
For information about how the Trust will collect and process your data for research purposes, plus the legal basis for collecting and using your information for research, please read here.
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
Health and care research should serve the public interest, which means that research sponsors have to demonstrate that their research serves the interests of society as a whole. They do this by following the UK Policy Framework for Health and Social Care Research. They also have to have a legal basis for any use of personally-identifiable information.
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.
Below is a list of current (Either recruiting new participants or in follow-up) Research Studies for which Norfolk and Suffolk NHS Foundation Trust is the Research Sponsor and Data Controller (Please click on study names for link to the HRA web record).
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 Studies - Non Sponsor (June 2018)
NSFT Educational Studies (June 2018)
NSFT Research policiesAt 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
firstname.lastname@example.org. Further guidance about conducting research in practice is available on the Researcher section of the website.
NB Please note that the following Research Policies are currently being revised in accordance with GPDR.
Confirming research Capacity and Capability
NSFT Research Operating Capability StatementNSFT 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 DataThe 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:
The performance below reflects studies which are considered to be interventional or clinical trials only.
Performance in Initiating: Clinical Trials
Performance in Initiating Q4 2017-2018
Performance in Initiating Q3 2017-2018
Performance in Initiating Q2 2017-2018
Performance in Initiating Q1 2017-2018
Performance in Initiating Q4 2016-17Performance in Initiating Q3 2016-17
Performance in Initiating Q2 2016-17
Performance in Initiating Q1 2016-17
Performance in Initiating Q4 2015-16
Performance in Initiating Q3 2015-16
Performance in Initiating Q2 2015-16
Performance in Initiating Q1 2015-16
Performance in Initiating Q4 2014-15
Performance in Initiating Q3 2014-15
Performance in Initiating Q1 Q2 2014-15
Performance in Delivering: Commercial Studies
Performance in Delivering Q4 2017-18
Performance in Delivering Q3 2017-2018
Performance in Delivering Q2 2017-2018
Performance in Delivering Q1 2017-2018Performance in Delivering Q4 2016-17Performance in Delivering Q3 2016-17
Performance in Delivering Q2 2016-17
Performance in Delivering Q1 2016-17
Performance in Delivering Q4 2015-16
Performance in Delivering Q3 2015-16
Performance in Delivering Q2 2015-16
Performance in Delivering Q1 2015-16
Performance in Delivering Q4 2014-15
Performance in Delivering Q3 2014-15
National Research Guidance, Frameworks and Policies [Links to non-NSFT Controlled External Websites]
European directive for Clinical Trial Regulations:
UK Clinical Trial Regulations
An Introduction to the UK Clinical Trial regulations
UK Policy Framework for Health and Social Care Research
Approving research under MCA section 34
MRC ethics guides
Informed Consent for Adults lacking capacity
Research Quality ServiceTo ensure that the research we conduct complies with regulations and codes of practice, the NSFT has a Research Quality Lead role, which oversees research practice in the Trust in the following ways, to help local research teams and service users feel confident the research we conduct:
Training needs analysis: Identifying the need for research related training within the Trust, developing, promoting and delivery of training both internally and externally.
Study set up: To assist on the set up of both portfolio and no portfolio studies within the Trust. This may include advice, support of trial management, informed consent process and trial file set up and management.
Monitoring: To ensure that the legal, national and organisational policies and frameworks are being adhered to. This includes the principle of GCP and Declaration of Helsinki (1964).