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Research compliance

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

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.

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).

 

Name of Research StudyTitle of studyReference Number
PRODIGY 1 [Feasibility Study]​Prevention of long term social disability amongst young people with emerging signs of severe mental illness: a pilot randomised controlled trial of social recovery cognitive behavioural therapy for young people with emerging severe mental illness.​​106548 (pre-HRA record)


[Study now in final follow-up phase. Full RCT sponsored by Sussex Partnership NHS Trust] ​
MOREThe Recovery Project: What does recovery mean to young people who have experienced mental health difficulties?221356
Aware'Employment; making it work': a qualitative phenomenological inquiry into the lived experience of Adults diagnosed With Attention Deficit Hyperactivity Disorder (ADHD) Employed by the NHS. The 'AWArE' study188886
TRACCThe demenTia Research And Care Clinic (TRACC)205788
iCARE wp1Towards Integrated support: The role of carer- and patient-level characteristics on family CARER quality of life at different stages of dementia (iCARE)225765
Secure EnvironmentsHow do Psychologically informed Planned environments (PIPEs) contribute to the integration of desistance narratives in personality disordered offenders?217860



 

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.


Non-NSFT Sponsored Research Studies (Aug 18)

Educational/Student Studies (Aug 18)


NSFT 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 rdofficemailbox@nsft.nhs.uk.  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. 


 

SOP # Short Title Date Approved Published Download
R&D001

Confirming research Capacity and Capability

24/11/2016 01/01/2017

RD001

 

R&D003 Research Integrity, Fraud and Misconduct 29/06/2017 01/07/2017

RD003

R&D005 Conducting Clinical Trials of Investigational Medicinal Products 26/06/2017 01/07/2017

RD005

R&D008 Research Trial Management: Trial Master Files and Site-Specific Files 27/04/2017 01/05/2017

RD008

R&D009 Research Auditing and Monitoring Procedures 27/04/2017 01/05/2017

RD009      ​

R&D012 Gaining Valid Informed Consent from Participants for the Purpose of Research Studies 28/06/2018 01/07/18

RD012 ​

R&D013 Research Study Close-down and Archiving Procedures 28/06/2018 28/06/2018

RD013

R&D016 v2.2 Research Adverse Event and Safety Reporting Procedures


28/06/2018 01/07/2018

RD016


Guidance:
SAEguidance

SAE Form:
SAEform

R&D029 Income Distribution from NIHR Adopted Industry Sponsored Studies 27/10/2016 01/11/2016

RD029

 
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 Initiating Q1 2018-2019

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 2016-17
Performance 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 Q1 2018-19

Performance in Delivering Q4 2017-18

Performance in Delivering Q3 2017-2018

Performance in Delivering Q2 2017-2018

Performance in Delivering Q1 2017-2018

Performance in Delivering Q4 2016-17
Performance 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

Performance in Delivering Q1 Q2 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 legislation​


 

UK Policy Framework for Health and Social Care Research​


 

Approving research under MCA section 34


 


 

MRC ethics guides

Children


Informed Consent for Adults lacking capacity​


 

Research Quality Service
To 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).