GDPR Guidance for Researchers

This webpage has been setup to provide a central repository of up to date information in relation to the General Data Protection Regulations (GDPR) and the Data Protection Act (DPA) 2018 for researchers in Leicester.

It is aimed specifically at researchers who work with data relating to living people and setup by the working group - Leicester GDPR for Research who can be contacted via ctusafety@le.ac.uk

The working group comprises representatives from research and information governance at the:

  • University of Leicester
  • University Hospitals of Leicester
  • Leicester Clinical Trials Unit
  • Leicester Biomedical Research Centre

Research Specific Guidance Notes

The working group have produced and will issue Guidance Notes summarising the changes relating to GDPR and the DPA, specific to research:

  1. Research Guidance Note 1 – GDPR for Research – An Introduction (PDF)
  2. Research Guidance Note 2 – Transparency (PDF)
  3. Research Guidance Note 3 – Safeguards, Subject Rights and Exemptions for Research
  4. Research Guidance Note 4 – GDPR Next Steps for Researchers

Transparency Assessment File Note Template (Word)

Organisational Guidance Notes

The University of Leicester have produced a number of Guidance Notes relating to GDPR generally and accessed via:

https://www2.le.ac.uk/offices/ias/resources/policies/gdpr

Training Material

In-depth training material will be published by the Medical Research Council (MRC) Learning Management System.

A complete set of GDPR resources is also available here:

https://mrc.ukri.org/research/facilities-and-resources-for-researchers/regulatory-support-centre/gdpr-resources

Leicester Clinical Trials Unit provide a training package below relating to the basics of confidentiality, data processing and GDPR.  This is intended as foundation guidance for staff, prior to further GDPR training as above.

The following package was adapted from material kindly shared by Dr Rachel Smith – Programme Manager, MRC:

GDPR for Research - The Basics (PowerPoint)

 

Handouts to go with the package:

HRA - GDPR: Transparency

HRA - GDPR: Safeguards

HRA - GDPR: Data Subjects Rights

 

National Guidance

Guidance has been produced nationally by various research organsations, below are some links:

HRA

GDPR: Guidance

GDPR: Technical Guidance

GDPR: Transparency

GDPR: Safeguards

GDPR: Data Subjects Rights

Transparency Wording: NHS Sites

Transparency Wording: Public Sector Sponsors

Using Confidential Patient Information without Consent (CAG)

 

MRC

GDPR Resources Page

GDPR: What researchers need to know – Blog post for researchers

GDPR - Preparations for implementation guidance note 1: What personal data you hold

GDPR - Preparations for implementation guidance note 2: Current legal situation

GDPR – Preparations for implementation guidance note 3: Consent in Research and Confidentiality

 

NHS Digital

GDPR guidance

GDPR Webinar

 

Information Commissioners Office

Anonymisation Code of PracticeUseful guide to anonymising datasets to remove personal data to ensure it meet the criteria for not being “personal data”

 

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Contact Details

Leicester Clinical Trials Unit
University of Leicester
Maurice Shock Building
University Road
Leicester
LE1 7RH

Tel: +44 (0)116 229 7246

Email: ctu@le.ac.uk