Resource index: Data

All:

Approvals

• NHS Information Centre: Medical Research Information Service

  The Medical Research Information Service provides health information to support medical researchers.

• Privacy Advisory Committee for Scotland

  Web site on PAC remit, application process and Information Statistics Division

• Privacy Advisory Committee for Scotland application form

  Link to PAC application form

Audit

• Information Commissioner's Office Guidance on Data Protection Audits (pdf)

  For all organisations holding identifiable personal data.

Confidentiality

• BMJ article: Confidentiality of personal health information used for research

  MRC Consent and Confidentiality group BMJ article by Dipak Kalra, Renate Gertz, Peter Singleton, Hazel M Inskip, BMJ 2006;333:196-198 (22 July). BMJ.com Extra: Tips for managing confidentiality.

• MRC Ethics Series: Personal Information in Medical Research

  Section 5: Safeguarding Confidentiality.

• NHS Code of confidentiality

  Department of Health guidance on disclosure.

• NHS Information Governance Toolkit

  NHS standards, applicable for all organisations holding identifiable data

• NIGB Section 251 security arrangements; access to System Level Security Policy

  Applications to use section 251 powers will need to complete a System Level Security Policy to provide proof of suitable security arrangements (scroll to fifth of page).

• Templates for confidentiality letters and agreements (doc)

  Three templates developed by the Confidentiality working group of the MRC Consent and Confidentiality project.

  Confidentiality agreements templates (56KB)

Consent (Data)

• AMS - Personal data for public good

  The Academy of Medical Sciences report - Personal data for public good: using health information in medical research.

• Association of the British Pharmaceutical Industry guidance

  Guidelines for the secondary uses of data for medical research purposes.

• BMJ article: Consent for the use of personal medical data in research

  MRC Consent and Confidentiality group BMJ article by Peter Singleton and Michael Wadsworth, BMJ 2006;333:255-258 (29 July).

• British Medical Association guidance

  Guidance on Secondary Uses of Patient Information.

• Connecting for Health: CRDB secondary uses report

  Report of the Care Record Development Board Working Group on the Secondary Uses of Patient Information.

• MRC Ethics Series: Personal Information in Medical Research

  Section 3: covers the complex legal environment surrounding consent.

• MRC Ethics Series: Personal Information in Medical Research

  Section 8: Information and consent forms.

• MRC Ethics Series: Personal Information in Medical Research

  Annex 3: The Data Protection Act 1998.

• MRC Guidance: Consent for Consent (pdf)

  Draft MRC guidance offering recommendations and drawing together existing guidance on accessing identifiable patient information without consent.

  MRC draft guidance Consent for Consent (54KB)

• Patient Information Advisory Group leaflet (pdf)

  Information about patients: An introduction to the Patient Information Advisory Group for health professionals and researchers.

Consent and Confidentiality (Data)

• Academy of Medical Sciences, University of Cambridge legal symposium (pdf)

  Report of symposium held to discuss the legal issues raised in AMS report, Personal Data for Public Good: Using Health Information in Medical Research.

• BMJ article: Balancing potential risks and benefits of using confidential data

  MRC Consent and Confidentiality group BMJ article by Christina Davies, Rory Collins, et al, BMJ 2006;333:349-351 (12 August).

• Connecting for Health contact details

  Initial enquiry point for access to NHS IT networks.

• Information Commissioner’s Office Guidance

  For organisations that hold identifiable data.

• MRC Ethics Series: Personal Information in Medical Research

  Section 2: Principles for working with identifiable personal information.

• NHS Information Centre: MRIS application flowchart

  Flowchart to help you with the process of applying to MRIS.

• NIGB - Ethics & Confidentiality Committee Applications

  Guidance for applications to the NIGB's Ethics & Confidentiality Committee who are responsible for providing section 251 approval to set aside the common law duty of confidentiality.

• NIGB - National Information Governance Board

  The National Information Governance Board for Health and Social Care (NIGB) is responsible for Section 251 of the NHS Act 2006 in England and Wales; and reviews applications for use of identifiable data where consent is not practicable.

Data

• Code of Practice to protect service user confidentiality (N. Ireland)

  Code of Practice to protect service user confidentiality (N. Ireland)

• HESonline

  Hospital Episode Statistics (HES) is the national statistical data warehouse for England of the care provided by NHS hospitals and for NHS hospital patients treated elsewhere. HES is the data source for a wide range of healthcare analysis for the NHS, government and many other organisations and individuals.

• NHS IC recommended participant information form wording

  NHS Information Centre recommended participant information form wording.

• NHS Information Security Management: NHS Code of Practice

  NHS Information Security Management: NHS Code of Practice

Data Sharing

• MRC Ethics Series: Personal Information in Medical Research

  Section 7.2: Re-use of data by third parties.

• MRC Ethics Series: Personal Information in Medical Research

  Section 7: Storage and re-use of data.

• Ministry of Justice: Data Sharing Review

  Link to the Data Sharing Report and recommendations by Richard Thomas and Mark Walport.

Information to participants

• Information Commissioner's Office Checklist (pdf)

  For organisations handling access requests.

• MRC Ethics Series: Personal Information in Medical Research

  Section 6.2: Feedback and publication.

Public/Patient Involvement

• INVOLVE leaflet for Public involvement in research grant applications (pdf)

  INVOLVE guidelines for researchers interested in public involvement in preparing grant applications.

• INVOLVE website

  INVOLVE promotes public involvement in NHS, public health and social care research, and provide useful advice on how to involve members of the public in research activities.

• Patient Information Advisory Group leaflet: Using patient information and involving service users in research (pdf)

  PIAG guide outlining what user involvement in research is, its importance, the methods and what is appropriate for individual studies.

Risk Management and Monitoring

• MRC Guidance: Health and Safety A Practical Guide for Research Involving the Public (pdf)

  An MRC publication giving advice about how to reduce the potential risks to research staff and the public.

• MRC Guidance: Risk Management in Public Health Research (pdf)

  MRC guidance tool, outlining potential risks and strategies for managing and monitoring such risks (developed for MRC units, also applicable to others).

  MRC Guidance Risk management in public health research (114KB)