Resource index: All categories

C:

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 (All research)

• BMJ article: Overcoming barriers to recruitment in health research

  MRC Consent and Confidentiality group BMJ article by Jenny Hewison and Andy Haines, BMJ 2006;333:300-302 (5 August).

• Department of Health Reference Guide to consent

  Advice on English law, developed for examination or treatment, many issues are relevant to research.

• GMC Research Guidance

  GMC research guidance on good practice in research and consent to research.

• MRC Ethics Guide: Medical research involving adults who cannot consent

  This guidance aims to set out the general principles for assessing whether individuals have the capacity to consent to participation in research. It also discusses participation in research projects when such capacity is lacking.

• NIHR CRN CC course on taking consent

  Course organised by NIHR Clinical Research Network aimed specifically at clinical research staff who have direct patient contact.

• NRES Guidance: Research involving adults unable to consent for themselves (pdf)

  Includes information on Mental Capacity Act 2005 and Adults With Incapacity Act 2000

• NRES Guidelines for writing Information Sheets and Consent Forms

  These guidelines should be followed for submission to all NHS Research Ethics Committees.

• NRES Questions & Answers to the Mental Capacity Act 2005 (V3)

  NRES guidance in the form of questions and answers

• NRES web page listing guidance on adults unable to consent for themselves

  NRES web page providing links to guidance produced by NRES and Department of Health; and links to the Mental Capacity Act 2005, Adults with Incapacity (Scotland) Act 2000, and associated Regulations.

• University of Kent: Consent checklist

  Tool developed to help with considerations for informed consent.

Consent (Children)

• MRC Ethics Series: Medical Research Involving Children

  Section 5: Children, ethics and the law.

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 (Tissues)

• MRC Ethics Series: Human Tissues and Biological Samples for Use in Research

  Section 6: Consent.

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.