Code A: Annex C - Consent requirements

This guidance outlines when consent is required for the storage and use of human tissue under the Human Tissue Act (HT Act).

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Storage and use of living donor tissue:

  • Scientific or medical information gathering that may benefit others
  • Public display
  • Research
  • Transplantation

Deceased donor material:

  • Consent is required for removal, storage and use for any scheduled purpose
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Activities Requiring Consent

Research Activities

When handling living donor tissue for research, consent is recommended where:

  • The research has received ethical approval
  • The tissue samples are non-identifiable

Image usage

Consent is recommended for making and displaying images of tissue samples

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Activities Where Consent is Recommended (Good Practice)

 Living Donor Tissue Storage and Usage

No consent required for:

  • Clinical audit procedures
  • Education or training in human health
  • Performance assessment activities
  • Public health monitoring
  • Quality assurance processes

Other Exempt Activities

  • Coroner's post-mortem examinations
  • Criminal justice purposes
  • Storage and use of existing holdings
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Activities Not Requiring Consent Under the HT Act

While HT Act consent is not required, please note:

  • Common law consent is mandatory for tissue removal from living persons
  • Follow relevant regional guidance:
  • Department of Health guidance on examination/treatment consent
  • DHSSPS Northern Ireland Reference guide
  • Welsh Assembly Government Guide
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Special Considerations for diagnosis and treatment
  • Code of Practice on Post-mortem examination
  • The Cremation (England and Wales) Regulations 2008
  • Section 39 of the HT Act (Criminal justice purposes)
  • General Medical Council guidance on visual/audio recordings
  • Relevant paragraphs in Code A: 68-72, 73-75, 76, 108-110
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Additional reference materials:
  • Multiple consents can be obtained simultaneously for different activities
  • Always refer to the latest guidance and legislation
  • Maintain proper documentation of all consent procedures
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Important notes
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Code A - Annex C - Consent requirements and good practice
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Code A - Annex C - Consent requirements and good practice.pdf
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Code A contents:
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Code A: Introduction
Code A: Section one - Guiding principles
Code A: Section two - The fundamental guiding principle of consent
Code A: Section three - Consent requirements
Code A: Annex A - Legislative background
Code A: Annex A - Legislative background
Code A: Annex B - Consent
Code A: Annex C - Consent requirements
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Download a pdf version of Code A here
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Code A: Guiding principles and the fundamental principle of consent
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