Last updated on 10 Jan 2025

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).

Activities Requiring Consent

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

Activities Where Consent is Recommended (Good Practice)

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

Activities Not Requiring Consent Under the HT Act

 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

Special Considerations for diagnosis and treatment

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

Additional reference materials:

  • 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

Important notes

  • Multiple consents can be obtained simultaneously for different activities
  • Always refer to the latest guidance and legislation
  • Maintain proper documentation of all consent procedures

Code A - Annex C - Consent requirements and good practice

Code A contents:

Download a pdf version of Code A here