Code A: Annex C - Consent requirements

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

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

 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

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

• 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

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