Code A: Section one - Guiding principles

11. The HTA’s existence and approach are founded on four guiding principles. These principles are derived from the HT Act, explicitly or implicitly, and actively inform our overall approach to regulation, our Codes of Practice, and our licensing Standards. The HTA believes that these principles should inform the actions of anyone involved in using materials originating from people, and therefore anyone undertaking activities falling within the remit of the HTA must give them due regard. Where the principles refer to tissue, they apply equally to entire organs.

12. Consent and the wishes of the donor, or where appropriate their nominated representatives or relatives¹ have primacy when removing, storing, and using human tissue. This means:

• human tissue, or bodies of the deceased, should be used in accordance with the expressed wishes of donors or their relatives
• donors and their relatives should be given the information they need to be able to make a decision that is right for them
• those seeking consent should do so with sensitivity and an appreciation of the particular circumstances in each case

13. Dignity should be paramount in the treatment of human tissue and bodies. This means:

• the dignity of the donor should be respected at all times;
• there should be mechanisms in place to protect bodies and human organs and tissue from harm;
• the privacy of the individual should be maintained;
• the disposal of human tissue should be managed sensitively and the method of disposal should be appropriate to the nature of the material;
• disposal of human tissue from the deceased should, where possible, be in line with their wishes, if known, or the wishes of the deceased person’s relatives;
• where human tissue is imported, importers should endeavour to ensure that it is sourced from a country that has an appropriate ethical and legal framework.

14. Quality should underpin the management of human tissue and bodies. This means:

• practitioners should be competent, have undertaken appropriate training and work with care in accordance with good practice and other relevant professional guidance;
• practitioners’ work should be subject to a system of governance that ensures the appropriate and safe storage and use of human tissue and which safeguards the dignity of the living or deceased;
• premises, facilities and equipment should be clean, secure and subject to regular maintenance;
• proper and accurate records and information should be maintained to ensure full traceability of human tissue and bodies of the deceased and donor tissue;
• patient data should be held securely and confidentially.

15. Honesty and openness should be the foundation of communications in matters pertaining to the use of human tissue and bodies. This means:

• communication with a donor, or person from whom consent is being sought, should be open, honest, clear and objective;
• serious incidents involving human bodies and tissue should be subject to rigorous investigation to ensure that lessons are learned and the risk of reoccurrence is minimised;
• establishments should adopt a policy of candour and transparency when dealing with serious incidents, as well as meeting their other, statutory and professional, duties of candour where appropriate;
• discussions about medical investigation or treatment are kept entirely separate from discussions relating to consent for scheduled purposes;
• establishments should be open and transparent in relation to arrangements for charging and reimbursement.

Detailed practical guidance on the application of these principles is available in the HTA’s sector-specific Codes and licensing Standards.

1. Throughout the Codes, the term ‘relatives’ should be taken to include a spouse or partner and, in cases where there are no relatives, close friends of the deceased person. Decisions regarding consent should be made according to the hierarchy of qualifying relationships as set out in the HT Act