Consent must be obtained and documented by appropriately trained professionals competent in the issues and processes of tissue donation. No coercion or inducement to donate must be applied during the consent procedure. The statutory requirements for consent are detailed in the relevant national legislation, the Human Tissue Act (2004)2 and the Human Tissue (Scotland) Act 2006.3 Further detailed guidance is laid out in the current version of the Human Tissue Authority Code of Practice on Consent4 and in the Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment.5
Living donors must be competent to give consent before donations can be accepted. Where donors are not competent, national legislation and the guidance of the Human Tissue Authority (HTA) must be followed. When a deceased person (while alive and competent) has explicitly consented to donation of organs and tissues then that consent is sufficient for the activity to be lawful. Where the wishes of the deceased are unknown, the Human Tissue Acts rank persons in a qualifying relationship for the purpose of obtaining consent to organ and tissue donation. The consent of the nominated representative or the highest ranking person at the time of death should be sought. In circumstances where this person does not wish to deal with the issue of consent, or is unable to do so, the next person in the ranking order is approached, but it is advisable to record this in the notes.
Consent must cover retrieval, testing, storage, discard and access to medical records. If the tissue may be used for research and development, or teaching, specific consent must be obtained for this as well. Explicit information must be given if tissues are to be retrieved for specific commercial use. Living donors and families of deceased donors must be informed that information relating to the donation will be stored in accordance with the Data Protection Act (1998)6 and may be shared with relevant healthcare professionals.
For deceased donors, information to be supplied to the next of kin regarding various aspects of tissue donation which forms the basis of consent should include the following:
Where the Coroner (the Procurator Fiscal in Scotland) is in legal possession of the body, permission must be requested to undertake the retrieval.