Clinicians and transplant teams are responsible for the overall care of donors and recipients, and for assessing the medical suitability of potential donors. The Regulations require the clinician with responsibility for the donor to refer the matter to the HTA. As part of this referral specific information, certain assurances are required to ensure the legislative requirements are addressed.
This section explains the consent exemptions from the Human Tissue Act (2004) (HT Act).
The following guidance has been produced to bring clarity to the issues surrounding consent for research relating to transplantation where donors are deceased. The Human Tissue Act (2004), The Human Transplantation (Wales) Act 2013 and the Organ Donation (Deemed Consent) Act 2019 all require expressed consent for research activities; deemed consent which applies to transplantation activities in England and Wales does not apply to research activities.
The purpose of this guidance is to set out our policy on human tissue xenografts, whether they are relevant material that fall under the licensing framework of the HT Act 2004 and the consent implications.
This page sets out the legal requirements of the HT Act with regard to consent for post-mortem examination, tissue retention and storage of tissue from the deceased.
Under the Human Tissue Act 2004, the HTA is required to license the storage of relevant material for ‘research in connection with disorders, or the functioning, of the human body’. This requirement applies to the storage of all relevant material, whether it has come from a living or a deceased person, and applies across all of England, Wales and Northern Ireland.
The Human Tissue Act 2004 requires that the removal of tissue from the deceased for research within the scope of the Act must always be licensed, on specified premises, and that specific minimum requirements are met.
This means that if, for example, a person wishes to remove relevant material from a deceased organ donor for research ‘in connection with disorders, or the functioning, of the human body’, the removal must always take place on premises licensed by the HTA for that purpose.