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.
The Human Tissue Authority’s (HTA) role in living organ donation is to ensure that there has been no reward sought or offered for the organ donation and that there is valid consent in place for the removal and use of the organ or part organ for the purpose of transplantation.
From 18 May 2020, the Organ Donation (Deemed Consent) Act 2019 introduces a system of deemed consent for organ and tissue donation in England.
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.
In preparation for ODT establishments considering or planning, for transplantation services to resume, we have created this guidance. This is aimed at transplant centres considering using “clean sites” or alternative hospital premises to their base location in order to resume their transplant programmes.
You will need to inform the HTA of your plans using the contact details at the bottom of the page.
