The HTA has reviewed the current template referral letter to promote greater consistency, reduce variability, and to ensure that all referral letters contain relevant donor information in line with the requirements of the Montgomery judgment.
As part of the review, we have also taken the opportunity to make some other changes.
The Human Tissue Authority (HTA), on behalf of Scottish Ministers, is responsible for assessing all living organ donation cases that take place in Scotland. The HTA also considers allogeneic donation of regenerative tissue where the donor is under 16 or an adult with incapacity in Scotland. Only once HTA approval is in place can these donations go ahead. The Human Tissue (Scotland) Act 2006 (HT Scotland Act) and The Human Organ and Tissue Live Transplants (Scotland) Regulations 2006 (the Regulations) govern living donation in Scotland.
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.
