Living organ donation approvals

IAs act as a representative of the HTA to ensure the requirements of the Human Tissue Act 2004 (The HT Act) and associated Regulations are met in all cases of living organ donation.

It is an offence under the Human Tissue Act 2004 (The HT Act) for the donor to receive a reward for donating an organ/part organ.

All donors are asked to provide a signed declaration confirming there is no reward associated with the organ donation and transplantation.  The declaration should be read and signed by the donor, or person consenting on the donor’s behalf either in the IAs presence or provided to the IA to submit to the HTA.

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. 

Once a donor has been deemed medically and clinically suitable to donate by their medical practitioner the donor will be required to attend an independent assessment. An independent assessment is an interview which is carried out by an Independent Assessor (IA) who is trained and accredited by the HTA. The IA interviews the donor and recipient both separately and together on behalf of the HTA and is independent of the healthcare teams who are involved with the medical process.