This page provides a summary of the key pieces of legislation, licensing frameworks, and a brief overview of responsibilities for Designated Individuals (DIs), Named Contacts (ODT sector only), Persons Designated (PDs) and Licence Holders.
With the interests of the public and those we regulate at the centre of our work, we aim to maintain confidence by ensuring that human tissue is used safely and ethically, and with proper consent. We regulate organisations that remove, store and use tissue for research, medical treatment, post-mortem examination, teaching and display in public. We also give approval for organ and bone marrow donations from living people.
This position statement is intended to notify transplant units, donors and recipients of the HTA’s current position.
If a donor requests, in advance, to re-direct their organ to a secondary recipient; the HTA would need to be satisfied that there is no duress, coercion and reward involved in the re-direction. For example, a father donating to his child at the same time that his wife also requires a transplant. In the unlikely event that the organ cannot be transplanted into the child, he may wish for the organ to go to his wife instead.
This is an explanation of the measures that transplant units should take when preparing living organ donors for the very rare possibility that their organ/part organ (which is otherwise transplantable), cannot be transplanted into the intended recipient. The purpose of this process is to ensure that living donor organs are not “wasted”.
The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplant Regulations) 2006 (the Regulations) requires the donor’s consent for a specified purpose.
In part, the Human Tissue Act 2004 was introduced to ensure that living organ donors have made an informed and voluntary decision to donate their organ; free from duress, coercion and reward. Organ trafficking and modern day slavery is a concern for all healthcare professionals.
IAs submit reports using the HTA Portal. This is a secure system which is data protected. The system allows IAs to write their reports electronically, upload supporting documents and save them before submitting them online to the HTA.
The Portal also includes a link to the Guidance to Transplant Teams and Independent Assessors for IAs to refer to when writing their report.
If you are interested in finding out more about becoming a living organ donor, please contact your local transplant team who will be able to provide you with more information:
