Professional

There are several situations where independent pathologists attend HTA-licensed establishments to carry out post-mortem (PM) examinations. Visiting pathologists sometimes take or send PM tissue away from the originating establishment for laboratory processing and or analyses. When the laboratory analyses are complete, independent pathologists sometimes store PM tissue on their own premises whilst they await the receipt of disposal instructions from the coroner or police.

Samples may be obtained from deceased infants and children in cases of sudden unexpected death in infancy and childhood (SUDIC), in line with national protocols. This practice may take place in Accident and Emergency departments and other areas of a hospital, for example in special care baby units and paediatric wards.

This policy describes the consent and licensing requirements under the Human Tissue Act (HT Act) for removal of relevant material from the deceased, in these cases.

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.