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.
The HTA regulates establishments in England, Wales and Northern Ireland that conduct licensed activities under the Human Tissue Act 2004 (HT Act). This includes establishments that remove samples from the deceased for certain purposes in the HT Act – called scheduled purposes.
Contact details for individual medical schools in Scotland can be found here. Note: The HTA does not regulate medical schools accepting body donations in Scotland, it is only the regulator in England, Wales and Northern Ireland.
The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Q&S Regulations) and the Blood Safety and Quality Regulations 2005 define ‘blood component’ as ‘a therapeutic constituent of human blood (red cells, white cells, platelets and plasma) that can be prepared by various methods’.
The HTA and MHRA have agreed to extend their existing policy relating to dendritic cells to allow collection of blood as a starting material for an ATMP to be performed under either a Tissues and Cells or Blood Establishment Licence.
This will make it more straightforward to procure blood and increase the number of sites in the UK where this activity can occur without increasing the number of licences required.