Human Tissue Authority

The regulator for human tissue and organs

Bone marrow and peripheral blood stem cell (PBSC) donation

The Human Tissue Act 2004 (HT Act) provides the legal framework for bone marrow and peripheral blood stem cell (PBSC) donation in England, Wales and Northern Ireland. In Scotland, the framework is provided by the Human Tissue (Scotland) Act 2006.

Under the HT Act, it is “an offence to remove bone marrow or PBSCs from for the purpose of transplantation unless the HTA gives permission” where donors cannot consent for themselves.

Potential donors and the person/s acting on the donor's behalf are interviewed by an Accredited Assessor (AA) who submits a report to the HTA.  

The role of the HTA in bone marrow and PBSC donation

The Human Tissue Authority (HTA) is only responsible for giving approval for bone marrow and PBSC (these are cells found in the bloodstream which are able to develop into all of the different cell types in the blood), cases where the donor is unable to consent for themselves. This is most often when the donor is a child who lacks the competence to consent but can also be when the donor is an adult that lacks the capacity to consent. In England, Wales and Northern Ireland, all donors under 18 have to undergo the Gillick test to prove capacity to consent. This is slightly different in Scotland where all donors aged 16 and under must receive HTA approval. The HTA makes the decision on whether each case can go ahead based on criteria set out by Parliament). Where a donor can give consent for themselves the HTA is not required to be involved in giving approval.

The HTA provides advice and guidance about the HT Act. We recommend that you read the following to familiarise yourself with HTA’s role and the PBSC and bone marrow donation process

  1. this leaflet alongside the other information provided by your transplant unit. This will help to inform you about what is involved for the donor, the recipient and the person consenting on the donor’s behalf.
  2. The HTA’s code of practice on the Donation of allogeneic bone marrow and peripheral blood stem cells for transplantation provides practical guidance to professionals and lays down standards to inform you about what is involved for the donor, the recipient and the person consenting on the donor’s behalf.
Audience: