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.

The HTA is responsible for assessing all donations of bone marrow or PBSC from adults who lack capacity to consent and children who lack competence to consent. Potential donors that lack capacity or competence must be referred to an Accredited Assessor (AA), who submits a report to the HTA following interviews with the donor, the person/s acting on the donor's behalf and the recipient. 

In England, Wales and Northern Ireland, all donors aged under 18 that are not competent to consent  must receive HTA approval before donation can proceed. This is slightly different in Scotland where all donors aged 16 and under must receive HTA approval whether or not they have capacity to consent. 

The HTA makes the decision on whether each donation can go ahead based on criteria set out by Parliament. Where a donor can 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: