Bone marrow and PBSC donations
The HTA is required to regulate some donations of bone marrow or peripheral blood stem cells (PBSC) for transplantation.
Adults who lack capacity and children who lack competence to consent
Under the Human Tissue Act 2004, any potential donation of bone marrow or PBSC from adults who lack capacity to consent and children who lack competence to consent, must be assessed by an Accredited Assessor and a report submitted to the HTA for consideration.
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.
Once accredited by the HTA, Accredited Assessors act as both a representative of the donor and the HTA. Further information about Accredited Assessors can be found on the Accredited Assessor page.
In Scotland, all donations by children (those under the age of 16) must be assessed by an Accredited Assessor and a decision made by the HTA.
Adults and children competent to consent
All donations of bone marrow and PBSC by adults and children competent to consent are approved locally in England, Wales and Northern Ireland and therefore do not require HTA approval.
When the consultant or senior member of the bone marrow team is satisfied that the requirements of the HTA’s codes of practice on the Donation of allogeneic bone marrow and peripheral blood stem cells for transplantation and on Consent have been met, they must complete:
1. A consent form that includes a statement by the donor that s/he has received and understood sufficient information to give informed consent
2. A declaration by the clinician that they have read and applied the HTA’s codes of practice. The HTA has created a model declaration form for this purpose. The declaration must be completed and attached to the donor's notes before the bone marrow or PBSC donation takes place. The declaration does not need to be submitted to the HTA.
Updated May 2011