Human Tissue Authority

The regulator for human tissue and organs

Bone marrow and peripheral blood stem cell (PBSC) donation: Legal Framework

Bone marrow and peripheral blood stem cell (PBSC) donation: Legal Framework

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 (link is external). PBSCs are cells found in the bloodstream which are able to develop into the different cell types found in blood.

Under the HT Act and the Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 (Regulations), it is “an offence to remove bone marrow or PBSCs from a living person for the purpose of transplantation unless the HTA gives permission” where the donor is a child under the age of 18, who is not competent to consent or adult lacking capacity to consent. The HT Act requires that any potential donation of bone marrow or PBSC from adults who lack the capacity to consent and children who lack the competence to consent must be assessed by an AA and a report submitted to the Human Tissue Authority (HTA) for consideration. Part of the HTA’s role is to act as an independent check that legally valid consent is in place for bone marrow and PBSC donations from adults without capacity or children who are not competent.

The HTA is responsible for making the decision on whether each case can go ahead based on criteria set out by Parliament in cases where the donor is unable to consent for themselves.  This is most often when the donor is a child - under the age of 18 - who lacks the competence to consent, or an adult that lacks capacity in England, Wales and Northern Ireland. The requirements for Scotland are slightly different and for further detail refer to the Human Tissue Authority guidance here for transplant teams, Independent Assessors and Accredited Assessors in Scotland.  

Where a donor, is an adult aged 18 and over in England, Wales and Northern Ireland or an adult aged 16 and over in Scotland and is competent to consent to the removal of bone marrow or PBSCs, the case does not need to be referred to the HTA for approval.

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

Securing Valid Consent

For consent to be valid, it must be given voluntarily, by an appropriately informed person who has the capacity to agree to the activity in question. Clinicians have the responsibility of ensuring that valid consent to the removal, storage and use of bone marrow or PBSC is in place prior to referral to the HTA. Consent for the first and each repeat donation must be in place before bone marrow or PBSC donation from a donor. 

In cases where donors are unable to give consent themselves, the consent is provided by a person acting on their behalf, which would usually be the court for adults lacking capacity and someone with parental responsibility for children lacking competence.

All decisions made on behalf of a donor must be made in the donor’s overall best interests, taking into account not only the medical but the emotional, psychological and social aspects of the donation, as well as the risks associated.

The Accredited Assessment (interview) and HTA decision-making process 

Before a transplant takes place, a donor and recipient must receive a full medical workup to determine whether they are suitable to undergo the procedure. The decision about whether a person is medically fit and suitable as a living bone marrow or PBSC donor is a matter for the practitioners concerned.

In cases requiring HTA approval, the clinician responsible for the donor must make a written referral to the HTA via an Accredited Assessor (AA). The Stem Cell Coordinator (SCC) will organize the interviews at a time that is suitable to the donor, the person consenting on the donor’s behalf, the recipient and the AA. The SCC will also organise a translator or make any other special arrangements, if needed.

The AA then conducts interviews with the donor, the person giving consent on the donor’s behalf and the recipient. After the interview, the AA has 10 working days to submit a report of the interviews to the HTA. The HTA then makes its decision on all cases based on the information provided within the report within five working days of the case submitted by the AA. The timeline starts from the point at which the HTA has all the information (i.e. the referral letter) it needs to assess the case.

For each case, the HTA must be satisfied that:

1.    no reward has been, or is to be, given;
2.    consent to removal for the purpose of transplantation has been given (or removal for that purpose is otherwise lawful);
3.    an AA has conducted separate interviews with the donor, the person giving consent, and the recipient and submitted a report of their interviews to the HTA.

Once the decision is made on each case the SCC and the medical practitioner with responsibility for the donor will be informed. The SCC communicates the decision to the donor, the person consenting on the donor’s behalf and the recipient on the HTA’s behalf.

Further information about the AA can be found here

For enquiries about the AA role, the person specification, or further information on how to apply to become an AA, please email or call 020 7269 1900.

Last updated on: 12 Feb 2020