Human Tissue Authority

The regulator for human tissue and organs

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

The role of the HTA in Bone Marrow and 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. PBSCs are cells found in the bloodstream which are able to develop into the different cell types found in blood.

Under the HT Act, 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 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 Human Tissue Authority (HTA) is responsible for giving approval 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 which means that all donors 16 or under must be referred to the HTA for approval for bone marrow or PBSC (in Scotland, known as, regenerative tissue). The HTA makes the decision on whether each case can go ahead based on criteria set out by Parliament.

Where a donor, is an adult over 18 in England, Wales and Northern Ireland or an adult over 16 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 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. The HTA’s guidance document for bone marrow and PBSC Transplant Units and Accredited Assessors.
     
  2. The HTA’s Code of Practice G on the Donation of allogeneic bone marrow and peripheral blood stem cells for transplantation provides practical guidance to professionals and lays down standards which will help to inform you about what is involved for the donor, the recipient and the person consenting on the donor’s behalf.

Securing Valid Consent: Adults who lack capacity and children who lack competence to 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 obtained before harvesting bone marrow or PBSC from a donor for transplantation. The giving of consent is a positive act.

In cases where donors are unable to give consent themselves, the decision about consent will be made 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.

Guidance on the process preceding donation of allogeneic bone marrow and PBSC: HTA Approval Process – Requirements for HTA Approval to be given

Before a transplant takes place, a donor and recipient must both 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 AA then conducts interviews with the donor, the person giving consent on the donor’s behalf and the recipient, and submits a report of their assessment to the HTA. The HTA then makes its decision based on the information provided within the report.

The Regulations require the HTA to 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.

Accredited Assessors and Interviews

The Regulations require that an AA must have conducted separate interviews with the donor, the person giving consent on the donor’s behalf and the recipient in order to gather the material that must be reported to the HTA. The purpose of the interviews is to ensure that donors are not forced to do something against their wishes, that no reward has been sought or offered and that the person consenting on the donor’s behalf has the capacity to make an informed decision. When children are involved, the AA will interview the donor and recipient in a way which reflects the child’s level of understanding to an age-appropriate level.

It is a criminal offence to carry out a transplant operation between two living people if the conditions of the HT Act are not met. This means valid consent must have been given.

The Accredited Assessment process

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 any other special requirements if they are needed.

After the interview, the AA has 10 working days to submit a report of the interviews to the HTA. The HTA aims to make a decision on all cases within five working days of the case being referred. 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.

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.

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