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
- 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.
- 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.
Securing valid consent: adults who lack capacity and children who lack competence to consent
Under the Human Tissue Act 2004, any potential donation of bone marrow or PBSCs from adults who lack the capacity to consent and children who lack the competence to consent, must be assessed by an Accredited Assessor 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 giving of consent is a positive act. 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.
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 without competence.
All decisions made on behalf of a donor must be made in the donor’s overall best interests; and must take into account not only the medical but also emotional, psychological and social aspects of the donation, as well as the risks.
The HTA referral process
Before a transplant takes place, a donor and recipient must both receive a full medical work-up 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 made by the patient’s clinicians and transplant unit.
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 Accredited Assessor (AA). The SCC will also organize a translator or any other special requirements if they are needed.
Accredited Assessors (AA) and interviews
All donors who lack competence or capacity to consent for themselves, along with the recipient and the person consenting on the donor’s behalf are required to see an Accredited Assessor (AA) is trained and accredited by the HTA. The clinician responsible for the donor must make a written referral to the HTA via an Accredited Assessor (AA).
AA must be independent of the care of both the donor and recipient, and therefore able to maintain their objectivity in any given case. The AA then conducts interviews with the donor, the person giving consent on the donor’s behalf and the recipient both together and separately on the HTA’s behalf. 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.
The AA interviews ensure that the requirements of the HT Act and Regulations have been met. The Human Tissue Act (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 require the HTA to be satisfied that:
- no reward has been, or is to be, given;
- consent to removal for the purpose of transplantation has been given (or removal for that purpose is otherwise lawful);
- 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.
The Regulations also specify that the following matters must be covered in every interview report submitted by the AA to the HTA:
- whether there is any evidence of duress or coercion affecting the decision to give consent;
- whether there is any evidence of an offer of a reward;
- whether there were any difficulties in communicating with the person interviewed (such as language or hearing), and if so, an explanation of how these difficulties were overcome.
The HTA then considers the case and makes a decision based on the information provided within the report.
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 HTA assessment process
After the interview, the AA has 10 working days to submit a report of the interviews to the HTA. The HTA must be satisfied that the matters described in the section above (Accredited Assessors and Interviews) have been explored. The HTA aims to make a decision on all cases within five working days following referral. The timeline starts from the point at which the HTA has all the information it needs to assess the case.
Once a decision is made for 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.
Consent for the first and each repeat donation must be obtained before collecting bone marrow or PBSC from a donor for transplantation. HTA approval is required for each repeat donation.