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.
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.
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 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 Human Tissue Authority (HTA) is only 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 who lacks competence to consent, but can also be when the donor is an adult that lacks capacity. A “child” is a person under the age of 18. A person becomes an adult on their 18th birthday.
This is slightly different in Scotland where all donors aged under 16 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 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.
All donors that 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) who is trained and accredited by the HTA.
The AA carries out interviews on our behalf. While the interview can be undertaken with all three people in the room, there will be questions of each person to answer where they are able to do so. The interviews fulfil a number of purposes. They ensure that the donor’s interests have been properly taken into account by the person giving consent. This means that the person giving consent must be able to say how they have reached the decision that the procedure is in the donor’s interest.
The interviews also ensure that the donor is not being asked 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.
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. Occasionally it may be necessary for a Court to decide whether a donation can proceed.
The HTA interviews will take place after the donor has been deemed medically suitable to donate by their medical practitioner. The Stem Cell Coordinator (SCC) will organise 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 being referred. The timeline starts from the point at which the HTA has all the information 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.