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.