Human Tissue Authority

The regulator for human tissue and organs

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.

Last updated on: 23 Oct 2017