Human Tissue Authority

The regulator for human tissue and organs

Revision of Guidance to Accredited Assessors and Bone Marrow/PBSC Clinicians

Please see below for a number of frequently asked questions from a specific category. Simply select one of the questions of interest, the answer will then appear below. For the complete list of categories please visit the main FAQs page.

The HTA has a statutory responsibility to make decisions on all cases of bone marrow and PBSC donation where the donor is a child who lacks competence to consent or the donor is an adult lacking capacity to consent.

Several cases over recent years have led the HTA to seek very specific legal advice. Following receipt of this advice, and under guidance from the HTA Authority (Board) members, we have taken the opportunity to strengthen the current regulatory system whilst reducing regulatory risk and ensuring that the approach we take in relation to our statutory responsibilities in this area is clear and proportionate.

There are three main areas of change to be aware of:

  • More specific focus on the best interests of the donor – the HTA must be assured in each case that the best interests have properly been considered by the person providing consent.
  • A formal referral letter must be written in each case which must include confirmation that the donor’s capacity has been explored, and confirmation that the donor lacks the competence to make the decision for himself/herself.
  • HTA must be assured that the person consenting on the donor’s behalf has parental responsibility. 

The HTA has published a new guidance document entitled ‘Guidance for Bone Marrow and Peripheral Blood Stem Cell Transplant Teams and Accredited Assessors in England, Wales and Northern Ireland’.

This guidance contains up to date information on the requirements of the law, what is expected of clinical teams and Accredited Assessors, as well as useful case studies. It provides clearer information on the role and responsibilities of the HTA, for example, what the HTA must be ‘satisfied of’ in order to give approval for each donation. 

The guidance also includes a list of useful links and resources.

Yes. The law is clear that a child becomes legally competent to make their own decisions on medical treatment matters when the child has sufficient capabilities and intelligence to fully understand what is proposed. If a child has this level of understanding and intelligence the child can give or refuse consent on his/her own behalf. 

There is no threshold age when children become competent; this should be assessed on a case by case basis. 

The HTA only has power to make a decision on a case if the donor is a child not competent to consent, or an adult lacking capacity to consent. The HTA must therefore explore competence before confirming whether or not we can make a decision on the case. If a child appears to have competence based on the AA interview, the HTA may:

  • request that the clinician referring the case provides the HTA with details of the competence assessment that was undertaken; and
  • if the matter remains unclear, make an application under the Children Act 1989 for the Court to decide if the donor child is competent to make their own decisions about medical treatment. The Court would then decide whether the child has competence to consent to the procedure for themselves.

The revised guidance clarifies the practices that should already be in place to undertake removal of regenerative material within the law, and put the donor’s best interests at the forefront of any decision.  

Key issues to be aware of:

  • The person giving consent (in cases where the donor is a child) must have parental responsibility for the child donor and the HTA will need to be assured that this is the case
  • A capacity/competence assessment must be carried out on all child donors, except where it is clear the donor lacks competence, for example, if the donor is a very young/pre-verbal child
  • The referral letter must confirm that the clinician with responsibility for the donor has had a conversation with the person consenting on behalf of the donor, about how they have considered the best interests of the donor in their decision. The letter must also confirm that the clinician is satisfied that the donation is in the best interests of the donor.
  • It is important to continue to explain the role of HTA to families and provide the HTA leaflet ‘Our role in bone marrow and peripheral blood stem cell donation’ available on the HTA website

Extensive legal advice has enabled the HTA to provide up to date guidance on the role and responsibilities of the AA.

Key issues to be aware of:

  • AAs must explore with the person consenting on the donor’s behalf that the decision to consent has been made in the best interests of the donor (explained further in the guidance document).
  • AAs are reminded that separate interviews must be carried out with the donor, recipient and with the person consenting on the donor’s behalf (the detail of what is required from each interview and how to overcome communication difficulties can be found in the guidance document).

Yes. You will be sent details of an online refresher package on Monday 1 June 2015 that will need to be completed by all Accredited Assessors by Monday 22 June 2015 in order to maintain accreditation. Please contact us for further information or if you have concerns that the deadline cannot be met.

The online refresher package will be based on information in the new guidance document.

The changes will be reflected in an updated portal form which will come into effect on 29 June 2015.

The portal reporting form will better reflect the information the HTA requires in order to make a decision on a case. There will be the opportunity at the end of the portal form for AAs to upload a copy of the referral letter that the HTA must receive.

If the online system is unavailable, an updated contingency form will be available on the HTA website from Monday 29 June 2015

Referral letters written by the medical practitioner with responsibility for the donor (or the appropriate nurse specialist) must be sent to the Accredited Assessor in advance of the statutory interview.

This letter must include confirmation that the donor lacks capacity/competence to consent and is therefore unable to make a decision about donation themselves. This means that a competence assessment must have been undertaken unless the donor clearly lacks competence, for example if they are a baby or very young child.

A template referral letter can be found here.