Human Tissue Authority open letter on pathology

“How real-life 'silent witnesses' save lives”, BBC Scrubbing Up column, 20 January 2010

Issue date: 22 January 2010

An open letter to:
Professor Sebastian Lucas
Department of Histopathology
King's College London

Dear Professor Lucas

I read with interest your recent column for the BBC website on the important work of pathologists. In particular I wanted to respond to some of the points you make about the regulation of post-mortem examinations by the Human Tissue Authority (HTA) and the taking of consent.

Informed consent is one of the key principles of the Human Tissue Act (HT Act) and our regulation, and helps ensure human tissue is taken, used and disposed of ethically and respectfully. The distress caused when tissue was retained without consent in the past demonstrates that the public want the right to decide what happens to their body and tissue, or that of their relatives, after their death. HTA regulation ensures that informed consent is given before hospital post-mortem examinations are carried out. It is misleading to suggest that consent for such examinations is only required as a result of the HT Act. In fact consent has always been a requirement – the HT Act built on existing law and existing good practice. Your assertion that the requirement for consent is the main reason for the decline in hospital post-mortem examinations is misleading. This type of post-mortem examination has been declining since the 1970s, at least, and we have no evidence that the 2004 legislation has furthered the decline.

Consent is a two-way process of communication, of which the consent form is just one element. It should not be completed until discussion and explanation has taken place. We published a model consent form to support the post mortem sector, and it was produced in response to calls from the sector and in collaboration with them. The model form reflects the different options available and we have made it clear that Trusts can use, adapt or discard it according to local needs.

We recognise that some pathologists are concerned about the impact of the legislation and our required regulation. For this reason, we have invested substantial resources to help the sector interpret the law, including publishing user-friendly codes of practice and providing extensive advice, guidance and training. Our recent evaluation of the impact of our regulation on research showed that, overall, participants reported we are performing well on delivering our role.

In addition to hospital post-mortem examinations, coroners’ post mortems and tissue from the living are also sources of tissue for research. For coroners’ post mortems the availability of tissue is a matter of good communication between coroners, pathologists and families. The HTA has published a model communication flowchart to help support this communication process. In terms of tissue from the living, much valuable tissue could be taken in life if consent for research is sought at the same time as consent for medical treatment. Consent may also not be required for research projects if the tissue is unlinked or if the project has research ethics committee approval.

Research strongly points to families readily agreeing to donate tissue for research if asked, and talking to families is a valuable opportunity to explain the importance of pathology in medical science.

I hope this provides you with more information about how the HTA is implementing our statutory remit in a way that supports the use of human tissue for research, whilst ensuring public confidence that tissue will not be used without consent. By doing this, we believe that professionals can have confidence that more tissue will be donated by the public for research – so providing long term healthcare benefits.

Yours sincerely

Adrian McNeil

Chief Executive
cc.
Specialist pathology and medical publications
Department of Health
Home Office
Royal College of Pathologists
Association of Anatomical Pathology Technology