Medical school staff are sometimes faced with the challenge of deciding whether the consent given by potential donors, often many years before their death, is valid if it contains colloquial terminology and not the specific terms stated in the Human Tissue Act 2004 (the HT Act). This document aims to provide guidance on the circumstances under which the consent may be deemed acceptable and can be acted upon.
Summary of legal requirements
The HT Act repealed and replaced several pieces of legislation in England, Wales and Northern Ireland, including the Anatomy Act 1984 which had governed the donation of bodies for the teaching of anatomy. The use of donated bodies to teach anatomy by dissection is referred to in the HT Act as the scheduled purpose of "anatomical examination", which is defined as 'Macroscopic examination by dissection for anatomical purposes'. In this definition, "anatomical purposes" are 'purposes of teaching or studying, or researching into, the gross structure of the human body'. The scheduled purpose of anatomical examination has specific consent requirements which require that the donor's consent is written, signed and witnessed. To facilitate the donation process, the HTA and medical schools encourage people who wish to donate their body for anatomical examination to complete and return a consent form from the facility of their choice, but they can alternatively (or in addition) include their consent in a will.
The issue with consent terminology
"Anatomical examination" is not a term commonly used by the general public, and therefore may not be used in body donation consent documents, such as in personal letters or wills. This means that medical schools are put in a difficult position of deciding whether consent is valid or not when they receive written consent documents which use different terminology such as 'use for medical research' or 'medical science'. Use of human tissue in research or education are other scheduled purposes which are also listed in the HT Act and therefore such consent raises the issue of whether the donor intended their body to be used only in research projects or to teach anatomy through dissection. A donation may be declined in cases where the family believe that the deceased wished their body to be used for anatomical examination but the terminology on the consent documentation does not clearly reflect this. This results in the body not being used in accordance with the wishes of the potential donor and can cause distress to the family.
When written consent documents use terminology other than "anatomical examination" and family members or nominated representatives can confirm and will put in writing that use for the scheduled purpose of anatomical examination was what the donor had intended, then it is reasonable to accept the body for that purpose. Establishments should not accept donations for anatomical examination where there are factors in the form of the written consent itself which would appear to rule out teaching, studying or researching into the gross structure of the human body. Where there are no family members or nominated representatives, or they were unaware of the donor's wishes, or hold conflicting opinions and therefore cannot provide reliable clarification of the donor's wishes, the consent remains ambiguous and establishments are advised to decline the donation.
It is essential that, where establishment staff have had to take a pragmatic and evidence-based decision, adequate records to demonstrate the rationale behind the decision are kept.
Where the validity of the consent to anatomical examination is questionable and this document does not provide all the necessary clarification, further information and advice can be obtained from the HTA:
Tel: 020 7269 1900
Issue date: 7 February 2012, reviewed December 2015