#17387 - Human Tissue Textbook Notes - Medical Law

HUMAN TISSUE

Herring Chapter 8 – Organ Donation and the Ownership of Body Parts

1. Introduction

• On the one hand, there is an acceptance of the importance of retaining bodily integrity, even of a deceased person, but on the other, there is the urgent need for organs to be transplanted and bodily material to be used for research, so that cures for diseases can be found.

• Although organ donation is still a very important topic, a host of other issues have risen to prominence in recent years.

  • Does a patient have any control over bodily material removed during an operation? If a scientist uses bodily samples to develop a wealth-creating discovery, do the people from whom the samples originate have any claim to the proceeds? Can, and should, it be possible to patent DNA sequences?

• The starting point for the issues raised concerning the legal regulation of bodily material is now the Human Tissue Act 2004.

2. The Human Tissue Act 2004

• The Human Tissue Act (HT Act) 2004 was passed following the scandals at Bristol Royal Infirmary and the Royal Liverpool Children's Hospital (Alder Hey) in 1999-2000, the details of which were revealed in the Kennedy and Redfern Inquiries.

  • What was discovered was that the retention of body parts and organs from dead children was common and widespread. This was often done without the consent or knowledge of the parents.

  • The public outrage at what had happened was enormous.

• The doctors concerned believed that there was nothing improper in what they were doing.

  • The removal of organs and bodily material can be justified on a number of medical grounds: it may be necessary to establish the cause of death, to diagnose the diseases from which the patient was suffering, to discover whether there were environmental causes of death, or to ensure that any lessons in relation to treatment of the relevant condition are learned.

  • It is useful for doctors to have a collection of organs and body parts to which to refer in the course of research, education, or preparing for other operations.

• It would, of course, be helpful for a surgeon about to operate on a heart with a particular abnormality to have a look at a heart with a similar abnormality in a collection of stored samples.

  • Further, banks of samples of bodily material can assist in research that seeks to discover what, if any, genetic form may predispose someone toward a particular disease

  • Chief Medical Officer: “There have been many occasions in the past where the study of tissue after death had led to discoveries in medical science which have resulted in the saving of lives and the relief of suffering. This has particularly been so in the field of cancer research”

• Also, it was thought that to ask parents' permission in this regard would only have added to the parents' distress.

  • The views of the hospitals involved were described in the Kennedy Report as ' institutional paternalism'

  • There was a genuine belief that whether they buried the whole of their child's body or most of it would not really bother parents.

  • Why waste a good example of a deformed heart by burying or cremating when it could be used to save lives and progress science?

• Interestingly, many of the parents involved stated that they would have consented had they been asked.

  • Their objection was that the doctors had treated the bodies of the children with contempt by plundering them for organs without seeking anyone's consent

  • <quote by one father, Paul Bradley>

• Mavis Maclean has emphasized that, for a parent who has seen their child die in hospital, the feelings of hopelessness and guilt can be enormous.

  • That final duty of the parent, to ensure a proper burial of their child, becomes the most painful and important of tasks.

  • To be prevented from doing that properly, because the body of the child has been decimated, can create feelings of failure, anger, and violation.

• A census carried out by the Chief Medical Officer for England (in 2000) and the Isaacs Report (in 2003) found that the kinds of practices at Alder Hey and Bristol were widespread across the country.

• The reports also found the law to be unclear and inconsistent.

  • It became apparent that new legislation was required and the HT Act 2004 followed

• At the heart of the Act is the notion of consent: bodily material can be retained or used only with the consent of the individual, or, in the case of children, their parents.

  • The point is this: it may be that many people will share the attitude that the doctors had in these cases.

  • Does it matter very much if a little bit of a body is retained for the benefit of science? But some people do object.

  • There are, for example, those with religious beliefs that demand that a body be buried whole. To them, it can matter enormously whether the body is buried complete

  1. The coverage of the Act

• The government has explained the purpose of the HTA 2004:

  • “The purpose of the Act is to provide a consistent legislative framework for issues relating to whole body donation and the taking, storage and use of human organs and tissue. It will make consent the fundamental principle underpinning the lawful storage and use of human bodies, body parts, organs and tissue and the removal of material from the bodies of deceased persons. It will set up an over-arching authority which is intended to rationalise existing regulation of activities like transplantation[16 ] and anatomical examination, [17] and will introduce regulation of other activities like postmortem examinations, [18] and the storage of human material for education, training and research.[19]

  • It is intended to achieve a balance between the rights and expectations of individuals and families, and broader considerations, such as the importance of research, education, training, pathology and public health surveillance to the population as a whole”

• The Act is restricted in its general coverage in four important ways

  • 1) Part I of the Act does not apply to the removal of human material from humans, but rather the storage and use of the material.

    • The Act is not designed to deal with complaints that a doctor improperly performed an operation or did so without proper consent (which are covered by the tort of negligence), but rather the way in which material is stored or used, after removal.

  • 2) The Act deals only with certain kinds of human material.

    • It does not deal with other animals, nor with some kinds of human material (for example sperm, eggs, embryos).

    • It does not cover photographs or other images of human material

  • 3) The Act deals only with the storage and use ofhuman material for particular purposes

  • 4) Part 1 of the Act is not intended to affect the way in which a coroner carries out his or her duties

  1. Section 1: lawfully storing or using bodily material

• The HT Act 2004 opens with a definition of what can lawfully be done with relevant materials (that is, certain bodily materials).

• The Act makes it lawful to do any of the following:

  • to store or use a whole body;

  • to remove, store, or use human material from a deceased person; and

  • to store and use human material from living people.

• These activities are lawful provided that:

  • there is the necessary consent; and

  • the act was done for a 'Schedule 1 purpose'.

• We need to clarify some of the terms used in this summary.

  1. Human material

• The Act governs 'relevant material'. Under the HTAct 2004, section 53, relevant material is tissue, cells, and organs of human beings, excluding gametes, embryos outside the body, and hair and nails from a living person.

  • Cell lines are also excluded by virtue of section 54(7), as is any other human material created outside the human body. Doubt has also been expressed whether the term covers the different organisms and bacteria that live in the human body but may not technically be human.

• However, the definition of 'human materials' is broad and a single cell can be classified as bodily material.

  1. Appropriate consent

• Consent must be given to the storage or use for the particular purpose in question.

  • So, for example, the fact that there is appropriate consent for the storage of an organ for the purposes of transplantation does not authorize the storage of the organ for research.

  • However, if a patient is willing for his or her material to be used in 'research', it is not necessary to obtain his or her consent for every individual research project.

• Consent can be specific (e.g. only for a particular research project) or for a generic project

  • A person can place conditions on their consent

  • Consent can be withdrawn at any time

  • Consent can be given orally, except in cases involving anatomical examination and public display, where it needs to be signed and witnessed

• What does 'consent' mean in this context?

  • Positive consent is required; a failure to object is insufficient.

  • Whether a person has capacity to consent is governed by the general law on consent, as discussed in Chapter 4

• Human Tissue Authority (HTA) Code of Practice on Consent

  • “To give consent, patients (or the person with parental responsibility) must understand the nature and purpose of what is proposed and be able to make a balanced judgement.

  • They should be told of any 'material' or 'significant' risks inherent in the way the sample will be obtained, how the tissue will be used and any possible implications of its use, eg, genetic tests.”

• Who can give consent?

• (i) Adults

  • Under the HT Act 2004, section 3, in the case of competent adults, appropriate consent can be provided only by the individual himself or herself.

  • The normal law on...