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Human Tissue Textbook Notes

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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.
o 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.
o 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.
o The public outrage at what had happened was enormous.
- The doctors concerned believed that there was nothing improper in what they were doing.
o 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.
o 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.
o 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.
o The views of the hospitals involved were described in the Kennedy Report as '
institutional paternalism'
o 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.
o Why waste a good example of a deformed heart by burying or cremating when it could be used to save lives and progress science?

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

- 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.
o That final duty of the parent, to ensure a proper burial of their child, becomes the most painful and important of tasks.
o 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.
o 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.
o The point is this: it may be that many people will share the attitude that the doctors had in these cases.
o Does it matter very much if a little bit of a body is retained for the benefit of science?
But some people do object.
o 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

2.1 The coverage of the Act
- The government has explained the purpose of the HTA 2004:
o "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]
o 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.
o 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 2 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

2.2 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:
o to store or use a whole body;
o 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:
o 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.

2.2.1 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.
o 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.

2.2.2 Appropriate consent
- Consent must be given to the storage or use for the particular purpose in question.
o 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.
o 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?
o Positive consent is required; a failure to object is insufficient.
o 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.
o 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 o

3 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.
o The normal law on consent, as set out in Chapter 4, applies.
(ii) Deceased adults

Consent or non-consent of a deceased adult can come from three sources

1) The deceased
 If the deceased has made his or her views clear, then those determine the question. Where the use of human tissue involves storage for the purposes of public display or anatomical examination, there must be consent in writing
 However, for all other activities under the Act, there is no need for the decision to be in writing.
 The decision must have been in force (i.e. not revoked) immediately before the person died.
o 2) An appointed representative
 If the person has died without expressing a decision about how his or her bodily material is to be used and he or she has appointed a 'representative',
the representative can make decisions on the deceased's behalf.
 The appointment must comply with the requirements in section 4. The representative can be appointed orally or in writing (for example under a will )
o 3) The person in the closest "qualifying relationship"
 If the person has died without expressing a decision and has not appointed a personal representative, then the person who is in the closest 'qualifying relationship' can make the decision.
 Section 27(4) ranks the qualifying relations in this order: (a) spouse or partner; (b) parent or child; (c) brother or sister; (d) grandparent or grandchild; (e) child of a person falling within paragraph (c); (f) stepfather or stepmother; (g) half-brother or half-sister; (h) friend of long standing.
 If there are two people of the same rank, then only the consent of one is required
(iii) Children

The law on consent in relation to children is set out in the HTAct 2004, section 2. 32 If the child is competent, then he or she may consent.
o Indeed, a competent child can make an advance decision concerning his or her consent and such a decision must be respect

If the child is not competent, then a person with parental responsibility will be able to consent for the child.
o Thus a parent with parental responsibility could consent that his or her child's organs be used for transplant, but only where the competent child had not expressed his or her views.
o If the child has died without anyone having parental responsibility, then someone in a
'qualifying relationship' can consent to the removal of the material, and its storage and use
(iv) Adults lacking capacity

Where an adult lacks capacity, consent can be deemed in certain circumstances under the Human Tissue Act 2004 (Persons who Lack Capacity to Consent and
Transplants) Regulations 2006.
o These permit the storage and use of relevant material for a "Schedule 1 purpose" if that is in the best interests of the person who lacks capacity
A Schedule 1 purpose o-2.2.3

4 A person's act is made lawful by the HTAct 2004, section l, if he or she is acting for a 'Schedule l purpose'.
o The Schedule divides these purposes into two parts.
o We shall see why shortly.
- PART 1

Purposes requiring consent: general

1 Anatomical examination.
o 2 Determining the cause of death.
o 3 Establishing after a person's death the efficacy of any drug or other treatment administered to him.
o 4 Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person).
o 5 Public display.
o 6 Research in connection with disorders, or the functioning, of the human body.
o 7 Transplantation.
- PART 2

Purposes requiring consent: deceased persons

8 Clinical audit.
o 9 Education or training relating to human health.
o 10 Performance assessment.
o 11 Public health monitoring.
o 12 Quality assurance.
- Under section 1(1), the following can be done with appropriate consent for any of the twelve purposes:
o (a) the storage of the body of a deceased person for use ... other than anatomical examination;
o [ ... ]
o (c) the removal from the body of a deceased person for use ... of any 'relevant material' of which the body consists or which it contains;
- The following can be done with appropriate consent for a purpose in Part 1 of Schedule 1:
o (d) the storage for use ... of any relevant material which has come from a human body;
- The following can be done for a purpose in Part 2 of Schedule 2, even without consent:
o (e) the storage for use ... of any relevant material which has come from the body of a deceased person
- There are special provisions dealing with the storage of bodies for anatomical examinations.
- Where a person is using bodily material for a purpose other than one approved in Schedule 1,
then, according to its Explanatory Notes, the 2004 Act does not apply.
o So an artist removing part of a corpse to use in a sculpture will not have done an act covered by the 2004 Act.
o The Act will not render such an act legal or illegal. However, the artist could still be guilty of, for example, the offence of theft

2.3 Storage and use of human material without consent
- A key principle in the Act is that someone's relevant material can be used only with their consent. But there are eight situations in which it is lawful to store and use human material even though there is no consent.
o These are as follows
- (i) A Schedule 1, Part II, purpose (such as education, training, and audit)
o As already mentioned, there is no need for 'appropriate consent' where human material from a live person is stored for a purpose in Part II of Schedule 1 of the Act5 --that is, if it is stored or used in connection with clinical audit, education, and training in relation to human health, performance assessment, public health monitoring, or quality control

Research is not included in this list, although the line between research and education and training may be blurred.
o The reason for these exceptions is that the use of material for these purposes is seen as intrinsic to the proper conduct of the patient's treatment or the health of the nation
(ii) The HTA deems there is consent

The HTA has the power to deem that there is consent where it is not possible to trace the individual from whom the material originated.
o The Authority is likely to use this power only where tissue relating to a relative of a patient could be used for genetic testing purposes to assist in the diagnosis or treatment of a patient. It has the power to deem consent where it is satisfied that material has come from the body of a living person, that it is in the interests of another person to obtain scientific or medical information about the individual, and that there is no reason to believe that the individual has died or has made a decision not to consent to the use of material. There is also power for the Authority to deem consent where reasonable attempts have been made to get a person to decide what he or she wants to happen to his or her human material and yet the person has not made a decision.
(iii) A High Court order

A High Court can order that appropriate consent is to be deemed for 'research purposes in connection with disorders, or the functioning of the human body'.
o These orders can cover the storage of relevant material' from the body of a living or a deceased person, and the removal and use of 'relevant material' from a body. The order will be made if it is in the public interest.
o However, the government has stated that this power is to be used only in the most exceptional of cases
(iv) Storage for research purposes

If 'relevant material' from living bodies is stored for the purpose of research in connection with disorders or the functioning of the human body, then consent is not required, provided that
 (a) the research has been ethically approved in line with regulations issued by the Secretary of State; and
 (b) the material has been anonymized so that it is not possible to identify the person from whom the material originates.
o This is an extremely important provision.
o Notably, it permits the use of material for research even where the patient positively objects

Note that this does not justify the removal of material without the consent of the patient.
o It therefore covers material that has been removed with consent, for example material removed during an operation.
(v) Surplus material

If material has been removed in the course of treatment, diagnostic tests, or research, then that material can be dealt with as waste and there is no need to obtain consent before disposing of it.
o So a tumour removed in the course of an operation can be disposed of without the explicit consent of the patient. It will be taken that consent to the operation will include consent to the disposal of the tumour.

6 (vi) Imported material

Consent is not required where the body or material has been imported from overseas

E.g. a hospital receives a consignment of organs for research purposes from, say,
Denmark.
o It is presumed that the law regulating the country of origin will provide adequate protection for their citizen's rights.
- (vii) Existing holdings

If a hospital or surgeon has bodies or material that were held for a Schedule l purpose immediately before the Act came into force, consent is not required.
o The HTA has issued a Code to deal with the storage, use, and disposal of existing holdings
- (viii) Coroners' activities

The functions of the coroner are not covered by the Act.
o A coroner may therefore authorize the retention of organs without complying with the provisions of the 2004 Act.
- As can be seen from this list, there are a large number of exceptions to the principle that a person's bodily material cannot be used without his or her consent.
- The following case illustrates that not every eventuality can be covered and demonstrates how the court dealt with the issue by relying on its inherent jurisdiction.
o CM v Executor of the Estate of EJ [2013] EWHC 1680

A doctor, CM, was driving home when she came across the body of EJ, who was bleeding profusely.
o She attempted emergency first aid, but EJ died. CM's hands become covered in EJ's blood.
o CM was worried that she may have become infected and started anti-retroviral medication, which made her ill. She wanted to obtain a sample of EJ's blood for tests.
o A family member was willing to give consent and the coroner was happy to approve,
but it was unclear what legal authorization could be given to allow the use of the samples.
o The court held that this would have to be under the inherent jurisdiction, which was available because a closest relative had given consent and the coroner was agreed .
Here, the court would use the inherent jurisdiction because CM had acted out of humanity and would otherwise suffer the uncertainty of not knowing whether she was diseased. There was also a public interest in enabling CM to return to work. The tests were ordered. The report notes that the tests were completed and returned negative.

2.4 The creation of the Human Tissue Authority
- The HT Act 2004, Part 2, set up the HTA, the remit of which covers the removal, use, storage,
and disposal of human material.
o The Authority has set up a scheme under which a licence is required for a range of activities connected with human tissue

It is an offence to conduct the activities without a licence
- Where a body breaches the terms of a licence, the licence may be revoked.
o The Authority has also produced codes of practice in connection with dealings with human tissue.
o The HTA has no power over actions performed for criminal justice purposes, such as coroner's post mortems
- The HT A's remit includes:
o the storage and use of human bodies and tissue, and the removal of tissue from human bodies, for scheduled purposes;
o the import and export of bodies and human tissue for scheduled purposes; and 7

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