History and background of human tissue transplantation and research

Human tissue transplantation has been a growing part of medical and scientific development for many years. In his book The Body as Property, Russell Scott recounts that more than 2000 years ago Indian surgeons were transplanting human skin in the operation of rhinoplasty.¹ Blood transfusions have long been commonplace and the 19th century saw the first transplantation of certain body parts, such as teeth and bone. The 20th century and more particularly the last 30 to 40 years have seen enormous developments in the field of human tissue transplantation. The first successful kidney transplant was performed in 1954 and the first successful transplant of a human heart took place in December 1967, in South Africa; but on that first occasion the recipient died 18 days later. However, a heart transplant performed in the United States only 10 months later kept the recipient alive for over 8 years.² Since that time the list of tissue, regenerative and non-regenerative, and even human and non-human, that has been transplanted with varying degrees of success has grown considerably. Herring has provided a useful list of the different types of organ transplantation currently available or being explored, and this is set out in Box 10.1.

At the time of writing, the use of human tissue for transplantation, research and other purposes in Australia is the subject of considerable controversy, discussion and debate. Much of this debate is beyond the scope of an undergraduate textbook and some aspects of the debate, particularly those relating to the use of human genetic material in research, will only be mentioned briefly, with further references supplied for the interested reader. Some of the controversy relates to the retention and use of human tissue after death and the conduct of post-mortem examinations, another topic not directly related to the regular work of nurses. However, this latter subject has been a matter of such concern among the general public, it will be discussed in some detail as nurses may find themselves required to answer questions by anxious patients and (more probably) relatives. As a matter of careful practice, specific questions about any matter relating to the use of human tissue should be referred to the appropriate treating medical practitioner, but this area of law has developed so rapidly that undergraduate nurses do now need to be aware of it.

Another area where the law has developed rapidly in recent years is the development of assisted reproductive technologies, and a short section will be included on the legal provisions in this area.

Development of law in relation to human tissue usage

The subject of human tissue transplantation obviously gives rise to significant legal issues. As is often the case, the law has been slow to respond to these issues. In addition, the established common-law principles are clearly inadequate when trying to cope with the complexities of the issues involved. Common-law principles have for many years recognised only a limited right to deal with a person’s body after death — usually only for the purposes of burial. Legislation in relation to the functions of the coroner clearly established the right to conduct post-mortems, and permission to do so could also be given by the surviving spouse or relative. Common-law limitations also prohibited the use of dead bodies and the retention of body organs for the teaching of anatomy and research purposes. Accordingly, it was necessary for parliaments to allow such procedures by passing the appropriate legislation, usually known as the Anatomy Act in most states and territories.

The common law has also never permitted the removal of body parts or organs from a living person. Such a principle rested largely on the belief that the removal of a body part or organ from a living person, even with the person’s consent, was not of benefit to that person and technically constituted the criminal offence of maim. In addition, the increasing amount of tissue transplantation, particularly kidney transplants, highlighted the fact that the state of the law was not sufficient to deal with the legal problems that arose. Those problems included the issue of consent generally, the removal of tissue from living persons and the need to make specific provisions concerning children.

The need for parliaments to legislate in this area was first recognised in Australia in 1976, when the then Commonwealth Attorney-General, Mr R J Ellicott, referred the whole matter of human tissue transplantation to the Australian Law Reform Commission under wide-ranging terms of reference. The commission produced its report in 1977, entitled Human Tissue Transplants.⁴ One of the main features of the report was the proposed draft legislation, which was set out in Appendix 4 to the report. It was intended that the draft legislation, presented to the Commonwealth Government in 1977, would be used as a model by all of the Australian states and territories in relation to this subject. The subject of tissue transplantation is an area within which the states and territories have power to legislate and hence the Commonwealth Government could not impose the draft legislation on the states or territories — it could only put it forward as a suggested model. The Commonwealth Government used the draft legislation proposed by the Australian Law Reform Commission as the basis for the Transplantation and Anatomy Act 1978 in the Australian Capital Territory.

Following the lead of the Commonwealth Government in the Australian Capital Territory, all states and territories have now introduced legislation based on the Commonwealth’s proposed draft legislation.⁵ The legislation deals with such matters as:

the donation of tissue by living persons, particularly with reference to children and the issue of consent (blood donations are dealt with separately);

the donation of tissue after death;

the donation of tissue for anatomical purposes;

issues arising in relation to post-mortem examinations;

a prohibition of trading in tissue;

a definition of death.

The even more complex legal issues arising from in-vitro fertilisation and embryo transplants are not dealt with in the legislation and have required further legislation by most jurisdictions in recent years. This will be discussed further later in this chapter.

The legislation varies to some extent between the states and territories, but in this area there is a significant degree of commonality between them, largely because they have adopted the draft legislation of the Australian Law Reform Commission. This particular piece of legislation is of importance to all hospitals and health personnel. It is of greatest significance to nursing and medical staff in intensive care and other such units because the majority of organs for transplantation come from patients who die from severe trauma, particularly as a result of motor vehicle accidents.

Each of the states and territories has adopted the parts or sections of the proposed draft legislation that they have considered relevant or necessary for their purposes. Not all states and territories have dealt, in their respective legislation, with all of the matters mentioned above. As an example, South Australia and Western Australia have not adopted the definition of death as proposed, and hence reference to that will not be found in their respective Acts. Also, New South Wales makes no reference to donations for anatomical purposes or schools of anatomy, as such matters are covered in the New South Wales Anatomy Act 1977.

Imogen Goold makes the observation that

The provisions of the various statutes are set out in Table 10.2. and will be discussed below.

Table 10.2 State and territory provisions for blood and tissue donation

The requirement for consent in live donations

Clearly in situations where tissue is to be donated the requirement for a valid consent is critical. Donating tissue carries with it a degree of risk due to the need to obtain the tissue from a live individual, but this risk becomes even more significant if the tissue removed will not regenerate. The requirements for consent to removal of non-regenerative tissue for donation are quite rigorous, and understandably so, particularly where children are concerned. At the time of writing, The National Health and Medical Research Council (NHMRC) Australian Health Ethics Committee (AHEC) is developing ethical guidelines on both living and deceased organ donation. A consultation draft document entitled Organ and tissue donation by living donors: Ethical guidelines for health professionals was issued in August 2006. The document points out that, currently in Australia, 40% of kidney donations are from living donors.⁷

The guidelines themselves embody a set of principles, which are a valuable guide to health professionals in terms of addressing the issues and concerns of living donors, and these are set out in Box 10.2.

BOX 10.2 Principles embodied in AHEC guidelines — Organ and tissue donation by living donors: Ethical guidelines for health professionals⁸

a) Living organ and tissue donation is an altruistic act, whether the donor and recipient are related or unrelated. Donation is recognised as an act of altruism and humanity that potentially benefits those in medical need and ultimately society as a whole.

b) Respect for all those involved is demonstrated through:

decision-making processes that ensure that both donors and recipients are fully informed about potential risks, and about alternatives to transplantation; and

ensuring that decisions about donation are free of coercion of any kind including undue emotional pressures or material incentives such as money or in-kind rewards.

c) In assessing whether to proceed with donation, the autonomy and welfare of the donor take precedence over the needs of the recipient to receive an organ.

d) Living donation only occurs when there are minimal risks of short- and long-term harm to the donor, with no clinically significant loss of a bodily function, and a high likelihood of a successful outcome for the recipient.

e) Those who cannot make informed decisions (for example young children or other dependent persons) are only considered as potential living donors for first degree relatives and only where there is a high likelihood of success and there are no alternative donors.

f) Conflicts of interest are minimised through the use of independent medical teams for potential donors and recipients and independent advocacy for the donor.

As this document is only at present a consultation document it will be important for nurses who are interested in this topic to visit the NHMRC website (www.nhmrc.gov.au) to view the final version of the document, particularly because often the publication of new versions of such documents may influence states and territories to amend their legislation. However, the principles themselves are sound and it would be unlikely that they would undergo significant change.

Adults

The requirement for consent to removal of regenerative tissue is similar for all statutes but the extent of detail differs. For example, the Transplantation and Anatomy Act 1978 (ACT) section 9 requires that the consent must be in writing; the person giving consent must not be a child (for the purposes of transplantation legislation, a child is a person under 18 years who is not married); and the person must ‘in the light of medical advice furnished to him [sic], understand[s] the nature and effect of the removal’. Furthermore, the consent must be signed ‘otherwise than in the presence of any members of his [sic] family’. These requirements having been met, the person can consent for removal of their regenerative tissue for transplantation or any other therapeutic, medical or scientific purposes. Consent may be revoked orally or in writing at any time. Other statutes such as the Human Tissue Act 1982 (Vic) section 7 do not spell out the requirement for understanding of the nature and effect of the removal, but as has been discussed in Chapter 4, those requirements are part of the common law in relation to consent to treatment. All statutes require the consent to be in writing.

Under all statutes there is a further requirement for a 24 hour ‘cooling-off period’ before the non-regenerative tissue can be donated and a specification that the time of consent shall be recorded. Some statutes also offer the option of a medical practitioner issuing a certificate in relation to consent; for example, section 10 of the Transplantation and Anatomy Act 1978 (ACT).

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