TISSUE AND ORGAN RETENTION FOR DIAGNOSIS, TREATMENT AND RESEARCH

• Jurisdiction: Australia

Australian legislative and common law approaches ..................................... [33D.100]

Tissue retention for transplantation .............................................................. [33D.110]

Tissue retention for medical education and research .................................. [33D.120]

Tissue retention for diagnosis ....................................................................... [33D.130]

United Kingdom law and practice ................................................................. [33D.140]

Suggested approach ..................................................................................... [33D.150]

[33D.100] Australian legislative and common law approaches

In considering the adequacy of the law relating to organ transplantation, the Australian Law Reform Commission's Report on Human Tissue Transplants published in 1977 (ALRC Report) found it necessary to consider autopsies and the use of tissue removed at autopsy. At that time, most Australian states and territories did not have legislation dealing with authority for autopsies and use of tissue. These jurisdictions were therefore reliant on the common law which the Commission found "offer[ed] no rule or principle dealing with human tissue transplants as such" and had "little useful contribution to make" on the issue of removal of tissue from a dead human body: ALRC Report, para 56. The ALRC was unable to find any direct judicial authority dealing with the subject of removal and use of human tissue from a dead body.

The ALRC readily recognised the need to clarify the legal position relating to permission for autopsies and tissue retention for purposes wider than investigation of the death. Autopsies were being performed but there was no basis in law for the beneficial use of tissue which was otherwise being discarded or wasted. In this context, it made recommendations regarding the procedures for authorising non-coronial autopsies. These were reflected in the enactment of substantially uniform legislative provisions requiring consent, or in some cases non-objection, either from the deceased in life or senior available next-of-kin, and prescribing the involvement of "designated officers" in hospitals or registered medical practitioners outside the hospital context.

In relation to retention and use of tissue removed at autopsy, the ALRC further recommended:

The procedures and characteristics of normal autopsies and the beneficial uses to which tissue routinely removed during autopsy may be put are such that the Commission unhesitatingly recommends some departure from the general principle of consensual giving upon which this report is based.

By recommending "some departure from the general principle of consensual giving", it appears that the ALRC intended that discussion of retention and use of the tissue would NOT form part of discussion about whether or not there would be an autopsy. This recommendation took legislative form in most Australian jurisdictions. For example, s 30(1), (2) and (3) of the Human Tissue Act 1982 (Vic) states that authority for the autopsy, whether by consent from the deceased, senior available next-of-kin or by authority of a designated officer or registered medical practitioner, or by a coroner's order, is sufficient authority for a registered medical practitioner . to remove tissue from the body of the deceased person ... (and) for the use, for therapeutic, medical or scientific purposes, of tissue removed . for the purpose of the post mortem examination.

It is important to note that organ and tissue retention following autopsy has nothing to do with organ donation and transplantation from brain dead individuals whose cardio-respiratory function is being artificially supported. Since its inception, such organ donation and transplantation, being in the context of intensive care units, operating theatres and "brain death", has only taken place with the express consent of senior next-of-kin, and this is the prescribed legal practice.

The inquiry into autopsy and anatomical dissection practices at the NSW Institute of Forensic Medicine (The Walker Inquiry) was commissioned by the NSW government in 2001. It was established following allegations aired on national television about some autopsy practices at the NSW Institute of Forensic Medicine. These included the provision for research of femora and knee joints, the use of cadavers by trainee surgeons to practise surgical techniques and the performance on cadavers of procedures purporting to yield significant information for use in criminal trials (eg, re-creating stab wounds and blunt injuries to the skull). Once the Inquiry began and sought public comment, the issue of concern was the retention of the brain in formalin for later dissection for diagnostic purposes.

The Inquiry found that the retention of the brains was clearly lawful but the other practices mentioned above were unlawful and in breach of the Human Tissue Act 1983 (NSW). However, the Inquiry exonerated the Director and his staff, concluding that they held honest and sincere, but incorrect, beliefs that what they were doing was lawful. In addition, they had conducted matters relating to these practices openly and transparently. Support for the Director's mistaken belief was found from a number of sources, including a coronial finding and in legal advice from the NSW Department of Health. The belief related to the purpose of the autopsy. The Director regarded the purposes of the autopsy (which was not defined in the statute) to be not just to establish the cause and manner of death but to include the provision of tissue/organs for medical research. This belief therefore allowed for the removal of any tissue from a dead body for research purposes, rather than just tissue that would otherwise have been removed for coronial purposes. This was regarded as wrong by the Inquiry.

There are three main categories of retention and use for organs and tissues removed at autopsy that may require explanation and discussion with coroners and or next-of-kin:

1. transplantation;
2. bio-medical education and research; and
3. diagnosis.

[33D.110] Tissue retention for transplantation

There are many potentially transplantable tissues that can be removed during a normal autopsy. For example, the heart is removed as part of every routine autopsy. This means that under the law, the aortic valve is legally available for allografting without any further reference to the family. Corneas are not removed routinely as part of an autopsy and therefore consent from the senior next-of-kin (or the deceased while alive) is necessary to...