Consent on human tissue the key, says legal expert

There is an urgent need to introduce legislation and guidelines embracing informed consent on the taking of organs and tissue…

There is an urgent need to introduce legislation and guidelines embracing informed consent on the taking of organs and tissue from patients following post-mortems in Irish hospitals, according to an expert in medical and legal issues.

Prof Denis Cusack of UCD said the only legislation which touched on human tissue was the Anatomy Act dating from the 1830s, and it only related to whole corpses.

Since then there had been a legislative void, other than a lot of common law, which allowed hospitals to take tissue from patients with few controls, although arrangements in recent decades were in line with national and international guidelines. Britain has had human tissue legislation in place since 1961.

On the practice in the Republic during the 1980s, which is the subject of an inquiry announced by the Minister for Health, he said: "It would have been in keeping with what was considered best practice at the time."

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The professor of forensic and legal medicine (and coroner for Kildare) said the concept of informed consent was not developed at that time, even with medical operations.

The medical attitude was paternalistic, whereby limited information was supplied to patients, with doctors more or less taking decisions for them.

University departments based in teaching hospitals were supplied with tissue for research, but he was not in a position to comment on what arrangements they had in place.

It was always difficult when an adult or child died to determine what the wishes of parents or relatives would be. A balance had to be struck between obtaining consent, not causing undue distress, and the vital need to ensure tissue was available to ensure medical advancement.

Hospitals believed their practice accorded with "best practice" rather than any specific legal provision.

He said he did not believe it was an issue of neglect on the part of the medical profession while people, in general, did not give any legal consideration to arrangements for dealing with human tissue at that time.

There was a need now for a "patient-centred" approach to human tissue, with "information and choice" being the key words. This would be in the best interests of all parties.

"We are in an age where people should be told, and understand, and are reassured that tissue is being used for good purposes with their agreement," Prof Cusack said.

This did not necessarily mean putting everything in statute form, but guidelines and protocols for post-mortem procedures were required.

The Coroners' Review Group established under the Department of Justice has been looking at these issues since 1998, he confirmed.

Legislation could focus on the wider area of rights and protections for patients and their families, he suggested. But concentrating on tissue "ownership" would raise the question of its sale, he warned. But legislation might be necessary to deal with tissue of commercial value.

Changes were also needed to ensure proper arrangements for the disposal of human tissue and organs. He himself was not happy with the use of the term "disposal".

In cases of sudden, unexpected or unnatural death, post-mortems were carried out under the jurisdiction of a coroner, who was obliged to determine the cause of death on behalf of the public, he pointed out. Issues of consent did not arise with such cases. More than 90 per cent of Irish adult post-mortems involve a coroner. Where children die in hospital, apart from an accident, it is usually due to medical/natural reasons related to their condition. The hospital may request a post-mortem in order to examine the efficacy of a treatment; to investigate if other factors may have contributed to the death; or to check if there are implications for the patient's family, or others.

Kevin O'Sullivan

Kevin O'Sullivan

Kevin O'Sullivan is Environment and Science Editor and former editor of The Irish Times