"Some of the first attempts at the legislation were just completely unworkable. And through pressure from a whole range of groups, the legislation was changed in the UK.  It's still not perfect, but it's better than it was"
James Ironside (UK)

  More quotes on Legislation and Regulation

As in every field of science and medicine, the ethical standards that underpin pathology practice are not cast in iron, but evolve in line with the continuous debate in societies about what is right and wrong.  “People who say to me that ethics don’t change I think are deluded,” says David Levison. 

People who say to me that ethics don’t change I think are deludedMany of the practices that were acceptable 10, 20, 30 years ago are not acceptable today.  As these interviews show, context, too, is important: practices that are acceptable in one culture may not be so in another.  Mostly the rules change gradually and piecemeal.  But sometimes a dramatic event precipitates a wholesale rethink. The Alder Hey controversy in the UK, which drew in a wide circle of institutions, was such an event. 

The result was the revised Human Tissue Act of 2004.  Interestingly, there is a fundamental difference between legislation in Scotland and the rest of the British Isles. 

According to Nicholas Wright “it all went terribly wrong in England, because the Alder Hey and the Bristol things were about autopsy tissues, right?  I can understand the problems with that, but the English government said, ‘We're going to wrap all tissues up together.’... Now we have the bizarre position whereby surgically-acquired tissues [as well as autopsy materials] in England are governed by the Act and you have to get all this permission and stuff, and in Scotland you don't have to do it.”

A universal preoccupation is how this “burden of legislation” is leading to a scarcity of material for research, and the negative impact this is having worldwide on organ and tissue archives that are so vital to medical progress.

We forget where [the momentum for safety laws] started sometimesThis issue, and other questions about patient consent for organ retention, are a major concern for many of the interviewees.  Some, such as David Levison and James Ironside in Scotland, are actively involved in interpreting the new laws and overseeing implementation. 
One strand of the continuing debate centres on finding the balance between individual and collective (ie public health) interests.  Sebastian Lucas argues that there is a case for “overriding what we now regard as narrow consensual requirements [when it is] outweighed by the public good it does”.
Juan Rosai gives an interesting historical perspective on autopsies and the issues of consent, while others shed light on current practices and developments in organ and tissue retention in countries such as South Africa and the United States.

A completely different angle on legislation is covered by Derrick Pounder, who talks about the forensic pathologist’s role in framing public health measures in terms of carbon monoxide poisoning, seat belt directives, and drink driving laws etc. “We forget where [the momentum for safety laws] started sometimes -- it started in the autopsy room.”

Key interviewees:
Sebastian Lucas, Nicholas Wright, David Levison, James Ironside, Irene Scheimberg, Miguel Reyes-Múgica, Waney Squier, Kumarasen Cooper

See also:
Alder Hey, History of Pathology, Autopsy



Nicholas WrightIt's too early to know the impact of [the Human Tissue Act], but the legislative burden… I mean, you have to keep records of all [tissue] sections you've cut... You cut 50 sections, you have to make a note of [every one], and then you have to dispose of them properly because they're under the Act – you can't just chuck them away, they have to sort of be incinerated and a record kept.  Because it's a human tissue you see! ...We have to get this Act changed.
 - Nicholas Wright (UK)  

James IronsideSome of the first attempts at the legislation were just completely unworkable.  And through pressure from a whole range of groups, the legislation was changed in the UK.  It's still not perfect, but it's better than it was.
 - James Ironside (UK)

There's the UK legislation and there's the Scottish Human Tissue Act, and there are differences between the two... There are things in the Scottish legislation that are better for everyone than the UK legislation.  Most people in the UK seem to agree.  The Scottish legislation doesn't cover tissue from living patients, it only covers tissue from deceased patients.  And it allows retention of blocks of tissue and slides as part of the medical record automatically, for the archive, either from consent autopsy or from clinico-legal autopsy. 
We feel this is particularly important, especially over issues of sudden infant death – we don't know what the cause is, and we need to be able to do research.
 - James Ironside (UK)

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