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|  |  | | (This debate is closed and is a read-only archive.) | | The Human Tissue Bill is the UK government's response to the 'body parts scandal' at Alder Hey and Bristol Royal Infirmary. Will the tighter regulations on consent help restore public confidence and hold doctors to account? Or could it further corrode the trust we put in the medical profession? How do we safeguard patients' right to autonomy and privacy without undermining medical research and the health service's ability to act in the public interest? | Injuring medicine
[25-May-2004]
| | 'Wouldn't NHS employees be better employed treating patients, rather than filling in consent forms every time a sample is taken?' |  | | | Disagreements about human tissue, like so many disagreements, are bedevilled by words that have different meanings.
| Take 'human tissue'. To those who suffered in the 'organ retention scandal', this means post-mortem tissue, but those drafting the new Human Tissue Bill  defined it as anything that contains human cells. In the bill in its present form, a urine sample gets much the same protection as the heart of a dead baby. So if I train someone how to diagnose bladder cancer by looking for cancer cells in a sample of urine, I'll risk committing a criminal offence, with penalties of up to three years in jail. I must throw the urine down the drain instead. Is this really what the parents of Alder Hey wanted?
| Take 'research'. Most medical ethicists seem to think of genetic tests for horrible, incurable, inherited brain diseases, where it's true that patients may not want to know their fate. But 'research' can also mean getting a few old microscope slides out of the archive, looking at them, and asking whether any of the things seen down the microscope correlate with the patient's subsequent survival, response to treatment, and so on. This might sound like trivial research, but it's not. Our current classification of cancer is based entirely on this kind of research, which has been going on since the nineteenth century, using millions of tissue samples, without consent. Nobody has been harmed, and patients benefited enormously. We need to continue this work; but it is now subject to the sort of concrete shackles that would be appropriate for the most intrusive kind of genetic testing.
| But take 'genetic testing'. I can look in your eyes and tell at a glance whether or not you've got Wilson's Disease, a rare inherited disorder of copper metabolism - so I've done a genetic test, without your consent. Well, lock me up for three years. Seriously, testing germline DNA is - usually - a contentious business, and as with using post-mortem tissue, informed consent is - in most circumstances - vital. But DNA in cancers develops innumerable random mutations, which determine the tumour's behaviour, and examining them tells me nothing about the DNA of the patient. But to the regulators it is all 'genetic testing' and highly controversial. (Although those drafting the Human Tissue Bill don't seem to have noticed that you can synthesise DNA from RNA in the laboratory, thereby taking it outside the scope of the bill completely….)
| Now take 'consent', the holy mantra of modern medical ethics. But do you mean explicit, implied, or presumed consent? Specific or generic consent? How much information is necessary?
| When someone dies, and there is a possibility that his or her tissue may be of benefit to society, then for society to remove that tissue surely requires consent. The tissue must be a gift, because it has another important use, as a focus for grieving, funeral ceremony and religious observance. I have absolutely no concerns about the requirements of the draft bill in relation to post-mortem tissue.
| But when a patient has a cancer removed, and the tissue is sent to me for diagnosis and testing, what exactly does it mean to say I must have the patient's consent? Is the doctor who removes the tumour asking the patient for a favour? Is this tissue a gift? Isn't the patient rather glad to be rid of the tumour? Isn't it more meaningful to say the patient requests removal and testing? To be sure, the request must be adequately informed, but consent is a misleading word.
| When the tests are complete, what happens to any tissue that is left over? If (as those drafting the Human Tissue Bill clearly believe) there is no need to distinguish between post-mortem tissue and surgically resected tissue, shouldn't we treat it the same, and give it back to the patient or relatives, to be disposed of or preserved as they see fit? But most people are not too keen to take away their resected rectum and its cancer. Surveys of public opinion show the vast majority perceive it as 'surgical waste', and expect the hospital to dispose of it - or, if possible, to put it to good use .
| So if a patient doesn't want his tissue back, is this not evidence that he has discarded it? How then can it be regarded as a 'gift' to society? In common law there is no theft in taking something that has been thrown away. Of course, any subsequent use must not damage the patient from whom it came, and must be ethically acceptable, as explained in detail by the Nuffield Council on Bioethics in 1995 . If a patient refuses to allow such use of tissue he doesn't want back, he presumably fears that it may be used against ethical rules. But if there is such mistrust, how can that patient trust a consent process? His only recourse is to take the tissue away and destroy it himself.
| But the government says that consent is paramount. It expects NHS staff to seek explicit consent for use of 'waste' tissue every time a sample is taken (we know the staff won't bother , but put that to one side). Let's assume that it takes just one minute to ask the questions, listen to the answers, write them down and transcribe the answers into a database. (Incidentally, Research Ethics Committees, which must approve all research involving human tissue, would view such a brief consent process with derision.) NHS laboratories process about 150million specimens per year from living patients, which means 150million minutes per year, equal to 1300 full-time jobs .
| But here's an ethical dilemma. Wouldn't those 1300 NHS employees be better employed treating NHS patients? Is this an ethical use of resources? Wouldn't it be better to tell patients what beneficial uses might be made of their resected tissues, and invite them to take them away if they don't like it?
| If living patients abandon their tissue, let that indicate consent. Let's then put abandoned tissue to good use, under suitable ethical supervision, for the good of all future patients.
| Peter Furness is a professor of renal pathology and consultant histopathologist in Leicester, England.
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