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Rapid Responses: Rapid Responses published:
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If post-mortem tissue and 'surgical waste' are treated alike...
- Peter N Furness (5 March 2004)
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Human Tissue use in Professional Examinations
- Timothy R Helliwell (7 March 2004)
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Lack of logic
- John H Scotson (10 March 2004)
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The Hunan Tissue Bill: a bad law that will harm medicine
- Amanda Herbert (23 March 2004)
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Peter N Furness, Consultant Histopathologist Leicester General Hospital LE5 4PW
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A further thought from one of the authors. The Government in this Bill insists on making no distinction between post-mortem tissue and ‘surgical waste’. This seems illogical, but no matter; let us follow where it leads. After death, the body (and all its parts) are passed to the relatives for disposal, by cremation or burial. The state doesn’t do it, unless there is no alternative. If surgically resected tissue is to be treated the same way, should we not at least offer to return all surgically resected material, left- over blood samples, urine samples etc. to the patient? If the patient declines this offer, we then have cast-iron evidence that the material has been ‘discarded’ or ‘abandoned’. Then, the arguments provided by the Nuffield Council on Bioethics in 1995 must be applicable. If the patient has discarded the tissue, it is surely acceptable for society to put it to any ethically acceptable use. Of course, to be ethically acceptable, that use must not harm the patient from whom the tissue came (amongst other constraints). I cannot see how a patient who has discarded the tissue could legitimately object to this, apart from the grounds that he/she does not trust the assurance that the tissue will not be put to a harmful use. A CONSENT PROCESS CANNOT RESOLVE THIS LACK OF TRUST. If a patient lacks such trust, why should he trust a consent process? He has already chosen not to trust the doctors, Research Ethics Committee and hospital administration which must oversee the consent process! The only rational recourse to such a patient is to oversee the destruction of the tissue himself. So, if the Government is to be consistent, we should give all patients information something like the following: “It is normal practice to send blood samples, and any tissue or organs removed surgically to the hospital pathology laboratory for examination, to provide information to help your healthcare.” “However, your tissue is yours; you may have it back at any time instead of, or after, this examination.” “If you do not require your specimen to be returned to you, we will assume that you have discarded it. It will normally be incinerated, but it may be used for training members of staff, for maintaining the standards of our diagnostic laboratories, or in research. Research will only be allowed if a Research Ethics Committee, which includes non-medical members and exists to safeguard patients, has agreed that it poses no chance of harming you. Your confidentiality will be preserved.” “You should be aware that the healthcare you have received has been developed by using the tissues of other patients in these ways in the past. However, if you object to any of these uses, please tell us, and we will return the material to you, after treatment to eliminate any risk of infection. You may then make your own arrangements for disposal.” I think that’s pretty clear. Importantly, it points out that the patient has benefited from the use of the tissues of others, and can choose whether or not to help patients that follow in the same way. Please don’t tell me that’s coercive; it’s an essential piece of information when making that decision. It’s a fact, and it shouldn’t be covered up. But I suspect this idea won’t be taken up. Why not, I wonder? Do ethicists feel the need to protect patients from reality? To pretend that patients have rights without responsibilities? Isn’t misleading patients in this way a new form of paternalism? Which, of course, is what got us into this mess in the first place... One might argue that the imposition of criminal penalties makes the consent process trustworthy. If that’s true (which I doubt), why not apply penalties to the abuse of trust – let there be criminal sanctions if a patient is harmed? At present, this law produces a criminal offence where no-one has been harmed and the ‘criminal’ was merely trying to improve healthcare. A truly victimless crime. The patient does not even need to complain! Competing interests: The author is one of the authors |
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Timothy R Helliwell, Reader in Pathology Department of Pathology, University of Liverpool, L69 3GA
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Dear Sir I fully endorse the views and concerns expressed by Professor Furness and Dr Sullivan on whether or not the draft Human Tissue Bill will achieve an appropriate balance between the rights of individuals and the benefits to society of the use human materials. The practicality of monitoring consent for all patients is a major concern, and observations of our own attempts to do this using a combination of a separate section on the consent form and a declaration on the laboratory request form suggest that, despite a major effort by the laboratories, this is not a reliable way of recording patients' views. One aspect of the use of human tissue that has not received much attention is in professional examinations. The examinations of the Royal College of Pathologists provide a critical appraisal of candidates' abilities to recognise disease processes in blood samples, cytology specimens and tissue biopsies. The examiners take great care to select material that will discriminate between those candidates who are competent and those who require further training. With the current wording of the Bill, one presumes that only material from patients who had given consent could be used in examinations. This unintended consequence of the legislation is likely to severely restrict the examiners' ability to set appropriately demanding examinations. Competing interests: None declared |
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John H Scotson, Retired General Practitioner WA14 2AN
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It is a strange anomaly when this country which aborts one in five pregnancies within the legal framework of the Abortion Act now seeks to condemn those who use any human tissue, including cells from blood and urine, without explicit permission. Logic, common-sense and right reason should be apparent in the framing of all legislation. This does not appear to be the case in respect to new human tissue bill with its proposed draconian penalties for infringements. Competing interests: None declared |
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Amanda Herbert, Consultant Pathologist St Thomas' Hospital SE1 7EH
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Dear Editor I hope that the editorial by Furness and Sullivan (1) will draw the attention of our clinical colleagues to the disastrous effect the Human Tissue Bill will have on clinical research and teaching unless the Government listens to the numerous attempts to suggest amendments. The effect on research is already being felt because Ethics Committees have felt it necessary to observe the Department of Health's advice, which pre- empts the Bill and says that research and teaching require consent. So far that DoH advice has not been observed so closely for teaching. The Bill will make pathologists risk imprisonment if they teach without informed consent except during the process of making the diagnosis. With cytology it is far more useful to teach (and set examinations) after the diagnosis has been made on cases where the outcome is known. In the case of cervical cytology, hospital consent forms do not cover most of this work because the specimens come from general practitioners and health clinics. GPs and nurses will be expected to request informed consent for most of the 4.5 million cervical smears carried out each year in the UK each year. During the six years I have worked at Guy's & St Thomas' 200,000 cervical cytology tests have been reported of which less than 500 (0.25%) have turned out to be useful teaching cases. Unless the Bill is amended, consent would be required on 400 occasions for every one test that would be useful for teaching. If consent is to be informed, it could be said that patients should be told the purposes for which their cells and tissue blocks may legitimately be used without their consent (clinical audit, external quality assurance, public health monitoring and teaching incidental to diagnosis and treatment) - and that they are only being asked to give consent for teaching after the report had been signed out. I would find that hard to explain, and am not alone in finding it equally hard to come up with an appropriate form of words for a consent form. Being an optimist by nature, I like to hope that the section on teaching will be amended, perhaps after the Bill has gone to the House of Lords, and that we will not have to conduct our teaching sessions in visiting rooms in Holloway or Wormwood Scrubs. We will then be left will clinical research being severely hampered by the Bill, as is already happening. I draw your attention to articles by John Humphrys in the Sunday Times and The Week, apparently after an interview with Chris Foster, Professor of Pathology in Liverpool, in which he says this Bill is "bad law and will make for bad medicine". We need more people, preferably outside pathology, to make that clear. Yours faithfully Dr Amanda Herbert MB BS FRCPAth
Reference 1 Furness P, Sullivan R. The Human Tissue Bill: criminal sanctions linked t opaque legislation threaten research. BMJ 2004; 328:533-4. Competing interests: Could be at risk of imprisonment if this Bill is passed! |
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