Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Anonymise all samples
- Trevor G. Kerr (3 October 2003)
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Bar Codes and Implied Consent
- Simon Knowles (3 October 2003)
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Blight on the use of human tissue in medical education and research
- Timothy R Helliwell (4 October 2003)
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Response form the author
- Peter N Furness (5 October 2003)
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EQA under threat too?
- John Nottingham (6 October 2003)
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taxation and tissue
- Simon Knowles (6 October 2003)
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Code Proper Secondary Use of Human Tissue in the Netherlands
- Peter H.J. Riegman (8 October 2003)
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Re: Anonymise all samples
- Adam F Padel (8 October 2003)
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Who will be the loser?
- Peter J Waugh (9 October 2003)
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Use of Surplus Human Tissue For Research
- Michael J Shackcloth, Robert Lowe, Emer McCarron, Walid C. Dihmis (11 October 2003)
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Patient consent to the use of human tissue taken from NHS patients, and stored for research purposes
- Nicholas J Wald, Carol Dezateux and Ann Bowling (14 October 2003)
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Universal consent form
- Ian M Frayling (15 April 2004)
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Implied consent or objection
- Gargi Sanyal (9 May 2005)
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Trevor G. Kerr, Medical Microbiologist Southern Health,Clayton, Australia, 3168
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If all samples, including blood, were labelled with nothing more than a unique code, and date, time and place of collection, they could be processed with no greater risk of error than exists at present. This way, samples would have relevance for a strictly limited period and purpose. They would have little commercial value, that could be sold on. Subjects would be unable to make financial claims on proceeds from work done on fully anonymised samples. The key to identification could be held by the subject, or the primary carer, or held in escrow by government agency. Much research, of the type conducted by Marshall and Warren, and the specific project referred to by Professor Furness, could flow on, unimpeded. Consent would be required to track the findings back to individuals, if familial studies are important. Consent would be required for extraction of demographic data, of the type necessary for pharmaceutical research. Consent should be required to place names in a cancer, or any other, registry, unless it is a matter of national security. Histopathologists need transient access to demographics, to interpret findings, but they do not need names on their slides. Competing interests: None declared |
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Simon Knowles, Pathologist Somerset
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Kerr writes “Histopathologists need transient access to demographics, to interpret findings, but they do not need names on their slides.“ I rather hope that such an opinion is born of the Australian warehouse approach to pathology and not a reflection of Dr Kerrs understanding of what cellular pathology is all about. I, for one, do need names on slides. I did not study medicine in order to make diagnoses on bar codes. I like names on request forms too, along with “demographics”. I like clinical details as well. Popping up to the ward to scrutinise notes, chatting to residents and radiologists, seeing patients and doing the odd fine needle aspiration are also clearly deviant acts which can have no place in the brave new world of Metropolitan Melbourne. The further “intelligent eye” pathology is sequestrated from the patient, the greater the clinical and medicolegal risk. And the less the degree of job satisfaction for the pathologist. Problems with recruitment? I wonder why. Champions of “rationalisation” of pathology and of corporate approaches to NHS activities should read these antipodean comments and reconsider. Simon Knowles Competing interests: I am a refugee from Australian warehouse pathology. |
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Timothy R Helliwell, Reader in Pathology Department of Pathology, University of Liverpool, Daulby Street, Liverpool L69 3GA.
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The editorial by Peter Furness highlights the concern felt by many in the NHS and Universities that the current regulations for the use of human materials in research strike an inappropriate balance between the autonomy of the individual in determining the use of their tissues, and the expectations of society that the medical community will strive to understand, treat and prevent diseases afflicting those tissues. Patients must be informed of the potential uses of blood samples and surgically derived tissues (and associated clinical information) at every opportunity. The prospective collection of material for clinical trials and research projects can reasonably be expected to be accompanied by informed consent. The difficulties arise for studies of uncommon diseases when it may take 10-20 years to acquire a sufficient number of samples to derive clinically-useful results. Archival collections are invaluable for this type of research which, if studied prospectively, would be delayed for decades or not be undertaken at all. The small research projects that follow serendipitous observations or which stimulate the minds of trainees (and potential researchers of the future) are unlikely to be possible with a significant long term decline in clinical researchers. The suggestion in the latest UK Department of Health proposals that explicit consent would be required for the use of human tissues in education and training will prevent undergraduate students from learning about diseases from surgical specimens received in pathology departments, will make all discussion about the teaching autopsy [3] irrelevant and will make it impossible to train future pathologists (and other health care professionals) about the diseases that they are expected to understand and treat. Implied consent is the only practical option for the educational use of human material and for archival studies for the reasons that are described by Furness [1]. For prospective research studies, hospitals should be required to seek the informed consent of patients for the storage of material in tissue banks (or the archives of pathology departments). This would require investment in the training of staff and the employment of facilitators who can ensure that patients have the information that they require in order to understand the nature and potential benefits of their valuable gift to society. Our legislators seem likely to blight health care education and research for a generation. While the laws on the use of human tissues need to be revised, what the health care community and society need is well-drafted legislation that will facilitate the appropriate use of human materials within an ethical framework that protects the rights of society as well as those of the individual. [1] Furness P. Consent to using human tissue. BMJ 2003; 327, 759-760. [2] Department of Health. Proposals for new legislation on human organs and tissue London. www.doh.gov.uk/tissue/legislationproposals.pdf (access 3 Oct 2003). [3] O’Grady G. Death of the teaching autopsy. BMJ 2003; 327, 802-803. Competing interests: The author is involved in non-commercial research using human tissues |
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Peter N Furness, Consultant Histopathologist Leicester General Hospital, LE5 4PW
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As the author of this article, naturally I agree with Dr Knowles and De Heliwell and I am grateful for their supportive comments. Concerning anonymisation, Dr Kerr proposes a solution which is sort of just about workable if, as Dr Knowles rightly points out, histopathologists cease to have clinical contact, which in my view would be disastrous. And it’s not a solution which would satisfy the latest published proposals from our Chief Medical Officer (reference 13 in the editorial). But there’s a more fundamental problem with the very variable understanding of the term ‘anonymisation’. Much of the recent literature on this subject accepts anonymisation as an alternative to explicit consent only if it’s irreversible. Anything less – such as Dr Kerr’s proposal – is ‘linked anonymisation’ or ‘secure coding’, and would still be seen by many as inadequate to permit research use of tissue samples. Irreversible anonymisation poses numerous problems. Quite apart from the limit it puts on the power of research, especially translational research, it can sometimes be positively unethical, notably because it prevents feedback of useful information. I have several examples, perhaps the most notable being where an ethics committee’s unthinking insistence on irreversible anonymisation quite possibly led to the failure to detect a baby with neonatal hypothyroidism. If that happened – and we will never know - then in my opinion the ethics committee was responsible for brain damage in a child. When ethics committees say ‘no’, it is not always an ethically ‘safe’ decision. But my other purpose for commenting is to toss into the ‘rapid responses’ a scurrilous thought which it just wouldn’t do to put in a formal editorial. Running the UK’s National Health Service obviously requires money. So we all pay taxes. Anyone who exercises their personal autonomy by refusing to pay taxes is a criminal. Society regards such people as selfish and immoral and would ultimately put such an individual in prison. Running the UK’s National Health Service also requires human tissue, at the very least for teaching, training and laboratory quality control, even if we do let other countries do the research. So how do we feel about those who exercise their autonomy by refusing to allow the NHS to use resected tissue to keep the NHS running, by insisting that it must be incinerated??? Actually I think it’s great that the altruism of the majority means that we can allow individuals the choice of deciding what happens to their tissues. If only we could do the same with taxes! But let’s be clear; IF you want the benefits of a modern health service, then controlling the use of resected tissue is a privilege granted by the generosity of others, not a basic human right. Any comments? Peter Furness Competing interests: The authos is involved in non-commercial research using human tissue |
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John Nottingham, consultant histopathologist Northampton General Hospital, Northampton NN1 5BD
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Dear Sir, It is now mandatory for consultant pathologists in the UK to take part in one or more External Quality Assurance (EQA) Schemes before being allowed to undertake certain types of work. Unsupervised reporting of cervical cytology and breast screening histopathology are two examples. The purpose of these schemes is to identify at an early stage poorly performing pathologists before they cause actual harm to living patients and act as an educational tool as part of continuing professional development. Most of the material is from resected tissue or routine cervical smears but may include post mortem material in some instances. Although the slides that are circulated to participants are anonymised, some linkage to the original patient is essential in some cases so that follow up or further biopsy may verify the original diagnosis. However, much of the recent guidance on the use of human material could potentially threaten these schemes. It is ironic that the very institutions that on the one hand impose these schemes to improve standards, on the other make it impossible to utilise tissue for anything other than diagnostic purposes without specific consent to do so. It is not only the teaching autopsy that is under threat by this very restrictive legislation but all forms of education for students and doctors. In the end it will be the patients that are the overall losers. Competing interests: I take part in and contribute material to several EQA schemes to maintain and improve standards in histopathology and cytopathology in the UK. |
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Simon Knowles, pathologist Somerset
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I agree with Peter Furness. The pendulum has swung too far in the direction of autonomy, at the expense of the duty of the individual to the greater good. My training and several of my research papers depended upon an assumption that tissue taken at surgery could be used for (non- malificent) research and teaching. But here we are, in 2003 and we must make the most of the culture in which we live and work. Our professional insensitivity to changes in community values was used as a defence against more serious accusations arising from Bristol and Alder Hey. We cannot use the same excuse a second time. Professor Furness has raised a point about duty which, far from being scurrilous is, in my opinion entirely arguable. I am attracted to his analogy with taxation, so here’s my suggestion: A. Those individuals who decline to allow the constructive use of their tissues should be taxed at a higher level. B. Conversely, the Professor should be allowed to remove 0.45Kg of tissue from any individual found in criminal breach of tax law for use in research without further consent. Simon Knowles Competing interests: I sit on a local research ethics committee and I still try to do a bit of research when I'm not banging on about consent. |
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Peter H.J. Riegman, Head ErasmusMC Tissue Bank Dept. Pathology, Josephine Nefkens Institute, Erasmus MC, PObox 1738, 3000DR Rotterdam, The Netherl
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In this for UK standards provoking article “Consent to using human tissue“ the right arguments have been put forward illustrated by good examples, why, in case of using left over tissue for medical science, most of the consent procedures ask too much for too little. It shows how consent procedures can be out of balance. Consent procedures have initially been developed to protect the interests of patients. Offering protection against involuntary use of their tissue for scientific experiments as main interest. In later stages other aspects emerged making most consent procedures too elaborate, using scarce resources of scientists and medical staff and therefore become an obstacle for doing even the most simple translational research experiments. The consequence is of the consent procedure is that it protects the patient from involuntarily use of there tissue, but in the long term harms the patient and future patients in innovation of their treatment. The solution here suggested “implied consent” looks very similar to the “Code Proper Secondary Use of Human Tissue” developed by the Federation of Medical Societies (FMWV) in the Netherlands. The Code was developed by bringing together all interest groups for secondary use on left over tissue. The consent procedure if tissues are coded linked is based on an opt-out system and forms a good balance between patient interests and scientific interests. As suggested, it can properly serve the small number (0.06%) of people who refuse their use tissue for commercial scientific purposes. People visiting the hospital are informed by a flyer, which can be found in waiting rooms and can even be handed out before undergoing surgery, describing the possibility that the patients left over tissue can be used in scientific medical experiments. In case the patient objects against the use of their tissue, they can fill out a form included in the flyer and send it to the hospital administration. The data on the form is entered in the hospital database and is checked against the contents of left over tissue banks. Tissues stored for experimental use derived from objecting patients will be destroyed. It offers protection against involuntary use and because it is not an elaborate and expensive procedure it allows translational research, from which hopefully the patient and future patients can benefit. In this way scientists and medical staff can fulfill their duty towards the patient to find ways to make the health care system better by using their scarce resources for performing translational research on left over patient material. In addition, this opt out system of consent, when making use of coded linked tissues, protects healed patients or worse, in the unfortunate case the patient has deceased, their family against unwanted and ethically difficult to defend questions concerning the permission to use left over tissue. It is of course instrumental that the flyer properly informs the public on the terms of the use of their left over tissue. It also gives the opportunity to make layers in the form of consent by letting people chose from a list of different possibilities, e.g. informed consent, commercial use etc. The text of the Code Proper Secondary Use of Human Tissue is available in English on the Internet: http://www.fmwv.nl/ Competing interests: None declared |
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Adam F Padel, Consultant Pathologist Aylesbury HP21 8AL
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I agree with Dr. Knowles that it is essential to have names of patients with Cellular Pathology requests. I am proud that every cytology slide and histology section in this lab bears the patient's name as well as a unique number. Our lab has recently enforced minimum labelling requirements - name, DOB and NHS number or hospital number. We had an interesting incident recently when a GP submitted specimens from three different patients but gave them all the same NHS number. The name on the slide indicates exactly who that tissue comes from. I find it very hard to understand the politically correct thrust for anonymity when patients themselves do not demand it; rather they are becoming more open. It has become a rarity for us to receive an anonymous cervical smear from the G-U medicine department. G-U medicine patients are asked whether they want to withhold their name from the lab. These days very few do; evidently they trust us. Withholding names from laboratory or other health care staff would be a further step in the dehumanization of medicine. Pathologists and other lab staff remember and use names as much as any other doctor. A name can immediately give me recall of past medical history and previous specimens which a number just would not do. Anonymity would not do justice to the vast majority of patients who are happy for their name to be used. It would not give them the choice to be known by their name. A very common complaint by hospital patients is that they do not want to be "just a number" - they want to be known by their name! If someone who wants my opinion does not trust me with their name why should I trust them with my name? I entirely agree with Professor Furness and others that use of surplus tissue and cells should be governed by implied consent. Otherwise we are imposing a huge burden on health care staff, both in clinics and laboratories to collect and record consent data, which I am sure most patients would think was a waste of valuable time and money. Competing interests: Consultant Pathologist hoping to still be able to train new medical, laboratory and other staff. |
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Peter J Waugh, Inspector HSE East Grinstead
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It is interesting to see how the arguements have evolved since the celebrated cases, which triggered off this debate. It is also extremely ironic that the consent issue over post mortem tissue has such an emotional element resulting in a relatively low response. One can understand this in most circumstances however it is not a good principle to encourage the idea of ownership where it comes to human remains. This idea has gained ground in during the last few years and has been promoted by a number of commentators who have been seeking to take advantage of public sensitivity over the issue. One does not wish to be insensitive where it comes to human tissue but I am troubled by the consequences of 'delegating' decisions on sensitive issues to a public that has been pulled in all directions often with scant regard to the fundamental values that are at stake. Of course there is now the mater of the genie that cannot be put back in the bottle and positions that have become entrenched. Will it now be possible to reverse the damage that has been done? I think that the only course of action is to convince the public by means of a coordinated campaign based on the undeniable fact that without proper access to human tissue for research and audit we will all suffer in the long term. Competing interests: None declared |
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Michael J Shackcloth, SpR Cardiothoracic Surgery The Cardiothoracic Centre, Thomas Drive, Liverpool, L14 3PE, Robert Lowe, Emer McCarron, Walid C. Dihmis
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Professor Furness highlights the concern felt by many in the NHS and Universities about the current regulations for the use of human materials in research (1). In our practice over 300 patients have been consented for use of surplus segments of artery and vein following coronary artery bypass surgery for research purposes. Over 99% of patients have agreed to take part in the research project. Two patients refused to consent to the research. Both felt that the consent process compounded pre-operative anxiety to the point that they were unable to discuss matters further. In neither case was there a fundamental objection to the retention of surplus tissues for research. One of the patients felt strongly enough to make the comment that 'he was now upset as he would not be helping patients in the future.' With the current political climate (following events at Bristol and Alder Hey), and the rigorous current regulations, research using human tissue has become increasingly difficult. This risks stifling any advancement in the field of cellular and organ pathophysiology In our experience and that outlined by Professor Furness there is an overwhelmingly positive response from patients for the use of human tissue for research. Thus, we believe that with ethical committee approval implied consent should suffice for research projects. This would avoid unnecessary patient anguish, at an already stressful time and allow a more efficient utilisation of research time. Currently it is ethical to accept implied consent to use surplus tissues for quality control (2). It therefore follows that it is ethical to use implied consent for research purposes. In the long term it is the patient that will benefit. References 1. Furness P. Consent to using human tissue. BMJ 2003; 327, 759-760. 2. Department of Health. Good practice in consent implementation guide: consent to examination or treatment. London: Department of Health, 2001. www.doh.gov.uk/consent/implementationguide.pdf (accessed 07 Oct 2003). (Tissue section, p 23.) Competing interests: All of the authors are involved in research using surplus human tissue |
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Nicholas J Wald, Professor and Head of Department of Environmental and Preventive Medicine Wolfson Institute of Preventive and Environmental Medicine, Charterhouse Sq., London, EC1M 6BQ ., Carol Dezateux and Ann Bowling
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Rapid response: Furness, P. Consent to using human tissues. BMJ 2003;327:759-760 (4 October) Patient consent to the use of human tissue taken from NHS patients, and stored for research purposes Nicholas J.Wald, Professor and Head of Department of Environmental and Preventive Medicine, The Wolfson Institute of Preventive Medicine, St Bartholomews and the Royal London School of Medicine and Dentistry. Carol Dezateux, Professor and Head of Centre for Paediatric Epidemiology and Biostatistics, Institute of Child Health. Ann Bowling, Professor of Health Services Research, University College London Medical School, Royal Free Campus. Peter Furness [1] argued that the use of tissue specimens from living patients is likely to be severely limited by the proposed new regulations which will replace the 1961 Human Tissue Act [2]. We agree. It is likely to damage medical research and public health surveillance. The problem arises from introducing a requirement to obtain consent for the use of data and samples routinely collected. Furness further raises the impracticality of obtaining consent to the use of human tissue in teaching, laboratory quality control and research [1]. The DoH document on the use of human organs and tissue states that “Organs and tissues should be removed, retained or used only for purposes for which patients have had the opportunity to give valid consent“ [2]. This apparently includes blood and urine samples. The paper continues that this implies that patients must be provided with explicit information about this, have the opportunity to ask questions and be able to give consent or register their objection [2]. Exception may apply for ‘quality assurance, in-service training, formal education, public health surveillance and investigating the performance of laboratory test kits’. Distinction between surveillance and research may be hard to define and these fine distinctions may prove to be to the detriment of public health. As Furness suggests, the proposed new regulations seem to have taken consent to participate in clinical trials as the model even though this is inappropriate for non-interventional research using existing samples since there is no possibility of harm given that patients’ identities are not revealed. While in-service training and quality assurance and audit would not require specific patient consent other non-interventional research would do so, even though the procedures and the implications for the patients are the same. This is inconsistent. Public health surveillance, which includes testing tissues (such as blood or urine) that are left over from clinical tests, would be jeopardised. The DoH document also states that ‘Patients have the right to ask for their samples not to be included in such surveys’ [2]. Such an “opt-out” provision may affect the validity of the research (since patients who opt out might be those whose outcomes or exposure differ in important ways to those who agree) and so prevent it from being done altogether. Of course patients should be given clear information about what may happen to remnant blood samples and other similar samples. This does not, however, mean that patients should have the right to demand withdrawal of their data or samples when this would have no detrimental effects to themselves yet be of great value to improving medical care. It divorces rights from responsibilities and, in effect, sanctions selfish behaviour that needlessly jeopardises the collective good. Requiring consent to the use of identifiable remnant samples would have prevented much valuable research such as the discovery that high AFP can be used to screen for open neural tube defects or that H pylori infection is associated with stomach cancer (critical evidence in showing that the infection is a cause of stomach cancer). It may not be widely recognised that often the research idea only emerges after the samples have been collected, when it may be impossible to obtain explicit prior consent. How can it be right to abandon a worthwhile research project that would cause no one harm? Residual tissue or samples such as blood, serum, saliva and urine should be allowed for use without consent provided this is for medical research conducted by a person under a professional duty of care (i.e. who could be suspended from a professional register for a material breach) and on the basis that no person will be identifiable in the results of the research so there is no possibility of harm or embarrassment arising from the research. There should be a clear public statement on this so the public are aware of the position and the safeguards regarding confidentiality. The objective should be that all observational medical research should be permitted without consent subject to enforceable professional guidelines such as those in the Royal College of Physicians Working Group Report [3]. This would be simple, clear, protect the rights of individuals and encourage valuable research, and also consistent with the utilitarian ethical principle of action for ‘the greater good’. We have written to this effect, along with 66 co-signatories, to the Chief Medical Officer at the Department of Health. References 1. Furness, P. Consent to using human tissue BMJ 2003;327:759-760 (4 October). 2. Department of Health. The use of human organs and tissue. An interim statement, London: Department of Health, April 2003. (www.doh.gov.uk/tissue/ 3. Royal College of Physicians Working Group Report Independent ethical review of studies involving personal medical records. J. Royal College of Physicians of London, 1994;28:439-443. Competing interests: None declared |
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Ian M Frayling, Consultant in Genetic Pathology & Director of Clinical Genetics Laboratory Institute of Medical Genetics, University Hospital of Wales, Cardiff, CF14 4XW
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Sir, I wrote the 'universal consent form' below a few years back, almost in a fit of pique, late one Friday afternoon after trying to produce a single form of consent for genetics in the aftermath of Alder Hey, but it would now seem germane in view of Prof Furness' leader on consent to tissue and the general theme of the BMJ this week. A major part of my work as a clinical cancer geneticist depends on testing archival material from tumours to diagnose familial cancer. The surviving relatives I see in clinic are invariably pleasantly surprised and only too thankful that pathologists have kept such material in the past. Those recently diagnosed with tumours are most impressed to find out that recently introduced tests, developed using archived tissue, can help diagnose familial cancer traits. A year ago, at another hospital, I had a cholecystectomy - on my teaching hospital consent form I specifically added that I would be upset if my operation/case/tissue was NOT used for teaching and research. Afterwards, my histopathologist colleague didn't know how to get my gall bladder and stones bottled for teaching purposes because 'we don't do it any more, sorry', so it now resides on the shelf above my head, in its original plastic pot. Yours, Ian Frayling Dr Ian M Frayling MA MB BChir PhD MRCPath
"By signing this I agree that my doctor is a reasonable person, applying common sense and trying to do their best in circumstances for which society takes collective responsibility. My doctor will attempt to do the best they can, but I accept that nobody is perfect and human beings are only human. In particular, any effective treatment is not without side -effects and all tests are fallible; in an attempt to reduce risks to a minimum, I understand drugs and procedures may have been tested on animals, first. I accept that my doctor may not mention every possible side-effect or complication because life is too short and they understandably wish not to worry me unnecessarily. My doctor or their delegate(s) can access and/or make available to others anything of use to my situation, me, my family or other humans or animals. For medical science to progress I accept clinical trials are necessary, but I will not complain if my case cannot be included in a clinical trial or study. Any tissue, gas, liquid or solid removed/expelled/exhaled/evaporated/derived from my body ceases to be my property; I understand that my body is no different from any other organism, in that ultimately all its components will be recycled in, for example, the carbon and nitrogen cycles. I agree to a post-mortem examination of my body, given that that is the only way of finding out what really went wrong in the end, and that it will benefit society as a whole, if not my nearest and dearest as well. All this does not affect my right to sue for damages in case of, for example, negligence, but I take responsibility that the overall cost of thus disaffecting the system may ultimately be to mine and everyone else's disadvantage." Competing interests: Doctor, pathologist, patient and member of society |
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Gargi Sanyal, Department of Medicine Princess Alexandra Hospital HarlowCM20 1JL
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Views of ethicst and new regulation can paralyse the arms of histopathology. Kennedy inquiry at Bristol Royal Infirmary and Redfern inquiry at the Liverpool Children Hospital adds to the over-reaction in the mind of people.The balance of wishes of people and research has to be elaborately discussed. Huge archive of sample of human tissue,organ are coorelating with the scientific research .Examples like archived autopsy of 198 soldiers helped to determine 1918 influenza pandemic.Auerbach's lung autopsy demonstrate the significance of smoking in the dysplasia in bronchial tissue. We have to see the participants in research should be respected and an adequate research design may make the purpose more acceptable. An effective oversight system is required to protect the needs of participants and also get approved ethically. This will indeed help the rationalisation and positive outcome of histopathology research . Dr Gargi Sanyal Competing interests: None declared |
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