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Law, ethics and medicine

Human tissue legislation: listening to the professionals
A V Campbell,1 S A M McLean,2 K Gutridge,3 H Harper4
Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Clinical Research Centre, Singapore; 2 Institute of Law, Ethics and Medicine, University of Glasgow, Glasgow, UK; 3 Centre for Ethics in Medicine, University of Bristol, UK; 4 Institute of Law, Ethics and Medicine, University of Glasgow, UK Correspondence to: Professor Alastair V Campbell, Chen Su Lan Centennial Professor of Medical Ethics and Director of the Centre for Biomedical Ethics at the Yong Loo Lin School of Medicine, National University of Singapore, Block MD11 #02-04 Clinical Research Centre, 10 Medical Drive, Singapore 117597; medavc@nus.edu.sg Received 10 July 2006 Revised 6 February 2007 Accepted 13 February 2007
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ABSTRACT The controversies in Bristol, Alder Hey and elsewhere in the UK surrounding the removal and retention of human tissue and organs have led to extensive law reform in all three UK legal systems. This paper reports a short study of the reactions of a range of health professionals to these changes. Three main areas of ethical concern were noted: the balancing of individual rights and social benefit; the efficacy of the new procedures for consent; and the helpfulness for professional practice of the new legislation and regulation. Recognition of these concerns may help in forging a new partnership between professionals and patients and their families.

The controversies that followed exposure of the retention and use of postmortem organs and tissue in Bristol,1 Alder Hey2 and Scotland3 led to a major revision of laws and regulation of all human tissue. Revelation of past practice, widely agreed to have been unacceptable, coupled with the requirements of the European Tissue Directive, have led to law reform in both Scotland and the rest of the UK. In England, Wales and Northern Ireland, law reform came in the shape of the Human Tissue Act 2004, although many of the finer details of the final shape of regulation have been left to the newly appointed Human Tissue Authority.4 However, one thing is clear from the 2004 Act. The source of power to retain, use and hold human tissue and organs resides in the consent either of the person himself or herself or otherwise of those who are qualified by an appropriate relationship with the deceased. In Scotland, the Human Tissue (Scotland) Act 2006 came into force on 1 September 2006, virtually simultaneously with its English equivalent. There are some differences between the two pieces of legislation—perhaps most significantly that the Scottish Act prefers the concept of ‘‘authorisation’’ to that of consent—but each legislative provision firmly espouses the need for agreement to be reached before tissue and/or organs are removed, retained or used. Although law reform has now taken place in England, as we have said, the new authority with responsibility for overseeing the uses of human tissue and organs is statutorily required to produce codes of practice. Some have already been formulated,5 but this will be an iterative process, meaning that there remains a real opportunity for the voice of professionals to be listened to as detailed policy is developed. To date, professional involvement has been primarily at the institutional level. The voices of the practitioners on the ground—pathologists, medical educators and scientists, transplant

surgeons, transplant coordinators and intensive care specialists—have been unevenly heard and often only in a defensive tone. Until now, many practitioners may have felt they were driven by the process rather than being directly engaged with it. Given the publicity afforded to past practices and the depth and strength of the feeling these practices generated, a defensive response from the professional bodies may have been understandable, but as time and law move on, there is now a real opportunity for professionals to participate actively and positively in shaping new law and practice, making them work for everyone concerned. In the light of these concerns, we carried out a small research project, over a period of 9 months, funded by the Biomedical Ethics Funding Committee of the Wellcome Trust, with the aim of examining professional narratives on the ethical, legal and practical aspects of professional practice involving the use of human organs and tissue.i The study was qualitative in nature and involved semistructured interviews designed to explore the following issues in relation to the use of human organs and tissue: current issues facing professionals; changes they had experienced in professional practice; and the predicted impact of the new legislation. Each member of the research team submitted a list of questions that focused on the above issues. These questions were discussed, developed and revised into open-ended questions. The discussion was informed by a multidisciplinary literature review. The research was carried out in two centres: Bristol and Glasgow. Given that this study was intended to examine the views of a range of professionals involved in the different uses of human tissue and organs, a random sample was deemed inappropriate. Respondents were purposively sampled: each had specific insight into different aspects of work with human tissue and organs. Interviews were conducted with 31 professionals: pathologists (n = 13); members of transplant teams (n = 13); anatomists (n = 2); researchers (n = 4). All interviews were recorded and transcribed. The analysis of interview data used thematic analysis tools associated with the grounded-theory approach to qualitative analysis. Preliminary codes were developed from two independent reviews of all the transcripts, after which the initial codes were peer-reviewed and revised to develop a consistent coding frame. The coding frame was used to examine all transcripts to identify emerging themes or hypotheses pertaining
A full report of this project is available from the corresponding author. J Med Ethics 2008;34:104–108. doi:10.1136/jme.2006.018358
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com Law. I don’t think autopsy is a private issue. Here is how a tissue coordinator described the problems in the old legislation: The fact that families and staff think that you are going to get consent for somebody to donate their tissue where in fact it’s legally worded that you are obtaining their lack of objection. there is no evidence that this happened to any serious extent. So if they put yes they are objecting to donation. the pathologists (understandably.1136/jme. You know we were told it was a good thing to keep organs. I felt awful. The transparency is what they like. but actually it is seeking lack of objection. 2012 .Published by group. even if. … because we were so out of touch with what the general public thought—apparently—and yet we were doing nothing that we hadn’t seen all our colleagues teach us to do. However.bmj. meaning that they want to give the corneas. As one pathologist put it. For some—the transplant team members and the anatomists—the need for a clearer legislative context was acknowledged and on the whole the new regime was seen to mirror their current practice. according to these professionals. Personally I think it would be a wonderful thing. some respondents saw a drop in the standard of autopsy practice.bmj. so I err on the side of caution and don’t take anything.Downloaded from jme. I know that half the people in the street would not hold that—they would hold the ethical position that the body belongs to the parents and the parents have an absolute right to decide what is done with it because it’s a private issue. One pathologist hoped for a very different future. Although there were fears that the retained organs controversy would have an adverse effect on donations of organs for transplant and cadavers for anatomical teaching and research. one in which pathology practice is out in the open: Medical science is going to be put back unless we move into a culture where we are all much more open about what it is we’re doing.018358 In the case of donation of cadavers. the anatomists had to deal with the distinction in the existing legislation between consent for teaching and consent for research. I think it’s too important. with much less done than was the case before all of the controversy: In autopsy I’m very reluctant to obtain any organs. but they do see a real danger that the balance of public goods—protection of the individual right to consent versus promotion of good medical practice—has gone awry. In this atmosphere. each covered by a different act: The forms that are sent out—because the legislation is entirely separate. And I think personally that was what was lost with Alder Hey and Bristol. And to find that this was something. This uncertainty about the future was shared by the researchers. are we going to be J Med Ethics 2008. the patient’s relatives have ticked the box ‘‘organs may be retained’’ I tend not to bother … Even taking histology now is a problem. the experiences of respondents from the transplant community and from anatomy were very different from those of the pathologists and tissue researchers. doi:10. since they were the main targets of criticism in the official reports and the media) felt less sure that the right balance had been struck. the change from ‘‘lack of objection’’ in the 1961 Act to a clear set of guidelines based on consent or authorisation was seen as clearly an improvement. And some of the forms and the way they’re filled in are ambiguous. provided it leads to a fuller debate about the competing values inherent in the controversy. And we’re very wary or I am personally. both groups were already accustomed to working within a framework of legislation (the Human Tissue Act 1961 and the Anatomy Act 1984) and the proposed new legislation was seen as a clarification or endorsement of current practice. where people are much more willing to speak to each other about what we are doing and much more willing to share out ideas. The need for transparency was echoed by a researcher. altruistic or are we each going to work in our own little private domain? BALANCING SOCIAL GOODS The attitudes of the different professional groups to the aftermath of the organ removal and retention controversies varied widely. DILEMMAS OF CONSENT Another respondent described the sense of fear and uncertainty that now surrounds postmortem pathology practice: I think you are intrinsically afraid of doing something which is against what the public perceive as normal practice because we know how people were hounded before. reflecting on changing attitudes to autopsy: My own viewpoint is that I do my job for the benefit of society and that autopsy is a form of altruism. Well. However. Quotations included in this report reflect the predominant themes identified in the analysis. I think it’s very much a public issue … And the other thing is that we are all members of society and as a group we need to decide what stance we are going to take.2006. For the transplant community. but I think we are some way off. obviously. Which might be to the detriment of the eventual diagnosis. for these groups the issue of consent (itself a cornerstone of the new legislation) was seen as crucial.34:104–108. absolutely awful. ethics and medicine to the relationship between codes. Moreover. despite. These respondents are not questioning the need for a clearer legislative regime than that of the past. As we noted above. that this was something people were getting death threats for was a terrible shock. and to do this and to do that. The organ retention controversy and the subsequent move to legislation need not be entirely negative in effect. The atmosphere of siege and unfair victimisation felt by some pathologists in relation to postmortem tissue is well conveyed by the following interview extract: We were made to feel like criminals.com on March 17. and potentially a source of continuing dilemma. for the Anatomy Act and the Tissue Act—at the moment basically we send out a lot of 105 . experienced in gaining consent for the use of surgical tissue: … patients are really happy that you’ve asked—whether or not ‘‘it’s just going to be discarded’’ they’re really happy that you’ve asked them and told them about it. the staff and family will fill in the form thinking it is a ‘‘consent form’’ and thus will circle yes to corneas.

Consent. to be prepared to participate. ethics and medicine information about exactly what would happen with the body and the person can then chose whether they donate their body for teaching or for research … and obviously if it’s been donated for research we can’t use it for teaching and vice versa. and yet they’re happy to donate. and attitudes to. that I want to look at 10 cases. through the research ethics committee system: Well again.ii All sought improvements in the current practice of.34:104–108. to be honest. for good reason. that is to say for diagnosis. consent. we do provide information and. If … there’s a kid lying in a babygrow. there was concern about the way in which grief would make it difficult for relatives to give consent: … the relative at the time of trying to make the decision is not really in a state to talk about these things because of the grief that the person is suffering and this is an issue that no one is kind of interested in looking at. with informed consent all the way for all sorts of things and I think that’s going to make it very difficult. another respondent. teaching. you know … so even to have an informed idea of an autopsy would be just horrendous. This respondent saw a positive moral gain in new legislation. to have the information. while consent was seen as important. had to cut both ways: I think because consent is so fundamental to this and consent is a two-way process and I’m quite happy to have a duty to inform. In Scotland. they would not wish to receive information about what this entailed. J Med Ethics 2008. no coercion. provided (in the case of research) the tissue is anonymised and the research is approved by a research ethics committee.. 106 ii We should note that considerations of this kind were one reason why the proposals of the Scottish inquiry were to adopt the concept of authorisation rather than consent. I find it absolutely amazing. they don’t look as if they belong on the slab. On the other hand. In fact the Act does permit this range of activities without consent on tissue from the living. I think there ought to have been greater freedom with regards to the examination of tissues as long as it’s done for the. that we also give them.bmj. It’s been very much against all that.com Law. it’s a two-way thing. in relation to the use of tissue from the living: Well.Downloaded from jme. that the authorisation we’re using is legitimate and there’s been no coercion and the patient has had time to consider the information. and that it’s not too much for them. Although there were other reasons. I’ve done some paediatric autopsy and you know the thing is if you see an old person lying on a slab they look as if they belong there. For other respondents. several respondents deplored the increasing bureaucratisation of the process. my research work. and their baby-grow off. expressed the concern that the consent or authorisation gained had to be genuine and legitimate: My main concern is that the consent is informed. we also adhere to the principles of informed consent. For one consultant anaesthetist. which is obviously one of the problems with the Acts at present. And so doing that autopsy is hellish. although objectively they would be willing to allow organs/tissue from a deceased person to be used for accepted purposes. This positive endorsement of the principle of consent. seeing the requirement for consent as too wideranging: It’s the detail of the consent that’s being asked [which we are concerned about] not who is being asked or who has the authority to say so. I think it’s just hardened up in a way that’s not considered all the other things that tissues and organs are necessary for. evidence taken by the Independent Review Group from some families suggested that.018358 . to collect data.Published by group. the new insistence on consent was seen as unduly restrictive. These comments were made while the Human Tissue Bill was still being debated. the heavy emotional loading in paediatric autopsy—for parents. which is one of the main things that has changed in the Act . which gave full scope to the spirit of the donation as a gift to be used to greatest effect: … I would have thought from an ethical point of view it would be better to make best use of this bequest so if they bequeath their body for research and you could use it for teaching as well then that is making the best use of the wonderful gift that they have given us. did not mean that respondents saw it as problem free. Another pathologist echoed these concerns as they relate to surgical tissue. that the information I’ve given has been comprehended. 2012 . and take off their nappy. however. to read the information one gives. doi:10. In another response. then. and there’ve been a lot of people poking needles in them and then suddenly he wants to chop them up. That hasn’t been the case. is seen as pivotal to best practice by these respondents. And they’re obviously in a very anxious state.1136/jme.2006. And I don’t think from my point of view that it’s a matter of who can and can’t … give consent. he claimed. the new legislation will cover only tissue from the deceased. and this was echoed by the other professional groups. that were done 10 years ago.bmj. Finally. but are also able to consider the fact that some patients do not want any more information. In the case of cadaveric donation.. the body it’s an old thing … But if you’ve got a child for two days or something like that. from a pathologist. especially in distressing circumstances: … many of our patients are undergoing surgery for cancer. the difficulties were the familiar ones of the problem of obtaining fully informed consent. the emphasis on consent underlined the need for partnership between patients and professionals when tissue from the living was needed for research—consent. a research nurse skilled in gaining consent from patients. For one pathologist.com on March 17. phew. but we also have the other side … the public has a duty to engage in the other side of it. so I think that would be a wonderful improvement if it were to be. And you have to take the teddy bear out of their arms. … and their life has just been given news that really has turned their lives upside down … we don’t add to that distress. research quality and all the rest of it. with a teddy bear. but also for the pathologist—is graphically portrayed: You know if you’ve lived with somebody for 40 years as a husband or wife. to educate.

Published by group. Although this limits the generalisations that can be made from the data. there may have been a perception that the professions involved were resistant to change and dragging their feet when it came to legislative proposals. and I think it’s also important for relatives. the physicians. This positive view was echoed by a consultant intensivist involved in transplantation: I think the law has always got to be a help. the clarification brought by the new legislation was welcome: It will finally tell us what we should do with all the archive material which we currently have from a previous era which we are sitting on because we are not allowed to touch it or do anything with it at all. … we’ve all been threatened with the rule that if we keep anything that we are not allowed to keep we might face a three-year prison term. A tissue coordinator saw benefits for the transplantation service in the clarity of the new law regarding retention of tissue and organs: Previously there was confusion for some about retained tissue from postmortem and I worried about the possible impact on donation and transplantation.1136/jme. But most respondents welcomed the changes. I mean I just can’t understand why there aren’t guidelines which say that it’s ok you know. the clinical scientists. the dire consequences of doing anything that might be deemed as outside the framework of what’s currently now acceptable. it allows boundaries around which both ourselves and the relatives can discuss issues. And I think it allows. we do claim that our research has revealed insights into how the professions have reacted to 107 For researchers. strengthens the validity of the research. definite framework to work with. harmonisation between Scotland and England is likely. everyone’s got to work within a certain framework. the criminal sanctions in the new law in England and Wales have created an atmosphere of uncertainty and fear in the minds of some pathologists: We are shackled at the moment and everyone is fighting shy of putting the wrong side of the line. and it kills research right. everybody will know. well who would look after my children day-to-day? WILL NEW LEGISLATION AND REGULATION HELP? At the time of the controversy over retained organs and the parliamentary debates on the Human Tissue Bill and the Human Tissue (Scotland) Bill. a view shared by many in the field … A lot of work was undertaken at the time to give information about the differences. DISCUSSION AND CONCLUSIONS We believe that these voices from the professional communities affected by changes in the legislation regarding human tissue raise some key ethical issues. the law is there to protect them. The Scottish legislation creates no such authority. we were able to identify descriptive codes that reflect the real dialogue of the professionals rather than a reduction or abstraction of their responses.com Law. because people will. And they’ll have a J Med Ethics 2008. I think it will be better.Downloaded from jme. to have a sense of trust in the law. I think that will improve. they should fight and be like a representative authority. it’s all anonymous and I have to go through all of this huge rigmarole. and its effects were yet to be felt. I’m a single parent. I don’t think it’s been a hindrance at all.) It is true that one respondent yearned for the old days. I think … it’s facililtatory. Given the above caveats.com on March 17. doi:10. but does empower the Scottish ministers to seek the assistance of any public authority (in this case the Human Tissue Authority) in exercising a number of their powers. will know exactly what they can do. It is therefore expected that on certain issues. a systematic and replicable method of analysis. welcoming the ‘‘vagueness of the original Human Tissue Act which didn’t cover anything really—which was nice in some ways’’. I mean that’s a huge thing. sort of. again. way of using it. it helps us do what we do and it gives us a legal framework within which to work. but that’s a very one-way system and it should be a bidirectional system. With the new Tissue Act again it’s clarity. This was strongly expressed by one anatomist: I think it’s absolutely essential that there is a very.6 Using aspects of this approach. ethics and medicine In the past I could have done it in a week. of course. too. These uncertainties are summed up in the following comments from a tissue researcher: In some ways they should fight our corner. as described by Glaser and Strauss. very tight legal framework. On the other hand. The analysis of the interview data used tools associated with the ‘‘grounded-theory’’ approach to qualitative analysis. the Authority was in the process of being set up. We’ve got more print letters about the consequences. This is certainly not the impression created by our respondents’ comments on forthcoming legislation and regulation. left and centre. (It is possible. the respondents expressed a mixture of hopes and fears about its likely helpfulness or unhelpfulness for professional practice. or the good will of. the respondents in England were able to discuss the relative advantages and disadvantages of having a new Human Tissue Authority.2006.018358 . so the thought that anything I did might lead to me being imprisoned.bmj. the surgeons.bmj. Our research was qualitative and was carried out with small groups of professionals in two centres. It’s one thing to act in a policing role to make sure we’re actually doing what we’re told.34:104–108. seeing them as helpful to their professional practice. And once that’s settled down and people get into the. that those strongly resistant to change declined to participate in our research. which should help guide future discussion of this contentious area and could also influence the ways in which the Human Tissue Authority and other relevant bodies act in the future. This element of clear direction was also seen as an advantage for future research: In terms of the material for research. 2012 . Actually we should be able to feed up to them and say actually this is just not feasible … and they should be able to fight the corner to make sure that the best interests of research and the best interests of. At the time of our study. these people who originally donated are actually properly represented. So far as regulation is concerned. or whatever. now I have to fill out a 57-page ethical form.

Independent Review Group on Retention of Organs at Post-Mortem. January 2001. 2. 6. there was a noticeable push towards regarding tissues and organs primarily as a valuable resource for the community. if it did. and the need for a new understanding of the ethical issues of tissue retention and use in terms of communitarian values. Edinburgh: Stationery Office. Consent/authorisation issues The controversy over retained organs revealed a major shift in social values.hta. on the grounds of giving greater clarity to the boundaries of their practice and of providing safeguards and assurances to patients and relatives. HC12. 7.http://www. In the field of tissue retention and use. Elaborating the actual content of the various codes of practice will certainly be informed by legal requirements. as an essential corrective to any one-sided view of how the uses of human tissue are to be regulated. but are rather the product of an ethos adopted by senior members of the profession and emulated by those in training. in relation to privacy. the law has become unequivocal. we would suggest that. such as organ transplantation and tissue research. Final report.uk/acts/acts2004/ ukpga_20040030_en_1 (accessed 1 December 2007). London. The strong awareness of these professionals of the undoubted benefit that may be obtained from the use of body parts can lead them to regard their procurement and use as a primary good. May 2001. different ethical issues arise.opsi. 4. prioritising and appropriate use of data. we hope that we have dispelled some myths about insensitivity in professional attitudes and have shown that. Although there seems to be consensus across professionals about the potential benefits of law reform in this area. It was notable in our research that ethics did not appear to play a major role in the day-to-day decisionmaking of professionals. the force of which was perceived only in retrospect.gov.bmj.com Law. Strauss AL. An implication of this would be that the current emphasis on individual choice could be inimical to the interests of society. The Royal Liverpool Children’s Inquiry.bmj. They stole my baby’s soul. http:// www. funded by the Wellcome Trust (Grant no. The same holds true for the use of postmortem tissue.1136/jme. A communitarian approach? From the point of view of ethical theory. However. Campbell AV. in the long run. often in difficult circumstances. However. when the outrage of those families kept in the dark about the retention of their relatives’ organs was made public. and so more important than the needs of individuals or families. This paper is based on a scoping study entitled ‘‘Ethical and practical concerns regarding changes to human tissue legislation’’. Human Tissue Authority.org.uk (navigate to Guidance. The clinical reality of gaining consent. ss 13–15. there is much in the new legislative changes that reflects a common cause and common concerns. Although nobody rejected outright the need for consent or authorisation. but if it is to commend itself to individuals.gov.uk (accessed 10 December 2007). seen as information too stressful for families to cope with and to be given a fully informed choice in all aspects of medical research revealed how central autonomy has become in all aspects of our social life. Specifically. however.bristol-inquiry. These ways of acting professionally cannot be legally prescribed.Published by group. Acknowledgements: We are indebted to all the participants in this research project for their willingness to speak freely and openly about their concerns. in anatomical dissection.34:104–108. Codes of Practice) (accessed 1 December 2007). 3. doi:10. 076028/B/04/Z). Willis M. People are no longer prepared to be the passive recipients of medical beneficence or to have themselves or their families treated merely as the ‘‘subjects’’ of research. despite misunderstandings that have arisen on both sides. http://www. The wide range of potential uses of human tissue opens up a whole range of ethical issues beyond those covered by legislation. Human Tissue Act 2004. We can give only an outline of these issues in this paper. we pick out three key areas: the relationship between the law and ethics. Bristol Royal Infirmary Inquiry. but in the last analysis much will depend on the professional judgment of individual practitioners and their willingness to recognise the ethical dilemmas in their work and to seek solutions through reflective and shared decision-making. Chicago: Aldine. The discovery of grounded theory: strategies for qualitative research. 5. Med Humanit 2005. the most interesting outcome of our research has been the suggestion from some of the professionals that the use of tissue in the future should become seen as shared community commitment. is far removed from the philosophical ideal of fully informed consent. ethics and medicine these changes and that it suggests ways in which the ethical dialogue may be carried forward in the future. This cultural change is one to which medical practice is rapidly adapting. it must be recognised that the law alone will not be sufficient to ensure ethical practice. REFERENCES 1. Glaser BG. and this will require a higher standard of training in clinical ethics (and possibly law) than currently is available. even though it may prevent the grosser abuses of professional power. This may reflect the current focus on legislative solutions to the problems that have arisen. recognising the inevitable tensions between individual rights and the common good. For example. greater attention will need to be paid to ethical training and debate in all of these fields. No doubt professional guidelines can be of some assistance here. particularly in the way grieving relatives are dealt with. an attitude of respect toward the deceased and a spirit of gratitude for the donation of their body is an essential part of ethical conduct at the dissection table. Interim report: Removal and retention of human material. In other areas. especially in distressing situations of serious illness or traumatic bereavement. the ambiguities associated with the central concept of consent. some tensions continue to divide opinion as to the appropriate model for managing human tissue and organs. By doing this. 1967. London: Stationery Office. Once again it is the subtlety of professional practice within the law that will need much more attention in the future.7 In the current paper we are trying to make the voices of the professionals heard. or at least that. but we suggest that they all merit further research. The inquiry into the management of care of children receiving complex heart surgery at the Bristol Royal Infirmary.31:101–4. 2012 . professionals and society at large it will need to be nuanced. Competing interests: None declared. But this leaves a major challenge for those who must implement the law.com on March 17. it was not recognised as such. and inevitably much of this focuses on the nature of consent.018358 . Ethics and the law We have noted how changes in the law have been welcomed by representatives of several professional groups.Downloaded from jme. One of us (AVC) has recently published a paper describing the reactions of families to the organ retention controversy and has described how the narratives of professionals and of patients and their relatives often fail to connect.2006. Demands not to be shielded from what was paternalistically 108 J Med Ethics 2008. 2001.

et al.full.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.com on March 17. 2012 .bmj. J Med Ethics 2008 34: 104-108 doi: 10.html#related-urls Email alerting service Receive free email alerts when new articles cite this article.com/content/34/2/104.bmj.html#ref-list-1 Article cited in: http://jme.2006.com Human tissue legislation: listening to the professionals A V Campbell. Sign up in the box at the top right corner of the online article.018358 Updated information and services can be found at: http://jme.Downloaded from jme. K Gutridge.html These include: References This article cites 1 articles.bmj.bmj.full. Topic Collections Articles on similar topics can be found in the following collections Research and publication ethics (326 articles) Notes To request permissions go to: http://group.com/content/34/2/104.bmj.com/content/34/2/104.bmj.full.Published by group. 1 of which can be accessed free at: http://jme.1136/jme.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.com/subscribe/ . S A M McLean.