Ethics

No single voice nor one perspective can claim to represent the whole of bioethics “Deep listening: bridging divides in local and global ethics” was the theme of the 7th World Congress of Bioethics, held in Sydney in November 2004. Preceded by the 5th Feminist Approaches to Bioethics Congress and followed by the 10th Australasian Bioethics Association Conference, the conference had 550 registered attendees from 35 different countries.1 The three conferences, running over 8 days, provided the biggest event in bioethics thus far in Australia and the Asia–Pacific region and demonstrated the breadth and heterogeneity of bioethics. The theme of the Congress — suggested by the word “dadirri”, meaning “deep listening”, from an Australian Aboriginal language — expressed the intention of the Planning Committee to explore a wide range of approaches to ethics in relation to health care and to provoke vigorous and productive discussion of the issues from different perspectives. The approaches ranged from those with a traditional focus on local issues in a clinical setting to broader reflections on bioethics at a global level. Emphasising the central importance of the indigenous theme, the keynote address of the Congress was delivered by Marcia Langton (Professor of Australian Indigenous Studies, University of Melbourne) on “Aboriginal intellectual and property rights”. Speakers at major plenary sessions included Thomas Pogge (Professor of Philosophy, Columbia University) on “World poverty”; Daniel Wikler (Professor of Public Health, Harvard University) and Daniel Brock (Professor of Social Medicine, Harvard University) on “Ethical issues in population health”; and Catriona MacKenzie (Associate Professor of Philosophy, Macquarie University) on “Conceptions of the body and autonomy”. There were 15 special symposia presented by specialist groups covering a wide range of subjects, including equity, refugees, torture, genetics, stem cells, biopolitics and HIV/AIDS, in addition to over 200 individual oral and poster presentations. The Congress program covered many topics of intense current interest — most notably cloning and stem cell research — and included many styles of presentation, such as talks, debates, panel presentations and group discussions. There was a program of Australian Indigenous dance and music, storytelling, poetry and art. There were also events for the general public that were well attended and aroused considerable interest, such as an open forum on biotechnology, stem cells and cloning and a debate between George Annas (Professor of Health, Law and Bioethics, Boston University) and Alex Capron (Director, Department of Ethics, Trade, Human Rights and Health Law, World Health Organization) on human rights and bioethics.2,3 A broader view of bioethicsThe Congress deliberately sought to extend the focus of bioethics discussions from traditional and important concerns about problems arising between doctors and patients to issues of wider compass, such as the broad social, cultural and political contexts that affect health and shape health care delivery. Also on the agenda were concerns about public health programs and the responsibilities of developed countries to contribute to health care in the developing world, as well as feminist and indigenous perspectives on bioethics. This combination of approaches precipitated some trenchant critical reflections on the philosophical assumptions on which bioethics itself has been based and revealed some tensions between differing views. Feminist perspectiveMany feminist writers have been critical of a prevailing assumption that individuals are autonomous decision-makers. From this perspective, Catriona MacKenzie argued that bioethics developed with a narrow, highly individualistic conception of personhood and autonomy. As an alternative, she outlined a “relational” approach to autonomy, according to which individuals and the decisions they make are understood as constituted within relationships of interdependence and embedded in complex social situations. Such a model necessarily draws attention to power relations within intimate and familial relationships and to oppressive or unequal social structures.4 Responsibility for health in the developing worldSome speakers built on this critique of power relations by drawing attention to power inequalities at a global level. For example, Solomon Benatar (Professor of Medicine, University of Capetown) proposed that HIV/AIDS be viewed not in isolation but as symptomatic of problems of poverty and injustice afflicting the developing world.5 Thomas Pogge argued that trade agreements between affluent countries disadvantage poorer countries and lead to systematic impoverishment and poor health of many people living in the developing world. As a result of this, he claimed, citizens in Western countries are not just innocent bystanders, but carry an unavoidable responsibility.6 One practical measure he proposed was to establish a system of financial incentives to encourage pharmaceutical companies to develop effective and inexpensive treatments for the major illnesses afflicting these countries. Tension between population health and individual perspectivesIn a controversial presentation that stimulated vigorous and sometimes heated debate, Daniel Brock and Daniel Wikler, using a rights-based framework, drew attention to the particular concerns of population health (rather than health care) and argued for a shift of emphasis away from managing disease to promoting health. While those who responded accepted the importance of a population perspective, they suggested that it did not go far enough in dealing with the problems of impoverished countries, and challenged those who engage in bioethical debates to become personally and politically engaged. One participant expressed concern that the proposed new focus on public and population health would lead to a diminished appreciation of the importance of issues affecting individuals. This brought to the surface a tension between those concerned with issues of individual freedom (including individual autonomy and human rights) and those who emphasise the role of society and culture in establishing ethical conduct and relationships. Human rights and bioethicsA further tension, expressed in the public debate, was between a human rights approach and more traditional approaches to topics in bioethics. In essence, the question became whether bioethics can (and should) be properly understood and addressed entirely in its own language and concepts, or whether it needs to be supplemented (or even replaced) by a human rights perspective. Indigenous ethics Aboriginal dancer: Clarence Slockee, Mindgingbal Clan of the Bundjalung Tribe, Northern NSW. There were also tensions evident in discussing the experiences of indigenous people in relation to majority cultures within their countries, and tensions surrounding issues of cultural difference. In her address, Marcia Langton adopted a broad approach to these issues and raised fundamental questions about knowledge and its dependence on culture, power and economic forms of relationship.7,8 Speakers from India, Sri Lanka, South Africa, New Zealand and Australia showed that indigenous populations face challenges in the delivery of health care that are in common across the world, such as disenfranchisement, lack of control over health programs and research, imposition of programs from outside, displacement from the land, prejudice and poverty. Nonetheless, there was a recognition of irreducible differences between cultures that require effective responses to be based on specific local needs and conditions. The discussion of indigenous issues, perhaps more than any other topic, made evident the need for openness to multiple perspectives. The challenge of accommodating diversityWhat can be concluded from this Congress, with its emphasis on listening across broad divides? One obvious conclusion is that there is no single voice nor one perspective that can claim to represent the whole of bioethics. There is no predominant theory or homogeneous position, nor is it constituted by just one focus. There are many areas of bioethical interest, including issues in the clinic, issues arising from new understandings in medicine (such as genetics) or possibilities presented by new technologies (such as stem cell research), and issues arising from feminist (and other) theoretical perspectives. Moreover, different levels of approach, ranging from a focus on individuals to a focus on populations (such as public health and indigenous health) raise different sets of ethical interests and concerns. In this context, “deep listening” can be understood as listening to each other, listening to different groups and listening to those with different voices. It implies an openness to a multiplicity of approaches. In drawing on a variety of perspectives on a health care issue, it is possible that some central concerns may rise above and be strengthened by this multiplicity, leading to an outcome that is recognised as ethical by all interested parties. It is also possible that some views will be incommensurable, some voices discordant, and decision-makers will have to determine that one set of values needs to take precedence over another. Nevertheless, we believe that many perspectives are needed to provide a wide vista and adequate understanding in preparation for informed, appropriate and nuanced decisions in health care. Human rights, population health and indigenous ethics can complement traditional perspectives. There is a need, both within health care education and in policy development, to consider issues from individual as well as wider social and cultural perspectives and to address disparities in power as part of a broader understanding of bioethics. The Congress demonstrated that diverse views can be accommodated, even when they are held passionately and discussion is vigorous. Listening for, and openness to, differences and commonalities worked well as a theme for the Congress. It is a capacity that remains to be encouraged in bioethics and applied in health care more generally.

Paul M McNeill MA, LLB, PhD · Ruth Macklin PhD · Angela Wasunna LLM · Paul A Komesaroff MB BS, PhD, FRACP

Trial registration, transparency and less reliance on industry trials are essential Over the past 20 years, politicians, hospital administrators and university deans have encouraged academic researchers to increase their participation in projects sponsored by the pharmaceutical industry, and the industry’s share of biomedical research has increased dramatically in that time (from 32% to 62% in the United States).1 Increasingly, the wisdom of this development has been challenged. It would be even better if testing drugs in patients was a public enterprise . . . The research agenda predominantly serves the interests of industry rather than those of patients. Surveys have shown that manipulation of clinical trials — whereby, if the results are published at all, the control treatment is disadvantaged by design, analysis, or interpretation2-5 — is common. Even when the results for the active and control therapies are no different, industry-sponsored trials come to a positive conclusion in favour of the sponsor’s drug five times more often than do not-for-profit-sponsored trials.4 This sponsor bias can have serious consequences. A meta-analysis supported by Merck concluded that there was no increased risk of arterial thrombosis with the company’s cyclo-oxygenase-2 (COX-2) inhibitor, rofecoxib.6 However, another meta-analysis, not sponsored by industry, showed an increased risk, which was apparent in publications available to the authors of the industry-sponsored meta-analysis 4 years before the drug was withdrawn because of thromboses.7 Such down-playing of harms in published papers has often required the collaboration, or acquiescence, of academic clinical researchers. It is likely that the widespread use of COX-2 inhibitors has caused thousands of premature deaths. An article by Henry and colleagues in this issue of the journal (page 557) reports important breaches in research integrity in industry-sponsored research, based on the experience of medical specialists in Australia.8 There are several reasons why the prevalence of the problems probably represents only the tip of the iceberg. Firstly, the authors note that their findings are limited by reliance on self-report, and only 39% responded. Secondly, while only about 9% of respondents reported one or more episodes of potentially serious research misconduct, the authors note that this is equivalent to 21% of those who had an active research relationship with industry. Thirdly, the authors did not consider protocol changes to be serious research misdemeanours. They need not be, but we found that at least one primary outcome was changed, introduced, or omitted while research was under way in 51 of 82 trials (62%).5 We think this is a serious problem as, with a median of 27 outcomes per trial,5 one would expect one outcome to become statistically significant by chance, even if the compared treatments were identical. Finally, 2% of respondents in the paper by Henry et al reported changes to study protocols while trials were under way.8 Our study comparing protocols with corresponding publications showed that formal changes submitted to scientific ethics committees are not common, but that informal changes are. We found that 86% of the respondents in a survey of triallists denied the existence of unreported outcomes, despite clear evidence to the contrary — we did not reveal to them until later that we had access to their trial protocols through the scientific ethics committees.5 Research misconduct and bias in intervention research could be markedly reduced if ongoing initiatives to register all trials at their inception, and ensure public access to trial protocols and all data generated by a trial, become successful. The International Committee of Medical Journal Editors have made a very positive and strong move towards this goal. They have agreed that after 1 July, 2005, its member journals, as a condition of considering a trial for publication, will require that it be registered in a public trials registry before patients enter the trial.9 Ethics committees would also have to play a central role to make this happen, and to ensure that commercial considerations will not be allowed to block access to the collected data, whether or not they are formally published. It would be even better, of course, if testing drugs in patients was a public enterprise (whether or not financed by industry) with blinding during data analysis and writing of manuscripts, till everyone involved had approved them.10 This would ensure that commercial influences on trial design, analysis, manuscript preparation and publication would no longer distort our views of the value of drugs and other treatments. It would also ensure that the comparison treatment was relevant, that the outcomes were directly relevant for patients, and that the patient population was relevant (eg, elderly patients in the case of COX-2 inhibitors, who are also those most likely to develop thromboses). A case in point is the publicly sponsored ALLHAT trial, the biggest trial ever performed on hypertension, which showed that the cheapest drug available was also the best.11 It is clear that governments could save money and treat patients better by investing much more in trials and academic trial centres than by relying on industry’s own trials and conclusions. Who would buy a washing machine that is five or 10 times more expensive than other machines just because its manufacturer has compared it with other machines and claims that it is the best? Unfortunately, such absurdities are often seen in health care, and are allowed to happen even in the absence of any direct head-to-head comparisons.

Peter C Gøtzsche MD, DrMedSci

Objectives: To characterise research relationships between medical specialists and the pharmaceutical industry in Australia.Design and setting: Questionnaire survey of medical specialists listed in the Medical Directory of Australia and believed to be in active practice, conducted in 2002 and 2003.Main outcome measures: Details of medical specialists’ involvement in pharmaceutical industry-sponsored research, and reports of potentially undesirable research outcomes.Results: Of 2120 specialists approached, 823 (39%) responded. Participation in pharmaceutical industry-sponsored research was more commonly reported by those in salaried practice (49%) than those in private practice (33%); P < 0.001. 216 reported that industry had made initial contact, compared with 117 who had initiated contact with industry. 14.0% of respondents reported premature termination of industry-sponsored trials, which they considered appropriate when in response to concerns about adverse drug effects. 12.3% of respondents reported that industry staff had written first drafts of reports, which they viewed as an acceptable practice for “internal” documents only. Of greatest concern to respondents were instances of delayed publication or non-publication of key negative findings (reported by 6.7% and 5.1% of respondents, respectively), and concealment of results (2.2%). Overall, 71 respondents (8.6%) had experienced at least one event that could represent breaches of research integrity.Conclusions: These data indicate a high level of engagement in research between the pharmaceutical industry and medical specialists, including those in private practice. Examples of possibly serious research misconduct were reported by 8.6% of respondents, equivalent to 21% of those with an active research relationship with industry.

David A Henry MB ChB, MRCP, FRCP · Suzanne R Hill PhD, GradDipEpi, FAFPHM · Evan Doran BA, PhD · David A Newby BPharm, PhD · Kim M Henderson BNurs, GradDip(HealthSocSci) · Jane Maguire BA, BNurs(Hon) · Barrie J Stokes BSc, MMath · Ian H Kerridge MPhil, FRCPA, FRACP · Paul M McNeill MA, LLB, PhD · Richard O Day MD, FRACP · Graham J Macdonald MD, FRACP, FRCP

Unrealistic expectations may overshadow genuine advances and focus attention more on failures For many years, scientists and clinicians have sought to harness the power of genes for treating disease. The potential for gene therapy to cure otherwise untreatable conditions, and to offer a completely new strategy where conventional medicine has limited efficacy, has attracted huge interest and investment of time and money from both academic and commercial biotechnology sectors. The field of gene therapy has therefore grown rapidly. However, unrealistic expectation has overshadowed genuine advances and focused attention more on clinical failures and unnecessary mistakes. Only recently, federal law enforcement officials announced a substantial settlement with the University of Pennsylvania after the death of a patient in a gene therapy trial in 1999. Consequently, gene therapy has been viewed with suspicion, and the tight regulatory control on the conduct of clinical studies has to some extent restricted progress. But is the frequently cited accusation that gene therapy has failed to deliver in the clinical arena justified, or is it another manifestation of unrealistic expectation? At the start of the 1990s, the first clinical trials of gene therapy were attempted for an inherited severe combined immunodeficiency (SCID) caused by deficiency of the intracellular enzyme adenosine deaminase (ADA).1-4 In the absence of definitive treatment, SCID of any molecular type is usually fatal within the first year of life, although patients with ADA deficiency can be supported by administration of exogenous bovine enzyme. Even so, this is often only partially effective, and is extremely expensive. The rationale for the development of gene therapy for SCID therefore derives from the severity of the illness, the inadequacy of conventional therapy, and the considerable morbidity and mortality associated with stem-cell transplantation, particularly from a mismatched donor. Efficacy in these early studies was limited, but a decade further on, gene transfer technology and cell handling protocols had been refined sufficiently to produce real clinical benefit. Four recent studies have demonstrated highly effective gene therapy for the X-linked form of SCID (SCID-X1) and ADA deficiency, using retroviruses to deliver the therapeutic genes into haemopoietic stem cells ex vivo5-8 (also Gaspar and Thrasher, unpublished data). Bearing in mind the outcome and adverse effects of conventional therapy, these are remarkable results and the first clear indication that gene therapy can offer a cure for some human diseases. In a few patients, including one reported in this issue of the Journal (page 458),9 the treatment has failed, indicating that there is more to learn about the effective dose of corrected cells and the potential for host factors to influence immune cell development.10 Many different types of vector have been tested in laboratory experiments to deliver therapeutic genes, and their effectiveness is largely determined by the host and tissue type. For stable gene transfer to dividing cells, such as haemopoietic cells, the new genetic material has to be retained through cell division and passed on to daughter cells. Although retroviruses are highly effective for this, their dependence on chromosomal integration brings with it the risk of inadvertent gene activation or inactivation. Having initially achieved successful immunological reconstitution, three patients with SCID-X1 (out of a total of 18 SCID-X1 and seven ADA-deficient patients treated to date) developed T cell lymphoproliferative disease about 3 years after the gene therapy pro-cedure. 11 In two of these patients, the enhancer sequences in the retroviral vector, which are responsible for effective transgene expression, had activated the LMO-2 proto-oncogene. There are likely to be other factors that contributed to cell transformation, but they have not yet been defined. It is therefore unclear whether all patients are at significant risk, or whether this is restricted to a few with SCID-X1. All this makes decision-making by regulatory authorities very difficult, as it would be unfortunate to withdraw potentially life-saving therapy from patients who have few rational alternatives. It is also difficult for families faced with deciding whether to participate in a new therapy with proven curative potential but an element of uncertainty in the longer term. In light of the third adverse event reported earlier this year, regulatory authorities in both France and the United States have put ongoing SCID-X1 studies on hold, although the US Food and Drug Administration have preserved the potential to treat patients in whom allogeneic transplantation has failed. Having considered all options, UK authorities have allowed trials to continue as before, with case-by-case review. This response seems to offer the most flexibility, as patients in whom conventional therapy is judged to be of very high risk can continue to benefit from gene therapy. Importantly, it also empowers families to participate, with informed consent, in the decision-making process. The Australian position is outlined in this issue of the journal (page 441).12 Fortunately, it is likely that much can be done to improve efficiency and safety of current protocols, and these developments are expected to enter clinical trial quite soon. The design of vectors used for gene delivery is clearly important, and modifications are possible that limit the risks of mutagenesis, such as incorporation of DNA and RNA insulator sequences in integrating vectors; use of self-inactivating vectors in which the powerful viral enhancer sequences are deleted; or targeting of safe regions in the genome. Ultimately, the development of homologous recombination or gene repair to accurately correct genetic mutations, or the construction of mitotically stable extrachromosomal vectors, would obviate many of these problems, but current technologies are inefficient. The potential for gene therapy to treat human disease is clear, and the clinical evidence is beginning to emerge. The time between concept and delivery of therapeutic success is really no different from that of other significant medical advances, and the continuing occurrence of side effects associated with established approaches, such as organ and bone-marrow transplantation, should not be forgotten. Undoubtedly, similar strategies will be applied to other severe conditions, but also to a larger number of non-lethal conditions associated with significant disability. In this latter case, the risks of therapy have to be more clearly defined in biologically relevant model systems. The expectation that this exciting new therapeutic modality will produce major immediate effects in the absence of either predictable or unexpected adverse events is unrealistic. More than ever, human clinical trials are necessary to establish the efficacy of gene therapy and to inform future technological development.

Adrian J Thrasher

The NHMRC has set up the Gene and related Therapies Research Advisory Panel (GTRAP) to oversee gene therapy research The cornerstone of clinical research involving humans in Australia is the HREC (Human Research Ethics Committee). All studies must be approved by an HREC at the investigators’ institute(s). The demands on these committees are considerable, particularly when cutting-edge technology is involved. This was the situation in 1994 when the National Health and Medical Research Council (NHMRC) formed GTRAP (Gene and related Therapies Research Advisory Panel). The function of GTRAP was to provide the NHMRC, researchers, clinicians and HRECs with advice on medical, scientific and technical issues related to gene therapy,1 a novel form of treatment that had just been introduced in the United States. Its use in Australia — to treat severe combined immunodeficiency (SCID) — is described in this issue of the Journal (page 458).2 The NHMRC, through its Australian Health Ethics Committee, required that HRECs not give final approval for a gene therapy trial unless that trial had also been reviewed and approved by GTRAP. In Australia, gene therapy requires both local HREC and national GTRAP oversight. The reason for this was the novelty of the treatment, which does not involve traditional drugs or chemicals, but cells that have been genetically modified. Risks such as insertional mutagenesis, now tragically seen after gene therapy of SCID-X1, were known in the early 1990s to be possible. 3 Another concern was the unintentional involvement of germ cells, although the original targets for gene transfer were somatic cells. Genetic errors in somatic cells would harm the patient, but those in germ cells could be passed on to future generations. GTRAP works closely with the Therapeutic Goods Administration (Australia’s equivalent of the US Food and Drug Administration [FDA]), the Office of the Gene Technology Regulator and the Australian Health Ethics Committee through members in common. The “and related” component of GTRAP’s title reflects the growing use that will be made of cellular therapies in clinical practice. The NHMRC has recently expanded the GTRAP terms of reference to include cell therapies in the broader sense, given the future possibility that genetically engineered stem cells (or xenotransplants) will be trialled in clinical research. This move parallels the Therapeutic Goods Administration’s proposed new regulatory framework for tissues and emerging biological therapies.4 Because of the inherent uncertainty surrounding these novel therapies, GTRAP requires that all treated patients (or their families) be contactable should problems develop in the longer term. All studies require the sponsors or investigators to provide annual reports, notifications of adverse events, and a final report on completion of the study. GTRAP’s current position on trials of gene therapy for X-linked SCID or other therapy involving potential risk combinations (retroviral vectors and stem cell targets) is similar to that followed by the FDA, outlined in this issue of the Journal.5 For SCID-X1, this means that gene therapy can still be considered as an option if there are no alternative treatments, such as a suitable allogeneic bone marrow transplantation, or if such transplantation has failed. In the case of the potential risk combinations outlined above, gene therapy could continue after review of the risk–benefit analysis, ongoing monitoring which now would need to include 6-monthly integration-site analysis (analysis of the patient’s cells to detect any potential oncogenic events early), and inclusion in the patient information sheet and consent form the information that acute leukaemia has occurred in children as a complication of gene therapy. In Australia, the clinical investigator and sponsor of two ongoing gene therapy studies involving SCID-X12 and HIV, respectively, placed their studies on voluntary clinical hold when two cases of leukaemia were reported in children who had received gene therapy for SCID-X1. Since then, the SCID-X1 clinical study has remained on voluntary hold. The HIV study, which uses a retroviral vector targeted to haemopoietic stem cells, came off voluntary hold when reassessed by GTRAP. This reassessment included a review of the risk–benefit analysis, implementation of the additional monitoring requirement, and rewording of the consent documents, as described above. Following the report of a third leukaemia complication, the HIV study, which is also being conducted in the United States, has continued pending further advice from the FDA as well as GTRAP. At present, there are no additional scientific data available to GTRAP that would require a clinical hold on the HIV study, although the patient information sheet and consent forms must again be changed to reflect three, rather than two, leukaemia cases. More information on GTRAP (including a list of all gene therapy studies undertaken in Australia) can be found on the NHMRC website (www.nhmrc.gov.au/research/gtrap.htm).

Ronald JA Trent PhD, FRACP, FRCPA

To the Editor: de Crespigny and Savulescu1 criticise legal and media attention given to the abortion of a 32-week fetus with suspected dwarfism in a case in which the expectant mother had become suicidal. At the same time, they appeal to populism to support legislative change in favour of easier access to late-term abortion. This paradox raises an intriguing point about public opinion and medical ethics. How can members of the public develop opinion unless they are told what is going on? The case was made known to the public (although the patient’s name and face were not shown) because a newspaper editor considered it to be of great interest to many people. The public rightly has an interest in this tragic case, as it relates to at least three controversial themes of significance to public and social health — disability, suicide and abortion. Unfortunately, in recent decades, balanced and informed debate about abortion has been lacking. Instead, the issue has been portrayed simplistically in terms of a woman’s “right to choose”, with little research into the desperate and often coercive circumstances and the harmful consequences of those choices. That late-term abortions are subject to unclear and complex state laws is testament to the fact that abortion is far from a closed case for the public, healthcare professionals and politicians. de Crespigny and Savulescu acknowledge that the case raises “profound and divisive ethical issues”. Yet, they later assure readers that the case “appears to be ethical”, adding to their overall implication that, if only Australia’s laws were clear, uniform and liberal, the media and the public would not have had any business in the matter. Many aspects of the doctor–patient relationship are regulated by legislation — an “intrusion” that is accepted in jurisdictions in which democracy and state-funded healthcare coexist, and necessarily so, to protect both doctor and patient. If legislative change is to occur, public consultation must be sought, and the public must be given more, not less, information about abortion.

Selena R Ewing BHSc

To the Editor: The article by de Crespigny and Savulescu is certainly thought provoking and timely. The harms they cite as caused by an uncertain legal environment are lamentable, although the outcomes were probably the result of multiple factors in addition to the justice system. To bring order, reason, compassion and justice to a clinical problem as complex as termination of pregnancy — especially late termination — requires a framework for decision-making. This should operate at the hospital level, at the national level among the professionals involved, and, as de Crespigny and Savulescu contend, in the national legal system. Most hospitals have now developed consistent guidelines to assist clinicians and patients in decisions regarding pregnancy termination (in the past, there was significant intrahospital diversity and uncertainty). More recently, clinicians involved with late termination of pregnancy for fetal abnormality in eight centres in six states and the Australian Capital Territory met in Melbourne to develop a consistent national set of guidelines. There was adequate consensus to produce a document that will soon be submitted for publication for wider community comment. Hopefully, this will facilitate better outcomes for all and perhaps even provide a stimulus for review and consistency of abortion laws.

Leslie Reti SM, FRCOG, FRANZCOG

In reply: Reti is correct that the outcomes of the late abortion case probably resulted from multiple factors in addition to the justice system. A pivotal one was the decision to divulge confidential patient information before there had been a thorough internal review. It is pleasing that hospitals are developing consistent guidelines, although, as we indicated in our article, these guidelines should not include responsibility for clinical decision-making by committee. The responsibility for clinical decision-making should reside with the doctor, and committees should have a purely advisory role. Consistent national professional guidelines are needed. These could be a stimulus for law reform. Without reform, it is only a matter of time before a single complaint about a case leads to a similar succession of adverse outcomes. Ewing writes that we “criticise legal and media attention given to the abortion”. We have no criticism of the media attention and would not presume to criticise the legal processes. Our criticism was of the “decision to expose the events to legal and media scrutiny”. That is, we criticised the decision to expose the case and those involved before a thorough internal review had been conducted. We support transparency and believe that secrecy in relation to medical procedures is contrary to public interest. We agree with Ewing that public consultation must be sought before legislative change. But one thing is clear — abortion law reform is essential. It is unacceptable that, in some cases, such as the late-abortion case we described, doctors may be charged with an indictable offence whether they agree to perform the abortion or not — under the law on abortion or child destruction if they agree to abortion, or under the law of homicide by negligence if they refuse abortion and the patient subsequently commits suicide.

Lachlan J de Crespigny MD, FRANZCOG · Julian Savulescu MB BS, BMedSci

Emma J Glasson,* John Wray† * Research Fellow, University of Western Australia, Telethon Institute for Child Health Research, West Perth, WA, and WA Register for Autism Spectrum Disorders; † Paediatrician, State Child Development Centre, West Perth, WA, and WA Register for Autism Spectrum Disorders Emma. GlassonAThealth.wa.gov.au To the Editor: There is growing international awareness about the realities and difficulties of obtaining written informed consent from patients to compile and use data recorded in population-based registries. In some cases, such data could be of substantial benefit to the community, while posing relatively low risk of infringing patients’ privacy.1-3 The Canadian Stroke Registry achieved only a 39% participation rate from 4285 eligible patients when applying a policy of written informed consent to their data collection, resulting in significant representation bias.1 The issues and consequences are mirrored in our own endeavour, since 1999, to maintain a prospective register of people diagnosed with autism spectrum disorders in Western Australia.4 As protocol, diagnosing clinicians in Western Australia ask parents for written consent to allow their autistic child’s name, date of birth and postcode to be forwarded to the register. However, for many reasons, parents are not always asked and diagnostic information is not always forwarded. Missed cases are collected annually from the major diagnostic and service provision centres, but only the sex and year of birth are recorded for the child. Between January 1999 and December 2002, 757 new cases of autism were registered in WA, but only 35% of parents gave written consent to include identifying details. Forty-three per cent of the 757 cases were identified by cross-referencing to diagnostic centres. When clinicians remember to notify new cases to the register, 56% of parents give consent, either at the time of diagnosis, or by sending the forms directly to the register, indicating that clinicians are instrumental in encouraging patient participation. Sometimes clinicians send anonymous diagnostic information without giving parents information about the register, and sometimes parents forget to send permission forms to the register. Various characteristics of the child or the child’s family have a bearing on whether consent is given. For example, consent is received for only 31% of children living in rural areas, 25% of children with no intellectual disability, 23% of children not Australian-born, and 16% of children from families whose primary language is not English. Without consent for every case, the register cannot accurately reflect the age or geographic distribution of children with autism. If the register only collected information on consenting cases, there would be severe under-ascertainment and the output would be notably biased. Perhaps more importantly, unidentifiable records cannot be linked to other datasets. Other WA population databases include information on hospitalisations, genetic testing, genealogical links, midwife notifications, birth defects, pharmaceutical history, and people with cerebral palsy. Linkage to these datasets would enormously facilitate population-based autism research to investigate the aetiology, associations and natural progression of autism disorders. The WA autism register is an internationally unique population-based resource, but its application is limited without the inclusion of identifying information. This remains the reality at a time when the research community and affected families desperately seek information about the condition and solutions for their children.

Emma J Glasson · John Wray

Perhaps a week of intensive training in critical thinking would be the best preparation for members of research ethics committees In a recent lecture at Monash University, the philosopher Raimond Gaita, Professor of Moral Philosophy at King’s College, University of London, and Professor of Philosophy at the Australian Catholic University, told the story of a woman facing a significant turning point in her life. It was a Friday, and a decision was needed by Monday, but she had unavoidable obligations over the weekend. She had a dear friend, a psychoanalyst and philosopher who had known her all her life. He knew her circumstances, her preferences and even her secret wishes. She contacted him and prevailed upon him to make the decision for her. In our private lives most of us would find it at least odd, and probably uncomfortable, to hand over responsibility for significant decisions to others. Yet, the prevailing paradigm for human research ethics committees has institutionalised this approach. Researchers themselves often do not consider the ethical implications of their work until it is time to fill out the various forms required by committees. Even then, the main concern is “getting through ethics” with minimal scarring of their proposal. The Nuremberg Code,1 the Helsinki Declaration,2 and even the National Health and Medical Research Council’s National statement on ethical conduct in research involving humans (the Statement),3 are not documents with which many researchers can claim significant familiarity. The reasons for their existence are faintly recalled, and current debates are only of interest if they impede research with which the researcher has a personal concern. Once an ethics committee has made its decision, there is no need to consider “ethics” again unless there is a significant adverse event. Although they undoubtedly provide a “safety net” to detect and prevent grossly unethical research, ethics committees must not and cannot be seen as the repositories for moral decision-making. Consider an imaginary (but highly plausible) ethics committee. It meets the Statement’s requirements for membership. Some members have attended the occasional seminar sponsored by the Australian Health Ethics Committee (AHEC), and some diligently read the AHEC Bulletin sent to registered committees. Some, though not all, of the members have actually read the Statement all the way through. One committee member doesn’t really agree with some of the content. The committee faces regular criticism by researchers for the amount of paperwork that must be submitted to it, and significant anger when it wishes to alter an aspect of a proposal for a multicentre trial. Although the committee’s deliberations are thorough, most of its recommendations consist of minor changes to the plain language and consent statement. It faces considerable (and understandable) pressure to reach rapid consensus. Rarely does a member ever register his or her dissent concerning a decision about which all other members of the committee feel comfortable. The committee is proud that it has never ultimately rejected any proposal. Some members of the committee are aware that they have acquiesced in decisions about which they had some misgivings. One or two of the most senior members know they can nearly always sway the committee to their point of view. In a recent editorial discussing clinical ethics committees, Margaret Somerville noted that: Committee decisions, as compared with individual ones, can spread the responsibility. A committee can make a decision that no one person — in particular, no committee member — acting alone would make.4 She uses the real-life example of decisions to shorten life by withholding treatment, or aborting a fetus, and the physicians doing this being morally reassured by the involvement of an Acute Clinical Ethics Service. She asks Might [this involvement] have allowed the caring team to implement decisions that their moral intuitions were indicating were unethical? While these decisions may have been ethical, we must always be aware that we ignore such intuitions at our ethical peril.4 Although clinical ethics committees perform a somewhat different function to human research ethics committees, there are significant similarities as far as the points made by Somerville are concerned. There is indeed comfort in allowing ourselves to be relieved of having to think about the implications of our actions, especially when the research dollar is concerned. It is problematic when the ethics review process is seen as a test of how much we are able to get away with. It cannot be persuasively argued that actions must be ethical because they have been approved by another person thought to be morally wiser. Nor is it helpful to allow oneself to be influenced to reach a decision in a group setting because of reasons of time, or because others have already reached consensus. If researchers have not thought through the ethical implications of their proposals, but instead leave that to the committee, and the committee makes decisions about which some of its members would be individually uncomfortable, this cannot be regarded as a satisfactory process. Perhaps the most essential preparation for members of research ethics committees is not studying the content of the Statement or the relevant law, but undertaking a week of intensive training in critical thinking. Perhaps we all must consider how best to deal with situations about which not all agree, and about which objections are morally relevant. Furthermore, there are many issues that are not well addressed by guidelines or law. What research should be done in the first place? How should communities from which participants are drawn be involved in the planning, implementation, monitoring and evaluation of research? What are the human rights implications of a study (particularly in populations significantly deprived of rights)? What responsibilities do researchers have to the larger community from which their subjects are drawn, and what do they owe to subjects after their research is completed? These questions and many more have important ethical dimensions. Many researchers are unaccustomed to thinking through the broader implications of their work. However, they are capable of doing what is necessary in order to fill out a form. In a seminal article in the New England Journal of Medicine, Henry Beecher stated The ethical approach to experimentation in man has several components; two are more important than the others, the first being informed consent . . . Secondly there is the more reliable safeguard provided by the presence of an intelligent, informed, conscientious, compassionate, responsible investigator.5 In concluding his lecture, Gaita rejected the notion of a “moral expert”, and called for us all to identify and rigorously analyse morally important issues without sentimentality. It is very difficult to improve on this.

Bebe Loff MA, LLB · Jim Black MB BS, PhD, FAFPHM

The Victorian Supreme Court has decided that artificial nutrition and hydration provided through a percutaneous gastrostomy tube to a woman in a persistent vegetative state may be withdrawn. The judge ruled, in line with a substantial body of international medical, ethical and legal opinion, that any form of artificial nutrition and hydration is a medical procedure, not part of palliative care, and that it is a procedure to sustain life, not to manage the dying process. Thus, the law does not impose a rigid obligation to administer artificial nutrition or hydration to people who are dying, without due regard to their clinical condition. The definition of key terms such as “medical treatment”, “palliative care”, and “reasonable provision of food and water” in this case will serve as guidance for end-of-life decisions in other states and territories. The case also reiterates the right of patients, and, when incompetent, their validly appointed agents or guardians, to refuse medical treatment. Where an incompetent patient has not executed a binding advance directive and no agent or guardian has been appointed, physicians, in consultation with the family, may decide to withdraw medical treatment, including artificial nutrition or hydration, on the basis that continuation of treatment is inappropriate and not in the patient’s best interests. However, Victoria and other jurisdictions would benefit from clarification of this area of the law.

Michael A Ashby MD, FRACP · Danuta Mendelson MA, LLM, PhD

Hugh G Dickson Chair, Human Research Ethics Committee, South Western Sydney Area Health Service, Locked Bag 7103, Liverpool BC, NSW 1871. Hugh. DicksonATswsahs.nsw.gov.au To the Editor: Roberts et al1 state that the National Health and Medical Research Council’s National statement on ethical conduct in research involving humans2 clearly outlines that, once approval has been gained from one human research ethics committee (HREC), other sites should accept that approval. Nowhere does the national statement state this. What Roberts et al appear not to appreciate is that research projects may consume resources within a health service. The HREC might also have the responsibility of ensuring that the tasks required for successful completion of research can be performed without compromising the standard of care of the health facilities in which the research is to be performed. The project in question required the extraction of medical records — someone has to do this and be paid for the task. While centralisation of human research ethics approval might make the task of approval of research faster, each administrative unit has to be able to decide whether to allow participation in a project given its current level of service demand. Approval for multicentre research will therefore still take time whether or not central ethics approval is obtained, and researchers will not find an easy solution to this.

Hugh G Dickson

Kerry J Breen Chair, Australian Health Ethics Committee, National Health and Medical Research Council, PO Box 9848, Canberra, ACT 2601. kerrybreenATaccess.net.au Comment: It is correct that the National Health and Medical Research Council’s National statement on ethical conduct in research involving humans1 (paragraph 3.4) does not say that other sites should accept ethics review of a research proposal from another human research ethics committee (HREC). However, the national statement is written to permit and encourage this, but not to enforce it. Dickson’s letter also raises the issue of the terms of reference of HRECs. He alludes to an additional role — as gatekeeper of an institution’s resources — which some may feel is beyond the domain of HRECs. The national statement provides the framework for the composition and role of HRECs in their work of ethical review, but does not prevent an institution from asking its committee to also be the steward of access to resources regularly used (eg, medical records, pathology laboratories). The national statement requires an institution to set out the terms of reference for its HREC, “including the scope of its responsibilities” (paragraph 2.2). The prime function of HRECs is to make recommendations about whether a research proposal is ethical, but the final approval about whether the research can proceed rests with each individual institution. Thus, there is more to getting approval for a research proposal than just the ethical review.

Kerry J Breen

David J Maxwell,* Karen I Kaye† * Project Officer, † Executive Officer, New South Wales Therapeutic Advisory Group, PO Box 766, Darlinghurst, NSW 2010. tagprojectATstvincents.com.au To the Editor: We are currently coordinating the New South Wales arm of a national quality assurance (QA) project to improve the management of community-acquired pneumonia in Australian hospital emergency departments (CAPTION project: Community-Acquired Pneumonia: Towards Improving Outcomes Nationally, funded by the National Prescribing Service). In the project drug usage evaluation methods are used, and it involves an audit (retrospective review of patient medical records) as well as feedback and targeted education of healthcare professionals about national management guidelines for community-acquired pneumonia.1 There is no direct patient contact at any stage. Because this is a QA project, we did not request that participating NSW hospitals seek human research ethics committee (HREC) review. However, we did request that the project proposal be supported by HRECs as a QA activity. Further endorsement from the Chief Executive Officer, Director of Emergency, Director of Pharmacy and other key people and groups was also required. According to the National Health and Medical Research Council (NHMRC),2 an appropriately planned QA activity can proceed without HREC review and patient consent if: there is consistency with National Privacy Principle 2.1(a); and all people involved in the activity are unlikely to suffer burden or harm. To assist hospitals reviewing this QA project proposal, we developed a number of tools that explicitly outlined the nature of the project and provided answers to the questions in the NHMRC document. 2 These tools were provided to emphasise that this QA project was consistent with NHMRC requirements. The NHMRC further describes the establishment of hospital policies to allow efficient review of QA proposals that involve minimal risk, burden, alteration of care or invasion of privacy. It is recommended that a member of the HREC be appointed to review such proposals. Despite the NHMRC recommendations and the provision of tools as described above, full HREC submissions have still been required by four out of eight hospitals to date (recruitment still ongoing). After receipt of an initial expression of interest, completing the HREC submission and obtaining approval in three of these hospitals has taken an average of 5 months. The HREC review has not yet been completed in the fourth hospital. As the project is only funded for a 2-year period, this has resulted in a significant delay in the progress of the project. We do not challenge the vital role of HRECs, and we value the importance of ensuring the safety and privacy of all involved in human research. If QA coordinators and HRECs work together within the NHMRC recommendations, valuable time and resources could be saved, for both parties. In doing so, the Australian Research Ethics Committees’ belief that “quality assurance activities are an essential and integral part of health care delivery that should be encouraged and facilitated” would be one step closer to becoming a reality.

David J Maxwell · Karen I Kaye

Martin B Van Der Weyden Editor, The Medical Journal of Australia, Locked Bag 3030, Strawberry Hills, NSW 2012. medjaustATampco.com.au Comment: The distress conveyed by Maxwell and Kaye is the latest in a litany of concerns and complaints to the Journal over recent years about the workings of ethics committees.1 At the centre of the protests is the perceived tardiness and inefficiency of human research ethics committees (HRECs) in Australia.2,3 But the past decade has also seen reform. The National Health and Medical Research Council (NHMRC) has clarified the relationship between research and quality assurance and when quality assurance proposals require ethical scrutiny.4 Furthermore, the NHMRC’s National statement on ethical conduct in research involving humans is clear in its advice that HRECs must establish working procedures that include “timely consideration and review of research protocols”, and it also outlines procedures for expediting review of minimal-risk research.5 On multicentre research, the statement is also clear, stressing the need to minimise unnecessary duplication in review of such research, and calling for “prompt and efficient consideration of multi-centre research protocols” and adoption of “other administrative procedures to accelerate timely consideration and avoid unnecessary duplication”.5 With such clear enunciations, what could go wrong? But, as Maxwell and Kaye attest, things do go wrong. It seems that either the NHMRC recommendations have yet to be translated into reality or the “silo” mentality of HRECs is deeply ingrained. The time may well have arrived to consider performance indicators for HRECs, or even an accreditation process. After all, clinical research and quality assurance should not be at the mercy of inefficient HRECs.

Martin B Van Der Weyden

While some cases of sexual exploitation involve predatory doctors, many other cases represent the culmination of a series of boundary crossings (non-exploitative departures from usual practice). The deliberate move to reduce formality in medicine has increased the likelihood of boundary crossings and violations. There are also individual doctor risk factors; boundary violations appear more likely when doctors are under stress, with insufficient emotional support. Preventive strategies include continuing education about ethics and the management of professional boundaries, along with appropriate psychological support structures for doctors. Doctors are often involved in other professional relationships as teachers, supervisors and team leaders; inappropriate sexual behaviour in these relationships is harassment. Public pressure for more punitive responses is likely if the profession is not seen to be doing all it can to deal with these issues effectively, and to be cooperating with other responsible agencies.

Cherrie A Galletly FRANZCP, PhD

I am on leave at present. The leave was planned but not voluntary. In May 2000 I received a writ concerning a woman with cerebral palsy, who was born 20 years ago. I had been the general practitioner obstetrician who attended her mother until I handed over to a specialist obstetrician for a caesarean section. At first I felt confident that my management was proper and there could be no case. Two years ago, however, a court settlement of $14 million changed everything. Since then I have been through intensive examination of everything I did during the 4 hours she was under my care. The notes and written answers to highly detailed questions now fill a 12 cm deep file box and I have become totally disillusioned with medicine and the law. The only records that exist from that time were the notes I wrote during her labour. Instead of providing a solid basis for my defence, as I thought, my notes have been dissected, with every nuance of each word explored and even the punctuation and layout questioned. The lawyers even questioned the fact that notes at different times during the labour were written in different pen. This threw me until I realised the event took place late at night into the early hours and I had probably attended in a tracksuit without a pen, and had used whatever I could borrow at the time I wrote each note. As the case approached I was forced to question and requestion everything. The stress began to take its toll on me, but I believed it would not affect my family and practice partner. How conceited! In retrospect my relationship with my wife, my children, my colleagues and staff all suffered as they each tried to support me. My practice has changed. I am constantly asking myself: “Did I miss anything? Have I performed all the tests?” — beyond any sensible practice of good medicine. Of course, I quit delivering babies two years ago. GP obstetrics was never a well paid practice, but I loved it. I had undertaken extensive training overseas as well as in Australia so that I could fulfil my role as a rural GP, caring for women in labour. When I found myself doubting everything I could no longer continue. From time to time, the lawyers would iterate that I would be judged by the standards of my peers. However, the repeated examinations made it plain that only a specialist obstetrician could be considered competent. The plaintiff’s lawyers couldn’t find an obstetrician in Australia to criticise my care, so imported one from overseas. The case was scheduled to start on a Monday (nearly 4 years after the initial writ had been served) and run for 4 to 6 weeks. I am a country GP and have only once had 6 weeks’ leave. On that occasion I had major surgery. At least I was given 3 months’ notice of the court schedule, so had time to find a locum and to refinance against our home to cover the loss. Most readers will be aware how difficult and expensive this is. Then at 12:30 on the Monday, my former partner and long-time friend telephoned to congratulate me that the case had been settled. He had been subpoenaed by the plaintiff’s lawyers to give evidence as to her disabilities and they had telephoned him to tell him he would no longer be required. I immediately called my solicitor and he confirmed the news. My wife and I cried. When I investigate a patient with a breast lump, I telephone her as soon as I have the result. As a caring doctor I never allow a third party to give sensitive results to my patients. Part of our contract with our patients is to be sensitive to their feelings and the effect our diagnoses can have. So I am disillusioned with the law. We are now having a few days to recoup. My sense of humour is returning and my practice partner and I shared a bottle of red wine last night and debriefed each other. I am not ready to return to work, but hope that catching up on correspondence, as well as the many odd-jobs I never had time to do, will give me a chance to regain my desire to be a good doctor. Kerr’s story highlights all that is wrong with the adversarial civil litigation process. The plaintiff can choose whether or not to bring a claim. However, once the writ is served, the defendant has only two options — settle or defend. In a cerebral palsy case, the potential multimillion-dollar cost of the claim means it is not an option to settle “for convenience”, or on commercial grounds, or to spare the defendant doctors and their families the psychological, professional and financial trauma of a protracted defence. If the best advice obtained for the defendant is that the plaintiff’s claim is weak, then the claim must be defended. The defendant doctor is locked into a “Clockwork Orange” scenario — nothing he or she can do can end the nightmare. The problem of course is that it is only “grey” claims that become protracted. If the expert evidence obtained by the defendant’s lawyers is that the plaintiff’s case is sound, an early settlement will be attempted. If the claimant has an inflated estimate of what their claim is worth, there may be a protracted argument about “quantum”, but otherwise the claim will be settled and everyone can get on with their lives. If the plaintiff receives advice that there was no departure from acceptable care and skill, or an important fact not known to the claimant’s lawyers and the experts commissioned by them emerges which makes that clear, the claim will be abandoned. Neither side will pursue a lost cause. The most painful part of this story is reading of the settlement “at the door of the court”. It is customary tactics, if the parties can’t agree, to bluff their way right to the door of the court. The barristers are there, fully kitted up in gowns and wigs. The clients hear the opposing barrister say, “Look over there — I’ve got my experts lined up ready to go. This is your last chance to talk sensibly.” That tactic of brinksmanship is what caused this country doctor the most distress. Three months beforehand, he was told that the case was unlikely to settle and that he should prepare for a 4- to 6-week hearing. Hence, the expense of a locum, and the need to refinance his home. Would even his own lawyer understand that a locum never pays his or her way; that even with a locum in the practice, the doctor would suffer a substantial loss of income? How can the courts be managed efficiently when court time is set aside on the parties’ estimate that a case will run for a number of weeks, but it collapses either just before starting, or on the first day? What an appalling waste of resources!! But this cri de cœur is closer to the bone. All parties to litigation suffer severe distress during the process. The medical indemnity insurers offer collegiate support to defendant members during the process. One (the Medical Defence Association of Victoria) offers access to confidential counselling services by an external psychologist at the fund’s cost. Litigation has the same emotional impact as a major illness, loss of a loved one, or a severe career setback. The stages of grief (as described by Elisabeth Kubler-Ross1) were transparently apparent in the members whose claims I managed. Some were clinically depressed, but were reluctant to admit it and seek help. None committed suicide, but I have heard of that happening overseas. Further, the protracted course of the litigation, and the accompanying incessant questioning about minutiae, has caused this doctor to second-guess his own competence. All I can offer is the platitude that an accusation of “negligence” is not an accusation of “incompetence”. Being sued, even successfully, does not mean that you are a “bad” doctor. The vast majority of claims I settled for doctors represented the one-off lapse or slip or error of a perfectly competent doctor. Most medical indemnity funds offer collegiate support. A senior clinician associated with the fund is assigned to the claim, not to manage it legally, but to be kept up to date on its management and, more importantly, to be available to discuss the medical aspects, at length and repeatedly, with the doctor. Even when a member is told that the case must be settled because the circumstances meet the legal test of negligence, mentoring can help the doctor learn from the case, put it in perspective, and then move on. Perhaps writing up his experience will have a psychologically cathartic effect on the author. It is no consolation to him that very few doctors go through his experience. At least 90% of claims brought against doctors are either settled or abandoned by the plaintiff. Very few get to the final stages of preparation for trial, even fewer actually go to trial, and even fewer go to verdict. Litigation leaves deep scars on defendant and plaintiff alike. Rumpole and his supporters might think the gladiatorial adversarial model of litigated compensation for personal injury represents the highest form of justice, but it has been abandoned for injuries arising from workplace and road accidents. Why has it not been abandoned for medical accidents?

Charles D Kerr FRACGP · Paul Nisselle AM, MB BS, FRACGP

The case of a 13-year-old girl given permission by the Family Court of Australia to begin a sex-change process involves complex issues. Nevertheless, the ethical justification for the decision is not complicated. In this case, it can be argued that the net benefit eclipses concerns about competence, autonomy and the appropriateness of the intervention. The debate this case generated in the media reminds us that one of the essential tasks in ethics debates is to get our facts straight. In a landmark judgment, the Chief Justice of the Family Court of Australia has given permission for a 13-year-old girl to begin a sex-change process. The biologically normal girl, referred to in the judgment as “Alex” or “he”, has been diagnosed with a gender-identity disorder and has experienced major depression, self-harming behaviour and suicidal thoughts.1* Gender-identity disorders, sometimes referred to as “gender dysphoria” (“dysphoria” indicating distress)5 or “transsexualism”, are rare and complex conditions in children and adolescents. According to a Royal College of Psychiatrists report,6 they are often associated with emotional and behavioural difficulties and involve psychological, biological, family and social issues. In the course of psychosexual development, the young person “experiences their phenotypic sex as incongruous with his or her own sense of gender identity”, and adolescents with this condition often experience intense distress. The majority of affected children eventually develop a homosexual orientation, but the outcome is not easily predicted. Only a small proportion become transsexuals or transvestites.6 In the present case, Alex has had a strong, longstanding desire to live as a male and become male in appearance and has gone to distressing lengths to conceal his female body. For example, to avoid having to use the female toilets, he started wearing nappies to school and would not drink liquids.1 Alex’s past life has been troubled. His father, with whom he was very close, died suddenly when Alex was young, and his mother rejected him. He now lives with an aunt. The proposed treatmentGender reassignment is a staged process. The proposed treatment for Alex involves, firstly, the continuous administration of a combination of oestrogen and progestogen that is a form of the contraceptive pill. The goal of this stage is solely to suppress menstruation, and the effects are “completely reversible”.1 The second stage of treatment for Alex involves hormone therapy with a luteinising-hormone-releasing-hormone analogue (to suppress the pituitary–ovarian axis) and testosterone; this can begin in 3 years’ time, at age 16, if Alex still wants to be a boy. Some changes with this stage of the treatment are irreversible. Changes include masculinisation of the voice, muscle growth, increase in facial and body hair, growth of the clitoris and behavioural effects.1 Surgery would complete the sex-change process; however, surgical intervention was not sought or contemplated in the court application. The Chief Justice authorised the stages of the proposed treatment as a “single package of reversible and irreversible treatment”, but the only aspect that will take immediate effect is administration of the contraceptive pill.1 Although Alex and his doctors have authorisation to commence the irreversible hormone therapy, surgical intervention is not part of that “package”. Alex would not be eligible for surgical intervention until he is at least 18 years old.1 From the age of 18, however, he will be legally entitled to make his own decisions. The legal basis of the decisionUnder the Family Law Act 1975 (Cwlth), the Family Court is required to “regard the best interests of the child as paramount”.1 The Chief Justice in this case based his decision on the High Court’s decision in Marion’s case.7 Matters to be considered include the particular condition of the child; the nature of the proposed treatment; reasons for the proposed treatment; alternative courses of treatment; desirability and effect of the proposed treatment compared with alternatives; physical, psychological and social implications of authorising or not authorising the proposed treatment; the nature and degree of any risk associated with authorising or not authorising the proposed treatment; and the views of the child’s guardian(s) and of the child.1 The Court was making the decision not because Alex lacked sufficient maturity and understanding or because he was a ward of the state. The permission of the Family Court was required because the proposed treatment was not considered a treatment for a “malfunction” or a “disease”.1 The “irreversible” element of the intervention, with accompanying “significant risk”, means that it falls into the legal category of “special medical procedures” — cases requiring court authorisation.1,8 Public debate generated by the decisionThe Court’s decision to allow the sex-change process has sparked public debate and provoked strong reactions in the media. Bioethicist Nicholas Tonti-Filippini has condemned the decision as “unbelievable” and called on the government to intervene. He argues that “all the evidence suggests that gender dysphoria is a form of mental illness and should be treated as a mental illness, not by trying to adjust her biologically to match the delusion”.9,10 Another critic claims that allowing the 13-year-old to begin the sex-change process is colluding with the fantasy rather than treating the condition — “like allowing a child who imagines he is a horse to undergo transformative surgery”.11 Some challenge the diagnosis and the proposed treatment by arguing that we should view Alex as a victim of emotional and psychological abuse: “We have a terrible feeling that Alex may have received too much intervention of the wrong kind, too soon.”12 Others have stated, “It’s her troubled mind we must work on, not her healthy body”,13 and “She is much, much too young to make this decision”.10 Some also worry that Alex will come to regret his decision.14,15 The competence of a 13-year-old to make this kind of decision and the implications of making competence determinations have also been debated. One newspaper editorial has called the Court’s decision “troubling”, because “it is a fair bet that what Alex wants now above all else may not be her heart’s desire in five, let alone 10 years’ time”.16 Another editorial claims that adolescent unhappiness cannot be measured from an adult’s perspective, and warns that “anyone who must deal with an adolescent’s misery needs to consider very carefully what the consequences of disregarding it may be”.17 Few commentators have come out in defence of the Court’s decision, but a spokesperson for the Australian and New Zealand College of Psychiatrists has said that the judgment was important “because it acknowledged the severity of Alex’s condition and allowed the appropriate treatment”.18 A representative of TransGender Victoria commended the decision, because adolescence is “the worst time” for people with gender-identity problems committing suicide.10 Identifying the issues of concern and assessing the debateThe overriding concern in this debate seems to be the possibility of harm. Some view the proposed medical treatment as inappropriate or premature and fear that Alex may later regret undergoing the treatment. Others think that the treatment offers relief and that withholding it would cause great harm. The competence of a young person to make this kind of decision, the goals of the intervention, and whether the end justifies the means also figure in the debate. An essential task of ethicsFirst of all, this case demonstrates one of the essential tasks of ethics — getting our facts straight. Some commentators who oppose the Court’s decision may have concluded that surgery is part of the proposed treatment or that surgery is inevitable. But this is not the case. The Court is not authorising sex-swap surgery. These critics have missed a crucial aspect of the judgment — and missed some subtleties in the decision. It is significant that the proposed treatment is a staged process that provides time for Alex to further explore the issue of gender identity. During this time, Alex will receive ongoing psychological and psychiatric support, which is an essential part of the proposed treatment authorised by the Court. Alex can elect to discontinue the treatment at any time.1 Is the treatment inappropriate?In response to the view that the treatment is inappropriate, it can be argued that treatment designed to reduce gender dysphoria is a “legitimate goal of intervention”, being treatment that reduces the degree of “social ostracism” and “psychiatric comorbidity”.19 For Alex, there is great benefit in being given permission to begin the first stage of treatment and there is great harm in not having his desire to live as a boy taken seriously. The benefits in commencing treatment are real, immediate and significant. Alex will gain immediate relief from distress, and his developing self-determination will be strengthened by having his preference acknowledged. Moreover, the first stage of treatment is completely reversible. Taking the pill on a continuing basis is not an unusual or bizarre treatment. Alex gains time, during which he will receive counselling and can further explore the issue of his gender identity, before the next stage of treatment goes ahead at age 16. Importantly, the decision allows for the possibility that Alex might change his mind. According to the Royal College of Psychiatrists report, a large element of management is “promoting the young person’s tolerance of uncertainty and resisting pressures for quick solutions”.6 Critics who assume that giving credibility to Alex’s preferences means he is set on an irreversible pathway ignore the role of the ongoing counselling support. Alex may decide not to proceed, but, if he does proceed, the counselling he will have received should assist him in having a clearer idea about his identity. The counselling will also help him to be better informed about the procedure and its implications. With this support, he is much more likely to be making an informed, autonomous decision. The harm of treating versus the harm of not treatingThe harms that may occur with the proposed treatment (eg, practical and social difficulties, victimisation, and the possibility of regret) are theoretical, while the harms of not proceeding with the proposed treatment are likely and substantial. According to the Royal College of Psychiatrists report, interventions that recognise and accept the problem of gender-identity disorders and remove the secrecy can bring considerable relief.6 In this regard, the Court’s decision, and the process that led to it, could be deemed therapeutic. The evidence presented tells of Alex’s depression and self-harming behaviour during the time when his desire to live as a boy was not taken seriously. Those who know him well are concerned that he may go back to the old behaviour if he is not permitted to commence the proposed treatment.1 The judge also expressed concern that, if the proposed treatment was not allowed to proceed, Alex’s “education and residential arrangements and his developmental socialisation would be jeopardised to his long term detriment”.1 It is worth noting that the proposed treatment is practised in The Netherlands and is recommended in the Standards of Care of the Harry Benjamin International Gender Dysphoria Association.20 While the application before the Court in this case did not include surgery, follow-up studies in The Netherlands on the postoperative success of transsexuals who began the treatment process in adolescence have noted improvement in the main treatment goal — that is, “diminution or resolution of gender dysphoria”.5 It was also found that these young people rated better in terms of psychological and social functioning than transsexuals who began treatment later on as adults. Postoperative regret occurs in some adults, but none of those who began the treatment process as adolescents experienced regret.5 These studies support the view that early intervention for those who continue on to pursue surgery can be justified by better outcomes. Competence to decideDifficult and complex issues also arise because of the questionable competence of a young person to make important decisions — especially decisions involving irreversible changes that could close off future options or be detrimental to long-term interests. We want to know whether the young person is competent and whether the decision is an autonomous one deserving respect (ie, a choice that is freely made “in accordance with a self-chosen plan”).21 The main values at stake in competence determinations for children and young people are wellbeing and autonomy (or, more aptly, their developing autonomy). Determining competence in young people involves trying to balance “protecting their wellbeing from the harmful consequences of their choices when their decision-making capacities are defective” with “respecting their interest in deciding for themselves when they are able”.22 Autonomy and making autonomous decisions requires stable values and a conception of the good, but instability is a feature of the values of children and young people. Young people “may give inadequate weight to the effects of decisions on their future interests, and also fail to anticipate future changes” in the things that are important to them.22 It can be argued that this case is unique in the sense that we do not have to grapple with the difficult issues of whether Alex is competent to make the decision, whether his decision is an autonomous one, and whether treatment of the kind proposed is appropriate only if its purpose is to cure a disease or correct a malfunction. These issues are eclipsed by considerations of benefit and harm. In this case, it is an added bonus that the proposed treatment is “entirely consistent” with what Alex wants, and that what Alex wants also accords with what the expert evidence indicates is in Alex’s best interests.1 It adds to the overall benefit. The Court’s decision is not about giving in to the unstable preferences of an immature person. In this case, the ultimate determinant of Alex’s wellbeing is his developmental needs rather than his capacity for deciding or his preferences. Part VII of the Family Law Act requires the Court to regard the child’s best interests when making medical treatment decisions. Rather than seeing the proposed treatment as closing off future options, it can be viewed as fostering Alex’s development and opportunities. Alleviating distress and thoughts of suicide benefit Alex’s mental and emotional health. According to his aunt, since commencement of plans to help Alex in his desire to live as a boy he has been happier, with improved behaviour, and “seems to have some direction and some plan for the future”.1 This case suggests that there is a point at which a condition that causes distress becomes medically significant. ConclusionThis case demonstrates the importance of weighing the benefits and harms involved in authorising or not authorising treatment. It highlights the value in respecting the developing autonomy of a young person, even though considerations about self-determination may not be the ultimate determinant of what should be done. In relation to the public debate, I believe that critics need better arguments to denounce the appropriateness of the proposed treatment. Critics have failed to recognise the benefit to Alex of having his wish to live as a boy taken seriously. Finally, the benefit that comes from the relief of distress may make us wonder whether the goals of the intervention really matter.

Merle P Spriggs BA, MBioeth, PhD

An Australian model could be used to get better “evidence” into legal decision-making The UK government is reviewing 258 cases in which a parent was convicted of murder, manslaughter or infanticide. This review follows the overturning of the conviction of one mother for the murder of two of her children, and the collapse of the prosecution case against another mother accused of murdering three of her children. In addition, the cases of thousands of children spirited into care, as they were deemed to be at risk of child abuse, may also be revisited. One of the key issues in these events has been the incorrectness of evidence advanced by an expert medical witness whose estimates of the probability of the occurrence of more than one sudden infant death occurring in a family were grossly incorrect. Both in the UK and Australia, primary care is not particularly well placed to detect cases of child abuse As a consequence of all these developments, UK doctors are now apparently reluctant to sit on child protection committees. A news item in the BMJ reporting this eventually generated 38 rapid online responses, reflecting varied but always strong views on the difficulty of getting the appropriate balance between protecting the child and destroying the family. The foregoing events raise two issues — how do we get better “evidence” into legal decision-making and, realising that we may never get it completely correct, should we have a system that is inclined to accept false positives or false negatives in attribution of guilt in cases of possible child abuse? Taking the issue of evidence first, one of Australia’s better-kept secrets is its excellent system of applying evidence to compensation claims of military veterans — a model which could be adopted elsewhere. The crux of the system is an independent panel that uses sound medical–scientific evidence to determine the causation of injury, disease or death in relation to exposure to military service. Although this does not relate to individual cases, but to the generality of exposure, the success of the program and the principles by which it operates provide a model that may be adapted in other jurisdictions. The independent panel arose from a request in 1994 by the Australian government to the Repatriation Commission. The Commission was asked to prepare, in consultation with veterans’ organisations, legislation to reform the process of decision-making about the causation of disease. The purpose of the reform was to create a more equitable and consistent system for dealing with claims for disability pensions received from Australian veterans and their dependants. One of the outcomes of the legislative reform was the formation of the Repatriation Medical Authority (RMA), an independent statutory authority responsible to the Minister for Veterans’ Affairs (see <www.rma.gov.au/>). The RMA consists of a panel of five practitioners eminent in fields of medical science. Their role is to determine “statements of principles” for any disease, injury or death that could be related to military service, based on sound medical–scientific evidence. The statements of principles state the factors that “must” or “must as a minimum” exist to cause a particular kind of disease, injury or death. The statements of principles also identify what constitutes “sound medical–scientific evidence” for the purpose of applying the relevant standards of proof relating to particular kinds of injury, disease or death affecting veterans: the “reasonable hypothesis” standard and the “reasonable satisfaction” (or “balance of probabilities”) standard. In its modern guise, epidemiology makes attribution of causation a rigorous process, with clear principles to be followed, and there can even be different levels of proof required for decisions from the same database. Acquiring these skills is quite different from the experience of clinical practice and significantly changes the definition of the traditional “expert witness”. The RMA has been externally reviewed and shown to make consistent decisions at its prescribed standards of proof. With such consistency in establishing causal decisions, all plaintiffs can be assured of a standardised level of judgement that does not vary from one expert witness to another. Such a system would not have allowed the error in assigning probabilities that occurred after the deaths of children in the UK. Having mentioned epidemiology, let’s move to the question of false positives or false negatives. Set the bar of suspicion too high, and child abuse will go unpunished. Set it too low, and there will be false accusations, imprisonment and family break-ups. What would be the epidemiological approach to this? First, there is a pressing need for better diagnostic tests. Are social workers and paediatricians trained well enough to identify and differentiate between real and alleged child abuse? Does this training identify the importance of pretest probability (the prevalence) and its influence on false positives and false negatives? While the training should include the relevant clinical, psychosocial, ethical and legal domains, there needs to be some good old-fashioned clinical epidemiology thrown in, to demonstrate that, in situations of low prevalence (as is usually the case with child abuse), the predictive value of a “positive” test is low. Paediatricians, social workers and primary care teams should receive more formal training and undergo some kind of accreditation and review process. Both in the UK and Australia, primary care is not particularly well placed to detect cases of child abuse or early warning signs of infanticide, and there are lost opportunities. Second, can we improve systems for reporting or our monitoring and evaluating services? An overhaul of current processes, development of less cumbersome reporting procedures, and better resourcing, as well as incentives for people to do this work, would be a start. In all this, the role of the media and various lobby groups in whipping up public concern cannot be forgotten — objectivity is difficult enough to achieve without these pressures. There is an obsession with identification and demonisation of paedophilia in Britain, fuelled by the tabloid press with its unhelpful, brutalising effect on complex social issues. But is child abuse less common in Australia? Are the media more, or less, responsible? Are paediatricians and social workers better trained? The Repatriation Medical Authority certainly sets a good example, which could be followed both within Australia and elsewhere for reducing the variability of expert opinion in possible child abuse and other medicolegal cases. Adopting this model in the UK may reduce the uncertainty surrounding child abuse that has transfixed the medical and general community here.

Richard F Heller MD, FRCP, FRACP, FAFPHM · Konrad Jamrozik DPhil, FAFPHM, MFPH · David P Weller MPH, PhD, FRACGP, FAFPHM

The United Kingdom is currently introducing public reporting of performance information for individual cardiac surgeons. The reports will indicate whether a surgeon has an acceptable level of performance, measured by in-hospital mortality. In the United States, surgeon-specific performance data have been available for over a decade. Arguments from both safety and accountability perspectives provide strong justifications for public reporting of such data. Were Australia to adopt similar public reporting processes, we should learn from overseas experiences. Surgical associations should be actively involved in developing data standards and processes for data collection, validation, analysis and publication. Any Australian policy initiative for public reporting of individual surgeon data should be backed by a political commitment to adequate funding.

David A Neil PhD · Justin G Oakley PhD · Steve Clarke PhD

John M N Hilton Associate Professor, Department of Pathology, University of Sydney; and Consultant in Forensic Medicine, PO Box 45, Katoomba, NSW 2780. kornhilATiinet.net.au To the Editor: Byard’s succinct dissertation on the Clark case1 omits one crucial aspect in redressing this miscarriage of justice. Without the vigorous and persistent efforts of a vocal and well directed support group, which included Mrs Clark’s legal team, their scientific and medical advisors, the Law Society of England, and her family, she would still be serving a life sentence in jail. An Australian example of the effectiveness of such a support group in combating injustice is afforded by the Lindy Chamberlain case.2 Historically, Sir Arthur Conan Doyle spearheaded the efforts — sustained over nearly 20 years — to exonerate Oscar Slater,3 an unfortunate German–Jewish immigrant to Glasgow who was condemned to death after a conviction for murder based largely on identification evidence given by one of the probable perpetrators. Slater was granted a reprieve from the death sentence at the last moment, only to serve some 17 years in a grim Scottish penitentiary. Less fortunate was Timothy Evans,4 who was convicted and hanged for murdering his wife and daughter on the evidence of one of London’s infamous mass murderers, John Christie. Evans was eventually pardoned — unfortunately, too late to save his life — largely thanks to a very active support group headed by the journalist Ludovic Kennedy. In contrast, those who lack such a support group are exemplified by Ziggy Pohl,5 who was convicted, despite rather than because of the evidence, of killing his wife in Queanbeyan, NSW. He served more than a decade in prison, only to have the true perpetrator confess after Pohl was released on parole. Byard highlights evidentiary shortcomings in one recent English case. How many other people have suffered the ignominy, distress and dire consequences of unjust convictions because they lacked the support of an individual or a group prepared to question the propriety of the conviction process?

John M N Hilton

One function of such services is to help clinicians ask the “right” questions The article by Gill and colleagues in this issue of the Journal (page 204)1 raises the issue of the ethics of clinical ethics services and, secondarily, their potential legal liability. Expressly or by implication, the article points to many difficulties and pitfalls of such services, and certainly raises more questions than it answers. But, in doing so, it reflects a necessary and valid function of ethics services: to help those who should make the decisions ask as many of the “right” (ie, ethically relevant) questions as possible. It is not the function of ethics services to make those decisions. The authors make some important points. Variability in decisions or failure to reach consensus does not mean ethics consultations are pointless — it is as important to highlight moral differences as to resolve them. When conducted well, clinical ethics services can be a valuable hospital resource and a powerful, critical voice contributing to ethical practice. “Doing ethics” is an exercise of power, and power must be exercised ethically. But simply a desire to do good is not sufficient to ensure that. Our goal of doing good can blind us to the harm that is also unavoidably inflicted, and sometimes that infliction is unethical. Doing ethics is a matter of both substance and process. Questions that help to provide insights about process ethics include: Who should decide? On what basis? Using which procedures? For what purposes? One of my “process” concerns about the Acute Clinical Ethics Service (ACES) described by Gill et al is that the ACES team does not necessarily include a person trained in applied or practical ethics and, moreover, that the authors do not recognise the need for doing so. I also have substantive or principle-based ethical concerns. For example, their “organisational principles” do not make it clear that, when values conflict, the basic ethical and legal presumption governing decision-making is that the patient’s values should take priority, and therefore that contravening them must be fully justified. Rather, these principles instruct the ACES to consider “the facts of the case and the values and preferences of all stakeholders”. Most ethical issues involve a conflict of values, which means values must be prioritised when not all can be honoured. Justifying the breaches of values that result is the essence of doing ethics. An important function of a clinical ethics service is to provide such justification or to comment on that provided by others. This allows the clinical ethics service to fulfil its advisory role in individual cases, to establish precedents that can guide future decisions and to serve a teaching function within the healthcare institution as a whole. However, my purpose here is to address the broader ethical issues underlying an ethics service rather than the ethical issues raised by the cases presented by Gill et al, with whose analysis and conclusions I do not necessarily agree. Committee decisions, as compared with individual ones, can spread the responsibility. A committee can make a decision that no one person — in particular, no committee member — acting alone would make. In all the cases described by Gill et al, the issue was that of shortening life (by either withholding treatment or aborting a fetus), and the physicians doing that were morally reassured by the ACES’s involvement. Might that have allowed the “caring team” to implement decisions that their moral intuitions were indicating were unethical? While these decisions may have been ethical, we must always be aware that we ignore such intuitions at our ethical peril. Could the ACES be legally liable for its advice?A clinical ethics service could be held legally liable if it failed to act as a reasonably competent committee. In a Quebec Superior Court case,2 the court held the ethics committee of a McGill teaching hospital liable for negligence in its review of the informed consent forms for a research protocol. The very remote risk of death was not disclosed. A subject in the research trial died from an anaphylactic shock reaction to the injection of a dye. If the membership of an ethics service or committee is not reasonably constituted, it could give rise to a claim based on systems negligence for failure to establish a reasonably safe system for ethics review. Not having a trained ethicist as part of a service or committee, or at least available for ad-hoc consultation, raises this issue, although that absence may be able to be justified. Moreover, an ethics committee and a “single ethics expert” are not mutually exclusive alternatives, as often both are needed. Ethics services or committees may have an obligation to report unethical and illegal actions. If they do not intervene at all, there may be no liability, but, having intervened, they may be liable for failure to take reasonable care when it is clear that that failure could result in harm to others. Patient consentThe basic presumption concerning patients’ medical records is that they are subject to strict duties of privacy and confidentiality. Therefore, obtaining informed consent from the patient (or the legal representative of an incompetent patient) to consult the ethics committee is necessary. Acting without such consent would need to be justified. As presently drafted, the organisational principles outlined by Gill and colleagues could cause some confusion as to whether these rules apply. Once again, it should be made clear that, in situations in which values conflict, the basic presumption is that the patient’s values should take priority. Characteristics of the members of the ethics consultation teamThe relationship between an ethics consultation team and the hospital administration raises the issue of conflict of interest in those people who are both members of the ethics service and part of the hospital organisation. If their obligations or goals as members of a clinical ethics service could conflict with their duties as people holding hospital appointments, then there is such a conflict, whether or not in the particular circumstance a conflict arises in practice. Strong ethical sensitivity is required to identify and deal with such conflicts. An assumption that people of good intention acting in good faith are competent ethics committee members — in particular, that they are, by virtue of those characteristics, sufficiently educated in ethics — is not valid. A recent US Institute of Medicine report3 has recommended that substantial resources be devoted to such education. Schools of ethicsGill and colleagues mention various schools of ethics that “may assist with the resolution of ethical conflicts”. These schools can be looked at as different “lenses” through which one can view a situation that raises ethical dilemmas. When all reflect back the same response, one can be reasonably certain that acting in that way is ethical. But when conflicting responses show up, difficulties arise. These difficulties usually reflect an irresolvable conflict of values. In such cases, it is very important to give the reasons (ie, justification) for giving priority to one value or set of values and thereby contravening another value or set of values. Indeed, providing such justification is the essence of “doing ethics”. ConclusionThe article by Gill and colleagues raises some very important issues, and the cases they describe may raise substantial controversy in relation to healthcare ethics services. Certainly, if North American experience holds true in Australia, many doctors may feel, at least initially, that their professional autonomy is threatened by an ethics committee or even an ethicist. Many nurses, however, will see ethics committees and ethicists as empowering them to challenge doctors’ decisions that they believe are unethical. Junior members of the medical profession, especially students and residents, and a few of its leaders, will be the first to accept the benefits of properly constructed ethics consultation services and to promote their integration into the healthcare setting. As ethics services become more familiar, more people will recognise both their benefits and (as we should always keep in mind) their dangers. Like democracy, ethics committees and ethics consultations are not a perfect system, but they are better than the alternative of having no ethics consultation process at all.

Margaret A Somerville AM, FRSC, LLD

Australian criminal law is a matter for states and territories. In relation to abortion, many laws are unclear and outdated, and are inconsistent between states and territories. Doctors practise under time constraints and on a case-by-case basis. Most current laws have grey areas that leave doctors vulnerable to accusations, negative publicity and career damage, especially in the case of late abortions. All jurisdictions should follow the Australian Capital Territory’s lead in allowing women to access abortion without fear of criminal prosecution. Federal, state and territory governments should introduce a single clear national law on abortion, both in early and late pregnancy.

Lachlan J de Crespigny MD, FRANZCOG, COGU · Julian Savulescu MB BS, BMedSci

In Australia there has been only limited experience with ethics consultation, and there are no reports of practical details. In 1999, the Institutional Clinical Ethics Committee at John Hunter Hospital, Newcastle, initiated an Acute Clinical Ethics Service (ACES) to formalise a perceived need within the hospital for ethics consultation. This need had previously been met by ad-hoc councils of “wise men”. The ACES approach uses a team of people with different perspectives to provide an ethics consultation in a timely manner. Our initial experience of ACES has shown that a formal process of ethics consultation may be preferable to informal approaches in many circumstances; even when genuine consensus is not possible, an ethics consultation nevertheless provides an opportunity to share different points of view and helps to avoid practices that may be unacceptable. The specific implications of acute ethics consultations are not yet fully elucidated.

Andrew W Gill FRACP · Peter Saul MRCP, FRCA, FFICANZCA · John McPhee BCom(Hons) (LegStud) · Ian Kerridge MPhil(Cantab), FRACP, FRCPA

Doctors should:

Ian H Kerridge BMed(Hons), MPhil, FRACP, FRCPA · John R McPhee BCom(Hons)(LegStud)