Ethics

Under state laws, a medical practitioner will not be found negligent if they acted in a manner that was widely accepted in Australia, by a significant number of respected practitioners in the field, as competent professional practice in the circumstances. This is known as the “peer professional practice defence”. The professional opinion being relied on must not be unreasonable (Victoria and Western Australia) or irrational (New South Wales and other states). The peer professional practice defence does not apply to claims of negligence arising from failure to warn patients about risks associated with medical treatment. This reinforces the importance of warning patients of material risks as determined by the High Court of Australia in Rogers v Whitaker. Recent cases demonstrate the successful operation of the peer professional practice defence, but also highlight its limitations. In practice, the legislation may not shield doctors from negligence claims as fully as originally intended.

Patrick D Mahar MB BS(Hons), LLB(Hons) · Justin A Burke MB BS(Hons), LLB(Hons), FANZCA

Trade in human tissue in Australia is prohibited by state law, and in ethical guidelines by the National Health and Medical Research Council: National statement on ethical conduct in human research; Organ and tissue donation by living donors: guidelines for ethical practice for health professionals. However, trade in human tissue products is a common practice especially for: reconstructive orthopaedic or plastic surgery; novel human tissue products such as a replacement trachea created by using human mesenchymal stem cells; biomedical research using cell lines, DNA and protein provided through biobanks. Cost pressures on these have forced consideration of commercial models to sustain their operations. Both the existing and novel activities require a robust framework to enable commercial uses of human tissue products while maintaining community acceptability of such practices, but to date no such framework exists. In this article, we propose a model ethical framework for ethical governance which identifies specific ethical issues such as: privacy; unique value of a person’s tissue; commodification of the body; equity and benefit to the community; perverse incentives; and “attenuation” as a potentially useful concept to help deal with the broad range of subjective views relevant to whether it is acceptable to commercialise certain human tissue products.

Nicholas Tonti-Filippini MA, PhD, FHERDSA · Nikolajs Zeps BSc(Hons), PhD

Is it time to relax or tighten the legislation on human embryo research? Over the past decade, human embryo research has generated both enormous scientific interest and extensive public debate. In response to this, Australia passed two Acts in 2002: the Research Involving Human Embryos Act 2002 (Cwlth) and the Prohibition of Human Cloning Act 2002 (Cwlth). Together, these Acts, and mirror legislation passed by all states and territories, enabled Australian scientists to undertake specific research involving human embryos, provided that they obtained a licence from the Embryo Research Licensing Committee of the National Health and Medical Research Council (NHMRC), reported regularly to this committee, and had their research approved and monitored by the appropriate institutional ethics committee. At the same time, these Acts prohibited a series of practices — including human cloning, creation of animal–human cybrids, maturation of research embryos beyond 14 days, and the buying and selling of human oocytes — and provided substantial penalties for breaches of the provisions. Consistent with the provisions of the Acts, the legislation was reviewed in 2005–2006 by the Lockhart Committee (the Legislation Review Committee chaired by the late John Lockhart). After extensive community consultation, the Committee made 54 recommendations for amending the existing legislation. Following further public and parliamentary debate (which culminated in a conscience vote in both federal chambers), almost all of these recommendations were accepted and implemented, by the amending legislation in 2006 or administrative changes made by the NHMRC and other relevant regulatory bodies. (The current federal legislation is the Research Involving Human Embryos Act and the Prohibition of Human Cloning for Reproduction Act 2002 [Cwlth].) As a consequence, while the major prohibitions present in the 2002 Acts remained, Australian scientists were able to create an embryo by somatic cell nuclear transfer (SCNT) for research purposes and conduct research on human embryos deemed unsuitable for implantation and on eggs in the process of fertilisation up to syngamy. The legislation is again up for review and, as in 2005–2006, the review must consider: developments in assisted reproductive technology and embryonic stem cell (ESC) research, international developments and legislation relating to the use of human embryos in research, the effectiveness of existing legislation (including whether it has acted as a barrier to important research or clinical practice), and community standards. Since 2006, research involving autologous and allogeneic transplantation of adult somatic stem cells has continued to advance (although the best evidence continues to be for treatment of malignant and immunological diseases) and early studies have confirmed that autotransplantation of haematopoietic and mesenchymal stem cells may have regenerative capacity in treating hepatic, pulmonary, cardiac, neurological and arthritic diseases. Over this period, human ESC research has also provided important insights into normal and pathological cellular biology, reproduction and embryogenesis, and the creation of disease models and systems for screening drugs and predicting toxicity.1 Animal studies of ESCs have also shown promising results in the treatment of spinal injury, neurodegenerative and demyelinating disorders and retinal disease, and the first Phase 1 clinical studies involving adults with spinal injury and stroke and children with macular dystrophy have begun.2-4 At the same time, a series of developments in related fields have also created enormous excitement. In 2006 and 2007, teams of scientists in Japan and the United States reported that they were able to derive induced pluripotent stem (iPS) cells by inducing forced expression of specific genes in adult somatic cells.5 These iPS cells, which resemble ESCs in terms of morphology, mitotic activity, telomerase activity and expression of stem cell genes and proteins, appeared to be an important breakthrough as they allowed generation of stem cells without the use of human embryos, did not require the use of donor oocytes, and avoided the problems of immune rejection and graft-versus-host disease because they were autologously generated.6 While proof-of-concept and animal studies of iPS cells in a range of degenerative disorders show great promise, recent research suggests that iPS cells may have a slightly different gene expression profile to human ESCs, have limited differentiation capacity and undergo premature ageing. Also, significant hurdles remain with regard to the efficiency and safety of iPS cells before human trials can begin.7-9 Recent research has also demonstrated that nuclei from “terminally differentiated” adult somatic cells can be induced (“reprogrammed”) to express genes that are typical of ESCs or of other lineages, and differentiated to form other cell types, thereby enabling autotransplantation of normal tissue to areas of disease, or the generation of new organs or tissues using tissue-engineering technologies.10-12 Despite the fact that this research is in its infancy, the promising results of research involving iPS cells and reprogrammed adult somatic stem cells has (predictably) led some to proclaim the demise of ESC research and to call for the repeal of legislative amendments enabling human ESC research and SCNT. This would be a mistake. Although developments in iPS cell research show promise and human ESC research has not yet been translated into medical therapies, this does not provide a reason for prohibiting ESC research. It remains unclear whether human ESCs, reprogrammed adult somatic stem cells and iPS cells will prove to be bioequivalent or to offer alternative or complementary cellular therapies.7 In addition, as the history of medical research demonstrates, the realisation of clinical benefits from basic research can take decades. Furthermore, the stem cells derived from SCNT may also yield benefits other than medical therapies, including cell lines for drug screening and for research into early embryonic development, normal organogenesis and certain disease states. And, perhaps most importantly, the idea that advances in one field of research should mean researchers are prevented, by law, from exploring another related field of research is, in many ways, antithetical to the principles and processes of science in a liberal democratic society. Australia’s existing regulatory framework provides the most effective means for ensuring that research is important, rigorous and ethically sound in its design and conduct. Should research yield important benefits consistent with the needs and goals of the community, it will prosper. Should it prove redundant, useless or totally at odds with the values of the community, it will not. For all these reasons, and because human embryo and stem cell research enjoy high levels of public support, we should not again seek to prohibit research involving human embryos or the derivation of stem cell lines by SCNT. Whether the current legislation needs to be liberalised further to enable research into mitochondrial diseases, the creation of cybrid embryos or the payment of egg donors, is a matter for debate.

Ian H Kerridge MPhil, FRACP, FRCPA · Aric Bendorf BA, MBioethics

To the Editor: Before and since 1 July 2010, when the National Registration and Accreditation Scheme for health practitioners commenced, the claim that mandatory reporting laws will deter impaired doctors from seeking help has frequently been made. It was on the basis of this claim that Western Australia legislated to exempt health professionals from reporting impaired practitioners they are treating. At a recent conference of the Royal Australian College of General Practitioners, a representative of a medical indemnity organisation labelled the mandatory reporting laws a disgrace because the health of impaired doctors who are deterred from seeking help for this reason would be put at risk. However, she also indicated that the problem was more one of perception than reality because doctors feared triggering a mandatory report automatically if they sought help from another doctor for a perceived impairment.1 It is a problem of perception because, under the laws, only doctors whose impairment places the public at risk of “substantial” harm are required to be reported.2 If doctors have an unreasonable fear of mandatory reporting, we can infer that many are unaware of the details of the laws, in particular the reporting thresholds. Yet an argument against introducing the laws was that doctors were already under an ethical obligation to report, to the relevant authority, unprofessional conduct, impairment or performance that would put patients at risk.3 For this argument to be valid, doctors would need to be aware of the details of mandatory reporting because the Medical Board of Australia’s code of conduct for doctors states, in its list of ethical obligations, that doctors should be aware of their reporting obligations.4 So this particular argument does not appear to be valid. Because medical professionalism puts the wellbeing of the patient first; because psychological or physical health status may affect professional performance; and because the Board, like the state boards that preceded it, has a primary duty to the safety of the public — any doctor whose impairment poses a substantial risk or, in the absence of that doctor’s insight, any treating doctor who considers that a substantial risk exists should surely feel ethically compelled to report the matter to the Board. No doctor whose impairment does not pose a substantial risk should feel deterred from seeking medical help. The consequences for impaired doctors who are reported under the new legislation are no different from those of reporting a doctor when it was “merely” an ethical requirement — being placed on an impaired practitioners’ register and supported, managed and monitored, while, in most cases, continuing to practise. If impaired doctors and their treating doctors feel deterred by mandatory reporting laws, we are entitled to conclude that there was, and continues to be, significant non-compliance with the ethical obligations that arguments against mandatory reporting depend on.

Malcolm H Parker

Four formal rounds of Trans-Pacific Partnership Agreement (TPPA) negotiations took place in 2010. They involved over 200 officials from Australia, the United States, New Zealand, Chile, Singapore, Brunei, Peru, Vietnam and Malaysia. Future negotiations officially are set to include three issues with public health and medicines policy implications for Australia and our region: ways to approach regulatory coherence and transparency; how to benefit multinational and small–medium enterprises; and multilateral investor–state dispute settlement. US-based multinational pharmaceutical companies are lobbying for TPPA provisions like those in the Australia–US Free Trade Agreement, which reduce government cost-effectiveness regulatory control of pharmaceuticals, threatening equitable access to medicines. They also advocate increased TPPA intellectual monopoly privilege protection, which will further limit the development of Australian generic medicine enterprises and restrict patient access to cheap, bioequivalent prescription drugs. Of particular concern is that proposed TPPA multilateral investor–state dispute settlement procedures would allow US corporations (as well as those of other TPPA nations) to obtain damages against Australian governments through international arbitral proceedings if their investments are impeded by Australian public health and environment protection legislation.

Thomas A Faunce BA LLB, BMed, PhD · Ruth Townsend RN, LLM

Professional ethical codes identify the issue of conflict of interest, which can distort doctors’ objective judgements concerning the best interests of patients. Legal fiduciary duties may be owed by doctors to patients in situations of potential conflict of interest. Prescribing and dispensing functions have been largely legally separated to prevent conflicts of interest arising. The advent of integrative medicine has been accompanied by an apparent growth of in-house selling of therapeutic products. Medical merchandising constitutes a prima-facie conflict of interest and may amount to notifiable conduct under the Health Practitioner Regulation National Law provisions. We believe that doctors who sell therapeutic products should adhere to strict conditions to avoid significantly departing from accepted professional standards. Doctors who have a reasonable belief that a colleague is failing to comply with these conditions could consider notifying the Medical Board of Australia.

Malcolm H Parker MB BS, MLitt, MD · Jon L Wardle BHSc(Nat), MPH · Michael Weir BA, LLM, PhD · Cameron L Stewart BEc, LLB(Hons), PhD

To the Editor: It is regrettable that research published by Studdert and colleagues suggests that barriers remain to the open disclosure of medical error in Australia.1 Although all states have enacted legislation to protect defendants who apologise to plaintiffs, such protection is variable and inconsistent across Australia.2 Most significantly, the definition of what constitutes an apology varies greatly from jurisdiction to jurisdiction, as do the various protections afforded to the apology. Unfortunately, this only serves to complicate what should be an open and candid discussion of the circumstances surrounding a medical error. However, the fear of legal action is not the only barrier preventing doctors from disclosing harm-causing medical errors to patients and their families. Acknowledging that an error has caused serious harm to a patient is extremely distressing to doctors, most of whom enter the medical profession with the aim of relieving the suffering of others. When their actions inadvertently result in harm to patients, the impact can be devastating.3 The emotional reaction to a medical error is usually one of intense anxiety and concern for the patient’s welfare, then deep reflection on how the error occurred and how the outcome might be mitigated. This may be followed closely by the doctor’s anxiety about his or her own welfare and the professional and legal consequences of the mistake, including the potential loss of reputation or even job. Consequently, doctors are sometimes tempted to rationalise away their role in causing harm or minimise their responsibility for disclosing mistakes and failures.4,5 However, an apology is a powerful tool to facilitate healing of the emotional scars of a patient’s injury. Furthermore, from the perspective of a medical indemnity insurer, while open and transparent disclosure of medical error would seem an improbable risk-management strategy, there is no doubt that a truthful and compassionate explanation of some errors that cause harm may actually reduce the risk of litigation.6 So, as Studdert and colleagues conclude, doctors should be and are supported and encouraged to enter into these difficult discussions by their insurer, without a presupposed fear that the actual process of open disclosure might contribute to the risk of litigation. One hopes that stakeholders will continue to work towards removing barriers to this process, with a greater focus on clinical risk management and less on recrimination and blame within the Australian health care system in years to come.

Julian L Rait · Elizabeth H Van Ekert

Never, ever, again . . . Why Australian abortion law needs reform. Caroline de Costa. Brisbane: Boolarong Press, 2010 (168 pp) ISBN 978 1 921555510. Caroline de Costa wrote her new book because of her belief that it is inappropriate to punish a woman for making the decision that she is unable to become a mother at this point in her life. The material has been carefully researched by the author, who is Professor of Obstetrics and Gynaecology at James Cook University, in Cairns, Queensland. It brings together into a single clear record the often confused history of abortion law and relevant court cases in both Queensland and elsewhere in Australia. The chapter on the long history of the family planning and abortion information service “Children by Choice” and its remarkable contribution to Queenslanders is enlightening. The book records gruesome personal stories of barbaric pre-1970 illegal abortions. They highlight the dangers to life and health to which Australian women, especially the poor and isolated, were exposed before court rulings that made some abortions lawful. The documentation of the history of the emergency contraceptive mifepristone (RU-486), which can be used for medical (non-surgical) abortion in early pregnancy or in the second trimester, is also valuable. The author knows the process well — she and her colleague were the first two doctors who were permitted by the Therapeutic Goods Administration to prescribe mifepristone in Australia. The book describes in detail the build-up to criminal action against Tegan Leach and her partner in Cairns, who were sent mifepristone from overseas. Leach appears to be the first Australian woman charged with procuring an abortion for herself. De Costa will publish an account of the court case on her website. De Costa’s book highlights the unclear and inconsistent abortion laws throughout Australia and the need for uniform and just laws as a first step in providing equitable access to abortion, including for mifepristone. This book documents how Australia continues to fail women who conceive but feel unable to raise a child at the time. I would strongly recommend this book to all obstetricians and gynaecologists, as well as others interested in women’s health. It adds to de Costa’s proud record as an advocate for women’s health.

Lachlan de Crespigny

This report summarises the presentations, discussion themes and outcomes of the National Forum: Assessment of Professional Behaviour of Medical Students held in Brisbane on 5 March 2010 The behaviour of doctors and medical students has received increasing attention in recent years, but its assessment has resisted straightforward integration into academic programs. Attempts to prevent the admission of the small number of students who are unsuitable for graduation and subsequent practice are yet to prove effective.1,2 National registration will require that virtually all Australian health professional students are registered with their respective national body;3-5 these students will therefore formally become members of their professions. The accountability thereby imposed on students and their schools will set new expectations for managing student behaviour in universities. In response to these issues, the Discipline of Medical Education, School of Medicine, University of Queensland (UQ) organised the National Forum: Assessment of Professional Behaviour of Medical Students, held in Brisbane on 5 March 2010. Participants confronted the conceptually and practically difficult problem of validly and reliably assessing the attitudes and behaviour of medical students as a component of their overall fitness to practise. ParticipantsThe forum was attended by 86 participants, including representatives of 13 Australian medical schools (from all mainland states), both New Zealand medical schools, Queensland Health and some of its public hospitals, the Medical Board of Queensland, the Health Quality and Complaints Commission of Queensland, the Australian Medical Council (AMC), medical student bodies, and other health professions. There were six presentations and two facilitated discussion sessions. Setting the sceneIn opening the forum, Professor Michael Keniger, Senior Deputy Vice-Chancellor, UQ, commented that issues relating to attitudes and behaviour are not restricted to medicine, and that an authoritative basis for a common approach is required, including the early detection of students who may pose problems later in their practices. The Commissioner of Queensland’s Health Quality and Complaints Commission,6 Professor Michael Ward, noted that although serious individual breaches of professionalism attract the most public attention, problems occur at two levels — the individual practitioner (often driven, arrogant and narcissistic) and the profession, which is immersed in a culture of silence. Failure at both levels has powered the “engines of external regulation”, including complaints commissions. Professor Ward suggested strategies that could be used to address these problems, including the avoidance of individual student selection “disasters”, the early identification of problem students, early responses to warning signs of aberrant practitioners, and individual remediation of both students and practitioners. Implicit in this is the need for the profession to raise “group intelligence”, deal with dysfunctional colleagues, and learn how to handle difficult conversations rather than turning a blind eye to poor practice. The AMC, the accrediting body for Australian and New Zealand schools, understands that measuring professionalism is less well developed than assessment in other areas, such as clinical skills and knowledge of biology and pathology, but it expects and encourages schools to monitor and assess student behaviour in a manner consistent with the principles of its recent publication for independent practitioners, Good medical practice: a code of conduct for doctors in Australia.7 The Chair of the AMC’s Medical School Accreditation Committee,8 Professor Michael Field, indicated that behaviour assessment is accepted as a routine element of medical education and that schools are required to develop robust processes overseeing student behaviour — incorporating clear standards and criteria, defined consequences of failure, and rules for progression. Schools should offer student support and counselling, and identify and deal with students whose lack of professionalism or impairment affects their ability and performance. AMC accreditation visits have revealed a wide range of approaches to assessing professional behaviour, and Professor Field noted that despite the expectation that schools establish professional behaviour committees, their processes have not always been accepted into the mainstream assessment practices of the schools. International experienceThe keynote address was given by Professor Maxine Papadakis, an academic physician and Associate Dean for Student Affairs at the School of Medicine, University of California, San Francisco (UCSF) and one of the United States’ pre-eminent researchers in the assessment of medical professionalism. She recounted the development at UCSF of the process for managing student behaviour. Dismissal can occur on the basis of sustained failure, indicated by “physicianship evaluation forms” issued by course directors or associate deans according to agreed patterns.9,10 Professionalism as a requirement for graduation is supported by large-scale studies showing that unprofessional student behaviour predicts disciplinary action as a registered physician,11,12 and that student professionalism ratings predict factors influencing patient care.13 Professor Papadakis urged a strong research effort to improve our expertise in remediation methods and underscored the deficiencies of professional culture by arguing for the reciprocal assessment of teaching staff by students. Current practice in AustraliaAssociate Professor Paul McGurgan (University of Western Australia) presented the results of a national survey on fitness-to-practise policies in Australian medical schools, a project conducted by senior medical students under his supervision (see Fitness-to-practise policies in Australian medical schools — are they fit for purpose?).14 The survey used the United Kingdom’s General Medical Council (GMC) categories of unprofessional behaviour for medical students,15 with a guiding assumption that fitness-to-practise policies should be developed in a nationally consistent way. Fifteen of the 19 Australian schools participated; 12 of these had fitness-to-practise policies, and six addressed all eight of the GMC’s best-practice criteria, but with variation in referral and remediation criteria. Seven schools excluded students during the 5-year study period, the most common reasons being persistent inappropriate attitude or behaviour (eight students) and criminal convictions (four students). The study revealed a lack of consistency across the schools, suggesting that a move towards a more collaborative approach is possible and should improve outcomes. Learning from other disciplinesAssociate Professor Lindy McAllister (UQ) described the development of the COMPASS system of assessing of student performance in the discipline of speech pathology.16 The instrument has high validity and reliability and is used formatively during mid-rotation evaluations and summatively during end-of-rotation evaluations. Students are assessed in clinical settings directly and on multiple occasions; the assessment includes four generic competencies — reasoning, communication, lifelong learning and professionalism, including behaviour — and seven occupation-specific competencies. An at-risk notification of grossly or persistent unprofessional behaviour may result in a student being withdrawn from a rotation and not permitted to return until agreed and monitored remedial work is completed. Student perspectivesTwo students from the University of Queensland Medical Society17 presented the society’s views on how student behaviour should be assessed. They described UQ’s personal and professional development interview process for students flagged as needing assistance — in any area, including attitudes and behaviour — as fair and equitable, yet daunting and stressful for some students, with some persistence of the (albeit incorrect) perception of a punitive, disciplinary and inquisitorial process. The students urged that satisfactory professional conduct be made a requirement for graduation, but called for better documentation of the rules and processes. They supported peer assessment, subject to the provision of adequate training, and a limited extension of behaviour assessment to social situations, where students are readily perceived as representatives of the school and the medical profession. They also pointed to social networking websites as possible settings for unprofessional behaviour. Future imperativesAssociate Professor Malcolm Parker (UQ) clarified the obligations of medical schools under the (at the time) imminent national registration scheme’s governing legislation.18 The statutory reporting requirements leave medical schools with the responsibility of directly managing student impairment that does not pose a direct risk of harm to the public and managing all student behaviour issues. He argued that assessment should be of actual, not simulated, behaviour, and that many instruments do not fulfil this requirement. He also questioned the possibility of remediating certain students, the appropriateness and effectiveness of purely academic sanctions (such as repeating rotations) for failure on professional behaviour grounds, and the continuing allegiance to strict confidentiality concerning students as they move into practice, which constrains any pre-emptive oversight by registration authorities. Participant perspectivesDuring the discussion sessions, participants raised the following issues and themes: The airline industry’s safety model includes training in how junior staff can convey critical information (in both senses of critical) to their seniors — a model that medical education must embrace more comprehensively. Unacceptable behaviour should be described objectively, rather than “diagnosing” personality traits and disorders in problem students. Although students with narcissistic personalities can conceal their behaviour from senior staff, students can often discern problems, highlighting the value of peer assessment. Peer assessment is valuable, but students’ sense of collegiality may minimise reporting rates. Administration staff are valuable sources of information, as they deal with behaviour that students would not always display to teachers. They provide formal reports on student behaviour in some schools. The responsibilities and scope of schools and students need to be clearly defined, so that judgements can be made reasonably and acted on. Some teachers are reluctant to critically assess students or junior medical staff for fear of terminating potential careers, but this may be changed by steady peer pressure over time. Students at younger ages may still be developing their “moral compasses”, but this can be accommodated by defining appropriate expectations for different stages and distinguishing these from criteria (such as honesty) that apply across programs. Simulated clinical scenarios may provide information on behavioural tendencies by seeking students’ responses in different contexts. Students should be positively encouraged to act professionally, and staff should provide feedback on good professional behaviour where appropriate. The main points raised by the speakers and participants are summarised in Box 1, and the actionable outcomes that were agreed on are listed in Box 2. 1 Assessing medical student professionalism: where are we now? The community expects doctors and other health professionals to behave appropriately. Failure at the levels of individual performance and the response of the profession have driven an increase in external regulation. The profession’s culture of silence about poorly performing peers reaches into student assessment and should be changed. A small number of students should not graduate and practise, on the grounds of their unsatisfactory behaviour. Admission processes do not effectively prevent these students from entering medical programs. Large-scale studies demonstrate that unprofessional student behaviour predicts later disciplinary action; student professionalism ratings predict quality of patient care. Under national registration, the Medical Board of Australia will not be responsible for assessing students’ professional attitudes and behaviour in medical schools; this will continue to be the responsibility of medical schools. The Australian Medical Council requires medical schools to support students and manage those who are impaired or demonstrate poor professionalism using clear standards and criteria, defined consequences of failure, and rules for progression. Descriptive behavioural criteria and accompanying standards are required for robust assessment; these can accommodate the moral maturation of students. Students strongly support assessment of professional behaviour, adequate documentation, and peer assessment with adequate training. The majority of Australian medical schools have fitness-to-practise policies and processes, but there is wide variation in referral and remediation criteria and processes. Assessment should arguably focus on actual behaviour, rather than behaviour observed during simulated situations, including formative and summative patient–student interactions, although simulations of various kinds can provide good teaching and feedback opportunities. Assessment should include feedback on positive as well as poor behaviour. Assessment should be accompanied by remediation, and adequate remediation requires further research. 2 Actionable outcomes of the National Forum: Assessment of Professional Behaviour of Medical Students 1. A forum report should be published in a major medical journal. 2. Representatives of the participants should write to the Medical Deans Australia and New Zealand,19 proposing that a trans-Tasman working group on the assessment of professional attitudes and behaviour be facilitated and supported. 3. The working group should define acceptable behaviour at different stages of a medical career; descriptors should be positive and inspirational. (The working group should also be involved in implementing outcomes 4–7.) 4. A nationally uniform approach should be adopted to align with the spirit and implementation of national registration and Good medical practice: a code of conduct for doctors in Australia.7 5. Further exploration and research should be undertaken in the areas of teaching professionalism, assessment processes and remediation. This includes collation of curricula in the related areas of ethics, law and professionalism. 6. Further academic articles should be published, covering descriptive and empirical work in assessment and remediation. 7. Any revision of the previously published position statement An ethics core curriculum for Australasian medical schools20 should more adequately address professional behaviour, its assessment, and its relationships with teaching ethics and law.

Malcolm H Parker MB BS, MLitt, MD · Jane Turner MB BS, FRANZCP, PhD · Paul McGurgan MB BCh, MRCOG, FRANZCOG · Lynne M Emmerton BPharm, PhD, MPS · Lindy L McAllister BSpThy, MA(SpPath), PhD · David Wilkinson MB BS, DSc, FRCP

Objectives: To describe current use and possible effects of Australian medical school fitness-to-practise policies (FTPPs), and to define and benchmark FTPP best practice.Design, setting and participants: A questionnaire-based study of Australian medical schools was conducted in August 2009.Main outcome measures: Use of FTPPs by medical schools; criteria used in FTPPs; remediation processes; numbers of students excluded for professional misconduct, reasons for exclusion, and year of study at time of exclusion.Results: The questionnaire was completed by 15 of 19 medical schools to which it was sent, and 12 schools reported using an FTPP. There was wide variation in the FTPP criteria used by individual schools, and use of an FTPP appeared to be independent of medical student registration with state medical boards and type of course entry. There were no apparent differences in medical student exclusion rates between schools with FTPPs and those without. The most common reason for exclusion was persistent inappropriate attitude or behaviour, including poor attendance, and most exclusions occurred by the third year of study.Conclusions: Most Australian medical schools use FTPPs, but these policies are variable and lack proven effectiveness. The variations in the numbers of students excluded by the different medical schools for unprofessional behaviour suggest discrepancies in the medical schools’ abilities to detect and manage students with problems in this area. Previous calls to develop a nationally consistent approach to the management of poorly behaving students should be addressed.

Paul M McGurgan MB BCh, MRCOG, FRANZCOG · Debbie Olson-White · Marie Holgate · Di Carmody RM, MPH

The ethics of pediatric research. David S Wendler. Oxford: Oxford University Press, 2010 (337 pp). ISBN 9780199730087. AS HEAD of the Unit on Vulnerable Populations, Department of Bioethics, NIH Clinical Center, in the United States, David Wendler continues to contribute to the rich debate on issues surrounding ethical research involving vulnerable populations, including children, who cannot give informed consent. This particular work was written while Wendler was a Faculty Fellow in Ethics at the Safra Center for Ethics at Harvard University, and is the result of over 10 years of research. A balanced and engaging analysis of the justifications for the ethical acceptability of non-beneficial paediatric research is critical, if we are to undertake ethically sound translational research in vulnerable populations to improve medical care. Scholars in clinical research ethics and, potentially, clinicians engaged in paediatric research should find this book of interest and value. Each well structured chapter includes brief summaries of the arguments presented in the chapters immediately preceding and succeeding it. Wendler is particularly helpful when he explores the ways in which concepts such as “social value”, “human interests and causes”, “wellbeing” and a “better life” influence the moral status of non-beneficial paediatric research. Additional diligence is called for by all parties where substitute consent is required. This topic could have received further critique as part of the two insightful and extended chapters on the contributions of participants. Acknowledging the shared responsibilities of clinicians, researchers, substitute decisionmakers, bioethicists, human research ethics committee members, regulators and publishers in ensuring good clinical research practice is essential for a sound examination of key issues. The book is relevant to an Australian audience, with reference to comparative regulatory frameworks here, the US, Canada and elsewhere. The book is well within reach of most budgets and would be a worthwhile addition to medical and social science libraries.

Jennifer M Fleming

Objectives: To explore the perceived impact of medicolegal concerns on how Australian doctors practise medicine and to compare doctors who have experienced a medicolegal matter with those who have not.Design and setting: Cross-sectional survey (posted in September 2007, with reminder 4 weeks later) of Australian doctors from all major specialty groups, trainees and a sample of general practitioners who were insured with a medical insurance company.Participants: 2999 respondents of 8360 who were sent the survey.Main outcome measures: Perceived practice changes due to concerns about medicolegal issues, beliefs about medicolegal issues, and the influence of medicolegal issues on both career choices and how doctors relate to their patients.Results: Respondents reported changes in practice behaviour due to medicolegal concerns, with 43% of doctors stating that they referred patients more than usual, 55% stating that they ordered tests more than usual, and 11% stating that they prescribed medications more than usual. Respondents also reported improved communication of risk (66%), increased disclosure of uncertainty (44%), developed better systems for tracking results (48%) and better methods for identifying non-attenders (39%) and for auditing clinical practice (35%). Concerns about medicolegal issues led to 33% considering giving up medicine, 32% considering reducing their working hours and 40% considering retiring early. These proportions were all significantly greater for doctors who had previously experienced a medicolegal matter compared with those who had not.Conclusions: This Australian study, like international studies, confirms that doctors’ concerns about medicolegal issues impact on their practice in a variety of ways. There is a greater perceived impact on those doctors who have previously experienced a medicolegal matter.

Louise M Nash MB BS(Hons), BA, FRANZCP · Merrilyn M Walton BA, MSW, PhD · Michele G Daly BSc(Hons), MSc · Patrick J Kelly BMath(Hons), PhD · Garry Walter BMedSc, PhD, FRANZCP · Elizabeth H van Ekert BA, DipEd, MMedHum · Simon M Willcock MB BS, PhD · Christopher C Tennant MD, MPH, FRANZCP

Objective: We reviewed resources for researchers interested in privacy issues surrounding secondary use of health data for research. These included applicable privacy regulations and available information on privacy perception in Australia. The review is timely because the current Australian Population Health Research Network infrastructure investments are likely to attract new researchers to the field.Data sources: We used Australian federal, state and territory regulations and programs, polls and surveys, public speeches and academic literature, and some international resources.Data synthesis: We identify four themes (de-identification, consent, bias and participation) emerging as areas of concern from the review, and discuss issues relevant to these themes. We provide arguments that excessive privacy regulation has a negative effect on public health research.Conclusions: There is little evidence of privacy complaints or breaches in health research, but significant concerns about consent and de-identification appear to persist in the community. New researchers need to take account of privacy regulation and may wish to take account of privacy perception when designing study and consent processes.

Christine M O'Keefe PhD, MBA, BSc(Hons) · Chris J Connolly LLB

To the Editor: Pridmore1 describes a case in which a man’s recent actions suggested suicidal intent. The man told police he had no ongoing suicidal plans and they took his words at face value. He subsequently killed himself. The High Court exonerated the police of any responsibility, a decision that seemed based on two premises: that suicide does not presuppose mental disorder; and that “There is no general common law duty of care to rescue a person from harm, including self-harm”.2 There is sufficient grey in both those inter-related premises to make a black-and-white judgment suspect. I share Pridmore’s position that suicide does not always equal mental disorder, although one wonders whether situational crises in individuals with subtle vulnerabilities could be subsumed under such a label. More important is the question of individual autonomy. The reason we have no common law requiring us to “rescue” another adult is because we set such a high value on autonomy. Although we assume a person’s competence, our curiosity about it should be aroused when people behave in unexpected ways. When the behaviour is strikingly different, and has potential for serious harm, are we not obliged to intervene or procure assessment? This is, I would have thought, a moral rather than legal or medical concern. This is what we would do for a child wandering on the road or a demented person lost at night. We might be free of legal or medical censure for ignoring them, but we would be embarrassed to publicly admit our failure to act if we might have done something useful at the time. Making serious preparation to kill yourself is strikingly different behaviour, and should raise questions about both your competence and autonomy. Perhaps not 100% but surely more than 50% of such people have a disorder. A person preparing to suicide is “more likely than not” mentally ill, and that is how the “common person” would surely see it: “guilty”, as it were, till proven innocent. Expertise is called for to make that final determination. The police certainly do not have the expertise. Why, then, would they not seek it? Furthermore, if the “rational, cooperative and responsible” man in this case had indicated his plans to “rationally” commit suicide to escape an intolerable predicament, it is hard to believe the police would have walked away, even though he may have been competent to make such a decision!

Paul T Dignam

When a patient presents to hospital after a suicide attempt and appears to refuse treatment, clinicians should first assess if he or she should be treated under mental health legislation, regardless of competence to refuse treatment. When it is not possible or is inappropriate to treat under mental health legislation, the person’s competence to refuse treatment should be assessed. If the patient is definitely competent, his or her decision to refuse treatment should probably be honoured. If an incompetent patient carries a document refusing treatment, clinicians must determine the validity of that document as an advance care directive — including whether or not the patient was competent at the time it was written. The law around the right to refuse treatment after a suicide attempt remains unclear and, if uncertain of what to do, clinicians should provide urgently required life-saving treatment and simultaneously seek an urgent court order to clarify how they should proceed. In all but extraordinary circumstances, a patient who refuses treatment after a suicide attempt can and should be given life-saving treatment, under either mental health legislation or the common law concept of necessity.

Christopher J Ryan MB BS, FRANZCP · Sascha Callaghan BEc(SocSci), LLB(Hons)

Hoffenberg. Physician and humanitarian. L Ross Humphreys. London: Royal College of Physicians, 2010 (xi + 174 pp). ISBN 9781860163661. “Hoffenberg” probably means little to most Australian doctors other than those fortunate Queenslanders who met him during his short tenure as Professor of Medical Ethics from 1993 to 1995. It means a lot, however, to expatriate South African-trained doctors, to Fellows of the Royal College of Physicians, London, and to Queenslander Ross Humphreys. Humphreys has written an eminently readable biography of one of those stars of the South African medical firmament who, after leaving the country during the apartheid era, distinguished themselves in their field in Britain. Unlike most of the other expatriate doctors in this group, Hoffenberg was, literally, exiled. Nevertheless, Sir Raymond (Bill) Hoffenberg shone among his fellow ex-South African FRCPs, Fellows of the Royal Society, Knights of the Realm and Nobel prize-winners. Humphreys, in explaining Hoffenberg’s forced departure from South Africa, provides an excellent introduction to apartheid. He details Hoffenberg’s progress, from his appointment at Birmingham University to his time as President of the Royal College of Physicians and President of Wolfson College, University of Oxford. He describes Hoffenberg’s interest and research in a wide range of diseases, and in teaching and mentoring colleagues, as well as his initiation of medical audit and his overwhelming concern with medical ethics. Hoffenberg never lost his emotional attachment to South Africa, as evidenced by his continued assistance to other “refugees” from the system and, when apartheid ended, his strong support for medical research and education in that country. His connection with Australia commenced when he came to Brisbane to join his sons. This little book will appeal to anyone with an interest in South Africa, in British medical history from the late 1960s to the early 1990s, and in medical education, research, clinical audit or ethics. My only criticism is of the proofreading. My friend and colleague is not Patricia but Priscilla Kincaid-Smith; sloppy grammar and punctuation require a double-take of some sentences, and I was saddened to see the need for “Apostrophe Man”.*

Peter C Arnold

Cystic fibrosis (CF) carrier testing can be used to inform reproductive decision making, allowing carriers to avoid having a child with CF. A government-funded, population-based CF carrier screening program would allow greater equity of access to this test. The setting in which CF carrier screening is offered significantly affects the extent to which participants make well informed, voluntary decisions to accept or decline testing. Screening offered before pregnancy and in non-clinical environments better promotes participant autonomy than screening offered in the prenatal consultation.

Lucy J Modra MB BS(Hons), BMedSci, GDipArts(Phil) · R John Massie MB BS, FRACP, PhD · Martin B Delatycki MB BS, FRACP, PhD

To the Editor: The medical view, which is repeatedly stated in the literature,1-3 is that up to 100% of those who complete suicide are suffering from a mental disorder. This leaves many doctors feeling they can be held responsible for all those who suicide, including those for whom there is no evidence of mental disorder. A recent High Court of Australia judgment, Stuart v Kirkland-Veenstra,4 illustrates that the medical and legal views of the relationship between suicide and mental disorder are different. In this case, a wife alleged that police officers had failed to provide a duty of care towards her husband, who had been found by the officers in a car with a hose leading from the exhaust pipe into a rear window, but with the driver’s window down and the car engine cold. The officers talked to the husband, who claimed marital problems but that he had changed his mind about suicide and was planning to go home and discuss matters with his wife. The officers felt the husband was rational, cooperative and responsible, with no evidence of alcohol or drug misuse; they offered him assistance (which he declined) and allowed him to leave. Later that day, the husband completed the suicide. He had not told the officers that he was expecting to be served with papers relating to fraud charges that afternoon. The Stuart v Kirkland-Veenstra judgment,4 in favour of the police officers, includes the following statements: Suicide and attempted suicide are seen as reflective of psychological or psychiatric issues which may or may not involve ‘mental illness’ according to established diagnostic conventions . . . Given the complexity and variety of factors which may lead to suicidal behavior, it would be a bold legislative step indeed to sweep it all under the rubric of mental illness, however widely defined. Word limits prevent me from giving more detail about the case, but interested readers will find this accessible judgment valuable. Clinicians dealing with “difficult” (but not mentally disordered) people in difficult circumstances often feel themselves to be in a perilous legal position, able to be held responsible for the actions of all those who choose to end their lives. The Stuart v Kirkland-Veenstra judgment clarifies the legal perspective, that suicide does not necessarily indicate the presence of a mental disorder, and that where mental disorder does not exist, human services personnel will not necessarily be held responsible for the actions of others.

Saxby Pridmore

I like this book. Its starting point is a recognition of medicine as a true profession — that is, an activity which, being concerned with deeply personal problems, is aimed at serving people in a manner which enables them to act on their own. Its subject matter is the pursuit of this honourable goal in a world in which resources are finite, medical practice is increasingly undermined by corporatisation, accountability threatens to become an end in itself and the community expects that treatment will always be successful. Its achievement is an informative sketch of what a doctor needs to know and do, over and above the adequate knowledge and practice of medical science, if he or she is to live out the Hippocratic commitment to the “benefit of the sick” in 21st-century Australia. The authors are specialist practitioners in both the medical and the legal professions, so the book is ethically informed without focusing on questions of ethical theory. After a brief introduction to forms of ethical thinking and the qualities of good doctors, the authors explain the professional and regulatory standards that structure and constrain medical practice today. Clarity is one of the authors’ virtues. They explain in advance which issues will be covered by their discussions and which won’t. Chapter 7, for instance, on negligence, professional liability and adverse events, aims to assist doctors to understand our current legal system for handling claims for damages and the closely associated system of professional medical indemnity (both of which have been the subject of considerable change in recent years). It describes a change in the notion of “negligent conduct” without debating the merits of the change. And in Chapter 19, on determining and certifying death and reporting deaths to the coroner, obligations deriving from the law in each jurisdiction are set out so as to reveal both common threads in the various laws and differences in detail between them. This book will truly be a useful and accessible guide for busy doctors. As I say, I like this book. (Reader, beware! I am one of many acknowledged in the credits.)

Bernadette M Tobin

Objective: To investigate community attitudes to abortion, including views on whether doctors should face sanctions for performing late abortion in a range of clinical and social situations.Design, setting and participants: An anonymous online survey of 1050 Australians aged 18 years or older (stratified by sex, age and location) using contextualised questions, conducted between 28 and 31 July 2008.Main outcome measures: Attitudes to abortion, particularly after 24 weeks’ gestation.Results: Our study showed a high level of support for access to early abortion; 87% of respondents indicated that abortion should be lawful in the first trimester (61% unconditionally and 26% depending on the circumstances). In most of the clinical and social circumstances described in our survey, a majority of respondents indicated that doctors should not face professional sanctions for performing abortion after 24 weeks’ gestation.Conclusions: Our data show that a majority of Australians support laws which enable women to access abortion services after 24 weeks’ gestation, and that support varies depending on circumstances. Simple yes/no polls may give a misleading picture of public opinion.

Lachlan J de Crespigny MD BS, FROCG, COGU · Dominic J Wilkinson MB BS, MBioeth, FRACP · Thomas Douglas BMedSc, MB ChB, BA(Hons) · Mark Textor BEc · Julian Savulescu MB BS, BMedSci, PhD

Mifepristone is a safe, effective and relatively cheap drug that plays an important role in women’s health care and is widely used for early medical abortion in many countries. The Therapeutic Goods Administration (TGA) can authorise mifepristone to be imported into and marketed in Australia. To date, no pharmaceutical company has applied to register mifepristone in Australia. The TGA can also permit medical practitioners to prescribe medicine that is not approved for marketing in Australia under the Authorised Prescribers scheme. The number of approvals for mifepristone has gradually increased, in spite of a complicated and protracted application process. Approval under the Authorised Prescribers scheme requires medical practitioners to comply with state or territory legislation. Abortion laws in Australia vary between jurisdictions, and in some states the law is unclear and confusing. The decriminalisation of abortion in all Australian jurisdictions would protect medical practitioners from criminal liability, promote the health interests of Australian women, and discourage the illegal importation of abortifacients that are being used without quality controls or medical supervision. The Victorian Abortion Law Reform Act 2008 is one legislative model for this.

Kerry A Petersen LLB, LLM, PhD

The pill and other forms of hormonal contraception. The facts. 7th ed. John Guillebaud, Anne MacGregor. Oxford: Oxford University Press, 2009 (xix + 193 pp). ISBN 9780199565764. Does life begin at fertilisation or implantation? At times, the sticky question about whether certain types of contraception are actually causing an abortion arises with patients or colleagues. This book helps by providing a discussion of some ethical aspects of contraception in one of the appendices, where the authors argue that one can write an equation for the definition of conception as follows: CONCEPTION = FERTILIZATION + IMPLANTATION (being with child) (crucial) (also crucial) This equation makes it possible to argue that methods of contraception which may block implantation are contraceptives, and not abortifacients. John Guillebaud is Emeritus Professor of Family Planning and Reproductive Health at University College London, and a guru in family planning. He first wrote this guidebook in 1980 as he is passionate about sharing his knowledge with women: “here are the facts, now you decide”. Anne MacGregor is an Instructing Doctor in Sexual and Reproductive Healthcare at the Royal College of Obstetricians and Gynaecologists, London. This “book about the Pill for a general readership” is a user-friendly explanation of the contraceptive pill and other hormonal contraceptive methods. There are plenty of diagrams, tables and flowcharts to assist the reader’s understanding of reproductive physiology, choice of pill and what to do about breakthrough bleeding and other management issues. Tables present the risks and side effects, but also the benefits of taking the Pill. Although many people regard the Pill as “unnatural”, one could argue that having regular menstrual cycles is an unnatural condition. Before contraception was available, women would have been pregnant or breastfeeding for most of their reproductive lives. Although the Pill is not suitable for all women, many women find that taking the Pill and being “a little bit pregnant” works well at one or more stages of their life, or “contraceptive ages” as this book puts it.

Lisa H Amir

Good medical practice: a code of conduct for doctors in Australia provides uniform standards to be applied in relation to complaints about doctors to the new Medical Board of Australia. The draft Code was criticised for being prescriptive. The final Code employs apparently less authoritative wording than the draft Code, but the implicit obligations it contains are no less prescriptive. Although the draft Code was thought to potentially undermine trust in doctors, and stifle professional judgement in relation to individual patients, its general obligations always allowed for flexibility of application, depending on the circumstances of individual patients. Professional codes may contain some aspirational statements, but they always contain authoritative ones, and they share this feature with legal codes. In successfully diluting the apparent prescriptivity of the draft Code, the profession has lost an opportunity to demonstrate its commitment to the raison d’etre of self-regulation — the protection of patients. Professional codes are not opportunities for reflection, consideration and debate, but are outcomes of these activities.

Malcolm H Parker MB BS, MLitt, MHthMedLaw

A sharp increase in the number of students graduating from Australian medical schools over the next few years looks set to outpace available intern positions. Graduating overseas students will be the first to miss out. While this treatment of overseas students is unlikely to be found unlawful, questions of fairness remain. From a policy standpoint, the bottleneck in intern places could be quite damaging as: it encourages Australian-trained medical graduates with high-quality training and culturally-relevant skills to leave; and it extinguishes a valuable opportunity to steer some of these graduates into geographical areas with the greatest medical workforce needs.

Katie J Elkin LLB(Hons), BSc · David M Studdert LLB, ScD

Objective: To evaluate the changes in the understanding of the manner and cause of death occurring during the course of coronial investigations.Design: Retrospective analysis of deaths reported to coroners in Australia between 1 July 2000 and 31 December 2007, using the National Coroners Information System.Main outcome measures: (i) Manner of death (natural, external, unknown); (ii) intent classification (eg, unintentional injury, suicide, assault) among deaths with external causes; and, (iii) changes in the manner of death and intent classification between the presumption made at case notification and the coroner’s final determination.Results: The coronial investigation changed the presumption about manner of death or intent classification in 5.2% (6222/120 452) of cases in which a presumption was made. Among deaths with a change in attribution from natural causes to external causes, unintentional falls (442/1891) and pharmaceutical poisoning (427/1891) each accounted for 23%. Among deaths with attribution changing from external causes to natural causes, the leading medical causes of death were cardiovascular compromise (551/842; 65%) and infection (124/842; 15%). Of deaths understood correctly at notification to be due to external causes, but the wrong external cause, 34% (206/600) were ultimately judged to be unintentional injuries, and 22% (133/600) were judged to be suicides.Conclusions: Coronial investigations transform basic understanding of cause of death in only a small minority of cases. However, the benefits to families and society of accurate cause-of-death determinations in these difficult cases may be considerable.

David M Studdert LLB, ScD, MPH · Stephen M Cordner MB BS, BMedSc, DipCrim