Ethics

To the Editor: Articles by Olver and Haines1,2 have catalysed robust discussion about the relationship between the pharmaceutical and device industries and the medical profession.3 These authors advocate changes in the direction of clinical cancer research and in health policy.2 In an era in which research into medicines is dominated by industry, they argue for greater scrutiny of data in a resource-constrained environment, and for fundamental changes in the collection, interpretation and ownership of data. We find their arguments sound and equally applicable to other areas of medicines research and health policy. Their primary recommendation is for “. . . a system to follow up and evaluate the outcomes of all treatments . . .” That is, that we exercise our duty to patients by monitoring and analysing existing clinical data to inform health care policy. There is a great deal of valuable clinical data collected that are not readily accessible because of ownership or privacy issues. For example, much business involving public health dollars is labelled “commercial in confidence”, and laboratory data held in many pathology databases are not accessible at all. The likely benefits to patients and society of transparency and data linkage in health care are greater than possible benefits to individuals of secrecy and privacy. Quality use of medicines (QUM) is one of the central objectives of Australia’s national medicines policy. QUM means selecting management options wisely; choosing suitable medicines if a medicine is considered necessary; and using medicines safely and effectively.4 Olver and Haines also identify issues relating to quality use of research. Quality use of research might include: supporting research into monitoring clinical outcomes related to drug use; supporting research into better use of existing drugs; and supporting truly independent guideline development. There continue to be advances. For example, registration of trials in public databases, such as the Australian New Zealand Clinical Trials Registry, should reduce publication bias.5 However, the decline of independent public sector clinical drug research and the marketing-based design of phase III and, increasingly, phase II industry-funded studies contribute additional bias to the available information. Olver and Haines’ arguments apply to all therapeutics, and particularly to all drug therapies. We strongly support their proposals for health data linkage and for quality use of research. These fit within existing health policy, and our continued failure to make full use of clinical data is an ethically compelling reason for improved political and clinical governance.

Matthew P Doogue · Kathleen M Knights

To the Editor: The expert working party that developed the Australian Medical Council (AMC) draft code of professional conduct referred to by Komesaroff and Kerridge1 was chaired by Joanna Flynn, past President of the Victorian Medical Practitioners Board (MPB [Vic]). Herein lies the crunch. The AMC is surely meant to be an independent and objective body — yet if it is aligned with the MPB (Vic), how can this be the case? Komesaroff and Kerridge state that the appendices to the AMC’s draft code “quote extensively (without attribution) the conclusions of guidelines developed by the Royal Australasian College of Physicians” and that “in the AMC’s version, the evidence, context and argumentation are omitted and the recommendations are presented as legally binding”.1 If this is the case, there is cause to question the integrity of the drafters of the code, to fear the code’s implications, and to request “that the whole process that gave rise to it be rigorously reconsidered”.1 Plagiarism cannot be condoned. To attribute honestly and give credit where credit is due is central to ethical practice, scientific discovery, education, accountability and learning. Similarly, context matters. In my opinion, integrity, the basis of ethics and morality, is measured by the extent to which context is valued and conceded. Ethical conduct demands both honesty and integrity. Doctors and the public, and government surely, place their trust in the AMC to objectively evaluate governing practices, laws and regulations, such as the Health Professions Registration Act 2005 (Vic) (“the HPR Act”), under which the MPB (Vic) operates, as well as professional conduct. Yet the authors of the AMC draft code fail to address the issue of the accountability of regulatory bodies and the fact that the HPR Act contains no benchmark for excellence: because context is omitted from the Act, “unprofessional conduct” cannot be defined and becomes relative. This leaves it open for any third party, including members of the regulatory authority itself, to abuse doctors and patients by being dismissive of the patient’s view (and thus, context), while claiming to protect patients and guide doctors. By contrast, the Medical Treatment Act 1988 (Vic), which is not mentioned in the AMC draft code, provides a benchmark for excellence in clinical practice with reference to both doctors and patients. This Act specifies (a) that the wishes of the patient to refuse treatment be respected, and (b) that medical practitioners who act in good faith in accordance with the patient’s expressed wishes be protected from any civil or criminal liability or disciplinary action by the regulatory board.2 As doctors, we are the naturally appointed advocates of our patients’ health preferences and wellbeing. Ensuring that choices are made for the patient’s benefit requires honesty and integrity at all levels of government.1,3,4 When a failure occurs in the system, it is imperative to have avenues of awareness, transparency, protection and evaluation available through public action and professional debate.1,3,5

John B Myers

In reply: The debate about the proposed national code of conduct (“the Code”) has raised a number of important issues, including those highlighted by Myers. The original draft aroused serious concern in the community about the potential role of a centralised bureaucracy with the power to enforce a set of precepts derived from a narrow, largely discredited, philosophical perspective. Although the revised draft now circulated for public comment is admittedly less objectionable than its predecessor, significant concerns remain relating to both its form and its content. The main issues are still the purpose and role of the Code and the confusion between ethical and legal discourses on which it is based. In a multicultural society in which pluralism and diversity are themselves regarded as inherently valuable, the very concept of a unitary set of criteria that define good practice is questionable. In this setting, the proper roles of codes of conduct and of ethics are not to enforce particular kinds of outcomes, but rather to inform and enrich practice. If the Code were devised as an educational process to stimulate clinicians to reflect critically on their existing practices and underlying values, it would be much more likely to change behaviour and increase community wellbeing.

Paul A Komesaroff · Ian H Kerridge

Health care-associated infections (HAIs) are a major clinical and economic problem in Australian hospitals, and a significant proportion are preventable. HAIs are the result of complex environmental, microbiological, pathological, behavioural and organisational factors, and prevention requires a multifaceted (“bundled”) approach, including appropriate policies, educational programs for health care workers, and adequate resources to implement them effectively. Failure to protect patients from avoidable harm, including HAIs, has significant ethical implications; it often reflects both organisational systems failure and non-compliance of health care workers with evidence-based policies, including hand hygiene. If implemented with appropriate safeguards, infection control “bundles” that include sanctions for poor compliance with hand hygiene and other infection control policies, will achieve sustained improvements where previous approaches have failed.

Gwendolyn L Gilbert MD, FRACP, MBioethics · Paul Y Cheung BSc(Hons), MAppLing, PhD · Ian B Kerridge BA, BMed(Hons), MPhil(Cantab)

To the Editor: Population health and clinical researchers have long endured time-consuming submission of applications for a single study to multiple human research ethics committees (HRECs), which each have their own application forms and processes. Each HREC form collects similar information, with slight variation but much repetition. They invariably differ in emphasis and space provided, precluding a simple cut-and-paste among forms. The resource burden of completing this step in the research process has been highlighted previously.1,2 Rarely does completion of multiple applications add value. Responding to researchers’ protestations, the Australian Health Ethics Committee developed a National Ethics Application Form (NEAF). An improved version (NEAF2) was released in August 2008, with recommendations it be adopted by ethics committees Australia-wide.3 While some state health departments have embraced the new form and reform processes,4 rationalisation has not occurred in all jurisdictions. As investigators on a 3-year (2008–2010) study of cardiovascular disease that is funded by the National Health and Medical Research Council (NHMRC) and requires access to hospital records throughout Western Australia, our first ethics application was submitted in November 2007. Sequential preparation and submission to other HRECs led to the requisite approval from all 12 HRECs taking a further 12 months to achieve after the first approval. Few of these committees accepted an application using NEAF at the time. Adopting the current version of NEAF5 — adding supplementary questions pertinent to each institution (if necessary) — and rationalisation of processes to access public hospital medical records would be enormously more efficient for researchers. Centralised processes could also reduce the impost on HRECs. Our experience with contrasting requirements of the various HRECs has included different reporting timelines (6–12 months), different reminders to report, different periods of study approval (1–4 years), use of institutional letterhead, requirements for at least one chief investigator to be a staff member of the institution auspicing the HREC, requirements that investigators personally attend the HREC meeting, and differences in whether faxed and digital signatures are accepted. Such differences in requirements and processes are documented,2,6 and inevitably delay substantive research. This ongoing waste of resources and energy — in processes that distract from quality research but do not enhance ethical integrity — increases the burden on both researchers and members of HRECs. Rationalising and streamlining ethics processes could free resources, allowing greater attention to research monitoring by HRECs and research translation by researchers. We urge expedited implementation of NEAF2 and further reform. State health departments and affiliated organisations should collaborate to rationalise processes and expedite centralised or reciprocal approvals where appropriate. The bold proposal for a national system to streamline the ethics review process within and across Australian jurisdictions7 will invigorate discussion of overdue reform.

Sandra C Thompson · Frank M Sanfilippo · Tom G Briffa · Michael S T Hobbs

Crime, Aboriginality and the decolonisation of justice. Harry Blagg. Sydney: Hawkins Press, 2008 (232 pp). ISBN 978 187606 719 9. Widely published, Harry Blagg is one of Australia’s eminent researchers on criminal justice in Aboriginal communities. His Crime, Aboriginality and the decolonisation of justice is both confronting and thought provoking. Every page had me thinking that people who work in the health sector should read this book. There are such parallels. While Blagg does not specifically write about health, I became more and more aware of the dynamic interaction between justice and health — ill health and crime. Blagg demonstrates a profound failure in the systems of justice in Australia for Aboriginal people, and this systemic failure is also applicable to health. There is much to learn. For example, much of the money in the justice system is spent at the rear end, within corrections, where funding is often channelled into preventive measures — prevention attended to too late. When Blagg writes about prison as a source of pain but not shame, with terms of reference that are different from those prescribed by white society, he is illustrating a great tragedy. He says prison becomes a place for acquiring some of the bounties of white society: food, medical services, education, meeting classificatory kin, conducting family business, taking a break and drying out. He acknowledges the cost to Aboriginal families and communities. However, Blagg does not point out that prison has another, deeply disturbing outcome. It is where extreme violence is learnt, and where sexually violent behaviours can be transferred back into communities. Blagg refutes allegations that Aboriginal customary laws condone violence against women and children, pointing to the wealth of research to the contrary. He suggests these laws contain considerable potential for renewal and healing. The book, while easy to read if you know the subject, will confront some readers and cause them to think more deeply about the “decolonisation” of justice. Hopefully, some readers might choose to also think more deeply about the deconstruction of the medical system, so that the development of hybrid initiatives of health and wellbeing might also be possible. At $49.95, the cost is a little more than I would have anticipated for a book of just over 200 pages. Nonetheless, it is good value for money. It has me thinking of links between law and health and the need to explore rather than ignore liminal spaces between Aboriginal notions of ceremony as forms of transition, including syncretic changes in status relationships between social domains — social domains that construct justice and health, or crime and ill health.

Judy Atkinson

Regina v Gillett deals with a man who did not disclose his epilepsy when seeking a drivers licence. Subsequently, he had a seizure while driving, causing an accident in which three people died. He was found guilty but appealed. During the trial to decide whether Gillett was guilty of dangerous driving occasioning death, the judge decided that the Austroads fitness-to-drive guidelines were extraneous to legal consideration of the acceptable risk to be attached to chronic medical conditions. Although the appeal was unsuccessful with respect to guilt and sentencing, it did reinstate the relevance of the Austroads guidelines when evaluating suitable risk with respect to potentially dangerous drivers. We suggest that even greater protection can be afforded to the community if a clearly enunciated warning, outlining a driver’s responsibilities, were to appear on each drivers license.

Roy G Beran MD, FRACP, FRACGP · Paul Gerber LLB, DJur · John A Devereux BA, LLB, DPhil

In June 2008, the ABC screened a television documentary involving a couple who decided to have an additional child in the hope of obtaining umbilical cord blood to treat their daughter who had leukaemia. The couple conceived naturally, meaning that there was a one in four chance that their child would be suitably matched. They seemed to be unaware of technologies that, if successful, could provide a near certainty that the next child would be a matched “saviour sibling”. This story raises questions about whether clinicians have an obligation to discuss emerging and morally contentious treatment options. Ignorance of technology, assumptions about availability, and medical assessment of burdens and benefits may affect attitudes towards treatment options, but they do not justify non-disclosure of information.

Kimberly A Strong BSc, GradDipGenCouns

Clinical guidelines are recommendations based on systematic identification and synthesis of the best available scientific evidence. The National Health and Medical Research Council (NHMRC) has published standards for guideline development. According to the NHMRC standards, guideline development must be a transparent and independent process, with full disclosure of any potential competing interests. Australian guidelines for prevention of venous thromboembolism have been published by an autonomous group. Several features of the processes used to produce and distribute these guidelines, such as pharmaceutical sponsorship, do not meet NHMRC endorsement standards. The guidelines may overstate the need for thrombo-prophylaxis in medical patients, and thus expose some patients to an unnecessary risk of bleeding complications. Despite this, these guidelines have been taken up avidly by national and state bodies responsible for safety and quality in health care, and mandated national application has been proposed.

J Alasdair Millar PhD, FRACP, FRCP

To the Editor: Two articles in the 19 January issue of the Journal1,2 and an article on the involvement of pharmaceutical companies in studies of their own products published in The Australian on the same day3 impel me to relate my own experience of attempting to influence my colleagues’ attitudes toward transparency in relationships with the pharmaceutical industry, and my good fortune to be working in a 21st century oncology clinical trials unit. The relationship between the science of pharmaceutical development and the science of oncology is robust and fruitful. While intending to be only mildly controversial, I caused great offence in my opening address to the Australian and New Zealand Children’s Haematology and Oncology Group annual meeting in 2008 by suggesting that it is no longer acceptable for any of us at the coalface of oncology to deal directly with pharmaceutical salespeople or for medical education to be directly funded by industry. I note the view of Tattersall and colleagues that “... sponsoring doctors to attend independent conferences is recognised as facilitating continuing medical education ...”.1 In my view, financial support for medical education should come from unaffiliated sources — perhaps competitive grants from the government, who may in turn raise funds from industry. Similarly, we must be able to deny (not just declare) a conflict of interest in our activities in clinical trials and practice, and teach the difference between clinical trials (phase III cooperative group randomised controlled trials of multidrug treatment, with wide eligibility criteria to benefit as many patients as possible) and drug trials (phase I or II single-agent trials with narrow eligibility criteria, such that adverse effects of new drugs are found quickly). Both groups of trials are essential for the benefit of patients with cancer and leukaemia, as is the need for clinicians to be — and to be seen to be — at arm’s length from industry. I have been fortunate to work in a clinical trials unit that is supported by a wise medical administration and an ethics committee devoted to the practice of clinical trials as the best evidence-based medicine for patients. Our unit has clinical research associates on staff, is an active member of the United States-based Children’s Oncology Group, and does not partake in trials directly sponsored by industry. Indeed, after 20 years in the field, I know the trade names of less than 10% of the drugs I prescribe. I decline invitations to see pharmaceutical representatives or to attend industry-sponsored events. I followed the leadership of my mentors and senior clinicians. Can I convince today’s trainees to follow suit?

Catherine H Cole

To the Editor: We support the findings of Tattersall and colleagues relating to the disclosure of competing interests by general practitioners to their patients, and we agree that greater transparency in general is required with physician–industry relationships.1 Such relationships have the potential to enhance patient outcomes through quality use of medicines. However, in the interests of a balanced perspective, several points regarding Tattersall et al’s article warrant attention. First, the 2007–08 BEACH (Bettering the Evaluation And Care of Health) survey suggests that the mean length of GP consultations in Australia is 15.1 minutes.2 Considering this, an adequate discussion or disclosure of industry links to each and every patient is simply not practical. Furthermore, the frequency with which GPs see industry representatives can vary greatly. Given these complexities, perhaps clinics could consider having a simple sign in the waiting room that states “We do/do not see pharmaceutical industry representatives”. Disclosures would be most valuable if interested parties agreed on definitions for categories of relationships and payments, uniform approaches to calculating amounts, and standards for information to be made public. Inconsistent practices could create the impression that some practices are being hidden.3 Second, we want to highlight the potential benefits of physician–industry collaborations. We recently organised a panel of Australian physicians to advise a pharmaceutical company on research initiatives that need to be undertaken in a highly specialised area of medicine. An Advisory Group Charter, describing the purpose of the group, desired outcomes, and remuneration, was developed and agreed upon by all members. In this case, physicians received remuneration for time spent reviewing documents and collecting information for the meeting, and to cover costs associated with non-attendance at clinic. The aim of the Charter and two-way confidentiality agreements was to ensure transparency. After reviewing the published literature, each physician shared information about treatment practices and outcomes. The physicians identified several areas that require further research and have the potential to enhance patient outcomes in the immediate future. However, they suggested that these initiatives could be undertaken without industry support. They advised the company to direct its research funding towards large, population-based research initiatives. This is just one example of how transparent collaborations can result in enhanced patient outcomes and a redirection of funding into areas of greatest need. While we agree that increased transparency is important for physician–industry relationships, and improvements can be made through such avenues as disclosure, a retreat from physician–industry collaborations is not in the interests of improved patient outcomes or enhanced quality use of medicines.

Brad S Dalton · Deborah J Richards

In reply: We thank Cole for her suggestions. We note the Royal Australasian College of Physicians Guidelines for ethical relationships between physicians and industry state: “Industry sponsorship to attend conferences ... should usually be restricted to those in which the professional anticipates active engagement ... and when attendance without support is not possible”.1 With regard to Dalton and Richards’ first point, our survey asked patients for their views about doctors in general and not specifically about general practitioners.2 We do agree that disclosure would be most valuable if definitions for categories of relationships and payments were agreed on. Unfortunately, the options we presented to patients in our survey did not include disclosure being presented on a website, a method that has recently been launched by the Cleveland Clinic in the United States.3 A US Senate Bill, if enacted, would require health companies to report all their financial links with doctors on a government website.4 The potential benefits of physician–industry collaboration were not presented in our survey. Obviously, having doctors advise the pharmaceutical industry is likely to be beneficial, but is it appropriate to continue relationships where industry is advising or educating doctors? Notable among the 41 recommendations of a report from a Royal College of Physicians working party in the United Kingdom, chaired by the Editor-in-Chief of the Lancet, are: the promotion of standards for prescribing at postgraduate level; a method for gradually ending the support of the pharmaceutical industry in the education of doctors in training; and any honorarium and fee, commercial or otherwise, paid to a doctor should be declared on a publicly accessible website.5 We strongly support any interventions that enhance the quality use of medicines.

Martin H N Tattersall · Aneta Dimoska

To the Editor: More than 1000 sunscreen products are marketed in Australia, and an increasing proportion (about one-third) incorporate engineered nanoparticles (ENPs). Defined as manufactured particles having one or more dimensions less than 100 nm (0.00001 cm), ENPs exploit the altered chemical reactivity and other changes that reduction to nanosize elicits. ENPs in sunscreen, such as titanium dioxide (TiO2) and zinc oxides, constitute effective broad-spectrum ultraviolet radiation (UVR) blocking agents with enhanced cosmetic transparency. The Australian Therapeutic Goods Administration (TGA), in approving such products, has stated that “there is no evidence that sunscreens containing these materials pose any risk to the people using them”.1 Similarly, authors of a recent article (written in collaboration with representatives of a cosmetic company) interpret the evidence as confirming that ENPs do not penetrate below the stratum corneum, or only in small amounts, producing limited cellular toxicity.2 Information on sunscreen packaging is not required to disclose the presence of ENPs. Yet, when TiO2 nanoparticles are incorporated into human cells in vitro, mobilisation of electrons by absorption of ultraviolet A (UVA) light produces reactive oxygen species and causes DNA damage (strand breakage and base modification). In fact, TiO2 has been used in this way to kill cancer cells in vitro.3 In sunscreens and cosmetic preparations, TiO2 is often coated to reduce this photocatalytic activity because over 90% of ambient UVR is UVA. However, evidence has now emerged that TiO2 in uncoated anatase form has been added to a marketed but as yet undivulged Australian sunscreen — in this form, TiO2 is capable of producing damaging photocatalytic free-radical reactions on particular steel roofing materials.4 Likewise, zinc oxide ENPs manufactured for use in sunscreens are potent biocides and subject to disposal restrictions in most countries. Despite the TGA’s stance, existing research does not comprehensively ensure the safety of all ENPs in sunscreens, particularly ENPs less than 40 nm in size applied long term to human skin that is immature, aged, diseased, damaged, hairy or covering flexural creases.5 The non-government organisation Friends of the Earth has compiled a list of sunscreens available in Australia that are claimed by the manufacturers to be free of nanoparticles.6 A New South Wales Government committee has recommended that, for regulatory purposes, ENPs be considered new chemical entities that require increased safety data.7 Policymakers should increase funding for objective research in this area (such as that by Macquarie University and the flagship project in nanotechnology of the CSIRO [Commonwealth Science and Industry Research Organisation]). Until such safety data are available, the TGA should apply the “precautionary principle”5 and, at a minimum, increase packaging information about nanoparticles in sunscreens.

Thomas A Faunce

Sed quis custodiet ipsos custodes? (Who guards the guardians?) To the Editor: Adler and Constantinou raised a concern about the ageing doctor1 that also worried me when I was practising as an anaesthetist. The same concern was raised recently in the Australian and New Zealand College of Anaesthetists Bulletin.2 In anaesthesia, decisions and actions have to be made in seconds and minutes, rather than days and weeks, and maintenance of standards is very important. Doctors practise largely in isolation, and may not be aware of their standard failing against the general standard. Operating theatres offer both an opportunity to observe the practice of others and a conduit for information on colleagues — nursing and medical. I used this opportunity in private and public practice by asking younger colleagues, one in each, to be my “buddy”, as in diving safety. They were asked to keep watch for any rumour of my declining standards and to report it to me. We would then discuss what to do: retrain or retire. The latter became more of an option the older I grew. This strategy opened up pathways. One was that the buddy was given the authority to approach me on the topic. Another was that I was open to the idea that my ability could diminish, while a third was that the hostility, so often seen in this setting, was abolished. I would rather be tapped on the shoulder by a sympathetic colleague than a medical board, a hostile coroner or a vindictive prosecution lawyer. In the end, there was no tap on the shoulder, and I went because I had had an enjoyable and rewarding career and could afford to retire. This allowed succession planning in both areas, public and private, and a younger colleague could embark on a similar path.

David G Fenwick

To the Editor: There is danger of a perception developing that, to ensure patient confidentiality, quality assurance (QA) activities in health care should be regarded as research. The Australian Law Reform Commission (ALRC) has delivered proposals for the review of the federal Privacy Act 1988 (Cwlth) that may lead to all but the most basic monitoring of health care activities being characterised as research.1 Recommendation 65–3 emphasises that “research” should include “the compilation or analysis of statistics” and the ALRC also stated that “some funding, management, planning, monitoring, improvement and evaluation activities also may be characterised as research”. This drives the possibility for policy interpretation of QA activities into the realm of research necessitating ethics approval and/or informed consent, rather than retaining the current level of exemption. Australian governments are crying out for increased transparency to improve safety, but labelling QA activities as formal research could seriously compromise and retard patient safety efforts. A key to enabling optimal patient safety is the implementation of evidence by practitioners competent in judgement, skill and knowledge within an environment characterised by leadership and adequate resources (for example, through morbidity and mortality meetings and clinical audits).2 Implementing clinical monitoring (eg, antibiotic use, so essential to optimal outcomes and to minimising antibiotic resistance) requires audit of patients’ files. Improvement in current practices requires scientific, planned, data-driven study with ongoing review, which includes elements that could easily be characterised as research. If these activities and resultant quality improvement efforts are now regarded as research, their progress may be impeded. It should be considered unethical not to act on established evidence. It would be dangerous to label as research surveillance and QA activities that are designed to ensure implementation of such evidence, even if they fall within the broad definition of research. Patient privacy and confidentiality must be managed within a transparent regulatory framework without impeding safety mechanisms with research frameworks that would inevitably lead to delays and increased costs, as well as seriously discouraging staff from implementing them. These effects are well documented overseas where the enactment of similar privacy rules relating to the use of patient information has resulted in detrimental unintended consequences.3,4 Work undertaken to discover new and better evidence needs to be regarded as research, not work to ensure that established evidence-based practice is properly implemented. Herein lies the difference. Although the National Health and Medical Research Council (NHMRC) provides advisory guidelines,5,6 the proposed privacy (health information) regulations to be developed by the Office of the Privacy Commissioner1 will provide the legal basis for the use of health information. The public benefit of QA activities with appropriate privacy management and regulation that avoids designation as research requires strenuous championing during development of the regulations to ensure continued improvement in patient safety.

Anthony P Morton · Susan E Smith · Peter R Croll · R Michael Whitby

A good death. An argument for voluntary euthanasia. Rodney Syme. Melbourne: Melbourne University Press, 2008 (xviii + 301 pp). ISBN 978 0 522 85503 6. In facing the management and termination of intolerable situations, a caring doctor involved in alleviating the final agonies of patients can berate the legal system’s impotence and governmental procrastination. Oncologists are frequently confronted by situations involving the end of a painful existence. Most are now assisted by specialists in palliative care, often disempowered by shortages of beds and frustrated by staff inadequately trained or less than sympathetic to the views of those who would like to see “physician-assisted by specialists in palliative care, often disempowered by shortages of beds and frustrated by staff inadequately trained or less than sympathetic to the views of those who would like to see “physician-assisted dying” as an alternative to only partially effective, cerebrally numbing analgesia. Cancer, of course, is not the only cause of a prolonged and tormented end to life. Some of the most distressing cases are associated with the neurological prisons that mean a fully conscious person is cut off from mobility, self-care, sensory input and communication. In a deeply personal, well researched and detailed book, Rodney Syme relates his own experiences which, over 30 years, have honed his ideas of how best to achieve the relief requested by the sufferer. Conditions that have to be met include a clear, unequivocal request to die by the patient. This is extremely difficult when communication has become impossible, and points to the need for a “living will”, assigning that responsibility to a nominated person. Nevertheless, euthanasia on demand is not his aim. Rationality is paramount, as is the physician’s responsibility in the decision process. Syme lays emphasis on the need to allow relatives and/or close associates the opportunity to say farewell and discusses the reasons for recommending the methods he does. He makes it clear why he has never adopted the execution-style injections of sedatives, analgesics and cardio-respiratory paralytics adopted in other countries. Although this is scarcely a textbook of suicidal methods or a scientific treatise, it is a valuable addition to the discussion of the subject. It may help medical practitioners to know that others have had to go through the same convolutions of conscience, and be of comfort to family members to follow the thoughts of a clearly caring doctor.

Thomas F Sandeman

Should intrusions by political bodies into personal reproductive decisions be an Australian fact of life? Babies are generally very good news for Australian families, and nationally there is acclaim that our previously declining birth rate has been on a clear rise since 2004 (Box).1 In part, this rise has been a result of welcome government intervention, and several articles and letters in this issue of the Journal relate to reproduction and government subsidy.1-7 Lain and colleagues assessed the effect on New South Wales birth rates of the Howard Government’s cash bonus of $3000 for the birth of a child, introduced on 1 July 2004;1 the then Treasurer, Peter Costello, quipped that a third child could be “for the country”. The Baby Bonus was increased to $5000 on 1 July 2008. Between 1997 and 2006, the proportion of first births in NSW (among a declining total number of births) increased steadily until 2004, after which the proportion of second births, and especially of third and subsequent births, began to rise.1 The timing of the turnaround and the strength of any causal link between the bonus and additional births invites further analysis, using data from the National Perinatal Statistics Unit (Box).8 The $3000 bonus payment to about 272 000 women giving birth nationally during 2005, and 282 000 in 2006, cost about $1.7 billion. We know that in these 2 years over 16 000 of the babies were conceived by in-vitro fertilisation (IVF), and that having an IVF baby most likely indicates reproductive intentions independent of the bonus. If the previous birth-rate trend for non-IVF babies had continued in 2005 and 2006, just over 250 000 babies would have been born in each of these years. This means that about 37 000 of the extra babies born in 2005 and 2006 were attributable to the bonus. The Baby Bonus thus represented a government investment of just over $45 000 for each extra baby. Comparing this figure with the total of $295 million paid out in IVF-related Medicare rebates in the same 2-year period for assisted conception of more than 16 000 IVF babies (an average of less than $20 000 for each baby), it is obvious that, as an ongoing government investment, Medicare funding of IVF is more than twice as productive as the bonus. The Rudd Government has now restricted the bonus to the more disadvantaged in the community by means-testing families. Acknowledging the need to “start in the womb” if we are to close the gap in life expectancy between Indigenous and non-Indigenous Australians,2 de Costa and Wenitong compare Australia’s Baby Bonus with a well established endowment scheme for babies in France that operates with some important differences. An extra payment is recommended for women who commence medically supervised antenatal care before 14 weeks’ gestation; and, instead of a lump sum after the birth, payments are made in instalments linked to positive health practices by the new mothers. The authors make a case for changing the way baby bonuses are delivered in Australia to assist all disadvantaged women to have healthy babies with better life prospects.2 IVF practices, meanwhile, have not stood still.3 When Medicare rebates were introduced for IVF services in 1989, a limit of six treatment cycles was set.9 As IVF practices and outcomes improved during the 1990s,10 including better methods for cryostoring excess early embryos for later transfers, the frequency of multiple pregnancies, with their attendant higher medical and social costs, increased disproportionately.3,10 Since 2000, improved pregnancy rates, the withdrawal of the six-cycle limit for Medicare rebates, and the introduction of the Medicare Safety Net (which decreases out-of-pocket expenses) have worked together to facilitate a fast-increasing practice in Australia of transferring just one IVF embryo at a time. This practice, known as elective single embryo transfer, or eSET, is now the benchmark for best practice. Its effect has been a sharp fall in multiple deliveries after IVF, from a peak of over 22% of confinements in 20008 to now single figures, and better pregnancy outcomes, as Wang et al report3. Improved storage techniques for immature sperm and unfertilised eggs are also pushing the frontiers of what’s possible, biologically and socially. Two such developments are reported in this issue of the Journal.4,5 When a young man is found to be terminally ill or dies suddenly, immature sperm can be collected from a testis before or after death, cryostored, and potentially be available for conceiving a child using IVF — but, if the legal constraint advocated by Middleton and Buist prevails, this will be allowed in Victoria and some other states only if the man has given proven written consent, irrespective of other evidence that this was his wish for his family.4 For women facing sterility from radiotherapy or chemotherapy and who are still to form a permanent relationship, the opportunity to store usable unfertilised eggs has also become technically practicable. Using vitrification, an ultra-rapid freezing method, retrieved mature eggs can be cryostored and, if they survive thawing, can resume a fertilisable physiological state. Given the rise in median maternal age at the birth of a first baby in Australia11 and the increasing physiological sterility of women from their mid 30s,12 this technique can also be used by healthy women to provide what Molloy et al refer to as “reproductive insurance”.5 This is not a development that should disrupt community social order. But governments tend to over-react,13 and can incite indignation. One man has written to the Journal in relation to a statutory limit in Victoria of 10 years for the storage of sperm (in his case his own, for his own use, having survived cancer treatment),6 beyond which each application for continued storage must have the individual approval of Victoria’s Infertility Treatment Authority.7 It seems some parliaments in our country would still subscribe to a 1993 report from Canada’s National Reproductive Technologies Commission, which claimed as paramount the need for “peace, order and good government power”13 and which unintentionally paraphrased Aldous Huxley’s “Community, identity, stability”, the world government’s ruling imperative in Brave new world.14 As Victoria’s statutes stand, a woman seeking “reproductive insurance”5 will likewise need, at a statutorily determined period and presumably regularly thereafter, to justify her decision to store her eggs to an appointed group of people of differing personal views, and she will also need their assent should she wish to take her eggs to another jurisdiction. The power of legislation to destroy individuals’ reproductive futures was demonstrated in the United Kingdom on 1 August 1996.15 Many infertile couples, not able to be contacted over a 3-month period, found out after the event that all UK IVF clinics, to avoid prosecution,16 had been forced by the UK’s Human Fertilisation and Embryology Authority to throw out more than 3000 embryos reaching their 5-year statutory storage limit without a properly formulated request for longer storage. Australia, like most countries, has a long history of government intervention in fertility issues. In 1983, it was the first country to adopt national ethical guidelines for the clinical conduct of IVF. For the safe development of IVF practices, it was considered necessary to do research involving human eggs and sperm (with consent of the providers).17 But (to cut a long story short), a conservative political reaction prevented such research in most states other than NSW until the federal parliament’s passage of the Research Involving Human Embryos Act 2002 (Cwlth). This conservative thinking still finds expression today, with the Australian Health Ethics Committee (a principal committee of the otherwise firmly evidence-based National Health and Medical Research Council [NHMRC]) arguing against research involving human embryos by resting on “an enduring ethical tradition of thought and belief” that has limited community support,18,19 at the expense of outcomes-based ethical principles.13,20 States that legislated to regulate IVF practices in the early 1980s, as Victoria did with its Infertility (Medical Procedures) Act 1984, faced what was then considered radical technology with uncertain social consequences, by applying similar, conservative, non-evidence-based principles. So rapidly were perspectives changing, however, that some parts of this Act were not proclaimed, some parts were later repealed, and, despite a 1996 overhaul of the Act, other parts have come into conflict with Commonwealth legislation.21 The Research Involving Human Embryos Act, which has been mirrored by most state legislatures, legalised embryo research across Australia through special and specific licences administered by the NHMRC. The community clearly recognises and supports the contribution that modern IVF practices make to responsible formation of families in Australia,22 but in Victoria a government authority established under the 1984 Act continues to be responsible for individual, personal decisions affecting all families who have or intend to have their sperm, eggs or embryos exposed in labs. In December 2008, the Assisted Reproductive Treatment Bill 2008, the second rewrite of the legislation in 24 years, and intended to broaden access to assisted reproductive technologies, was passed by the Victorian parliament. Cabinet has apparently over-ridden the advice of the state’s Law Reform Commission and imposed a fitness-to-parent code — compulsory police and child-protection checks — before infertile or childless people can attempt to form families with technological help. The Act also provides for a Patient Review Panel appointed by the Health Minister, with a “primary role” in determining applications for IVF and medically assisted conception.23 For couples with the disability of infertility who need medical help to have children, “the bedroom” is, alas, now a nostalgic metaphor for lost privacy. Intrusions by politically appointed committees into people’s lives and their personal reproductive decisions in Victoria and some other states are real and set to increase. With governments at the bedroom door determined to be part of the detail, too often it’s still two steps in and just a rare step out. Annual IVF and non-IVF births in Australia, 1991–2006 IVF = in-vitro fertilisation. Non-IVF births in 2005 and 2006 above the preceding 4 years’ average (dotted line) are potentially attributable to the Baby Bonus. Data source: Australian Institute of Health and Welfare National Perinatal Statistics Unit.

Robert P S Jansen MD, FRACP, FRANZCOG · Sandra K Dill AM, BComm, MLS

An unexpected consequence of the increase in the use of fertility treatment is that emergency department and intensive care doctors are receiving requests from wives (actual or de facto) of dying or recently deceased men for sperm removal. Legislation in all states and territories regulates removal of sperm from a dying man and, provided that lawful consent is obtained, a doctor can harvest sperm. In several states, including Victoria, harvested sperm cannot be used in a fertilisation procedure without the man’s consent, and debate surrounds the issue of consent and how it can be proved. Recent Victorian Law Reform Commission recommendations attempt to streamline the law to make a man’s consent the cornerstone of decision making for both harvesting and subsequent use of sperm.

Sarah L Middleton BA/LLB(Hons), PhD · Michael D Buist FRACP, FJFICM, PostGradCertHlthEcon

To the Editor: Before starting chemotherapy, many young men with cancer arrange to have their sperm stored to allow them the chance to father a child later. However, hundreds of these Australian cancer survivors have been informed that their stored sperm samples were to be destroyed by government order. The Victorian Infertility Treatment Act 1995 mandates that stored sperm must be destroyed after 10 years.1 In contravention of the Universal Declaration of Human Rights and even the preamble to the Infertility Treatment Act itself, it would seem that the main action of Infertility Treatment Authority (ITA) policy is to stop genetically unfit people from reproducing. Because some cancer and leukaemia survivors will have germline mutations that caused their disease, the 10-year storage cut-off is a tool for eugenics. Although eugenics policies of the 1930s and 1940s have been rescinded and are looked back upon with disapproval by many ethicists and civil libertarians, none have spoken out against the current Act. Australian civil rights groups speak out about forced sterilisation in other countries; why have none looked at the government actions in our own country? When I appealed to the ITA 7 years ago for an extension of storage time, I found the response I received to be arrogant and insensitive. The ITA representative implied that the legislation exists merely to deal with samples that people have forgotten about. When one has to pay several hundred dollars every year to continue storing sperm, I expect most people would stop paying if they didn’t want the sperm stored any longer. It is a physical, emotional and financial ordeal to survive leukaemia or cancer in youth and young adulthood. Many young men who survive choose not to have a family immediately after initial treatment because they don’t know their chances of survival. In my own case, this was highlighted by the circumstances of a friend who had a bone marrow transplant several years earlier and chose to have a child by in-vitro fertilisation. Unfortunately, he died from an unexpected complication of his treatment soon after his baby was born. Unable to get life insurance after leukaemia treatment, many individuals choose to wait until they are more financially secure (leukaemia or cancer will quickly throw a young person into debt) before starting a family. Being a doctor, I am prepared to fight such authoritarian directives, but many other men, now cured of their disease, would simply have given up their hope of having a family after receiving this draconian news. Forced sterilisation is unacceptable in this country, and this legislation must be amended. In reply: The Victorian Government develops policy around matters concerned with the storage of gametes and embryos and determines the length of storage time for sperm, eggs or embryos via specific clauses within legislation (the Infertility Treatment Act 19951). It is the role of the Infertility Treatment Authority (ITA) to administer the Infertility Treatment Act. Section 51 of this Act provides that gametes must not remain in storage for more than 10 years, unless the ITA has given its approval for a longer period. The ITA approves storage extensions on application from men or women who have stored gametes before undergoing chemotherapy for cancer. The ITA is sympathetic to people requiring a longer storage time for medical reasons and makes every attempt to discuss any issues arising with storage. People who have stored gametes for their own use have, to date, been granted an extension. The intent of the legislation is not to restrict people undergoing chemotherapy from having children, but to provide a timeframe for review of storage of gametes by the owners. If the owners of gametes or embryos have not kept their contact details up-to-date with the place where their reproductive material is stored, then the gametes or embryos can be removed from storage once they reach the statutory time limit, rather than being kept indefinitely. The current Act will be replaced by the Assisted Reproductive Treatment Act 2008, passed by the Victorian Parliament in December last year. The requirement for gaining approval for extension of storage will not change; however, applications for extension of storage beyond 10 years will now be made to a new Patient Review Panel. The ITA would be more than happy to provide further information about how the application process works, and the Chief Executive Officer, Louise Johnson, can be contacted on (03) 8601 5250 or ita@ita.org.au.

Jock Findlay

Severe childhood obesity and its associated comorbidities are increasing in prevalence. Extreme childhood obesity may be viewed as a mirror image of severe non-organic failure to thrive. Parental neglect may be a causative factor in both circumstances. When suspicion of parental neglect arises, health care professionals may have both an ethical obligation and a statutory duty to notify child protection services. Guidelines on the point at which medical practitioners should seek state assistance in cases of severe childhood obesity would be helpful, not only for medical practitioners, but also for child protection services.

Shirley M Alexander MB ChB, MRCPCH, FRACP · Louise A Baur BSc(Med), PhD, FRACP · Roger Magnusson BA, LLB(Hons), PhD · Bernadette Tobin MA, MEd, PhD

Available evidence indicates that rates of childhood overweight and obesity have been increasing over the past two decades, but inconsistencies between study methods moderate the strength of this evidence. Concomitant health problems and associated costs make it imperative that primary prevention initiatives are introduced to combat the obesity epidemic. Fundamental to informed action is anthropometric monitoring, which if properly implemented will identify changes over time in specific populations to inform policies, practices and services aimed at prevention and treatment. Sample representativeness is essential for valid trend and prevalence data, but efforts to obtain population-based anthropometric data from school children with the required written parental consent have been thwarted by low participation rates. Notable improvements in participation rates when utilising opt-out consent, in which participation is assumed unless otherwise indicated, are evident from local as well as international studies. Opt-out consent can facilitate anthropometric monitoring, delivering a more informed, best-value-for-money response to the obesity epidemic. Health and education ethics committees need to acknowledge the benefits of opt-out consent for “low-risk” anthropometric measurement, which ultimately upholds the individual’s rights.

Joanne M Stubbs BScPsychol(Hons), MPH · Helen M Achat BEd, MSc, ScD

To the Editor: Arnold is correct to question whether the New South Wales reportable misconduct legislation will be effective,1 because it relies on doctors making a judgement about whether a colleague has flagrantly departed from accepted standards of professional practice. Doctors have a high threshold for referring to medical boards, in part because they perceive the system to be adversarial rather than recognising that individual and system factors can combine to create poor professional performance. Also, medical boards have no direct ability to modify the workplace circumstances to make them more supportive of a poorly performing doctor. Poor performance has multiple causes, including mental and physical illness, cognitive impairment, substance misuse, professional isolation, and personality disorders.2 Flagrantly poor performance is rare, but research shows that the prevalence of poor performance is about one in a hundred doctors per annum.2 Many of these doctors are amenable to local remediation, provided there are properly promulgated procedures. The United Kingdom and some states in the United States have developed systems for assessing poorly performing doctors that require directors of medical services to manage complaints locally. In the UK, the National Clinical Assessment Service is available to support medical directors in more complicated cases. Consequently, the number of referrals to the General Medical Council has decreased, but the number of doctors being reviewed has increased to the number that would be expected from research.3 Doctors reviewed by medical boards in Australia do not reach the predicted prevalence levels, and boards’ processes seem slow by comparison with what can be done locally. It is a moot point whether Dr Jayant Patel would have been reported under the new NSW legislation, because some of his colleagues appeared not to have thought that he flagrantly departed from accepted standards. The real problems in Bundaberg were that there were no local mechanisms for health professionals to raise their concerns. For almost 2 years, the director of medical services at the hospital took no direct action.4 Queensland Health is developing local processes that will be administered by directors of medical services supported by a clinical performance support service.5 The evidence against relying solely on medical boards and in favour of local procedures for managing poorly performing doctors is now incontrovertible. Currently, many poorly performing doctors are not being identified and offered remediation, and patients are being left at risk. These are important issues for the National Health and Hospitals Reform Commission.

James A Dunbar · Prasuna Reddy

In reply: The opinion expressed by Dunbar and Reddy that: “The real problems in Bundaberg were that there were no local mechanisms for health professionals to raise their concerns” ignores the many real difficulties (canvassed in my editorial)1 confronting any member of staff who tried to raise their concerns within that institution. Local mechanisms cannot play their part if the institution’s senior staff do not wish to implement them. The ability of and, indeed, encouragement for all staff, regardless of seniority, to report their concerns directly to the medical board, bypasses all local deterrents. Our medical boards have the experience needed to sort out the major from the trivial, the genuine from the frivolous, incompetence from impairment. Dunbar and Reddy continue: “The evidence against relying solely on medical boards and in favour of local procedures for managing poorly performing doctors is now incontrovertible.” This is a straw man. No one, to my knowledge, has made any such suggestion. What I support is: (i) a direct avenue for someone local to report to the medical board; (ii) diligent and sensitive enquiry by the medical board; and (iii) if needed, the cooperative implementation of remediation by the local entity and the medical board.

Peter C Arnold

The humanities offer tools for wise application of biomedical knowledge and promotion of humane medical care Writing in the New York Times, columnist David Brooks recently described a “distinct brand of social misfits” in “fields like law, medicine or politics, where a person’s identity is defined by career rank”.1 He fears that their childhoods may have been spent in domestic “achievatrons” that ensured their academic success but compromised their interpersonal skills. Brooks believes that American society produces a disproportionate number of people with a “rank-link imbalance”, which he described as “the social skills required to improve their social rank, but none of the social skills that lead to genuine bonding”. These people have opinions about everything and “treat their conversational partners the way the Nazis treated Poland. They crush initial resistance, and the onslaught of accumulated narcissism is finally too much to bear”.1 It is hard to know whether Australia has a disproportionate number of “misfits” in law, medicine or politics, but if this is the case, Brooks suggests that they are the people most likely to force their way to the top of their career ladder and make life miserable for the rest of us. One way of producing doctors (or lawyers or politicians) with a capacity for genuine bonding might be to broaden their education.2 However, physician and writer Rafael Campo argues that “no one has proven that injecting the humanities in any form into medical settings translates to more humane physicians or better cared-for patients”.3 Campo’s use of the word “injecting” is telling; it conveys a sense of the humanities as something foreign to medicine. To appreciate whether the humanities are indeed foreign to medicine, try to imagine a health care facility in which no ethical issues are explored, no lessons have been learnt from the past, no cultural awareness is displayed, no written words (other than technical communications) appear, and no books, films, television programs, plays or concerts are discussed by patients or staff. Imagine that there are no artworks, no music and no other aesthetically pleasing elements. Although some of our hospitals are admittedly run down, the products of the arts and humanities are nevertheless all around us. Two recent Australian examples illustrate why we need to draw on the humanities in health care. The first is the front cover of the 19 May 2008 issue of this Journal, which depicts the phrase “Sorry, the first step” spelt out in candles in front of Parliament House.4 Many doctors are indeed sorry that biomedical solutions to Indigenous health problems have been confounded by ignorance concerning Indigenous history and culture.5 Fortunately, the Indigenous Health Curriculum Framework prepared for the Committee of Deans of Australian Medical Schools gives priority to topics such as culture, self and diversity, Indigenous history and society, and models of health service delivery.6 All of these areas draw on knowledge and insights from the humanities. The arts also offer teaching resources that provide for better cultural understanding. Recent examples include the film Ten canoes, which imaginatively recreates the world of the Yolngu people; Kate Grenville’s novel The secret river, and Doris (Garimara) Pilkington’s book Follow the rabbit-proof fence and its subsequent film adaptation; and plays Murras, Coordah and The keepers, which explore the impact of government policies of forced removal. Such resources communicate and educate by being emotionally engaging. The second example relates to quality and safety in health care. Among the competencies outlined in the National Patient Safety Education Framework are communication skills, teamwork, leadership, honesty and respect.7 The intellectual foundations for these competencies lie in the medical humanities, in particular psychology, sociology, philosophy and ethics as applied to medical practice. Biomedicine puts at our disposal the tools for safe, effective health care; the humanities explore their wise application in practice. Certain educational approaches accommodate the humanities better than others.8 Problem-based learning and its variants engage students’ emotions by giving each patient a story. However, problem-based learning is easily subverted by ignoring or parodying the human, experiential features of clinical problems. Privileging biomedical subjects over the humanities quickly alerts students to what counts as knowledge.3 A good medical curriculum provides time and resources for emotional engagement, reflection, and independent, self-directed learning — qualities that characterise what is best about the study of the humanities.9 The human experience of illness is most powerfully conveyed to students by those who have first-hand knowledge. It can be supplemented by poems, novels and films that faithfully represent that experience: Iris, A beautiful mind and The sea inside (which explore dementia, schizophrenia and quadriplegia, respectively) are recent examples. The Medical Humanities website of New York University provides an extensive database of resources on literature, arts and medicine.10 In the United States, the Accreditation Council for Graduate Medical Education has identified compassionate patient care and professionalism among six required competencies for residents, which training programs must assess.11 It has been suggested that the humanities, and specifically bioethics, could contribute to resident education.12 However, it has been argued that time and effort would be better spent in humanising the US health care system itself.13 The humanities cannot make people behave well. The late John Eisenberg, Director of the Agency for Healthcare Research and Quality in the US, has shown that doctors respond to many different influences.14 Well intentioned educational interventions will not produce more humane doctors if their role models’ behaviour suggests that it is better to do well than to do good. Medical facilities are moral worlds15 in which humane behaviour is elicited by being treated humanely,16 both in medical schools and in clinical settings.17 The humanities provide insight into why people (including patients, doctors and politicians) behave as they do and have done in the past. Equipping students with such insight is a necessary but not a sufficient strategy in the never-ending battle with the rank-link misfits.

J Jill Gordon MPsychMed, PhD, FRACGP

To the Editor: Spriggs and Gillam1 recently evaluated the updated guidance on ethical conduct in human research from the National Health and Medical Research Council (NHMRC),2 with particular reference to paediatric consent. The introduction in 2007 of the National Ethics Application Form (NEAF; http://www.neaf.gov.au) represented an attempt to streamline the process of obtaining ethics approval from multiple human research ethics committees (HRECs) for multicentre research. In 2007, just prior to mandatory introduction of the NEAF, we submitted identical NEAFs to 13 HRECs, covering all Australian states and territories, for an epidemiological study into childhood empyema. All but one HREC accepted the NEAF, but, despite use of the same form by the majority, we identified a variety of inconsistencies. With regard to child consent or assent, 11 HRECs required a single child information sheet and consent form; one required two separate age-appropriate forms; and one questioned the planned involvement of children in the consent/assent process and did not require a child’s consent. This latter response arguably contravenes the United Nations Convention on the Rights of the Child, which provides for a child’s right to information in a form they can comprehend, whether or not they have the ability to make decisions.3 Other inconsistencies included the time taken to obtain approval, which ranged from 1 day to 197 days (median, 31 days). One HREC defined a child as being aged less than 18 years; the others used a cut-off of 16 years. One HREC responded that the application did not specifically address local Aboriginal and Torres Strait Islander peoples’ issues, which suggests that the NEAF may not be sufficient to cover such site-specific requirements. One HREC required plain-language translation of consent and information sheets, and another required Aboriginal translation. Also of concern, the NEAF requires justification for the inclusion of Aboriginal or Torres Strait Islander children and other groups where ethical considerations may be different, such as children with intellectual impairment or mental illness. This approach places the wrong emphasis on the desired outcome, which is to give due consideration to cultural, social, health, psychological and local issues that may introduce ethical concerns that are not the same for all children, and it risks exclusion of some children from research that is relevant to them. We suggest the NEAF should instead include a justification for exclusion of any children as a result of cultural or religious background or social or psychological problems. This would provide an alternative way of gathering information about ethically relevant issues, to ensure best practice in ethical conduct or research. Clearly, there is a lack of consistency across Australia in engaging children in research, including the consent/assent process. We believe that use of the NEAF alone is insufficient to rectify these inconsistencies, and now is the time to consider a single national ethics committee for Australia, similar to the National Research Ethics Service recently introduced in the United Kingdom (http://www.nres.npsa.nhs.uk).

Adam Jaffe · Roxanne E Strachan · Katrina J Williams