Ethics

Objective: To assess the efficacy, with respect to participant understanding of information, of a computer-based approach to communication about complex, technical issues that commonly arise when seeking informed consent for clinical research trials.Design, setting and participants: An open, randomised controlled study of 60 patients with diabetes mellitus, aged 27–70 years, recruited between August 2006 and October 2007 from the Department of Diabetes and Endocrinology at the Alfred Hospital and Baker IDI Heart and Diabetes Institute, Melbourne.Intervention: Participants were asked to read information about a mock study via a computer-based presentation (n = 30) or a conventional paper-based information statement (n = 30). The computer-based presentation contained visual aids, including diagrams, video, hyperlinks and quiz pages.Main outcome measures: Understanding of information as assessed by quantitative and qualitative means.Results: Assessment scores used to measure level of understanding were significantly higher in the group that completed the computer-based task than the group that completed the paper-based task (82% v 73%; P = 0.005). More participants in the group that completed the computer-based task expressed interest in taking part in the mock study (23 v 17 participants; P = 0.01). Most participants from both groups preferred the idea of a computer-based presentation to the paper-based statement (21 in the computer-based task group, 18 in the paper-based task group).Conclusions: A computer-based method of providing information may help overcome existing deficiencies in communication about clinical research, and may reduce costs and improve efficiency in recruiting participants for clinical trials.

Asuntha S Karunaratne BBiomedSc(Hons), PhD · Stanley G Korenman MD · Samantha L Thomas PhD · Paul S Myles MB BS, MD, FCARCSI · Paul A Komesaroff PhD, MB BS, FRACP

Because of the complex aetiology of modern obesity patterns, isolated therapeutic or public health measures will not solve the obesity problem. Consumers must be made aware of the ways in which the food industry influences their food purchases. Government needs to prioritise health ahead of industrial productivity and increased consumption. An obesity intervention wish list is presented as a suggested reform package: prohibit all forms of marketing of energy-dense, nutrient-poor foods; introduce measures such as kilojoule caps, prohibition of bundling, and greater uniformity in packaging design to make energy-dense, nutrient-poor foods less enticing and less amenable to bulk purchase; redesign supermarkets to promote fresh rather than energy-dense, nutrient-poor foods; cease provision of government subsidies to food processing industries; tax energy-dense, nutrient-poor foods to create a disincentive to purchasing of these foods; and regulate the location and number of fast-food outlets by enacting urban planning laws

Bebe Loff LLB, MA(Lond), PhD · Brad R Crammond MA(Hons), LLM

Assessment of medical fitness to drive can be a sensitive and difficult task, particularly when it involves a condition such as epilepsy, where impairment is intermittent. The patient, their doctor and the driver licensing authority (DLA) each have responsibilities, both to the patient and to the wider community of road users. DLAs in Australia have shifted most of the responsibility for determining fitness to drive to the treating doctor. This creates a conflict of interest and may lead to unsafe decisions, damage to the doctor–patient relationship, interference with medical management and legal vulnerability for the doctor. Australian neurologists have argued for a system in which the treating doctor provides objective information about the patient’s condition, rather than an opinion on fitness to drive, and the DLA uses that information to determine fitness. This must be supported by an expert review process. Although drivers are legally obliged to notify the DLA when they become unfit, most people are unaware of this law. However, passing this responsibility to doctors in the form of mandatory reporting is counterproductive to road safety.

Ernest R Somerville MB BS, FRACP, FRCP · Andrew B Black BMedSc, MB BS, FRACP · John W Dunne MB BS, FRACP

Researchers have longstanding concerns about the logistical and administrative burdens posed by ethics review of multisite studies involving human participants. Centralised ethics review, in which approval by one committee has authority across multiple sites, is widely touted as a strategy for streamlining the process. The Harmonisation of Multi-centre Ethical Review (HoMER) project is currently developing such a system for Australia. It is unclear how centralised review will work for multisite Indigenous health research, where the views of local stakeholders are important and community consultation is mandatory. Our recent experience in conducting the National Indigenous Eye Health Survey (NIEHS) shows how elaborate the current ethics approval and community consultation processes can be, and points to several lessons and ideas to guide pending reforms.

David M Studdert LLB, ScD, MPH · Tamara M Vu LLB · Sarah S Fox BA · Ian P Anderson MB BS, PhD · Jill E Keeffe PhD · Hugh R Taylor MB BS, MD

To the Editor: The evaluation by Hicks and colleagues of the centralised ethics review system in New South Wales1 codifies important additional time delays facing researchers conducting multicentre trials that include NSW. These delays have direct financial consequences that continue to limit the viability (especially when staff are on time-limited grants) and productivity of multisite research in Australia, without adding value to the ethical conduct of the research.2 There is also inconsistency between the approaches of the lead ethics committee (LEC) and site-specific ethics committees in the way they deal with protocol amendments and adverse event governance, further compounding the delays in initial review. Five multicentre clinical trials are currently being conducted by the Palliative Care Clinical Studies Collaborative (PaCCSC),3 a national initiative to improve the evidence for symptom therapeutics at the end of life. Submissions for ethics review occurred between May 2008 and July 2009 across nine sites in five states. As in the study by Hicks et al,1 ethics review submissions included the NSW LEC, but because these submissions were more recent than those reported by Hicks et al, they were submitted on the National Ethics Application Form (NEAF). Hicks and colleagues state there is benefit in standard documentation, but using the NEAF does not reduce the need for collating complete sets of documentation for each site-specific approval and any subsequent amendments or adverse events.4 For the PaCCSC, LEC and site-specific review in NSW achieved approval in a median of 119 days (range, 76–209), compared with 107 days (range, 6–172) for individual committees in other states. Hicks and colleagues1 did not quantify the costs generated by these delays. Given that staff are often employed to prepare ethics submissions and then retained for the definitive study, additional delays in approval are costly, especially with finite, competitive grants funding. Costs of multisite ethics review applications have previously been quantified in Australia,2 but the additional delays in NSW from the requirement for site-specific approval are estimated to have cost the PaCCSC about $4000 per study per site in salaries and on-costs. Across three NSW sites and five studies, $55 000 has been spent without measurable ethical or research governance benefits. Theoretically, LEC review should streamline protocol amendments and adverse events reporting, as they are the responsibility of the LEC. But although protocol amendments are supposed to be reviewed only by the LEC, some site-specific committees continue to insist on approving all amendments.4 Efforts to consolidate adverse event reporting have made some progress.5 All adverse events are reported to the LEC for review, and any required response should be shared with site-specific committees. Again, some non-lead sites continue to insist on separately reviewing adverse events rather than using the LEC as intended.

Tania Shelby-James · Meera R Agar · David C Currow

To the Editor: Hicks and colleagues presented a study contrasting the ethics review system in two multicentre trials.1 They concluded that the introduction of a centralised ethics review process in New South Wales did not reduce the overall time taken to receive approval, but did help to reduce the time and resources involved in preparing applications. We are establishing a multicentre trial to prospectively evaluate and refine a model to predict patient outcomes after endovascular aortic aneurysm repair.2 This will involve collaboration between vascular surgeons at over 40 sites throughout Australia, one site in the United Kingdom and six sites in New Zealand. We, along with Hicks and colleagues, have experienced difficulty in establishing our multicentre trial. Multiple individual ethics applications have been submitted to human research ethics committees (HRECs) throughout Australia. The National Ethics Application Form (NEAF) was created to minimise inconsistencies and reduce the time and resources required when submitting ethics applications to multiple HRECs. Although the NEAF was designed to increase efficiency and quality,3 in reality it has done little to facilitate the submission process. It has been useful in NSW and Queensland, which have processes to allow the review of multicentre trials, but few HRECs in other Australian states accept the entire form, and often they have their own specific requirements. This has resulted in increased costs and time, as well as different interpretations of the trial protocol — effects that Hicks and colleagues found were reduced with a centralised ethics system. We are at least 9 months behind schedule in establishing our trial after having submitted over 25 individual applications. This has resulted in substantial losses in patient recruitment and research time. Other researchers have also reported on the excessive time and resources required to submit ethics applications.4 Like Hicks and colleagues (and no doubt other researchers), we are advocates of the Harmonisation of Multi-centre Ethical Review (HoMER) initiative.5 This national system would allow single ethics review that would be recognised by all institutions participating in a collaborative research project, without re-review by their institutional HREC. It is uncertain how many HRECs will adopt the HoMER initiative, but we remain optimistic that HoMER can solve problems that the NEAF has not. Central coordination of the ethics review process may help standardise documentation, as demonstrated by Hicks and colleagues, but clearly other factors, such as the time required for approval, need to be addressed.

Kate L Fitzpatrick · Margaret Boult · Robert A Fitridge

To the Editor: Hicks and colleagues are to be commended for reporting the benefits of the single ethics review system for multicentre trials in reducing the time taken for review, reducing unnecessary duplication of effort, and standardising documentation.1 They based their analysis on the overall time to approval, which included both an ethics and a governance component. The single ethics review model introduced by NSW Health in July 2007 separates scientific and ethics review from business or governance review (which requires site-specific approval). The Australian Research Ethics Database, developed by Infonetica for NSW Health, is used by the Cancer Institute NSW Clinical Research Ethics Committee (CREC) to track and manage multicentre research projects. It uses a 60-calendar-day clock to measure the time from submission to approval.2 The 60-day period sets a benchmark and represents a reasonable target review time. This clock stops, for example, when the CREC has sent a letter to the investigator and is awaiting a response. This method of measurement makes the total number of days for ethics review even shorter — for example, for the CO.20 trial described by Hicks and colleagues,1 the total number of days would be 66 rather than the 77 days they reported. It should be noted that if the CREC, which I chaired, sought changes to the participant information sheet after the first review of a research submission, the response was approved by the executive of the committee between full committee meetings. We used executive review more extensively than other committees to save time. This and other efficiencies, such as reducing the time between submission and the first ethics committee review and using a paperless review system, make it more likely that we will achieve a review time of less than 60 days as the committee becomes more experienced. This makes the adoption of a single ethics review system even more attractive.

Ian N Olver

To the Editor: Mitchell raises issues that strongly reflect on the professional standing of the medical profession.1 His particular focus is on the pharmaceutical industry, and on much needed changes as highlighted by Medicines Australia.2 Similar concerns exist in the medical technology industry where the transparency of relationships is becoming increasingly important. Mitchell highlights the fact that self-regulation by the medical profession has been largely ineffective.1 In this day of international corporate activity in the delivery of health care, the declaration of the Hippocratic Oath is no longer sufficient. The Royal Australasian College of Surgeons (RACS) published a code of conduct in 2006.3 This has been supplemented recently by the code of conduct of the Australian Medical Council.4 Separately, the Medical Technology Association of Australia has published its guidelines for industry groups.5 However, the dominant criticism of these documents is that compliance is voluntary. The RACS believes it is critical that the profession takes leadership in this complex issue to ensure that trust is maintained in the patient–doctor relationship. Consequently, we have recently expanded our code of conduct with a comprehensive policy dealing with interactions with the medical technology and pharmaceutical industries.6 We are introducing a sanctions policy to strengthen compliance. If there is a breach of the guidelines, the fellow or trainee concerned will need to confirm ongoing adherence to the RACS code of conduct. If there is a repeat offence, then cause will need to be given as to why the fellow should not have his or her fellowship removed or the trainee should not be dismissed from the training program. As professionals, these issues of integrity, transparency and trust are fundamental. The doctor–patient relationship must be our primary focus, and should not be violated by any perceived or real conflict of interest.

Ian R Gough · Ian Dickinson · Guy Maddern · Michael Grigg · David J Hillis

To the Editor: There is no doubt that the relationship between doctors and the pharmaceutical industry, described by Mitchell,1 is a complex one. Mitchell states that: “There are few, if any, analogies for the relationship between the medical profession and the pharmaceutical industry”.1 We contend that, as medical professionals are to the pharmaceutical industry, nutritional health professionals are to the food industry. Nutritional health professionals, like medical professionals, span the health care spectrum — from research and public health to tertiary care — and include doctors, dietitians, nutritionists and nurses. The food industry is more expansive than the pharmaceutical industry, encompassing primary producers, manufacturers, retailers and parts of the pharmaceutical industry. Some definitions include alcohol as part of the food industry. As well as this difference in magnitude, there are other substantial differences between the pharmaceutical and food industries. Contact between the food industry and health professionals is ubiquitous and unavoidable, but lacks the oversight provided by the, albeit voluntary, Medicines Australia code of conduct.2 It is unrealistic to suggest that health professionals should be completely divorced from the food industry. The alcohol industry is, however, the exception.3 Appropriate engagement between health professionals and the food industry has the potential to improve population health.4 Product reformulation (to improve the nutrient profile, such as reducing salt or fat content) and repackaging (to make smaller portions) are examples of successful partnerships between health professionals and the food industry. The food industry must work with health professionals to respond to consumer demand for healthier foods. Yet many of these foods are still of questionable nutritional quality, or of benefit only in very specific cases. Medications, on the other hand, must be proven before they enter the market. Finally, the food industry is able to advertise directly to the public and use health professionals to promote their products. This creates opportunities for endorsement — perceived or otherwise — of specific foods or brands by key opinion leaders, like doctors or sporting icons, who have varying degrees of nutritional expertise but are nevertheless viewed by the public as credible. Increasing rates of obesity legitimately prompt greater scrutiny of food industry activity. Analogous to the relationship between the pharmaceutical industry and doctors, it is equally necessary to “. . . expeditiously formalise a relationship of integrity and transparency . . .” between health professionals and the food industry.1 A code of conduct, equivalent to that of Medicines Australia, may be a necessary next step.

Iain S Pratt · Clare L Hughes · Terry J Slevin

To the Editor: In his article on the relationship between doctors and the pharmaceutical industry, Mitchell highlights moves to bring about greater transparency.1 While such moves are important, they do not go nearly far enough. Mitchell states that “it is not the relationship between medical practitioners and the pharmaceutical industry per se that is the problem, but how that relationship is enacted”.1 I disagree. The marketing activities of pharmaceutical companies are often justified by reference to the role that they play in the development of new medications, summarised in the statement “we need them”. In fact, the vast majority of the world’s most valuable medications were discovered and, in most cases, developed without pharmaceutical company involvement. Even recent advances, such as 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, originated with the brilliant work of researchers in the basic biological sciences.2 The progression from discovery to the development, testing and approval of a new drug does require large investments by pharmaceutical companies, but they do this for commercial reasons, in the hope of delivering profits to their shareholders. Naturally, they endeavour to promote their products and maximise their profits. As Mitchell outlines, their means include gifts, honoraria, sponsorship of events, “key opinion leaders” and “ghost writing”.1 As Mitchell also outlines, it is well established that all these manoeuvres are effective in altering doctors’ prescribing practices.1 Mitchell recommends that “we go down the route of disclosure of earnings from industry”.1 But is transparency enough? Is it enough to read that the keynote speaker at a symposium received an honorarium from a pharmaceutical company? Is it enough to know that delegates’ meals, entertainment or travel were paid for by a pharmaceutical company? Is it enough to know that your pen was provided by the manufacturer of X? (Isn’t that why the company’s name is written on it?) The fact that we need pharmaceutical companies to develop new drugs does not justify any of these activities, all intended to influence our decisions about whether and when to use their products. The fact that pharmaceutical companies cannot advertise or sell directly to their customers (ie, patients) in no way justifies marketing through intermediaries (ie, doctors and pharmacists). The recent report of the Association of American Medical Colleges is clear and forthright in proscribing many of these activities.3 Mitchell summarises their recommendations nicely, so I am surprised and disappointed that he does not go on to recommend proscription himself, rather than just transparency.

Richard Kelly Barnes

Ethics in practice. Moral theory and the professions. Andrew Alexandra, Seumas Miller. Sydney: UNSW Press, 2009 (ix + 278 pp). ISBN 9781742230306. Most people who become interested in ethics or moral philosophy, I suspect, start with strong convictions about what is right or wrong in various individual instances, and then get to wondering what underlies these convictions, and whether they can be rationalised. Alexandra and Miller use this approach effectively in their book, Ethics in practice. The authors provide many literary and “real-life” case studies at the beginning of each chapter, to probe moral intuition, before exploring theories that have been advanced to make sense of morality, and the arguments for and against certain kinds of behaviour. This is not a comprehensive overview of moral philosophy; nor does it tackle any particular area of moral philosophy in great depth. Health professionals who have already significantly engaged in the biomedical ethics literature will probably find that there is not much new here (in fact, not much at all). Abortion and embryonic stem cell research are sidestepped altogether and end-of-life decisions are dealt with in a relatively brief discussion that focuses mainly on active euthanasia. However, possibly because it avoids these well worn areas, and addresses some often-neglected topics, I found this book refreshing. The morality of recreational drug use and its prohibition, filial responsibility, and corruption are enormous social issues that deservedly get attention. I found the chapter on professional role morality particularly useful and I intend to use some of its insights in my teaching of medical students. The book is written in a clear, balanced, analytical style that is easy to read, and assumes no prior knowledge. It is largely a “primer”, likely to be most appealing to those (from any background) with a budding interest in ethics and moral philosophy, who have done little reading previously — my 18-year-old daughter was immediately engaged. I think it will also interest those whose interest in ethics has hitherto been with specific “biomedical” issues who would like to start to read more widely.

Charles D Douglas

Hospital funding based on achieving targets for numerical key performance indicators was implicated in Queensland’s Bundaberg Base Hospital scandal and has driven hospital data fraud in Victoria and New South Wales. Nationally uniform legislation is required to make health service reporting standards consistent and to criminalise public sector data fraud. Urgent action is needed to develop realistic outcome measures that base hospital funding more on the quality and safety of patient care and less on patient throughput numbers.

Antony Nocera FACEM, MSc(Emergency Planning and Disaster)

To the Editor: The research article by Keogh and colleagues1 on uptake of genetic testing and insurance implications highlights the need to ensure that Australian insurance industry policy in relation to genetic testing does not increase the risk of adverse health outcomes. The authors called upon the insurance industry and the Human Genetics Advisory Committee (HGAC) of the National Health and Medical Research Council (NHMRC) to reconsider the use of genetic information in relation to insurance.1 Another recently published study has also raised concerns about the way genetic information is used in the insurance industry.2 The HGAC has had initial discussions with the insurance industry about: avoiding genetic discrimination in the insurance setting; developing policies and guidelines to ensure appropriate use of genetic test results in insurance underwriting; promoting genetic education and training in the financial industry; and providing support for consumers and health professionals wanting to challenge adverse decisions. Through the HGAC, the NHMRC will encourage the development of an evidence-based process for assessment of genetic tests for use by the insurance industry, to ensure that it meets the required standard for underwriting. This will, in turn, support appropriate, equitable consumer access to optimal health care.

Warwick P Anderson

To the Editor: Robertson and Kerridge1 criticised our article “Patient privacy versus protecting the patient and the health system from harm”2 based on an interpretation that we were advocating notification for all patients with somatisation disorders, but our recommendation for a confidential notification system pertained specifically to factitious disorder. We agree that “ignoring or failing to integrate mental health care in future health planning is to invite a higher burden of morbidity, mortality and cost”.1 Indeed, we do not wish to “[constrain] the patient’s interaction with the health system”, but rather believe that a more complete, accurate and easily available patient history would allow doctors to optimise such patients’ care within the system. Clinically appropriate resource allocation would substitute appropriate psychiatric/psychological and primary care for more costly and inappropriate (potentially harmful) emergency and procedural care, such as numerous cardiac catheterisations. The case described in our article illustrates well the higher burden of morbidity and cost that the patient, and the system, had to endure because of the failure of multiple health providers across a range of acute settings to diagnose and treat the patient’s primary illness.2 Avoidance of truthful disclosure on the part of the patient contributes to this diagnostic failure. An electronic medical record (EMR) notification in this kind of case would allow any given doctor to overcome the otherwise almost insurmountable barriers to collating such a patient’s history, and thus to be aware of, to balance and to manage the factitious disorder diagnosis — a notoriously difficult task.3 Robertson and Kerridge argue there is a lack of evidence for “costly” EMR systems. However, it has been found that “Hospitals with automated notes and records [have] fewer complications, lower mortality rates, and lower costs”.4 A truly private portable EMR should help all patients obtain more appropriate and cost-effective care, by reducing duplication of costly investigations and doctors’ time spent chasing records. Conversely, patients might reasonably abhor a privacy system that inadvertently results in duplicate computed tomography scans — the prior records being “private” and unavailable — when radiation exposure increases the risk of cancer.5 We would be the first to acknowledge the risk of “stigmatisation” and agree with safeguards to mitigate potential consequences, as mentioned in our article.2 However, in the case of this patient and others in a similar situation, we still believe that he, the doctors struggling to provide appropriate care, and the system deserve better, which certainly won’t happen with the status quo.

Dawn E DeWitt · Ravi Bhat · Stephanie Ward

My 16-year-old daughter’s heart saved the life of another teenage girl, and her other organs were used to save or improve the lives of six other people. I still believe in organ donation, but there are facts about the donation process that are emotionally confronting and difficult, and we should be given better information so that we are more prepared for the realities of it. These facts should be made clear to anyone considering organ donation, but especially to those who have to make the final decision. The hospital bedside is neither the place nor the time to discover these facts for the first time. In February 2009, my family was eight months into a global circumnavigation aboard our sailing yacht. We had called into a marina in Phuket, Thailand, and our daughter Ali was watching a huge superyacht tie up at a jetty. An error was made during the docking procedure, which caused a cleat to be torn out of the jetty and the heavy mooring rope to whiplash with extreme force. Ali suffered serious head injuries and was rushed to the Bangkok Hospital Phuket, where she was examined by neurosurgeons. That first night we were told there was no brain activity and no brain stem function, but as certain tests had to be carried out before she could be legally pronounced brain dead, we then waited for five days with her in the hospital before life support could be “turned off”. Late on day four, the neurosurgeon told my husband and me that Ali had failed the final tests and would now be declared legally brain dead. He then asked — gently and with no urging — if we wished to consider organ donation. It was not something we had thought about. For four days we had stayed by Ali’s bedside, keeping shifts with the rest of our immediate family who had flown in from Australia, talking, singing, weeping, telling jokes, massaging her hands and feet, unable to lose that flickering of hope for a miracle. Organ donation was part of a step we hadn’t yet reached. The doctor explained that, if we agreed to donation, the transplant team would arrive from Bangkok the next day — or whenever we were ready — and Ali would be taken to the operating theatre and the useful organs removed. She would be returned to us later in the week, and we were assured that she would look perfectly fine. The doctor also pointed out that he had nothing to do with the transplant team, that they were from a different hospital altogether, and that Ali’s organs would not be used in this hospital. We could also change our minds at any time, regardless of signing the document. That sounded acceptable, and we signed. Without actually discussing it, each one of us assumed that we would sit with Ali while life support was disconnected and be with her as she stopped breathing, and that she would then be taken to theatre. Later that evening, the person in charge of organising the organ donation came to see us and explain how it would happen. Awkwardly, the woman explained to us that, no, we couldn’t sit with our precious child as she drew her last breath and her heart stopped its beating. For the organs to be in perfect transplant condition, they had to be removed from a body that was technically still functioning. She would be taken to theatre still attached to life support. Our immediate response was one of horror and disbelief, and we told her that no one would be taking our child while she still had a heartbeat, that they would have to wait until she was dead. The woman, obviously feeling very awkward and uncomfortable, said that was fine, that was our prerogative, but the only organs that might then be able to be used would be the corneas, and not much else. We spent the rest of the night in turmoil. Logically, we knew that our daughter was gone, that an exhaustive testing regime proving brain death meant she was dead. We understood the reasons why the procedure had to happen that way — that as soon as the heart stopped beating and oxygen stopped being delivered to the cells in the body, the organs would immediately begin to deteriorate. We also knew Ali would want her organs donated. She was the kind of kid who couldn’t walk past someone with his hand out or someone who looked upset. But the sudden reality of what her donation asked of us was unbearable. Early the next morning, I phoned a doctor we knew in Australia. He confirmed that it was the correct procedure; that for the best possible transplant potential, the organs had to be removed from a body still attached to life support, with a beating heart supplying oxygen to the tissues. This was why organ donation was such a controversial issue. We wanted to honour what we knew Ali’s wishes would have been, and we wanted the donation to be as useful and as beneficial as possible, to make the best possible gift on her behalf. But doing so meant that we had to absorb these confronting facts about organ donation at a time when we were overcome with grief. I knew that none of us could walk away from her while she still seemed to be alive — her skin warm, her chest rising and falling, the machine beeping her pulse rate, all those signs you hang on to as proof of life even though you know it’s hopeless. I talked to the rest of the family and explained the procedural requirements. We had to accept — emotionally as well as rationally — that the only things keeping Ali’s heart beating and her chest rising were machines. We had to acknowledge that she was already gone. When the team was assembled, we would say our goodbyes and then call them in when we were ready to let Ali be taken from us. It was the hardest thing I’ve ever had to do in my life, and it should not have happened that way. No family should have to face the shock of discovering these details for the first time at that point. I am an educated, widely read, well informed Australian woman and, then and still, a registered donor, but I knew nothing about the procedural requirements for organ donation. No one I have spoken to since, apart from doctors, has had any idea either. None of us had ever been in the situation where we needed to know. Since returning to Australia, I have studied the Medicare leaflet about organ donation — the one that comes with your drivers licence renewal — and the new organ donation website (http://www.donatelife.gov.au). There was no mention anywhere of the emotional impact you might need to be prepared for, nothing that said: You need to know certain facts about organ donation that may be emotionally confronting and difficult. It’s a good idea to talk about these facts with your family before they might be called upon to face them in a hospital ... The deceased will be taken to the operating theatre still attached to life support. This may be upsetting for the donor’s family because the person has the appearance of being alive. You will need to remind yourself that a diagnosis of brain death means that the person is already dead. Breathing and heartbeat are being maintained by machines in order to ensure the organs stay healthy and usable ... If clear information was provided in advance about brain death, life support procedures and the requirements for organ removal, then at least we might have been a little more prepared. At some point in the past most of us would have talked about it, academically and dispassionately, but with further information we could have already considered the notion of “beating heart donation” and had the chance to consider the sacrifice the family of an organ donor is called upon to make. It might be argued that in Australia we would have had these facts carefully and sensitively explained to us at the hospital. I am sure it also happens in Thailand, and certainly an effort was made to explain it to us, in spite of language barriers. However, the real point here is that the hospital bedside is not the place or the time to find out these facts for the first time. If such information was available, then perhaps there might be more consent to organ donation at the hospital bedside. I never previously understood why a family would go against a potential donor’s signed consent. Now I can completely understand a family countermanding their child’s wishes when they discover at the last moment what it means — that they have to hand over their apparently still living child, and that they must give up the final solace of the survivor, of holding their loved one in their arms as they take their last breath. We are parents, sisters, brothers and children of the dead person. We are not all going to be rational and sensible at such a time. Ali was a very healthy 16-year-old who had never had a serious illness. Her heart saved the life of a teenage girl in Bangkok a day later, and her other organs were used to save or improve the lives of six other people. I still believe in organ donation. But human beings often make decisions based on emotional responses. We are already facing the most unutterable grief when our children, our husbands or wives, our parents or siblings, are declared brain dead. Please, make people aware of everything involved in organ donation through the leaflets and websites, so that the ordinary person is better prepared, at least in some way, to deal with it if they’re unlucky enough to have to face it one day.

Joanne M van Os

Comment: Death is a reality that confronts us all at different times and in different ways. Death of a child, especially your own child, is an ever-present fear. Sadly, every day, somewhere in the world, parents will be confronted by the death of their child in an intensive care unit (ICU). Surrounded by the paraphernalia of high-tech medicine, those who work in the ICU must bring understanding to the family with both sympathy and empathy. Brain death does not seem like death in the same way as cardiac death, and that disconnection between what we know and what we feel is described here with exquisite pain by Ali’s mother.1 van Os first calls for sensitivity from the medical, nursing and other staff in emergency and intensive care departments — clearly spoken here, and indeed spoken before by others. This call has been well heard in Australia and New Zealand, where specific training has been provided to ICU teams for the past 15 years by a program called ADAPT (Australasian Donor Awareness Programme).2 It is not possible to qualify as an intensive care specialist without first completing this training program. The process of gaining permission to proceed to organ donation in Australia should leave none of the uncertainties that crept up unannounced on van Os and her family.1 Our transplant coordinators are trained, and our organ donation agencies have specific bereavement counselling programs to provide care for the donor’s family after organ donation. Emotional doubt over brain death is inescapable, but we try harder here to resolve these concerns than in many places in the world, which may be one reason why our organ donation rates fall behind those in many other countries. The second call from van Os is to ensure that the community is better informed about the realities of organ donation. Providing appropriate information to the community has been a continual struggle. The expenditure of sufficient advertising money to get these complex messages across has been deemed an unacceptable use of the health dollar. However, there are other ways, and we can always improve our act. The recently created Australian Organ and Tissue Authority is doing just that.3 Ms van Os, your calls have been heard. Somewhere, every minute of every hour of every day, someone dies for lack of the decision that you and your family took — but it was not that day for a teenage girl with heart failure in Thailand.

Jeremy R Chapman

Comment: The families of organ donors are usually deprived of the opportunity to be present when the donor’s heart stops beating. As this personal account by van Os eloquently demonstrates,1 forsaking this opportunity can be experienced as an additional loss — one that exacerbates a family’s trauma during the donation process and that possibly imperils the donation itself. We should not underestimate the cultural significance of heartbeat and breath, and the symbolic importance of the moment in which they cease. Neither is diminished by medical redefinitions of death. Should we do more to educate Australians about the fact that a donor must enter the operating theatre attached to a respirator with a heart still beating? There may be some reluctance to do so on the grounds that drawing attention to this might drive Australia’s low donation rates even lower. There is also no strong precedent to do so; countries with high donation rates such as Spain, France and the United States do not generally make this information publicly available. On the other hand, information provided to Australians about organ donation does now routinely include discussion of other sensitive issues, such as the diagnosis of brain death, the organ retrieval process and the physical appearance of the donor’s body after surgery.2 Although no amount of disclosure can fully prepare a donor’s family for the experiences they are about to face,3 a more detailed and carefully worded explanation of why brain death necessitates the mechanical ventilation of a donor immediately before surgery may help address the key issue identified by van Os: that the hospital bedside is not the place to find out about this for the first time. Overseas experience suggests that organ donation after brain death depends heavily on trust.4,5 Trust surely rests on frank and open disclosure. If the latter also helps to prevent one nasty shock to a family being exacerbated by another, then there are two sound reasons to pursue this policy.

Aric Bendorf

Here are some tips to keep in mind And others you may simply find Essential to your research design Whether it’s RCT or double blind The ethical considerations you must ponder Ethical considerations Are not mere exaggerations Or NHMRC machinations Designed to prompt procrastination Or slow your application Because we know there is little time at your disposal — for work on your proposal Above all: Be sure your patients are content To give to you informed consent There is no need to reinvent Reasons to cause malcontent You’re just required to present Any unclear danger or event That may be considered torment Or cause harm and discomfort to your participants And: Speaking of those who comprise your experimental troupe Always consider those of a vulnerable group This is of prime importance and not just another hoop For you to jump through Now: Is it possible I ask? Multi-institution review will be a thing of the past? Best not to speculate — or move too fast Remember the adage that good things don’t last Indeed the number of review boards is beyond belief So if multi-site approval is giving you grief Be joyous and thankful — there is a portent of relief Just get on the website and fill out the NEAF Also keep in mind: It’s sad but true That expedited review is for only a few Of those of us who knew Exactly what to do To construe the application With minimal frustration And get it through administration Without submitting 15 hard copies . . . And remember: Maintaining confidentiality Is not merely a formality But involves matters of morality Not to mention of legality So choose your methods carefully So all your risks are plain to see The bottom line is: To obtain ethical clearance Takes skill and perseverance And it’s not just for appearance But proof of your adherence To all ethical considerations in your research NHMRC = National Health and Medical Research Council. NEAF = National Ethics Application Form.

Diann S Eley MSc, PhD

Ethics and law for the health professions. 3rd ed. Ian Kerridge, Michael Lowe, Cameron Stewart. Sydney: The Federation Press, 2009 (xxv + 895 pp). ISBN: 978 1 86287 730 6. Comprehensive, accurate and up-to-date references on the law are indispensable in my work, so the third edition of Ethics and law for the health professions will join a couple of others to which I regularly refer. There are chapters on truth-telling, confidentiality, consent, the limits of medical treatment, cardiopulmonary resuscitation, genetics and biotechnology, sexuality and reproduction, abortion, treatment of children, treatment of people with mental illness and with chronic diseases, the elderly, post-coma unresponsiveness, organ donation and transplantation, end-of-life care, public health, infectious diseases, indigenous health care, resource allocation, research, animals and the environment, complementary medicine, and the pharmaceutical industry; each chapter provides succinct accounts of the relevant laws, judgments and legal reasoning. The authors clearly distinguish ethics from the law, both in general and in relation to each of the topics they discuss. They offer an informative introduction to the controversy among jurisprudents about how best to think about the nature of the law. The book also has a useful table of cases, table of statutes and an index. I would have only one minor reservation about recommending the book as a text in bioethics: the ethical content is not as strong as the legal content. As an example, the authors say that, with technological change and the passage of time, our ethics must change. However, this assumes that ethics is a set of very specific, very detailed, very current rules about how we should act. Further, the doctrine of the sanctity of life, properly understood, neither says nor implies that it is morally prohibited intentionally to let a person die or that it is morally prohibited to base decisions relating to the prolongation or shortening of human life on considerations of the kind or quality of a person’s life. That said, Ethics and the law for health professions will be a useful reference work for health care professionals.

Bernadette M Tobin

Introducing a new disclosure form for member journals of the International Committee of Medical Journal Editors Disclosure of financial associations of authors of articles published in biomedical journals has become common practice. The information provided in these disclosures helps readers understand the relationships between the authors and various commercial entities that may have an interest in the information reported in the published article. At present, many journals ask authors to report such relationships by completing a form with information about their financial associations. The journals then either post the complete information online or create a summary of the information and publish it with the article in question. Although efforts are underway to establish uniform reporting systems, there is currently no uniform vehicle for the disclosure of financial associations. Thus, authors may provide similar information to different journals in multiple formats. In addition, slight differences between journals in requirements for reporting can lead to confusion, as the same individual may report different information to different journals. With this editorial, which is being published simultaneously in all International Committee of Medical Journal Editors (ICMJE) journals, we introduce a new disclosure form that has been adopted by all journals that are members of the ICMJE. We encourage other journals to adopt this reporting format, and we are placing the form in the public domain. We ask authors to disclose four types of information: their associations with commercial entities that provided support for the work reported in the submitted manuscript (the time frame for disclosure in this section of the form is the life span of the work being reported); their associations with commercial entities that could be viewed as having an interest in the general area of the submitted manuscript (the time frame for disclosure in this section is the 36 months before submission of the manuscript); any similar financial associations involving their spouses or their children under 18 years of age; and non-financial associations that may be relevant to the submitted manuscript. The form now posted on the ICMJE website (http://www.icmje.org/coi_disclosure.pdf) includes instructions and examples to help authors provide the required information. A sample completed form is also available (http://www.icmje.org/sample_disclosure.pdf). Authors can download the form from the Internet, add the information, and save the completed form on their computers. The completed form can then be uploaded to the website of the journal that has requested the information. As all ICMJE journals now use the same reporting format, authors may save a partially completed form on their computers; when a manuscript is ready for submission to a journal that accepts this reporting format, authors can simply complete the form by adding information specific to the manuscript and then upload the completed form to the journal’s website. Our goal is to make the process of disclosure uniform and easy; the new form should eliminate the need to reformat disclosure information for specific journals. We realise this disclosure form requires authors to report a great deal of information about their relationships with entities that could be viewed as having interests that compete with the research being reported. With this in mind, some journals may ask for all these details at the time of initial manuscript submission, whereas other journals may ask for much less information at submission and require the detailed form to be completed later in the editorial process. These decisions will be left to the discretion of each journal. We also realise that to be useful, the reporting format must be responsive to community needs. Although ICMJE member journals have “use tested” the form, there may be situations that are not covered by the form, aspects of the instructions that are unclear, or bugs in the programming that we have not yet discovered. Therefore, we regard the period from publication of this editorial until 10 April 2010 as a period of beta testing. We encourage you to let us know about problems that arise with the form and to send us your comments by using the comments feature at the home page of the ICMJE website (http://www.icmje.org). The ICMJE will meet in late April 2010 and will adapt the form to address concerns identified by users. In the future, we will revisit the form’s usefulness and modify it as needed. We are grateful to the authors who take the time to provide complete disclosure information and thus help to ensure the transparency of the publication process. By adopting a uniform format, we hope to make the process of disclosing competing interests easier for authors and less confusing for readers.

Jeffrey M Drazen MD · Martin B Van Der Weyden MD, FRACP, FRCPA · Peush Sahni MS, PhD · Jacob Rosenberg MD, DSc · Ana Marusic MD, PhD · Christine Laine MD, MPH · Sheldon Kotzin MLS · Richard Horton FMedSci · Paul C Hébert MD, MHSc · Charlotte Haug MD, PhD, MSc · Fiona Godlee MB BChir, BSc · Frank A Frizelle MB ChB · Peter W de Leeuw MD, PhD · Catherine D DeAngelis MD, MPH

Objective: To investigate the frequency of, and factors associated with, Australian doctors’ involvement in medicolegal matters.Design, setting and participants: Cross-sectional survey of Australian doctors (specialists, trainees and general practitioners) insured with the medical insurance company Avant. A self-report questionnaire was mailed to Avant members in September 2007 to gather data on their involvement in medicolegal matters. Information on psychiatric morbidity and alcohol consumption was also collected using the General Health Questionnaire and the Alcohol Use Disorders Identification Test.Main outcome measures: Occurrence and type of past and current medicolegal matters with which doctors have been involved.Results: Of 8500 doctors invited to participate, 2999 returned completed surveys (36% response rate). Sixty-five per cent of respondents had been involved in a medicolegal matter at some time, and 14% were involved in a current matter. The two most common types of medicolegal matter were claims for compensation and complaints to a health care complaints body. Doctors were more likely to be involved in medicolegal matters if they were male, worked in high-intervention areas of medicine (surgery and obstretics/gynaecology), and worked longer hours.Conclusion: Our study concurs with other studies in finding an association between medicolegal matters and being male, working long hours and working in high-intervention areas of medicine. Unlike other studies, we found no association between age and involvement in a current medicolegal matter. Our findings also pose the question of whether psychiatric morbidity in doctors is a cause or effect of the medicolegal process.

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

Objective: To determine the adequacy of consent documentation related to descriptions of intended procedures, associated risks and treatment alternatives, and to analyse trends in the adequacy of consent documentation in a specialty surgical unit.Design, patients and setting: Retrospective reviews of consent forms for all patients on the Urology Unit waiting list of the Repatriation General Hospital, Adelaide on three occasions. Reviews were undertaken during 2005, 2007 and 2008, with a minimum of 12 months between reviews.Results: 1280 consent documents were evaluated. No trend in the studied criteria of adequacy of documentation was observed during the study period. Overall, 18.5% of consent forms described procedures using plain language. In 15.3% of consent forms, a significant component of the procedure was described using only an acronym, without further explanation. In 6.6% of consent forms, procedure descriptions contained only acronyms, abbreviations or technical terminology, with no plain language word. The purpose of the operation was conveyed in 10.1% of consent forms. Relevant risks were provided in 4.1%. Any indication of the magnitude of procedural risks was provided in only four of 1280 forms. No consent form provided information about alternative treatments.Conclusions: We believe these findings are broadly representative of current hospital practice and that the community should consider whether an acronym or technical terminology is appropriate for documenting consent. If not, can minimum practice standards be defined, and should any emerging recommendations be mandated?

Mark T Siddins MB BS(Hons), MS, FRACS(Urol) · Elizabeth M Klinken BM BS, BSc · Lee R Vocale BM BS, BSc

The relationship between medicine and the pharmaceutical industry in the United States is undergoing rapid and momentous change; US Senator Grassley has alleged inadequate disclosure of earnings from industry and lack of acknowledgement of conflicts of interest by leading academics. This article is based on the premise that it is not the relationship per se that is the problem, but rather how that relationship is enacted. The influential 2008 report of the Association of American Medical Colleges (AAMC) has provided detailed recommendations on appropriate interactions between academic physicians and industry (eg, proscribing receipt of gifts including travel support, and proscribing speaking at industry-sponsored educational programs). Contrary to expectations, there has been widespread acceptance of such guidelines. In Australia, details of all industry-sponsored educational events are now listed on the Medicines Australia website. Australian doctors have no alternative but to drastically improve the transparency of their interactions with industry, both in terms of the remuneration received and disclosure of potential conflicts of interest. Australian universities should seriously consider developing recommendations similar to those of the AAMC.

Philip B Mitchell MD, FRANZCP, FRCPsych

A 71-year-old man who presented to hospital with chest pain and a history of cardiovascular disease was repeatedly hospitalised over the course of a month for care that included multiple investigations, intensive care, transfer to and from a metropolitan hospital, discharge, and readmissions for collapse, hemiparesis, and vision change. The medical team excluded underlying disease related to his initial chest pain and subsequent neurological symptoms. A search for (undisclosed) prior hospitalisations revealed multiple previous admissions and invasive investigations at hospitals across Australia, resulting in a diagnosis of Munchausen syndrome. Assuming that, despite interventions, patients with Munchausen syndrome or somatoform disorders often continue to seek care at other hospitals, we discuss the implications of this patient’s behaviour for the health care system, society, and the risk to his own health. In our view, this case highlights conflicts between privacy legislation and doctors’ mandates to protect the patient from harm, as well as their duty to attend to the financial viability of health services by communicating with other potential health care providers. The health care system and similar patients may benefit from efforts to educate doctors about this spectrum of disorders and from considering the implementation of a highly confidential, structured notification system.

Dawn E DeWitt MD, FACP, FRACP · Stephanie A Ward MB BS · Sandeep Prabhu MB BS(Hons), LLB(Hons) · Bruce Warton MB BS, GradDipHealth

Patients who present repeatedly for care with medically unexplained symptoms raise challenges for the health system. One proposed strategy for dealing with such patients is the introduction of electronic medical records (EMRs) to identify these patients and thus limit the demands on resources their management involves. This measure may ultimately be appropriate but fails to consider equally critical core issues in psychiatric ethics. Identifying patients as “somatisers” invites a problematic relaxation of clinical vigilance, increasing the likelihood that an actual life-threatening medical problem will not be identified. Management of such patients requires regular, structured therapeutic contact with a skilled mental health clinician, that is independent of the patient’s distress level. Psychiatric problems and medical problems are frequently seen as two distinct, unrelated categories. This is a false dichotomy, as mental health and physical health are interdependent. Given patient privacy considerations, EMRs would be unlikely to reveal the kind of sensitive mental health information needed for the identification and management of somatising patients in busy health systems. Cost-effective interventions for somatising patients’ problematic behaviour, such as structured clinical intervention, antidepressant medication and cognitive behaviour therapy, are available at a fraction of the cost of EMR systems. Citing cost savings as a justification for violating the privacy of mental health patients compounds the manifest injustice these patients already face in the health system.

Michael D Robertson MB BS(Hons), FRANZCP · Ian H Kerridge MPhil, FRACP, FRCPA