Editorial : Law and ethics for the bioeconomy and beyond

The convergence of biological, technological and economic realms of life has fostered the development of the bioeconomy as a new feature of contemporary society. As the meaning of life and the human body is redefined in the context of the bioeconomy, new challenges have emerged for ethics and law In the face of these challenges, it is imperative that the currency of regulatory frameworks is maintained through the processes of regular review and update. The National Health and Medical Research Council has recently released the new National Statement on Ethical Conduct in Human Research to provide guidance for health research in Australia. The new National Statement will play an important part in supporting innovation and the development of the knowledge economy.

A new national women's health policy : legal, ethical and policy initiatives to support women's health

In 1989 the first National Women's Health Policy was launched in Australia. Now, 20 years later, the Federal Government has announced plans for the development of a new National Women's Health Policy to address the health needs of Australian women. The Policy will be based on five principles: gender equity; health equity between women; a focus on prevention; an evidence base for interventions; and a life course approach. This editorial examines the role for law in the development of a new National Women's Health Policy. It considers the relevance of regulatory frameworks for health research in supporting an evidence base for health interventions and analyses the requirement in the National Health and Medical Research Council's National Statement on Ethical Conduct in Human Research for "fair inclusion" of research participants. The editorial argues for a holistic approach to women's health that includes regulatory frameworks for research, identification of funding priorities for research, and the need for a dedicated government department or agency to promote women's health.

Freedom to choose? Embryo selection, reproductive decision-making and the role of the state

Involving the biopsy of an eight-cell embryo, PGD has been hailed as a means of making reproductive decisions without having to face the heart-wrenching decision to abort an affected foetus. However, controversy around the kinds of traits for which testing can be done, and who has access to the technology, has led to questions about the way in which the technology is developing. Women who are allowed to access in vitro fertilisation (IVF) services can currently also access PGD in limited circumstances.

Calculate excess mortality during heatwaves using Hilbert-Huang transform algorithm

Background Heatwaves could cause the population excess death numbers to be ranged from tens to thousands within a couple of weeks in a local area. An excess mortality due to a special event (e.g., a heatwave or an epidemic outbreak) is estimated by subtracting the mortality figure under ‘normal’ conditions from the historical daily mortality records. The calculation of the excess mortality is a scientific challenge because of the stochastic temporal pattern of the daily mortality data which is characterised by (a) the long-term changing mean levels (i.e., non-stationarity); (b) the non-linear temperature-mortality association. The Hilbert-Huang Transform (HHT) algorithm is a novel method originally developed for analysing the non-linear and non-stationary time series data in the field of signal processing, however, it has not been applied in public health research. This paper aimed to demonstrate the applicability and strength of the HHT algorithm in analysing health data. Methods Special R functions were developed to implement the HHT algorithm to decompose the daily mortality time series into trend and non-trend components in terms of the underlying physical mechanism. The excess mortality is calculated directly from the resulting non-trend component series. Results The Brisbane (Queensland, Australia) and the Chicago (United States) daily mortality time series data were utilized for calculating the excess mortality associated with heatwaves. The HHT algorithm estimated 62 excess deaths related to the February 2004 Brisbane heatwave. To calculate the excess mortality associated with the July 1995 Chicago heatwave, the HHT algorithm needed to handle the mode mixing issue. The HHT algorithm estimated 510 excess deaths for the 1995 Chicago heatwave event. To exemplify potential applications, the HHT decomposition results were used as the input data for a subsequent regression analysis, using the Brisbane data, to investigate the association between excess mortality and different risk factors. Conclusions The HHT algorithm is a novel and powerful analytical tool in time series data analysis. It has a real potential to have a wide range of applications in public health research because of its ability to decompose a nonlinear and non-stationary time series into trend and non-trend components consistently and efficiently.

Health Law in Australia [Second Edition]

Health Law in Australia is the country’s leading text in this area and was the first book to deal with health law on a comprehensive national basis. In this important field that continues to give rise to challenges for society Health Law in Australia takes a logical, structured approach to explain the breadth of this area of law across all Australian jurisdictions. By covering all the major areas in this diverse field, Health Law in Australia enhances the understanding of the discipline as a whole. Beginning with an exploration of the general principles of health law, including chapters on “Negligence”, “Children and Consent to Medical Treatment”, and “Medical Confidentiality and Patient Privacy”, the book goes on to consider beginning-of-life and end-of-life issues before concluding with chapters on emerging areas in health law, such as biotechnology, genetic technologies and medical research. The contributing authors are national leaders who are specialists in these areas of health law and who can share with readers the results of their research. Health Law in Australia has been written for both legal and health audiences and is essential reading for undergraduate and postgraduate students, researchers and scholars in the disciplines of law, health and medicine, as well as health and legal practitioners, government departments and bodies in the health area, and private health providers.

Interpreting and comparing risks in the presence of competing events

Competing events are common in medical research. Ignoring them in the statistical analysis can easily lead to flawed results and conclusions. This article uses a real dataset and a simple simulation to show how standard analysis fails and how such data should be analysed

Preventing infections following caesarean section

Surgical site infections following caesarean section are a serious and costly adverse event for Australian hospitals. In the United Kingdom, 9% of women are diagnosed with a surgical site infection following caesarean section either in hospital or post-discharge (Wloch et al 2012, Ward et al 2008). Additional staff time, pharmaceuticals and health supplies, and increased length of stay or readmission to hospital are often required (Henman et al 2012). Part of my PhD investigated the economics of preventing post-caesarean infection. This paper summarises a review of relevant infection prevention strategies. Administering antibiotic prophylaxis 15 to 60 minutes pre-incision, rather than post cordclamping, is probably the most important infection prevention strategy for caesarean section (Smaill and Gyte2010, Liu et al 2013, Dahlke et al 2013). However the timing of antibiotic administration is reportedly inconsistent in Australian hospitals. Clinicians may be taking advice from the influential, but out-dated RANZCOG and United States Centers for Disease Control and Prevention guidelines (Royal Australian and New Zealand College of Obstetricians and Gynaecologists 2011, Mangram et al 1999). A number of other important international clinical guidelines, including Australia's NHMRC guidelines, recommend universal prophylactic antibiotics pre-incision for caesarean section (National Health and Medical Research Council 2010, National Collaborating Centre for Women's and Children's Health 2008, Anderson et al 2008, National Collaborating Centre for Women's and Children's Health 2011, Bratzler et al 2013, American College of Obstetricians and Gynecologists 2011a, Antibiotic Expert Group 2010). We need to ensure women receive preincision antibiotic prophylaxis, particularly as nurses and midwives play a significant role in managing an infection that may result from sub-optimal practice. It is acknowledged more explicitly now that nurses and midwives can influence prescribing and administration of antibiotics through informal approaches (Edwards et al 2011). Methods such as surgical safety checklists are a more formal way for nurses and midwives to ensure that antibiotics are administered pre-incision (American College of Obstetricians and Gynecologists 2011 b). Nurses and midwives can also be directly responsible for other infection prevention strategies such as instructing women to not remove pubic hair in the month before the expected date of delivery and wound management education (Ng et al 2013). Potentially more costly but effective strategies include using a Chlorhexidine-gluconate (CHG) sponge preoperatively (in addition to the usual operating room skin preparation) and vaginal cleansing with a povidone-iodine solution (Riley et al 2012, Rauk 2010, Haas, Morgan, and Contreras 2013).

Genetic susceptibility to environmental toxicants : the interface between human and experimental studies in the development of new toxicological concepts

The growing knowledge of the genetic polymorphisms of enzymes metabolising xenobiotics in humans and their connections with individual susceptibility towards toxicants has created new and important interfaces between human epidemiology and experimental toxicology. The results of molecular epidemiological studies may provide new hypotheses and concepts, which call for experimental verification, and experimental concepts may obtain further proof by molecular epidemiological studies. If applied diligently, these possibilities may be combined to lead to new strategies of human-oriented toxicological research. This overview will present some outstanding examples for such strategies taken from the practically very important field of occupational toxicology. The main focus is placed on the effects of enzyme polymorphisms of the xenobiotic metabolism in association with the induction of bladder cancer and renal cell cancer after exposure to occupational chemicals. Also, smoking and induction of head and neck squamous cell cancer are considered.

Including or excluding conflicts of interest among expert peer reviewers had little impact on funding success, a case study from Australia

Competition for research funding is intense and the opinions of an expert peer reviewer can mean the difference between success and failure in securing funding. The allocation of expert peer reviewers is therefore vitally important and funding agencies strive to avoid using reviewers who have real or perceived conflicts of interest. This article examines the impact of including or excluding peer reviewers based on their conflicts of interest, and the final ranking of funding proposals. Two 7-person review panels assessed a sample of National Health and Medical Research Council (NHMRC) of Australia proposals in Basic Science or Public Health. Using a pre-post comparison, the proposals were first scored after the exclusion of reviewers with a high or medium conflict, and re-scored after the return of reviewers with medium conflicts. The main outcome measures are the agreements in ranks and funding success before and after excluding the medium conflicts. Including medium conflicts of interest had little impact on the ranks or funding success. The Bland–Altman 95% limits of agreement were ± 3.3 ranks and ± 3.4 ranks in the two panels which both assessed 36 proposals. Overall there were three proposals (4%) that had a reversed funding outcome after including medium conflicts. Relaxing the conflict of interest rules would increase the number of expert reviewers included in the panel discussions which could increase the quality of peer review and make it easier to find reviewers.

Outcomes in gastric and junctional cancer using neoadjuvant and adjuvant chemotherapy (epirubicin, oxaliplatin, and capecitabine) and radical surgery

Background The MAGIC/UK Medical Research Council (MRC) trial set the standard of care for treatment of resectable gastric and junctional adenocarcinoma, demonstrating that perioperative chemotherapy with epirubicin, cisplatin and 5-fluorouracil (ECF) confers a survival benefit over surgery alone. The randomized ECF for advanced and locally advanced esophagogastric cancer (REAL-2) trial showed that, in the metastatic setting, the EOX regimen (epirubicin, oxaliplatin and capecitabine) is as effective as ECF, with a favourable toxicity profile. Methods Consecutive patients with resectable gastric or junctional adenocarcinoma treated with perioperative EOX, between 2007 and 2012, were retrospectively analysed. Results Fifty-nine patients (12 female, 47 male), commenced EOX therapy; 47 underwent surgery. A good pathological response was seen in 34 %, (16/47). Disease recurrence occurred in 19 patients (19/47, 40 %). Median overall survival was 22 months, with 4-year survival of 47 %. Chemotoxicities were consistent with those previously reported for this regimen. Conclusion This study in a high-volume centre demonstrates that EOX in resectable gastric and junctional adenocarcinoma is associated with a reasonable safety profile, and efficacy consistent with that reported for ECF.

Health consequences of exposure to e-waste : a systematic review

Background The population exposed to potentially hazardous substances through inappropriate and unsafe management practices related to disposal and recycling of end-of-life electrical and electronic equipment, collectively known as e-waste, is increasing. We aimed to summarise the evidence for the association between such exposures and adverse health outcomes. Methods We systematically searched five electronic databases (PubMed, Embase, Web of Science, PsycNET, and CINAHL) for studies assessing the association between exposure to e-waste and outcomes related to mental health and neurodevelopment, physical health, education, and violence and criminal behaviour, from Jan 1, 1965, to Dec 17, 2012, and yielded 2274 records. Of the 165 full-text articles assessed for eligibility, we excluded a further 142, resulting in the inclusion of 23 published epidemiological studies that met the predetermined criteria. All studies were from southeast China. We assessed evidence of a causal association between exposure to e-waste and health outcomes within the Bradford Hill framework. Findings We recorded plausible outcomes associated with exposure to e-waste including change in thyroid function, changes in cellular expression and function, adverse neonatal outcomes, changes in temperament and behaviour, and decreased lung function. Boys aged 8–9 years living in an e-waste recycling town had a lower forced vital capacity than did those living in a control town. Significant negative correlations between blood chromium concentrations and forced vital capacity in children aged 11 and 13 years were also reported. Findings from most studies showed increases in spontaneous abortions, stillbirths, and premature births, and reduced birthweights and birth lengths associated with exposure to e-waste. People living in e-waste recycling towns or working in e-waste recycling had evidence of greater DNA damage than did those living in control towns. Studies of the effects of exposure to e-waste on thyroid function were not consistent. One study related exposure to e-waste and waste electrical and electronic equipment to educational outcomes. Interpretation Although data suggest that exposure to e-waste is harmful to health, more well designed epidemiological investigations in vulnerable populations, especially pregnant women and children, are needed to confirm these associations. Funding Children's Health and Environment Program, Queensland Children's Medical Research Institute, The University of Queensland, Australia.

The Australian prehospital pandemic risk perception study and an examination of new public health roles in pandemic response for ambulance services

This report is one of a series of products resulting from a National Health and Medical Research Council (NHMRC) Urgent Research Grant – Pandemic Influenza [No 409973]. The research targeted two key aspects of planning and preparedness for a human influenza pandemic, namely:

Where to after Drink Rite: An evaluation of opportunities for police and community promotion of an anti-drink driving message in the licensed venue setting. Report to the National Drug Strategy Law Enforcement Funding Committee

Estimating the prevalence of drink driving is a difficult task. Self‐reported drink driving indicates that drink driving is far more common than official statistics suggest. In order to promote a responsible attitude towards alcohol consumption and drink driving within the Queensland community, the Queensland Police Service, Queensland Health and Queensland Transport developed the ‘Drink Rite’ program (Queensland Police Service information sheet, 2009). However, the feasibility of the program is now in doubt as the National Health and Medical Research Council’s guidelines for alcohol consumption changed in 2009 to state “For healthy men and women, drinking no more than four standard drinks on a single occasion reduces the risk of alcohol‐related injury arising from that occasion” (NHMRC Publication, 2009, p. 51). As such, adhering to the NHMRC guidelines places restrictions on how the existing Drink Rite program can be operated (i.e. by reducing the number of standard drinks provided to participants from eight to four). It is arguable that a reduction in the number of alcoholic drinks provided to participants in the program will result in a large reduction in observed BAC readings. This, in turn, will lead to a potential loss of message content when discussing the variation in the effects of alcohol.