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Background The patient–clinician interaction is a site at which defensive practice could occur, when clinicians provide tests, procedures and treatments mainly to reduce perceived legal risks, rather than to advance patient care. Defensive practice is a driver of low‐value care and exposes patients to the risks of unnecessary interventions. To date, patient perspectives on defensive practice and its impacts on them are largely missing from the literature. This exploratory study conducted in Australia aimed to examine the views and experiences of healthcare consumer representatives in this under‐examined area. Methods Semi‐structured interviews were conducted with healthcare consumer representatives involved in healthcare consumer advocacy organisations in Australia. Data were transcribed and analysed thematically. Results Nine healthcare consumer representatives participated. Most had over 20 years of involvement and advocacy in healthcare, including personal experiences as a patient or carer and/or formal service roles on committees or complaint bodies for healthcare organisations. Participants uniformly viewed defensive practice as having a negative impact on the clinician–patient relationship. Themes identified the importance of fostering patient–clinician partnership, effective communication and informed decision‐making. The themes support a shift from the concept of defensive practice to preventive practice in partnership, which focuses on the shared interests of patients and clinicians in achieving safe and high‐value care. Conclusion This Australian study offers healthcare consumers' perspectives on the impacts of defensive practice on patients. The findings highlight the features of clinician–patient partnership that will help to improve communication and decision‐making, and prevent the defensive provision of low‐value care. Patient or Public Contribution Healthcare consumer representatives were involved as participants in this study.

Research, policy and practice in the field of interprofessional collaboration have focused on how medical, nursing, allied health and social care practitioners work together to positively impact patient care. This paper extends conceptual thinking about interprofessional practice by focusing on lawyers as part of the interprofessional mix. This attention is prompted by medical���legal partnerships (MLPs), a service model by which lawyers join health care settings to assist patients with unmet, and often health-harming, legal needs. MLPs are present in around 450 hospitals and other health care sites across the United States and the model has spread to other countries, including Australia, the United Kingdom and Canada. However, enthusiasm for the MLP model is not yet matched by good evidence on how, when and for whom the model works. Interprofessional scholars contend that imprecise terminology and poor conceptualization of interprofessional arrangements hinder high-quality research and evaluation. In response to their critiques, this paper formulates a stepwise conceptual framework to guide the design, implementation and study of interprofessional arrangements that connect health, social care and legal practitioners. This framework draws on findings from national surveys of MLP initiatives in several countries and adapts several key conceptual frameworks that have been developed from systematic reviews of interprofessional working in primary health care. These conceptual frameworks are valuable because they promote clarity about different modes of interprofessional working and characterize the factors at macro (policy, funding), meso (organizational) and micro (practitioner, patient) levels that help or hinder professionals from different disciplines in working together. The paper considers factors at these three levels that require particular attention when lawyers join health care settings and proposes questions for future research in this emerging area.

© 2019, © 2019 Taylor & Francis. Enduring powers of attorney (POAs) are commonly used legal instruments that enable older people to plan for asset management in the event of future incapacity. The policy objective of POAs–empowering control over money and property–are frustrated when POAs are misused to financially exploit older people. This commentary integrates theory and evidence to propose a conceptual framework for POA-facilitated financial exploitation (POA-FE). Identified risk factors include inadequate knowledge about the POA role; family conflicts; attitudes of entitlement; and lack of planning and preparation for financial decision-making. POA-FE occurs on a continuum of behavior and strategies for preventing POA-FE are suggested using strengths-based approaches for older people and their attorneys.

Background Defensive practice occurs when physicians provide services, such as tests, treatments and referrals, mainly to reduce their perceived legal or reputational risks, rather than to advance patient care. This behaviour is counter to physicians’ ethical responsibilities, yet is widely reported in surveys of doctors in various countries. There is a lack of qualitative research on the drivers of defensive practice, which is needed to inform strategies to prevent this ethically problematic behaviour. Methods A qualitative interview study investigated the views and experiences of physicians in Australia on defensive practice and its contribution to low value care. Interviewees were recruited based on interest in medico-legal issues or experience in a health service involved in ‘Choosing Wisely’ initiatives. Semi-structured interviews averaged 60 min in length. Data were coded using the Theoretical Domains Framework, which encapsulates theories of behaviour and behaviour change. Results All participants (n = 17) perceived defensive practice as a problem and a contributor to low value care. Behavioural drivers of defensive practice spanned seven domains in the TDF: knowledge, focused on inadequate knowledge of the law and the risks of low value care; skills, emphasising patient communication and clinical decision-making skills; professional role and identity, particularly clinicians’ perception of patient expectations and concern for their professional reputation; beliefs about consequences, especially perceptions of the beneficial and harmful consequences of defensive practice; environmental context and resources, including processes for handling patient complaints; social influences, focused on group norms that encourage or discourage defensive behaviour; and emotions, especially fear of missing a diagnosis. Overall, defensive practice is motivated by physicians’ desire to avoid criticism or scrutiny from a range of sources, and censure from their professional peers can be a more potent driver than perceived legal consequences. Conclusions The findings call for strengthening knowledge and skills, for example, to improve clinicians’ understanding of the law and their awareness of the risks of low value care and using effective communication strategies with patients. Importantly, supportive cultures of practice and organisational environments are needed to create conditions in which clinicians feel confident in avoiding defensive practice and other forms of low value care.

In this article, we advocate the adoption of universal vulnerability as a core value in bioethics. We argue that understanding vulnerability as the universal human condition—and rejecting the labelling of particular individuals or groups as vulnerable—would benefit bioethics and the research it governs. Bioethics first engaged with vulnerability in the context of participation in research and this continues to define how the value is typically understood. Thus, vulnerability is generally deployed to describe individuals (or populations), where real or perceived deficiencies limit the ability to function and to protect themselves from risks. Revisiting this initial context and the participation in research of people living with dementia, we note that the bioethical position of excluding the ‘vulnerable’ from research has led to major gaps in evidence and knowledge to inform care and support. Turning to universal vulnerability, we consider the research design and practices that the approach would mandate. We emphasise the importance of inclusive design and mechanisms of institutional support that enable participation. We argue that these positively impact on the scientific value of research and address social justice concerns around social inclusion. Our aim is to provoke a fundamental reassessment of how vulnerability is conceived of in bioethics.

Background Shortages of skills needed to deliver optimal health care in rural and remote locations raises questions about using extended scopes of practice or advanced practice models in a range of health professions. The nurse practitioner (NP) model was introduced to address health service gaps; however, its sustainability has been questioned, while other extended scope of practice roles have not progressed in Australia. This study aimed to explore the experiences and perceptions of NPs and their colleagues about barriers to and enablers of extended scope of practice and consider the relevance of the findings to other health professions. Methods Semi-structured, in-depth interviews were conducted with primary, nurse practitioner informants, who were also invited to nominate up to two colleagues, as secondary informants. Data analysis was guided by a multi-level, socio-institutional lens of macro-, meso- and micro-perspectives. Results Fifteen primary informants and five colleagues were interviewed from various rural and remote locations. There was a fairly even distribution of informants across primary, aged, chronic and emergency or critical care roles. Key barriers and enablers at each level of analysis were identified. At the macro-level were legal, regulatory, and economic barriers and enablers, as well as job availability. The meso-level concerned local health service and community factors, such as attitudes and support from managers and patients. The micro-level relates to day-to-day practice. Role clarity was of considerable importance, along with embedded professional hierarchies and traditional role expectations influencing interactions with individual colleagues. Given a lack of understanding of NP scope of practice, NPs often had to expend effort promoting and advocating for their roles. Conclusions For communities to benefit from extended scope of practice models of health service delivery, energy needs to be directed towards addressing legislative and regulatory barriers. To be successful, extended scope of practice roles must be promoted with managers and decision-makers, who may have limited understanding of the clinical importance. Support is also important from other members of the interprofessional health care team. Electronic supplementary material The online version of this article (10.1186/s12912-019-0337-z) contains supplementary material, which is available to authorized users.

This study systematically maps empirical research on physicians' views and experiences of hedging-type defensive medicine, which involves providing services (eg, tests, referrals) to reduce perceived legal risks. Such practices drive over-treatment and low value healthcare. Data sources were empirical, English-language publications in health, legal and multi-disciplinary databases. The extraction frame-work covered: where and when the research was conducted; what methods of data collection were used; who the study participants were; and what were the study aims, main findings in relation to hedging-type defensive practices, and proposed solutions. 79 papers met inclusion criteria. Defensive medicine has mainly been studied in the United States and European countries using quantitative surveys. Surgery and obstetrics have been key fields of investiga-tion. Hedging-type practices were commonly reported, including: ordering unnecessary tests, treatments and referrals; suggesting invasive procedures against professional judgment; ordering hospitalisation or delaying discharge; and excessive documentation in medical records. Defensive practice was often framed around the threat of negligence lawsuits, but studies recognised other legal risks, including patient complaints and regulatory investigations. Potential solutions to defensive medicine were identified at macro (law, policy), meso (organisation, profession) and micro (physician) levels. Areas for future research include qualitative studies to investigate the behavioural drivers of defensive medicine and intervention research to determine policies and practices that work to support clinicians in de-implementing defensive, low-value care. (c) 2021 Elsevier B.V. All rights reserved.

Background and Objectives Human research ethics statements support the equitable inclusion of diverse groups. Yet older people are underrepresented in clinical research, especially those with impaired decision-making capacity. The aim of this study was to identify the perspectives and experiences of older persons and their caregivers of research participation with impaired decision-making capacity. Research Design and Methods Scoping review of the literature and online sources in January–February 2019 (updated June 2020) according to Joanna Briggs Institute methodology and PRISMA Extension for Scoping Reviews. English-language peer-reviewed research articles and Australian online narratives were included. Data were tabulated and narratively synthesized. Results From 4,171 database records and 93 online resources, 22 articles (2000–2019, 82% United States, 16 first authors) and one YouTube webinar (2018) were initially included; updated searches yielded an additional article (2020) and YouTube webinar (2020). Studies were heterogeneous in terminology, methods, and foci, with hypothetical scenarios, quantitative analyses, and examination of proxy consent predominating. Participants (N = 7,331) were older persons (71%), caregivers of older persons with dementia/cognitive impairment (23%), and older persons with dementia/cognitive impairment (6%). Synthesis identified 2 themes: willingness to participate and decision-making approaches. Discussion and Implications Research participation by older persons with dementia may be optimized through reducing risks and burdens and increasing benefits for participants, greater consumer input into study development, and shared and supported decision-making. Older persons’ and caregivers’ perspectives and experiences of research participation with impaired decision-making capacity require investigation in a greater range of countries and conditions other than dementia, and dissemination through more varied media.

Advance research directives (ARDs) are a means by which people can document their wishes about research participation in the event of future incapacity. The concept of ARDs emerged in literature in the 1980s and they have since been endorsed in some ethics guidelines and position statements. To date, formal legal recognition is limited. A few empirical studies have investigated the views of researchers and other stakeholders on ARDs and tested strategies to implement such directives. To further knowledge in this area, we undertook a survey of dementia researchers in Australia (n=63) to examine their views on ARDs. Recent law reform initiatives in Australia aim to provide a statutory framework for ARDs and the National Statement on Ethical Conduct in Human Research supports advance research planning, especially for participants who may experience cognitive impairment. Most of the survey respondents (>80%) thought ARDs would promote autonomy in decision-making and enable opportunities for people with cognitive impairment to be included in research. Respondents indicated concern about directives not being available when needed (71%) and that ethics committees would not accept ARDs (60%). Few respondents had used ARDs, but a majority (from 57–80%) would be willing to offer ARDs for a range of research activities, such as observing behaviour, taking measures, accessing records, and taking blood samples or scans. Nearly all respondents (92%) agreed that current dissent should override prior wishes stated in an ARD. The survey findings are contextualised with attention to ethics guidelines, laws and practices to support advance research planning.

This article reports on an elder abuse pilot project that involved legal and health practitioners (n=17) in a regional centre in New South Wales. The aim of the project was to design and test the feasibility and acceptability of a pilot intervention to improve detection and response for older clients at risk of or experiencing various forms of elder abuse. Using a qualitative approach, interviews and focus groups elicited practitioners’ experiences in identifying and responding to elder abuse among their older clients and their views on the use of structured screening processes. Participants reported they mostly encounter situations of financial exploitation and psychological abuse, perpetrated by adult children against older parents. No practitioners reported the use of an elder abuse-specific screening tool, but perceived the benefits of structured screening questions to enable conversations about elder abuse and to support earlier identification of problem situations. Barriers to elder abuse screening included practitioners’ concerns about communication strategies, professional role boundaries, and inadequate response options. Participants supported a ‘triage’ approach with graduated use of screening questions and responses scaled to the immediacy and severity of the problem. Respect for the autonomy of older people was emphasised, along with professionals’ key role in providing advice and resources to empower their older clients. This study applies the contextual theory of elder abuse, which highlights the individual, relational, community and societal contexts in which abuse occurs and can be identified, mitigated and prevented. Investigation of the role and perspectives of legal and health professionals helps to further develop this contextual theory.

Background In 2014, Alberta’s health service providers implemented a province-wide Advance Care Planning (ACP) and Goals of Care Designation policy. Despite significant efforts, barriers to full implementation remain including lack of public comprehension across health, legal and other public systems. A World Cafe consultation revealed multi jurisdictional recommendations to ‘normalize ACP.’ Methods Through the ACP Collaborative Research Innovation Opportunities program, we formed a collaboration with lawyers, Legal Education Society of Alberta, Canadian Bar Association, Law Society of Alberta, palliative care physicians, patient advocates, academics, provincial health care providers and other stakeholders. A community of practice propagated spontaneously. Surveys and focus groups identified barriers, knowledge and resource gaps, and novel solutions, including joint health-legal education. Results Traditional approaches to ACP have been siloed. We expand on the innovative medico-legal framework to include other stakeholders including community agencies, faith groups, health advocacy agencies, national ACP projects, and the financial planning and insurance industries. Ongoing collaborative activities include community engagement, education, policy and practice innovation, which bundles activities relating to health care planning with those relating to personal and financial planning. Our business case addresses the identified gaps and adopts public recommendations through activities to coordinate, integrate and/or support development/implementation of a community volunteer program, an electronic registry for ACP and Goals of Care documentation, and a legal toolkit. Conclusion In practice, ACP spans medical, legal, social and personal domains. Multi-disciplinary and multi-sector approaches are posited to improve knowledge and uptake of ACP while improving the quality of life of Albertans.

© 2019 Elsevier Ltd People with dementia are under-represented in clinical research, in part due to the ethical and legal complexities of involving people in studies who may lack capacity to consent. Excluding this population from research limits the evidence to inform care. The attitudes and practices of researchers are key to the inclusion of people with dementia in research, however, there are few empirical studies on researchers' perspectives in this area. A cross-sectional study involved researchers in Australia who had experience in the ethical aspects of conducting dementia-related studies with human participants (n = 70). Data were collected via an online survey from November 2017 to January 2018. Most respondents (97%) agreed with the importance of including people at all stages of dementia in research, yet around three-quarters of respondents perceived ethical and legal rules and processes as unduly restrictive or time-consuming. Researchers reported variable practices in assessing prospective participants' capacity to consent to their studies. Various tools are used for this purpose, ranging from tools designed for research (eg, MacArthur Competence Assessment Tool for Clinical Research) to more general cognitive function screens (eg, Mini Mental State Exam). Few respondents (14%) routinely exclude people from studies who are unable to give their own consent, but instead seek permission from proxy decision-makers, such as legally appointed guardians or family carers. Respondents reported positive and negative outcomes of ethics review processes. Positive outcomes included strengthening the protections for participants with cognitive impairment while negative outcomes included delays and inconsistent decisions from different ethics committees. The findings suggest a need for improved strategies in the research context to assess and enhance the decision-making capacity of people with dementia to support appropriate opportunities for inclusion. Education for ethics committees, proxy decision-makers and other gatekeepers is also needed to reduce barriers to participation in research.

© 2019, Journal of Bioethical Inquiry Pty Ltd. People with dementia have commonly been excluded from research. The adverse impacts of this exclusion are now being recognized and research literature, position statements, and ethics guidelines increasingly call for inclusion of people with dementia in research. However, few published studies investigate the views of potential participants on taking part in research should they experience dementia-related cognitive impairment. This cross-sectional survey examined the views of people aged sixty and older (n=174) attending hospital outpatient clinics about clinical research participation if they had dementia and impaired decision-making ability. Over 90 percent of respondents were agreeable to participating in a wide range of research activities, such as cognitive testing, physical measurements, imaging procedures, and blood draws. For drug studies, however, agreement dropped to 60 percent. Altruism was a strong motivator for research participation. In regard to who should be involved in decisions about their participation in research during periods of incapacity, respondents mostly preferred the person they appoint as their substitute decision-maker for healthcare matters (88%) or a doctor or health professional on the research team (78%). Over three-quarters (79%) expressed interest in making an advance research directive. The study findings are discussed in relation to law reforms in Australia that aim to strengthen respect and inclusion for people with impaired decision-making capacity, especially by providing frameworks for advance planning for research participation.

Legal education traditionally focuses on domestic law, but a major shift is underway to internationalize the law school curriculum with the aim of developing twenty-first-century lawyers as global lawyers. This chapter first identifies important contextual factors influencing Australian law schools to incorporate overseas work and study immersion courses into the curriculum. Second, it presents a case study and proposed evaluation of internationalization initiatives at the University of Newcastle Law School, New South Wales, focused on overseas work-integrated learning and intensive study trips in the Asia–Pacific region. Third, the chapter concludes with reflections on the opportunities and challenges from the perspective of legal educators who must develop their own intercultural competence and navigate new ways of working with overseas service providers and academic institutions.

© 2018 The Author(s). Background: Advance personal planning is the process by which people consider, document and communicate their preferences for personal, financial and health matters in case they lose the ability to make decisions or express their wishes in the future. Discussion: Advance personal planning is most often undertaken by individuals who are seriously ill, often in the context of a medical crisis and/or at the time of admission to hospital. However, the clinical utility and legal validity of the planning process may be compromised in these circumstances. Patients may lack sufficient capacity to meaningfully engage in advance personal planning; there may be insufficient time to adequately reflect on and discuss wishes with key others; and there may also be limited opportunity for inter-professional input and collaboration in the process. Here, we propose an agenda for research to advance the science of advance personal planning by promoting a 'whole community' approach. Adoption of advance personal planning at a community level may be achieved using a variety of strategies including public media campaigns, intervening with professionals across a range of health care and legal settings, and mobilising support from influential groups and local government. One potentially promising method for encouraging earlier adoption of advance personal planning among a broader population involves a community action approach, whereby multiple evidence-based strategies are integrated across multiple access points. Community action involves calling on community members, professionals, community and/or government organisations to work collaboratively to design and systematically implement intervention strategies with the aim of bringing about desired behaviour change. An example of a community action trial to improving uptake and quality of advance personal planning is described. Conclusion: While promising, there is a need for rigorous evidence to demonstrate whether a community action approach is effective in establishing whole community adoption of advance personal planning.

Advance care planning (ACP) is the process of thinking about, discussing and documenting one’s preferences for future health care. ACP has important benefits: people who have a written directive are more likely to receive care that accords with their preferences, have fewer hospitalizations, and die in their preferred location. This article focuses on the important role that legal professionals have in advising and assisting clients with ACP. Studies report that people who have a written advance care plan are more likely to have received assistance in preparing the document from a lawyer than from a doctor. Yet virtually no research engages with the legal profession to understand lawyers’ attitudes, beliefs, and practices in this important area. This article starts to fill this gap by reporting the findings of a survey of lawyers in the province of Alberta. The results reveal lawyers’ practices in relation to ACP, their perceptions of their professional role and factors that support or hinder lawyers in working with clients on ACP, and their preferences for resources to assist them in helping their clients. To the authors’ knowledge, this is the first survey of lawyers on their practices in relation to ACP.

Background: There are growing calls for elder abuse screening to be conducted by a range of community-based service providers, including general practitioners (GPs), practice nurses, home care workers and lawyers. Improved screening may be a valuable first step towards improving elder abuse detection and response; however, practitioners need evidence-based strategies for screening and follow-up. Objective: This article summarises several brief screening tools for various forms of elder abuse. Screening tool properties and evidence gaps are noted. As elder abuse often requires multidisciplinary responses, initiatives to connect health, legal and other service providers are highlighted. Discussion: GPs are trusted professionals who are well placed to identify older patients at risk of, or experiencing, various forms of abuse. They should be aware of available screening tools and consider how best to incorporate them into their own practice. They also play an important role in multidisciplinary action to address elder abuse.

© 2018 Informa UK Limited, trading as Taylor & Francis Group. Elder abuse is a serious and under-detected problem. Law reform agencies and legal profession regulatory authorities have called for action to ensure that lawyers meet their ethical obligations to older clients, including identifying and acting on risk factors for abuse. Screening tools to detect situations of elder abuse exist, but they are targeted mainly at health and social care practitioners. Drawing on international literature, this article identifies and discusses screening tools that could be adapted for use by legal professionals. Three general categories of screening are relevant for lawyers who serve older clients: (1) elder abuse screening tools that cover all domains of abuse or target specific behaviours, such as financial exploitation; (2) screening for decision-making capacity, especially taking account of the impact of abuse or neglect on capacity; and (3) screening to probe the suitability of a person to act in a formal decision-making role for an older person. The article emphasises the importance of implementing screening processes and follow-up actions in a manner that fosters a therapeutic relationship between the older client and the lawyer. It concludes with recommendations for further research in this important area.

Many factors affect whether and how practitioners from different professions work together to deliver healthcare services. In a recent review, Mulvale, Embrett, and Razavi (2016) identified 18 fact...

Genetic information is widely recognised as being particularly sensitive personal information about an individual and his or her family. This article presents an analysis of the privacy policies of Australian companies that were offering direct-to-consumer genetic testing services in 2012–13. The results of this analysis indicate that many of these companies do not comply with the Privacy Act 1988 (Cth), and will need to significantly reassess their privacy policies now that significant new amendments to the Act have come into force. Whilst the Privacy Commissioner has increased powers under the new amendments, the extent to which these will mitigate the deficiencies of the current regime in relation to privacy practices of direct–to-consumer genetic testing companies remains unclear. Accordingly, it may be argued that a privacy code for the direct-to-consumer genetic testing industry would provide clearer standards. Alternatively it may be time to rethink whether a sui generis approach to protecting genetic information is warranted.

A review of the key issues associated with the commercialization of biobanks Timothy Caulfield∗, Sarah Burningham, Yann Joly, ZubinMaster, Mahsa Shabani, Pascal Borry, Allan Becker, Michael Burgess, Kathryn Calder, Christine Critchley, Kelly Edwards, Stephanie M. Fullerton, Herbert Gottweis, Robyn Hyde-Lay, Judy Illes, Rosario Isasi, Kazuto Kato, Jane Kaye, Bartha Knoppers, John Lynch, AmyMcGuire, Eric Meslin, Dianne Nicol, Kieran O’Doherty, Ubaka Ogbogu, Margaret Otlowski, Daryl Pullman, Nola Ries, Chris Scott, Malcolm Sears, HelenWallace andMa’n H. Zawati†

The author reviews recent changes in legislation in Canada and abroad in the area of patient privacy. consent and electronic health records (EHRs). In her overview of Canadian legislation, she examines the existing patchwork of legal requirements, as well as ethical obligations governing health information and policy initiatives aimed at harmonizing approaches across Canada. Internationally, the United Kingdom and Australia are reviewed on how those jurisdictions are addressing the issue of protecting patient privacy while developing operable EHR schemes. The author concludes that as EHR schemes develop, stringency of privacy and consent protections will likely wane in favour of establishing workable systems and. as a consequence, appropriate security mechanisms should be implemented to safeguard personal information.

© 2017, Journal of Bioethical Inquiry Pty Ltd. Research is crucial to advancing knowledge about dementia, yet the burden of the disease currently outpaces research activity. Research often excludes people with dementia and other cognitive impairments because researchers and ethics committees are concerned about issues related to capacity, consent, and substitute decision-making. In Australia, participation in research by people with cognitive impairment is governed by a national ethics statement and a patchwork of state and territorial laws that have widely varying rules. We contend that this legislative variation precludes a consistent approach to research governance and participation and hinders research that seeks to include people with impaired capacity. In this paper, we present key ethical principles, provide a comprehensive review of applicable legal rules in Australian states and territories, and highlight significant differences and ambiguities. Our analysis includes recommendations for reform to improve clarity and consistency in the law and reduce barriers that may exclude persons with dementia from participating in ethically approved research. Our recommendations seek to advance the national decision-making principles recommended by the Australian Law Reform Commission, which emphasize the rights of all adults to make their own decisions and for those with impaired capacity to have access to appropriate supports to help them make decisions that affect their lives.

Interprofessional collaboration in healthcare describes a model of practice where multiple health professionals work together in a team-based approach to patient care. A growing body of literature demonstrates that interprofessional collaboration advances healthcare quality and safety, improves patient outcomes and experiences of care, and promotes job satisfaction among health professionals. Governments and health organisations across Canada are working to advance interprofessional healthcare delivery. This paper examines the importance of law in supporting a shift to interprofessional collaboration in Canadian healthcare and discusses two key aspects of the legal context in which health practitioners work. First, the paper discusses trends in the legal regulation of health professions in Canada, including law reform initiatives aimed at promoting collaborative practice and expanding scopes of practice to break down the historically siloed approach to healthcare delivery. Second, the papers examines civil liability rules that courts apply when allegations of negligence are made against health care providers working in team-based situations. New legislative models that provide for expanded and overlapping scopes of practice, and which introduce new professional roles into the health workforce, may raise legal concerns regarding responsibility for patient care and outcomes. The paper illustrates how legal innovations, such as new models of health profession regulation, and legal adaptability, through judicial understanding of the modern context of health service delivery, are important to the advancement of interprofessional collaboration in Canadian healthcare.

As US President Barack Obama noted in his 2015 State of the Union address, precision medicine promises to deliver ‘the right treatments, at the right time, every time to the right person’ which ‘gives us one of the greatest opportunities for new medical breakthroughs that we have ever seen’.1 These comments were a prelude to a $215 million funding commitment by the President to his Precision Medicine Initiative, the aim of which is to ‘pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients’.2 The objectives include an undertaking to modernize the current regulatory landscape.

Objectives: The A/H1N1 mass vaccination program in Canada garnered considerable attention from the media, including extensive newspaper coverage. Media reports have been shown to influence the public’s health care decisions, including vaccination choices. We analyzed Canadian newspapers’ portrayal of the A/H1N1 vaccine including mention of risks and benefits of the vaccine and whether the article supported, questioned or was neutral about the vaccine. Methods: We compiled a data set of Canadian newspaper articles (N=234) and conducted a frequency content analysis to examine discussion and/or mention of evidence concerning vaccination, risks of the A/H1N1 virus and the vaccine, and tone of article in regards to the vaccination program in Canada. Results: Reasons for getting vaccinated appeared in 71.8% of the articles, whereas only 18.4% provided reasons against getting vaccinated. Discussion of evidence to support claims for or against getting vaccinated appeared in only 27.8% and 6.8% of the articles, respectively. Risks associated with contracting the A/H1N1 virus were discussed in 49.6% of the articles and risks of the A/H1N1 vaccine were discussed in 12.4% of the articles. Conclusion: Newspaper coverage in Canada was largely supportive of the A/H1N1 mass vaccination program. However, serious risks associated with contracting the A/H1N1 virus were also frequently discussed in the print media. The news articles rarely presented direct evidence to support statements that the vaccine was safe, effective and properly tested. Known risks (such as potential allergic reactions and flu-like side effects) of the vaccine were rarely reported. The relationship between media portrayals and vaccine uptake warrants further research. Key words: Newspapers; influenza vaccines; Canada

This article analyzes the content of articles in major newspapers in the United States, Canada, and the United Kingdom that discuss legislative and policy measures to control obesity. The aim was to identify and compare measures that attract media attention in the three jurisdictions: the tone of print media coverage, the characterization of obesity, and attitudes toward government interventions to address obesity. We collected 360 articles published between January 1989 and April 2009 in 12 major newspapers: 83 were published in the United States, 85 in Canada, and 192 in the United Kingdom. Articles in the three jurisdictions discussed the nature and causes of obesity in similar terms, but revealed differences in attitudes toward obesity and toward legal and policy interventions to control rising obesity rates. Obesity is reported principally as a lifestyle problem, but articles state (in varying proportions) that individuals, governments, and industry all share a role in addressing modern environments to promote healthier choices.

Nutritional genomics has reached the public through applications of the Human Genome Project offered direct to consumers (DTC). The ability to pursue nutrigenetic testing without the involvement of a health care professional has received considerable attention from academic and policy commentators. To better understand the knowledge and attitudes of Canadian health care professionals regarding nutritional genomics and nutrigenetic testing, qualitative research in the form of focus group discussions was undertaken. Four key themes emerged: (1) concerns over DTC testing; (2) lack of health care professional competency; (3) genetic scepticism and inevitability; (4) expectation of regulation. Together, they indicate that health care professionals have little knowledge about nutritional genomics and hold contradictory attitudes towards genomics in general, and to nutritional genomics in particular. Respondents argue in favour of a delivery model where health care professionals act as intermediaries. They are also aware of their lack of competency to provide such services. To ensure greater public protection, respondents cite the importance of more stringent regulatory oversight of DTC genetic testing. Whether such an approach is necessary to address the various ethical and social issues raised by nutrigenetic testing remains an open debate.

Modern environments promote overeating and sedentary behaviour, and the resulting epidemic of chronic disease is a major public health challenge of the early 21st century. Governments and experts around the world are sounding the alarm about the medical, economic and social costs of escalating rates

A wide variety of genetic tests are now being marketed and sold in direct-to-consumer (DTC) commercial transactions. However, risk information revealed through many DTC testing services, especially those based on emerging genome wide-association studies, has limited predictive value for consumers. Some commentators contend that tests are being marketed prematurely, while others support rapid translation of genetic research findings to the marketplace. The potential harms and benefits of DTC access to genetic testing are not yet well understood, but some large-scale studies have recently been launched to examine how consumers understand and use genetic risk information. Greater consumer access to genetic tests creates a need for continuing education for health care professionals so they can respond to patients' inquiries about the benefits, risks and limitations of DTC services. Governmental bodies in many jurisdictions are considering options for regulating practices of DTC genetic testing companies, particularly to govern quality of commercial genetic tests and ensure fair and truthful advertising. Intersectoral initiatives involving government regulators, professional bodies and industry are important to facilitate development of standards to govern this rapidly developing area of personalized genomic commerce.

A growing variety and number of genetic tests are advertised and sold directly to consumers (DTC) via the Internet, including nutrigenomic tests and associated products and services. Consumers have more access to genetic information about themselves, but access does not entail certainty about the implications of test results. Potential personal and public health harms and benefits are associated with DTC access to genetic testing services. Early policy responses to direct-to-consumer (DTC) genetic testing often involved calls for bans, and some jurisdictions prohibited DTC genetic tests. Recent policy responses by oversight bodies acknowledge expansion in the range of DTC tests available and suggest that a "one-size-fits-all" regulatory approach is not appropriate for all genetic tests. This review discusses ethical and regulatory aspects of DTC genetic testing, focusing particularly on nutrigenomic tests. We identify policy options for regulating DTC genetic tests, including full or partial prohibitions, enforcement of existing truth-in-advertising laws, and more comprehensive information disclosure about genetic tests. We advocate the latter option as an important means to improve transparency about current evidence on the strengths and limits of gene-disease associations and allow consumers to make informed purchasing decisions in the DTC marketplace.

A national survey investigated the current practices of reprocessing and reusing single-use medical devices in Canadian acute-care hospitals. Our response rate was 72% (413 responses), and 28% of hospitals reprocess single-use devices. The results showed that Canadian hospital practices have not changed much in the past decade.

This commentary addresses some of the key legal challenges associated with establishing a national public health agency in Canada. These include issues related to privacy and confidentiality of personal health information in the public health context, constraints on the jurisdiction and powers of a national agency, the need to respect individual rights and freedoms in an outbreak situation, and international cooperation in infectious disease control. The authors are part of a research initiative, comprised of experts in law, public health policy and medicine, that is currently analyzing legal considerations that may influence the mandate of a national public health agency in regard to infectious disease activities. This article discusses critical issues raised at a meeting in August 2004 that brought the research team together with key federal and provincial policy-makers and members of the public health community. The commentary emphasizes that law sets the foundation for public health activities, and the promise of a national public health agency will only be realized if significant legal issues are examined early on to ensure the agency is built on a robust legal and policy framework.

Many studies examining several aspects of multi-institutional research ethics review and the opinions of different stakeholders show the current process to be resource intensive and inefficient. We discuss the experiences and opinions of individual Canadian allergy/asthma researchers engaged in multi-centre research and find that most researchers are dissatisfied, perceive the process as ineffective, and strongly desire some type of reform. These results highlight the tension between efficiency in research ethics review and the effective protection of subjects. Harmonization initiatives and alternate review strategies are being implemented throughout Canada and should help increase efficiency while not compromising the protection of research subjects. With time, evidence gathered from empirical studies that evaluate these new strategies will help determine the effectiveness of the various reform strategies for multi-site ethics review.

Background: The environment is suspected to play an important role in the development of childhood asthma. Cohort studies are a powerful observational design for studying exposure–response relationships, but their power depends in part upon the accuracy of the exposure assessment. Objective: The purpose of this paper is to summarize and discuss issues that make accurate exposure assessment a challenge and to suggest strategies for improving exposure assessment in longitudinal cohort studies of childhood asthma and allergies. Data synthesis: Exposures of interest need to be prioritized, because a single study cannot measure all potentially relevant exposures. Hypotheses need to be based on proposed mechanisms, critical time windows for effects, prior knowledge of physical, physiologic, and immunologic development, as well as genetic pathways potentially influenced by the exposures. Modifiable exposures are most important from the public health perspective. Given the interest in evaluating gene–environment interactions, large cohort sizes are required, and planning for data pooling across independent studies is critical. Collection of additional samples, possibly through subject participation, will permit secondary analyses. Models combining air quality, environmental, and dose data provide exposure estimates across large cohorts but can still be improved. Conclusions: Exposure is best characterized through a combination of information sources. Improving exposure assessment is critical for reducing measurement error and increasing power, which increase confidence in characterization of children at risk, leading to improved health outcomes.

Background Research involving minors has been the subject of much ethical debate. The growing number of longitudinal, pediatric studies that involve genetic research present even more complex challenges to ensure appropriate protection of children and families as research participants. Long-term studies with a genetic component involve collection, retention and use of biological samples and personal information over many years. Cohort studies may be established to study specific conditions (e.g. autism, asthma) or may have a broad aim to research a range of factors that influence the health and development of children. Studies are increasingly intended to serve as research platforms by providing access to data and biological samples to researchers over many years. This study examines how six birth cohort studies in North America and Europe that involve genetic research handle key ethical, legal and social (ELS) issues: recruitment, especially parental authority to include a child in research; initial parental consent and subsequent assent and/or consent from the maturing child; withdrawal; confidentiality and sample/data protection; handling sensitive information; and disclosure of results. Methods Semi-structured telephone interviews were carried out in 2008/09 with investigators involved in six birth cohort studies in Canada, Denmark, England, France, the Netherlands and the United States. Interviewees self-identified as being knowledgeable about ELS aspects of the study. Interviews were conducted in English. Results The studies vary in breadth of initial consent, but none adopt a blanket consent for future use of samples/data. Ethics review of new studies is a common requirement. Studies that follow children past early childhood recognise a need to seek assent/consent as the child matures. All studies limit access to identifiable data and advise participants of the right to withdraw. The clearest differences among studies concern handling of sensitive information and return of results. In all studies, signs of child abuse require reports to authorities, but this disclosure duty is not always stated in consent materials. Studies vary in whether they will return to participants results of routine tests/measures, but none inform participants about findings with unknown clinical significance. Conclusions Analysis of how cohort studies in various jurisdictions handle key ELS issues provides informative data for comparison and contrast. Consideration of these and other examples and further scholarly exploration of ELS issues provides insight on how best to address these aspects in ways that respect the well-being of participants, especially children who become research subjects at the start of their lives.

Natural health products such as herbs, vitamins and homeopathic medicines are widely available in Canadian pharmacies. Purpose: to conduct a systematic analysis of Canadian pharmacy policies and guidelines to explore pharmacists’ professional responsibilities with respect to natural health products. Methods: Legislation, codes of ethics, standards of practice and guidance documents that apply to the practice of pharmacy in each Canadian jurisdiction were systematically collected and examined to identify if, and how, these instruments establish professional duties in regard to natural health products. Results: The majority of Canadian jurisdictions now include some explicit reference to natural health products in standards of practice policy or guideline documents. Often natural health products are simply assumed to be included in the over-the-counter (OTC) product category and thus professional responsibilities for OTCs are relevant for natural health products. A minority of provinces have specific policies on natural health products, herbals or homeopathy. In addition, the National Association of Pharmacy Regulatory Authorities’ Model Standards of Practice specifically refers to natural health products. Most policy documents indicate that pharmacists should inquire about natural health product use when counselling patients and, when asked, should provide accurate information regarding the efficacy, toxicity, side effects or interactions of natural health products. Public messaging also indicates that pharmacists are knowledgeable professionals who can provide evidence-based information about natural health products. Conclusions: Explicit policies or guidelines regarding pharmacists’ professional responsibilities with respect to natural health products currently exist in the majority of Canadian jurisdictions. Los productos sanitarios naturales, tales como las plantas medicinales las vitaminas y los medicamentos homeopáticos están ampliamente disponibles en las farmacias canadienses. Objetivo: Realizar un análisis sistemático de las políticas y guías farmacéuticas canadienses para explorar las responsabilidades profesionales de los farmacéuticos con respecto a los productos sanitarios naturales. Métodos: Se recopilaron y analizaron sistemáticamente los códigos de ética, los estándares de práctica y las guías que son de aplicación al ejercicio de la farmacia en cada jurisdicción canadiense para identificar si, y como, establecían deberes profesionales en relación a los productos sanitarios naturales. Resultados: La mayoría de las jurisdicciones canadienses actualmente incluyen alguna referencia explícita a los productos sanitarios naturales en los estándares de práctica, políticas o guías. A menudo se asume que los productos sanitarios naturales están incluidos en la categoría de productos over-the-counter (OTC) así que las responsabilidades profesionales para los ORC son de aplicación para los productos sanitarios naturales. Una minoría de provincias tiene políticas específicas sobre productos sanitarios naturales, plantas medicinales u homeopatía. Además, los estándares de práctica de la Asociación Nacional de Autoridades Regulatorias de la Farmacia se refieren a los productos sanitarios naturales. La mayoría de las políticas indican que los farmacéuticos deberían preguntar sobre el uso de los productos sanitarios naturales cuando aconsejan a los pacientes y, cuando se les pregunte, deberían proporcionar información precisa sobre eficacia, toxicidad, efectos adversos o interacciones de los productos sanitarios naturales. La publicidad también indica que los farmacéuticos son profesionales expertos que pueden proporcionar información basada en la evidencia sobre los productos sanitarios naturales. Conclusiones: Actualmente existen en la mayoría de las jurisdicciones canadienses políticas explícitas o guías sobre la responsabilidad profesional de los farmacéuticos con respecto a los productos sanitarios naturales.

The factors that affect health status and the development of disease are complex and multi-factorial. Understanding the causes, treatment and prevention of disease requires methods that allow the exploration of a wide range of variables. As a result, there is a trend in the health research community toward large, multi-site interdisciplinary research projects – such as longitudinal cohort studies that include the collection of personal information and, increasingly, biological samples, from participants. This type of multi-site research raises numerous ethical and legal issues, including a need for a research ethics board (REB) review at multiple institutions and a need to understand and comply with applicable legislation in each jurisdiction. The collection, long-term retention, and use of personal information and biological samples raise concerns about consent for continuing use of information and samples and the need for robust data/sample handling and security protocols.

Health organizations in canada have invested considerable resources in strategies to improve knowledge and uptake of advance care planning (acp). Yet barriers persist and many canadians do not engage in the full range of acp behaviours, including writing an advance directive and appointing a legally authorized decision-maker. not engaging effectively in acp disadvantages patients, their loved ones and their healthcare providers. This article advocates for greater collaboration between health and legal professionals to better support clients in acp and presents a framework for action to build connections between these typically siloed professions.

The authority to quarantine individuals was tested by the 2003 global outbreak of SARS. Quarantine was used during that lime as a public health intervention tool to attempt to control the disease in Toronto. The outbreak put the public health preparedness of the Ontario legal system to the test. This article examines the legal issues related to the use of quarantine as a tool to control infectious disease outbreaks using the Ontario SARS epidemic as a case study. The author first analyzes the laws authorizing public health officials to use quarantine and then identifies the legislative gaps that SARS exposed in these laws. The article then looks at the current legislative reform efforts to create a more prepared legal environment in the event of another public health crisis such as SARS. In addition, the impact of quarantine on an individual and his or her family, including social and economic impacts, as well as its effect on the health care system is discussed. Finally, the legal limits on the use of quarantine are further examined. The author concludes that, because it is likely that a novel infectious agent such as SARS will surface in the future, the public health authorities must be vigilant by ensuring public health legal preparedness.