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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 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.

Objectives Doctors’ fear of legal liability and defensive practices are commonly cited as drivers of low value care. Defensive practices involve ordering tests and procedures, making referrals, and prescribing drugs to reduce perceived legal risks, rather than to advance patient care. Survey data report that defensive medicine is prevalent in countries across the world and significantly contributes to health care costs. This project aimed to understand psychosocial drivers and features of defensive practice. Methods Qualitative research with three groups of participants with medico-legal expertise purposively recruited from: (1) medical defence organisations/indemnity insurers, (2) medical colleges and societies and (3) peak healthcare consumer organisations, in Australia. Around 10 participants will be interviewed in each group (n=30–35 in total) using a semi-structured interview schedule grounded in the Theoretical Domains Framework of behavior change. The interview elicits participant’s views on e.g. drivers of defensive practice and low value care; barriers to and enablers of high value care; medical practices that are highly defensive (ie, driven mostly by legal fear); and potential interventions to address these problems. Interviews are audio-recorded, transcribed, and analysed thematically using Framework Analysis. Results Note that recruitment and interviews are ongoing at the time of abstract submission but will be completed in time for the conference. So far we have conducted 5 interviews of around 60 minutes each. Initial findings reveal that participants perceive defensive practice as a persistent problem, with drivers of low value care identified at the patient, clinician and policy level. According to the participants, strategies to reduce defensive practice should address factors such as: clinicians’ lack of knowledge of legal risks and responsibilities; challenges around doctor-patient communication and shared decision-making; and intolerance of uncertainty. Several participants emphasised the need for clinical leadership in this area and the importance of senior, respected clinicians setting examples and sending messages about avoiding defensive practice. Conclusions Defensive practice is driven by a complex constellation of factors. Our results so far suggest that interventions to address this problem should focus on promoting clinicians’ knowledge of legal duties and risks, enhancing their communication skills and changing their behaviour with the help of role models and peer support.

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.

Objectives Clinicians’ fear of legal liability and defensive practice are commonly cited as drivers of low value care. Defensive practice involves ordering tests and procedures, making referrals, and prescribing drugs mainly to reduce perceived legal risks, rather than to advance patient care. Literature on defensive practice dates back to the 1980s but has never been systematically analysed. We conducted the first-ever mapping review of published empirical studies on defensive practice. Methods We searched SCOPUS, Academic Search Complete (EBSCO), HeinOnline and Ovid MEDLINE with no restrictions. Two authors independently screened and extracted data using EPPI Reviewer software. We extracted data on: year of publication; country of study; study setting (eg, general practice clinic, emergency department); population studied (eg, GPs, surgeons); method of data collection (eg, survey, interview, record audits); and disciplinary affiliation of investigators (eg, medicine, law, economics). We also extracted key findings on the types of defensive practice reported, drivers of this behaviour, and proposed solutions. Results A total of 67 studies met our inclusion criteria. Most empirical studies on defensive practice have been done in the United States (28 out of 67), by medical researchers using quantitative surveys of clinicians, especially general practitioners, obstetricians and psychiatrists. Research activity on defensive practice intensified markedly from 2011 to present, with an increase in studies outside the US. This timing coincides with the expansion of international campaigns, such as Choosing Wisely, that promote appropriate care. Ordering unnecessary tests was the most commonly reported defensive practice. In addition to fear of legal liability, the culture of medicine and patient expectations were identified as drivers of low value care that can lead to overdiagnosis and overtreatment. Proposed solutions included ameliorating clinicians’ ‘existential anxiety’ about medico-legal risk and reducing ‘blame culture’ through system-level changes. Conclusions Available empirical data on defensive practice is limited by the predominant focus on the American medico-legal context. Caution is needed in applying these data to other countries with differing healthcare and legal systems. More qualitative research is needed to explore the behavioural drivers of defensive practice and potential solutions to legal fears that contribute to overdiagnosis and overtreatment. Our Australian research is a step toward filling this gap.

© 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.

© 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.

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...

Living with mental health challenges can result in a greater likelihood of using psychoactive substances at harmful levels, while in some people substance use can trigger mental health symptoms or conditions. In addition to diagnostic and treatment complexities, people experiencing mental health-substance use problems (MHSU), their family and health professionals, as well as researchers, policy and law makers and law enforcement workers are frequently faced with dilemmas involving competing beliefs, values, priorities, policies, and laws. For many health professionals and services, diagnosis is an integral part of the process of assessment with the view to treatment. The creation and use of employee assistance programs that are contracted out to private mental health professionals otherwise unconnected to the employing organisation is one way to address confidentiality concerns. In regard to MHSU, any existing or proposed intervention - including legislation, funding allocations to programs, treatment options - can be scrutinised to ask whether it does or is likely to produce healthier outcomes.

The provision of unnecessary healthcare is a serious problem in Australia and involves two key legal issues. First, doctors’ fear of litigation drives defensive practices – ordering tests and procedures, making referrals, and prescribing drugs to reduce perceived legal risks, rather than to advance patient care. Second, suboptimal communication and decision making processes undermine a patient’s right to make informed healthcare choices. This article critically analyses these problems and proposes solutions. An extensive body of medico-legal literature is synthesised to highlight gaps between legal requirements and what happens in practice. Negligence case law is discussed to clarify legal principles and show that courts discourage defensive practice. Finally, the article presents practical strategies to enhance communication and shared decision making in the clinical encounter.

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.

Objectives:The aim of this study was to assess the evidence that reuse of medical devices marketed for single use only (SUDs) is safe, effective and cost-effective, and to consider the use and health services impact of this practice in Canada.Methods:A systematic review was performed of studies that reported clinical or economic outcomes following reuse of SUDs in humans. Direct costs of adverse health events associated with SUD reuse and indications of budget impact were obtained using data for devices for laparoscopic cholecystectomy and coronary angioplasty. Legal and ethical issues were reviewed, drawing on material relevant to Canada. Data on current reuse of SUDs were obtained through a survey of Canadian acute care hospitals.Results:Studies of variable quality suggested that SUD reuse could be safe and effective, and would give cost savings, if there were no adverse events. Eliminating reuse of SUDs for laparoscopic cholecystectomy and coronary angioplasty would add less than 0.1 percent to costs of the procedures over 1 year. Adverse health events associated with device reuse create liability risks; patients should be informed of any known or foreseeable risks of reuse. Most of the 28 percent (111/398) of acute hospitals that reprocess SUDs do so in-house. Some do not have a written policy or an incident reporting mechanism.Conclusions:There is insufficient evidence to establish the safety, efficacy and cost-effectiveness of reusing SUDs. Legal and ethical issues require attention to minimize liability and maintain patient safety and trust. Some hospitals that reprocess SUDs do not have adequate documentation. These findings do not support the reuse of SUDs in Canadian hospitals.

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 chapter discusses key legal issues raised by the contemporary trend to managing and sharing patient information via electronic health records (EHR). Concepts of privacy, confidentiality, consent, and security are defined and considered in the context of EHR initiatives in Canada, the United Kingdom, and Australia. This chapter explores whether patients have the right to withhold consent to the collection and sharing of their personal information via EHRs. It discusses opt-in and opt-out models for participation in EHRs and concludes that presumed consent for EHR participation will ensure more rapid and complete implementation, but at the cost of some personal choice for patients. The reduction in patient control over personal information ought to be augmented with strong security protections to minimize risks of unauthorized access to EHRs and fulfill legal and ethical obligations to safeguard patient information.

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.

Publisher Summary This chapter crystallizes the diverse content in a set of recommendations that provide future direction for the field of nutrigenomics. These recommendations are derived from an analysis about the most important issues in the current cycle of nutrigenomics and focus on the topics such as science, ethics, law, regulation, and communication. This chapter deals with developing and translating nutrigenomic science, regulating nutrigenomic tests and health claims, and communicating to the public. The ultimate goal of nutrigenomics is frequently described as the ability to give genetics-based advice to people so they can alter their diet and other lifestyle factors to prevent or mitigate chronic disease. Nutrigenomics applications presently focus on providing health benefits to proactive individuals.

Publisher Summary This chapter discusses direct-to-consumer (DTC) advertising and sale of genetic tests, specifically nutrigenetic tests that claim to identify genetic variations thought to affect nutrient metabolism and predispose individuals to diseases risks that are mitigated through dietary and other lifestyle modifications. It gives an overview of types of health-related genetic testing services currently advertised and sold DTC. The growing range of DTC tests available has prompted advocacy of risk-based regulation. The chapter considers where nutrigenetic tests fall into current attempts to categorize such tests and notes that they straddle a boundary between “medical” and “lifestyle” tests. The chapter examines various regulatory tools that may be applied to DTC genetic tests and favors improved information disclosure about the strengths and limits of the current generation of DTC genetic tests. It also endorses efforts to use existing consumer protection laws to police companies that make false or misleading claims. It summarizes harms and benefits said to be associated with DTC genetic tests, then examines options for regulating DTC genetic tests, including prohibitions on DTC tests, allowing DTC access only for tests considered to be of lower risk, enforcing truth-in-advertising legislation against DTC companies that make false and/or misleading claims, and publicizing educational resources to help consumers make more informed decisions about purchasing genetic tests.

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.

Nutrigenomics, the conjunction of molecular nutrition with human genomics, is among the first publicly available applications of the human genome project. Nutrigenomics raises ethical, legal and social issues particularly with respect to how the public may access nutrigenetic tests and associated nutritional and lifestyle advice. Current regulatory controversy focuses on potential harms associated with direct-to-consumer (DTC) marketing of nutrigenetic tests and especially the need to protect consumers from unreliable tests, false claims and unproven dietary supplements. Nutrigenomics does, however, offer the potential of important health benefits for some individuals. The regulation of nutrigenomic services is slowly evolving, but there is little indication of increased professional capacity to support service delivery. Primary care physicians have minimal training in nutrition and genetics, and medical geneticists are in high demand and short supply. Dietetic practitioners are experts in nutrition science and interest in nutrigenomics is growing among members of this professional group. However, as with physicians, dietetics practitioners would require considerable training to bring nutrigenomics into their practice capacity. A downside of regulatory restrictions on direct consumer access to nutrigenomics companies is that responsible businesses may be hindered in meeting emergent public demand while health care professional groups have not yet developed capacity to provide nutrigenomics services.

Background The medical and legal fields coalesce around advance care planning (ACP). There is an opportunity for the legal community to be a stronger partner in the uptake of ACP beyond advance directive completion. Analysis is required of gaps in resources and supports to help lawyers promote and be engaged in ACP conversations. Aim To develop an ACP legal toolkit to help lawyers promote and be engaged in ACP communication. Methods Two workshops for researchers (5), lawyers (17), clinicians (3), and other stakeholders (8) from the legal and medical communities are being held in Alberta, Canada to discuss lawyers’ roles, needs and barriers regarding ACP. These workshops will bring together key stakeholder groups who have been working in parallel and have a keen interest in improving the uptake of ACP, but have otherwise had few opportunities to connect e.g. the Canadian Bar Association, Legal Aid, legal education organisations, academics, government representatives, and patient advisors. The intended outcomes of the meetings are to establish the contents of an ACP legal toolkit, establish roles and responsibilities around compiling the toolkit, and to develop a plan for dissemination. A core group (10) from these meetings will attend a follow up meeting about implementation. Results A description of the meeting results, the ACP legal toolkit, its compilation, development and dissemination will be presented

The 2003 global outbreak of Severe Acute Respiratory Syndrome (SARS) was an abrupt reminder that infectious diseases pose a continuing threat to human health. In 1967, U.S. Surgeon General William H. Stewart declared “it was time to close the book on infectious diseases” (Garrett, 1994, citing W.H. Stewart, “A Mandate for State Action,” presented at the Association of State and Territorial Health Officers, Washington, DC, December 4, 1967). In the latter half of the twentieth century, many shared this bold view that medical science had vanquished infectious disease. As a result, public health struggled to remain relevant in the face of advances in pharmaceuticals, surgery, genetics and other areas that were becoming increasingly dominant in the quest to extend and enhance human life. SARS forced many to rethink the significance of public health and the crisis, though relatively short-lived, (for commentary on the disparities between the responses to HIV and SARS, see e.g. Altman (2003)) underscored the need to rebuild public health capacity that had been allowed to slip down the health system priority list.

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.