Nola Ries has expertise in health law and policy, with a particular focus on: law, ageing and health; legal aspects of health system reform; governance of health research; regulation of health practitioners; public health law; and health technology regulation.
A cross-disciplinary researcher, Nola applies empirical methods to investigate intersecting health and legal problems. Her research is reform-oriented and aims to build an evidence base to inform better law, policy and practice. She has a keen interest in interprofessional collaboration, including health-justice partnerships, to improve access to justice and health outcomes through integrated service provision.
Nola publishes widely in legal, health and policy journals, with over 50 peer-reviewed articles and approximately 45 book chapters, major reports, commissioned papers and other publications. Across team and individual projects,she has received competitive grants totalling over $2M from funders including the National Health and Medical Research Council, the NSW Department of Family and Community Services and the Canadian Institutes of Health Research.
Nola joined UTS in 2017 after three years at the University of Newcastle Law School, where she served as Deputy Dean, Research and established an Evidence-based Law and Practice research group.
Prior to moving to Australia in 2013, Nola was a legal academic and practitioner in Canada. She practiced in human rights litigation and constitutional and administrative law and served as a legal consultant to government departments and health professional organisations.
Member, Law | Health | Justice Research Centre, UTS:Law
Admitted as a Solicitor of the Supreme Court of New South Wales
Member, Medico-Legal Society of New South Wales
Member (Non-practicing), Law Society of British Columbia, Canada
Australian Research Fellowship in Health Services and Policy Research (2015/16): Choosing Wisely: Understanding Law’s Contribution as a Cause of and a Cure for Unwise Healthcare Choices
Australia-Japan Emerging Research Leader Award, Australian Academy of Technology and Engineering (2016): Socio-Legal Aspects of Assistive Technologies for Dementia Care
James Kreppner Fellowship in Blood System Studies, Canadian Blood Services (2010-2012): Consent, Privacy and Property: An Analysis of Legal Principles and Rules Relevant to a National System for Blood, Organs and Tissues in Canada
Service (selected activities)
Divisional Committee Member, Australian Association of Gerontology (NSW), 2017 - present
Member, Reference Group on Elder Abuse in the Hunter, 2016 - present
Law School Representative (elected), Board of the Faculty of Business and Law, University of Newcastle, 2015 – 2017
Member, National Professional Practice and Standards Committee, Occupational Therapy Australia, 2014 – 2015
Member, Joint University of Victoria-Vancouver Island Health Authority Research Ethics Review Panel, 2008-2010
Member, Advisory Board, School of Public Health and Social Policy, University of Victoria, 2009-2010
Member, Canadian Institutes of Health Research Ethical, Social and Legal Issues Advisory Committee for the Canadian Longitudinal Study on Aging, 2008-2010
Editorial Board Member - HIV/AIDS Policy & Law Review, 2007-2009
Current projects include:
Action on Elder Abuse: A Pilot Project to Improve Screening and Intervention through Health-Legal Collaboration (2017-2018)
This project aims to improve detection and support for older adults in the Newcastle, NSW region who are at risk of or experiencing abuse. The project brings together practitioners in health, aged care and legal sectors for interprofessional training on elder abuse. Participants will be trained in the use of a screening process to identify potential situations of abuse and will be supported with referral pathways and resources to assist clients. Funded by the NSW Department of Family and Community Services.
Australian Community of Practice in Research in Dementia (2016 – 2021)
This is an NHMRC-funded program of research led by investigators at the University of Newcastle. Nola is co-leading a project examining community perceptions concerning issues of capacity and supported and substitute decision making for people with dementia. She is also leading studies on the legal and ethical aspects of involving people with cognitive impairment in research.
Advance Care Planning and Goals of Care Alberta: A Population Based Knowledge Translation Intervention Study (2013-2017)
With Canadian collaborators, Nola is co-leading a project that investigates lawyers’ role in assisting clients with planning for future incapacity, as well as strategies to enhance health-legal sector collaboration to improve the quality and uptake of advance care planning. Funded by Alberta Innovates Health Solutions.
Choosing Wisely: Understanding Law's Contribution as a Cause of and a Cure for Unwise Healthcare Choices (2016-2018)
This project analyses issues relevant to the Choosing Wisely initiative, an international campaign to reduce the provision of unnecessary medical tests, treatments and referrals. It examines strategies to improve clinicians' understanding of the law, reduce defensive medical practices and improve consent processes. This project continues from Nola's 2016 Australian Fellowship in Health Services and Policy Research.
Selected Past Projects
Priority Research Initiative in Evidence-based Law and Practice (2016-2017)
Nola conceived of and established a research group and led research in the areas o: Legal Education, Equity & Scholarship; and Health, Justice and Social Affairs. Funder: University of Newcastle
Planning Ahead: A Community Legal Education Initiative (2014-2015) Nola conceived of and co-led this pilot project to deliver legal education in community health settings to older adults and persons with chronic diseases. She designed and carried out an evaluation to study the impact of community legal education on the target audiences. Funder: University of Newcastle
Consent, Privacy and Property: An Analysis of Legal Principles and Rules Relevant to a National System for Blood, Organs and Tissues in Canada (2010-2012) Funder: Canadian Blood Services
Analysis of Privacy Policies and Practices of Direct-to-Consumer Genetic Testing Companies: Private Sector Biobanking and Privacy Protection Norms (2009-2010) Funder: Office of the Privacy Commissioner of Canada
Social Issues in Nutritional Genomics: The Design of Appropriate Regulatory Systems and Issues of Public Representations and Understanding (2006-2009) Funder: Advanced Foods and Materials Network, a Network of Centres of Excellence
Use of Legal Interventions to Address Environmental Factors Implicated in the Obesity Epidemic: The Role of Law as a Public Health Tool (2006-2008) Funder: Canadian Institutes of Health Research
Moving Forward with Birth Cohort Research in Canada: The Legal and Ethical Foundations for the CHILD Study (2006-2008) Funder: Allergy, Genes and Environment Network, a Network of Centres of Excellence
Genetically Modified Herbicide Tolerant Crops: Assessing Farm Safety, Legal Liability and Insurance Issues (2006-2008) Funder: Advanced Foods and Materials Network, a Network of Centres of Excellence
Legal Foundations for a National Disease Control and Surveillance Agency in Canada (2004-2006) Funder: Canadian Institutes of Health Research
Governance Instruments and Child Health: Informing Canadian Policy (2005-2006) Funder: Health Canada, Health Policy and Research Program
Electronic Health Records and the Personal Information Protection and Electronic Documents Act (2004-2005) Funder: Office of the Privacy Commissioner of Canada
Ries, N. 2013, Public Health Law and Policy in Canada, 3rd, LexisNexis Canada.
Nutrigenomics is the rapidly developing field of science that studies nutrient-gene interaction. This field has broad implications for understanding the interaction of human genomics and nutrition, but can also have very specific implications for individual dietary recommendations in light of personal genetics. Predicted applications for nutrigenomics include genomics-based dietary guidelines and personalized nutrition based on individual genetic tests. These developments have sweeping ethical, legal and regulatory implications for individuals, corporations and governments. This book brings together experts in ethics, law, regulatory analysis, and communication studies to identify and address relevant issues in the emerging field of nutritional genomics. Contributing authors are experts in the social aspects of biotechnology innovation, with expertise in nutrigenomics. From addressing the concern that nutrigenomics will transform food into medicine and undermine pleasures associated with eating to the latest in the science of nutrigenomics, this book provides a world-wide perspective on the potential impact of nutrigenomics on our association with food. Explores the rapidly developing, yet not fully understood, impact of nutrigenomics on the relationship to food medicalization, genetic privacy, nutrition and health. Provides ground for further exploration to identify issues and provide analysis to aid in policy and regulation development Provides ethical and legal insights into this unfolding science, as well as serving as a model for thinking about issues arising in other fields of science and technology. © 2009 Elsevier Inc. All rights reserved.
Castle, D. & Ries, N. 2009, Nutrition and Genomics Issues of Ethics, Law, Regulation and Communication, Academic Press.
Issues of Ethics, Law, Regulation and Communication David Castle, Nola Ries.
The chapters in this book follow nutrigenomics from the laboratory bench, to the
market, regulatory domains, individuals and health care professionals, the
Ries, N. & Mansfield, E. 2018, 'Elder Abuse: The role of general practitioners in community-based screening and multidisciplinary action', Australian Journal of General Practice, vol. 47, no. 4, pp. 132-135.
Ries, N., Douglas, M., Simon, J. & Fassbender, K. 2018, 'How Do Lawyers Assist Their Clients with Advance Care Planning? Findings from a Cross-Sectional Survey of Lawyers in Alberta, Canada (2018) 55(3) Alberta Law Review', Alberta Law Review, vol. 55, no. 3, pp. 683-701.View/Download from: UTS OPUS
Ries, N. 2017, 'Choosing Wisely: Law's Contribution as a Cause of and a Cure for Unwise Health Care Choices', Journal of Law and Medicine, vol. 25, pp. 1-20.
The provision of unnecessary health care 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 health care choices. This article critically analyses these problems and proposes solutions. An extensive body of medico-legal literature is synthesised to highlight the gaps between legal requirements and what happens in practice. Negligence case law is discussed to clarify legal principles and shows that courts discourage defensive practice. Finally, the article presents practical strategies to enhance communication and shared decision-making in the clinical encounter.
Ries, N., Thompson, K. & Lowe, M. 2017, 'Including People with Dementia in Research: An Analysis of Australian Ethical and Legal Rules and Recommendations for Reform', Journal of Bioethical Inquiry, vol. 14, no. 3, pp. 359-374.
Ries, N.M. 2017, 'Law matters: How the legal context in Canada influences interprofessional collaboration.', Journal of interprofessional care, vol. 31, no. 4, pp. 417-419.View/Download from: UTS OPUS or Publisher's site
Ries, N.M., Thompson, K.A. & Lowe, M. 2017, 'Including People with Dementia in Research: An Analysis of Australian Ethical and Legal Rules and Recommendations for Reform', Journal of Bioethical Inquiry, vol. 14, no. 3, pp. 359-374.View/Download from: Publisher's site
© 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.
Nicol, D., Bubela, T., Chalmers, D., Charbonneau, J., Critchley, C., Dickinson, J., Fleming, J., Hewitt, A.W., Kaye, J., Liddicoat, J., McWhirter, R., Otlowski, M., Ries, N.M., Skene, L., Stewart, C., Wagner, J. & Zeps, N. 2016, 'Precision medicine: drowning in a regulatory soup?', Journal of Law and the Biosciences, vol. 3, no. 2, pp. 281-303.View/Download from: Publisher's site
Ries, N. 2016, 'Innovation in Healthcare, Innovation in Law: Does the Law Support Interprofessional Collaboration in Canadian Health Systems?', Osgoode Hall Law Journal, vol. 54, no. 1, pp. 97-124.View/Download from: UTS OPUS
Interprofessional collaboration in health care describes a model of practice in which multiple health professionals work together in a team-based approach to patient care. A growing body of literature demonstrates that interprofessional collaboration advances health care quality and safety, improves patient outcomes and experiences of care, and promotes job satisfaction among health professionals. Governments and health organizations across Canada are working to advance interprofessional health care delivery. This article examines the importance of law in supporting a shift to interprofessional collaboration in Canadian health care and discusses two key aspects of the legal context in which health practitioners work. First, the article discusses trends in the legal regulation of health professions in Canada, including law reform initiatives aimed at promoting collaborative practice and at expanding scopes of practice to break down the historically siloed approach to health care delivery. Second, the article examines civil liability rules that courts apply when allegations of negligence are made against health care providers working in team-based situations. regarding responsibility for patient care and outcomes. The article 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 health care.
Ries, N. 2016, 'Lawyers and Advance Care and End-of-Life Planning: Enhancing Collaboration between Legal and Health Professions', Journal of Law and Medicine, vol. 23, no. 4, pp. 887-906.
Ries, N. 2016, 'Prescribe with Caution: The Response of Canada's Medical Regulatory Authorities to the Therapeutic Use of Cannabis', McGill Journal of Law and Health, vol. 9, no. 2, pp. 215-254.
Canada was one of the first countries worldwide to legalize the use of cannabis for therapeutic purposes. The federally regulated cannabis access program has not had the support of medical regulatory authorities, however, and recent changes to federal rules are controversial in imposing responsibility on physicians to prescribe the drug, which is unapproved and illegal outside the medical use laws. This paper analyzes the response of Canada's ten medical regulatory authorities to these legal changes and provides critical commentary on the legal and ethical guidance provided to physicians who treat patients seeking to use cannabis therapeutically. The paper considers the role of doctors as gatekeepers, the profession's concerns about medico-legal risks of cannabis prescription, stigmatization and barriers to care for patients who use cannabis, and the need for research to continue to build the evidence base to inform therapeutic prescription of the drug. The Canadian experience provides lessons for other jurisdictions that are considering liberalizing cannabis use laws.
Ries, N., Douglas, M., Simon, J. & Fassbender, K. 2016, 'Doctors, Lawyers and Advance Care Planning: Time for Innovation to Work Together to Meet Client Needs', Healthcare Policy | Politiques de Santé, vol. 12, no. 2, pp. 13-18.View/Download from: Publisher's site
Ries, N., Johnston, B. & McCarthy, S. 2016, 'Legal education and the ageing population: Building student knowledge and skills through practical experiences in collaboration with community organisations', Adelaide Law Review, vol. 37, no. 2, pp. 495-522.
Ries, N., Johnston, B. & McCarthy, S. 2016, 'Technology-Enabled Legal Service Delivery for Older Adults: What Can Law Learn from TeleHealth? Findings from an International Review of Literature', Elder Law Review, vol. 10.
Ries, N.M., Douglas, M., Simon, J. & Fassbender, K. 2016, 'Doctors, Lawyers and Advance Care Planning: Time for Innovation to Work Together to Meet Client Needs.', Healthcare policy = Politiques de sante, vol. 12, no. 2, pp. 12-18.View/Download from: UTS OPUS
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.
Caulfield, T., Burningham, S., Joly, Y., Master, Z., Shabani, M., Borry, P., Becker, A., Burgess, M., Calder, K., Critchley, C., Edwards, K., Fullerton, S.M., Gottweis, H., Hyde-Lay, R., Illes, J., Isasi, R., Kato, K., Kaye, J., Knoppers, B., Lynch, J., McGuire, A., Meslin, E., Nicol, D., O'Doherty, K., Ogbogu, U., Otlowski, M., Pullman, D., Ries, N., Scott, C., Sears, M., Wallace, H. & Zawati, M.H. 2014, 'A review of the key issues associated with the commercialization of biobanks', Journal of Law and the Biosciences, vol. 1, no. 1, pp. 94-110.View/Download from: Publisher's site
Nicol, D., Hagger, M., Ries, N. & Liddicoat, J. 2014, 'Time to Get Serious about Privacy Policies: The Special Case of Genetic Privacy', Federal Law Review, vol. 42, no. 1, pp. 149-179.
Ries, N. 2013, 'Research with Blood Donated for Transfusion Purposes', Health law review, vol. 21, no. 2.
Ries, N. & Fisher, K. 2013, 'The Increasing Involvement of Physicians in Complementary and Alternative Medicine: Considerations of Professional Regulation and Patient Safety', Queen's Law Journal, vol. 39, no. 1, pp. 273-299.
Ries, N. 2012, 'Legal and Policy Measures to Promote Healthy Behaviour: Using Incentives and Disincentives to Control Obesity', McGill Journal of Law and Health, vol. 6, no. 1, pp. 1-40.View/Download from: UTS OPUS
This article examines incentives as a health policy option to encourage healthier behaviours and considers the emerging body of literature that evaluates the effectiveness and impact of incentives as public health policy tools. Incentives - including rewards and penalties - vary widely in their force, from indirect (or mild) to direct (or strong) incentives. At one end of the incentive spectrum are strategies that invite healthier behaviour, such as urban planning measures to encourage walking and cycling. In the middle of the incentive spectrum are measures such as tax credits for those who participate in sports and fitness programs or "fat taxes" on high-calorie, low-nutrition foods. These strategies target individuals' pocketbooks and thus may have a stronger influence on behaviour change. The most direct incentives are governmental or private sector schemes that use monetary payments or penalties to induce behaviour change. While this article focuses on incentives targeted at individuals, it briefly discusses several examples of incentives aimed at businesses, particularly food retailers.
The use of incentives as a health policy tool has several key legal dimensions. First, governments rely on legal powers, such as taxation laws and zoning regulations, to implement certain kinds of incentives. Second, in their operation and impact, incentives may infringe on legally protected rights. In particular, the use of "sticks" rather than "carrots" may be criticized on the grounds that they are coercive, discriminate unfairly, and promote individual blame. Third, public health law is concerned with the use of legal and policy measures to create conditions in which people may be healthy. It is important, therefore, to evaluate incentive programs to determine their effectiveness in ameliorating obesogenic environments and creating conditions for improved dietary and physical activity behaviours.
Rising rates of overweight and obesity are of serious concern in Canada. Until recently, discussion of policy options to promote healthier lifestyles has ignored the topic of direct financial incentives. The idea of paying people to lose weight or adopt healthier behaviours is now attracting study and debate. Some governments and companies are already experimenting with reward programs. Available evidence indicates that financial incentives help promote short-term change, but there is a dearth of evidence on longer-term programs and outcomes. Targeted incentives for specific risk groups have shown more success. With creative design, targeted use and evaluation, financial incentives for weight loss and healthy behaviour may be a useful addition to the health policy toolkit.
Ries, N.M. 2012, 'Nudge or not: can incentives change health behaviours?', Healthcare Papers, vol. 12, no. 4, pp. 37-41.
The approach of "nudging" people toward healthier behaviours is currently in vogue, and user financial incentives (UFIs) are one possible nudge tool. Interesting debates arise as to the criteria UFIs must meet to qualify as a nudge. The more pressing issue, however, is to determine how UFIs can be structured and implemented to motivate and sustain health behaviour change. To date, Canadian public health strategies to promote physical activity and balanced nutrition focus mainly on information provision, with some product regulation measures and indirect financial incentives. Governments cannot afford direct UFI programs to incent all 60% of overweight and obese Canadians to reduce their body mass, but governments could consider UFIs targeted to specific risk groups where a shorter-term intervention could have long-term payoffs.
Arrandale, V.H., Brauer, M., Brook, J.R., Brunekreef, B., Gold, D.R., London, S.J., Miller, J.D., Özkaynak, H., Ries, N.M., Sears, M.R., Silverman, F.S. & Takaro, T.K. 2011, 'Exposure assessment in cohort studies of childhood asthma.', Environmental health perspectives, vol. 119, no. 5, pp. 591-597.View/Download from: UTS OPUS or Publisher's site
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.
Caulfield, T., Ries, N. & Barr, G. 2011, 'Variation in Ethics Review of Multi-Site Research Initiatives', Amsterdam Law Forum, vol. 3, no. 1, pp. 104-122.
Master, Z., Ries, N.M. & Caulfield, T. 2011, 'Balancing Efficiency and the Protection of Research Participants: Canadian Allergy/Asthma Researchers' Perspectives on the Ethics Review of Multi-Site Health Research', Journal of Clinical Research & Bioethics, vol. 02, no. 05.View/Download from: Publisher's site
Rachul, C., Ries, N. & Caulfield, T. 2011, 'Canadian newspaper coverage of the A/H1N1 vaccine program', Canadian Journal of Public Health, vol. 102, no. 3, pp. 200-204.
Ries, N. 2011, 'Regulating Public Health Risks: Case Studies of Food Allergens and Transfusion Transmissible Infections', Health Law Journal, vol. 19, pp. 1-44.
Ries, N. & von Tigerstrom, B. 2011, 'Legal Interventions to Address Obesity: Assessing the State of the Law in Canada', University of British Columbia Law Review, vol. 43, no. 2, pp. 361-416.
Ries, N.M., Rachul, C. & Caulfield, T. 2011, 'Newspaper reporting on legislative and policy interventions to address obesity: United States, Canada, and the United Kingdom.', Journal of public health policy, vol. 32, no. 1, pp. 73-90.View/Download from: Publisher's site
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.
Caulfield, T., Ries, N.M., Ray, P.N., Shuman, C. & Wilson, B. 2010, 'Direct-to-consumer genetic testing: good, bad or benign?', Clinical genetics, vol. 77, no. 2, pp. 101-105.View/Download from: Publisher's site
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.
Ries, N.M. 2010, 'Ethics, health research, and Canada's aging population.', Canadian journal on aging = La revue canadienne du vieillissement, vol. 29, no. 4, pp. 577-585.
Ries, N.M. & von Tigerstrom, B. 2010, 'Roadblocks to laws for healthy eating and activity.', CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, vol. 182, no. 7, pp. 687-692.View/Download from: Publisher's site
Ries, N.M., Hyde-Lay, R. & Caulfield, T. 2010, 'Willingness to pay for genetic testing: a study of attitudes in a Canadian population.', Public health genomics, vol. 13, no. 5, pp. 292-300.View/Download from: Publisher's site
BACKGROUND: This article reports results of a 2008 telephone survey of approximately 1,200 residents of the Province of Alberta, Canada. The majority of respondents reside in urban centers, have some post-secondary education, and report annual family income near or above the Canadian average. The goal was to explore attitudes and interest regarding different types of genetic tests. METHODS: Respondents were asked about their willingness to pay for tests to gain information about genetic factors related to manageable conditions, serious, unpreventable disease, healthy food choices, psychiatric conditions, going bald (asked of men only), and gaining weight. The price categories were CAD 0, CAD 1-499, CAD 500-1,999 and CAD 2,000+. Respondents were also asked about factors that would motivate interest in genetic testing, such as availability of treatment, curiosity, and reproductive decision-making. They were also asked if the public health insurance system should pay for certain types of tests. RESULTS: Across all test categories, few respondents expressed willingness to pay more than CAD 500 out of their own pocket. 62% stated that the public health insurance system should pay for genetic tests for manageable conditions and opinion was divided about whether the government should fund tests for serious, unpreventable conditions and tests to inform healthy eating choices. CONCLUSION: The principal motivator for interest in genetic testing was to learn clinically relevant details to inform health-related decisions. Curiosity about genetic risk had only a modest impact on consumer interest. In general, younger respondents (18-35 years) expressed somewhat greater willingness to pay than older respondents, especially those 65 and older.
Ries, N.M., LeGrandeur, J. & Caulfield, T. 2010, 'Handling ethical, legal and social issues in birth cohort studies involving genetic research: responses from studies in six countries.', BMC medical ethics, vol. 11, p. 4.View/Download from: UTS OPUS or Publisher's site
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 inform...
Weir, M., Morin, K., Ries, N. & Castle, D. 2010, 'Canadian health care professionals' knowledge, attitudes and perceptions of nutritional genomics.', The British journal of nutrition, vol. 104, no. 8, pp. 1112-1119.View/Download from: Publisher's site
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.
Farrell, J., Ries, N.M., Kachan, N. & Boon, H. 2009, 'Foods and natural health products: Gaps and ambiguities in the Canadian regulatory regime', Food Policy, vol. 34, no. 4, pp. 388-392.View/Download from: Publisher's site
Canadian regulations have different rules for foods and natural health products (NHPs) regarding allowable health claims, requirements for use in clinical trials and good manufacturing standards and labeling requirements. How these rules apply to products at the food-NHP interface is often unclear. This paper describes the regulatory environment and explores two product examples - probiotic yogurt and green tea - to illustrate the issue. In addition, results from a qualitative study of NHP/food researchers highlights the confusion and frustration of those working in the field. Interim agreements between the NHP and Foods Directorate of Health Canada regarding products reviews provide a temporary response but regulatory amendments, accompanied by clear guidance to stakeholders, are needed. © 2009 Elsevier Ltd. All rights reserved.
Moran, T., Ries, N. & Castle, D. 2009, 'a cause of action for regulatory negligence? The regulatory framework for genetically modified crops in Canada and the potential for regulator liability', Revue de Droit et Technologie de l'Université d'Ottawa / University of Ottawa Law and Technology Journal, vol. 6, pp. 1-23.
Rodal, R., Ries, N. & Wilson, K. 2009, 'Influenza Vaccination for Health Care Workers: Towards a Workable and Effective Standard', Health Law Journal, vol. 17, pp. 297-337.
von Tigerstrom, B. & Ries, N. 2009, 'Cancer Surveillance in Canada: Analysis of Legal and Policy Frameworks and Tools for Reform', Health Law Journal, vol. 17, pp. 1-49.
Farrell, J., Ries, N.M. & Boon, H. 2008, 'Pharmacists and natural health products: A systematic analysis of professional responsibilities in Canada', Pharmacy Practice, vol. 6, no. 1, pp. 33-42.
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 pioducts. 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.
Hailey, D., Jacobs, P.D., Ries, N.M. & Polisena, J. 2008, 'Reuse of single use medical devices in Canada: clinical and economic outcomes, legal and ethical issues, and current hospital practice.', International journal of technology assessment in health care, vol. 24, no. 4, pp. 430-436.View/Download from: Publisher's site
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.
Polisena, J., Hailey, D., Moulton, K., Noorani, H.Z., Jacobs, P., Ries, N., Normandin, S. & Gardam, M. 2008, 'Reprocessing and reuse of single-use medical devices: a national survey of Canadian acute-care hospitals.', Infection control and hospital epidemiology, vol. 29, no. 5, pp. 437-439.View/Download from: Publisher's site
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.
Ries, N. 2008, 'Piling on the Laws, Shedding the Pounds? The Use of Legal Tools to Address Obesity', Health Law Journal, pp. 101-126.
Ries, N. 2008, 'Regulating Nutrigenetic Tests: An International Comparative Analysis', Health law review, vol. 16, no. 3, pp. 9-20.
Ries, N.M. & Castle, D. 2008, 'Nutrigenomics and ethics interface: direct-to-consumer services and commercial aspects.', Omics : a journal of integrative biology, vol. 12, no. 4, pp. 245-250.View/Download from: Publisher's site
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.
Samuel, J., Ries, N., Malkin, D. & Knoppers, B.M. 2008, 'Biobanks and Longitudinal Studies: Where are the Children?', GenEdit, vol. 6, no. 3, pp. 1-8.
Spady, D., Ries, N., Ladd, B.D., Buka, I., Osornio-Vargas, A.R. & Soskolne, C. 2008, 'Governance Instruments that Protect Children's Environmental Health: Is Enough Being Done?', Environmental Law Review, vol. 10, no. 3, pp. 200-217.
Castle, D. & Ries, N.M. 2007, 'Ethical, legal and social issues in nutrigenomics: the challenges of regulating service delivery and building health professional capacity.', Mutation research, vol. 622, no. 1-2, pp. 138-143.View/Download from: Publisher's site
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.
Ries, N. 2007, 'Food, Fat and the Law: A Comment on Trans Fat Bans and Public Health', Windsor Review of Legal and Social Issues, vol. 23, pp. 15-26.
Ries, N. 2007, 'Growing Up as a Research Subject: Ethical and Legal Issues in Birth Cohort Studies Involving Genetic Research', Health Law Journal, pp. 1-41.
Ries, N. 2006, 'Legal Rights, Constitutional Controversies, and Access to Health Care: Lessons from Canada', Medicine and Law, vol. 25, no. 1, pp. 45-57.
Ries, N. 2006, 'Patient Privacy in a Wired (and Wireless) World: Approaches to Consent in the Context of Electronic Health Records', Alberta Law Review, vol. 43, no. 3, pp. 681-712.
Ries, N. & Caulfield, T. 2006, 'First Pharmacogenomics, Next Nutrigenomics: Genohype or Genohealthy?', Jurimetrics, vol. 46, no. 3, pp. 281-308.
Bailey, T.M. & Ries, N.M. 2005, 'Legal issues in patient safety: the example of nosocomial infection.', Healthcare quarterly (Toronto, Ont.), vol. 8 Spec No, pp. 140-145.
Ries, N.M. & Caulfield, T. 2005, 'Legal foundations for a national public health agency in Canada.', Canadian journal of public health = Revue canadienne de sante publique, vol. 96, no. 4, pp. 281-283.
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.
Ries, N.M. & Moysa, G. 2005, 'Legal protections of electronic health records: issues of consent and security.', Health law review, vol. 14, no. 1, pp. 18-25.
Ries, N.M. 2004, 'Public health law and ethics: lessons from SARS and quarantine.', Health law review, vol. 13, no. 1, pp. 3-6.
Ries, N.M. 2003, 'Section 7 of the Charter: a constitutional right to health care? Don't hold your breath.', Health law review, vol. 12, no. 1, pp. 29-35.
Ries, N.M. 2003, 'The uncertain state of the law regarding health care and section 15 of the charter.', Health law journal, vol. 11, pp. 217-239.
Ross, N.M., Ries, N., Meredith, J. & Campbell, S. 2018, 'Local to Global: Incorporating Overseas Work and Study in the Law School Curriculum' in Hall, T., Gray, T., Downey, G. & Singh, M. (eds), The Globalisation of Higher Education - Developing Internationalised Education in Research and Practice.
Turner, A., Ries, N. & Baker, A. 2017, 'Mental health-substance use' in Cooper, D.B. (ed), Ethics in Mental Health-Substance Use.
Ries, N. 2015, 'Health Professionals and the Organisation of Healthcare: Current Trends'.
Ries, N. 2014, 'Health Professionals and the Organisation of Healthcare: Current Trends' in Joly, Y. & Knoppers, B.M. (eds), Routledge Handbook of Medical Law and Ethics, pp. 155-167.View/Download from: Publisher's site
Ries, N. 2013, 'Human Health Care: The Promise of Animal Biotechnology' in Brunk, C. & Hartley, S. (eds), Designer Animals: Mapping the Issues in Animal Biotechnology, University of Toronto Press.
Ries, N. 2011, 'Charter Challenges' in Downie, J., Caulfield, T. & Flood, C. (eds), Canadian Health Law and Policy, LexisNexis Canada, pp. 615-651.
Ries, N. & Kellogg, K. 2011, 'Canada' in Nys, H. (ed), International Encylopaedia of Laws: Medical Law, Kluwer Law International.
Brunk, C., Ries, N. & Rodgers, L. 2009, 'Regulatory and Innovation Implications of Religious and Ethical Sensitivities Concerning GM Food' in Brunk, C. & Coward, H. (eds), Acceptable Genes: Religious Traditions and Genetically Modified Foods, SUNY Press.
Ries, N. 2009, 'Longitudinal Studies Involving Children and Adolescents' in Knoppers, B.M., Avard, D. & Samuel, J. (eds), Paediatric Research in Canada, Les Éditions Thémis.
Samuel, J., Ries, N., Malkin, D. & Knoppers, B.M. 2009, 'Biobanks and Children: Comparative International Policies' in Knoppers, B.M., Avard, D. & Samuel, J. (eds), Paediatric Research in Canada, Les Éditions Thémis.
Ries, N. 2008, 'Legal Issues in Health Information and Electronic Health Records' in Kushniruk, A. & Borycki, E. (eds), Human, Social, and Organizational Aspects of Health Information Systems.
Caulfield, T. & Ries, N. 2006, 'Public Opinion, Consent and Population Genetic Biobanks' in Knoppers, B.M. (ed), Genomics and Public Health: Legal and Socio-Ethical Perspectives.
Caulfield, T. & Ries, N.M. 2005, 'Politics and paradoxes: Chaoulli and the Alberta reaction' in Access to Care, Access to Justice: The Legal Debate Over Private Health Insurance in Canada, pp. 413-428.