Handling ethical, legal and social issues in birth cohort studies involving genetic research: responses from studies in six countries

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusions</p> <p>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.</p

Older persons’ and their caregivers’ perspectives and experiences of research participation with impaired decision-making capacity: A scoping review

Background and Objectives: Human research ethics statements support equitable inclusion of diverse groups. Yet older people are under-represented in clinical research, especially those with impaired decision-making capacity. The aim of this study was to identify perspectives and experiences of older persons and their caregivers of research participation with impaired decision-making capacity. Research Design and Methods: Scoping review of literature and online sources in January-February 2019 (updated June 2020) according to Joanna Briggs Institute methodology and PRISMA Extension for Scoping Reviews. English-language peer-reviewed research articles and Australian online narratives were included. Data were tabulated and narratively synthesized. Results: From 4171 database records and 93 online resources, 22 articles (2000-2019, 82% United States, 16 first authors) and one YouTube webinar (2018) were initially included; updated searches yielded an additional article (2020) and YouTube webinar (2020). Studies were heterogeneous in terminology, methods and foci, with hypothetical scenarios, quantitative analyses and examination of proxy consent predominating. Participants (n=7331) were older persons (71%), caregivers of older persons with dementia/cognitive impairment (23%) and older persons with dementia/cognitive impairment (6%). Synthesis identified two themes: willingness to participate and decision-making approaches. Discussion and Implications: Research participation by older persons with dementia may be optimized through reducing risks and burdens and increasing benefits for participants, greater consumer input into study development, and shared and supported decision-making. Older persons’ and caregivers’ perspectives and experiences of research participation with impaired decision-making capacity require investigation in a greater range of countries and conditions other than dementia, and dissemination through more varied media

The effects of pulmonary rehabilitation in patients with non-cystic fibrosis bronchiectasis: protocol for a randomised controlled trial

BACKGROUND: Non-cystic fibrosis bronchiectasis is characterised by sputum production, exercise limitation and recurrent infections. Although pulmonary rehabilitation is advocated for this patient group, its effects are unclear. The aims of this study are to determine the short and long term effects of pulmonary rehabilitation on exercise capacity, cough, quality of life and the incidence of acute pulmonary exacerbations. METHODS/DESIGN: This randomised controlled trial aims to recruit 64 patients with bronchiectasis from three tertiary institutions. Participants will be randomly allocated to the intervention group (supervised, twice weekly exercise training with regular review of airway clearance therapy) or a control group (twice weekly telephone support). Measurements will be taken at baseline, immediately following the intervention and at six and 12 months following the intervention period by a blinded assessor. Exercise capacity will be measured using the incremental shuttle walk test and the six-minute walk test. Quality of life and health status will be measured using the Chronic Respiratory Questionnaire, Leicester Cough Questionnaire, Assessment of Quality of Life Questionnaire and the Hospital Anxiety and Depression Scale. The rate of hospitalisation will be captured as well as the incidence of acute pulmonary exacerbations using a daily symptom diary. DISCUSSION: Results from this study will help to determine the efficacy of supervised twice-weekly pulmonary rehabilitation upon exercise capacity and quality of life in patients with bronchiectasis and will contribute to clinical practice guidelines for physiotherapists in the management of this population. TRIAL REGISTRATION: This study protocol is registered with ClinicalTrials.gov (NCT00885521)

A randomised controlled trial of supplemental oxygen versus medical air during exercise training in people with chronic obstructive pulmonary disease: Supplemental oxygen in pulmonary rehabilitation trial (SuppORT) (Protocol)

© 2016 Alison et al. Background: Oxygen desaturation during exercise is common in people with chronic obstructive pulmonary disease (COPD). The aim of the study is to determine, in people with COPD who desaturate during exercise, whether supplemental oxygen during an eight-week exercise training program is more effective than medical air (sham intervention) in improving exercise capacity and health-related quality of life both at the completion of training and at six-month follow up. Methods/Design: This is a multi-centre randomised controlled trial with concealed allocation, blinding of participants, exercise trainers and assessors, and intention-to-treat analysis. 110 people with chronic obstructive pulmonary disease who demonstrate oxygen desaturation lower than 90 % during the six-minute walk test will be recruited from pulmonary rehabilitation programs in seven teaching hospitals in Australia. People with chronic obstructive pulmonary disease on long term oxygen therapy will be excluded. After confirmation of eligibility and baseline assessment, participants will be randomised to receive either supplemental oxygen or medical air during an eight-week supervised treadmill and cycle exercise training program, three times per week for eight weeks, in hospital outpatient settings. Primary outcome measures will be endurance walking capacity assessed by the endurance shuttle walk test and health-related quality of life assessed by the Chronic Respiratory Disease Questionnaire. Secondary outcomes will include peak walking capacity measured by the incremental shuttle walk test, dyspnoea via the Dyspnoea-12 questionnaire and physical activity levels measured over seven days using an activity monitor. All outcomes will be measured at baseline, completion of training and at six-month follow up. Discussion: Exercise training is an essential component of pulmonary rehabilitation for people with COPD. This study will determine whether supplemental oxygen during exercise training is more effective than medical air in improving exercise capacity and health-related quality of life in people with COPD who desaturate during exercise. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12612000395831 , 5th Jan,201

Innovation in Healthcare, Innovation in Law: Does the Law Support Interprofessional Collaboration in Canadian Health Systems?

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

Human health care: the promise of animal biotechnology

The instrumental use of animals for human benefit is expanding through transgenic technologies, including the technological capacity to modify animals at the genetic level to enhance their suitability to meet human health needs. Numerous possibilities exist to use animal biotechnology to benefit human health. Through transgenesis, goats, cattle, rabbits, and other mammals can produce proteins in their milk to be extracted to develop pharmaceuticals for human use. Pigs can be genetically modified to produce organs and tissues compatible for transplantation in people. Transgenic animals can be engineered for immunity against diseases that afflict them and that can be transmitted across species to cause human disease. Livestock raised for human consumption can be genetically altered to produce more nutritious meat and milk, to eliminate allergenic components, or to reduce the environmental impacts of industrial animal production. Most of these applications are still at the research stage, but some may enter the marketplace or medical practice sooner rather than later. This chapter discusses these various uses of transgenic animals, all aimed at promoting human health. The chapter takes an expansive view of health, which includes the use of animals for direct therapeutic purposes such as drug production and organ supply, but also their use as sources of nutrition for humans, as disease vectors for humans, and as living beings whose cultivation by humans has environmental consequences

Lawyers and advance care and end-of-life planning: enhancing collaboration between legal and health professions

Abstract In Australia and internationally, advance care planning (ACP) is emphasised as an important means by which individuals can express their wishes for health care during future periods of incapacity. ACP has mainly been promoted in health care settings and very little is said about the role of lawyers, despite the fact that some people are more likely to discuss their health care wishes with a lawyer than with a doctor. This article addresses this significant gap and advocates for collaboration between legal and health professionals to assist clients with advance care and end-of-life planning. It articulates the importance of law and lawyers in ACP and discusses the medical-legal partnership model as a means to increase inter-professional collaboration. It analyses how collaboration can tackle client, practitioner and system-centred barriers and recognise ACP as a preventive legal and health care practice that supports clients\u27 interests and promotes their autonomy

Health professionals and the organisation of healthcare: current trends

This chapter addresses contemporary challenges facing modern healthcare systems and the ways in which the regulation and practices of health professionals must adapt and change to meet such demands. In many countries around the world, health systems are facing enormous, interrelated pressures. Escalating healthcare costs are a pressing concern. The increase in healthcare expenditures exceeds GDP growth in many nations (Pammolli et al. 2012) and is being driven by multiple factors, including aging populations and the growing burden of chronic diseases such as cardiovascular diseases, metabolic disorders, cancers and mental health conditions (Organization for Economic Cooperation and Development (OECD) 2011; Rechel et al. 2013). The Lancet's 'Global Burden of Disease Study,' published in 2012, underscored the major social and personal impacts of chronic, non-communicable diseases, pointing out that people are living more years with disability and disease. According to the World Economic Forum, the global financial costs of the non-communicable disease burden will exceed US$30 trillion over the next twenty years (Bloom et al. 2011)