There has been little, if any, discussion of the issue as of now b. There has been discussion among researchers, but little discussion among policy makers c. There has been discussion among both researchers and policy makers d. I am not sure -or other answer 1.1 In Australia, genomic research would require ethics approval like any other human research. DTP research would also attract the general requirements for approving human research, including minimizing risk and ensuring consent (Chapter 2.1-2.3 National Statement). In addition, there are specific requirements for Genomic Research in the National Statement in Chapter 3.3. Any proposed DTP genomic research would need to comply with the specific requirements of Chapter 3.3 to be satisfactorily addressed for ethical approval. 1.2 The National Health and Medical Research Council has the issue of Direct to Customer Genetic Testing under consideration and has published three relevant information documents. 1 1.3 The Commonwealth Australia Government, Department of Health has issued guidance for the Provision of Direct-to-Consumer Genetic Tests: Guiding Principles for Providers. 2 The Australian Genomics Health Alliance (AGHA) published a news page on Understanding Direct-to-Consumer Genetic Testing, with information on clinical-grade testing. 3 2. Assume that a researcher in your country wants to conduct DTP genomic research with participants in your country and that such research is subject to IRB/REC review. Please describe the conditions for IRB/ REC approval, if it could be approved at all.
IntroductionElectronic patient-reported outcomes (ePROs) have tremendous potential to optimise palliative and supportive care for children with cancer, their families and healthcare providers. Particularly, these children and their families are subjected to multiple strains caused by the disease and its treatment. The MyPal digital health platform is designed to address these complex demands by offering pursuant ePRO-based functionalities via two mobile applications, one developed for children and the other for their parents.Methods and analysisIn this observational prospective feasibility study, 100 paediatric oncology patients aged between 6 and 17 years and at least one of their parents/legal guardians will be recruited at three clinical sites in two European countries (Germany and Czech Republic). They will use the mobile applications which are part of the novel digital health platform. During a 6-month study period, participants will complete various ePROs via the applications addressing quality of life, satisfaction with care and impact of the disease on the family at monthly intervals. Additionally, priority-based symptom reporting is integrated into a serious game for children. Outcomes that will be assessed concern the feasibility and the evaluation of the newly designed digital health platform to contribute to the evidence base of clinical ePRO use in paediatric oncology and palliative care process.Ethics and disseminationThe MyPal-Child study obtained ethical approval from the Ethics Committee responsible for the University of Saarland, that is, the Ärztekammer des Saarlandes, the Ethics Committee of the Medical School Hannover and the Ethics Committee of the University of Brno. Study results will be disseminated through scientific publications, presentations at international conferences, congresses and a final report to the European Commission. General publicly accessible information can be found on the project website (www.mypal-project.eu) and social media.Trial registration numbersU1111-1251-0043, DRKS00021458, NCT04381221.
The increasing number of digital solutions developed for use in clinical health care settings is accompanied by new challenges to develop and conduct clinical studies that include eHealth technologies. Clinical study implementation plans often disregard or underestimate the necessity of additional administrative and logistic tasks required at clinical sites as well as ethical aspects to test digital solutions. Experiences made in the run-up of an observational clinical feasibility study at three international clinical sites in the framework of the MyPal project (https://mypal-project.eu/) result in recommendations to avoid delays and barriers in the planning of such prospective studies in clinical and also palliative care for increased efficiency.
The EPHOR Consortium, Rob Stierum a loskeletal disorders. 4 Conservative estimates of the global burden of occupational disease vary between 3% and 7% of global mortality, translating to 1.5 to 2.3 million deaths each year. [5][6][7] In the European Union (EU), approximately 300,000 work-related deaths per year are estimated resulting in economic losses of Abstract. Exposures at work have a major impact on noncommunicable diseases (NCDs). Current risk reduction policies and strategies are informed by existing scientific evidence, which is limited due to the challenges of studying the complex relationship between exposure at work and outside work and health. We define the working life exposome as all occupational and related nonoccupational exposures. The latter includes nonoccupational exposures that may be directly or indirectly influenced by or interact with the working life of the individual in their relation to health. The Exposome Project for Health and Occupational Research aims to advance knowledge on the complex working life exposures in relation to disease beyond the single high exposure-single health outcome paradigm, mapping and relating interrelated exposures to inherent biological pathways, key body functions, and health. This will be achieved by combining (1) large-scale harmonization and pooling of existing European cohorts systematically looking at multiple exposures and diseases, with (2) the collection of new high-resolution external and internal exposure data. Methods and tools to characterize the working life exposome will be developed and applied, including sensors, wearables, a harmonized job exposure matrix (EuroJEM), noninvasive biomonitoring, omics, data mining, and (bio)statistics. The toolbox of developed methods and knowledge will be made available to policy makers, occupational health practitioners, and scientists. Advanced knowledge on working life exposures in relation to NCDs will serve as a basis for evidence-based and cost-effective preventive policies and actions. The toolbox will also enable future scientists to further expand the working life exposome knowledge base.
As the world reflects upon one year since the first cases of coronavirus disease 2019 (COVID-19) and prepare for and experience surges in cases, it is important to identify the most crucial ethical issues that might lie ahead so that countries are able to plan accordingly. Some ethical issues are rather obvious to predict, such as the ethical issues surrounding the use of immunity certificates, contact tracing, and the fair allocation of vaccines globally. Yet, the most significant ethical challenge that the world must address in the next year and beyond is to ensure that we learn the ethical lessons of the first year of this pandemic. Learning from our collective experiences thus far constitutes our greatest moral obligation. Appreciating that decision-making in the context of a pandemic is constrained by unprecedented complexity and uncertainty, beginning in June 2020, an international group of 17 experts in bioethics spanning 15 countries (including low-, middle-, and high-income countries) met virtually to identify what we considered to be the most significant ethical challenges and accompanying lessons faced thus far in the COVID-19 pandemic. Once collected, the group met over the course of several virtual meetings to identify challenges and lessons that are analytically distinct in order to identify common ethical themes under which different challenges and lessons could be grouped. The result, described in this paper, is what this expert group consider to be the top five ethical lessons from the initial experience with COVID-19 that must be learned.
IntroductionThe systematic collection of electronic patient-reported outcome (ePRO) in the routine care of patients with chronic haematological malignancies such as chronic lymphocytic leukaemia (CLL) and myelodysplasia syndromes (MDS) can constitute a very ambitious but worthwhile challenge. MyPal is a Horizon 2020 Research & Innovation Action aiming to meet this challenge and foster palliative care for patients with CLL or MDS by leveraging ePRO systems to adapt to the personal needs of patients and caregiver(s).Methods and analysisIn this interventional randomised trial, 300 patients with CLL or MDS will be recruited across Europe. Patients will be randomly allocated to early palliative care using the MyPal system (n=150) versus standard care including general palliative care if needed (n=150). Patients in the experimental arm will be given access to the MyPal digital health platform which consists of purposely designed software available on smartphones and/or tablets. The platform entails different functionalities including physical and psychoemotional symptom reporting via regular questionnaire completion, spontaneous self-reporting, motivational messages, medication management and a personalised search engine for health information. Data on patients’ activity (daily steps and sleep quality) will be automatically collected via wearable devices.Ethics and disseminationThe integration of ePROs via mobile applications has raised ethical concerns regarding inclusion criteria, information provided to participants, free and voluntary consent, and respect for their autonomy. These have been carefully addressed by a multidisciplinary team. Data processing, dissemination and exploitation of the study findings will take place in full compliance with European Union data protection law. A participatory design was adopted in the development of the digital platform involving focus groups and discussions with patients to identify needs and preferences. The protocol was approved by the ethics committees of San Raffaele (8/2020), Thessaloniki ‘George Papanikolaou’ Hospital (849), Karolinska Institutet (20.10.2020), University General Hospital of Heraklion (07/15.4.2020) and University of Brno (01-120220/EK).Trial registration numberNCT04370457.
Better use can be made of data on parental occupational exposures and health collected in birth cohorts, exploiting their life-course perspective and allowing the study of rarely investigated topics such as work-family conflicts. Ethical challenges related to repurposing of data can be addressed thanks to the trustful relationships established with participants and implementing appropriate safeguards to protect their fundamental rights.
This paper explores the ethical dimension of the opportunity to offer improved electronic patient-reported outcome (ePRO) systems addressing personal needs of pediatric cancer patients, their parents and caregivers, with regard to technological advance of digital health. This opportunity has been explored in the MyPal research project, which aims to assess a patient-centered service for palliative care relying on the adaptation and extension of digital health tools and concepts available from previous projects. Development and implementation of ePROs need to take place in a safe, secure and responsible manner, preventing any possible harm and safeguarding the integrity of humans. To that end, although the final results will be published at the end of the project, this paper aims to increase awareness of the ethical ramifications we had to address in the design and testing of new technologies and to show the essentiality of protection and promotion of privacy, safety and ethical standards. We have thus reached a final design complying with the following principles: (a) respect for the autonomy of participants, especially children, (b) data protection and transparency, (c) fairness and non-discrimination, (d) individual wellbeing of participants in relation to their physical and psychological health status and e) accessibility and acceptability of digital health technologies for better user-engagement. These principles are adapted from the Ethics Guidelines for a trustworthy Artificial Intelligence (AI) which provide the framework for similar interventions to be lawful, complying with all applicable laws and regulations, ethical, ensuring compliance to ethical principles and values and robust, both from a technical and social perspective.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.