A critical examination of legal and ethical considerations for nutrigenetic testing with recommendations for improving regulation in Canada: from science to consumer.
Ontology highlight
ABSTRACT:
SUBMITTER: Horne J
PROVIDER: S-EPMC8249086 | biostudies-literature | 2020 Jan-Dec
REPOSITORIES: biostudies-literature
Publications
A critical examination of legal and ethical considerations for nutrigenetic testing with recommendations for improving regulation in Canada: from science to consumer.
Horne Justine J Gilliland Jason J Madill Janet J Shelley Jacob J
Journal of law and the biosciences 20200101 1
Similar Datasets
Project description:Digital Pathology (DP) is a platform which has the potential to develop a truly integrated and global pathology community. The generation of DP data at scale creates novel challenges for the histopathology community in managing, processing, and governing the use of these data. The current understanding of, and confidence in, the legal and ethical aspects of DP by pathologists is unknown. We developed an electronic survey (e-survey), comprising 22 questions, with input from the Royal College of Pathologists (RCPath) Digital Pathology Working Group. The e-survey was circulated via e-mail and social media (Twitter) through the RCPath Digital Pathology Working Group network, RCPath Trainee Committee network, the Pathology image data Lake for Analytics, Knowledge and Education (PathLAKE) digital pathology consortium, National Pathology Imaging Co-operative (NPIC), local contacts, and to the membership of both The Pathological Society of Great Britain and Ireland and the British Division of the International Academy of Pathology (BDIAP). Between 14 July 2020 and 6 September 2020, we collected 198 responses representing a cross section of histopathologists, including individuals with experience of DP research. We ascertained that, in the UK, DP is being used for diagnosis, research, and teaching, and that the platform is enabling data sharing. Our survey demonstrated that there is often a lack of confidence and understanding of the key issues of consent, legislation, and ethical guidelines. Of 198 respondents, 82 (41%) did not know when the use of digital scanned slide images would fall under the relevant legislation and 93 (47%) were 'Not confident at all' in their interpretation of consent for scanned slide images in research. With increasing uptake of DP, a working knowledge of these areas is essential but histopathologists often express a lack of confidence in these topics. The need for specific training in these areas is highlighted by the findings of this study.
| S-EPMC8822384 | biostudies-literature
Project description:Clinical trials to address the COVID-19 public health emergency have broadly excluded pregnant people from participation, illustrating a long-standing trend of clinical trial exclusion that has led to a clear knowledge gap and unmet need in the treatment and prevention of medical conditions experienced during pregnancy and of pregnancy-related conditions. Drugs (includes products such as drugs, biologics, biosimilars and vaccines) approved for a certain medical condition in adults are also approved for use in pregnant adults with the same medical condition, unless contraindicated for use in pregnancy. However, there are limited pregnancy-specific data on risks and benefits of drugs in pregnant people, despite their approval for all adults. The United States Food and Drug Administration-approved medical products are used widely by pregnant people, 90% of whom take at least 1 medication during the course of their pregnancy despite there being sparse data from clinical trials on these products in pregnancy. This overall lack of clinical data precludes informed decision-making, causing clinicians and pregnant patients to have to decide whether to pursue treatment without an adequate understanding of potential effects. Although some United States Food and Drug Administration initiatives and other federal efforts have helped to promote the inclusion of pregnant people in clinical research, broader collaboration and reforms are needed to address challenges related to the design and conduct of trials that enroll pregnant people, and to forge a culture of widespread inclusion of pregnant people in clinical research. This article summarizes the scientific, ethical, and legal considerations governing research conducted during pregnancy, as discussed during a recent subject matter expert convening held by the Duke-Margolis Center for Health Policy and the United States Food and Drug Administration on this topic. This article also recommends strategies for overcoming impediments to inclusion and trial conduct.
| S-EPMC9351207 | biostudies-literature
Project description:The international context of Indigenous mental health and wellbeing has been shaped by a number of key works recognizing Indigenous rights. Despite international recognitions, the mental health and wellness of Indigenous Peoples continues to be negatively affected by policies that ignore Indigenous rights, that frame colonization as historical rather than ongoing, or that minimize the impact of assimilation. Research institutions have a responsibility to conduct ethical research; yet institutional guidelines, principles, and policies often serve Indigenous Peoples poorly by enveloping them into Western knowledge production. To counter epistemological domination, Indigenous Peoples assert their research sovereignty, which for the purposes of this paper we define as autonomous control over research conducted on Indigenous territory or involving Indigenous Peoples. Indigenous sovereignty might also be applied to research impacting the landscape and the web of animal and spiritual lives evoked in a phrase such as "all my relations." This narrative review of material developed in the Canadian context examines the alignment with similar work in the international context to offer suggestions and a practice-based implementation tool to support Indigenous sovereignty in research related to wellness, mental health, and substance use. The compilation of key guidelines and principles in this article is only a start; addressing deeper issues requires a research paradigm shift.
| S-EPMC10866143 | biostudies-literature
Project description:In citizen science, in-depth interviews have advanced the understanding of project leaders' and citizen scientists' objectives, motivations, attitudes, and concerns. The issues encountered by researchers conducting in-depth interviews in citizen science are likely not unique to this field. However, these issues can surface and play out in distinct ways that depend on the scientific and sociopolitical circumstances of citizen science communities and projects. Researchers' experiences conducting in-depth interviews are the subject of a growing literature that describes considerations for conducting research with discrete populations. We aim to contribute to this literature by describing salient practical, ethical, and legal issues to consider when interviewing biomedical citizen scientists, with a focus on bottom-up biomedical citizen scientists who have loose or no affiliations with traditional scientific institutions. These issues concern how to define the interview population; earn trust and demonstrate trustworthiness given past treatment of bottom-up biomedical citizen scientists by traditional researchers and institutions; adapt research practices to the strong culture of openness that characterizes bottom-up biomedical citizen science; and manage potential safety concerns. This essay draws on our own experiences and those of other qualitative researchers and makes suggestions for addressing these issues in ways intended to protect study integrity and demonstrate respect for participants. We also identify questions that would benefit from broad input and continued study. Our objectives in sharing these lessons learned are to support future research and to improve understanding of this exciting participatory space.
| S-EPMC10238071 | biostudies-literature
Project description:BackgroundConsumer perceptions of legal cannabis products may drive willingness to purchase from the illegal or legal market; however, little is known on this topic. The current study examined perceptions of legal products among Canadian cannabis consumers over a 3-year period following federal legalization of non-medical cannabis in 2018.MethodsData were analyzed from Canadian respondents in the International Cannabis Policy Study, a repeat cross-sectional survey conducted in 2019-2021. Respondents were 15,311 past 12-month cannabis consumers of legal age to purchase cannabis. Weighted logistic regression models examined the association between perceptions of legal cannabis and province of residence, and frequency of cannabis use over time.ResultsIn 2021, cannabis consumers perceived legal cannabis to be safer to buy (54.0%), more convenient to buy (47.8%), more expensive (47.2%), safer to use (46.8%) and higher quality (29.3%) than illegal cannabis. Except for safety of purchasing, consumers had more favourable perceptions of legal cannabis in 2021 than 2019 across all outcomes. For example, consumers had higher odds of perceiving legal cannabis as more convenient to buy in 2021 than 2019 (AOR = 3.09, 95%CI: 2.65,3.60). More frequent consumers had less favourable perceptions of legal cannabis than less frequent consumers.ConclusionsThree years since legalization, Canadian cannabis consumers generally had increasingly favourable perceptions of legal vs. illegal products - except for price - with variation across the provinces and frequency of cannabis use. To achieve public health objectives of legalization, federal and provincial governments must ensure that legal cannabis products are preferred to illegal, without appealing to non-consumers.
| S-EPMC9644504 | biostudies-literature
Project description:Much of the fear and uncertainty around Zika epidemics stem from potential association between Zika virus (ZIKV) complications on infected pregnant women and risk of their babies being born with microcephaly and other neurological abnormalities. However, much remains unknown about its mode of transmission, diagnosis and long-term pathogenesis. Worries of these unknowns necessitate the need for effective and efficient psychosocial programs and medical-legal strategies to alleviate and mitigate ZIKV related burdens. In this light, local and global efforts in maintaining fundamental health principles of moral, medical and legal decision-making policies, and interventions to preserve and promote individual and collectiveHuman Rights, autonomy, protection of the most vulnerable, equity, dignity, integrity and beneficence that should not be confused and relegated by compassionate humanitarian assistance and support. This paper explores the potential medical and ethical-legal implications of ZIKV epidemics emergency response packages and strategies alongside optimizing reproductive and mental health policies, programs and best practice measures. Further long-term cross-borders operational research is required in elucidating Zika-related population-based epidemiology, ethical-medical and societal implications in guiding evidence-based local and global ZIKV maternal-child health complications related approaches and interventions. Core programs and interventions including future Zika safe and effective vaccines for global Zika immunization program in most vulnerable and affected countries and worldwide should be prioritized.
| S-EPMC5574124 | biostudies-literature
Project description:ObjectivesThe objective was to identify and describe the published guidance and current academic discourse of ethical issues and standards related to the use of Social Media Research for generating patient insights for the use by health technology assessment (HTA) or health policy decisions.MethodsA scoping review of the literature was conducted in PubMed and Embase and identified 935 potential references published between January 2017 and June 2021. After title and abstract screening by three reviewers, 40 publications were included, the relevant information was extracted and data were collected in a mind map, which was then used to structure the output of the review.ResultsSocial Media Research may reveal new insights of relevance to HTA or health policies into patient needs, patient experiences, or patient behaviors. However, the research approaches, methods, data use, interpretation, and communication may expose those who post the data in social media channels to risks and potential harms relating to privacy, anonymity/confidentiality, authenticity, context, and rapidly changing technologies.ConclusionsAn actively engaged approach to ensuring ethical innocuousness is recommended that carefully follows best practices throughout planning, conduct, and communication of the research. Throughout the process and as a follow-up, there should be a discourse with the ethical experts to maximally protect the current and future users of social media, to support their trust in the research, and to advance the knowledge in parallel to the advancement of the media themselves, the technologies, and the research tools.
| S-EPMC11570170 | biostudies-literature
Project description:Direct-to-consumer genetic testing (DTC-GT) is becoming increasingly widespread. The aim of this research was to systematically review the literature published on healthcare professionals' knowledge and views about DTC-GT, as an update to a 2012 systematic review. The secondary aim was to assess the knowledge and views of healthcare professionals on the ethical and legal issues pertaining to DTC-GT. A systematic search was performed to identify all relevant studies that have been conducted since 2012. Studies fulfilled the inclusion criteria if they were primary research papers conducted on healthcare professionals about their knowledge and views on health-related DTC-GT. PubMed, Embase, CINAHL, PsycINFO and Medline databases were searched from 2012 to May 2021. Title and abstract were screened, and full texts were reviewed by two study authors independently. New papers included were appraised and data were extracted on study characteristics, knowledge and views on DTC-GT, and ethical and legal issues. A narrative synthesis was conducted. Nineteen new papers were included, along with eight papers from the previous review. There was considerable variation in study participants with differing views, awareness levels, and levels of knowledge about DTC-GT. Genetic counsellors and clinical geneticists generally had more concerns, experience, and knowledge regarding DTC-GT. Ten ethical concerns and four legal concerns were identified. Healthcare professionals' knowledge and experience of DTC-GT, including awareness of DTC-GT ethical and legal concerns, have only minimally improved since the previous review. This emphasises the need for further medical learning opportunities to improve the gaps in knowledge amongst healthcare professionals about DTC-GT.
| S-EPMC9553629 | biostudies-literature
Project description: Not available
| S-EPMC11015037 | biostudies-literature
Project description:Neuroscience research is producing big brain data which informs both advancements in neuroscience research and drives the development of advanced datasets to provide advanced medical solutions. These brain data are produced under different jurisdictions in different formats and are governed under different regulations. The governance of data has become essential and critical resulting in the development of various governance structures to ensure that the quality, availability, findability, accessibility, usability, and utility of data is maintained. Furthermore, data governance is influenced by various ethical and legal principles. However, it is still not clear what ethical and legal principles should be used as a standard or baseline when managing brain data due to varying practices and evolving concepts. Therefore, this study asks what ethical and legal principles shape the current brain data governance landscape? A systematic scoping review and thematic analysis of articles focused on biomedical, neuro and brain data governance was carried out to identify the ethical and legal principles which shape the current brain data governance landscape. The results revealed that there is currently a large variation of how the principles are presented and discussions around the terms are very multidimensional. Some of the principles are still at their infancy and are barely visible. A range of principles emerged during the thematic analysis providing a potential list of principles which can provide a more comprehensive framework for brain data governance and a conceptual expansion of neuroethics.
| S-EPMC9799320 | biostudies-literature