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Several recent gene patent controversies have energized and refocused the human gene patent debate in Canada. These include the use of the Myriad test for breast cancer by the provinces, patenting of the Severe Acute Respiratory Syndrome virus and a recent Supreme Court decision rejecting the patenting of 'higher life forms'. These cases place the emerging policy conflicts between the innovation and commercialization agenda of the government and the desire to provide equitable access to health care in sharp focus. Another challenge faced by Canada is the powerful influence of the United States in policy decisions. Although these issues have raised awareness about the possibility of reforming the patent system, Parliament has yet to consider any of the suggested reforms of the Canadian patent system and there are no formal proposals pending.

Governments and financial institutions in several jurisdictions are planning or implementing nonmedical/'forced' switches by cutting drug coverage for reference biologics and funding only less expensive biosimilars. Switches raise numerous ethical and legal challenges, as the drugs are framed as not being identical and, despite strong evidence for noninferiority of some biosimilars, there is controversy over whether switching can sometimes lead to adverse events. Canadian law generally requires physicians to give precedence to their patients' best interests over social interests such as cost containment. The primacy of patients' interests is also clearly reflected in professional policies and codes of ethics. Moreover, physicians are obligated to disclose everything a reasonable person in the patient's position would want to know when obtaining informed consent for treatment, including addressing not only scientific information but also relevant social controversy about nonmedical switches. Under Canadian law, physicians may be obligated to tell patients about the ability to access unfunded biologics, even if patients lack the resources to obtain them. In sum, while there is no inherent right to funding for reference biologics in Canada, physicians in some circumstances may have a legal obligation as fiduciaries to advocate on behalf of patients to remain on a reference biologic. At a minimum, the controversy surrounding switching will necessitate, as part of the consent process, a robust and thorough disclosure of relevant risks, benefits and reasonable alternatives.

Article ; Cet article de revue examine les préoccupations éthiques lors de recherches menées chez les usagers potentiellement vulnérables de drogues injectables (PWID) dans un contexte canadien. L'Énoncé de politique des trois Conseils : Éthique de la recherche avec des êtres humains aborde un large éventail de principes traditionnels de l'éthique de la recherche concernant les personnes vulnérables mais le fait au détriment de la clarté et de la précision. La vulnérabilité est contextuelle plutôt qu'absolue. Dans le cadre de recherche auprès des personnes vulnérables, le consentement éclairé devrait être obtenu par une personne indépendante et la compréhension devrait être vérifiée à l'aide d'un questionnaire. Les participants peuvent être vulnérables en raison de nombreux facteurs, notamment la toxicomanie, les maladies chroniques, le statut socio-économique et ethnique et le faible niveau d'éducation. La capacité de PWID à donner un consentement éclairé peut être compromis par une influence indue ou une intoxication mais les recherches existantes montrent que ni le mode ni l'ampleur de l'indemnisation n'ont un effet significatif sur les nouveaux taux de consommation de drogues. L'indemnisation peut également contribuer à dissiper la méprise thérapeutique. L'intoxication plutôt que l'influence indue est la principale préoccupation lors de l'obtention du consentement éclairé des PWID. La stigmatisation des PWID comme incapables de consentir devrait être évitée. L'exclusion paternaliste de la recherche peut nuire aux PWID et exacerber leur vulnérabilité en réduisant notre connaissance et notre capacité à les traiter spécifiquement. En tant que tel, nous devons recueillir de meilleures données concernant les effets des politiques d'éthique de la recherche. Les études menées à ce sujet devraient être axées sur les expériences, les perspectives et les besoins des participants à la recherche qui sont potentiellement vulnérables. Les comités d'éthique de la recherche au Canada devraient adopter une approche fondée sur des preuves lors de l'application du pouvoir discrétionnaire pour les propositions en recherche clinique. ; This review article considers ethical concerns when doing research on potentially vulnerable people who inject drugs (PWID) in a Canadian context. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans broadly addresses many of the traditional ethical principles of research on vulnerable persons, but does so at the cost of clarity and precision. Vulnerability is contextual rather than absolute. When doing research with vulnerable persons, informed consent should be obtained from an independent person, and comprehension should be checked using questioning. Participants can be vulnerable due to many factors, including addiction, chronic disease, socioeconomic and racial status, and lack of education. The ability of PWID to give informed consent can be compromised by undue influence or intoxication, but existing research shows that neither the mode nor the magnitude of compensation has a significant effect on new rates of drug use. Compensation can also help dispel the therapeutic misconception. Intoxication rather than undue influence is the main concern when obtaining informed consent from PWID. The stigmatization of PWID as incapable of consent should be avoided. Paternalistic exclusion from research can harm PWID and exacerbate their vulnerability by reducing our knowledge of and ability to specifically treat them. As such, we must collect better data about the effects of research ethics policies. Studies to this effect should focus on experiences, perspectives and needs of potentially vulnerable research participants. Research ethics boards in Canada should adopt an evidence-based approach when applying discretionary power to proposals for clinical research.

An increasing number of genetic tests are moving from the laboratory to the clinical setting. It seems an appropriate time to assess the interest and receptivity of the public toward genetic testing services. This is particularly so given the concerns that have been expressed about the commercialization of genetic testing technologies. To this end, the paper begins with an overview of the concerns and benefits associated with commercialization. This is followed by a review of a selection of survey data relevant to the potential 'genetic testing market' (i.e., the attitudes, perceptions and knowledge of the public, patients and professionals). We conclude that although emerging data and past experience suggest that the actual uptake of genetic tests may fall short of expectations, the strong public interest and perceived right of access disclosed in the survey research indicate a future potential for a large testing market. As such, the concerns associated with the commercialization process warrant careful consideration.

The COVID-19 pandemic has created communication challenges exacerbated by the circulation of misinformation and the politicization of science. The case of hydroxychloroquine is an illustrative example, with the drug being aggressively promoted as a cure even while emerging evidence demonstrated the contrary. This research analyzed how hydroxychloroquine discussions took place on Twitter from 21 to 28 April 2020, a key period in developments around the drug. We collected, in real time, tweets with "hydroxychloroquine" over this period, which resulted in a dataset of nearly one million tweets from over 350,000 Twitter accounts. Our content analysis provides specific details of how hydroxychloroquine was promoted and critiqued, and which accounts were tweeting. Findings showed a highly polarized environment with active bots and conspiracy propagators, where political perspectives dominated the Twittersphere in the place of science-focused discussions.

Abstract Background No two countries have adopted identical regulatory measures on cloning. Understanding the complexity of these regulatory variations is essential. It highlights the challenges associated with the regulation of a controversial and rapidly evolving area of science and sheds light on a regulatory framework that can accommodate this reality. Methods Using the most reliable information available, we have performed a survey of the regulatory position of thirty countries around the world regarding the creation and use of cloned embryos (see Table 1 ). We have relied on original and translated legislation, as well as published sources and personal communications. We have examined the regulation of both reproductive cloning (RC) and non-reproductive cloning (NRC). Results While most of the countries studied have enacted national legislation, the absence of legislation in seven of these countries should not be equated with the absence of regulation. Senator Morin was not correct in stating that the majority of recent legislation bans both RC and NRC. Recent regulatory moves are united only with regard to the banning of RC. While NRC is not permitted in seventeen of the countries examined, it could be permitted in up to thirteen countries. Conclusions There is little consensus on the various approaches to cloning laws and policies, and the regulatory position in many countries remains uncertain.

The obligation to maintain the privacy of patients and research participants is foundational to biomedical research. But there is growing concern about the challenges of keeping participant information private and confidential. A number of recent studies have highlighted how emerging computational strategies can be used to identify or reidentify individuals in health data repositories managed by public or private institutions. Some commentators have suggested the entire concept of privacy and anonymity is "dead", and this raises legal and ethical questions about the consent process and safeguards relating to health privacy. Members of the public and research participants value privacy highly, and inability to ensure it could affect participation. Canadian common law and legislation require a full and comprehensive disclosure of risks during informed consent, including anything a reasonable person in the participant or patient's position would want to know. Research ethics policies require similar disclosures, as well as full descriptions of privacy related risks and mitigation strategies at the time of consent. In addition, the right to withdraw from research gives rise to a need for ongoing consent, and material information about changes in privacy risk must be disclosed. Given the research ethics concept of "non-identifiability" is increasingly questionable, policies based around it may be rendered untenable. Indeed, the potential inability to ensure anonymity could have significant ramifications for the research enterprise. ; L'obligation de préserver la vie privée des patients et des participants à la recherche est fondamentale en recherche biomédicale. Toutefois, les défis à relever pour maintenir la confidentialité des informations sur les participants suscitent une inquiétude croissante. Un certain nombre d'études récentes a mis en évidence les manières d'utiliser les nouvelles stratégies informatiques pour identifier ou réidentifier les personnes dans les banques de données de santé gérées par des institutions publiques ou privées. Certains commentateurs ont laissé entendre que les concepts de vie privée et d'anonymat sont "morts" dans leur ensemble, ce qui soulève des questions juridiques et éthiques sur le processus de consentement et sur les garanties relatives à la protection de la vie privée en matière de santé. Les membres du public et les participants à la recherche accordent une grande importance à la protection de la vie privée, et l'incapacité à garantir celle-ci pourrait avoir une incidence sur la participation. La common law et la législation canadienne exigent une divulgation complète et exhaustive des risques lors du consentement éclairé, y compris tout ce qu'une personne raisonnable dans la position du participant ou du patient voudrait savoir. Les politiques en matière d'éthique de la recherche exigent des divulgations similaires, ainsi que des descriptions complètes des risques liés à la vie privée et des stratégies d'atténuation lors du consentement. En outre, le droit de se retirer de la recherche entraîne la nécessité d'un consentement continu, et toute information sur l'évolution du risque pour la vie privée doit être divulguée. Étant donné que le concept de "non-identifiabilité" en matière d'éthique de la recherche est de plus en plus discutable, les politiques qui s'y rattachent pourraient devenir intenables. En effet, l'incapacité potentielle à garantir l'anonymat pourrait avoir des conséquences importantes sur l'activité de recherche.

BACKGROUND: Private umbilical cord blood banking is a for-profit industry in which parents pay to store blood for potential future use. Governments have noted the tendency for private banks to oversell the potential for cord blood use, especially in relation to speculative cell therapies not yet supported by clinical evidence. We assessed the regulatory landscape governing private cord bank marketing in Canada. MAIN BODY: Because the problematic marketing of private cord blood banking for future use often relates to speculative future cell therapies that do not exist and are not being advertised for current clinical use, most private blood bank marketing seems to fall outside Health Canada's regulatory scope. However, this problematic marketing is regulated by the Competition Bureau pursuant to the Competition Act. While representations relating to future hypothetical treatments may not always be subject to the legal requirement for claim substantiation, the law also prohibits individuals and companies from knowingly or recklessly making representations that are "false or misleading in a material respect." A representation is materially false or misleading when it could "influence a consumer's behavior or purchasing decisions," and consumers are likely to be considered to be "credulous and inexperienced" for the purposes of assessing an advertisement's general impression. Because all of the potential benefit of the banking is derived from the potential future use of the biological material for health interventions directed toward the customers and their relatives, and because we know the best available medical evidence indicates a very low probability of utility in this context, we can say with confidence that some private cord blood banking claims are materially misleading. Moreover, to the extent that medical professionals are involved in private bank interactions with customers or hold ownership stakes in private banks, they are subject to professional codes, standards of practice, and potentially fiduciary ...

Abstract Purpose of review To date, there has been little analysis of the degree to which emerging incentive initiatives are permissible under Canadian law. The purpose of this review is to examine the relevant law – including legislation and case law – in order to clarify the legality of existing proposed incentive schemes. Sources of information Legislation and case law. Findings Organ donation is governed by provincial legislation that, in general, bans the exchange of any "benefit" or any form of "valuable consideration" in return for an organ. As such, these laws are tremendously restrictive and could have significant implications for emerging and proposed procurement policy. Implications Given the need for innovative, ethically appropriate policies to increase donation rates, we suggest that the time is right to rethink the potentially restrictive nature of Canada's organ donation laws.

A clear income gradient exists for the sport and physical activity (PA) participation of Canadian children. Governments in Canada recently introduced tax credits to alleviate the financial burden associated with registering a child in organized physical activity (including sport). The majority of these credits, including the Children's Fitness Tax Credit, are non-refundable (i.e., reduces the amount of income tax a person pays). Such credits are useful only for individuals who incur a certain level of tax liability. Thus, low-income families who may pay little or no income tax will not benefit from the presence of non-refundable tax credits. In this commentary, we argue that the non-refundable tax credit is inherently inequitable for promoting PA. We suggest that a combination of refundable tax credits and subsidized programming for low-income children would be more equitable than the current approach of the Canadian government and several provinces that are expending approximately $200 million to support these credits.

Abstract Background Understanding the perception of patients on research ethics issues related to biobanking is important to enrich ethical discourse and help inform policy. Methods We examined the views of leukemia patients undergoing treatment in clinics located in the Princess Margaret Hospital in Toronto, Ontario, Canada. An initial written survey was provided to 100 patients (64.1% response rate) followed by a follow-up survey (62.5% response rate) covering the topics of informed consent, withdrawal, anonymity, incidental findings and the return of results, ownership, and trust. Results The majority (59.6%) preferred one-time consent, 30.3% desired a tiered consent approach that provides multiple options, and 10.1% preferred re-consent for future research. When asked different questions on re-consent, most (58%) reported that re-consent was a waste of time and money, but 51.7% indicated they would feel respected and involved if asked to re-consent. The majority of patients (62.2%) stated they had a right to withdraw their consent, but many changed their mind in the follow-up survey explaining that they should not have the right to withdraw consent. Nearly all of the patients (98%) desired being informed of incidental health findings and explained that the information was useful. Of these, 67.3% of patients preferred that researchers inform them and their doctors of the results. The majority of patients (62.2%) stated that the research institution owns the samples whereas 19.4% stated that the participants owned their samples. Patients had a great deal of trust in doctors, hospitals and government-funded university researchers, moderate levels of trust for provincial governments and industry-funded university researchers, and low levels of trust towards industry and insurance companies. Conclusions Many cancer patients surveyed preferred a one-time consent although others desired some form of control. The majority of participants wanted a continuing right to withdraw consent and nearly all wanted to be informed of incidental findings related to their health. Patients had a great deal of trust in their medical professionals and publically-funded researchers as opposed to profit-based industries and insurance companies.

At present there is an enormous discrepancy between our nanotechnological capabilities (particularly our nanobiotechnologies), our social wisdom, and consensus on how to apply them. To date, cost considerations have greatly constrained our application of nanotechnologies. However, novel advances in microsystem platform technologies are about to greatly diminish that economic constraint while developing new industries. Properly used in a solid legal and ethical framework, within an educated population, these advances will vastly enrich our quality of life without being intrusive. Improperly used, these technologies could lead to a modern-day Luddism, social turmoil, or possibly even to emulating those societies described in the darkest of novels. These technologies must be developed in tandem with the social and legal frameworks needed to ensure that they improve both individuals and our society. To ensure that this occurs, we need to have the ethical, legal, scientific, and engineering experts working together and with the public.