Reconsenting paediatric research participants for use of identifying data.

When a minor research participant reaches the age of majority or the level of maturity necessary to be granted legal decision-making capacity, reconsent can be required for ongoing participation in research or use of health information and banked biological materials. Despite potential logistical concerns with implementation and ethical questions about the trade-offs between maximising respect for participant agency and facilitating research that may generate benefits, reconsent is the approach most consistent with both law and research ethics.Canadian common law consent requirements are expansive and likely compel reconsent on obtaining capacity. Common law doctrine recognises that children are entitled to decision-making authority that reflects their evolving intelligence and understanding. Health consent legislation varies by province but generally either compels reconsent on obtaining capacity or delegates the ability to determine reconsent to research ethics boards. These boards largely rely on the Canada's national ethics policy, the Tri-Council Policy Statement, which states that, with few exceptions, reconsent for continued participation is required when minors gain capacity that would allow them to consent to the research in which they participate. A strict interpretation of this policy could require researchers to perform frequent capacity assessments, potentially presenting feasibility concerns. In addition, Canadian policy and law are generally consistent with the core principles of key international ethical standards from the United Nations and elsewhere.In sum, reconsent of paediatric participants upon obtaining capacity should be explicit and informed in Canada, and should not be presumed from continued participation alone.

Privacy and artificial intelligence: challenges for protecting health information in a new era.

BACKGROUND: Advances in healthcare artificial intelligence (AI) are occurring rapidly and there is a growing discussion about managing its development. Many AI technologies end up owned and controlled by private entities. The nature of the implementation of AI could mean such corporations, clinics and public bodies will have a greater than typical role in obtaining, utilizing and protecting patient health information. This raises privacy issues relating to implementation and data security. MAIN BODY: The first set of concerns includes access, use and control of patient data in private hands. Some recent public-private partnerships for implementing AI have resulted in poor protection of privacy. As such, there have been calls for greater systemic oversight of big data health research. Appropriate safeguards must be in place to maintain privacy and patient agency. Private custodians of data can be impacted by competing goals and should be structurally encouraged to ensure data protection and to deter alternative use thereof. Another set of concerns relates to the external risk of privacy breaches through AI-driven methods. The ability to deidentify or anonymize patient health data may be compromised or even nullified in light of new algorithms that have successfully reidentified such data. This could increase the risk to patient data under private custodianship. CONCLUSIONS: We are currently in a familiar situation in which regulation and oversight risk falling behind the technologies they govern. Regulation should emphasize patient agency and consent, and should encourage increasingly sophisticated methods of data anonymization and protection.

Peddling promise? An analysis of private umbilical cord blood banking company websites in Canada.

Private umbilical cord blood banking is growing around the world. A family's decision to bank cord blood publicly or privately can be influenced by numerous sources including healthcare practitioners, personal networks, the popular press, social media and marketing discourse from private entities. Issues have been raised concerning how private banks market their services, particularly with regards to the likelihood of use and for what purposes cord blood can be used. The objective of this study was to analyze the marketing on the seven company websites offering private cord blood storage in Canada. We performed a mix of content and general qualitative analysis on the seven websites. Our analysis shows substantial hype around cord blood uses, amplifying the promise of speculative uses and distorting the likelihood of use. Findings show that this promotional messaging often deploys communication strategies which draw on testimonials and emotionally-charged narratives. Questions should be asked about whether the promissory aspects of these websites constitute breaches of Canadian law or regulation. Careful monitoring of the private cord blood space is important for ensuring that the Canadian public is adequately and accurately informed of the services being offered.

Genes, cells, and biobanks: Yes, there's still a consent problem.

From a research perspective, the interest in biobanking continues to intensify. Governments and industry have invested heavily in biobanks, as exemplified by initiatives like the United Kingdom Biobank and United States' Precision Medicine Initiative. But despite this enthusiasm, many profound legal and ethical challenges remain unresolved. Indeed, there continues to be disagreements about how best to obtain consent and the degree and nature of control that research participants retain over donated samples and health information. Emerging social trends-including concerns about commercialization and perceived rights of continuing control ("biorights")-seem likely to intensify these issues.

Non-Invasive Prenatal Screening: Navigating the Relevant Legal Norms.

The implementation of non-invasive prenatal screening (NIPS) in Canada will be affected by legal norms. The law can shape physician behaviour, help to crystallize standards of care, influence utilization patterns, and reflect and reinforce patient expectations. In Canada, failure to inform a patient about NIPS, or misinterpretation of NIPS results, could result in a successful "wrongful birth" claim if the patient subsequently gives birth to a child with a condition that had been detectable. Given that research shows that physicians' decisions are influenced by concerns about liability, malpractice law seems likely to encourage increased recommendation and use of NIPS. Physicians' fiduciary and negligence-based disclosure standards require they consider both objective factors as well as a specific patient's subjective and reasonable beliefs, fears, desires, and expectations. Thus, physicians likely must address dominant public discourses and controversies relevant to NIPS. Given the existence of spin, hype, and misinformation about NIPS, there is an increasing need for a robust consent process and, when appropriate, genetic counselling. In sum, the law will define and bound the acceptable behaviour of physicians recommending or administering NIPS, and nudge the technology's implementation forward. Physicians and policymakers should be aware of the potential impact of these legal norms on both utilization and public expectations.

The law and problematic marketing by private umbilical cord blood banks.

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 obligations that further prohibit misleading marketing. CONCLUSIONS: Private cord blood bank marketing that advertises hypothetical future treatments can be misleading and may influence consumer behaviour. This marketing may breach existing advertising law. Regulatory bodies should enforce the law in order to help prevent public health and personal financial harm.

Regulatory and policy tools to address unproven stem cell interventions in Canada: the need for action.

BACKGROUND: The marketing of unproven direct-to-consumer stem cell interventions is becoming widespread in Canada. There is little evidence supporting their use and they have been associated with a range of harms. Canada has been slower to act against clinics offering these interventions than other jurisdictions, including the United States. Here, we outline the regulatory and policy tools available in Canada to address this growing problem. MAIN BODY: Health Canada's regulations governing cell therapies are complex, but recent statements make it clear that Health Canada believes it has jurisdiction over many of the currently marketed stem cell interventions. Still, further regulatory clarity is needed from Health Canada, as are increased directed enforcement efforts on interventions that fall within their scope. The Competition Bureau, via the Competition Act, prohibits advertisers from making materially false or misleading promotional representations. The Competition Bureau could collaborate with the scientific community to analyze the claims of existing clinics in Canada, and impose sanctions upon those who breach the established standard. Professional regulators, including provincial colleges of physicians and surgeons, have considerable power over what products and services their members can offer. Every college of physicians in Canada requires, via policy and codes of ethics, that doctors maintain evidence-based practices. This requirement is incompatible with offering many unproven stem cell interventions. Litigation may be another tool, including the use of fraud, misrepresentation and/or negligence claims for failing to meet the required standard of care. Finally, political pressure on federal and provincial lawmakers could encourage changes to marketing, cell therapy and professional regulations that would allow a more comprehensive response. CONCLUSIONS: In sum, there are many existing tools that can be used to protect the public from unproven stem cell interventions. Increased bureaucratic will and grassroots efforts are needed in order to effect a positive policy response.

Non-invasive Prenatal Testing and the Unveiling of an Impaired Translation Process.

Non-invasive prenatal testing (NIPT) is an exciting technology with the potential to provide a variety of clinical benefits, including a reduction in miscarriages, via a decline in invasive testing. However, there is also concern that the economic and near-future clinical benefits of NIPT have been overstated and the potential limitations and harms underplayed. NIPT, therefore, presents an opportunity to explore the ways in which a range of social pressures and policies can influence the translation, implementation, and use of a health care innovation. NIPT is often framed as a potential first tier screen that should be offered to all pregnant women, despite concerns over cost-effectiveness. Multiple forces have contributed to a problematic translational environment in Canada, creating pressure towards first tier implementation. Governments have contributed to commercialization pressure by framing the publicly funded research sector as a potential engine of economic growth. Members of industry have an incentive to frame clinical value as beneficial to the broadest possible cohort in order to maximize market size. Many studies of NIPT were directly funded and performed by private industry in laboratories lacking strong independent oversight. Physicians' fear of potential liability for failing to recommend NIPT may further drive widespread uptake. Broad social endorsement, when combined with these translation pressures, could result in the "routinization" of NIPT, thereby adversely affecting women's reproductive autonomy. Policymakers should demand robust independent evidence of clinical and public health utility relevant to their respective jurisdictions before making decisions regarding public funding for NIPT.

Communicating About Precision Transplantation Tools.

Purpose of review: Precision tools that ensure molecular compatibility can help prevent rejection and improve kidney transplantation outcomes. However, these tools will generate controversy because they are perceived to and can in fact impact equity in the ethics of allocation. They may also affect the extent to which physicians can advocate for their patient fiduciaries, as generally required by Canadian professional ethics and law. Sources of information: Electronic databases such as Google Scholar and PubMed were searched for peer-reviewed literature, and Google search engine was used to identify the news articles, jurisprudence, legal information, and other relevant websites cited. Methods: We discuss controversies precision transplantation tools will likely generate, consider what challenges will arise from their implementation, and provide recommendations of avenues and content for communication to address these issues. Key findings: Communication about the translation of new precision tools will be challenging as media portrayals of transplantation often focus on individual narratives about access to transplantation and fail to center the issues of utility, allocation, and rejection. Incomplete portrayals of this nature will need to be countered with explanations of how new precision tools can be of net benefit when implemented equitably, as maintaining trust in the donation and transplantation system is key. Limitations: Our manuscript focuses on precision medicine applications pertaining to the implementation of molecular compatibility in transplantation. Distinct communication content and avenues may need to be considered in other contexts. Implications: Clear, accurate, and strategic communication is key to managing translation of precision medicine tools. For this purpose, we provide detailed recommendations for stakeholder engagement, content, and avenues for communicating about precision transplantation tools.

Motif de la revue: Les outils de précision assurant la compatibilité moléculaire peuvent aider à prévenir le rejet et à améliorer les résultats de la transplantation rénale. Or, ces outils susciteront une controverse parce qu'ils sont perçus comme ayant une incidence sur l'équité dans l'éthique de l'allocation, et qu'ils peuvent effectivement en avoir une. Ces outils sont également susceptibles d'influer sur les limites au sein desquelles les médecins peuvent défendre les intérêts de leurs patients fiduciaires, comme l'exigent l'éthique professionnelle et le droit canadien. Sources: Des bases de données électroniques telles que Google Scholar et PubMed ont été consultées à la recherche de la documentation évaluée par des pairs. Le moteur de recherche Google a servi à répertorier les articles de presse, la jurisprudence, les informations juridiques et les autres sites Web pertinents cités. Méthodologie: Nous discutons des controverses qui seront vraisemblablement générées par les nouveaux outils de précision liés à la transplantation. Nous examinons également les défis qui découleront de leur mise en œuvre et nous formulons des recommandations sur les stratégies et le contenu à adopter dans les communications qui aborderont ces questions. Principales observations: La communication entourant l'application des nouveaux outils de précision posera un défi, car les représentations médiatiques de la transplantation se concentrent le plus souvent sur des récits individuels liés à l'accès à la transplantation, et ne mettent pas en lumière les problèmes liés à l'utilité, l'attribution et le rejet. Ces représentations incomplètes devront être contrebalancées par des explications sur la façon dont les nouveaux outils de précision pourront être bénéfiques s'ils sont mis en œuvre équitablement; car il est essentiel de maintenir la confiance dans le système de don et de transplantation. Limites: Notre article porte sur les applications de la médecine de précision en lien avec la mise en œuvre d'outils mesurant la compatibilité moléculaire en transplantation. Il faudra possiblement envisager des stratégies et un contenu de communication distincts dans d'autres contextes. Conclusion: Une stratégie de communication claire et précise est essentielle pour gérer l'application des outils de la médecine de précision. À cette fin, nous fournissons des recommandations détaillées sur l'engagement des intervenants, ainsi qu'en matière de contenu et de stratégies pour les communications liées aux nouveaux outils de précision en transplantation.

Demographic and psychometric predictors associated with engagement in risk-associated alternative healthcare behaviours.

This paper builds on prior work exploring the use of risk-associated alternative healthcare (RAAH) in Canada. RAAH uptake was surveyed to explore the characteristics of adult RAAH users and the value of established psychometric instruments previously used in alternative healthcare studies in predicting RAAH behaviours: the Control Beliefs Inventory (CBI), the Reward Responsiveness Behavioural Activation System (RBAS) scale, the Positive Attitudes to Science (PAS) scale, the Satisfaction with Orthodox Medicine (SOM) scale, and the brief version of the Susceptibility to Persuasion-II (StP-II-B) scale. Findings suggest RAAH is influenced by gender, age, income, education, employment, chronic illness status, and ethnicity. Engagement in some form of RAAH was common (around 40%) and the most common types of RAAH use reported were physical manipulation and herbal/nutritional supplement use. Other higher-risk AH activities (such as use of toxins and physically invasive procedures) were also reported by about 5% of respondents. The StP-II-B and PAS instruments were predictive of the likelihood of engagement in RAAH behaviours, as illustrated by higher risk tolerance, desire for novelty, positive attitude to advertising and social influence, and positive beliefs about science. The CBI, RBAS, and SOM instruments were not predictive overall. However, the CBI and SOM instruments were predictive of engagement with physical manipulative RAAH activities, while the RBAS was predictive of herbal/nutritional RAAH engagement. These findings can help inform health professionals' understanding of public health-seeking behaviours with respect to risk.

A taxonomy of risk-associated alternative health practices: A Delphi study.

Defining alternative health care and the recording of associated adverse events and harm remains problematic. This Canadian study aimed to establish and classify risk-associated alternative health practices in a Delphi study undertaken with an interdisciplinary panel of 17 health experts in 2020. It provides a new functional definition of alternative health care and an initial taxonomy of risk-associated alternative health care practices. A number of risk-associated practices were identified and categorized into general practices that conflict with biomedical care or largely untested therapies, alternative beliefs systems, physical manipulative alternative therapies, and herbal and nutritional supplements. Some risk significant harms including major physical injuries or even death. The lack of systematic methods for recording adverse events in alternative health care makes establishing the frequency of such events challenging. However, it is important that people engaging with alternative health care understand they are not necessarily risk-free endeavours, and what those risks are.

Compelled Disclosure of Confidential Information in Patient Safety Research.

ABSTRACT: The protection of confidential research data is of key importance to clinical patient safety research. A review of selected Canadian and American case law indicates that although the relationship between researcher and participant has not been recognized as privileged, court-ordered disclosure of confidential research information seems to be a rare occurrence. In this review, we examine how confidentiality issues are presented in informed consent form templates and in relevant research ethics policies. We find an agreement among research policy documents that all information gathered should be treated as confidential, unless otherwise required by law. Confidentiality provisions in informed consent forms reflect the reality that in some cases, the law can compel disclosure of confidential data. There is, therefore, a potential tension between the law and existing research ethics policy. It has been suggested that researchers have an ethical and possibly legal duty to actively resist disclosure requests. We conclude that it is reasonable for researchers to disclose, as part of the informed consent process, how rare successful disclosure demands are and that steps will be taken to oppose such demands.

The Law and Ethics of Switching from Biologic to Biosimilar in Canada.

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.

Policy Challenges for Organ Allocation in an Era of "Precision Medicine".

There is increasing interest in the use of precision medicine tools and evidence-based outcome measures for donor-recipient matching to optimize transplant outcomes. Although the shift toward greater precision can provide health and resource benefits, it may be perceived as conflicting with both established equity-focused organ allocation norms and the legal and ethical obligations of health care providers and related institutions. With increasing evidence that various forms of human leukocyte antigen (HLA) mismatch and/or prognostic biomarkers can affect outcomes, the tension between maximizing utility and ensuring equity seems likely to intensify. In Canada, health care providers are generally required by law to put the interests of their patient, such as access to an organ, above the needs of the health care system and other patients. In addition, transplantation right of access lawsuits, which have been successful in the past, could affect the implementation of precision approaches. These legal tensions could be further heightened by media representations, which have historically favored strong rights of access. When implementing new precision technologies in organ allocation, there will be a recurrent need for policymakers to revisit the balance of equity and utility and to assess how to craft rules that reflect our society's conception of a fair allocation system.

Les outils de la médecine de précision et les mesures de résultats fondées sur des données probantes suscitent de plus en plus d'intérêt pour le couplage donneur-receveur afin d'optimiser le résultat d'une transplantation. Bien qu'une plus grande précision offre des avantages sur la santé et pour les ressources, elle peut être perçue comme entrant en conflit avec les normes d'attribution des organes axées sur l'équité, et avec les obligations éthiques et juridiques des fournisseurs de soins et des établissements auxquels ils sont rattachés. Avec le nombre croissant de preuves indiquant que diverses formes d'incompatibilité HLA ou de biomarqueurs pronostiques peuvent affecter les résultats, le différend opposant l'augmentation de leur utilisation au respect de l'équité risque de s'accentuer. Au Canada, les fournisseurs de soins sont légalement tenus de placer l'intérêt du patient, tel que l'accès à un organe, devant les besoins du système de santé et des autres patients. De plus, la mise en œuvre d'approches de précision est susceptible d'être influencée par les poursuites liées aux droits d'accès à une transplantation qui ont abouti dans le passé. Ces tensions juridiques pourraient être exacerbées par les représentations qu'en donnent les médias, ces derniers ayant historiquement favorisé le droit à l'accès. Ainsi, au moment de mettre en œuvre de nouvelles technologies de précision pour l'attribution des organes, les décideurs devront constamment revoir l'équilibre entre équité et pertinence, de même que la façon d'élaborer des règles reflétant notre conception sociétale d'un système équitable d'attribution des organes.

Portrayal of umbilical cord blood research in the North American popular press: promise or hype?

Aim: This study examined how umbilical cord blood (UCB) use was portrayed in the English language North American popular press. Methods: Directed content analysis was conducted on 400 articles from 2007 to 2017 containing 'cord blood,' published by the most read Canadian and American news sources. Results: A total of 86.3% of the articles detailed UCB treatments and therapies, the majority of which align with clinical evidence. Some articles portrayed speculative/experimental therapies as efficacious. Public and private banking initiatives received substantial attention, and were portrayed diversely. Promotional narrative messaging was evident around private banking. Conclusion: Findings demonstrate the need for continual monitoring of the media portrayals of UCB as stem cell and transplantation research develops and as clinics continue to operate.

The "subluxation" issue: an analysis of chiropractic clinic websites.

BACKGROUND: Vertebral subluxation theories are controversial in chiropractic. Divisions are evident in the chiropractic community among those who align their practices to subluxation theories and those who do not. This study investigated how many clinics offering chiropractic in the Canadian province of Alberta promote a theory of subluxation, which health ailments or improvements were linked to subluxation, and whether the subluxation discourse was used to promote chiropractic for particular demographics. METHODS: Using the search engine on the Canadian Chiropractic Associations' website, we made a list of all clinics in Alberta. We then used Google searches to obtain a URL for each clinic with a website, totalling 324 URLs for 369 clinics. We then searched on each website for "subluxation" and performed content analysis on the related content. RESULTS: One hundred twenty-one clinics' websites (33%) presented a theory of vertebral subluxation. The health ailments and improvements discussed in relation to subluxation were wide-ranging. An observed trend was the marketing of chiropractic for children, which was observed on 29 clinic websites (8%). CONCLUSIONS: Based on the controversy surrounding vertebral subluxation, the substantial number of clinic websites aligning their practice with vertebral subluxation should cause concern for regulatory bodies.