iPS cells: mapping the policy issues.

Given the explosion of research on induced pluripotent stem (iPS) cells, it is timely to consider the various ethical, legal, and social issues engaged by this fast-moving field. Here, we review issues associated with the procurement, basic research, and clinical translation of iPS cells.

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.

Donation and transplantation coverage in the Canadian media: a content analysis of story focus over 2 decades.

Media coverage affects policy and debates around organ donation and transplantation. We performed a content analysis of stories in the Canadian popular press with a focus on organ donation and transplantation. We built a data set of articles published between Jan. 1, 2000, and May 7, 2019, that included 2082 articles, and we assessed their headlines and lead paragraphs to determine the stories' focus and tone. The most common topics were recipients and donors (46.4%), policy (31.6%) and raising awareness/funds (26.6%). The tone of the articles was positive in 39.1%, neutral in 34.4%, and negative in 26.5%. The strong focus on patients in the reporting may be clouding critical policy discussions. Health communicators and policy-makers should continually assess how to create engaging messaging that remains accurate.

Crowdfunding Campaigns and COVID-19 Misinformation.

Objectives. To understand whether and how crowdfunding campaigns are a source of COVID-19-related misinformation.Methods. We searched the GoFundMe crowdfunding platform using 172 terms associated with medical misinformation about COVID-19 prophylaxes and treatments. We screened resulting campaigns for those making statements about the ability of these searched-for or related terms to prevent or treat COVID-19.Results. There were 208 campaigns worldwide that requested $21 475 568, raised $324 305 from 4367 donors, and were shared 24 158 times. The most discussed interventions were dietary supplements and purported immune system boosters (n = 231), followed by other forms of complementary and alternative medicine (n = 24), and unproven medical interventions (n = 15). Most (82.2%) of the campaigns made definitive efficacy claims.Conclusions. Campaigners focused their efforts on dietary supplements and immune system boosters. Campaigns for purported COVID-19 treatments are particularly concerning, but purported prophylaxes could also distract from known effective preventative approaches. GoFundMe should join other online and social media platforms to actively restrict campaigns that spread misinformation about COVID-19 or seek to better inform campaigners about evidence-based prophylaxes and treatments.

Discussing non-invasive prenatal testing on Reddit: The benefits, the concerns, and the comradery.

OBJECTIVE: As the use of non-invasive prenatal testing (NIPT) increases, its benefits and concerns are being examined through surveys, qualitative studies, and bioethical analysis. However, only scant research has examined public discourse on the topic. This research examined NIPT discussions on the social media platform Reddit. METHOD: Content and qualitative description analysis was performed on 98 NIPT discussions (2682 comments), obtained by inputting "NIPT" into Reddit's search engine. RESULTS: Detailing of benefits and concerns was found in collaborative and supportive discussions. Overall, NIPT is seen as valuable and desirable. Some concerns focused on cost-related barriers to access, anxiety related to testing, and interpretation of results. NIPT is often portrayed as offering peace of mind and is sometimes described as a means of preparing for possible outcomes. CONCLUSION: In the discussions analyzed, NIPT is seen, overall, as valuable and greater access to it is desired. Some questions and concerns about NIPT were evident. Reddit stands as a valuable and appreciated tool for individuals wishing to discuss NIPT and to solicit and share information, opinions, and experiences. Health care providers should consider the ways social platforms such as Reddit can be engaged to better inform and educate the public.

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.

Crowdfunding Cannabidiol (CBD) for Cancer: Hype and Misinformation on GoFundMe.

Objectives. To use crowdfunding campaigns to better understand how cannabidiol (CBD) is represented (and misrepresented) as cancer-related care.Methods. We analyzed CBD-related crowdfunding campaigns (n = 155) created between January 2017 and May 2019 in multiple countries on GoFundme.com.Results. More than 81.9% of campaigns fundraised CBD for curative or life-prolonging reasons, and 25.2% fundraised for pain management.Conclusions. Most campaigns seeking funds for CBD for cancer-related care on GoFundMe are for curative or life-prolonging purposes and present CBD definitively as an effective treatment option. In general, campaigners supported their funding requests with anecdotal claims of efficacy and referenced sources of information that were either not evidence-based or that misrepresented existing evidence.Public Health Implications. Misinformation around CBD for cancer is widespread on medical crowdfunding campaigns. Given the potential adverse impact, crowdfunding platforms, like GoFundMe, must take steps to address their role in enabling and spreading this misinformation.

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.

Promotion of Testing for Celiac Disease and the Gluten-Free Diet Among Complementary and Alternative Medicine Practitioners.

INTRODUCTION: We identified the frequency and assessed the validity of marketing claims made by American chiropractors, naturopaths, homeopaths, acupuncturists, and integrative medicine practitioners relating to the diagnosis and treatment of celiac disease and nonceliac gluten sensitivity (NCGS), both of which have increased in prevalence in recent years. METHODS: We performed a cross-sectional study analyzing websites of practitioners from 10 cities in the United States and analyzed the websites for any mention of celiac or NCGS as well as specific claims of ability to diagnose, ability to treat, and treatment efficacy. We classified treatments promoted as true, false, or unproven, as assessed independently by 2 authors. RESULTS: Of 500 clinics identified, 178 (35.6%) made a claim regarding celiac disease, NCGS, or a gluten-free diet. Naturopath clinic websites have the highest rates of advertising at least one of diagnosis, treatment, or efficacy for celiac disease (40%), followed by integrative medicine clinics (36%), homeopaths (20%), acupuncturists (14%), and chiropractors (12%). Integrative medicine clinics have the highest rates of advertising at least one of diagnosis, treatment, or efficacy for NCGS (45%), followed by naturopaths (37%), homeopaths (14%), chiropractors (14%), and acupuncturists (10%). A geographic analysis yielded no significant variation in marketing rates among clinics from different cities. Of 232 marketing claims made by these complementary and alternative medicine (CAM) clinic websites, 138 (59.5%) were either false or unproven. DISCUSSION: A significant number of CAM clinics advertise diagnostic techniques or treatments for celiac disease or NCGS. Many claims are either false or unproven, thus warranting a need for increased regulation of CAM advertising to protect the public.

CRISPR in the North American popular press.

PURPOSE: CRISPR is often called one of the century's most important discoveries and is commonly discussed in terms of its momentous potential impacts. This study analyzed how CRISPR is discussed in the North American popular press, including how it is defined, and which benefits and risks/concerns are attributed to the technology. METHODS: Using the Factiva database, we identified 228 relevant, nonduplicated articles containing either "CRISPR" or "C.R.I.S.P.R.," published in popular US and Canadian news sources between 1 January 2012 and 12 July 2017. Content analysis was performed on the articles. RESULTS: CRISPR is most often discussed in the context of human health (83.8%), compared with animals (26.3%) and plants (20.6%). Nearly all articles (96.1%) presented CRISPR's potential benefits; 61.4% of articles presented CRISPR-related risks/concerns, the vast majority of which focused on the uncertainty surrounding CRISPR, specifically with respect to germline modifications. CONCLUSIONS: Overall, the discourse suggests a strong promotion of CRISPR, but an element of caution is also evident. Technical as well as ethical, legal, and social risks/concerns play a prominent role. This media portrayal of CRISPR might help facilitate more sophisticated and balanced policy responses, where the scientific potential of the technology is highlighted alongside broader social considerations.

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.

Representing a "revolution": how the popular press has portrayed personalized medicine.

PURPOSE: This study investigated the portrayal of "personalized" and "precision" medicine (PM) in North American news over the past decade. Content analysis of print and online news was conducted to determine how PM has been defined and to identify the frames used to discuss PM, including associated topics, benefits, and concerns. METHODS: A data set was built using the FACTIVA database, searching for popular North American publications with the terms "personalized (personalised) medicine" and/or "precision medicine" from 1 January 2005 to 15 March 2016. The final set of publications totaled 774. RESULTS: PM is almost exclusively defined as related to genetics and is often part of a story related to cancer. The PM story is overwhelmingly one of highlighting (potential) benefits and optimism, especially in shorter publications, and ones where PM is not the main focus. This promotional PM discourse has remained fairly consistent over the past decade. CONCLUSION: The numerous concerns associated with PM have received little attention over the past decade, especially in articles more likely to be encountered by a more general audience. This promotion of PM serves as an example of the science hyping that takes place in science reportage and may have implications for consumers, public expectations, and related health policy.

Spinning the Genome: Why Science Hype Matters.

There is a growing body of literature that describes both the degree to which science is hyped and how and why that hype happens. Hype can be described as an inappropriate exaggeration of the significance or potential value of a particular study or area of science. Evidence tells us that this spin happens throughout the science translation process. There is hype in research grants, peer-reviewed publications, scientific abstracts, institutional press releases, media representations, and, of course, in the associated marketing of a new product. There is also evidence that it has played a particularly significant role in the area of genetic research. Science hype is a complex phenomenon that involves many actors. And it is, at least to some degree, the result of systemic pressures imbedded in the current incentives associated with biomedical research. This article reviews what the evidence says about the sources of hype, the social and scientific harms, and what can be done to nudge us in the right direction.

Geolocalisation of athletes for out-of-competition drug testing: ethical considerations. Position statement by the WADA Ethics Panel.

Through the widespread availability of location-identifying devices, geolocalisation could potentially be used to place athletes during out-of-competition testing. In light of this debate, the WADA Ethics Panel formulated the following questions: (1) should WADA and/or other sponsors consider funding such geolocalisation research projects?, (2) if successful, could they be proposed to athletes as a complementary device to Anti-Doping Administration and Management System to help geolocalisation and reduce the risk of missed tests? and (3) should such devices be offered on a voluntary basis, or is it conceivable that they would be made mandatory for all athletes in registered testing pools? In this position paper, the WADA Ethics Panel concludes that the use of geolocalisation could be useful in a research setting with the goal of understanding associations between genotype, phenotype and environment; however, it recognises that the use of geolocalisation as part of or as replacement of whereabouts rules is replete with ethical concerns. While benefits remain largely hypothetical and minimal, the potential invasion of privacy and the data security threats are real. Considering the impact on privacy, data security issues, the societal ramifications of offering such services and various pragmatic considerations, the WADA Ethics Panel concludes that at this time, the use of geolocalisation should neither be mandated as a tool for disclosing whereabouts nor implemented on a voluntary basis.