"No one went into pharmacy to sell a lot of Coca-Cola. It's just sort of a necessary evil" - Community pharmacists' perceptions of front-of-store sales and ethical tensions in the retail environment.

Background: Community pharmacists are expected to uphold ethical duties to patients and society while maintaining independent businesses or fulfilling expectations of corporate owners. Canadian pharmacy colleges provide only indirect guidance on the retail setting of the profession. Little is known about whether pharmacists identify ethical issues in retail pharmacy or around the sales of non-drug products. Objective: This study sought to examine pharmacists' perceptions of their roles in health promotion, the factors that influence the selection of front-of-store products, and ethical issues relating to their dual roles as health care providers and retailers. Methods: In 2020, 25 Canadian pharmacists participated in semi-structured phone interviews. Interviews were audio-recorded, anonymized, transcribed verbatim, and thematically analyzed using qualitative methods. Results: Almost all participants described their role primarily as a health care provider, though some described themselves as 50-50 health care providers and retailers. Most staff pharmacists reported little control over front-of-store product selection. Where participants reported some control, external factors such as business viability and profitability impacted their choices, though some reported selecting products based on the needs of their patient community or their personal beliefs. The dominant tensions described stemmed from participants' dual roles as health care providers and retailers, though specific issues and situations were varied, ranging corporate targets, to service provision, to the sales of unproven or unhealthy products. Participants suggested solutions to the issues they described, ranging from a complete overhaul of the licensing structure of community pharmacies, down to one-on-one conversations with patients. Conclusion: Our findings suggest that the retail setting of community pharmacy produces unique ethical tensions: the imposition of retail sales standards and targets are commonplace, and business viability is a primary driving force in front-of-store product selection. Clear guidance from Canadian pharmacy colleges and legislators to address these tensions and issues may be necessary.

Ethical, Legal, and Social Implications (ELSI) Research: Methods and Approaches.

The article provides an overview of select methodologies that are commonly used in ELSI ("ethical, legal, and social implications") research. ELSI is a field that focuses on the analysis of the societal implications of cutting-edge biomedical research and technologies. The article aims to provide an accessible reference on well-established research methods that aspiring and seasoned ELSI researchers can rely on as a starting point for exploring how to design and conduct ELSI studies. © 2022 Wiley Periodicals LLC.

ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update.

The International Society for Stem Cell Research has updated its Guidelines for Stem Cell Research and Clinical Translation in order to address advances in stem cell science and other relevant fields, together with the associated ethical, social, and policy issues that have arisen since the last update in 2016. While growing to encompass the evolving science, clinical applications of stem cells, and the increasingly complex implications of stem cell research for society, the basic principles underlying the Guidelines remain unchanged, and they will continue to serve as the standard for the field and as a resource for scientists, regulators, funders, physicians, and members of the public, including patients. A summary of the key updates and issues is presented here.

Promoting Ethical Payment in Human Infection Challenge Studies.

To prepare for potential human infection challenge studies (HICS) involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SARS-CoV-2 HICS participants should be paid. Because the goals of paying HICS participants, as well as the relevant ethical concerns, are the same as those arising for other types of clinical research, the same basic framework for ethical payment can apply. This framework divides payment into reimbursement, compensation, and incentives, focusing on fairness and promoting adequate recruitment and retention as counterweights to concerns about undue inducement. Within the basic framework, several factors are especially salient for HICS, and for SARS-CoV-2 HICS in particular, including the nature of participant confinement, anticipated discomfort, risks and uncertainty, participant motivations, and trust. These factors are reflected in a payment worksheet created to help sponsors, researchers, and ethics reviewers systematically develop and assess ethically justifiable payment amounts.

Media representations of COVID-19 public health policies: assessing the portrayal of essential health services in Canadian print media.

AIMS: The study assessed how the Canadian print media represented essential healthcare services during the COVID-19 pandemic, including the controversial decision to include liquor and cannabis stores in essential services lists. METHODS: Mixed-method content analysis of 67 articles published in major Canadian English language newspapers between March 23 and April 1, 2020. Articles were analyzed and coded by two raters. Ratings were analyzed in SPSS. RESULTS: Few articles in the sample discussed essential healthcare services and the inclusion of liquor and cannabis stores in essential services lists. Majority of the articles that discussed both topics framed the discussion positively and consistently with current knowledge and evidence. CONCLUSION: Canadian print media representations of essential healthcare services and associated public debate are largely descriptive and, therefore, fail to engage critically with or advance public understanding of an important health policy issue.

Bioethics and practical justice in the post-COVID-19 era.

The ethical concept of justice, as it relates to the development and deployment of innovative health technologies, commands the fair and equitable distribution of burdens and benefits. In bioethics, specific guidance on practical strategies for achieving what this concept of justice demands are somewhat elusive. Drawing on issues of justice arising or likely to arise in the context of the search for a vaccine or cure for COVID-19, this paper argues for a focus on the concept of "practical justice" in post-pandemic bioethics work. To illustrate the value and promise of this concept, the paper reflects on an approach to achieving practical justice in health biotechnology research that is grounded in a commitment to offer technical assistance to developing and under-resourced nations.

Virtual care: Enhancing access or harming care?

COVID-19 has catalyzed the adoption of virtual medical care in Canada. Virtual care can improve access to healthcare services, particularly for those in remote locations or with health conditions that make seeing a doctor in person difficult or unsafe. However, virtual walk-in clinic models that do not connect patients with their own doctors can lead to fragmented, lower quality care. Although virtual walk-in clinics can be helpful for those who temporarily lack access to a family doctor, they should not be relied on as a long-term substitute to an established relationship with a primary care provider. Virtual care also raises significant privacy issues that policy-makers must address prior to implementing these models. Patients should be cautious of the artificial intelligence recommendations generated by some virtual care applications, which have been linked to quality of care concerns.

Canada's Assisted Human Reproduction Act: Pragmatic Reforms in Support of Research.

Canada's Assisted Human Reproduction Act is long overdue for Parliamentary review. We argue that the current regulation of research using human reproductive materials is not proportionate, not responsive to the uncertain threats posed to human and environmental health and safety, and is not considerate of diverse values in a democratic society. We propose tailored regulatory carve-outs for in vitro research for currently prohibited activities, such as gene editing, and for the exercise of Ministerial Discretion for access by Canadians to experimental in vivo interventions that are currently prohibited, such as mitochondrial replacement therapy. Our recommendations are bounded by constitutional constraints that recognize political and practical challenges in keeping oversight of this research under Federal jurisdiction, whether conducted in academic or private sectors. The proposed nuanced regulatory scheme should be overseen by a new national Agency, modeled on a blend of the Canadian Stem Cell Oversight Committee and Assisted Human Reproduction Canada.

Realigning gene editing with clinical research ethics: What the "CRISPR Twins" debacle means for Chinese and international research ethics governance.

The announcement of the "CRISPR babies" reignited the debate surrounding the ethical, legal and social implications of germline gene editing. Despite having been conducted in the context of a clinical trial, Dr. Jiankui He's research appears to have violated both Chinese regulations and standard ethical procedures, as well as internationally accepted research and bioethical standards. It is within this context that our commentary surrounding the question of the enforceability of Chinese regulations in such a case. We argue that Chinese regulations do align with internationally accepted standards. Yet, the question remains, in what ways can China strengthen and update its regulatory framework to better address the benefits and challenges associated with emerging technologies, delineate clear enforcement mechanisms and specify criteria for ethics approval.

The bench is closer to the bedside than we think: Uncovering the ethical ties between preclinical researchers in translational neuroscience and patients in clinical trials.

Millions of people worldwide currently suffer from serious neurological diseases and injuries for which there are few, and often no, effective treatments. The paucity of effective interventions is, no doubt, due in large part to the complexity of the disorders, as well as our currently limited understanding of their pathophysiology. The bleak picture for patients, however, is also attributable to avoidable impediments stemming from quality concerns in preclinical research that often escape detection by research regulation efforts. In our essay, we connect the dots between these concerns about the quality of preclinical research and their potential ethical impact on the patients who volunteer for early trials of interventions informed by it. We do so in hopes that a greater appreciation among preclinical researchers of these serious ethical consequences can lead to a greater commitment within the research community to adopt widely available tools and measures that can help to improve the quality of research.

The involvement of Canadian physicians in promoting and providing unproven and unapproved stem cell interventions.

BACKGROUND: Direct to consumer offerings of unproven stem cell interventions (SCIs) is a pressing scientific and policy issue. According to media reports, providers of SCIs have emerged in Canada. This study provides the first systematic scan of Canadian providers and associated trends and claims. METHODS: The study sample consisted of 15 websites retrieved from a Google™ keyword search. The websites were assessed by a rater using a peer-reviewed coding frame that queried treatment location, stem cell offerings, treatment claims, supporting evidence, and legal and regulatory compliance. A second rater reviewed a subset of the websites for purposes of inter-rater reliability. Disagreements between raters were resolved by consensus. Data collected by the raters was analyzed in SPSS. RESULTS: Physicians are the dominant treatment providers in Canada. Providers operate in urban and semi-urban areas in the most populous provinces. SCIs provided are mainly autologous adult stem cells for multiple conditions including musculoskeletal disorders, spinal cord injury (SCI) and diabetes. Efficacy and benefits of treatment are prominently and positively portrayed, while risks are not mentioned or portrayed as trivial. Regulatory concerns are not discussed. CONCLUSIONS: The involvement of physicians in promoting and providing unproven and unapproved SCIs raises significant ethical, legal and regulatory concerns. Treatment claims and trends appear to contravene applicable professional standards, statutory obligations, and consumer protection laws. While the number of providers observed is still marginal, urgent and proactive regulatory response is needed to prevent proliferation of a potentially exploitative and harmful market for unproven SCIs in Canada.

Research on Human Embryos and Reproductive Materials: Revisiting Canadian Law and Policy.

Research involving human embryos and reproductive materials, including certain forms of stem cell and genetic research, is a fast-moving area of science with demonstrated clinical relevance. Canada's current governance framework for this field of research urgently requires review and reconsideration in view of emerging applications. Based on a workshop involving ethics, legal, policy, scientific and clinical experts, we present a series of recommendations with the goal of informing and supporting health policy and decision-making regarding the governance of the field. With a pragmatic and principled governance approach, Canada can continue its global leadership in this field, as well as advance the long-term health and well-being of Canadians.

Promotion and marketing of bioidentical hormone therapy on the internet: a content analysis of websites.

OBJECTIVE: To evaluate the quality of information presented and claims made on websites offering bioidentical hormone therapy (BHT) products or services. METHODS: A quantitative content analysis was completed on 100 websites promoting or offering BHT products or services. Websites were identified through Google search engine from September to October 2013. Search terms included "bioidentical hormone therapy" or "bioidentical progesterone," accompanied by "purchase or buy," "service," or "doctors." The Brief DISCERN instrument was used to determine the quality of the health information. RESULTS: Websites were from Canada (59%), United States (38%), and other countries (3%). Almost half of the websites originated from medical clinics (47%), and healthcare professionals offering BHT services included physicians (50%), pharmacists (19%), and naturopaths (16%). Majority of websites promoted BHT as custom-compounded formulations (62%), with only 27% indicating that BHT is also commercially available. Websites overall claimed that BHT had less risk compared with conventional hormone therapy (62%). BHT was described as having less breast cancer risk (40%), whereas over a quarter of websites described BHT as "protective" for breast cancer. Websites mainly targeted women (99%), with males mentioned in 62% of websites. Product descriptors used to promote BHT included individualization (77%), natural (70%), hormone imbalance (56%), and antiaging (50%). The mean Brief DISCERN score was 15, indicating lower quality of information. CONCLUSIONS: Claims made about BHT on the internet are misleading and not consistent with current professional organizations' recommendations. Understanding how BHT may be promoted on the internet can help healthcare professionals when educating patients.

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.

A blueprint for the next generation of ELSI research, training, and outreach in regenerative medicine.

Regenerative medicine has attracted the interest of scientists, physicians, and patient communities, and as well as policy-makers and the broader public given related ethical, legal, and social implications. Here we examine past initiatives in the ethical, legal and social implications arena in regenerative medicine, and offer our views on actionable priorities for the future in six key areas: capacity building, policy, engagement with industry, resaerch ethics, communication, and community building.

Community Pharmacists' Views and Practices Regarding Natural Health Products Sold in Community Pharmacies.

BACKGROUND: Reports of regulatory and evidentiary gaps have raised concerns about the marketing and use of natural health products (NHPs). The majority of NHPs offered for sale are purchased at a community pharmacy and pharmacists are "front-line" health professionals involved in the marketing and provision of NHPs. To date, the involvement of pharmacists in pharmacy care involving NHPs and the degree to which concerns over the safety, efficacy, marketing and regulation of NHPs are addressed in pharmacy care in Canada have not been studied. METHODS: Using Qualtrics, a web-based data collection and analysis software, and a study instrument made up of fifteen (15) open-ended, closed and rating scale questions, we surveyed the attitudes and practices of 403 community pharmacists in the Canadian province of Alberta regarding NHPs offered for sale in community pharmacies. RESULTS: The majority of pharmacists surveyed (276; 68%) recommend NHPs to clients sometimes to very often. Vitamin D, calcium, multivitamins, prenatal vitamins, probiotics and fish oil and omega-3 fatty acids were the most frequently recommended NHPs. The most common indications for which NHPs are recommended include bone and musculoskeletal disorders, maintenance of general health, gastrointestinal disorders and pregnancy. Review articles published in the Pharmacist's Letter and Canadian Pharmacists Journal were the primary basis for recommending NHPs. The majority of pharmacists surveyed (339; 84%) recommend the use of NHPs concurrently with conventional drugs, while a significant number and proportion (125; 31%) recommend alternative use. Pharmacists in the study overwhelmingly reported providing counselling on NHPs to clients based on information obtained mainly from the Natural Medicines Comprehensive Database. CONCLUSIONS: The study findings indicate a high prevalence of pharmacy care relating to NHPs among study participants. Although pharmacists' practices around NHPs are consistent with the existing licensing framework, we found some involvement in problematic practices that necessitate further research and potential policy scrutiny. The study also uncovered patterns of recommendations, including sources relied on in recommending NHPs and in providing counselling to patients, that raise concerns about the quality and credibility of NHP-related care provided to pharmacy patrons.

The commercialization of university-based research: Balancing risks and benefits.

BACKGROUND: The increasing push to commercialize university research has emerged as a significant science policy challenge. While the socio-economic benefits of increased and rapid research commercialization are often emphasized in policy statements and discussions, there is less mention or discussion of potential risks. In this paper, we highlight such potential risks and call for a more balanced assessment of the commercialization ethos and trends. DISCUSSION: There is growing evidence that the pressure to commercialize is directly or indirectly associated with adverse impacts on the research environment, science hype, premature implementation or translation of research results, loss of public trust in the university research enterprise, research policy conflicts and confusion, and damage to the long-term contributions of university research. The growing emphasis on commercialization of university research may be exerting unfounded pressure on researchers and misrepresenting scientific research realities, prospects and outcomes. While more research is needed to verify the potential risks outlined in this paper, policy discussions should, at a minimum, acknowledge them.