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.

Racial Equity, Diversity and Inclusion in Bioethics: Recommendations from the Association of Bioethics Program Directors Presidential Task Force.

Recent calls to address racism in bioethics reflect a sense of urgency to mitigate the lethal effects of a lack of action. While the field was catalyzed largely in response to pivotal events deeply rooted in racism and other structures of oppression embedded in research and health care, it has failed to center racial justice in its scholarship, pedagogy, advocacy, and practice, and neglected to integrate anti-racism as a central consideration. Academic bioethics programs play a key role in determining the field's norms and practices, including methodologies, funding priorities, and professional networks that bear on equity, inclusion, and epistemic justice. This article describes recommendations from the Racial Equity, Diversity, and Inclusion (REDI) Task Force commissioned by the Association of Bioethics Program Directors to prioritize and strengthen anti-racist practices in bioethics programmatic endeavors and to evaluate and develop specific goals to advance REDI.

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.

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.

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.

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.

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.

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.

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.

Policy recommendations for addressing privacy challenges associated with cell-based research and interventions.

BACKGROUND: The increased use of human biological material for cell-based research and clinical interventions poses risks to the privacy of patients and donors, including the possibility of re-identification of individuals from anonymized cell lines and associated genetic data. These risks will increase as technologies and databases used for re-identification become affordable and more sophisticated. Policies that require ongoing linkage of cell lines to donors' clinical information for research and regulatory purposes, and existing practices that limit research participants' ability to control what is done with their genetic data, amplify the privacy concerns. DISCUSSION: To date, the privacy issues associated with cell-based research and interventions have not received much attention in the academic and policymaking contexts. This paper, arising out of a multi-disciplinary workshop, aims to rectify this by outlining the issues, proposing novel governance strategies and policy recommendations, and identifying areas where further evidence is required to make sound policy decisions. The authors of this paper take the position that existing rules and norms can be reasonably extended to address privacy risks in this context without compromising emerging developments in the research environment, and that exceptions from such rules should be justified using a case-by-case approach. In developing new policies, the broader framework of regulations governing cell-based research and related areas must be taken into account, as well as the views of impacted groups, including scientists, research participants and the general public. SUMMARY: This paper outlines deliberations at a policy development workshop focusing on privacy challenges associated with cell-based research and interventions. The paper provides an overview of these challenges, followed by a discussion of key themes and recommendations that emerged from discussions at the workshop. The paper concludes that privacy risks associated with cell-based research and interventions should be addressed through evidence-based policy reforms that account for both well-established legal and ethical norms and current knowledge about actual or anticipated harms. The authors also call for research studies that identify and address gaps in understanding of privacy risks.

Advanced Regenerative Medicines for Rare Diseases: A Review of Industry Sponsors Investment Motivations.

Despite regulatory changes designed to stimulate investment in therapies for rare diseases, many of these conditions lack government-approved treatments. Advanced regenerative medicines, which are therapies and clinical interventions aimed at healing or replacing damaged or defective human cells, tissues, and organs, offer great promise for addressing many rare diseases. A major challenge facing advanced regenerative medicines for rare diseases is securing financial support to assist in bringing a therapy to market. This paper describes the factors cited by pharmaceutical industry players globally for sponsoring the development of advanced regenerative medicines for rare diseases. The paper examines the motivations of 53 sponsors that meet the latter criteria. The motivations behind investments were broadly similar amongst sponsors and map closely onto regulatory requirements for clinical development and marketing authorization of advanced therapeutic products, including the presence of accelerated or attenuated pathways for regulatory approval, use for indications with high unmet medical needs, and/or that have advantages over existing therapies, and robust preclinical data. Other factors include availability of investment incentives and opportunities for off-label use in the post-approval stages.

Clinical use of autologous cell-based therapies in an evolving regulatory landscape: A survey of patient experiences and perceptions.

Background: Clinical treatments involving autologous cell-based therapies (ACBT) remain prevalent despite a lack of scientific backing and an evolving regulatory landscape aimed at assessing their safety and efficacy for clinical adoption. This study seeks to assess patients' experiences and perceptions of clinical treatments involving ACBT and their knowledge and views of the regulatory context and associated governance issues. Methods: An anonymous online survey of 181 participants who have been treated or are in the process of being treated with ACBT was conducted. Recruitment was via social media platforms. Data was collected through Qualtrics and analyzed using SPSS 29 for the quantitative responses and NVivo 1.7.1 for the qualitative responses. Results: Several themes emerged from the data, including the prominent role of healthcare providers throughout the patient journey, informational practices during the clinical encounter, the high prevalence of pay-for-participation trials, patients' gaps in regulatory knowledge, and patients' priorities regarding clinical trials and regulation of ACBT. Conclusions: The study makes a novel contribution to the literature by providing the first analysis of patients' experiences and perceptions of an emerging cell-based therapy within an evolving regulatory landscape. The findings serve as a valuable resource for developing policy, promoting scientific rigor, and ensuring ethical oversight of ACBT and other upcoming cell-based therapies.

"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.

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.