To prepare for potential human infection challenge studies involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SAR...

BackgroundThe 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.DiscussionThere 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.SummaryThe 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. (shrink)

Numerous social, economic and academic pressures can have a negative impact on representations of biomedical research. We review several of the forces playing an increasingly pernicious role in how health and science information is interpreted, shared and used, drawing discussions towards the role of narrative. In turn, we explore how aspects of narrative are used in different social contexts and communication environments, and present creative responses that may help counter the negative trends. As traditional methods of communication have in many (...) ways failed the public, changes in approach are required, including the creative use of narratives. (shrink)

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. (shrink)

Direct to consumer offerings of unproven stem cell interventions 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. 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. 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 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. 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. (shrink)

The peer commentaries on our Target Article, “Promoting Ethical Payment in Human Infection Challenge Studies,” offer a number of insights that will help advance the co...

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. (shrink)