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Canada has historically relied on a system of ad hoc committees for ethical guidance on public health and science policy, unlike the more centralized approach of more than 140 countries worldwide. Here, drawing on interviews with leaders across the country, we offer a perspective on the imperative and a strategy for a coordinated, Bioethics Council for Canada structured to ensure proactive thinking, provide rapid responses, and engage the public on urgent bioethics matters concerning the health and well-being of Canadians.

Abstract Background People with amyotrophic lateral sclerosis (ALS) face disability- and travel-related barriers to research participation. We investigate the usefulness and acceptability of asynchronous, online focus groups (AOFGs) for research involving people affected by ALS (patients and family caregivers) and outline lessons learned. Methods The ALS Talk Project, consisting of seven AOFGs and 100 participants affected by ALS, provided context for this investigation. Hosted on the secure itracks Board™ platform, participants interacted in a threaded web forum structure. Moderators posted weekly discussion questions and facilitated discussion. Data pertaining to methodology, participant interaction and experience, and moderator technique were analyzed using itracks and NVivo 12 analytics (quantitative) and conventional content analysis and the constant-comparative approach (qualitative). Results There was active engagement within groups, with post lengths averaging 111.48 words and a complex network of branching interactions between participants. One third of participant responses included individual reflections without further interaction. Participants affirmed their co-group members, offered practical advice, and discussed shared and differing perspectives. Moderators responded to all posts, indicating presence and probing answers. AOFGs facilitated qualitative and quantitative data-gathering and flexible response to unanticipated events. Although total participation fell below 50% after 10–12 weeks, participants valued interacting with peers in an inclusive, confidential forum. Participants used a variety of personal devices, browsers, and operating systems when interacting on the online platform. Conclusions This methodological examination of AOFGs for patient-centred investigations involving people affected by ALS demonstrates their usefulness and acceptability, and advances knowledge of online research methodologies. Lessons learned include: early identification of research goals and participant needs is critical to selecting an AOFG platform; although duration longer than 10–12 weeks may be burdensome in this population, participants were positive about AOFGs; AOFGs offer real world flexibility enabling response to research challenges and opportunities; and, AOGFs can effectively foster safe spaces for sharing personal perspectives and discussing sensitive topics. With moderators playing an important role in fostering engagement, AOFGs facilitated rich data gathering and promoted reciprocity by fostering the exchange of ideas and interaction between peers. Findings may have implications for research involving other neurologically impaired and/or medically vulnerable populations.

Abstract Health technology assessment (HTA) can be used to make healthcare systems more equitable and efficient. Advances in precision oncology are challenging conventional thinking about HTA. Precision oncology advances are rapid, involve small patient groups, and are frequently evaluated without a randomized comparison group. In light of these challenges, mechanisms to manage precision oncology uncertainties are critical. We propose a life-cycle HTA framework and outline supporting criteria to manage uncertainties based on real world data collected from learning healthcare systems. If appropriately designed, we argue that life-cycle HTA is the driver of real world evidence generation and furthers our understanding of comparative effectiveness and value. We conclude that life-cycle HTA deliberation processes must be embedded into healthcare systems for an agile response to the constantly changing landscape of precision oncology innovation. We encourage further research outlining the core requirements, infrastructure, and checklists needed to achieve the goal of learning healthcare supporting life-cycle HTA.

Abstract Background Hospital patients who use drugs may require prolonged parenteral antimicrobial therapy administered through a vascular access device (VAD). Clinicians’ concerns that patients may inject drugs into these devices are well documented. However, the perspectives of patients on VAD injecting are not well described, hindering the development of informed clinical guidance. This study was conducted to elicit inpatient perspectives on the practice of injecting drugs into VADs and to propose strategies to reduce associated harms. Methods Researchers conducted a focused ethnography and completed semi-structured interviews with 25 inpatients at a large tertiary hospital in Western Canada that experiences a high rate of drug-related presentations annually. Results A few participants reported injecting into their VAD at least once, and nearly all had heard of the practice. The primary reason for injecting into a VAD was easier venous access since many participants had experienced significant vein damage from injection drug use. Several participants recognized the risks associated with injecting into VADs, and either refrained from the practice or took steps to maintain their devices while using them to inject drugs. Others were uncertain how the devices functioned and were unaware of potential harms. Conclusions VADs are important for facilitating completion of parenteral antimicrobial therapy and for other medically necessary care. Prematurely discharging patients who inject into their VAD from hospital, or discontinuing or modifying therapy, results in inequitable access to health care for a structurally vulnerable patient population. Our findings demonstrate a need for healthcare provider education and non-stigmatizing clinical interventions to reduce potential harms associated with VAD injecting. Those interventions could include providing access to specialized pain and withdrawal management, opioid agonist treatment, and harm reduction services, including safer drug use education to reduce or prevent complications from injecting drugs into VADs.

Abstract Background People with amyotrophic lateral sclerosis (ALS) are at high risk for severe outcomes from Covid-19 infection. Researchers exploring ALS and Covid-19 have focused primarily on system response and adaptation. Using Protection Motivation Theory, we investigated how people with ALS and family caregivers appraised and responded to Covid-19 threat, the ‘costs’ associated with pandemic response, and how health professionals and systems can better support people affected by ALS who are facing public health emergencies. Methods Data were drawn from the ‘ALS Talk Project,’ an asynchronous, moderated focus group study. Participants were recruited from regions across Canada. Seven groups met online over 14 weeks between January and July 2020. Fifty-three participants contributed to Covid-19 discussions. Data were qualitatively analyzed using directed content analysis and the constant-comparative approach. Results Participants learned about the Covid-19 pandemic from the media. They rapidly assessed their vulnerability and responded to Covid-19 threat by following recommendations from health authorities, information monitoring, and preparing for worst-case scenarios. Adopting protective behaviors had substantial response costs, including adaptations for medical care and home support workers, threatened access to advance care, and increased caregiver burden. Participants expressed need for ALS-specific, pandemic information from trusted health professionals and/or ALS health charities. Telemedicine introduced both conveniences and costs. Prior experience with ALS provided tools for coping with Covid-19. Threat and coping appraisal was a dynamic process involving ongoing vigilance and adaptation. Findings draw attention to the lack of emergency preparedness among participants and within health systems. Conclusions Clinicians should engage ALS patients and families in ongoing discussions about pandemic coping, strategies to mitigate response costs, care pathways in the event of Covid-19 infection, and changing information about Covid-19 variants and vaccines. Healthcare systems should incorporate flexible approaches for medical care, leveraging the benefits of telemedicine and facilitating in-person interaction as needed and where possible. Research is needed to identify strategies to mitigate response costs and to further explore the interaction between prior experience and coping. Further study is also needed to determine how communication about emergency preparedness might be effectively incorporated into clinical care for those with ALS and other medically vulnerable populations.

A growing body of evidence suggests that news media which includes a sympathetic portrayal of a mother bereaved by substance use can increase public support for harm reduction initiatives. However, the extent to which such news media coverage occurs in Canada is unknown, and research has not documented how the news media in Canada covers such stories. We undertook a mixed-method secondary analyses of 5681 Canadian newspaper articles on harm reduction (2000-2016). Quantitative analyses described the volume and content of harm reduction reporting featuring a mother whose child's death was related to substance use while qualitative thematic analysis provided in-depth descriptions of the discourses underlying such news reporting. Newspaper articles featuring a mother whose child's death was related to substance use were rarely published (n = 63; 1.1% of total harm reduction media coverage during the study period). Deductive content analysis of these 63 texts revealed that coverage of naloxone distribution (42.9%) and supervised drug consumption services (28.6%) were prioritized over other harm reduction services. Although harm reduction (services or policies) were advocated by the mother in most (77.8%) of these 63 texts, inductive thematic analysis of a subset (n = 52) of those articles revealed that mothers' advocacy was diminished by newspaper reporting that emphasized their experiences of grief, prioritized individual biographies over structural factors contributing to substance use harms, and created rhetorical divisions between different groups of people who use drugs (PWUD). Bereaved mothers' advocacy in support of harm reduction programs and services may be minimized in the process of reporting their stories for newspaper readers. Finding ways to report bereaved mothers' stories in ways that are inclusive of all PWUD while highlighting the role of broad, structural determinants of substance use has the potential to shift public opinion and government support in favour of these life-saving services.

COVID science is being both done and circulated at a furious pace. While it is inspiring to see the research community responding so vigorously to the pandemic crisis, all this activity has also created a churning sea of bad data, conflicting results, and exaggerated headlines. With representations of science becoming increasingly polarized, twisted, and hyped, there is growing concern that the relevant science is being represented to the public in a manner that may cause confusion, inappropriate expectations, and the erosion of public trust. Here we explore some of the key issues associated with the representations of science in the context of the COVID-19 pandemic. Many of these issues are not new. But the COVID-19 pandemic has placed a spotlight on the biomedical research process and amplified the adverse ramifications of poor public communication. We need to do better. As such, we conclude with 10 recommendations aimed at key actors involved in the communication of COVID-19 science, including government, funders, universities, publishers, media, and the research communities.

In the event of the current COVID-19 pandemic and in preparation for future pandemics, open science can support mission-oriented research and development, as well as commercialization. Open science shares skills and resources across sectors; avoids duplication and provides the basis for rapid and effective validation due to full transparency. It is a strategy that can adjust quickly to reflect changing incentives and priorities, because it does not rely on any one actor or sector. While eschewing patents, it can ensure high-quality drugs, low pricing, and access through existing regulatory mechanisms. Open science practices and partnerships decrease transaction costs, increase diversity of actors, reduce overall costs, open new, higher-risk/higher-impact approaches to research, and provide entrepreneurs freedom to operate and freedom to innovate. We argue that it is time to re-open science, not only in its now restricted arena of fundamental research, but throughout clinical translation. Our model and attendant recommendations map onto a strategy to accelerate discovery of novel broad-spectrum anti-viral drugs and clinical trials of those drugs, from first-in-human safety-focused trials to late stage trials for efficacy. The goal is to ensure low-cost and rapid access, globally, and to ensure that Canadians do not pay a premium for drugs developed from Canadian science.

Abstract Background Parents of children living with chronic but manageable conditions hope for improved therapies or cures, including Advanced Therapy Medicinal Products (ATMPs). Multiple pediatric clinical trials for ATMPs are underway, but the risk profile of ATMPs for chronic conditions is largely unknown and likely different than for terminal pediatric illnesses. Applying Protection Motivation Theory modified to the context of pediatric ATMP clinical trial enrollment, our study analyses information needs of parents of children living with chronic manageable conditions: Type 1 Diabetes (T1D) or Inherited Retinal Diseases (IRD). Methods We conducted semi-structured interviews with 15 parents of children living with T1D and 14 parents of children living with an IRD about: a) family background and the diagnostic experience; b) awareness of gene and stem cell therapy research and clinical trials for T1D and IRD; c) information sources on trials and responses to that information; d) attitudes to trial participation, including internationally; e) understanding of trial purpose and process; and f) any experiences with trial participation. We then discussed a pediatric ATMP clinical trial information sheet, which we developed with experts. We applied directed qualitative content analysis, based on PMT, to examine the information preferences of parents in deciding whether to enrol their children in stem cell or gene therapy clinical trials. Results Parents balanced trial risks against their child’s ability to cope with the chronic condition. The better the child’s ability to cope with vision impairment or insulin management, the less likely parents were to assume trial risks. Conversely, if the child struggled with his/her vision loss, parents were more likely to be interested in trial participation, but only if the risks were low and likelihood for potential benefit was high. Conclusions Fear of adverse events as part of threat appraisal was the predominant consideration for parents in considering whether to enroll their child living with a manageable, chronic condition in a pediatric clinical trial of an ATMP. This consideration outweighed potential benefits and severity of their child’s condition. Parents called for available safety data and fulsome communication processes that would enable them to make informed decisions about clinical trial enrolment on behalf of their children.

Abstract Background Health care system decision makers face challenges in allocating resources for screening, diagnosis and treatment of hepatitis C. Approximately 240,000 individuals are infected with the hepatitis C virus (HCV) in Canada. Populations most affected by HCV include Indigenous people, people who inject drugs, immigrants and homeless or incarcerated populations as well as those born between 1946 and 1965. Curative but expensive drug regimens of novel direct acting antivirals (DAAs) are available. We aim to identify social values from academic literature for inclusion in health technology assessments. Methods We conducted a scoping review of academic literature to identify and analyze the social values and evidence-based recommendations for screening, diagnosis and treatment of HCV in Canada. After applying inclusion/exclusion criteria, we abstracted: type of intervention(s), population(s) affected, study location, screening methods, diagnostics and treatments. We then abstracted and applied qualitative codes for social values. We extracted social value statements and clustered them into one of 4 categories: (1) equity and justice, (2) duty to provide care, (3) maximization of population benefit, and (4) individual versus community interests. Results One hundred and eighteen articles met our inclusion criteria on screening, diagnosis and treatment of HCV in Canada. Of these, 54 (45.8%) discussed screening, 4 (3.4%) discussed diagnosis and 60 (50.8%) discussed treatment options. Most articles discussed the general population and other non-vulnerable populations. Articles that discussed vulnerable populations focused on people who inject drugs. We coded 1243 statements, most of which fell into the social value categories of equity and justice, duty to provide care and maximization of population benefit. Conclusion The academic literature identified an expanded set of social values to be taken into account by resource allocation decision makers in financially constrained environments. In the context of hepatitis C, authors called for greater consideration of equity and justice and the duty to provide care in making evidence-based recommendations for screening, diagnosis and treatment for different populations and in different settings that also account for individual and community interests.

International drug regulators use conditional drug approval mechanisms to facilitate faster patient access to drugs based on a lower evidentiary standard typically required of drug approvals. Faster and earlier access is justified by limiting eligibility to drugs intended for serious and life-threatening diseases and by requiring post-market evidence collection to confirm clinical benefit. One such mechanism in Canada, the Notice of Compliance with Conditions (NOC/c) policy, was introduced in 1998. Today, most of the drugs approved under the NOC/c policy are for oncology indications. We analyze oncology drugs approvals under the NOC/c policy to inform discussions of two tradeoffs applied to conditional drug approvals, eligibility criteria and post-market evidence. Our analysis informs recommendations for Canada's proposed regulatory reforms approach to conditional approvals pathways. Our analysis demonstrates that under the current policy, eligibility criteria are insufficiently defined, resulting in their inconsistent application by Health Canada. Regulatory responsiveness to post-market evidence from post-market clinical trial and foreign jurisdiction regulatory decisions is slow and insufficient. In the absence of sufficient regulatory responsiveness, physicians and patients must make clinical decisions without the benefit of the best available evidence. Together, our analysis of the two core tradeoffs in Canada's conditional drug approval provides insight to inform the further development of Canada's proposed agile regulatory approach to drugs and devices that will expand the use of terms and conditions.

Background: Communication about end of life, including advance care planning, life-sustaining therapies, palliative care, and end-of-life options, is critical for the clinical management of amyotrophic lateral sclerosis patients. The empirical evidence base for this communication has not been systematically examined.Objective: To support evidence-based communication guidance by (1) analyzing the scope and nature of research on health communication about end of life for amyotrophic lateral sclerosis; and (2) summarizing resultant recommendations.Methods: A scoping review of empirical literature was conducted following recommended practices. Fifteen health-related and three legal databases were searched; 296 articles were screened for inclusion/exclusion criteria; and quantitative data extraction and analysis was conducted on 211 articles with qualitative analysis on a subset of 110 articles that focused primarily on health communication. Analyses summarized article characteristics, themes, and recommendations.Results: Analysis indicated a multidisciplinary but limited evidence base. Most reviewed articles addressed end-of-life communication as a peripheral focus of investigation. Generic communication skills are important; however, substantive and sufficient disease-related information, including symptom management and assistive devices, is critical to discussions about end of life. Few articles discussed communication about specific end-of-life options. Communication recommendations in analyzed articles draw attention to communication processes, style and content but lack the systematized guidance needed for clinical practice.Conclusions: This review of primary research articles highlights the limited evidence-base and consequent need for systematic, empirical investigation to inform effective communication about end of life for those with amyotrophic lateral sclerosis. This will provide a foundation for actionable, evidence-based communication guidelines about end of life. Implications for research, policy, and practice are discussed.

Life sciences research that uses genetic resources is increasingly collaborative and global, yet collective action remains a significant barrier to the creation and management of shared research resources. These resources include sequence data and associated metadata, and biological samples, and can be understood as a type of knowledge commons. Collective action by stakeholders to create and use knowledge commons for research has potential benefits for all involved, including minimizing costs and sharing risks, but there are gaps in our understanding of how institutional arrangements may promote such collective action in the context of global genetic resources. We address this research gap by examining the attributes of an exemplar global knowledge commons: The DNA barcode commons. DNA barcodes are short, standardized gene regions that can be used to inexpensively identify unknown specimens, and proponents have led international efforts to make DNA barcodes a standard species identification tool. Our research examined if and how attributes of the DNA barcode commons, including governance of DNA barcode resources and management of infrastructure, facilitate global participation in DNA barcoding efforts. Our data sources included key informant interviews, organizational documents, scientific outputs of the DNA barcoding community, and DNA barcode record submissions. Our research suggested that the goal of creating a globally inclusive DNA barcode commons is partially impeded by the assumption that scientific norms and expectations held by researchers in high income countries are universal. We found scientific norms are informed by a complex history of resource misappropriation and mistrust between stakeholders. DNA barcode organizations can mitigate the challenges caused by its global membership through creating more inclusive governance structures, developing norms for the community are specific to the context of DNA barcoding, and through increasing awareness and knowledge of pertinent legal frameworks.

Background: The process of translating preclinical findings into a clinical setting takes decades. Previous studies have suggested that only 5-10% of the most promising preclinical studies are successfully translated into viable clinical applications. The underlying determinants of this low success rate (e.g. poor experimental design, suboptimal animal models, poor reporting) have not been examined in an empirical manner. Our study aims to determine the contemporary success rate of preclinical-to-clinical translation, and subsequently determine if an association between preclinical study design and translational success/failure exists. Methods: Established systematic review methodology will be used with regards to the literature search, article screening and study selection process. Preclinical, basic science studies published in high impact basic science journals between 1995 and 2015 will be included. Included studies will focus on publicly available interventions with potential clinical promise. The primary outcome will be successful clinical translation of promising therapies - defined as the conduct of at least one Phase II trial (or greater) with a positive finding. A case-control study will then be performed to evaluate the association between elements of preclinical study design and reporting and the likelihood of successful translation. Discussion: This study will provide a comprehensive analysis of the therapeutic translation from the laboratory bench to the bedside. Importantly, any association between factors of study design and the success of translation will be identified. These findings may inform future research teams attempting preclinical-to-clinical translation. Results will be disseminated to identified knowledge users that fund/support preclinical research.

Abstract National and international public–private partnerships, consortia, and government initiatives are underway to collect and share genomic, personal, and healthcare data on a massive scale. Ideally, these efforts will contribute to the creation of a medical information commons (MIC), a comprehensive data resource that is widely available for both research and clinical uses. Stakeholder participation is essential in clarifying goals, deepening understanding of areas of complexity, and addressing long-standing policy concerns such as privacy and security and data ownership. This article describes eight core principles proposed by a diverse group of expert stakeholders to guide the formation of a successful, sustainable MIC. These principles promote formation of an ethically sound, inclusive, participant-centric MIC and provide a framework for advancing the policy response to data-sharing opportunities and challenges.

Editorial summary Genome editing using clustered regularly interspersed short palindromic repeats (CRISPR) and CRISPR-associated proteins offers the potential to facilitate safe and effective treatment of genetic diseases refractory to other types of intervention. Here, we identify some of the major challenges for clinicians, regulators, and human research ethics committees in the clinical translation of CRISPR-mediated somatic cell therapy.

We assessed the extent to which the publication of clinical trial results of innovative cell-based interventions reflects International Society for Stem Cell Research best practice guidelines. We assessed: (1) characteristics and time to publication of completed trials; (2) quality of reported trials; and (3) results of published trials. We identified and analyzed publications from 1,052 novel stem cell clinical trials: 179 (45.4%) of 393 completed trials had published results; 48 trials were registered by known stem cell tourism clinics, none of which reported results. Completed non-industry-sponsored trials initially published more rapidly, but differences with industry-sponsored trials decreased over time. Most publications reported safety, and 67.3% (mainly early-stage trials) reported positive outcomes. A higher proportion of industry trials reported positive efficacy. Heightened patient expectations for stem cell therapies give rise to ethical obligations for the transparent conduct of clinical trials. Reporting guidelines need to be developed that are specific to early-phase clinical trials.

The extent of actor heterogeneity is known to influence the outcomes in natural resource commons, and scholars have recently begun addressed the impact of heterogeneity on knowledge commons creation and sustainability. There is increasing evidence to challenge the dominant theory that heterogeneity is uniformly disadvantageous, but little is known about heterogeneity in knowledge commons. Here, we analyse heterogeneity as it applies to rules for governing a knowledge commons – the DNA barcode commons. DNA barcodes are short, standardized gene regions that can be used to inexpensively identify unknown specimens, and proponents have led international efforts to make DNA barcodes a standard species identification tool. The dominant actors in the commons are researchers in diverse fields, and the global scope of barcoding means these researchers work in countries with varying levels of biodiversity, research infrastructure, and financial resources for scientific endeavours. This cultural and wealth heterogeneity among actors results in challenges for constructing and governing the commons, including its supporting infrastructure of databases and biorepositories. We interviewed participants in DNA barcoding, and collected organizational documents. We applied the grammar of institutions to identify institutional statements, and categorized each statement based on institutional logics theory. We found that institutional logics theory is an effective applied research tool to study heterogeneity in knowledge commons. Our analysis also suggested that heterogeneity is a challenge to developing shared expectations in global knowledge commons, but participants can design institutional statements to bridge gaps in expectations.

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.

Canadian academic and industry stakeholders are concerned about the inclusion of “virus-like particles or sub-viral particles” in the definition of New Substances Notification Regulations for Organisms (NSNR(O)) which impacts clinical cell and gene therapy and commercialization. The requirement of an independent 120 days Environment and Climate Change Canada (ECCC) review preceding a Health Canada review on quality and environmental concerns places an additional burden on Sponsors submitting clinical trial applications (CTA) and/or New Drug Submissions (NDS). A workshop initiated by CellCAN and BIOTECanada with participants from Environment and Climate Change Canada, Health Canada, the Public Health Agency of Canada and Innovation, Science and Economic Development (Ottawa, March 19, 2018) with invited stakeholders discussed approaches to streamline the environmental review process. The following main recommendations were the focus of the workshop: A regulatory policy to clarify Canadian Environmental Protection Act (CEPA)'s definition of “living organism.” This is currently defined as “a substance that is an animate product of biotechnology.” A regulatory policy could potentially exempt “human cells touched by biotechnology for use in human medicinal products” from this definition to clarify any unintended overreach of CEPA, particularly as it applies to non-genetically modified cell therapies.A guidance document to better interpret NSNR(O) Schedule 1 requirements by CTA/NDS sponsors to satisfy the environmental review process.An amendment at the level of regulations, to the NSNR (O) to create a deferment to postpone environmental assessment of micro-organisms used in the manufacturing during investigational clinical trials (pre-market stage). The regulations would apply at the time of market authorization evaluation and review, when sufficient clinical data on vector shedding has been collected, as part of the investigational clinical trials.Amendment to Schedule 4 of the CEPA to include the Food and Drugs Act and Regulations (Food and Drugs Act /FDR) as an exclusion to the application of CEPA. This would remove the current dual regulation of cell and gene therapies by both CEPA and Food and Drugs Act /FDR.These recommendations and other options were discussed at the workshop. These recommendations if adopted will significantly streamline the current regulatory burden and harmonize environmental assessment requirements with other jurisdictions.

Whereas biological materials were once transferred freely, there has been a marked shift in the formalisation of exchanges involving these materials, primarily through the use of Material Transfer Agreements (MTAs). This paper considers how risk aversion dominates MTA negotiations and the impact it may have on scientific progress. Risk aversion is often based on unwarranted fears of incurring liability through the use of a material or loss of control or missing out on commercialisation opportunities. Evidence to date has suggested that complexity tends to permeate even straightforward transactions despite extensive efforts to implement simple, standard MTAs. We argue that in most cases, MTAs need do little more than establish provenance, and any attempt to extend MTAs beyond this simple function constitutes stifling behaviour. Drawing on available examples of favourable practice, we point to a number of strategies that may usefully be employed to reduce risk-averse tendencies, including the promotion of simplicity, education of those engaged in the MTA process, and achieving a cultural shift in the way in which technology transfer office (TTO) success is measured in institutions employing MTAs.

High-throughput sequencing (HTS) of immunoglobulin (B-cell receptor, antibody) and T-cell receptor repertoires has increased dramatically since the technique was introduced in 2009 (1–3). This experimental approach explores the maturation of the adaptive immune system and its response to antigens, pathogens, and disease conditions in exquisite detail. It holds significant promise for diagnostic and therapy-guiding applications. New technology often spreads rapidly, sometimes more rapidly than the understanding of how to make the products of that technology reliable, reproducible, or usable by others. As complex technologies have developed, scientific communities have come together to adopt common standards, protocols, and policies for generating and sharing data sets, such as the MIAME protocols developed for microarray experiments. The Adaptive Immune Receptor Repertoire (AIRR) Community formed in 2015 to address similar issues for HTS data of immune repertoires. The purpose of this perspective is to provide an overview of the AIRR Community’s founding principles and present the progress that the AIRR Community has made in developing standards of practice and data sharing protocols. Finally, and most important, we invite all interested parties to join this effort to facilitate sharing and use of these powerful data sets (join@airr-community.org).

Cellular immunotherapies promise to transform cancer care. However, they must overcome serious challenges, including: (1) the need to identify and characterize novel cancer antigens to expand the range of therapeutic targets; (2) the need to develop strategies to minimize serious adverse events, such as cytokine release syndrome and treatment-related toxicities; and (3) the need to develop efficient production/manufacturing processes to reduce costs. Here, we discuss whether these challenges might better be addressed through forms of public–private research collaborations, including public–private partnerships (PPPs), or whether these challenges are best addressed by way of standard market transactions. We reviewed 14 public–private relationships and 25 underlying agreements for the clinical development of cancer cellular immunotherapies in the US. Most were based on bilateral research agreements and pure market transactions in the form of service contracts and technology licenses, which is representative of the commercialization focus of the field. We make the strategic case that multiparty PPPs may better advance cancer antigen discovery and characterization and improved cell processing/manufacturing and related activities. In the rush toward the competitive end of the translational continuum for cancer cellular immunotherapy and the attendant focus on commercialization, many gaps have appeared in our understanding of cellular biology, immunology, and bioengineering. We conclude that the model of bilateral agreements between leading research institutions and the private sector may be inadequate to efficiently harness the interdisciplinary skills and knowledge of the public and private sectors to bring these promising therapies to the clinic for the benefit of cancer patients.

Health researchers are increasingly using community-based participatory research approaches because of the benefits accrued through ongoing community engagement. The documentation of our research partnership highlights key ethical and analytical challenges researchers face in participatory research, particularly in projects partnering with service providers or cultural brokers in cross-cultural settings. In this article, we describe how choices made to accommodate a participatory research approach in the examination of vaccination behavior impacted the process and outcomes of our qualitative inquiries. First, we found that employing multiple interviewers influenced the breadth of discussion topics, thus reducing the ability to achieve saturation in small study populations. This was mitigated by (a) having two people at each interview and (b) using convergent interviewing, a technique in which multiple interviewers discuss and include concepts raised in interviews in subsequent interviews to test the validity of interview topics. Second, participants were less engaged during the informed consent process if they knew the interviewer before the interview commenced. Finally, exposing identity traits, such as age or immigration status, before the interview affected knowledge cocreation, as the focus of the conversation then mirrored those traits. For future research, we provide recommendations to reduce ethical and analytical concerns that arise with qualitative interview methods in participatory research. Specifically, we provide guidance to ensure ethical informed consent processes and rigorous interview techniques.

Background. Research in northern Canada focused on Aboriginal peoples has historically benefited academia with little consideration for the people being researched or their traditional knowledge (TK). Although this attitude is changing, the complexity of TK makes it difficult to develop mechanisms to preserve and protect it. Protecting TK becomes even more important when outside groups become interested in using TK or materials with associated TK. In the latter category are genetic resources, which may have commercial value and are the focus of this article. Objective. This article addresses access to and use of genetic resources and associated TK in the context of the historical power-imbalances in research relationships in Canadian north. Design. Review. Results. Research involving genetic resources and TK is becoming increasingly relevant in northern Canada. The legal framework related to genetic resources and the cultural shift of universities towards commercial goals in research influence the environment for negotiating research agreements. Current guidelines for research agreements do not offer appropriate guidelines to achieve mutual benefit, reflect unequal bargaining power or take the relationship between parties into account. Conclusions. Relational contract theory may be a useful framework to address the social, cultural and legal hurdles inherent in creating research agreements.

Material transfer agreements exist to facilitate the exchange of materials and associated data between researchers as well as to protect the interests of the researchers and their institutions. But this dual mandate can be a source of frustration for researchers, creating administrative burdens and slowing down collaborations. We argue here that in most cases in pre-competitive research, a simple agreement would suffice; the more complex agreements and mechanisms for their negotiation should be reserved for cases where the risks posed to the institution and the potential commercial value of the research reagents is high.

The cost of whole genome sequencing is dropping rapidly. There has been a great deal of enthusiasm about the potential for this technological advance to transform clinical care. Given the interest and significant investment in genomics, this seems an ideal time to consider what the evidence tells us about potential benefits and harms, particularly in the context of health care policy. The scale and pace of adoption of this powerful new technology should be driven by clinical need, clinical evidence, and a commitment to put patients at the centre of health care policy.

ObjectivesEffective communication by public health agencies during a pandemic promotes the adoption of recommended health behaviours. However, more information is not always the solution. Rather, attention must be paid to how information is communicated. Our study examines the television news, which combines video and audio content. We analyse (1) the content of television news about the H1N1 pandemic and vaccination campaign in Alberta, Canada; (2) the extent to which television news content conveyed key public health agency messages; (3) the extent of discrepancies in audio versus visual content.MethodsWe searched for "swine flu" and "H1N1" in local English news broadcasts from the CTV online video archive. We coded the audio and visual content of 47 news clips during the peak period of coverage from April to November 2009 and identified discrepancies between audio and visual content.ResultsThe dominant themes on CTV news were the vaccination rollout, vaccine shortages, long line-ups (queues) at vaccination clinics and defensive responses by public health officials. There were discrepancies in the priority groups identified by the provincial health agency (Alberta Health and Wellness) and television news coverage as well as discrepancies between audio and visual content of news clips. Public health officials were presented in official settings rather than as public health practitioners.ConclusionThe news footage did not match the main public health messages about risk levels and priority groups. Public health agencies lost control of their message as the media focused on failures in the rollout of the vaccination campaign. Spokespeople can enhance their local credibility by emphasizing their role as public health practitioners. Public health agencies need to learn from the H1N1 pandemic so that future television communications do not add to public confusion, demonstrate bureaucratic ineffectiveness and contribute to low vaccination rates.