Navigating Informed Consent Requirements and Expectations in Cluster Randomized Trials: Research Ethics Board Members' and Researchers' Views.

Informed consent is a cornerstone of ethical human research. However, as cluster randomized trials (CRTs) are increasingly popular to evaluate health service interventions, especially as health systems aspire toward the learning health system, questions abound how research teams and research ethics boards (REBs) should navigate intertwining consent and data-use considerations. Methodological and ethical questions include who constitute the participants, whose and what types of consent are necessary, and how data from people who have not consented to participation should be managed to optimize the balance of trust in the research enterprise, respect for persons, the promotion of data integrity, and the pursuit of the public good in the research arena. In this paper, we report the findings and lessons learned from a qualitative study examining how researchers and REB members consider the ethical dimensions of when data can be collected and used in CRTs in the evolving research landscape.

Deploying an ethics needs assessment to inform a navigational tool for research compliance pathways at a provincial Canadian health authority.

Practitioners aim to improve healthcare systems and clinical care through a variety of activities as part of a learning healthcare system. Yet the distinction between projects requiring Research Ethics Board (REB) approval or not is becoming increasingly blurred, making it difficult for researchers and others to classify projects and then navigate the required compliance pathway appropriately. To address this challenge, the Provincial Health Services Authority (PHSA) of British Columbia (BC) created a decision tool called the "PHSA Project Sorter Tool" to serve its diverse community while also meeting the unique needs of the BC regulatory and policy environment. The goal of the tool was to standardize and clarify organizational project review and ensure project leads were referred to the appropriate review body or service provider within the PHSA in the most efficient manner possible. In this paper, we describe the ethics needs assessment that was conducted to inform the tool and the results of our ongoing evaluation of the tool since it was launched in January, 2020. Our project shows that this simple tool can reduce burdens on staff and provide clarity to users by standardizing processes and terms and directing users to appropriate internal resources.

Research recruitment and consent methods in a pandemic: a qualitative study of COVID-19 patients' perspectives.

BACKGROUND: Virtual data collection methods and consent procedures adopted in response to the COVID-19 pandemic enabled continued research activities, but also introduced concerns about equity, inclusivity, representation, and privacy. Recent studies have explored these issues from institutional and researcher perspectives, but there is a need to explore patient perspectives and preferences. This study aims to explore COVID-19 patients' perspectives about research recruitment and consent for research studies about COVID-19. METHODS: We conducted an exploratory qualitative focus group and interview study among British Columbian adults who self-identified as having had COVID-19. We recruited participants through personal contacts, social media, and REACH BC, an online platform that connects researchers and patients in British Columbia. We analyzed transcripts inductively and developed thematic summaries of each coding element. RESULTS: Of the 22 individuals recruited, 16 attended a focus group or interview. We found that autonomy and the feasibility of participation, attitudes toward research about COVID-19, and privacy concerns are key factors that influence participants' willingness to participate in research. We also found that participants preferred remote and virtual approaches for contact, consent, and delivery of research on COVID-19. CONCLUSIONS: Individuals who had COVID-19 are motivated to participate in research studies and value autonomy in their decision to participate, but researchers must be sensitive and considerate toward patient preferences and concerns, particularly as researchers adopt virtual recruitment and data collection methods. Such awareness may increase research participation and engagement.

Due to the COVID-19 pandemic, many research groups started conducting research activities virtually. In this study, we invited individuals who had COVID-19 to share their views about how researchers recruit patients and get their consent to participate in studies about COVID-19. Through interviews and focus groups, we found that British Columbians who had COVID-19 are motivated to participate in COVID-related studies, as long as researchers maintain usual precautions around data privacy and accommodate preferences for participation. Future studies may use these patient perspectives to make informed decisions that will increase and support patient recruitment, consent and retention in research studies.

COVID-19 Outbreak: Understanding Moral-Distress Experiences Faced by Healthcare Workers in British Columbia, Canada.

Pandemic-management plans shift the care model from patient-centred to public-centred and increase the risk of healthcare workers (HCWs) experiencing moral distress (MD). This study aimed to understand HCWs' MD experiences during the COVID-19 pandemic and to identify HCWs' preferred coping strategies. Based on a qualitative research methodology, three surveys were distributed at different stages of the pandemic response in British Columbia (BC), Canada. The thematic analysis of the data revealed common MD themes: concerns about ability to serve patients and about the risks intrinsic to the pandemic. Additionally, it revealed that COVID-19 fatigue and collateral impact of COVID-19 were important ethical challenges faced by the HCWs who completed the surveys. These experiences caused stress, anxiety, increased/decreased empathy, sleep disturbances, and feelings of helplessness. Respondents identified self-care and support provided by colleagues, family members, or friends as their main MD coping mechanisms. To a lesser extent, they also used formal sources of support provided by their employer and identified additional strategies they would like their employers to implement (e.g., improved access to mental health and wellness resources). These results may help inform pandemic policies for the future.

A proposed de-identification framework for a cohort of children presenting at a health facility in Uganda.

Data sharing has enormous potential to accelerate and improve the accuracy of research, strengthen collaborations, and restore trust in the clinical research enterprise. Nevertheless, there remains reluctancy to openly share raw data sets, in part due to concerns regarding research participant confidentiality and privacy. Statistical data de-identification is an approach that can be used to preserve privacy and facilitate open data sharing. We have proposed a standardized framework for the de-identification of data generated from cohort studies in children in a low-and-middle income country. We applied a standardized de-identification framework to a data sets comprised of 241 health related variables collected from a cohort of 1750 children with acute infections from Jinja Regional Referral Hospital in Eastern Uganda. Variables were labeled as direct and quasi-identifiers based on conditions of replicability, distinguishability, and knowability with consensus from two independent evaluators. Direct identifiers were removed from the data sets, while a statistical risk-based de-identification approach using the k-anonymity model was applied to quasi-identifiers. Qualitative assessment of the level of privacy invasion associated with data set disclosure was used to determine an acceptable re-identification risk threshold, and corresponding k-anonymity requirement. A de-identification model using generalization, followed by suppression was applied using a logical stepwise approach to achieve k-anonymity. The utility of the de-identified data was demonstrated using a typical clinical regression example. The de-identified data sets was published on the Pediatric Sepsis Data CoLaboratory Dataverse which provides moderated data access. Researchers are faced with many challenges when providing access to clinical data. We provide a standardized de-identification framework that can be adapted and refined based on specific context and risks. This process will be combined with moderated access to foster coordination and collaboration in the clinical research community.

CRAFT-A Proposed Framework for Decentralized Clinical Trials Participation in Canada.

Canada's vast geography, and centralized delivery of cancer care and clinical trials create barriers for trial participation for patients in remote and rural settings. The development and implementation of a framework that enables safe and regulatory compliant trial participation through local healthcare providers would benefit Canadian patients, clinicians, trial sponsors and the health care system. To address this issue, representatives of Canada's cancer clinical trial community met to identify key challenges and develop recommendations for remote patient participation in trials. A structured literature review identified remote/rural trial delivery models. A panel of expert stakeholders reviewed the models and participated in a workshop to assess health system readiness, identify needed processes, tools and mechanisms, and develop recommendations for a Canadian framework for decentralized clinical trial conduct. The Canadian Remote Access Framework for clinical Trials (CRAFT) represents a risk-based approach used by site investigators to delegate responsibilities for a given trial to satellite health centres within a hub-and-spoke "trial cluster". The Framework includes specific recommendations to ensure research experience, capacity, regulatory compliance and patient safety. Canada's cancer care and telemedicine systems can be leveraged to enable broader access to clinical trials for patients who are geographically remote from cancer centres. CRAFT's risk-based framework is based on other successful models of remote trial patient management and is in the pilot implementation phase in Canada.

Benefits and Risks of Visitor Restrictions for Hospitalized Children During the COVID Pandemic.

To control the spread of severe acute respiratory syndrome coronavirus 2, the virus responsible for coronavirus disease 2019, many hospitals have strict visitor restriction policies. These policies often prohibit both parents from visiting at the same time or having grandparents or other family members visit at all. We discuss cases in which such policies created ethical dilemmas and possibly called for compassionate exceptions from the general rules.

Addressing the affordability of cancer drugs: using deliberative public engagement to inform health policy.

BACKGROUND: Health system expenditure on cancer drugs is rising rapidly in many OECD countries given the costly new treatments and increased rates of use due to a growing and ageing population. These factors put considerable strain on the sustainability of health systems worldwide, sparking public debate among clinicians, pharmaceutical companies, policy-makers and citizens on issues of affordability and equity. We engaged Canadians through a series of deliberative public engagement events to determine their priorities for making cancer drug funding decisions fair and sustainable in Canada's publicly financed health system. METHODS: An approach to deliberation was developed based on the McMaster Health Forum's citizen panels and the established Burgess and O'Doherty model of deliberative public engagement. Six deliberations were held across Canada in 2016. Transcripts were coded in NVivo and analysed to determine where participants' views converged and diverged. Recommendations were grouped thematically. RESULTS: A total of 115 Canadians participated in the deliberative events and developed 86 recommendations. Recommendations included the review and regular re-review of approved drugs using 'real-world' evidence on effectiveness and cost-effectiveness; prioritisation of treatments that restore patients' independence, mental health and general well-being; ensuring that decision processes, results and their rationales are transparent; and commitment to people with similar needs receiving the same care regardless of where in Canada they live. CONCLUSIONS: The next steps for policy-makers should be to develop mechanisms for (1) re-reviewing effectiveness and cost-effectiveness data for all cancer drugs; (2) making disinvestments in cancer drugs that satisfy requirements relating to grandfathering and compassionate access; (3) ensuring fair and equitable access to cancer drugs for all Canadians; and (4) fostering a pan-Canadian approach to cancer drug funding decisions.

Community recommendations on biobank governance: Results from a deliberative community engagement in California.

United States-based biorepositories are on the cusp of substantial change in regulatory oversight at the same time that they are increasingly including samples and data from large populations, e.g. all patients in healthcare system. It is appropriate to engage stakeholders from these populations in new governance arrangements. We sought to describe community recommendations for biorepository governance and oversight using deliberative community engagement (DCE), a qualitative research method designed to elicit lay perspectives on complex technical issues. We asked for stakeholders to provide input on governance of large biorepositories at the University of California (UC), a public university. We defined state residents as stakeholders and recruited residents from two large metropolitan areas, Los Angeles (LA) and San Francisco (SF). In LA, we recruited English and Spanish speakers; in SF the DCE was conducted in English only. We recruited individuals who had completed the 2009 California Health Interview Survey and were willing to be re-contacted for future studies. Using stratified random sampling (by age, education, race/ethnicity), we contacted 162 potential deliberants of whom 53 agreed to participate and 51 completed the 4-day DCE in June (LA) and September-October (SF), 2013. Each DCE included discussion among deliberants facilitated by a trained staff and simultaneously-translated in LA. Deliberants also received a briefing book describing biorepository operations and regulation. During the final day of the DCE, deliberants voted on governance and oversight recommendations using an audience response system. This paper describes 23 recommendations (of 57 total) that address issues including: educating the public, sharing samples broadly, monitoring researcher behavior, using informative consent procedures, and involving community members in a transparent process of biobank governance. This project demonstrates the feasibility of obtaining meaningful input on biorepository governance from diverse lay stakeholders. Such input should be considered as research institutions respond to changes in biorepository regulation.

Assessing the quality of a deliberative democracy mini-public event about advanced biofuel production and development in Canada.

The importance of evaluating deliberative public engagement events is well recognized, but such activities are rarely conducted for a variety of theoretical, political and practical reasons. In this article, we provide an assessment of the criteria presented in the 2008 National Research Council report on Public Participation in Environmental Assessment and Decision Making (NRC report) as explicit indicators of quality for the 2012 'Advanced Biofuels' deliberative democracy event. The National Research Council's criteria were selected to evaluate this event because they are decision oriented, are the products of an exhaustive review of similar past events, are intended specifically for environmental processes and encompass many of the criteria presented in other evaluation frameworks. It is our hope that the results of our study may encourage others to employ and assess the National Research Council's criteria as a generalizable benchmark that may justifiably be used in forthcoming deliberative events exploring different topics with different audiences.

Sharing with More Caring: Coordinating and Improving the Ethical Governance of Data and Biomaterials Obtained from Children.

INTRODUCTION: Research on complex health conditions such as neurodevelopmental disorders increasingly relies on large-scale research and clinical studies that would benefit from data sharing initiatives. Organizations that share data stand to maximize the efficiency of invested research dollars, expedite research findings, minimize the burden on the patient community, and increase citation rates of publications associated with the data. OBJECTIVE: This study examined ethics and governance information on websites of databases involving neurodevelopmental disorders to determine the availability of information on key factors crucial for comprehension of, and trust and participation in such initiatives. METHODS: We identified relevant databases identified using online keyword searches. Two researchers reviewed each of the websites and identified thematic content using principles from grounded theory. The content for each organization was interrogated using the gap analysis method. RESULTS: Sixteen websites from data sharing organizations met our inclusion criteria. Information about types of data and tissues stored, data access requirements and procedures, and protections for confidentiality were significantly addressed by data sharing organizations. However, special considerations for minors (absent from 63%), controls to check if data and tissues are being submitted (absent from 81%), disaster recovery plans (absent from 81%), and discussions of incidental findings (absent from 88%) emerged as major gaps in thematic website content. When present, content pertaining to special considerations for youth, along with other ethics guidelines and requirements, were scattered throughout the websites or available only from associated documents accessed through live links. CONCLUSION: The complexities of sharing data acquired from children and adolescents will only increase with advances in genomic and neuro science. Our findings suggest that there is a need to improve the consistency, depth and accessibility of governance and policies on which these collaborations can lean specifically for vulnerable young populations.

Ethical considerations in biobanks: how a public health ethics perspective sheds new light on old controversies.

Biobanks, collections of biospecimens with or without linked medical data, have increased dramatically in number in the last two decades. Their potential power to identify the underlying mechanisms of both rare and common disease has catalyzed their proliferation in the academic, medical, and private sectors. Despite demonstrated public support of biobanks, some within the academic, governmental, and public realms have also expressed cautions associated with the ethical, legal, and social (ELSI) implications of biobanks. These issues include concerns related to the privacy and confidentiality of data; return of results and incidental findings to participants; data sharing and secondary use of samples; informed consent mechanisms; ownership of specimens; and benefit sharing (i.e., the distribution of financial or other assets that result from the research). Such apprehensions become amplified as more researchers seek to pursue national and cross-border collaborations between biobanks. This paper provides an overview of two of the most contentious topics in biobank literature - informed consent and return of individual research results or incidental findings - and explores how a public health ethics lens may help to shed new light on how these issues may be best approached and managed. Doing so also demonstrates the important role that genetic counselors can play in the ongoing discussion of ethically appropriate biobank recruitment and management strategies, as well as identifies important areas of ongoing empirical research on these unresolved topics.

Consent in escrow.

Disasters such as flash flooding, mass shootings, and train and airplane accidents involving large numbers of victims produce significant opportunity for research in the biosciences. This opportunity exists in the extreme tails of life events, however, during which decisions about life and death, valuing and foregoing, speed and patience, trust and distrust, are tested simultaneously and abundantly. The press and urgency of these scenarios may also challenge the ability of researchers to comprehensively deliver information about the purposes of a study, risks, benefits, and alternatives. Under these circumstances, we argue that acquiring consent for the immediate use of data that are not time sensitive represents a gap in the protection of human study participants. In response, we offer a two-tiered model of consent that allows for data collected in real-time to be held in escrow until the acute post-disaster window has closed. Such a model not only respects the fundamental tenet of consent in research, but also enables such research to take place in an ethically defensible manner.

Consent in escrow: opting to opt in.

In this paper, we reply to Taylor's (2015) peer commentary on consent-in-escrow. Specifically, we clarify the utility of this novel approach, the way in which it minimizes risks to participants, and how it differs from existing opt-out methods. We further explore its potential use in fields beyond disaster research.

Collision or convergence?: beliefs and politics in neuroscience discovery, ethics, and intervention.

Discovery and interventions for neurological disorders have a unique capacity to galvanize public opinion over issues of access, human rights, decision making, and the definition of disease. Here we highlight five cases where beliefs and politics prevailed over evidence and ethics. We examine lessons from them about the communication of risk and the power of public influence on science, society, and policy.

Toward disaster-resilient cities: characterizing resilience of infrastructure systems with expert judgments.

Resilient infrastructure systems are essential for cities to withstand and rapidly recover from natural and human-induced disasters, yet electric power, transportation, and other infrastructures are highly vulnerable and interdependent. New approaches for characterizing the resilience of sets of infrastructure systems are urgently needed, at community and regional scales. This article develops a practical approach for analysts to characterize a community's infrastructure vulnerability and resilience in disasters. It addresses key challenges of incomplete incentives, partial information, and few opportunities for learning. The approach is demonstrated for Metro Vancouver, Canada, in the context of earthquake and flood risk. The methodological approach is practical and focuses on potential disruptions to infrastructure services. In spirit, it resembles probability elicitation with multiple experts; however, it elicits disruption and recovery over time, rather than uncertainties regarding system function at a given point in time. It develops information on regional infrastructure risk and engages infrastructure organizations in the process. Information sharing, iteration, and learning among the participants provide the basis for more informed estimates of infrastructure system robustness and recovery that incorporate the potential for interdependent failures after an extreme event. Results demonstrate the vital importance of cross-sectoral communication to develop shared understanding of regional infrastructure disruption in disasters. For Vancouver, specific results indicate that in a hypothetical M7.3 earthquake, virtually all infrastructures would suffer severe disruption of service in the immediate aftermath, with many experiencing moderate disruption two weeks afterward. Electric power, land transportation, and telecommunications are identified as core infrastructure sectors.

Hopes and fears for professional movement in the stem cell community.

We examine here how the issue of professional migration in stem cell research has been explored in news media, government documents, and the peer-reviewed literature. The results shed light on how patterns of and forces that motivate these movements are depicted and highlight issues of significance to the stem cell community.

Spinning a stem cell ethics web.

The goal of this study was to provide an ethics education resource for trainees and researchers in the Canadian Stem Cell Network that would address the multiple ethical challenges in stem cell research including accountability in and for research across its multiple dimensions. The website was built using a bottom-up type approach based on an ethics needs assessment in combination with a top-down expert-driven component. There have been 3,615 visitors to the website since it was launched in July, 2011. The ongoing rate of returning visitors (20%) indicates that the website is becoming a valuable tool used multiple times.