
Charles WeijerWestern University | UWO · Department of Philosophy
Charles Weijer
MD, PhD
About
377
Publications
79,080
Reads
How we measure 'reads'
A 'read' is counted each time someone views a publication summary (such as the title, abstract, and list of authors), clicks on a figure, or views or downloads the full-text. Learn more
9,230
Citations
Introduction
Additional affiliations
July 2005 - present
July 2005 - present
July 1998 - June 2005
Publications
Publications (377)
The robust design and conduct of pragmatic cluster randomised trials may be in tension with the ethical requirement to obtain written informed consent from prospective research participants. In our experience, researchers tend to focus on whether a waiver of consent is appropriate for their studies. However, pragmatic cluster randomised trials rais...
Background
Randomized controlled trials with pragmatic intent aim to generate evidence that directly informs clinical decisions. Some have argued that the ethical protection of informed consent can be in tension with the goals of pragmatism. But the impact of other ethical protections on trial pragmatism has yet to be explored.
Purpose
In this art...
Objective
Cluster randomised trials (CRTs) are used for evaluating health-related interventions in low-income and middle-income countries (LMICs) but raise complex ethical issues. To inform the development of future ethics guidance, we aim to characterise CRTs conducted exclusively in LMICs by examining the types of clusters, settings, author affil...
Background Randomised trials often struggle with recruitment, retention, and delays, impacting both finances and patient care. To improve trial processes, trialists can do Studies Within A Trial (SWATs) that compare trial process alternatives. Although SWATs are recognized by funders, there are differences in how they are implemented, such as diffe...
Normothermic regional perfusion (NRP) is a surgical technique that can improve the quality and number of organs recovered for donation after the determination of death by circulatory criteria. Despite its promise, adoption of NRP has been hindered because of unresolved ethical issues. To inform stakeholders, this scoping review provides an impartia...
Précis
The administration of Pre-Mortem Interventions (PMIs) to preserve the opportunity to donate, to assess the eligibility to donate, or to optimize the outcomes of donation and transplantation are controversial as they offer no direct medical benefit and include at least the possibility of harm to the still-living patient. In this article, we d...
Background:
Donor interventions, including medications, protocols, and medical devices administered to donors, can enhance transplantable organ quality and quantity and maximize transplantation success. However, there is paucity of high-quality evidence about their effectiveness, in part because of ethical, practical, and regulatory challenges, an...
The COVID-19 pandemic touched off an unprecedented search for vaccines and treatments. Without question, the development of vaccines to prevent COVID-19 was an enormous scientific accomplishment. Further, the RECOVERY and Solidarity trials identified effective treatments for COVID-19. But all was not success. The urgent need for COVID-19 prevention...
Jon Merz raises two objections to our article on the ethics of behavioral influences in trial recruitment. In this response, we defend our article against these objections. We argue that Merz’s critique rests on a misunderstanding of our article, defend the daily life standard as a guardrail for leveraging cognitive biases, and argue that rejecting...
Introduction
In donation after circulatory determination of death, death is declared 5 min after circulatory arrest. This practice assumes, but does not explicitly confirm, permanent loss of brain activity. While this assumption is rooted a strong physiological rationale, paucity of direct human data regarding temporal relationship between cessatio...
Objective
Functional neuroimaging may provide a viable means of assessment and communication in patients with Guillain-Barré Syndrome (GBS) mimicking the complete locked-in state. Functional neuroimaging has been used to assess residual cognitive function and has allowed for binary communication with other behaviourally non-responsive patients, suc...
While randomized controlled trials are essential to health research, many of these trials fail to recruit enough participants. Approaching recruitment through the lens of behavioral science can help trialists to understand influences on the decision to participate and use them to increase recruitment. Although this approach is promising, the use of...
Introduction:
To improve dementia care delivery for persons across all backgrounds, it is imperative that health equity is integrated into pragmatic trials.
Methods:
We reviewed 62 pragmatic trials of people with dementia published 2014 to 2019. We assessed health equity in the objectives; design, conduct, analysis; and reporting using PROGRESS-...
Objectives
Normal saline (NS) and Ringer’s lactate (RL) are the most common crystalloids used for fluid therapy. Despite evidence of possible harm associated with NS (eg, hyperchloremic metabolic acidosis, impaired kidney function and death), few large multi-centre randomised trials have evaluated the effect of these fluids on clinically important...
This handbook is currently in development, with individual articles publishing online in advance of print publication. At this time, we cannot add information about unpublished articles in this handbook, however the table of contents will continue to grow as additional articles pass through the review process and are added to the site. Please note...
Objectives
To describe the extent to which pragmatic trials underachieved or overachieved their target sample sizes, examine explanations and identify characteristics associated with under-recruitment and over-recruitment.
Study design and setting
Secondary analysis of an existing database of primary trial reports published during 2014–2019, regis...
Cluster randomized trials (CRT) of non-pharmacological interventions are an important means of improving the quality of care and quality of life of people living with dementia (PLWD) in long-term care (LTC) homes. PLWD in LTC homes are, however, vulnerable in manifold ways. Therefore, researchers require guidance to ensure that the rights and welfa...
Background:
Pragmatic trials aim to generate evidence to directly inform patient, caregiver and health-system manager policies and decisions. Heterogeneity in patient characteristics contributes to heterogeneity in their response to the intervention. However, there are many other sources of heterogeneity in outcomes. Based on the expertise and jud...
Introduction
The process of controlled organ donation after circulatory determination of death (cDCDD) results in ischaemic injury to organs and leads to poorer outcomes in organ recipients. Although not yet used in Canada, normothermic regional perfusion (NRP) is a perfusion technology used postmortem with cDCDD donors to selectively restore perfu...
Objective
Randomized trials labelled as “pragmatic” are attractive to funders, patients, and clinicians as the label implies that the results are directly applicable to clinical care. We examined how authors justify use of the label (e.g., by referring to one or more PRECIS (PRagmatic Explanatory Continuum Indicator Summary)-2 domains).
Study desi...
Research participants are afforded protections to ensure their rights and welfare are not unduly jeopardized by research activities. Yet people who do not meet the criteria for research participant status may likewise be impacted by research activities, and ethicists argue that protections should be afforded these “research bystanders.” The standar...
Non-therapeutic research with imminently dying patients in intensive care presents complex ethical issues. The vulnerabilities of the imminently dying, together with societal disquiet around death and dying, contribute to an intuition that such research is beyond the legitimate scope of scientific inquiry. Yet excluding imminently dying patients fr...
Social media's rise means policies requiring anonymity in organ donation are obsolete, say Nicholas Murphy and Charles Weijer
Introduction:
This review aims to describe the landscape of pragmatic randomized controlled trials (RCTs) in the context of Alzheimer's disease (AD) and related dementias with respect to ethical considerations.
Methods:
Searches of MEDLINE were performed from January 2014 until April 2019. Extracted information included: trial setting, intervent...
Objectives
To describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.
Methods
Survey of primary trial reports, published 2014–2019, identified using an e...
Background
Early in the COVID-19 pandemic, the urgent need to discover effective therapies for COVID-19 prompted questions about the ethical problem of randomization along with its widely accepted solution: equipoise. In this scoping review, uses of equipoise in discussions of randomized controlled trials (RCT) of COVID-19 therapies are evaluated t...
Controlled donation after circulatory determination of death (cDCDD) is an important strategy for increasing the pool of eligible organ donors.
Donation after circulatory determination of death has increased the number of organs available but can result in worse recipient outcomes than organs recovered from donors after neurologic death. Normothermic regional perfusion is a novel tool that can circumvent the shortcomings of donation after circulatory determination of death. However, its im...
Background
The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges.
Objectives
To provide a summary of knowledge on placebo control...
In a cluster randomised trial (CRT), intact groups—such as communities, clinics or schools—are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed cons...
Background
Severe brain injury is a leading cause of death and disability. Diagnosis and prognostication are difficult, and errors occur often. Novel neuroimaging methods can improve diagnostic and prognostic accuracy, especially in patients with prolonged disorders of consciousness (PDoC). Yet it is currently unknown how family caregivers understa...
Background:
Cluster randomized trials (CRTs) are trials in which intact groups such as hemodialysis centers or shifts are randomized to treatment or control arms. Pragmatic CRTs have been promoted as a promising trial design for nephrology research yet may also pose ethical challenges. While randomization occurs at the cluster level, the intervent...
Objective
We established a large database of trials to serve as a resource for future methodological and ethical analyses. Here, we use meta-data to describe the broad landscape of pragmatic trials including research areas, identification as pragmatic, quality of trial registry data and enrolment.
Study Design and Setting
Trials were identified by...
The COVID-19 pandemic has highlighted the challenges of evidence-based health policymaking, as critical precautionary decisions, such as school closures, had to be made urgently on the basis of little evidence. As primary and secondary schools once again close in the face of surging infections, there is an opportunity to rigorously study their reop...
Objective: To understand the multiple and sometimes conflicting roles substitute decision makers (SDMs) of individuals in a vegetative state (VS), minimally conscious state (MCS), or with locked-in syndrome (LIS) perform while caring for a loved one and the competing priorities derived from these roles.
Methods: We conducted semi-structured qualita...
Primary Objective: To understand the experiences of family members of individuals in a locked-in state (LIS), minimally conscious state (MCS), or vegetative state (VS) with the health-care system when caring for their family member.
Research Design: The study adopted a qualitative descriptive approach drawing on central tenets of constructivist gro...
Individual‐cluster trials randomize groups of individuals but deliver study interventions directly to individual participants. We examine three arguments that might justify the perception that the bar for a waiver of consent should be lower in such trials than for individually randomized trials. We contend that if these arguments are treated as suf...
Many treatments are adopted into clinical practice without a solid evidence base and might be used heterogeneously across settings. Rigorous randomised controlled trials are therefore needed to inform decisions about the comparative effectiveness of treatments in common use. The mainstay of comparative effectiveness research is pragmatic trial desi...
Background
Pragmatic cluster randomized trials (CRTs) offer an opportunity to improve health care by answering important questions about the comparative effectiveness of treatments using a trial design that can be embedded in routine care. There is a lack of empirical research that addresses ethical issues generated by pragmatic CRTs in hemodialysi...
Background:
The hemodialysis setting is suitable for trials that use cluster randomization, where intact groups of individuals are randomized. However, cluster randomized trials (CRTs) are complicated in their design, analysis, and reporting and can pose ethical challenges. We reviewed CRTs in the hemodialysis setting with respect to reporting of...
Background:
Novel rationales for randomizing clusters rather than individuals appear to be emerging from the push for more pragmatic trials, for example, to facilitate trial recruitment, reduce the costs of research, and improve external validity. Such rationales may be driven by a mistaken perception that choosing cluster randomization lessens th...
Purpose:
To generate foundational knowledge in the creation of a quality-of-life instrument for patients who are clinically diagnosed as being in a vegetative or minimally conscious state but are able to communicate by modulating their brain activity (i.e., behaviourally nonresponsive and covertly aware). The study aimed to identify a short list o...
https://blogs.bmj.com/medical-ethics/2020/04/27/is-it-ethical-to-forcibly-withdraw-ventilators-from-nursing-home-patients-for-reallocation-to-covid-19-patients/
Background:
Cluster randomized trials are common in health research in low- and middle-income countries raising issues that challenge interpretation of standard ethical guidelines. While the Ottawa Statement on the ethical design and conduct of cluster randomized trials provides guidance for researchers and research ethics committees, it does not...
Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challe...
Hemodialysis is a life-sustaining treatment for persons with kidney failure. However, those on hemodialysis still face a poor quality of life and a short life expectancy. High-quality research evidence from large randomized controlled trials is needed to identify interventions that improve the experiences, outcomes, and health care of persons recei...
Background:
There is a concern that the apparent effectiveness of interventions tested in clinical trials may not be an accurate reflection of their actual effectiveness in usual practice. Pragmatic randomized controlled trials (RCTs) are designed with the intent of addressing this discrepancy. While pragmatic RCTs may increase the relevance of re...
Background:
Stepped-wedge cluster randomized trials (SW-CRTs) are increasingly popular in health-related research in both high- and low-resource settings. There may be specific ethical issues that researchers face when designing and conducting SW-CRTs in low-resource settings. Knowledge of these issues can help to improve the ethical conduct of SW...
Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this paper is to provide a summary of current knowledge on placebo controls in surgical trials.
A placebo control is a complex type of comparison group and, although powerful, presents many challenges in a surgica...
Background:
All studies classified as research involving human participants require research ethics review. Most regulation and guidance on ethical oversight of research involving human participants was written for pharmacotherapy interventions. Interpretation of such guidance for cluster-randomized trials and stepped-wedge trials, which commonly...
In this issue of JME , Watson et al call for research evaluation of government health programmes and identify ethical guidance, including the Ottawa Statement on the ethical design and conduct of cluster randomised trials, as a hindrance. While cluster randomised trials of health programmes as a whole should be evaluated by research ethics committe...
Background
Pragmatic trials are intended to directly inform clinical or health policy decision making. While pragmatic trials may help to address concerns regarding the disconnect between research and practice they may also raise new ethical challenges.
Methods
Semi-structured interviews with 45 key stakeholders (methodologists, clinical investig...
This article provides an ethical analysis of psychedelic research involving disorders of consciousness patients. We apply two internationally-accepted approaches for analyzing the ethics of human research, the Value-Validity Framework and Component Analysis, to a research program recently proposed by Scott and Carhart-Harris. We focus on Scott and...
The human immune system is critical for maintaining health and providing protection from infectious diseases and cancer. Major advances in our understanding of the immune system have largely emerged from studies using animal models such as mice. However, this mouse-centric research has also limited our ability to comprehend the human immune system...
Background and objectives:
Cluster randomized trials are commonly used to evaluate public health, knowledge translation, and health service interventions. Cluster trials raise novel ethical issues, however, and the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials (2012) provides researchers and research ethics commit...
The increasing use of cluster randomised trials in low-resource settings raises unique ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomised Trials is the first international ethical guidance document specific to cluster trials, but it is unknown if it adequately addresses issues in low-resource settings. In t...
A pragmatic cluster-randomized trial (CRT) is a research design that may be used to efficiently test promising interventions that directly inform dialysis care. While the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials provides general ethical guidance for CRTs, the dialysis setting raises additional considerations....
Functional MRI shows promise as a candidate prognostication method in acutely comatose patients following severe brain injury. However, further research is needed before this technique becomes appropriate for clinical practice. Drawing on a clinical case, we investigate the process of obtaining informed consent for this kind of research and identif...
Background:
Quality and service improvement (QSI) research employs a broad range of methods to enhance the efficiency of healthcare delivery. QSI research differs from traditional healthcare research and poses unique ethical questions. Since QSI research aims to generate knowledge to enhance quality improvement efforts, should it be considered res...
Background
Randomized controlled trial (RCT) trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of act...
This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for the stepped wedge cluster randomised trial (SW-CRT). The SW-CRT involves randomisation of clusters to different sequences that dictate the order (or timing) at which each cluster will switch to the intervention condition. The statement was developed to allow...
Janet Jull, Mark Petticrew, Elizabeth Kristjansson, Manosila Yoganathan , Jennifer Petkovic, Peter Tugwell, Vivian Welch and the CONSORT-Equity 2017 and Boston Equity Symposium participants. Engaging knowledge users in development of the CONSORT-Equity 2017 reporting guideline: a qualitative study using in-depth interviews. Research Involvement and...
Background:
There is a widely recognized need for more pragmatic trials that evaluate interventions in real-world settings to inform decision-making by patients, providers, and health system leaders. Increasing availability of electronic health records, centralized research ethics review, and novel trial designs, combined with support and resource...
Introduction
0.9% saline and Ringer’s lactate are the two most common resuscitation crystalloid fluids. 0.9% saline may lead to hyperchloraemic metabolic acidosis and may be associated with impaired kidney function and death. Few large multicentre randomised trials have been conducted to evaluate the effect of these two fluids on clinically importa...
Background To date there is no established consensus of assessment criteria for evaluating research ethics review. Methods We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic...
We cast a novel perspective on two distinct populations: patients who become accidentally intraoperatively aware after receiving general anesthesia and severely brain-injured patients who are diagnosed as being in a vegetative state. In both cases, patients are behaviorally non-responsive -and on this basis presumed to lack consciousness- yet, reta...