Ethics Board Members Research Articles

Needs and preferences of REB members in the development of a new TCPS 2 training program in Canada

Despite advancements in human research ethics and the growing significance of Research Ethics Board (REB) members, educational opportunities specifically tailored to their needs remain lacking in many countries. In response to this gap, our research aims to understand the demographics, needs, and preferences for educational opportunities of REB members in Canada. We conducted a survey that found REB demographics to be diverse and have different perceptions of their roles on topics such as the evaluation of the scientific merit of studies and responsibilities to stakeholders. We found that REB members in general prefer online tutorials and webinars for their education. Educators interested in facilitating the development of future training programs should consider the needs and preferences of REB members outlined in this publication.

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.

Factors relating to nonpublication and publication bias in clinical trials in Canada: A qualitative interview study.

This study aims to understand factors contributing to nonpublication and publication bias in clinical trials in Canada. Qualitative interviews were conducted between March 2019 and April 2021 with 34 participants from the Canadian provinces of Alberta, British Columbia and Ontario, including 17 clinical trial investigators, 1 clinical research coordinator, 3 research administrators, 3 research ethics board members and 10 clinical trial participants. We conducted a thematic analysis involving coding of interview transcripts and memo-writing to identify key themes. Several factors contribute to nonpublication and publication bias in clinical trial research. A core theme was that reporting practices are shaped by incentives within the research system taht favour publication of positive over negative trials. Investigators are discouraged from reporting by experiences or perceptions of difficulty in publishing negative findings but rewarded for publishing positive findings in various ways. Trial investigators more strongly associated positive clinical trials than negative trials with opportunities for industry and nonindustry funding and with academic promotion, bonuses and recognition. Research institutions and ethics boards tended to lack well-resourced, proactive policies and practices to ensure trial findings are reported in registries or journals. Clinical trial reporting practices in Canada are shaped by incentives favouring reporting of positive over negative trials, such as funding opportunities and academic promotion, bonuses and recognition. Research institutions could help change incentives by adopting performance metrics that emphasize full reporting of results in journals or registries.

Ethical Issues in Research: Perceptions of Researchers, Research Ethics Board Members and Research Ethics Experts.

In the context of academic research, a diversity of ethical issues, conditioned by the different roles of members within these institutions, arise. Previous studies on this topic addressed mainly the perceptions of researchers. However, to our knowledge, no studies have explored the transversal ethical issues from a wider spectrum, including other members of academic institutions as the research ethics board (REB) members, and the research ethics experts. The present study used a descriptive phenomenological approach to document the ethical issues experienced by a heterogeneous group of Canadian researchers, REB members, and research ethics experts. Data collection involved socio-demographic questionnaires and individual semi-structured interviews. Following the triangulation of different perspectives (researchers, REB members and ethics experts), emerging ethical issues were synthesized in ten units of meaning: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. This study highlighted several problematic elements that can support the identification of future solutions to resolve transversal ethical issues in research that affect the heterogeneous members of the academic community.

‘Cambridge Moralica’ - Towards an Ethical Framework for Social Media Analytics

En route to the unravelling of today’s multiplicity of societal challenges, making sense of social data has become a crucial endeavour in Information Systems (IS) research. In this context, Social Media Analytics (SMA) has evolved to a promising field of data-driven approaches, guiding researchers in the process of collecting, analysing, and visualising social media data. However, the handling of such sensitive data requires careful ethical considerations to protect data subjects, online communities, and researchers. Hitherto, the field lacks consensus on how to safeguard ethical conduct throughout the research process. To address this shortcoming, this study proposes an extended version of a SMA framework by incorporating ethical reflection phases as an addition to methodical steps. Following a design science approach, existing ethics guidelines and expert interviews with SMA researchers and ethicists serve as the basis for redesigning the framework. It was eventually assessed through multiple rounds of evaluation in the form of focus group discussions and questionnaires with ethics board members and SMA experts. The extended framework, encompassing a total of five iterative ethical reflection phases, provides simplified ethical guidance for SMA researchers and facilitates the ethical self-examination of research projects involving social media data.

Industry Sponsor Influence in Clinical Trial Reporting in Canada: A Qualitative Interview Study

Approximately 40% of randomized controlled trials are not published, leading to publication bias and less informed clinical decision-making. Qualitative interviews were conducted to understand whether and how industry sponsors of clinical trials of drugs and biologics in Canada influence decisions to report trial results. Participants eligible for an interview included clinical trial investigators and research coordinators with experience in drug research, research ethics board members with at least 1 year of experience in ethical review of trials, research administrators with knowledge of dissemination of clinical trial findings or relations with trial sponsors, and trial participants who had taken part in a drug trial as an adult in the 5 years before their interview. Semi-structured interviews were held in person or by telephone between March 2019 and April 2021 with participants in Alberta, British Columbia, and Ontario, Canada. Qualitative analysis included coding of interview transcripts and identification of key themes. Interviews were conducted with 34 participants, including 17 clinical trial investigators, 1 clinical research coordinator, 3 research administrators, 3 research ethics board members, and 10 clinical trial participants. Participants involved in the conduct, administration, or ethical review of trials represented a range of medical disciplines. Interview participant accounts indicated that in some cases, industry sponsors influence whether results are reported. A core theme was that companies have a weaker incentive to publish trials with unfavorable findings and trials for products that they have decided not to develop further. Companies may influence reporting in various ways, including stopping trials early and not reporting results of stopped trials, owning and controlling access to data, and negotiating clinical trial agreements in multicenter trials that do not fully protect the ability of investigators to publish. Internal company trials represent an additional source of unpublished trials. More broadly, the research system creates a dependency on funding from industry sponsors that may weaken the ability of researchers and research institutions to negotiate terms with industry sponsors that would fully protect publication rights. Interviews with trial investigators and others connected to trial research indicate that in some cases, industry sponsors of clinical trial research in Canada influence whether results are reported. Policies aiming to bring about full reporting of trials could benefit from considering the commercial incentives of companies and the ways in which industry sponsors may influence clinical trial reporting. Future research could examine the generalizability of these findings to other jurisdictions.

Canadian Librarians as Research Ethics Board Members: An Exploratory Case Study

Very little is known about Canadian librarians who sit on Research Ethics Boards (REBs) or Institutional Review Boards (IRBs). There is some background information on various roles of librarians on REBs, but that is usually from the perspective of one or two authors and often relating to the health sciences. Librarianship continues to evolve, especially in the areas of research data management, research support, and scholarly communication. It is, therefore, important to understand the changing expectations and responsibilities that librarians may have in Canada in order to encourage and support them as they meet institutional needs. This exploratory case study will document the reasons that motivate Canadian librarians to sit on REBs, the training they have received, the benefits achieved, and their overall experience.

Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol for a Cross-Sectional Web-Based Survey Study.

BackgroundAlthough several studies have been conducted and several articles have been published on India's new clinical trial regulations, very few have examined the views of investigators and ethics board members regarding modifications to the previous regulations. Overall, they have neglected to find out the opinions of other relevant professionals, such as research assistants, coordinators, associates, and managers. To our knowledge, no study has yet investigated the awareness and opinions of Indian research professionals on the new 2019 regulations.ObjectiveThis study aims to describe the awareness and opinions of Indian research professionals on the new drug and clinical trial regulations.MethodsIn this cross-sectional, Web-based study, we will conduct an open survey for various Indian research professionals. These professionals will be selected randomly using multiple sources. The survey questionnaires, which have already been validated, were developed using the form function in Google docs. A Web link was generated for participants to take the survey. Descriptive statistics will be shown as means and standard deviations for constant variables, whereas certain variables will instead be shown as numbers and percentages.ResultsThe survey was opened in July 2019. Enrollment has already started and will be completed in three months. The results calculations are expected to begin in October 2019.ConclusionsThe results of the survey are expected to represent the views of research professionals on the new regulations that will support the development of clinical research and the pharmaceutical industry in India. These regulations are expected to help advance clinical trials, help with the approval of new drugs, and enhance ethical norms in the country.International Registered Report Identifier (IRRID)PRR1-10.2196/14744

Using Participatory Design to Inform the Connected and Open Research Ethics (CORE) Commons.

Mobile health (mHealth) research involving pervasive sensors, mobile apps and other novel data collection tools and methods present new ethical, legal, and social challenges specific to informed consent, data management and bystander rights. To address these challenges, a participatory design approach was deployed whereby stakeholders contributed to the development of a web-based commons to support the mHealth research community including researchers and ethics board members. The CORE (Connected and Open Research Ethics) platform now features a community forum, a resource library and a network of nearly 600 global members. The utility of the participatory design process was evaluated by analyzing activities carried out over an 8-month design phase consisting of 86 distinct events including iterative design deliberations and social media engagement. This article describes how participatory design yielded 55 new features directly mapped to community needs and discusses relationships to user engagement as demonstrated by a steady increase in CORE member activity and followers on Twitter.

Considerations for adaptive design in pediatric clinical trials: study protocol for a systematic review, mixed-methods study, and integrated knowledge translation plan

BackgroundAlthough children have historically been excluded from clinical trials (CTs), many require medicines tested and approved in CTs, forcing health care providers to treat their pediatric patients based on extrapolated data. Unfortunately, traditional randomized CTs can be slow and resource-intensive, and they often require multi-center collaboration. However, an adaptive design (AD) framework for CTs could be used to increase the efficiency of pediatric CTs by incorporating prospectively planned modifications to CT methods without undermining the integrity or validity of the study. There are many possible adaptations, but each will have ethical, logistical, and statistical implications. It remains unclear which adaptations (or combinations thereof) will lead to real-world improvements in pediatric CT efficiency. This study will identify, evaluate, and synthesize the various regulatory, ethical, logistical, and statistical considerations and emerging issues of AD in CTs that could be used to evaluate the use of drugs in children.Methods/designFollowing the development of a peer-reviewed search strategy, a systematic review on AD in CTs will be conducted. Data on regulatory, ethical, logistic, and statistical considerations as well as population and trial design characteristics will be synthesized. A mixed-methods study including surveys and focus groups with regulators, research ethics board members, biostatisticians, clinicians, and scientists, as well as representatives from patient groups and the public will evaluate the opportunities and challenges in applying AD in trials enrolling children and propose recommendations on best practices.DiscussionThis study will deliver practical recommendations on the use of AD in pediatric CTs. Collaboration and consultation with national and global partners will ensure that our results meet the needs of researchers, regulators, and patients, both locally and globally, and that they remain current and relevant by engaging a wide variety of stakeholders. Overall, this research will enrich the knowledge base regarding if, how, and when AD can be used to answer research questions with fewer resources while still meeting the highest ethical standards and regulatory requirements for CTs. In turn, this will result in increased high-quality clinical research needed by health care providers so they have access to appropriate, population-specific evidence regarding the safe and effective use of medicines in children.

The Effect of Research Compensation in the Form of Cheques on Gamblers' Cash-in Behaviour

A view that is commonly held by Research Ethics Board members is that offering money as research compensation has the potential to unduly influence or even coerce subjects into participating in studies. Because money is the core resource of gambling activity, gamblers with financial needs might show an increased propensity to take part in research that offers financial compensation. We hypothesized that pathological gamblers at electronic gambling machines in venues outside of casinos would tend to cash in their compensation cheque faster than non-pathological gamblers would. The current results support this hypothesis. It is therefore necessary to understand gamblers' motivations related to research activities and the ways in which the research context can sustain rational decision making when gamblers consider taking part in scientific studies.

Research Ethics Board (REB) Members’ Preparation for, and Perceived Knowledge of Research Ethics

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) was first developed to establish a standard of practice in research ethics by the three federal agencies responsible for funding institutional research in Canada: Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council (NSERC), and Social Sciences and Humanities Research Council (SSHRC). In 2010, a second edition of the policy, known as the TCPS 2, was released with updated information and expanded coverage of research ethics issues. According to the TCPS 2, the Agencies’ mandate is “to promote research that is conducted according to the highest ethical standards,” and the TCPS 2 serves as a benchmark for this with respect for human dignity as its underlying value. Research institutions receiving Agency funding are to comply with this policy statement by forming Research Ethics Boards (REBs) to review all research involving human participants. The intention behind this review requirement is to provide a proportionate assessment of the benefit-to-risk ratio of the research, and in that process, to safeguard “respect for persons”, express a “concern for welfare”, and uphold “justice” (CIHR, SSHRC, NSERC 2010, p. 8). Research may not proceed until ethics approval is granted by an institution’s REB. The current study evaluates REB members’ perspectives on their knowledge of research ethics, and juxtaposes these perceptions with those of researchers. Specifically, we are interested in the extent to which REB members with less experience read the TCPS 2, and whether those with less experience have decreased confidence in their ethics knowledge.

A Study of the Impact of Informed Consent Procedures on Participant Responses in Trauma-Related Research

ABSTRACTResearchers and ethics board members are often concerned about the possibility of adverse reactions to trauma-related research. While research has shown that participants in trauma-related studies rarely experience adverse reactions, mild short-term emotional distress is common. While a number of protections have been suggested to minimize risks for more vulnerable subgroups of participants, no research to date has tested how modifications to informed consent procedures may affect the data collected and participant reactions to the research. One-hundred and forty-five college students were separated into five conditions with different modifications to the informed consent procedures. Participants completed surveys on trauma experience, posttraumatic stress, coping, and reactions to research participation. The results showed no differences among the conditions on all outcome measures. It appears that modifications to informed consent procedures geared toward minimizing risk do not affect the quality of the data collected nor change reactions to participating in trauma-related research.

Canadian research ethics board members' attitudes toward benefits from clinical trials.

BackgroundWhile ethicists have for many years called for human subject trial participants and, in some cases, local community members to benefit from participation in pharmaceutical and other intervention-based therapies, little is known about how these discussions are impacting the practice of research ethics boards (REBs) that grant ethical approval to many of these studies.MethodsTelephone interviews were conducted with 23 REB members from across Canada, a major funder country for human subject research internationally. All interviews were digitally recorded and transcribed verbatim. After coding, the data was analyzed to identify central themes and topics. Themes were identified, application of the themes was confirmed, and these themes were then used to populate the findings of this manuscript.ResultsOur analysis of the interviews identified two primary themes when considering what benefits are owed to research participants and their communities. 1) Most study participants felt that given that these studies are led by persons in the role of researcher rather than health care provider, they had a limited obligation to provide benefits to study participants. 2) These REB members were all working in Canada, a high income country where most residents enjoy high levels of access to health care. As a result of this context, the study participants tended to focus on ethical concerns including obtaining informed consent and avoiding undue inducement to participate in research rather than ensuring that study participants directly benefit from successful trials.ConclusionsResearch on REB members’ attitudes toward what benefits are owed to study participants and community members is needed in other countries in order to determine how context affects these attitudes.

Analysis of research ethics board approval times in an academic department of medicine.

As part of an ongoing effort to better understand barriers to academic research, we reviewed and analyzed the process of research ethics applications, focusing on ethics approval time, within the Department of Medicine from 2006 to 2011. A total of 1,268 applications for approval to use human subjects in research were included in our analysis. Three variables, risk category (minimal vs. non-minimal risk), type of funding, and year of submission, were statistically significant for prediction of ethics approval time, with risk status being the most important of these. The covariate-adjusted mean time for approval for minimal risk studies (35.7 days) was less than half that of non-minimal risk protocols (76.5 days). Studies funded through a for-profit sponsor had significantly longer approval times than those funded through other means but were also predominantly (87%) non-minimal risk protocols. Further investigations of the reasons underlying the observed differences are needed to determine whether improved training for research ethics board (REB) members and/or greater dialogue with investigators may reduce the lengthy approval times associated with non-minimal risk protocols.

Developing a guideline for clinical trial protocol content: Delphi consensus survey

BackgroundRecent evidence has highlighted deficiencies in clinical trial protocols, having implications for many groups. Existing guidelines for randomized clinical trial (RCT) protocol content vary substantially and most do not describe systematic methodology for their development. As one of three prespecified steps for the systematic development of a guideline for trial protocol content, the objective of this study was to conduct a three-round Delphi consensus survey to develop and refine minimum content for RCT protocols.MethodsPanellists were identified using a multistep iterative approach, met prespecified minimum criteria and represented key stakeholders who develop or use clinical trial protocols. They were asked to rate concepts for importance in a minimum set of items for RCT protocols. The main outcome measures were degree of importance (scale of 1 to 10; higher scores indicating higher importance) and level of consensus for items. Results were presented as medians, interquartile ranges, counts and percentages.ResultsNinety-six expert panellists participated in the Delphi consensus survey including trial investigators, methodologists, research ethics board members, funders, industry, regulators and journal editors. Response rates were between 88 and 93% per round. Overall, panellists rated 63 of 88 concepts of high importance (of which 50 had a 25th percentile rating of 8 or greater), 13 of moderate importance (median 6 or 7) and 12 of low importance (median less than or equal to 5) for minimum trial protocol content. General and item-specific comments and subgroup results provided valuable insight for further discussions.ConclusionsThis Delphi process achieved consensus from a large panel of experts from diverse stakeholder groups on essential content for RCT protocols. It also highlights areas of divergence. These results, complemented by other empirical research and consensus meetings, are helping guide the development of a guideline for protocol content.

Are Canadians Providing Advance Directives about Health Care and Research Participation in the Event of Decisional Incapacity?

Advance planning for health care and research participation has been promoted as a mechanism to retain some control over one's life, and ease substitute decision making, in the event of decisional incapacity. Limited data are available on Canadians' current advance planning activities. We conducted a postal survey to estimate the frequency with which Canadians communicate their preferences about health care and research should they become incapacitated. We surveyed 5 populations (older adults, informal caregivers, physicians, researchers in aging, and research ethics board members) from Nova Scotia, Ontario, Alberta, and British Columbia. We asked respondents whether they had expressed their preferences regarding a substitute decision maker, health care, and research participation in the event of incapacity. Two out of 3 respondents (62.0%; 95% CI 59.1% to 64.8%) had been advised to communicate their health care preferences in advance. Oral expression of wishes was reported by 69.1% of respondents (95% CI 66.8% to 71.3%), and written expression by 46.7% (95% CI 44.3% to 49.2%). Among respondents who had expressed wishes in advance (orally or in writing), 91.2% had chosen a substitute decision maker, 80.9% had voiced health care preferences, and 19.5% had voiced preferences regarding research participation. Having been advised to communicate wishes was a strong predictor of the likelihood of having done so. Advance planning has increased over the last 2 decades in Canada. Nonetheless, further efforts are needed to encourage Canadians to voice their health care and research preferences in the event of incapacity. Physicians are well situated to promote advance planning to Canadians.

Comfort with proxy consent to research involving decisionally impaired older adults: do type of proxy and risk-benefit profile matter?

Dementia research often requires the participation of people with dementia. Obtaining informed consent is problematic when potential participants lack the capacity to provide it. We investigated comfort with proxy consent to research involving older adults deemed incapable of this decision, and examined if comfort varies with the type of proxy and the study's risk-benefit profile. We surveyed random samples of five relevant groups (older adults, informal caregivers, physicians, researchers in aging, and Research Ethics Board members) from four Canadian provinces. Respondents were presented with scenarios involving four types of proxies (non-assigned, designated in a healthcare advance directive with or without instructions specific to research participation, and court-appointed). Given a series of risk-benefit profiles, respondents indicated whether they were comfortable with proxy consent to research for each scenario. Two percent of the respondents felt proxy consent should never be allowed. In all groups, comfort depended far more on the risk-benefit profile associated with the research scenario than with type of proxy. For research involving little or no risk and potential personal benefits, over 90% of the respondents felt comfortable with substitute consent by a designated or court-appointed proxy while 80% were at ease with a non-assigned proxy. For studies involving serious risks with potentially greater personal benefits, older adults and informal caregivers were less comfortable with proxy consent. A large majority of Canadians are comfortable with proxy consent for low-risk research. Further work is needed to establish what kinds of research are considered to be low risk.

Scientists’ Perspectives on the Ethical Issues of Stem Cell Research

This paper describes findings from an ethics education project funded by the Canadian Stem Cell Network (SCN). The project is part of a larger research initiative entitled "The Stem Cell Research Environment: Drawing the Evidence and Experience Together". The ethics education study began with a series of focus groups with SCN researchers and trainees as part of a "needs assessment" effort. The purpose of these discussions was to identify the main ethical issues associated with stem cell (SC) research from the perspective of the stem cell community. This paper will focus on five prominent themes that emerged from the focus group data including: (1) the source of stem cells; (2) the power of stem cells; (3) working within a charged research environment; (4) the regulatory context; and (5) ethics training for scientists. Additional discussions are planned with others involved in Canadian stem cell research (e.g., research ethics board members, policy makers) to supplement initial findings. These assessment results combined with existing bioethics literature will ultimately inform a web-based ethics education module for the SCN. We believe that our efforts are important for those analyzing the ethical, legal, and social issues (ELSI) in this area because our in depth understanding of stem cell researcher perspectives will enable us to develop more relevant and effective education material, which in turn should help SC researchers address the important ethical challenges in their area.

Anonymous Self-Evaluation of Performance by Ethics Board Members: A Pilot Study

EVALUATING THE EFFECTIVENESS OF A Reserch Ethics Committee or Institutional Review Board (IRB) continues to be a difficult task. There are limited data that examine the perceptions of members of IRBs about their own performance or methods that would allow comparison among IRB panels at a single institution or between institutions. We piloted an anonymous survey instrument that examined members' attitudes about the efficiency, procedures and outcomes of IRB meetings and developed a process for presentation and discussion of these results with panel members. This quality improvement process was initially completed with one panel, and then replicated with two other IRB panels at one institution. This allowed comparison of perceived IRB performance across panels at a single institution. Further research is required to determine the association between IRB members' perception of performance and other measures of IRB effectiveness and to examine the perceived performance of IRBs by other research stakeholders.