Canada’s Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans mandates that all research involving human subjects be reviewed and approved by a research ethics board . We have little evidence on how researchers are dealing with this requirement in multisite studies, which involve more than one REB. We retrospectively examined 22 REB submissions for two minimal-risk, multisite studies in leading Canadian institutions. Most REBs granted expedited review to the studies, while one declared the application to (...) be exempt from review. Time between submission and approval ranged greatly, from four to 546 days. We received a total of 155 REB queries for changes and clarifications, most of which asked for further information, clarification, or additional documents. Less than a third of the REB queries were requests for specific changes, and a vast majority had a very limited impact on the research projects. Institutions also varied broadly in their description of what was required of local principal investigators. We conclude that the organizational and practical challenges these results imply could deter researchers from embarking on multisite research projects, and that recently proposed changes to the TCPS will not solve these problems. (shrink)

Genomic research may uncover results that have direct actionable benefit to the individual. An emerging debate is the degree to which researchers may have responsibility to offer results to the biological relatives of the research participant. In a companion study to one carried out in the United States, we describe the attitudes of Canadian Research Ethics Board chairs to this issue and their opinions as to the role of the REB in developing related policy.

In order to illuminate the potential harms of MRI research, we present data obtained by examining MRI research proposal files that had been submitted for review to several Canadian Research Ethics Boards. The data reveal that REB review of the studies contained omissions, considerable variability, and sometimes confusion regarding MRI research risks and risk classification. If our findings reflect the general state of REB review of MRI research in Canada and elsewhere, there is a (...) pressing need for REBs to be educated about MRI risks in order to responsibly facilitate the disclosure of these research risks in consent forms and during the consent process. Developing a standard template consent form that discloses MRI research risks might be a way to ensure attention to and disclosure of risks. (shrink)

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 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. (shrink)

InTowards a Canadian Research Strategy ForApplied Ethics, I put forward proposals to advance Canadian research in applied ethics. I focus on the assessment made of Canadian teaching, consulting, and research in business and professional ethics and then on the strategy proposed for advancing work in these areas. I argue for research which is [1] oriented to the ethical needs of those in business and the professions, [2] interdisciplinary, and [3] involves the creation of (...) national and international networks. I then offer some preliminary observations on the first two years of the new research strategy''s operation. (shrink)

The report entitled An Analysis of the Canadian Research and Development System for Agriculture/Food which was presented to the Science Council of Canada in July, 1991 contains many far-reaching recommendations for revisions of the research and educational components of the Agriculture/Food System in Canada. The report calls for research of holistic and interdisciplinary nature. It calls for determination of research priorities by broadly constituted committees which would include reporesentaitves heretofore not included in the process of (...) decisionmaking regarding scientific research. In addition, it calls for restructuring of the agricultural education system. The Co-editors of this Journal, believe that these recommendations should be wildely discussed and, therefore, requested publication of the Executive Summary of this Report. (shrink)

This study examined Canadian Research Ethics Board practices concerning continuing ethics review of approved studies. A mail-out questionnaire was used to elicit information from Canadian REB representatives about whether their board engaged in continuing ethics review, and, if so, what their methods were. The study found that a majority of REBs conduct continuing ethics review. REBs conduct continuing ethics review of clinical trial research significantly more often than of academic research. The study also found little (...) difference in the frequency of continuing ethics review between academic and other types of REBs. The most commonly reported method for conducting continuing ethics review was a review of ongoing research reports. (shrink)

BackgroundThe amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access (...) to registries and biobanks.MethodsChairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank.ResultsThere was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied.ConclusionParticipants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation. (shrink)

Objective: To examine how research ethics boards review research projects in emerging disciplines such as functional neuroimaging.Design: To compare the criteria applied and the decisions reached by REBs that reviewed the same mock research protocol in functional neuroimaging.Participants: 44 Canadian biomedical REBs, mostly working in public university or hospital settings.Main measurements: The mock research protocol “The Neurobiology of Social Behavior” included several ethical issues operating at all three levels: personal, institutional and social. Data consisting of (...) responses to closed questions were analysed quantitatively. Qualitative analysis of open-question responses used mixed classification.Results: Similar criteria were used by most participating REBs. Yet the project was unconditionally approved by 3 REBs, approved conditionally by 10 and rejected by 30.Conclusions: The results point to the difficulty for REBs of reviewing all kinds of research projects, regardless of field, by relying on international and national norms framed in general terms and a possible variation between REBs in the interpretation of their mandate for the protection of research subjects. (shrink)

Background: Despite potential benefits of the return of research results to research participants, the TriCouncil Policy Statement , which reflects Canadian regulatory ethical requirements, does not require this. The policies of Canadian research ethics boards are unknown.Objectives: To examine the policies of Canadian university based REBs regarding returning results to research participants, and to ascertain if the presence/absence of a policy may be influenced by REB member composition.Design: Email survey of the coordinators of (...) Canadian university based REBs to determine the presence/absence of a policy on return of research results to research participants both during an ongoing study and at conclusion. REB coordinators were asked to return a copy of the policy or guidelines and to describe the member composition of their REB.Findings: Of 50 REBs that were contacted 34 responded and 22 met the inclusion criteria. Two had a policy that governed the return of research results while on a study, and seven following the completion of a study. Presence of an ethicist or a lawyer on the REB did not influence the presence/absence of such policies. No REBs had specific guidelines describing how participants should be informed of results.Conclusions: Most REBs did not require researchers to disclose study results to research participants either during or following a study. Thus this study identifies an ethical shortcoming in the conduct of human research in Canada. It has also demonstrated that there are no clear recommendations by REBs to facilitate the return of results to participants following research projects. (shrink)

In Canada, all research conducted by individuals associated with universities must be subjected to review by research ethics boards (REB). Unfortunately, decisions reached by REBs may seriously compromise the integrity of university-based research. In this paper attention will focus on how requirements of REBs and a legal department in four Canadian universities affected response rates to a survey of domestic and international students. It will be shown that in universities in which students were sent a legalistic (...) cover letter to a mail survey, or were required to sign a consent form, lower response rates were achieved than in universities in which students were sent a relatively friendly letter. In turn, lower response rates resulted in: sample characteristics that deviated from population characteristics; a reduction in the possibility of testing research hypotheses; and increased survey costs. As a consequence, it is argued that the unreasonable demands of REBs are seriously compromising the quality of research that can be carried out on Canadian university students. (shrink)

Nursing research in palliative care raises specific and challenging ethical issues. Questions have arisen about whether such research is morally justified, given the low likelihood of direct benefit to dying patients as research participants. The Canadian Code of ethics for registered nurses outlines eight primary values intended to guide nursing practice. We use these values to explore the moral dimensions of research with the palliative care population. Our conclusion is that palliative care research is (...) needed to foster excellent care for these patients and their families, but that nurses must remain constantly vigilant to ensure that participants are protected from resultant harms. Through this exploration we highlight particular considerations that nurse researchers must contemplate when accessing a vulnerable population. (shrink)

The central role that the media plays in communicating to the public health research findings has long been recognized (Cassels 2007), and concerns regarding the media's ability to convey health is...

Physician-researchers are bound by professional obligations stemming from both the role of the physician and the role of the researcher. Currently, the dominant models for understanding the relationship between physician-researchers' clinical duties and research duties fit into three categories: the similarity position, the difference position and the middle ground. The law may be said to offer a fourth.

In order to ensure an adequate and ongoing protection of individuals participating in scientific research, the impacts of new biomedical technologies, such as Next Generation Sequencing , need to be assessed. In this light, a necessary reexamination of the ethical and legal structures framing research could lead to requisite changes in informed consent modalities. This would have implications for Institutional Review Boards , who bear the responsibility of guaranteeing that participants are verifiably informed, and in sufficient detail, to (...) understand the reality of genetic research as it is practiced now. Current literature allowed the identification of key emergent themes related to the consent process when NGS was used in a research setting. (shrink)

BackgroundResearch ethics and the measures deployed to ensure ethical oversight of research (e.g., informed consent forms, ethics review) are vested with extremely important ethical and practical goals. Accordingly, these measures need to function effectively in real-world research and to follow high level standards.MethodsWe examined approved consent forms for Magnetic Resonance Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) studies approved by Canadian research ethics boards (REBs).ResultsWe found evidence of variability in consent forms in matters of physical (...) and psychological risk reporting. Approaches used to tackle the emerging issue of incidental findings exposed extensive variability between and within research sites.ConclusionThe causes of variability in approved consent forms and studies need to be better understood. However, mounting evidence of administrative and practical hurdles within current ethics governance systems combined with potential sub-optimal provision of information to and protection of research subjects support other calls for more scrutiny of research ethics practices and applicable revisions. (shrink)

In a large proportion of health care research based on the retrospective review of records, minimal breach of patient confidentiality appears to be inevitable. This occurs at initial identification of and access to the chart, selected on the basis of the condition under investigation, and while individual identifiability can be blocked at subsequent stages, at this point it does occur. Prospective individual consent is impractical because often neither the desirability nor the specific subject of the research is known (...) at the time of making the record, and retrospective patient tracing to obtain it is often impossible. I argue that the benefit of the research outweighs the minimal breach of confidentiality, and that in my own jurisdiction, this appears to be envisaged and accepted in Canadian law. (shrink)

Our intention is to contribute to the development of Canadian Nursing and Medical Education (NursMed) and efforts to redress deepening, intersecting health and social inequities. This paper addresses the following two research questions: (1) What are the ways in which Decolonial, Intersectional Pedagogies can inform Canadian NursMed Education with a focus on critically examining settler‐colonialism, health equity, and social justice? (2) What are the potential struggles and adaptations required to integrate Decolonial, Intersectional Pedagogies within Canadian NursMed (...) Education in service of redressing intersecting health and social inequities? Briefly, Decolonial, Intersectional Pedagogies are philosophies of learning that encourage teachers and students to reflect on health through the lenses of settler‐colonialism, health equity, and social justice. Drawing on critical ethnographic research methods, we conducted in‐depth interviews with 25 faculty members and engaged in participant observation of classrooms in university‐based Canadian NursMed Education. The research findings are organized into three major themes, beginning with common institutional features influencing pedagogical approaches. The next set of findings addresses the complex strategies participants apply to integrate Decolonial, Intersectional Pedagogies. Lastly, the findings illustrate the emotional and spiritual toll some faculty members face when attempting to deliver Decolonial, Intersectional Pedagogies. We conclude that through the application of Decolonial, Intersectional Pedagogies teachers and students can support movements towards health equity, social justice, and unlearning/undoing settler‐colonialism. This study contributes new knowledge to stimulate dialog and action regarding the role of health professions education, specifically Nursing and Medicine as an upstream determinant of health in settler‐colonial nations such as Canada, United States, Australia, and New Zealand. (shrink)

Gregor Sebba's monumental Bibliographia Cartesiana; A Critical Guide to the Descartes Literature 1800-1960 (The Hague: Nijhoff, 1964) is the basic bibliographical tool of pre-1960 Descartes scholarship. While somewhat weak in its coverage of twentieth century Anglo-American analytical literature on Descartes, it is outstanding ic its coverage of continental scholarship. Willis Doney's "Bibliography," in his Descartes: A Collection of Critical Essays (New York: Doubleday, 1967), largely rectifies Sebba’s lack of coverage of pre-1960 analytical work on Descartes. Subsequent to Doney's 1967 bibliography, (...) there have been several useful bibliographical updates, including the excellent "Bulletin Cartésien," published annually in the Archives de Philosophie. However, Vere Chappell and Willis Doney's Twenty-Five Years of Descartes Scholarship, 1960-1984: A Bibliography (forthcoming, New York: Garland, 1987) promises to become the definitive update of Sebba. The present bibliography is designed to supplement the above bibliographies by listing Canadian and American dissertations on Descartes and Cartesianism from 1865 through 1984. It lists dissertations alphabetically by author and provides locations in Dissertations Abstracts as well as University Microfilms order numbers, whenever available. (shrink)

This dissertation explores the life and work of a philosophy of education and multicultural education teacher, through the use of narrative inquiry. As a Palestinian/Lebanese Canadian researcher, teacher, mother, activist and writer, I present the journey of freeing myself from colonial grand narratives through the construction of my personal, practical knowledge and values, while providing an answer to the question: “What does it mean to be situated on the boundary between the English West and the Middle Eastern Arab world?” (...) I demonstrate how the Orientalist tradition, as defined by Edward Said, served to confuse, frustrate, and alienate me as an embodied person situated within a web of historical, ethnic, linguistic, social, and cultural tensions. I describe how, having been educated in an English missionary school in the context of a Palestinian culture of dispossession and Diaspora, this education served to paradoxically both estrange and enrich me. I demonstrate how narrative inquiry, modeled after Clandinin and Connelly, has enabled me to understand and communicate who I really am as an educator in the multiple social contexts I have known. Through story-ing my epistemology, I illustrate how the Canon in philosophy and the grand meta-narratives underpinning it served to oppress and alienate me over the years. I emphasize that education is not value-neutral. My autobiographical writing in this dissertation explores how the constructs of ethnicity, gender, religion, culture, language, and class serve to shape thinking and values. [...]. (shrink)

We considered the question of how corporate social responsibility differs between Canada and the U.S. Prior research has identified that national institutional differences exist between the two countries [Freeman and Hasnaoui, J Business Ethics 100:419–443, 2011], which may be associated with variations in their respective CSR practices. Matten and Moon [Acad Manag Rev 33:404–424, 2008] suggested that cross-national differences in firms’ CSR are depicted by an implicit–explicit conceptual framework: explicit CSR practices are deliberate and more strategic than implicit CSR (...) practices. We compared Canada and U.S. CSR and examined how CSR strategic alliances, CSR reporting, and CSR performance in the two countries correspond to implicit versus explicit CSR practices, which we link to stakeholder and signaling perspectives. We relied upon a new database, the Sustainalytics Global Platform, and we found a positive association exists between CSR strategic alliances and the number of years that firms have issued standalone CSR reports in both countries. Moreover, we found that CSR scores mediated this association in the U.S., as U.S. firms with high CSR scores typically engage in more CSR strategic alliances. In Canada, we did not find this mediating effect. Our findings suggest that U.S. firms engage in signaling activities that are more strategic and explicit than their Canadian counterparts. This paper closes with implications for practice and theory. (shrink)

As part of a larger study eliciting Canadian producer and non-producer views about animal welfare, open-ended, semi-structured interviews were used to explore opinions about animal welfare of 20 Canadian pig producers, most of whom were involved in confinement-based systems. With the exception of the one organic producer, who emphasized the importance of a “natural” life, participants attached overriding importance to biological health and functioning. They saw their efforts as providing pigs with dry, thermally regulated, indoor environments where animals (...) received abundant feed, careful monitoring and where prospective disease outbreaks could be minimized and controlled. Emphasis was also placed on low-stress handling and agreeable working conditions which were believed to promote good animal care. The fact that pigs tend to respond to such conditions with steady growth reinforced the belief that good welfare was provided. Participants supported the use of sow gestation stalls, but with some reservations, and expressed concern about welfare problems that could occur if sows were grouped. Invasive procedures (castration, tail-docking, teeth clipping) were recognized as painful but were accepted because they were seen as: (1) necessary for sales or management; (2) satisfactory trade-offs to prevent worse welfare problems such as injury or infection; or (3) sufficiently short-term to be relatively unimportant. Participants were adamantly opposed to animal neglect and some welcomed actions of animal protectionists that expose poor care. Producers also welcomed natural-science-based approaches to improving animal welfare. The findings contribute to a broader effort to identify overlapping values among different stakeholder groups as a basis for formulating mutually agreeable, farm animal care and handling polices. (shrink)

Magnetic observations were essential for polar navigation, and were carried out systematically on both sea and land-based expeditions to the Canadian Arctic throughout the nineteenth century. John Franklin took a particular interest in magnetic studies and encouraged the Admiralty to adopt Robert Were Fox's dip circle. The establishment of the Toronto magnetic observatory provided a base for John Henry Lefroy's survey of the North West Territories. The Royal Navy's programme of magnetic research, commenced in the aftermath of the (...) Napoleonic Wars, was maintained until the British Arctic Expedition of 1875–76, commanded by Nares. In all these expeditions, the nature and limits of the observations were determined by the available instruments. (shrink)