Canadian Research Ethics Boards Research Articles

Assent in Pediatric Critical Care Research: A Cross-Sectional Stakeholder Survey of Canadian Research Ethics Boards, Research Coordinators, Pediatric Critical Care Researchers, and Nurses.

Survey of four stakeholder groups involved in defining and obtaining assent for research in Canadian PICUs to better understand their perspectives and perceived barriers to assent. Cross-sectional survey. Fourteen tertiary-care pediatric hospitals in Canada. Research Ethics Board Chairs, pediatric critical care nurses, research coordinators, and researchers. None. A total of 193 participants responded. Thirty-seven percent (59/159) thought it was "Never/Almost Never" (59/159, 37%) feasible to obtain assent during the first 48 hours of PICU admission, and 112 of 170 (66%) indicated there are unique barriers to assent at the time of enrollment in PICU studies. Asking children for assent was most frequently rated as Important/Very Important for interviews/focus groups with the child (138/180, 77%), blood sample collection with a needle poke for research (137/178, 77%), and studies involving genetic testing with results communicated to the child/legal guardian (134/180, 74%). In two scenarios where a child and legal guardian disagreed about study participation, most respondents indicated that whether the child should still be enrolled would depend on the patient's age (34-36%), and/or the risk of the study (24-28%). There was a lack of consensus over how the assent process should be operationalized, and when and for how long children should be followed to seek assent for ongoing study participation. Most stakeholders (117/158, 74%) thought that children should have the opportunity to decide if their samples could stay in a biobank once they are old enough to do so. There was an overall lack of consensus on the feasibility of, and challenges associated with, obtaining assent at the time of study enrollment and on how key aspects of the assent process should be operationalized in the PICU. This highlights the need for guidelines to clarify the assent process in pediatric critical care research.

The Changing Research Data Landscape and the Experiences of Ethics Review Board Chairs: Implications for Library Practice and Partnerships

Academic libraries have to a large extent taken the lead in facilitating new approaches to research data management, but changes to the research data landscape have had an impact on numerous areas of academic work, including ethics review. Using interpretive phenomenological analysis of interviews with chairs of Canadian research ethics boards, this study explores how ethics review boards have experienced changes to data policy and related technologies in order to describe the ethical implications of new approaches to data management and to explore ways in which the library, ethics review boards, and other campus partners might harmonize efforts to support emerging data practices. While ethics review boards in Canada are keenly aware of open data policies, data publishing in practice is still nascent. There is uncertainty about the adoption of changing technologies for research and their impacts on privacy protection. Where responsibility lies for addressing these uncertainties is often unclear. Academic libraries and research ethics boards are well-suited to engage in mutual knowledge transfer and to integrate data management planning and ethics review processes. Institutional-level oversight that includes all campus departments impacted by changes to the research data landscape may facilitate improved communication and reduce role ambiguity.

Impact of Next Generation Sequencing on the Organization and Funding of Returning Research Results: Survey of Canadian Research Ethics Boards Members.

Research Ethics Boards (REBs) are expected to evaluate protocols planning the use of Next Generation Sequencing technologies (NGS), assuring that any genomic finding will be properly managed. As Canadian REBs play a central role in the disclosure of such results, we deemed it important to examine the views and experience of REB members on the return of aggregated research results, individual research results (IRRs) and incidental findings (IFs) in current genomic research. With this intent, we carried out a web-based survey, which showed that 59.7% of respondents viewed the change from traditional sequencing to NGS as more than a technical substitution, and that 77% of respondents agreed on the importance of returning aggregated research results, the most compelling reasons being the recognition of participants’ contribution and increasing the awareness of scientific progress. As for IRRs specifically, 50% of respondents were in favour of conveying such information, even when they only indicated the probability that a condition may develop. Current regulations and risk to participants were considered equally important, and much more than financial costs, when considering the return of IRRs and IFs. Respondents indicated that the financial aspect of offering genetic counseling was the least important matter when assessing it as a requisite. Granting agencies were named as mainly responsible for funding, while the organizing and returning of IRRs and IFs belonged to researchers. However, views in these matters differ according to respondents’ experience. Our results draw attention to the need for improved guidance when considering the organizational and financial aspects of returning genetic research results, so as to better fulfill the ethical and moral principles that are to guide such undertakings.

Evaluation of a cartoon-based knowledge dissemination intervention on scientific and ethical challenges raised by nutrigenomics/nutrigenetics research

ContextThe push for knowledge translation on the part of health research funding agencies is significant in Canada, and many strategies have been adopted to promote the conversion of knowledge into action. In recent years, an increasing number of health researchers have been studying arts-based interventions to transform knowledge into action. This article reports on the results of an online questionnaire aimed at evaluating the effectiveness of a knowledge dissemination intervention (KDI) conveying findings from a study on the scientific and ethical challenges raised by nutrigenomics-nutrigenetics (NGx) research. The KDI was based on the use of four Web pages combining original, interactive cartoon-like illustrations accompanied by text to disseminate findings to Canadian Research Ethics Boards members, as well as to NGx researchers and researchers in ethics worldwide. MethodsBetween May and October 2012, the links to the Web pages were sent in a personal email to target audience members, one thematic Web page at a time. On each thematic Web page, members of the target audience were invited to answer nine evaluation questions assessing the effectiveness of the KDI on four criteria, (i) acquisition of knowledge; (ii) change in initial understanding; (iii) generation of questions from the findings; and (iv) intent to change own practice. FindingsResponse rate was low; results indicate that: (i) content of the four Web pages did not bring new knowledge to a majority of the respondents, (ii) initial understanding of the findings did not change for a majority of NGx researchers and a minority of ethics respondents, (iii) although the KDI did raise questions for respondents, it did not move them to change their practice. ConclusionsWhile target end-users may not feel that they actually learned from the KDI, it seems that the findings conveyed encouraged reflection and raised useful and valuable questions for them. Moreover, the evaluation of the KDI proved to be useful to gain knowledge about our target audiences’ views since respondents’ comments allowed us to improve our understanding of the disseminated knowledge as well as to modify (and hopefully improve) the content of the Web pages used for dissemination.

Ethics application protocols for multicentre clinical studies in Canada: A paediatric rheumatology experience

Individual institutions govern research ethics applications and each must administer and regulate their own protocols. Variations in ethics review procedures and expectations among centres impose impediments to efficiently conducting multicentre studies. Observations relating to preparing multisite ethics documents for a study conducted by Canadian paediatric rheumatology investigators are described. Research ethics applications from the 12 participating centres were compared. Although the applications were similar in their content, they differed in their formatting. All applications shared a commitment to ensuring that the study conformed to exemplary ethical standards. There is wide variation in the multicentre clinical study ethics application process at the institutional level. Considering the common fundamental elements required by all ethics review boards, the present study conceptualized introducing a discipline-specific uniform ethics application process acceptable to all Canadian research ethics boards. This may be a more efficient strategy that could help lessen the burden of collaborative research.

Consent in critical care trials: a survey of Canadian research ethics boards and critical care researchers

PurposeReliance on third party consent for patients without decision-making capacity presents unique challenges for critical care research. We compared the attitudes and beliefs of Canadian research ethics boards (REBs) and intensive care unit researchers toward the use of various consent models for a low-risk randomized controlled trial. Materials and MethodsSelf-administered, scenario-based survey. ResultsSixty-two percent of eligible REBs (n = 83) and 78% of eligible researchers (n = 124) completed the questionnaire. The REBs were less comfortable endorsing alternative consent models when a substitute decision maker was unavailable, including consent provided by (a) the intensivist involved with the trial (2.0% vs 15.3%; P = .014), (b) the intensivist not involved with the trial (10.0% vs 36.7%; P = .001), (c) 2 physicians (the intensivist and another consultant, neither of whom is involved with the trial) (18.0% vs 54.1%; P < .001), and (d) 2 physicians involved neither with the trial nor the patient's care (10.2% vs 52.0%; P < .001). In similar circumstances, REBs were less comfortable approving both deferred (8.0% vs 43.3%; P < .001) and waived (4.1% vs 22.4%; P = .005) consent. ConclusionsIn this survey of scenarios involving low-risk critical care research, REBs were significantly more conservative in approving alternative consent models compared with investigators.

Informed consent for MRI and fMRI research: Analysis of a sample of Canadian consent documents

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.

Who's minding the shop? The role of Canadian research ethics boards in the creation and uses of registries and biobanks.

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.