Research 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.

Psychology, ethics, and research ethics boards

ABSTRACT Research Ethics Boards (REBs) at universities are chaired and staffed by researchers who serve to enforce codes of ethics by scrutinizing research proposals. Yet there is widespread dissatisfaction with the REB approval process. This article examines the sources of that dissatisfaction, the place for codes of ethics in the conducting of research, the evidence for risk to research participants as the basis for those codes, and the effectiveness of REBs in protecting research participants. We offer suggestions for how REB chairs, members, and researchers can improve the REB approval process so that it is fair and responsive.

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.

Epistemic Strategies in Ethical Review: REB Members' Experiences of Assessing Probable Impacts of Research for Human Subjects.

Research ethics boards (REBs) are charged with applying ethical standards to protect the rights and interests of research subjects. Little, however, is known about how REB members perceive probable impacts of research participation for subjects. Drawing on in-depth interviews with 40 Canadian REB members, we identify three frequently reported epistemic strategies, including reliance on a local REB culture or ethos, use of resident authorities, and protective imagination. Far less commonly described strategies included direct or indirect contact with research subjects. REB members also reflected upon significant gaps in their knowledge and thus the importance of knowing what we don't know. Recommendations arising from this support an evidence-based practice for ethics review involving clear epistemic standards for REBs learning about subjects' experiences.

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.

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.

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.

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.

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.

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.

Public Health Research Involving Aboriginal Peoples: Research Ethics Board Stakeholders’ Reflections on Ethics Principles and Research Processes

Objectives: The second edition (2010) of the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS2) prescribes a set of principles and provisions for engagement with Aboriginal communities. The objective of this study was to explore research ethics board (REB) stakeholder perspectives on the principles and processes of reviewing and conducting public health research with Aboriginal populations and communities. Method: Twenty-four semi-structured qualitative interviews were conducted with REB staff, chairs, members (academic, community and student), and ethics policy key informants with knowledge of the ethics review process, including four Aboriginal participants. Interviews were professionally transcribed verbatim and thematically analyzed using NVivo 8 qualitative data management software. Results: Three dominant themes emerged specific to ethical research practices with Aboriginal communities: 1) the importance of understanding Aboriginal research as a distinct form of research; 2) the unique nature and complexity of negotiating community consent; and 3) the importance of trust and relationship-building in the research process. Conclusion: Thematic results highlight the most prominent issues that REB participants encountered in reviewing research involving Aboriginal peoples. Continued attention needs to be paid to acknowledging and respecting issues of diversity in research involving diverse First Nations, Inuit and Metis peoples. While specific to Aboriginal peoples, the TCPS2 guidelines also illustrate processes and practices that may assist in the development of respectful, collaborative public health research relationships with other historically marginalized populations. Key words: Ethics, research; ethical review; community-based participatory research; Aboriginal research

Public health research involving aboriginal peoples: research ethics board stakeholders' reflections on ethics principles and research processes.

The second edition (2010) of the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS2) prescribes a set of principles and provisions for engagement with Aboriginal communities. The objective of this study was to explore research ethics board (REB) stakeholder perspectives on the principles and processes of reviewing and conducting public health research with Aboriginal populations and communities. Twenty-four semi-structured qualitative interviews were conducted with REB staff, chairs, members (academic, community and student), and ethics policy key informants with knowledge of the ethics review process, including four Aboriginal participants. Interviews were professionally transcribed verbatim and thematically analyzed using NVivo 8 qualitative data management software. Three dominant themes emerged specific to ethical research practices with Aboriginal communities: 1) the importance of understanding Aboriginal research as a distinct form of research; 2) the unique nature and complexity of negotiating community consent; and 3) the importance of trust and relationship-building in the research process. Thematic results highlight the most prominent issues that REB participants encountered in reviewing research involving Aboriginal peoples. Continued attention needs to be paid to acknowledging and respecting issues of diversity in research involving diverse First Nations, Inuit and Métis peoples. While specific to Aboriginal peoples, the TCPS2 guidelines also illustrate processes and practices that may assist in the development of respectful, collaborative public health research relationships with other historically marginalized populations.

The evolution of research ethics in Canada: Current developments.

A decade ago the three major granting agencies produced a policy statement that governs research ethics in most venues in Canada; they have recently (2010) circulated a revised statement: The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 2nd Edition (TCPS-2). There are both major and minor revisions, including changes to the guiding principles, that will have an impact on psychological research. This paper outlines some of the changes and compares them with the Canadian Code of Ethics for Psychologists (3rd Ed.), which is also about to undergo a revision process. Keywords: ethics, justice, vulnerability, consent, deception Resume Il y a environ 10 ans, les trois principaux organismes subventionnaires ont etabli un enonce de politiques qui regit les principes deontologiques de la recherche dans la plupart des etablissements au Canada. Ils ont publie, en 2010, une version revisee de ce document, intitule Enonce de politique des trois Conseils : ethique de la recherche avec des etres humains. Cette deuxieme edition comprend des modifications a la fois majeures et mineures, notamment des changements aux lignes directrices, qui auront des repercussions sur la recherche en psychologie. Cet article presente certaines des modifications apportees et les comparent au Code canathen de deontologie professionnelle des psychologues (3e edition), qui, lui aussi, fera l'objet d'une revision sous peu. Mots-cles : deontologie, justice, vulnerabilite, consentement, deception. Following some high-profile horror stories in Canadian research such as the MKULTRA brainwashing experiments at the Allan Memorial Institute of the Royal Victoria Hospital in Montreal from 1957 to 1964 (Klein, 2008), there was general agreement among granting agencies that there should be more control over federally funded research. This led to the development of a set of rules, and eventually a policy statement, that embraced research with human subjects/participants in medicine, the natural sciences, the social sciences, and the humanities. Despite some initial controversy over the attempt to develop a common code for disparate disciplines, for a decade now Research Ethics Boards (REBs) across the country have been applying similar standards to all studies involving humans - whether or not those studies receive federal funding. The granting agencies knew from the start that the document would have to evolve; changes would have to be made to take account of problems and complaints coming out of the experience of researchers and REBs working with the new policy. The agencies created the Interagency Panel on Research Ethics (PRE) and the Secretariat on Research Ethics (SRE), which had a mandate to further develop the policy statement. In 2010, the agencies introduced a revised version: The TriCouncil Policy Statement on Ethical Conduct for Research Involving Humans - 2nd Edition (TCPS-2). A major difference in process this time was a series of broad consultations with scholars, REB members, ethicists, and others. The Panel on Research Ethics held meetings in centres across Canada and received more than 2,000 pages of written comments (Eggertson, 201 1). The Canadian Psychological Association (CPA) participated in these consultations. Among the many changes in TCPS-2, there are revisions to the guiding principles. The first version had eight principles; TCPS-2 has pared the list to three. In this paper I will compare those principles with the principles of the Canadian Code of Ethics for Psychologists (Canadian Psychological Association, 2000) and discuss some implications of the revised statement for psychological researchers. The three guiding principles in TCPS-2 are Respect for Persons, Concern for Welfare, and Justice. The first of these is functionally the same as Respect for the Dignity of Persons, Principle I in the CPA Code. Both emphasise the intrinsic value of human beings and the respect and consideration they are due whether in research (TCPS-2) or in all professional activities of psychologists including research (CPA). …

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.