Schedule

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  • 29 avril Mardi


  • 30 avril Mecredi


  • 1 mai Jeudi


  • Tuesday, April 29


  • Wednesday, April 30


  • Thursday, May 1


  • La recherche en santé à l’ère de l’IA : explorer les défis et repenser l’évaluation éthique par les comités d’éthique de la recherche

    DESCRIPTION OF SESSION

    À l'ère de l'intelligence artificielle (IA), les comités d'éthique de la recherche (CER) sont confrontés à des défis dans l’évaluation des projets impliquant l’IA, notamment ceux nécessitant l’utilisation massive de données dans divers domaines, y compris la santé. En plus des défis persistants tels que le manque de ressources, de formation et de temps, les CER doivent répondre à des enjeux qui semblent être amplifiés, comme la confidentialité des données, le consentement individuel et la protection de la vie privée dans le cadre de recherches employant des référentiels de données à grande échelle. Ces défis sont encore plus complexes dans les contextes de partenariats public-privé et de recherche transfrontalière en IA en santé, où la diversité des cadres législatifs et éthiques complique les évaluations. Cette présentation offrira un aperçu des défis auxquels les CER au Canada sont confrontés dans l’évaluation des projets de recherche en IA dans le domaine de la santé. Elle mettra en lumière l’inadéquation de certains principes éthiques dans les politiques actuelles (e.g. l'Énoncé de politique des trois conseils ou EPTC2), tels que le consentement libre et éclairé, et de leur mise en œuvre, face aux spécificités et aux risques propres aux projets d'IA en santé. Enfin, la présentation exposera un projet de recherche visant à explorer les préoccupations, les défis et les besoins des CER, entre autres, afin de proposer des pistes de réflexion pour contribuer à une éthique de la recherche capable de répondre aux évolutions de cet écosystème de recherche en mutation.
    Sessions

  • L'éthique de la recherche en contexte de recherche-création

    DESCRIPTION OF SESSION

    La recherche-création est une méthodologie de recherche particulièrement utilisée en sciences humaines et sociales (recherche en cinéma, musique, aménagement, communication, etc.). La recherche se fait en dialogue avec des participants humains, dans un contexte de création ou de co-création d'oeuvres. La recherche est souvent accompagnée d'une réflexion commune sur la démarche. En relation avec des êtres humains, les projets de recherche en recherche-création doivent obtenir une demande d'approbation éthique. Cependant, en raison du déroulement spécifique de ces recherches, l'évaluation éthique de ces projets de recherche rencontre quelques défis intéressants. Dans notre communication à deux voix (éthicien et chercheur-créateur) et dans une perspective de dialogue, nous présenterons, d'une part, les questions que se posent les CER dans leur évaluation éthique de tels projets, et d'autre part, les questions des chercheurs-créateurs face à la demande d'approbation éthique, ainsi que le travail en commun afin procéder à une approbation éthique.
    Sessions

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  • Empowering Perspectives: Rethinking and Reimagining Community Research and Participant Engagement

    DESCRIPTION OF KEYNOTE

    Drawing from his vast community research experiences and narratives from various stakeholders across Canada, Dr. Laryea ‘s presentation advocates for a shift in perspectives and new approaches to research with communities. He stresses the need for rigorous and demonstrable guidelines that encourage researchers to move beyond knowledge generation to more impactful research that empowers and sustains communities. This strategy compels the researcher to leave something of value behind after each research.
    Keynote
    Keynote Q&A

  • Past Presidents Panel
    Keynote
    Keynote Q&A

  • REB Basics

    DESCRIPTION OF SESSION

    REB Basics
    Sessions

  • Moving beyond the gender binary in health research: the critical role of Research Ethics Boards

    DESCRIPTION OF SESSION

    Sex (biological attributes) and gender (social–cultural considerations) in research are important factors for diagnoses, treatment, and prevention strategies. However, these factors are routinely either not included in health research, used interchangeably, or are included in a binary and cisnormative fashion. Cis-women, trans, non-binary and gender-diverse persons experience additional health inequities compared to cisgender men, in part due to limited evidence informing care. The importance of diverse representation of participants in research studies to optimize health has resulted in calls for greater inclusion of participants from minoritized gender identities Research Ethics Boards (REBs) play a critical role in identifying gaps at the earliest stage of research development and ensuring alignment with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), specifically article 4.1 on appropriate inclusion. Thus, REBs are ideally positioned to promote ethical, gender-inclusive health research. This presentation will introduce participants to Beyond the Binary in Canada, a multi-year process that brought together researchers, community members that experience gender-related health inequities, REB members, and research administrators from across the country to create a nationally relevant Guide. The Beyond the Binary in Canada Guide identifies and evaluates the three main approaches to gender-inclusive language in health research (gender-additive, gender-neutral and anatomy-based), provides practical examples of how to integrate gender-inclusive language, and provides guidance on community engaged and trauma and resiliency informed research. Session Details The presentation will illustrate why gender-inclusive language matters, share good practices for community engaged and trauma and resiliency informed research, and provide practical examples of how REB members can promote and sustain implementation of gender relevant and inclusive research. Key learning outcomes for participants • Increased understanding of the importance of and different approaches to gender-inclusive health research • Increased knowledge of the critical role that reviewers and REBs can play to advance relevant gender-inclusivity in research, ensuring alignment with the TCPS2 core principle of justice. This will include practical examples of how to apply this principal to research inclusion criteria, recruitment strategies and materials, and consent forms. • Increased use of gender-inclusive language principles (via practical REB examples) and knowledge of good practices for community engaged and trauma and resiliency informed research, illustrated with practical examples and exercises for building skills and promoting reflexivity among individuals and teams. While the Beyond the Binary in Canada Guide and this presentation will focus on the context of health research, the information shared with respect to gender-inclusive language, community engagement, trauma and resiliency informed research practice, and the role of reviewers and REBs is relevant for research in all fields.
    Sessions

  • Privacy and Artificial Patients: Are Synthetic Patient Data Anonymous or Anonymized ?

    DESCRIPTION OF SESSION

    Generative Artificial Intelligence (AI) is commonly associated with Large Language Models that output human-like text, but it can also generate structured output like tabular data, enabling the creation of artificial patients or, more broadly, synthetic data (SD). A generative model can be trained using real personal health information, and then produces artificial patients from that learned data distribution. The most often applied use case for SD in healthcare is privacy-preserving sharing of data, particularly in secondary research. SD therefore can play an important role as a research and innovation accelerator while protecting individual privacy. Some large data custodians have already made synthetic versions of their health data publicly available such as Israel’s National Registry of Live Births or the French public health system claims and hospital dataset. Furthermore, SD is being increasingly shared as part of open science efforts to make research datasets more broadly accessible. The privacy-preserving capability of generative AI comes from there being no direct link between the synthetic data to real records (and thereby to real identities). As a result, it is often viewed as privacy preserving by design and thereby as a higher standard than more traditional anonymization techniques. The identifiability of SD is an important consideration for research ethics boards (REBs). In the Tri-Council Policy Statement 2 (TCPS 2), anonymous data is data that “never had identifiers associated with it (e.g., anonymous surveys) and risk of identification of individuals is low or very low” while anonymized data “is irrevocably stripped of direct identifiers, a code is not kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or very low”. Anonymous data is exempt from the REB review process. The question arises: Is SD anonymous or anonymized ? There are instances where REBs in Canada and the USA treat research as exempt from review if it relied exclusively on synthetic data. At the same time, legal opinions on SD under European jurisdiction are accumulating that treat generative AI as analogous to other privacy-enhancing technologies, so that SD can qualify as non-identifiable data if residual risks are very low. Privacy laws do not typically explicitly refer to SD, nor do they spell out the standards to be met to lower the risk. Court cases that could create precedents are lacking, and very few (non-Canadian) data protection authorities have published SD guidelines. Therefore, the treatment of SD remains an open question. In the proposed session, we will provide an analysis of the privacy (risks) of SD and analyze its identifiability status to provide an answer to the question of whether it can and should be treated as anonymized or anonymous information in the context of REB reviews. The session will consist of presentations from the legal, research, and privacy policy perspectives. After the session attendees will understand what synthetic data is, the privacy risks in synthetic data, how these risks can be mapped to contemporary definitions of concepts of anonymous and anonymized as defined in the TCPS 2, and gaps between these definitions and modern privacy technologies such as synthetic data generation.
    Sessions

  • Pediatric Clinical Trials: Past, Present and Future

    DESCRIPTION OF SESSION

    “Children are not just small adults” is a common refrain, but less commonly known is what that means, when and why it arose, and how it has impacted clinical research and drug development. The journey towards inclusion of pediatric participants in clinical trials is littered with regulatory carrots and sticks, such that we have shifted from protecting children from research to protecting them through research, and the global regulatory landscape that contribute to this continues to shift and grow. There is still a long way to go. In Canada, 50-80% of drugs are used off-label in children. To encourage pediatric drug development, Canada is currently conducting a 2 year pilot (2024-2026) on a pediatric study submission policy that is modeled after those that have been in effect in the USA and Europe for the past couple of decades. These continue to develop, with notable advances such as the RACE for Children Act that came into effect in the USA in 2020, and setbacks such as the recent surprising cancellation in the USA of provisions that support pediatric research, particularly for oncology and rare diseases. Here, I will explain what “children are not small adults” means from an historical, regulatory, physiological, and ethical perspective. Highlighting key regulatory milestones, current developments, and future needs along with discussion of practical aspects of pediatric trial planning will be accomplished with reference to the ethical considerations that underpin pediatric clinical research. Common assumptions will be touched on, and topics such as consent/assent, inclusion of adolescents, pediatric medical trauma, and pediatric plans will be considered from an ethical and practical perspective.
    Sessions

  • REB Basics

    DESCRIPTION OF SESSION

    REB Basics
    Sessions

  • Health Research in the Age of AI: Exploring the Challenges and Rethinking Research Ethics Board Reviews

    DESCRIPTION OF SESSION

    À l'ère de l'intelligence artificielle (IA), les comités d'éthique de la recherche (CER) sont confrontés à des défis dans l’évaluation des projets impliquant l’IA, notamment ceux nécessitant l’utilisation massive de données dans divers domaines, y compris la santé. En plus des défis persistants tels que le manque de ressources, de formation et de temps, les CER doivent répondre à des enjeux qui semblent être amplifiés, comme la confidentialité des données, le consentement individuel et la protection de la vie privée dans le cadre de recherches employant des référentiels de données à grande échelle. Ces défis sont encore plus complexes dans les contextes de partenariats public-privé et de recherche transfrontalière en IA en santé, où la diversité des cadres législatifs et éthiques complique les évaluations. Cette présentation offrira un aperçu des défis auxquels les CER au Canada sont confrontés dans l’évaluation des projets de recherche en IA dans le domaine de la santé. Elle mettra en lumière l’inadéquation de certains principes éthiques dans les politiques actuelles (e.g. l'Énoncé de politique des trois conseils ou EPTC2), tels que le consentement libre et éclairé, et de leur mise en œuvre, face aux spécificités et aux risques propres aux projets d'IA en santé. Enfin, la présentation exposera un projet de recherche visant à explorer les préoccupations, les défis et les besoins des CER, entre autres, afin de proposer des pistes de réflexion pour contribuer à une éthique de la recherche capable de répondre aux évolutions de cet écosystème de recherche en mutation.
    Sessions

  • Leveraging and Learning from AI in Research Ethics: A Case Study in Automating TCPS2 Navigation

    DESCRIPTION OF SESSION

    As artificial intelligence tools become increasingly prevalent in research administration, understanding both their potential and limitations is crucial. This presentation examines a case study from unique perspectives—a research ethics expert and a research coordinator—of using AI to help navigate the complexity of the TCPS2, revealing important insights about the challenges of automating complex ethical decision-making processes. While AI successfully generated structured decision pathways from the policy text, expert validation revealed significant gaps in capturing the nuanced interconnections between TCPS2 Articles and the contextual subtleties essential to ethical review. Through the complementary lenses of expert oversight and practical application, we explore how AI tools can support but not replace human expertise in research ethics, highlighting specific instances where algorithmic interpretation missed crucial policy interconnections. The findings demonstrate both the promise and limitations of AI in research ethics administration, while emphasizing the continued importance of human judgment and expertise, and the value of diverse perspectives in evaluating new technologies.
    Sessions

  • How a Single REB Review Can Look in Canada – Key Learnings from the CHEER Project

    DESCRIPTION OF SESSION

    The Canadian Collaboration for Child Health: Efficiency and Excellence in the Ethics Review of Research (CHEER) project, in its final year, has learned much over the course of the grant. The primary aims of the project were to address inefficiencies in the ethics review process for multisite, multijurisdictional pediatric research by streamlining REB review using a single board of record model. The current system, involving multiple Research Ethics Boards (REBs) and application forms, is often burdened by delays, inconsistent decisions, and resource strain. To address these challenges, CHEER started work in 2020 to move towards a single REB review for paediatric research. Using REB qualification to build trust and community, as well as education, CHEER has implemented a board of record model across the provinces of Nova Scotia and Ontario, with Newfoundland and Labrador joining soon. We will highlight some of the successes and challenges we encountered along the way and some of the key learnings that can be applied to a future vision for streamlined REB review for multijurisdictional research across Canada.
    Sessions

  • Open Networking Café – Conference Theme Topic

    DESCRIPTION OF SESSION

    Open Networking Café – Conference Theme Topic
    Sessions

  • From Seat Warmer to My Eureka Moment: A Community Representative’s Inspiring Journey with a Research Ethics Board

    DESCRIPTION OF SESSION

    The focus of this presentation is to share the enriching and insightful nature of my experience, as a Community Representative, highlighting the journey and growth I have encountered as a new member of a Human Research Ethics Board, with the hope of shedding more light on the scope expansiveness of the position, and the possibilities for self, and professional development, and contribution to the welfare of the community.
    Sessions

  • CanReview: Advancing Clinical Trials Through a Pan-Canadian Single Research Ethics Review System

    DESCRIPTION OF SESSION

    CanReview is a pan-Canadian collaboration supported by the Accelerating Clinical Trials (ACT) Consortium to enable single research ethics review for multi-site clinical trials conducted across Canada while ensuring the highest ethical standards. Collaborating with Research Ethics Boards, research teams, Indigenous community members, institutions and sponsors, patients and family partners and many others, we are co-developing a system to enhance efficiencies and increase Canada’s competitiveness, expand clinical trials to underserved, rural and remote locations, and promote equitable access to trial participation. Together, we are building a Canada-wide ethics review system that benefits all people in Canada. This presentation will provide an overview of CanReview, highlighting the critical need for a single research ethics review system for multi-site clinical trials across Canada and outlining the selection process that led to this transformative collaboration. Additionally, we will explore CanReview’s governance structure and how the system operates to streamline ethics reviews, foster collaboration, and enhance access to clinical trials nationwide. Finally, we will share an update on CanReview’s progress to date, and how members from across Canada’s clinical trials community can get involved.
    Sessions

  • “Ethical considerations of EDI in research and EDI considerations of ethics review”

    DESCRIPTION OF KEYNOTE

    Ethical considerations of EDI in research and EDI considerations of ethics review
    Keynote
    Keynote Q&A

  • Relational ethics and community impact in health research: Lessons learned from working alongside and in partnership with diverse communities in Peel Region, Ontario

    DESCRIPTION OF SESSION

    The conceptualization of community impact and representation in health research has traditionally been identified and reported by academics, service providers, and health researchers, who often fail to recognize how their research may truly impact communities in their everyday lives. In 2018, the Family and Child Health Initiative (FCHI) began through conversations alongside community partners and members in Peel Region, Ontario, to learn about community priorities surrounding child, youth, and family health and how healthcare providers and researchers could work in partnership with community organizations and members to co-design health solutions that were meaningfully impacted the community. Over the years, ongoing community conversations have supported FCHI to become a community-based participatory research program that centres the voices of diverse communities by integrating research practices such as community advisory boards, peer research assistant positions, membership on community response tables, and visual participatory and co-design methods. This workshop will share learnings from several of FCHI’s community-based projects, drawing on the concept of “relational ethics” and sharing how researchers need to prioritize relationships and care for others in their work. Through storytelling and interactive activities, workshop participants will be provided with useful tools and resources for working in partnership and alongside diverse communities in research to understand community impact.
    Sessions

  • Revising TCPS and the RCR Framework’s Guidance on Research involving First Nations, Inuit and Métis communities: A Status Update

    DESCRIPTION OF SESSION

    The Secretariat on Responsible Conduct of Research (SRCR) has begun an initiative to update its guidance in the Tri-Agency Framework: Responsible Conduct of Research (RCR Framework) and TCPS as they pertain to research with First Nations, Inuit and Métis Peoples, communities and territories. In this session, SRCR will outline the steps that have been taken to date and its preliminary plans for the initiative over the next two years. Topics discussed will include: - preliminary findings of a literature review that will inform the development of a community engagement plan, and - highlights of a proposed engagement plan. Attendees will be invited to ask questions and provide their views on what the engagement plan should include and what they would want to see in an updated Chapter 9 and RCR Framework.
    Sessions

  • Respectful Relationships in First Nations Research in Manitoba: History and Impacts of the First Nations Regional Ethics Board

    DESCRIPTION OF SESSION

    In 1998, the First Nations Health Information Research Governance Committee (HIRGC) was formed by Chiefs in Assembly in Manitoba, Canada. The creation of this First Nations Ethics Review Board (REB) was an important step in asserting First Nations sovereignty over research in Manitoba. First Nations rights have historically been ignored in research ethics and by academic researchers resulting in mistreatment and misuse of our people and data. The HIRGC serves as a regulatory body and gatekeeper of First Nations data in Manitoba by reviewing and overseeing research proposals to ensure that they adhere to ethical principles of Free Prior Informed Consent; First Nations OCAP® principles; First Nations ethics; and Benefits to First Nations. For over two decades the HIRGC has asserted First Nations rights and self-determination to ensure that research is conducted ethically, respectfully, and in alignment with research sovereignty principles. This presentation explores the history and impacts of the First Nations HIRGC in Manitoba. Presenters will speak to asserting First Nations ethical principles, repatriation of First Nation's data, overseeing First Nation census processes and other important considerations for Indigenous communities interested in establishing their own REBs. The evolution and impact of HIRGC highlights the need to protect Indigenous Knowledge; foster equitable partnerships between researchers and First Nations communities; and highlights First Nations REBs as one of many tools working towards a more respectful First Nations research landscape.
    Sessions

  • Are REBs Ready for AI?

    DESCRIPTION OF SESSION

    The recent surge in the availability and use of Artificial Intelligence (AI), such as LLM software applications, like ChatGPT, ought to prompt urgent discussion in the fields of clinical research and research ethics board (REB) review. Myriad concerns include data privacy and security, informed consent, data validity and biases, equity, and research grant exploitation issues. Amid these discussions, this workshop probes a crucial inquiry: are research ethics boards adequately equipped to grapple with the ethical intricacies stemming from the integration of AI in clinical research? In this interactive workshop we will discuss ethical challenges related to the growing use of AI in the research enterprise, highlight some of the current capabilities of AI, and through an AI-generated protocol identification exercise, we will call attention to the need for REB preparedness to effectively identify and respond to the use of AI. Research participants will be prompted to consider: Can REBs (their own REB, if applicable) reliably detect AI-generated research documents, and how does this capacity – or lack thereof – impact their ability to ensure research integrity? Participants will leave with a heightened awareness of the reality of the use of AI in research and a better awareness of their own limitations. We hope this workshop can motivate the pursuit of professional development opportunities, encourage the development of REB policies and/or creation of education materials (i.e. curriculum or certifications). The workshop will be delivered virtually and use interactive tools, including SLIDO.
    Sessions

  • Tracing Words, Tracking People: Ethical Concerns in AI-Driven Demographic Profiling

    DESCRIPTION OF SESSION

    Once a tool for literary analysis and forensic linguistics, stylometry has evolved into a powerful AI-driven technique for authorship attribution, plagiarism detection, and demographic profiling. With the integration of natural language processing (NLP) and deep learning, researchers now use stylometry to screen for mental health conditions, predict neurological disorders, and infer personal attributes such as gender identity and national origin. These advancements, while powerful, raise significant ethical concerns around privacy, consent, and bias, as stylometric methods can prospectively uncover identities from seemingly anonymous data. This talk will explore the history and future of stylometry, discussing key applications, emerging methods, and controversial uses, while addressing the ethical principles that should shape research ethics oversight. Attendees will gain a clearer understanding of stylometry's potential and the ethical safeguards required for responsible research implementations.
    Sessions

  • Indigenous led Research Ethics Review – a how to guide for racist and colonized institutions and the people in them trying to enact and embody acts of Reconciliation.

    DESCRIPTION OF SESSION

    Repeat efforts to improve the research ethics review related to Indigenous-led research projects has occupied multiple initiatives in British Columbia. Since the advent of the CIHR Indigenous guidelines, the TRC and in BC, the adoption of UNDRIP, the MMIWWG and In Plain Sight reports, institutions have recognized their parts to redress and improve the research-related processes of which research ethics review is only one. While individuals, groups and projects have offered insights, pathways, and knowledge gathering efforts no model has yet come forward and been acknowledged as a way for separate entities – namely Indigenous Nations and ICCOs to work with research institutions including hospitals – to enact the above named recommendations and principles. Ongoing discussions have improved but not directly addressed how REBs and their staff in these institutions may offer an administrative structure and model which enables Nations or ICCOs to institution review of such projects while meeting required policies, regulations and institutional requirements. The model outlined in this presentation and coming paper uses two examples of how to enact this work conducted by the Island Health REB and staff with local Nations and supports to illustrate this as one proposed pathway.
    Sessions

  • Open Networking Café – Conference Theme Topic

    DESCRIPTION OF SESSION

    Open Networking Café – Conference Theme Topic
    Sessions

  • From Researcher to Reviewer: Insights from the Frontlines of Ethical Research

    DESCRIPTION OF SESSION

    Transitioning from a researcher with over 25 years of experience in Iran to a Research Ethics and Regulatory Specialist in Canada has been both a personal and professional journey of growth. My path included a formative period as a researcher at the University of British Columbia (UBC), where I adapted to the Canadian research landscape and connected with scholars in the field of research ethics. This experience, combined with my background as a nursing educator and researcher, has shaped my approach to the ethical oversight of research projects. As a researcher, I navigated the complexities of designing and implementing studies in diverse healthcare settings, with a focus on ethical principles such as justice, fairness, and respect for participants. Today, as a research ethics specialist at Fraser Health, I draw on these experiences to review research proposals critically, ensuring they meet ethical guidelines and promote inclusive, socially responsible practices. My dual perspective as both a researcher and a reviewer allows me to bridge the gap between study design and ethical compliance, offering insights that enhance the rigor and fairness of research. In my current role, I encounter recurring ethical challenges, such as ensuring equitable inclusion in research and addressing power dynamics in participant recruitment. These challenges underscore the importance of balancing regulatory requirements with the practical realities of conducting research. My role involves not only evaluating proposals but also mentoring researchers, fostering dialogue, and advocating for ethical practices that reflect the diversity of our communities. Through this work, I have developed a deeper appreciation for the intersection of research and ethics. The transition from conducting studies to overseeing their ethical integrity has broadened my understanding of the critical role that research ethics administrators play in safeguarding participants and advancing knowledge. By sharing insights from the frontlines of ethical research, I aim to highlight the value of a collaborative, reflective approach to research ethics that supports both researchers and participants.
    Sessions

  • “Quo Vadis Health Data Sharing?”

    DESCRIPTION OF KEYNOTE

    Open science is premised on the cost-efficient dissemination of data across national and organizational boundaries, for future research use. Its fruition requires broad alignment on the acceptable purposes of data use. However, defining, interpreting, and communicating rights in health data in a compatible manner is a challenge. The rising prominence of data protection law in regulating exchange, relative to bioethics norms, prompts cautiousness and risk-aversion in data exchange. Changes in informal research norms, in private law arrangements enabling data exchange, and in foundational public law are needed. The Pan-Canadian Health Data Charter provides the principles for person and population health data sharing. In addition, GA4GH Ethical Provenance mechanisms strive to develop interoperable tracking mechanisms that enable permissions in biomedical research data to be recorded and communicated across independent research organizations. Quo vadis health data sharing?
    Keynote
    Keynote Q&A

  • Cultural Inclusion and Accountability Workshop

    DESCRIPTION OF SESSION

    Title: Building a Research Roadmap for Cultural Inclusion and Accountability Part II Authors: Victoria Ennis Med (presenter), Rulan Parekh MD, MS, FRCPC, Cynthia Maxwell MD FRCSC DABOM, Alison Williams PhD, Soumia Meiyappan MSc PMP, Marie Steele MHSc Abstract: In April 2025, the Women’s College Hospital (WCH) Department of Academics will host a Cultural Inclusion and Accountability Workshop focused on Black communities to create a WCH-specific research roadmap. This roadmap will guide researchers, the Research Ethics Board, and the institution in engaging meaningfully with Black communities. The goal is to improve healthcare outcomes through research and knowledge application. Objectives include: i) increasing knowledge on anti-Black racism to strengthen Black health outcomes and research participation among the Black community, ii) increase knowledge and application of the Engagement, Governance, Access and Protection (EGAP) framework among researchers at WCH, iii) inviting expert insights to develop a research roadmap for Black participants, and iv) conduct a needs assessment to understand Black communities and participation in research, thereby ultimately strengthening our REB review process and our institutional learning centered on TCPS2 Chapter 4, 9 and 10. Expected outcomes include creating a WCH-specific roadmap for ethical research including Black participants and communities. Additionally, we want to better understand how the TCPS2 principles might be operationalized in different ways based on the community needs. Our learning from Chapter 9 and our past workshop focused on Indigenous communities (held in Mar. 2023) has given us a framework on what considerations are important to communities that have faced marginalization and health inequities. There is limited guidance on study design, execution, implementation and knowledge translation for the Black community. Our researchers and REB will learn from this workshop, contribute to the development of a roadmap and advance competence, compliance and expand the breadth of TCPS2 principles. The attendees will comprise of WCH staff, researchers, WCH REB members, clinicians, students and administrative staff, as well as external speakers and community members relevant to Black health equity. The research disciplines involved in this event will include Research Ethics, Community Partnerships, Maternal Health, Mental Health, Breast Cancer, and Allyship. The key themes of the event will be data governance, ethics/consent, patient & community engagement, and health disciplines as they relate to research with Black communities.
    Sessions

  • Informed Consent Contexts and Research Data Sharing

    DESCRIPTION OF SESSION

    FAIR (Findable, Accessible, Reusable, Interoperable) research data do not exist as discrete entities. Rather, they form a part of larger packages of information, the whole of which is essential to reuse. Secondary use of research data requires access to the contexts of their collection, management, and organization, usually in the form of documentation and metadata that accompany data files when they are shared. While research data management educational initiatives and data repository guidelines have clearly communicated the importance of providing methodological and structural contexts when sharing non-sensitive data, ethical contexts have received much less attention. Ethical contexts, which include information about ethics oversight for data collection and the terms of participant consent, are crucial for secondary use of data. Just as documentation and description allow secondary researchers to understand the nature of a dataset, ethical contexts reveal limits on reuse established during the original data transaction. As broad consent procedures become more commonplace across disciplines and at all levels of data sensitivity, it is increasingly important that the terms of consent are made clear when data are shared. Knowledge of the original terms of consent allows secondary researchers to act in accordance with participant expectations and may reduce the burden on research ethics boards when deliberating on secondary uses of human data. This presentation will outline a study that examined the extent and nature of informed consent contexts in the datasets of a large multidisciplinary data repository. We examined all individual-level human datasets published in the Borealis data repository between January 2022 and September 2024 to determine the frequency and methods with which informed consent information was shared, how intent to share data is described in letters of consent, and the degree to which access and use conditions adhere to the original terms of consent. We found that informed consent contexts are infrequently included with public datasets and, among those datasets that include consent information, only a slight majority impose conditions of data access and use that reflect the original terms of consent. Going further, a qualitative analysis of consent documentation suggests that the provision of information with respect to data sharing is generally sparse, with few details provided about confidentiality or future uses of research data. This presentation will provide recommendations for ways in which ethics boards and repository stewards can collaborate to help ensure that commitments to participants are framed and enacted accurately and that ethical contexts are clearly communicated when research data are shared. Key Outcomes Attendees will advance their understanding of: * The importance of communicating the consent contexts of open datasets to potential secondary researchers; * How terms of research data access and use are established in data repositories, and the importance of harmonizing conditions of secondary data use with terms of consent; * How research ethics boards and data stewards can collaborate to ensure that terms of broad consent for unknown future use of data are enacted in accordance with participant expectations.
    Sessions

  • Development of AI/ML REB review tools at BC Cancer: A collaborative multi-disciplinary approach

    DESCRIPTION OF SESSION

    As Artificial Intelligence (AI) and Machine Learning (ML) techniques become rapidly prominent in the research landscape, Research Ethics Boards (REBs) nationally are reshaping their review processes and considerations to address the growing breadth of ethical considerations in applying AI/ML to human data. In a rapidly evolving research landscape, AI/ML techniques are currently being integrated into research and applied to human data at an unprecedented rate. The REB must remain empowered to target critical concerns in order to ensure a comprehensive understanding and identification of the unique ethical implications that AI/ML can pose to our patient population and healthcare system. BC Cancer's REB has adopted a proactive strategy to address the recent rise in the number of AI/ML-based research ethics applications. We will discuss the development of BC Cancer's AI/ML review tools used by both researchers and REB members which streamline and standardize the process of evaluating AI/ML-based research. We will identify and explore the challenges and strategies involved in managing these reviews, including re-evaluating the REBs role in AI/ML reviews and the review model adapted to collaborate with AI/ML experts in overseeing the review of these research applications. This session will highlight how an adaptable and informed REB can navigate an evolving research landscape to address ethical oversight with the use of collaborative AI/ML review tools. Please come prepared with thoughts or questions regarding AI/ML-based research ethics during the collaborative portion of this session.
    Sessions

  • Four questions to consider before waiving consent requirements in pragmatic cluster randomized trials

    DESCRIPTION OF SESSION

    Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in routine conditions to inform the decisions of patients, healthcare providers, and health systems managers. While most pragmatic trials use individually randomized designs, about 35% use cluster randomized designs. Cluster randomized trials (CRTs) involve randomly allocating groups (e.g., clinics or hospitals), as opposed to individuals (e.g., patients), to study interventions. However, the robust design and conduct of pragmatic CRTs may be in tension with the ethical requirement to obtain informed consent from research participants. As a result, researchers and research ethics committees tend to focus on whether an alteration or waiver of consent is appropriate for these trials. But pragmatic CRTs raise other important questions that have direct implications for determining when an alteration or waiver of consent is permissible. To assist those involved in the design and review of pragmatic CRTs, this presentation will outline four critical questions to consider: (1) What is the nature of the intervention being evaluated? (2) Is the choice to use cluster randomization justified? (3) Can the risk of recruitment bias be addressed? and (4) Is an alteration or waiver of consent appropriately justified? Two case studies will be used to illustrate how researchers and research ethics committees can undertake a stepwise ethical analysis of a planned pragmatic CRT.
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  • Unlocking the Benefits of CTO’s Newest REB Qualification Program: A New Path for Non-Clinical Research Institutions

    DESCRIPTION OF SESSION

    The Clinical Trials Ontario (CTO) Research Ethics Board (REB) Qualification Program is well recognized as the system utilized in Ontario for evaluating REB compliance with clinical trial regulations and ethical requirements. Qualifying through CTO enables an REB to demonstrate that they meet the professional standard and therefore can reap the benefits of Qualification including participation in CTO Stream - reciprocity and single review of multi-site research. This system has had a good uptake over the decade, primarily by hospitals, as well as by a few universities with clinical or biomedical REBs. However, most universities and colleges have not applied for the Qualification Program because of its focus on clinical trial regulations which do not apply to the disciplines, fields and methods that their REBs review. Recognizing the need for all research institutions to benefit from Qualification, we created the Multidisciplinary Research (MDR) REB Qualification Program. After creating the MDR REB standard operating procedures that were internally and externally validated and made available through CAREB and CTO websites, we began pilot testing the MDR Qualification Program. Through the pilot we have learned valuable lessons that are being integrated into the final program. In this session, we will discuss the value of MDR REB Qualification to institutions who review primarily non-clinical research and the activities we can provide in assessing your readiness for Qualification. We will also talk about where the program is going and how it will benefit those institutions that are qualified. The REB lead of our first pilot visit will discuss her experiences with the process and what tips she would give to those considering the program. Finally, we will open the session to audience members to ask questions about the program and what supports are available to them in considering REB Qualification. Join us as we introduce the MDR REB Qualification Program and don’t miss the chance to learn how this evolving program can support your REB’s growth, offer greater access to streamlined research ethics reviews, and open new opportunities for collaboration across institutions!
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  • ‘We’re not making it as easy as we might’: issues and opportunities Open Science mandates present to Canadian ethics officers and librarians supporting human participatory research

    DESCRIPTION OF SESSION

    Background: Open Science (OS) offers a grand challenge by demanding both cultural and structural change across the ecosystem to realize global benefit and research accountability. The regulatory function of ethics review for human participatory research (HPR) ensures protection of the participant throughout the entire research project. With OS mandates, the review process and its stakeholders are located at the centre of this challenge: upholding the values of OS while also defending participant autonomy and privacy, community stewardship and situational policy obligations, as well as evaluating and managing other risks. Data management plans (DMPs) reflect all these aspects in a project. Purpose: To explore the experiences of supporting research data management (RDM) and/or DMPs as part of ethics review process by ethics officers, chairs and librarians and/or staff. Methodology: Eight semi-structured, individual interviews were conducted and audio recorded by the author. Transcripts were analyzed using a critical realist approach to identify patterns of support considerations. Analysis/Findings: An inter-related grouping of themes arose from participant reflections in their organizations: time, capacity, personal v. system-constructed relationships. Time, and its consumption, was the determining factor in both providing access to support and demonstrating its value. Definitions of capacity extend beyond infrastructure limitations and availability to require a collective knowledge and awareness across all organizational levels. Relationships are the ‘engine’ of capacity, and in the absence of system-identified networks, the efficacy of support is dependent on the provider’s agency, leadership mobilization, and ‘known quantity’ within the organization. These themes, informed by the participant’s function and positionality within their organization, together contributed to an overall thematic perception of paralysis v. engagement with respect to data management plan adoption and utility, and an ‘us against the system’ dynamic. Data management topics of data sharing, deposit and sovereignty were issues of specific concern. Conclusions: To better meet the complex, interdisciplinary challenges of OS-related data management-ethics concerns, a movement from solo or isolated units of support, defined by process or discipline, to new matrixed system structures which facilitate role awareness, knowledge exchange, and common language should be encouraged.
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  • Exception from Informed Consent in Emergency Research - Canadian Challenges and Opportunities

    DESCRIPTION OF SESSION

    In the United States conducting trials under Exception from Informed Consent (EFIC) have been applicable only under narrow clinical circumstances when prospective informed consent is not possible. Research Ethics Boards (REBs) are able to approve such studies under a clear regulation framework, including the conduct of public disclosures and community consultations. Canadian TCPS2 regulation mandates appropriate use of a waiver or deferral of consent model. Conducting trials in Canada that includes patients in critical conditions such as in the Emergency Department (ED), when a legally authorized representative is not available, may include exception from consent for serious compromise to health, but stipulates that the intervention should not be greater risk than standard of care, or clearly justified by the benefit. This creates some significant challenges for investigators in the field of emergency and intensive care, especially in cases of scientific equipoise. Furthermore, Exception from Informed Consent trials usually seek subjects in numerous sites, in order to achieve an appropriate sample size for exceptionally rare conditions. This represents further challenges when studies seek participation of sites in the USA and in Canada, when REBs framework is different. This active session will focus on the foundation of Exception from Informed Consent trials, and ways REBs can review this unique type of studies in order to allow investigators to advance emergency and intensive care related trials. A focus in the session will be on the differences and opportunities for Canadian REBs when reviewing Exception from Informed Consent trials conducted across the border (USA and Canada). We will review examples of clinical circumstances when prospective informed consent is not possible, including studies that were conducted in Canada.
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  • Open Networking Café – Conference Theme Topic

    DESCRIPTION OF SESSION

    Open Networking Café – Conference Theme Topic
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  • Researching Nudism and Naturism: Ethical Considerations

    DESCRIPTION OF SESSION

    In this presentation, I seek to discuss the importance of Chapter 9, "Research Involving the First Nations, Inuit, and Métis Peoples of Canada" of the TCPS and specifically the vital role of "building reciprocal, trusting relationships." However, I am interested in the possibilities and necessities for Chapter 9 outside of the context of FNIM peoples. A recent interpretation notes, "While Chapter 9 is designed to guide research involving those communities, its discussion of respectful relationships, collaboration and engagement between researchers and participants may also be an important source of guidance for research involving other distinct communities. The need to respect a community’s cultural traditions, customs and codes of practice may extend beyond FNIM communities." In my current research, I am engaging with nudists and naturists, and when conceptualizing of this project I knew that it would be essential to build "reciprocal, trusting relationships," and so I have drawn extensively on the principles set out in Chapter 9. Nudism, at its most basic, is about the social practice of communal nakedness. In Canada, there are, according to some estimates about 35,000 nudists; however, some 69% of Canadians have engaged in some "nudist activities" as observed by the Federation of Canadian Naturists in a 2014 survey (these activities range from sleeping nude through going to a nude beach). However, there is also significant concern among many nudists that their identities might be known, for instance, fears about custody or fears about what will happen if an employer finds out they are a nudist, how might a middle school teacher be affected if people find out they are nudist, etc. Thus there is some sense of precarity and fear amongst nudists. Many of the spaces where nudists congregate require admission, background checks, etc., and so, there is an expectation of some level of privacy. As such, this becomes a rich and complex space to study, especially in our current cultural moment where there is so much anxiety about bodies and naked bodies (i.e. locker rooms and bathrooms). Moreover, how does a researcher, particularly a textile (non-nudist) researcher engage with historical materials that likely includes photographs not only of men and women, but also boys and girls. How does a researcher engage a community with whom they may have little in common, a community that may even make them uncomfortable? A researcher engaging with nudism has many ethical considerations to consider, and this is not necessarily an easy task. While this research is not about Indigenous peoples, the lessons learned from Chapter 9 speak broadly to how we can begin to Indigenize and decolonize our ethical relationships as part of ongoing daily practices and while researching marginalized, precarious, or stigmatized groups. Chapter 9 serves as an important, if not essential, model for studying communities that find themselves or are positioned on the outside. While my focus in this presentation is on nudism and naturism, the insights could be beneficial to studying any number of "subcultures," which are often marginalized or have been subject to dubious and perhaps even abusive scholarship.
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