Workshop

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With a focus on real-world case studies, research ethics scenarios, and REB reviews, this interactive workshop is designed for new REB members or anyone seeking to strengthen their understanding of research ethics review. Utilizing a blend of presentations, collaborative group activities, and guided self-reflection, workshop participants will gain a foundational understanding of the ethical review framework, covering the structure and function of REBs, defining researcher and reviewer responsibilities, differentiating between levels of review, and applying key principles in assessing risk, obtaining informed consent, and safeguarding participants.

Workshop

DESCRIPTION OF SESSION

Many researchers in Canada initiate pan-Canadian studies, although certain rules and regulations governing these projects do not have a pan-Canadian application. This workshop’s first objective is to explain the key provisions of the Quebec Civil Code that are relevant to research in healthcare. Its second objective is to examine how the content of these provisions align with, and differ from, those of the Tri-Council Policy Statement (TCPS).

Workshop

DESCRIPTION OF SESSION

Background: The shift toward online recruitment methods, accelerated by the COVID-19 pandemic, has brought to the forefront the growing concern of encountering fraudulent participants in health care research. The increasing prevalence of this issue poses a serious threat to the reliability and integrity of research data, use of limited research dollars, and subsequent findings. Aim: To gain insights into how researchers detect and mitigate fraudulent behavior in their work and develop recommendations, we conducted a study to explore the experiences of health care researchers (HCRs) who have encountered fraudulent participants while using online recruitment methods and platforms. Method: Using a multimethod sequential design, this pilot study included a web-based survey followed by a semi-structured interviews. Results: A total of 37 HCRs participated, with 13 completing interviews. Online platforms such as Facebook, email, Twitter (subsequently rebranded X), and newsletters were most commonly used by participants for study recruitment. 31 participants indicated that fraudulent participation occurred in studies that mentioned incentives in their recruitment communications, with 26 of HCRs offering physical or electronic gift cards as incentives. Researchers identified several indicators of suspicious behavior, including email surges, discrepancies in contact or personal information, geographical inconsistencies, and suspicious responses to survey questions. HCRs emphasized the need for a comprehensive screening protocol that extends beyond eligibility checks and is seamlessly integrated into the study protocol, grant applications, and research ethics board submissions. Workshop: A presentation of the study findings, along with strategies to detect and mitigate fraudulent participants will be presented. This will be followed by small group discussions of: 1) the ethical implications of the problem, and inherent in mitigation strategies; 2) how to adequately react to the ongoing and pervasive threat of fraudulent participants given the ever-changing state of AI; 3) the potential for a collective response through establishing a community of practice to keep abreast of the evolving problem.

Workshop

DESCRIPTION OF SESSION

With a focus on real-world case studies, research ethics scenarios, and REB reviews, this interactive workshop is designed for new REB members or anyone seeking to strengthen their understanding of research ethics review. Utilizing a blend of presentations, collaborative group activities, and guided self-reflection, workshop participants will gain a foundational understanding of the ethical review framework, covering the structure and function of REBs, defining researcher and reviewer responsibilities, differentiating between levels of review, and applying key principles in assessing risk, obtaining informed consent, and safeguarding participants.

Workshop

DESCRIPTION OF SESSION

Research ethics in northern contexts requires more than compliance with national standards—it requires a commitment to reconciliation, respect for Indigenous governance, and recognition of diverse knowledge systems. The Research Ethics Boards (REBs) at Yukon University and NWT’s Aurora College (AC), both compliant with TCPS2 standards, operate within a unique northern context. Yukon University’s REB review is based on the institution’s pledge to “honour and support reconciliation with Yukon First Nations” and to “include, respect, and honour Yukon First Nations’ knowledge, worldviews, cultural and traditional practices.” The AC REB review aligns with the requirements of the NWT Knowledge Agenda and NWT Scientists Act, emphasizing practical ethics review processes tailored to northern realities. This presentation explores how these factors shape REB deliberations and decisions beyond conventional standards to incorporate local lenses emphasizing Indigenous data sovereignty, community benefit, knowledge co-creation, and respect for cultural protocols. Using select case studies, we illustrate how REBs collaborate with researchers to support regional development, uphold self-government agreements, and build capacity within northern communities. Key themes include: • Navigating the intersection of institutional ethics requirements and Indigenous governance authority. • Building research partnerships rather than extractive relationships. • Balancing academic freedom with community accountability. • Developing review processes that recognize Indigenous knowledge systems as equal to Western scientific frameworks. Through our experiences we aim to provide insights for other REBs seeking to navigate the complexities of research in Indigenous and northern settings.

Workshop

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Artificial Intelligence (AI) is an emerging field with a plethora of ethical challenges. Given the lack of significant guidance in terms of regulation, Research Ethics Board’s (REB) are left to determine the ethical issues and risks associated with AI research. Additionally, as with many emerging technologies and practice, the identification and management of ethical issues often lag behind the pace of development. AI is expanding rapidly within healthcare and is being applied across a wide range of programs and areas. As such, THP REB identified significant gaps in both resources available and REB reviewer’s foundational AI knowledge needed to perform comprehensive and appropriate ethics reviews. REB reviewers often face challenges identifying which additional questions to ask, and which questions may not be applicable given the type of research being conducted and the stage of the AI life cycle. To address this gap, THP sought to develop an independent REB specializing in AI research ethics review. Through the development of a novel AI focused REB, the REB has sought to deepen its overall knowledge of AI, and to develop a robust awareness of the types of ethical issues that can arise at all stages in the life cycle of AI research. Through engagement with AI researchers, other REBs and REB members, and AI Ethics experts, THP’s REB is in the process of finalizing several resources and tools, including an AI-specific reviewer guide for our reviewers, to support robust, ethical and proportionate review of AI research.

Workshop

DESCRIPTION OF SESSION

Effective onboarding is essential for preparing new Research Ethics Board (REB) and Research Ethics Office (REO) members to carry out consistent, high-quality reviews. Institutions often rely on informal or legacy processes, which can lead to variable reviewer competency and uneven understanding of policy and practice. This workshop will walk through structured onboarding models used at two institutions and offer participants a set of practical approaches they can adapt to their own settings. The session will highlight a specific onboarding process used at Ontario Tech University, which includes an introductory orientation on REB governance and procedures, a self-directed training phase using CAREB resources, and a mentored peer-review exercise with senior REB members. In parallel, we will outline Queen’s University’s staged onboarding process, which includes mentored delegated-level reviews, consent form assessments, supported by iterative feedback from the Chair and the REO. Together, these examples show how a structured, competency-based approach can strengthen reviewer confidence, improve the clarity and quality of review comments, and support consistency in decision-making. The workshop will compare different training models, discuss the role of mentorship and feedback, and provide templates and strategies for building or refining institutional onboarding frameworks. Participants will leave with practical tools they can tailor to their own REBs to support sustainable, effective member training. Learning Objective: By the end of this workshop, participants will be able to formulate a training/onboarding package for both REB and REO members staff. These skills will be reinforced through interactive breakout activities that foster discussion and practical application of concepts.

Workshop

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Chapter 9 of the TCPS, Research Involving First Nations, Inuit and Metis Peoples of Canada was first introduced in the TCPS in 2010. Since then, the landscape for the ethical conduct of research in this area has evolved. The Secretariat on Responsible Conduct of Research therefore understands that Chapter 9 would benefit from additional or updated guidance to support communities, researchers and research ethics boards (REBs) on the appropriate conduct and review of this research. The Secretariat proposes to convene a panel discussion comprised of experts from Indigenous-led and institutional REBs who have successfully developed and implemented policies and procedures to ensure that the research they review aligns not solely with the principles outlined in Chapter 9 but also with community principles and priorities. The discussion will also provide an opportunity for conference attendees to share perspectives on how Chapter 9 can be updated to reflect evolving community needs and expectations.

Workshop

DESCRIPTION OF SESSION

A growing body of research has been published on the promising ways that the acoustic properties (how voice sounds) and speech (linguistic content and what is said) can be leveraged as digital biomarkers in various health conditions. The underlying premise is that troubles in physical, neurological and mental health can affect the speech production mechanism and result in alterations of one’s speech. Research has therefore highlighted emerging benefits on developing AI models that use speech for the diagnosis, prognosis, and monitoring of conditions such as Parkinson's disease, Alzheimer's disease, mood diseases, speech conditions, and much more. Given the cost effectiveness and non-invasive nature of voice data collection, it is not difficult to grasp the potential of leveraging those data for the diagnosis and monitoring of complex conditions. Research on voice and speech biomarkers has grown rapidly, thanks to work from research groups, start-ups, small companies and big industry players, but this rapid growth also underscores the need to actively engage members of research ethics boards (REB) and institutional review boards (IRB), ensuring they are equipped to assess studies involving voice and speech data with confidence and clarity. This workshop will present a tool created to support REB and IRB members in their evaluation of these research project. The tool’s conceptual design and modules incorporate insights from semi-directed interviews and focus group done with members of REB and IRB (n=31), researchers in the field (n=16), patient advocacy groups (n=21), patients, healthy individuals (n=31) and healthcare providers (n=30) from Canada and the United States of America. This workshop will be an opportunity for participants to engage with the tool, and to contribute to its refinement before its release, to help ensure that the tool is both practical and responsive to the realities of ethical review.

Workshop

DESCRIPTION OF SESSION

Indigenous research ethics requires more than procedural compliance with TCPS2. It requires a shift in worldview — from a focus on individual risk and individual consent toward relational accountability, collective rights, and Indigenous governance over how knowledge about Indigenous Peoples is created, interpreted, and shared. Many REB members, particularly those who are newer, struggle to evaluate Indigenous research-related applications when conventional REB frameworks do not fully align with Indigenous ethical principles and relational accountability, especially in areas where ethical risks are not clearly “triggered” through typical application prompts. This interactive workshop will introduce foundational concepts in Indigenous research ethics using the Kahnawà:ke Schools Diabetes Prevention Program (KSDPP) Code of Research Ethics as a real, community-driven model that operationalizes Indigenous sovereignty, community consent, collective data ownership, and decision-making authority throughout the research lifecycle. Through small group dialogue, collaborative review of mock protocols, and scenario-based discussion, attendees will explore a range of ethical issues relevant to Indigenous research. One specific case example will examine the “public domain dilemma” — where researchers assume publicly available Indigenous data are free to use without Indigenous engagement — demonstrating how collective identity, cultural significance, and sovereignty continue to apply even when data are in the public arena. Participants will leave this workshop with practical tools, stronger confidence, and ethically grounded questions they can integrate into REB screening and review practices. This session supports REB members to more effectively recognize when Indigenous community engagement is required, how to identify potential harm beyond individual risk, and how to support research that aligns with Indigenous priorities, values, and governance.

Workshop

DESCRIPTION OF SESSION

What does First Nations research ethics look like in practice? How can regional research ethics support First Nations sovereignty at a community level? This workshop will be informed by expertise of the Health Information Research Governance Committee (HIRGC), a regional First Nations Research Ethics Board (REB) in Manitoba. Since 1998, the HIRGC has been mandated by the Assembly of Manitoba Chiefs to assert First Nations data governance and protect First Nations data at a regional level. The HIRGC ensures that regional research by, with, and for First Nations adheres to ethical principles of Free Prior Informed Consent; First Nations OCAP® principles; First Nations ethics; and Benefits to First Nations. Workshop participants can expect to understand the history and composition of a regional First Nations REB, as well as explore the imperatives of First Nations consent, elements of trusting relationships, and how to ensure research projects create meaningful benefits to First Nations. This workshop will be delivered by two Committee members and the Research Ethics Coordinator.

Workshop

DESCRIPTION OF SESSION

Given the variability of topics and applicants for a research ethics application to a Research Ethics Boards (REB) or Institutional Review Board (IRB) from undergraduate students, professional students, advanced-level trainees, such as medical residents and fellows, graduate students, and post-doctoral fellows, plus, of course, faculty members – new and experienced – the types and scope of studies under review by a REB/IRB is enormous. Although training sessions are offered by REBs/IRBs and/or through centralized online courses to help applicants learn how to effectively apply for ethics approval for their study, many applicants may not avail themselves of that opportunity. This can result in many deficiencies and errors in applications that can require more time to review. Generative AI (gen AI) has been used to create clinical research ethics applications/protocols using study descriptions from applicants in order to decrease the time for application writing and to “provide additional consistency for reviewers.” (Godwin, 2023). This workshop’s goal is to describe a potential method for using gen AI that could provide applicant feedback on their application prior to formal ethics review, i.e., provide a method to train and give feedback to applicants. Additionally, we wish to provide opportunities for participants to discuss the pros and cons of this type of gen AI tool for use in research ethics applications and protocols and to discuss priority areas for pre-review feedback. An outcome would be a summary of advantages and disadvantages of such a gen-AI tool for applicants and REB/IRB reviewers. Reference: Ryan C. Godwin, Ayesha S. Bryant, Brant M. Wagener, Timothy J. Ness, Jennifer J. DeBerry, LaShun L. Horn, Shanna H. Graves, Ashley C. Archer, Ryan L. Melvin, IRB-draft-generator: A generative AI tool to streamline the creation of institutional review board applications, SoftwareX, Volume 25, 2024, 101601,ISSN 2352-7110,https://doi.org/10.1016/j.softx.2023.101601. (https://www.sciencedirect.com/science/article/pii/S2352711023002972)

Partner Updates

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CIHR, SRCR, Health Canada, CARA, PRIM&R, N2

Keynote Presentation

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Coming soon

Concurrent Breakout Sessions

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Research in Nunavut must be governed by high ethical expectations that emphasize community involvement, clear communication, and accountability. This presentation outlines key requirements that REBs should be aware of when reviewing projects that involve Nunavut communities. Co-design is essential, where research questions, methods, and timelines are developed in collaboration with community partners before project approval. The session also describes standards for research conduct, including working in community settings, coordinating with local organizations, and ensuring that activities align with cultural and practical realities in Nunavut. In addition, researchers are expected to provide meaningful benefits to participating communities, such as training opportunities, locally relevant outputs, and accessible knowledge-sharing plans. We will discuss how these expectations intersect with institutional ethics review and the Nunavut licensing process. The goal is to support REBs in identifying gaps in applications and guiding researchers to meet Nunavut’s ethical, procedural, and community-engagement requirements.

Concurrent Breakout Sessions

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The rise of synthetic data and digital twin technologies is transforming biomedical research and clinical trial design, allowing investigators to model interventions on simulated “participants.”. Marketed as efficient, ethical, and low-risk, these technologies obscure profound ethical concerns, particularly for First Nations, Métis, and Inuit communities whose data, identities, and bodies have long been extracted, simulated, or represented without consent. This session responds to the CAREB 2025 theme, “The Power of Presence in Research Ethics: Live, Virtual, United,” by demonstrating how these emerging tools create the opposite: research without presence, without relationship, and without accountability. Synthetic datasets and digital twins risk generating “datafied Indigenous bodies” from legacy datasets, administrative health systems, or algorithmic predictions, none of which fall cleanly under existing REB definitions of human participant research. As a result, these technologies can bypass and undermine community governance, Indigenous Data Sovereignty (IDSov) principles and relational ethics, raising urgent questions for research oversight bodies across Canada. Drawing on our work in Indigenous clinical trials, distinctions-based data governance, and rights-based research infrastructures, we map the ethical fault lines created by simulated research environments and identify how current ethics systems are not equipped to protect communities when the “participants” are synthetic, but the harms are real. Through case analyses and relational dialogue, we offer pathways for REBs, institutions, and communities to approach the increasing use of synthetic data with a critical lens and to ensure that Indigenous sovereignty, consent, and governance remain central in digital research landscapes.

Concurrent Breakout Sessions

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Research ethics in small and rural communities demand a nuanced and context-sensitive approach that considers factors like close-knit social networks, limited anonymity, and unique cultural dynamics. Researchers working in these environments must prioritize ethical practices that respect local values, avoid reinforcing existing disparities, and foster genuine community benefit. This presentation explores the unique ethical responsibilities of rural researchers, emphasizing the importance of co-creating research agendas with community members and mitigating unintended consequences. The presentation will include case studies from research conducted at a rural college that has prioritized positive contributions to community development throughout all programming and service areas. Attendees will be invited to share their experiences and participate in building a collaborative set of practical strategies to guide ethical research that builds trust and strengthens rural communities.

Concurrent Breakout Sessions

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In an era marked by the rapid advancement of technology, the ethical landscape of research is undergoing significant changes, particularly regarding vulnerable populations. This presentation explores the critical ethical dimensions of integrating artificial intelligence and novel research methodologies within studies involving neurodiverse children. As a Postdoctoral Fellow and Research Ethics Review Officer, Dr. Liton Furukawa offers a unique, human-centered perspective, exploring how to meticulously balance the promise of groundbreaking discoveries with an unwavering commitment to participant welfare. Drawing upon her expertise as a multisensory intervention specialist and educational expert, Dr. Furukawa will illuminate the challenges and propose innovative frameworks for ethical governance, ensuring that the pursuit of progress responsibly serves the best interests of neurodiverse children. Attendees will gain actionable insights into shaping a moral compass for research in the age of emergent technologies.

Concurrent Breakout Sessions

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What is therapeutic misconception? Can it occur even though a person is clearly told that a procedure is for research purposes? It appears that certain individuals can mistake their participant-researcher relationship for a patient-doctor relationship. They can also misconstrue their participation in research as partaking in a different treatment. Furthermore, it appears that the line between research and care is getting increasingly blurry. This session will explore the concept of therapeutic misconception, its legal and ethical issues, and some strategies research ethics board can consider to limit or avoid it.

Concurrent Breakout Sessions

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Community-engaged research is built on relationships, shared decision making, and flexible approaches that evolve in response to community priorities, sometimes occurring in real-time. These values often sit uneasily beside the structured processes, documentation requirements, and participant protection-focused lens of Research Ethics Boards (REBs) and Research Ethics Offices (REOs). This session explores the tensions between what community-engaged researchers need to carry out meaningful community-engaged work and what REBs must consider under the TCPS 2. Drawing on experiences from both sides, this session will look at how current application questions, review practices, and interpretations of core principles can unintentionally create barriers for researchers working in partnership with communities. Topics include challenges related to process-based consent, collective decision making, co-ownership of data, evolving methods, and differing expectations about timelines and documentation. At the same time, we will highlight how the TCPS 2 already supports many community-engaged principles, especially around respect, mutual benefit, and justice, and where REBs have the flexibility to adapt. The session will focus on identifying a middle ground that maintains strong participant protections while recognizing the relational and iterative nature of community-engaged work. Participants will consider practical ways REBs and REOs can evolve, including rethinking application templates, creating guidance for shared governance, supporting ongoing consent processes, and building review models that value community priorities. The aim is to move toward a more responsive ethics environment that protects participants, reduces administrative friction, and strengthens the integrity of the ethics process while boosting the impact of community-engaged research.

Concurrent Breakout Sessions

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Research Ethics Boards (REBs) are often experienced as intimidating “black boxes” by researchers and daunting service roles by members themselves. Yet, at their best, REBs function not as regulatory gatekeepers alone, but as essential partners in protecting participants, strengthening research quality, and navigating rapidly evolving ethical terrain. The REB Bestie You Didn’t Know You Needed… introduces A Canadian Research Ethics Board Member’s Companion Guide, a practical, accessible, and deeply contextualized resource for new and experienced REB members alike. Drawing on national policy, real-world case studies, and decades of leadership in research ethics administration, this work demystifies the full lifecycle of REB review, from protocol assessment and consent processes to conflicts of interest, privacy, vulnerable populations, and emerging issues such as artificial intelligence, data repositories, and international research. The session will showcase how the Companion Guide reframes REB work as participant-centred, equity-informed, and collaboration-driven, while offering concrete tools for ethical decision-making in complex, high-stakes contexts. Attendees will gain an insider’s view of how REBs operate in practice, where common breakdowns occur, and how thoughtful, well-prepared REB members truly become the “besties” that ethical research—and researchers—didn’t know they needed. The session will focus on identifying a middle ground that maintains strong participant protections while recognizing the relational and iterative nature of community-engaged work. Participants will consider practical ways REBs and REOs can evolve, including rethinking application templates, creating guidance for shared governance, supporting ongoing consent processes, and building review models that value community priorities. The aim is to move toward a more responsive ethics environment that protects participants, reduces administrative friction, and strengthens the integrity of the ethics process while boosting the impact of community-engaged research.

Concurrent Breakout Sessions

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In 2025, the University of Winnipeg’s Human Research Ethics Board (UHREB) launched a three-part workshop series, Community-Based Ethics: Bringing TCPS Policy to Life Through Education, Engagement and Collaboration, funded by the Secretariat on Responsible Conduct of Research’s SETS program. The workshops were designed to strengthen understanding and application of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2, 2022), with particular attention to Chapter 9 (Research Involving the First Nations, Inuit, and Métis Peoples of Canada) and Article 2.11 (Research Involving Other Distinct Communities). Through collaboration with the National Centre for Truth and Reconciliation (NCTR), local community organizations, and UHREB members, participants explored reconciliation as an ethical framework, discussed jurisdiction-specific community concerns, and identified practical strategies to integrate these principles into REB processes. Using an empowerment evaluation approach, the project emphasized learning through reflection and dialogue among researchers, REB members, and community partners. The workshops resulted in a shared understanding of how reconciliation principles inform ethical review and community engagement, the development of new UHREB guidance to support research involving communities, and strengthened relationships between UHREB, local partners, and national ethics leaders. This presentation will share the workshops’ process, findings, and “What We Learned and What We Did” report outcomes, offering an applied model for building ethical capacity and community collaboration within institutional REBs.

Concurrent Breakout Sessions

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This panel-style discussion will focus on engagement between research ethics and research data management (RDM) at both the local and national levels. Each panelist is a research data professional and has worked with a local institutional REB, either as a member, officer, or advisor. Each panelist is also a member of the Sensitive Data Expert Group (SDEG) within the Research Data Management Network of Experts supported by the Digital Research Alliance of Canada. The SDEG has engaged with the Secretariat on the Responsible Conduct of Research on the most recent revisions to the TCPS2 related to data repositories, and with the Tri-Council more broadly on their RDM policy, and in particular, the data deposit requirement. In addition to acting as an expert advisory body on sensitive research data related-considerations for national policy impacting REB review, SDEG members have worked closely with REBs to provide data management expertise in support of ethics review. By discussing our unique experiences as practitioners working at the local level and how they inform our national work, this panel will highlight the importance of engagement, and the power of strong relationships, between RDM professionals and REB professionals.

Concurrent Breakout Sessions

DESCRIPTION OF SESSION

Indigenous Peoples—First Nations, Métis, and Inuit—have always held sophisticated governance systems that regulate knowledge, relationships, and collective responsibility. Yet, research ethics infrastructures in Canada continue to rely primarily on Western frameworks that do not fully account for Indigenous sovereignty, relational accountability, or community-defined presence. As Indigenous leaders in clinical trial research, we work every day in the ethical space between community authority, regulatory oversight, and the lived realities of participants who carry the histories of research-related harm. This session responds directly to the CAREB 2025 theme, “The Power of Presence in Research Ethics: Live, Virtual, United,” by highlighting how Indigenous communities conceptualize presence not as a modality (in-person or virtual) but as a relational practice grounded in trust, visiting, kinship, and collective consent. We share experiences from First Nations-, Métis-, and Inuit-led clinical trials that demonstrate how engagement and trust are built through sustained presence, how virtual and hybrid models can uphold relational ethics, and how community governance structures can coexist with—and often strengthen—REB processes. Through case examples—including the Inuit Country Foods Mental Health Trial, the Two-Spirit Métis Care Trial, and First Nations-led training pathways—we illustrate how sovereignty-affirming trials navigate: community-led consent processes and ethical decision-making; OCAP® and distinctions-based data governance; multilevel ethics approvals (community, territorial/provincial, institutional); the Rememberings Tool as a relational accountability guide rather than a compliance checklist; the role of REBs in supporting institutional readiness for Indigenous governance. Participants will gain practical strategies for integrating relational presence, trust-building, and Indigenous ethical frameworks within institutional ethics systems. Our goal is to demonstrate that meaningful engagement is not an add-on—it is the foundation of ethical research across all platforms and contexts.

Concurrent Breakout Sessions

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Emerging and Disruptive Technologies (EDTs) , including AI and data research; xenotransplantation (and all necessary steps leading to it); gene-based therapies and novel pharmacological products, delivery systems and devices, are the result of purposeful research and development and have the potential for intended or unintended negligent or malicious use. In part due to their rapidly evolving and innovative nature, the Canadian regulatory framework provides little guidance to researchers, research institutions, industry, and funders on risk mitigation for potential harms arising from EDTs. In addition, only a fraction of the knowledge creation continuum of EDTs is governed, leaving the majority to be overseen generically and by analogy. I propose to focus my talk on how REBs can evaluate the harms and benefits of research proposals involving EDTs and arrive at a societally acceptable risk assessment. The intended outcome of the discussion would be to lead to wider engagement by CAREB and the research community in creating a risk assessment framework for evaluating EDTs in research proposals.

Concurrent Breakout Sessions

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The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), specifically article 4.1 on Appropriate Inclusion, specifies that individuals should not be excluded from the opportunity to participate in research on the basis of gender, unless there is a valid reason for such exclusion. In health, sex—referring to biological attributes—and gender—reflecting social and cultural dimensions—are critical for diagnosis, treatment, prevention, and shaping social determinants. Yet these factors are often omitted, conflated, or applied in binary and cisnormative ways in health and other research. Cis women, as well as trans, non-binary, and gender-diverse people, face additional health inequities relative to cisgender men, due in part to the limited evidence available to guide appropriate health promoting interventions, care, treatment. In response to calls from researchers, community members that experience gender-related health inequities, Research Ethics Board (REB) members, research administrators, and researchers from across Canada created the nationally relevant Beyond the Binary in Canada Guide to support researchers to conduct gender-inclusive research. Recognizing the critical role of REBs in identifying gaps at the earliest stage of research development and ensuring alignment with ethical standards, we are building on this foundation to co-create guidance and implementation tools to support REBs. Highlighting themes of engagement, reciprocity, and trust in the co-creation process, we will share the results of a national needs assessment to identify capacity building and implementation tools desired by REBs to advance gender-inclusive research and the resources developed to meet identified needs.

Secretariat Discussion:

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Ask Us Anything: Engaging with the TCPS – Your Questions, Our Priorities