Schedule

Make Sure to Double Check the Schedule before your session. There are links to pdf agendas near the bottom of this page. You can also see any changes made in our News Section.
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  • Wednesday April 1st


  • Thursday April 2nd


  • Friday April 3th


  • 08:30 - 10:00
    Since 2014, the Office of Research Ethics Compliance at Queen’s University has undergone significant changes regarding policies, processing, and staff resources. The most recent policy change has been negotiated with the Queen’s University Faculty Association (QUFA) to implement mandatory CORE training for all ethics applicants. We have also developed a policy to minimize lapses in ethics clearance; launched a Quality Assurance Review Program, have developed and implemented eight new ethics application forms; created useful LOI/CF checklists and templates, and implemented the use of administrative/REB reviewer checklists. The Office of Research Ethics Compliance would like to reflect on all of this hard work and share ‘the Good, the Bad and the Ugly’ with other REB administrators. We initiated a Quality Improvement survey to ask the ‘hard’ questions to the research community with respect to our services. The objective of this workshop will provide participants with a summary of our updated policies, tools and checklists, as well as to share some results from our survey. We are of the mindset to streamline resources for all REBs and will be happy to share new policies, checklists and tools presented during the workshop.
    Tools etc for REBs

  • 08:30 - 10:00
    National initiatives, including CIHR’s Strategy for Patient-Oriented Research (SPOR) and the TCPS 2 (2018)’s expansion of Chapter 9 to include all distinct communities impacted by research, supports initiatives to close the gap between researchers and knowledge users in the health care sector. To facilitate ethical involvement of community members and patient partners into the research process, REB members and administrators can play an integral role in supporting ethical knowledge translation (KT) and dissemination activities. This interactive workshop will engage REB members and administrators in reviewing sample KT and dissemination plans submitted for REB review, including a framework to evaluate meaningful KT activities within the REB review process and ways to address KT plans in provisos. Considerations will include understanding the appropriate application of integrated versus end of grant KT plans, what KT activities mean for the informed consent process, and how community REBs can be included within the traditional REB review framework. Learning Objectives: 1. Overview of ethical considerations within the context of Patient Oriented Research (POR) and research involving communities – how they converge and diverge from traditional principles of Respect for Persons, Concern for Welfare, and Justice. 2. Understand elements of an ethical and well-devised KT plan. 3. Develop skills to evaluate integrated and end-of-grant KT plans. 4. A discussion on potential frameworks to guide REB review of KT plans. 5. Ethical considerations related to informed consent and KT activities.
    Resources for REB Review

  • 08:30 - 16:30
    Details to come
    REB Basics in English

  • 08:30 - 16:30
    Details to come
    REB Basics in French

  • 10:30 - 12:00
    To be provided
    Tools etc for REBs

  • 10:30 - 12:00
    BC Cancer Research Ethics Board (REB) and the Biospecimen and Biobanking Research Services (BBRS) have observed an increased number of ethical issues related to research involving biobanks (collections of human biospecimens and associated data). These include deficiencies in knowledge about biobank governance and structure resulting in an overall lack of standardization leading to concerns in two main categories: legacy and sustainability, and consent. As a first step in addressing these challenges, BC Cancer Research Center has implemented mandatory registration of all new biospecimen collections in the CTRNet Biobank registration program. This program is of value to REBs as it provides an additional degree of oversight re transparent biobank governance and provides assurance that a biobank is aware of national biobanking standards and how to access education, training, and support. Similar approaches are now being taken by other institutions in BC and elsewhere in Canada. In order to address legacy and sustainability concerns, the BC Cancer REB have initiated a process of undertaking consultations with research teams of all currently approved and newly submitted biobanks to ensure they are designed to conform with current and best practice ethical considerations. Finally, the BC Cancer REB and BBRS are developing standardized consent forms, as well as innovative consenting processes such as e-consent, and the use of interactive technology to inform and educate participants. The purpose of the workshop is to share information about the processes the BC Cancer REB and BBRS and are implementing to deal with biobanking challenges and to invite discussion and share experiences in order to ensure Canadian REBs are knowledgeable and skilled in the rapidly changing ethical environment of biobanking.
    Resources for REB Review

  • 13:30 - 14:15
    Research Improvements Through Harmonization in Manitoba (RITHIM) is an initiative that began in 2015 and is now in the advanced phases of implementation. RITHIM will create a streamlined and harmonized process for the ethics, privacy and operational impact review of health research in Manitoba. This new review process will be supported by an electronic platform. This session will explore the challenges and opportunities experienced in the process of harmonization in Manitoba.
    Tools etc for REBs

  • 13:30 - 14:15
    The TCPS2 (2018) clarifies the need for ethics review of course-based research activities despite the fact that those activities do not meet the definition of research as outlined in Art. 2.1. Ethics review for course-based research activities is required because “because of the possible risks to those recruited to participate in such activities, and the fact that, from their perspective, such activities may appear indistinguishable from those that meet this Policy’s definition of research” (TCPS2, Art. 2.1 application). In this presentation, we share our institution’s guidelines aimed at providing researchers with tools to understand the ethics review requirements for non-research pedagogical activities. Although ethics reviews for program evaluations or quality assurance studies share some of the same elements of course-based research activities, they fall outside the purview of the TCPS2. In this talk we will present 2 case studies that highlight the different challenges that can emerge from research that doubles as program evaluations/quality assurance studies and from pedagogical activities that resemble research. We also discuss the implications of conducting research ethics reviews and granting ethics clearance to activities that are not research.
    Resources for REB Review

  • 14:15 - 15:00
    In an effort to reduce bureaucratic redundancy and improve quality and consistency of ethical review, REBC has developed and launched harmonized models of review that took into consideration administrators working “on the ground” at REB offices in BC’s health authorities and research universities. The creation of the BCEHI’s harmonized models and subsequent creation of an online ethics platform for multi-jurisdictional review, incorporates feminist and de-centralized strategies of collective governance with an emphasis on relationship-building through collaboration, mutual trust and reciprocity and institutional autonomy. REB administrators voluntarily collaborated to design a model that created a space for dialogue outside the predominantly biomedical context of research ethics in Canada.
    Tools etc for REBs

  • 14:15 - 15:00
    The scope of the Tri-Council Policy Statement (TCPS2) includes course-based research activities where the primary purpose is pedagogical, as the “possible risks to those recruited to participate in such activities” and the activities themselves are not clearly distinct from those that the Policy defines as research (Application of Article 6.12). At the University of Calgary, there was considerable confusion across different Faculties over what constituted course-based research, whether ethical review was necessary, and how ethical oversight should proceed. Some of the questions posed by faculty members and administrators included: What if the activities are not considered “a disciplined inquiry or systematic investigation?” When does a course-based activity constitute regular REB review vs course-based delegated review, and what is the difference? What if the results are not disseminated outside of the classroom? What if the results are shared in a non-academic format? What happens to course-based data after the course is over? Does the format and type of knowledge dissemination matter in terms of review? In 2018, the University of Calgary’s Conjoint Faculties Research Ethics Board (CFREB) embarked on a yearlong journey to obtain clarity and compliance with TCPS2 regulations concerning course-based delegated review. In our proposed presentation, we review this journey, starting with the results of a campus-wide investigation of existing delegated sub-committees on campus. Next, we examine the guidance documents created for instructors, course-based delegated reviewers, and researchers. We then report on the insight gained after sharing and presenting these guidelines to a subset of instructors and delegated sub-committee members. Last, we share case-study examples and allow conference participants to think through these guidelines in a practical, interactive way.
    Resources for REB Review

  • 15:30 - 16:30
    To be provided
    Tools etc for REBs

  • 15:30 - 16:30
    Cluster randomization is an increasingly important trial design that can help advance the agenda of the pragmatic trial and provide essential information about the effectiveness and comparative effectiveness of interventions used routinely in medical practice. In addition to the parallel-arm design, cluster cross-over and stepped wedge designs are becoming increasingly popular. When such designs are embedded within routine clinical practice with waivers of informed consent, they have several methodological and logistical advantages over traditional patient randomized designs. However, these trials raise ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to responsibly fulfill their respective roles. This workshop will use the FLUID and TRACTION trials to illustrate these issues, stimulate discussion, and inform the development of proposed solutions. FLUID is an ongoing pragmatic comparative effectiveness cluster cross-over trial currently taking place ─ with waived consent ─ at hospitals in Ontario. FLUID compares the effects of two commonly used resuscitation fluids: Normal Saline versus Ringer’s Lactate, on death and hospital readmissions. TRACTION is a pragmatic trial currently being planned at hospitals in Ontario and Manitoba, to evaluate whether a hospital policy of universal use of tranexamic acid during major surgeries safely reduces red blood cell transfusions. The methodological and ethical implications of cluster versus individual randomization will be discussed. Both FLUID and TRACTION raise several challenging ethical issues: What is an appropriate justification for cluster randomization? When individual-level interventions are implemented institution-wide as a policy in a cluster randomized trial, may one proceed without patient consent? Do patients need to be notified about the trial; if so, how? How should risk be evaluated given prior efficacy and safety data in other settings? After a series of presentations by trialists, methodologists and ethicists, we will engage in interactive discussions with the audience using a web-based audience response system.
    Resources for REB Review

  • 08:45 - 8:50
    As the President of CAREB-ACCER kicks off the conference, we can reflect on the past, present and future. We celebrate the past 20 years of the organization, we are excited about all the presentations (pun intended), and we look to a bright future and another 20 years.
    Where
    Newbridge Ballroom

  • 09:15 - 10:30
    Where
    Newbridge Ballroom

  • 11:15 - 11:30
    The Canadian Institutes of Health Research (CIHR) will provide an update on work directly relevant to CAREB and its members including, the CIHR Strategic Plan for 2020-2030; and, the CIHR Ethics Guidance for Developing Research Partnerships with Patients and Researchers.
    Plenary Sessions
    Where
    Newbridge Ballroom

  • 11:30 - 11:45
    The update from the Office for Human Research Protections (OHRP) will focus on issues that have emerged in the transition to the revised Common Rule, the changes in the regulations for the protection of human subjects in research supported or conducted by many federal agencies in United States of America, including the Department of Health and Human Services. Questions have emerged about how the revisions affect studies initiated before the regulations were revised that are still ongoing, particularly in the context of multi-site or cooperative research studies and the single Institutional Review Board (IRB) requirement effective in January of 2020. The Update will address those questions. Key Words: Revised Common Rule, Transition, Single IRB Requirement
    Plenary Sessions
    Where
    Newbridge Ballroom

  • 11:45 - 12:00
    Plenary Sessions
    Where
    Newbridge Ballroom

  • 13:00 - 14:00
    The vast majority, if not all, new mothers report unwanted, intrusive thoughts of accidental harm befalling their infant. More impressively, half of all new mothers also report unwanted, intrusive thoughts of hurting their infant on purpose, even though they care deeply for their infant and have no desire to cause harm. Among psychologically vulnerable women, these unwanted, intrusive thoughts of infant-related harm can lead to the development of an anxiety-related condition, obsessive compulsive disorder (OCD). Frequently, perinatal care providers react very strongly when new mothers disclose that they are experience unwanted, intrusive thoughts of infant-related harm, especially thoughts of intentional harm. Their reactions can include monitoring the mother for evidence of child abuse and even removing the infant from their care. This occurs despite the fact that there is no evidence that OCD sufferers are at risk of behaving violently or of acting on the content of their unwanted, intrusive thoughts. The purpose of this research was to follow-up on our pilot study (N = 100) in which 100% of new mothers reported unwanted, intrusive thoughts of accidental harm related to their infant and slightly less than half reported unwanted, intrusive thoughts of harming their infant on purpose. In this pilot work we also found no relationship between unwanted, intrusive thoughts of hurting one's infant on purpose and actual aggression towards the infant. In the new study, we sought to answer these same questions in a much larger sample. Specifically, we sought to answer the following questions: 1) How common are new mothers' unwanted, intrusive thoughts of infant-related accidental and intentional harm? 2) How common is OCD among pregnant and postpartum women? 3) Are new mothers' who report unwanted, intrusive thoughts of hurting their baby on purpose more likely to also report harming their infant compared with mothers who do not report these thoughts? A total of 763 English-speaking women participated in this research. Women were recruited proportionally from hospitals, city centers and rural communities across British Columbia between January 23, 2014 and September 09, 2016. They were administered online questionnaires and a diagnostic interview (by phone) at approximately 33-weeks gestation, and 7-weeks and 4-months postpartum. The study assessed intrusive and unwanted thoughts of harm related to the infant, obsessive-compulsive disorder (OCD) and maternal aggression towards the infant. Our preliminary findings are as follows: 1) One hundred percent of the new mothers in this study reported unwanted, intrusive thoughts of accidentally harm coming to their infant, and a full 50% reported unwanted, intrusive thoughts of hurting their infant on purpose. 2) We found no relationship between unwanted, intrusive thoughts of intentional, infant-related harm and child harming behaviours. 3) OCD among pregnant and postpartum women is more common than previously thought. In order to answer the study questions, some complex research methodology was required. This was particularly true for our assessment of child harming behaviours. The methodology we used was highly effective and may be of benefit to other scientists studying parental aggression towards children. These methods will be discussed in full. Keywords: Postpartum harm thoughts, Obsessive-compulsive disorder, Child harm
    Plenary Sessions
    Where
    Newbridge Ballroom

  • 14:00 - 15:00
    The 2016 Alberta wildfires, which destroyed entire neighbourhoods of urban Fort McMurray, and the 2013 Lac-Mégantic, Québec train derailment and explosion illustrate that Canadian communities are not immune to environmental public health (EPH) disasters. Disasters expose the population, responders and volunteers to a range of contaminants and stressors, which may harm physical and mental health. Public health authorities who responded to these and other incidents have repeatedly expressed the need for better integration of scientific assets and methodologies to better inform both emergency response and recovery. EPH disasters typically offer a brief window of time to collect ephemeral exposure data and biospecimens and to start scientific research that could improve both health outcomes and capabilities for future response, yet proactive approaches to enable a rapid response are generally lacking. The pan-Canadian Disaster Research Response Initiative (CanDR2) was created to enhance the integration of EPH expertise and research into disaster response and recovery. This session will highlight the work of the CanDR2 Network, with a particular focus on the development of tools to streamline REB review of disaster response research. Specifically, development of a generic protocol for disaster-related research will be discussed, based on the “RAPIDD” protocol created by the National Institute of Environmental Health Sciences from the US National Institutes of Health. To expedite the review process in the event of an EPH disaster and to minimize delays in starting disaster response research, REBs would be encouraged to pre-approve this protocol, and at the time of a disaster, researchers would simply amend the protocol as appropriate and seek REB approval for the amendment. This session will explore the ethical considerations of this approach (and of disaster response research more broadly) and discuss the practical implications of adopting and implementing this protocol across the country. Keywords: wildfires, disaster response, CANDR2
    Breakout Sessions

  • 14:00 - 15:00
    oncern for the protection of research participants is heightened when studies involve those in vulnerable circumstances. Ethics reviews carried out by Research Ethics Boards (REBs) can be limited because REBs are far removed from the research and cannot adequately assess participants’ unique strengths and vulnerabilities. When participants need protection, it is often provided by research assistants (RAs) because they are the people most closely involved. Little is known, however, how RAs play their important role. In our previous work on assessing vulnerability in research ethics (Peter & Friedland, 2017) we used feminist ethics to conceptualize the care elements inherent in protecting participants. Here we use Walker’s (2003) notion of moral competency to help us understand the roles of RAs. We asked, “How do RAs understand their moral responsibilities in relation to their interactions with participants in vulnerable circumstances?” In this presentation, we describe the two main themes, along with their subthemes, that resulted from our analysis of five focus groups held with experienced RAs. The findings of this study (Friedland & Peter, 2019) suggest that RAs have an important, but largely, unrecognized, role in protecting participants in vulnerable circumstances. While RAs who do this work appear to possess a variety of moral competencies, they would benefit from better preparation for their roles, and more support from the principal investigators who employ them. Keywords: Vulnerable, Research Associates, Moral Compass
    Breakout Sessions

  • 14:00 - 15:00
    Historically, the field of research ethics analyzes the ethical and legal questions raised by research involving human subjects. Its main focus is to ensure that study participants are protected and that clinical research is conducted in a way that serves the needs of participants and society as a whole. The role of Research Ethics Boards (REBs) is to ensure that projects are reviewed and evaluated based on risk and that the study protocol adheres to the principles that govern the ethical conduct of research involving humans. But, what do we do if there is no protocol? No hypothesis? The use of Artificial Intelligence and machine learning is a rapidly advancing field in healthcare. The use and analysis of large scale data in healthcare research is beginning to challenge REBs to look at how they judge the ethical consequences of scientific research using big data. What are the risks? What about consent? What are the biases and are they different? The traditional REB review framework may not be applicable and the questions are many. So what do we do? We need to challenge ourselves to think outside the box and develop a new framework to evaluate these types of studies while maintaining the foundational principles of research ethics. Keywords: Legal, society, new framework for ethics
    Breakout Sessions

  • 14:00 - 15:00
    The medical research and bioethics communities continue to debate the regulatory and ethical issues raised by comparative effectiveness research. Much of the debate was spurred by a controversial finding in a determination letter issued by the Office of Human Research Protections (OHRP) in 2013 regarding the Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants (SUPPORT) Trial. OHRP published draft guidance in 2014. Critical comments in the ensuing literature suggested that applying the draft guidance would inflate the perception of risk, lead to lengthy informed consent forms, include treatment risks as risks of research, and require disclosure of options to subjects that clinicians frequently do not provide to their patients when delivering clinical care, all of which could hinder the conduct of comparative effectiveness research. The debate over comparative effectiveness research studies has also led to questions about determining exactly what counts as the ‘standard of care’, and how the standard of care in current practice is related to the treatments prescribed in the arms of a clinical trial evaluating the standard of care. This in turn raises issues about how this relationship affects both the scientific merits of the study design and the potential impact of the study’s findings for influencing practice. These issues affect the ethical status of the trial. Using Case Study examples, this session will explore the regulatory and ethical considerations in the U.S. Revised Common Rule and the TCPS to consider Comparative Effectiveness Trials in which there is one or more standard(s) of care. Key Words: Research Risks, Comparative Effectiveness Research, Standard of Care
    Breakout Sessions

  • 14:00 - 15:00
    The Group for Ethics and Engagement in Indigenous Community Research Partnerships (EIP) Background: There is a need for practical guidance in health research conducted with Indigenous people, in ways that promote equitable partnerships. A document called Canadian Institutes for Health Research Guidelines for Health Research Involving Aboriginal People (2007-2010) ("CIHR Guidelines") promotes a principled approach to research in partnership with Indigenous communities, and is complementary to current ethics policy. The CIHR Guidelines are the source of inspiration for the development of a training resource. Methods: A team of Indigenous and non-Indigenous researchers conducted a synthesis of the literature and review of case studies. Some of our team were involved and/or provided leadership in the development of the CIHR Guidelines and have continued to further ethical thought and practice to bring forward Indigenous perspectives in health research. Results: Our team consists of a growing number of academic and community member contributors, and is known as the Group for Ethics and Engagement in Indigenous Community Research Partnerships (EIP). The team has developed an open access, online training resource designed to assist researchers who are new to research in partnerships with Indigenous communities, or who are researchers-in-training. The training resource is in the form of four modules, developed to provide clear guidance on how to conduct research that reflects, advances, and meets expectations for ethical, collaborative, and culturally supportive engagement with Inuit, Métis and First Nations individuals and communities. The intent of the training resource is for it to be shared, to build a network to train the trainers, and in other ways that effect change. Conclusion: We introduce a shareable training resource as a complement to the current ethics policy that furthers action on equitable research partnerships Keywords: Indigenous, partnerships, training
    Breakout Sessions

  • 14:00 - 15:00
    In 2004, the Ontario Cancer Research Ethics Board (OCREB) implemented a streamlined review process for multi-centre cancer trials in Ontario resulting in minimized redundancy, increased consistency, and decreased cost in comparison to having a study reviewed by an REB at every participating study site. In 2015, Research Manitoba launched an initiative called RITHIM (Research Improvement Through Harmonization in Manitoba) to harmonize the system for ethics, privacy, and impact review of health research. In June 2017, CancerCare Manitoba contacted OCREB to explore the possibility of expanding the OCREB model beyond Ontario, and with the perseverance of a patient advocate, the idea gained momentum. OCREB, Research Manitoba, CancerCare Manitoba and the University of Manitoba REB are now working on a pilot REB streamlining project. The results of the pilot will provide the foundation for a larger scale project aimed at determining the feasibility of a pan-Canadian approach to REB review. With a constant focus on trust-building and recognition of provincial nuances, the pilot project provides a multi-stage approach that moves through established models of harmonized ethics review. The process begins with a facilitated review stage with debriefing meetings to understand convergence and divergence between the two ethics boards. The project will move through the different review models by consensus, identifying and managing any barriers and challenges that arise, ultimately to achieve a single REB review model for Ontario and Manitoba for multi-centre cancer research. Current status, accomplishments, next steps, and the potential benefits to research participants, REB members and investigators, will all be presented. Keywords: multi-jurisdictional, harmonized review, benefits
    Breakout Sessions

  • 15:00 - 15:45
    Poster presentations ARECCI 2.0 – a Vision for a Canadian Approach ARECCI - A PRoject Ethics Community Consensus Initiative – was designed to provide screening guidance, risk identification and mitigation support for knowledge-generating projects that are not being reviewed by an REB. The ARECCI Guidelines and Screening tools continue to be hosted by Alberta Innovates and have been used by project teams and academic institutions across Canada and around the world for almost 20 years. The number and complexity of projects has expanded beyond QI and Evaluation. The authors propose that it is now time to collaboratively re-tool the ARECCI processes and tools, building on our 2 decades of experience. As part of this collaboration, the authors propose a process to address this on a national level, with close collaboration with those institutions and organizations wishing to update their individual processes. This is an opportunity for an innovative, collaborative approach to provide an easy to navigate pathway for more robust, standardized guidance for a wide range of knowledge-generating projects. Authors: Debbie Mallett, Jacqueline Senych, Jennifer Palacios Gender and Fieldwork in International Security: Risks to Researchers and Best Practices by Canadian Research Ethics Boards It has been documented that women are underrepresented in the fields of international security, conflict studies, and political violence. Many barriers to the field of international security have been identified in the literature, yet little attention has been paid to the unique challenges facing women who conduct fieldwork in volatile and insecure regions. In particular, women are often at higher risk than their male counterparts in these conflict zones, and must take extra precautions when endeavouring to conduct such fieldwork. Ethics and safety remain a crucial and integral component of conducting international security fieldwork, yet research on the best practices for accounting for these gender specific risks from the perspective of ethics applications has largely been ignored. This research therefore investigates the extent to which women account for these unique challenges in their research ethics submissions, and the manner in which Research Ethics Boards manage these risks. To this end, this poster presents an analysis of policy and approaches to managing gender-related risks across Research Ethics Boards of research intensive universities across Canada’s U15 Group of Canadian Research Universities, as well as data gained from interviews with individuals that conduct fieldwork in fragile contexts. The poster will also identify best practices and lessons learned towards creating a systematic and robust way of managing the unique safety and ethics challenges facing women conducting fieldwork in international security. Author: Tanya Bandula-Irwin
    Meals & Refreshments
    Where
    Newbridge Foyer

  • 15:45 - 16:00
    Data management has reached a new level of maturity and sustainability in Canada. Factors driving this evolution include RDM policies from federal funding agencies, national funding for data management as part of a new Digital Research Infrastructure organization, and Portage advances in RDM platforms, services, tools, and training. Portage has been at the forefront of RDM evolution in Canada. Portage partnered with federal funders by promoting and informing RDM policy development through four years of consultation, and by providing practical solutions to institutions and researchers seeking to comply with policy requirements. Portage partnered with government to inform decisions surrounding a national strategy for digital research infrastructure, which, happily, includes Data Management as one of three key components (alongside Advanced Research Computing [ARC] and Research Software [RS]). And, through a variety of fruitful and collaborative partnerships, Portage has expanded institutional and researcher RDM capacity by providing support for data management planning, data deposit, training, and adoption of best practices in data stewardship. Specific to the CAREB audience, this presentation will report on progress made on two ‘sensitive data’ initiatives – (i) development of deposit-friendly language for ethics applications and data-access agreements, and (ii) a data management planning template for research involving indigenous data. Find out more about this in the breakout session tomorrow
    Plenary Sessions
    Where
    Newbridge Ballroom

  • 16:00 - 17:00
    We often hear about algorithms run amok, for instance, facial recognition software that cannot distinguish minority faces, or credit cards that award lower credit limits to women than to their husbands who have lower credit ratings. This session will demystify what artificial intelligence ("AI") is, will show how it works, and will provide an overview of some of the ethical and other challenges raised by algorithms, including bias, threats to privacy and security, transparency and explainability, accountability and liability issues, and the technological unemployment anticipated as a result of the fourth industrial revolution. Keywords: Artificial intelligence, Fourth industrial revolution
    Plenary Sessions
    Where
    Newbridge Ballroom

  • 08:45 - 09:00
    A warm welcome to the conference on April 3. We hope you are enjoying the sessions and have many ah-ha moments.
    Plenary Sessions
    Where
    Newbridge Ballroom

  • 09:00 - 10:00
    Designer babies, once found only in science fiction, have become a reality. In November 2018, twin girls Lulu and Nana were born from genome edited embryos. We are entering a new era of human evolution with the advent of a technology called CRISPR, which allows scientists to modify our genes. CRISPR shows great promise for therapeutic use, but also raises thorny ethical, legal, political, and societal concerns because it can be used to make permanent changes to future generations. Who decides whether we genetically modify human beings and, if so, how? In this presentation I will explain why we must all have a role in determining our future as a species. The scientists who develop and use genome-editing tools should not be the only ones making decisions about future uses of the technology. Such decisions must be the fruit of a broad societal consensus. It is in our collective interest to assess and steer the development and implementation of genome editing technologies. Members of the public with different interests and diverse perspectives must be among the decision makers; only in this way can we ensure that societal concerns are taken into account and that responsible decisions are made. We must be engaged and informed, think critically, and raise our voices as we create our future together. The future of humanity is in our hands. Keywords: Gene editing, CRISPR, Future
    Keynote
    Where
    Newbridge Ballroom

  • 10:45 - 11:45
    In a world of big data, cloud services, and social media, it can be difficult to know how to keep data safe and secure. In a research environment with a wide variation in terms of technical literacy, the job of managing data gets even harder. In this presentation we will provide you with four simple tools to help REBs evaluate the risk level of data and determine if researchers have taken the appropriate steps to ensure their data is appropriately managed throughout its lifecycle, from collection to destruction. We will focus on the ways in which responsible digital data management can support diversity and inclusion and help us move toward a more equitable distribution of knowledge and power. From indigenous data sovereignty movements to the inclusion of rural and remote people though digital data transfer, responsible digital data management is a key part of promoting equity and our tools make it easy. Keywrods: Big Data, Data management, Tools
    Breakout Sessions

  • 10:45 - 11:45
    Background: Pragmatic RCTs are intended to provided results that are directly relevant to clinical or health policy decisions, with designs concordant with this aim. While their intent to more closely align research with real-world applications may address concerns regarding the disconnect between research and practice they may also raise new ethical concerns. Methods: We conducted interviews with key stakeholders (methodologists, clinical investigators, ethicists, regulators, lay members of study teams). Interviewees were identified through published articles, funding decisions, centers known to be engaged in the design or conduct of pragmatic trials, and our investigator network. Results: We conducted 45 interviews between April-September 2018, with interviewees largely from the USA (16), Canada (10), UK (10) and mainly patient partners within study teams (16), clinical investigators (10), methodologists (7) and ethicists (7). Issues that were deemed to be more relevant or enhanced in relation to the oversight of pragmatic trials were: Risk identification and what counts as minimal risk?; The distinction (and relevance) between research, quality improvement, and practice; The potential for expanded populations affected by the trial and protections owed; The broader range of stakeholders in relation to the trial and determining their roles and responsibilities; Determining and reporting interventions or comparators as usual care, and; Determining when alterations to traditional informed consent approaches are appropriate. Discussion: To date the literature is dominated by discussion of consent and the research-practice distinction. Risk evaluation in this space was felt to be an area in need of development, particularly in relation to trials of routinely used interventions and whether these constitute research. The question of whether equal obligations are owed to all individuals affected by the trial has largely not been addressed. Each of these issues have substantive implications for the oversight of pragmatic trials. Keywords: consent, clinical trials
    Breakout Sessions

  • 10:45 - 11:45
    Globalization, combined with significant changes in society, finances, communication, and mass access to weapons and technology, have redefined security. The Canadian Armed Forces have changed to adapt to this evolving security climate. The key asset to any organization, including the Canadian Armed Forces, is high-quality personnel. Attracting and retaining personnel engaged in a dangerous, physically demanding, emotionally draining, and complex profession is challenging. A significant factor in the retention and maintenance of personnel is effective healthcare. The federal government, not provincial governments, is responsible for the health care, and documentation of that healthcare, of members of the Canadian Armed Forces. However, what happens to military medical records when the member leaves the military and enters society as a civilian? Who is responsible for the transfer of military medical records, and how can this vital information make it into the provincial health care system to ensure data-driven decisions when the patient, a veteran, is in greatest need? We examine veterans' access to their health records from multiple perspectives, including the need for education concerning the understanding of Veteran Literacy, the movement and transference of medical files, and the ethics of researching Veterans under the umbrella of Chapter 9. Are former members of the Canadian Armed Forces vulnerable, or are we biased because of their job description? Keywords: Veterans, Vulnerable, Healthcare
    Breakout Sessions

  • 10:45 - 11:45
    Significant strides have been made within systems of research ethics oversight through the development of indigenous-run research ethics boards (REBs). By transferring power and authority over the process of research ethics review, the likelihood that past research harms will be repeated is decreased and the chances of ensuring direct benefits to communities through research are increased. While the development of such boards should be celebrated, increasing demands can be heard from other marginalized communities who also wish to have a say in processes of research ethics oversight. In Canada, community members recently released A Manifesto for Ethical Research in the Downtown Eastside, Quebec Native Women Inc. put forward Guidelines for Research with Aboriginal Women, while community-research exchanges have been established in order to facilitate research that directly benefits communities (e.g. CURE Montreal). Across the border, community-based REBs have sprung up in the Bronx and San Francisco, seeking to protect the rights of those in communities that often experience research as exploitative. Like indigenous communities, these settings also attract a significant number of short-term researchers, have experienced a history of harms within research, and often see projects that benefit researchers more than communities. The demands of these communities raise several difficult questions: 1) Which communities deserve more agency in research ethics oversight and why? 2) How might we define and delineate such communities when there is no clear structure of leadership? 3) What forms of involvement might appropriately support these demands? A preliminary proposal that seeks to address these questions is offered, including justifications for community involvement in research ethics oversight and suggestions for how we might identify community boundaries and engage community members in processes of research ethics review. Concerns related to representation and increased burdens on marginalized communities are also considered. Keywords: Community involvement, burdens on marginalized, appropriate involvement
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  • 10:45 - 11:45
    Recent efforts to expand Tri-Council funding eligibility to non-academic organizations have provided Indigenous groups the opportunity to hold and administer research funds independently – an important step towards building Indigenous capacity for leading research that affects their communities. In order to hold Tri-Council funds, organizations must establish an in-house research ethics board (REB) or identify an existing REB (an REB of record) to review all research carried out under the auspices of the organization. Given that Indigenous organizations are seeking Tri-Council eligibility to increase the direct oversight of research by Indigenous people, there may be reluctance to designate an existing REB from another organization as the REB of record. Furthermore, Indigenous organizations are responsible for considering a broader spectrum of ethics review than REBs that only apply the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), as they are representing community concerns at the REB review level. The Northwest Territories (NWT) provides a unique and complex environment for imagining how research ethics review can be accomplished by Indigenous organizations with multiple (and sometimes competing) spheres of representation at multiple levels. The high volume of research conducted in the territory, paired with the expansion of Tri-Council eligibility to Indigenous organizations, provides an opportunity to start interrogating the tensions between academic and Indigenous conceptions of ethical research, authority, representation, and self-determination in research. This presentation describes the progress of a study that explores review processes, priorities, and values in the NWT by working with Indigenous governing organizations to a) map the process of research review throughout the territory, b) understand how the visions of research ethics review in NWT Indigenous organizations align with and diverge from the vision articulated in TCPS2, c) collaborate on a model of research ethics review that addresses the needs of NWT communities and TCPS2. Keywrods: Indigenous, capacity building, proposed model
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  • 14:30 - 15:30
    Data management has reached a new level of maturity and sustainability in Canada. Factors driving this evolution include RDM policies from federal funding agencies, national funding for data management as part of a new Digital Research Infrastructure organization, and Portage advances in RDM platforms, services, tools, and training. Portage has been at the forefront of RDM evolution in Canada. Portage partnered with federal funders by promoting and informing RDM policy development through four years of consultation, and by providing practical solutions to institutions and researchers seeking to comply with policy requirements. Portage partnered with government to inform decisions surrounding a national strategy for digital research infrastructure, which, happily, includes Data Management as one of three key components (alongside Advanced Research Computing [ARC] and Research Software [RS]). And, through a variety of fruitful and collaborative partnerships, Portage has expanded institutional and researcher RDM capacity by providing support for data management planning, data deposit, training, and adoption of best practices in data stewardship. Specific to the CAREB audience, this presentation will report on progress made on two ‘sensitive data’ initiatives – (i) development of deposit-friendly language for ethics applications and data-access agreements, and (ii) a data management planning template for research involving indigenous data. Keywords: Data management, national strategy, RDM policy
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  • 14:30 - 15:30
    In 2018, Clinical Trials BC completed the Canadian Clinical Research Participation Survey, a national project asking participants about their experiences taking part in clinical trials. It showed that many participants were left with unanswered questions both during and after the research study. This is problematic for three reasons: (1) it leaves participants feeling unsatisfied with their experiences in research, which results in attrition and less willingness to participate in research in the future; (2) Canadian Tri Council Policy Statement clearly states that informing participants of research results is as important as disseminating results to the research community; (3) the Canadian Institutes of Health Research acknowledges the impact of research on the health care system is directly related to effectively communicating research findings back to knowledge users, including members of the public that may be affected by those findings. Researchers have a responsibility to “close the loop” by communicating learnings to their participants; failure to do so may reduce the effectiveness, impact, and acceptability of their research in a real world setting. To help solve this problem Clinical Trials BC, through the BC Academic Health Science Network, formed a working group of participants, researchers, ethics administrators, and decision makers to learn from each other and make suggestions for future clinical trials. We will present the topics we explored within the group and the communication practices we recommend for improving the experiences of participants taking part in clinical trials. We acknowledge there are limitations to what information may be provided to research participants, and that the recommendations provided may not work in every situation. However, we believe that by applying these suggestions where possible, we can improve the experience of participants taking part in clinical trials, which may also lead to longer retention in a study and willingness for future participation. Keywords: clinical trials, participant experience
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  • 14:30 - 15:30
    Yukon College has a strong commitment to the indigenization of academic and research programs and the reflection of leadership in reconciliation through partnerships with Yukon First Nations. Yukon College spent considerable time developing its institutional relationship with Yukon First Nations in 2008, establishing the President’s Advisory Committee on First Nations Initiatives (PACFNI) and the office of First Nations Initiatives (FNI). PACFNI includes representatives from all 14 YFNs and three bordering Nations and gives YC high level advice to YC’s President on matters related to all aspects of the institution, including research. As Yukon College will officially transition to a university in May 2020, these relationships are a foundation for all academic operations, including research ethics. The Yukon College REB has been in operation since 2013. Since it began steps have been taken to ensure that the Yukon First Nations requirements are considered in reviews. Most recently and with support from the Tri-Council, a research study was undertaken by Yukon College to examine the potential for a research ethics review process that better reflects Yukon First nations worldviews and how this might be considered in internal research ethics reviews. We conduct an in-depth review of the implications and benefits from the perspective of our small college, and from the Indigenous perspective, through interviews with First Nations Elders and PACFNI. We also detail the spectrum of potential initiatives for including the Yukon First Nations perspective that could be implemented to adjust our existing research ethics process, keeping in mind the current implementation of the Tri-Council Policy Statement-2 and the Canadian Council for Animal Care. Keywords: Yukon College, First Nation perspectives
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  • 14:30 - 15:30
    Funding agencies and the Tri-councils are calling for greater participation in research of community members and patient partners beyond simply participants or “human subjects”. The call goes beyond simply having an “advisory committee” that includes people that could potentially fit the inclusion criteria of a research project to including community partners during all stages of the research life-cycle as researchers with unique and valued perspectives and expertise. Traditionally, researchers and REBs have turned to the TCPS2 tutorial to help educate research teams about research ethics. Some academic institutions even require it of all researchers interacting with human participants. Many BC institutions are an example of this. However, in community-based research, it can be difficult to provide relevant and meaningful research ethics training for community-based researchers, i.e. patient partners, peer researchers, community partners etc. Using the Overdose Prevention Peer Research Assistant (OPPRA) program in Vancouver’s Downtown Eastside (DTES) as a case, we will present a different way to bring research ethics training to community researchers. The OPPRA program brings social justice to the focal point of research in the DTES and provides research and research ethics training to build capacity within the community. This takes research ethics training to something beyond what the TCPS2 tutorial offers to something that is directly relevant to the community. Details of a series of collaborative workshops about research ethics offered in the DTES will be presented along with learnt best practices. We will also discuss education examples for patient partners in hospital settings and in rural communities. Keywords: Community Based Research, Research Ethics Education, Peer Researchers, Patient Partners
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  • 14:30 - 15:30
    Drawing on experiences operationalizing an ever-evolving multi-jurisdictional 18-year longitudinal epidemiological study, the dual Research Coordinator and Research Ethics Board (REB) perspectives offered in this session will provide unique insights into a wide array of practical research ethics-related challenges over the lifetime of a study. While longitudinal studies provide unique insights and are essential for reliably capturing patterns subject to variability over time, there are incredible barriers to setting up and maintaining these studies. Simply from a research ethics perspective, these areas include: contending with progressive, multi-institutional and international review, including British Columbia’s new harmonization initiative; responding to two updates to TCPS 2 policy (2014, 2018); respectful retention and maintaining participant consent in an aging and diverse cohort; accessing medical records post-mortem; and, negotiating participant risks related to open-ended research questions. In this session, we will explore how contending with common challenges in each of these areas has revealed grey areas that push the limits of current guidelines and necessitate a collaborative solutions-driven approach between the REB(s), researchers and relevant stakeholders. This session will offer practical solutions to hurdles we have overcome through this approach, as well as thought-provoking insights into outstanding challenges. Keywords: multi-jurisdictional, harmonization, challenges, opportunities
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  • 14:30 - 15:30
    Ethical decision-making is inherent to the REB deliberation process. While the TCPS2 contains myriad principles, standards, and examples that are indispensable in guiding this process, decision-making is nonetheless susceptible to nonrational processes that can undermined the quality, consistency, and perceived fairness of REB decisions. Nonrational processes can be framed within three interrelated components: relational (interpersonal dynamics), affective (emotional influences), and cognitive (biases and heuristics). Each of these represent important, yet often unheeded, components of the decisional process. In this presentation I provide detailed explanations and examples of these influencing processes along with ways in which REBs can work to mitigate their effects.
    Breakout Sessions

  • 15:45 - 16:45
    By the end of this presentation, you should be able to: 1. Describe the key regulatory requirements of FDA for drug research with humans 2. Know which additional considerations must be taken into account by REBs when reviewing research subject to FDA regulations 3. Learn about some common findings that I have identified during audits of Canadian investigator sites that are related to FDA regulations Keywords: FDA regulations, audits, considerations of regulatory requirements
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  • 15:45 - 16:45
    The Ontario Brain Institute is a provincially‐funded, not‐for‐profit research centre created to maximize the impact of neuroscience and establish Ontario as a world leader in brain research. A critical component of this mandate is to share neuroscience data, nationally and internationally to maximize data utility, reusability, and accessibility. Participant privacy is of highest import when sharing data and must be at the forefront of all decisions. The OBI data release model is one that is firmly grounded in meaningful consent and a constant mindfulness that participants, whose data is uploaded to Brain-CODE, are trusting us to keep their data safe. One solution presented to protect participants is the use of anonymization techniques such as bucketing, redaction and date shifting. However, when data samples are incredibly small, the removal of direct and potential (quasi) identifiers is so expansive that the data utility is lost, along with many of the benefits of research data sharing. This is when we must consider other possible ways to protect participants’ rights and privacy. The model of anonymization is also limited when you expand the release of data to other modalities such as genomic data. This talk will present the major challenges of supporting research data sharing and data utility while ensuring that participant privacy protections remain in place. This is particularly critical when items that are considered identifiers are mission critical to answer the research question. Keywords: data sharing, privacy
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  • 15:45 - 16:45
    This session brings a First Nations lens to ethical review of research, considering how the principles of Ownership, Control, Access and Possession (OCAP®) are implemented, and how cultural safety and humility can be reflected in the research process. We will look back on the first year of the First Nations Health Authority (FNHA) engaging in the ethical review process in British Columbia, asking the audience to participate in critically considering several case study examples of projects engaging researchers, institutions, and the First Nations communities we serve. About FNHA: In 2019, FNHA joined Research Ethics BC (REBC), a collaboration amongst BC regional health authorities and major academic institutions to provide a harmonized ethics review process. Working to transform the health and well-being of First Nations in BC, FNHA participates in research projects that reflect the 7 Directives (given to the organization from First Nations when it was formed). FNHA recognizes the ongoing impact of colonization on the health and well-being of Indigenous people, and supports the rise of self-determination through community-driven and Nation-based governance over the research process. FNHA is the health and wellness partner to 203 First Nations in British Columbia (BC). FNHA is the first province-wide health authority of its kind in Canada, in 2013 assuming the health programs, services, and responsibilities formerly handled by Health Canada. Our vision is to transform the health and well-being of First Nations in BC by dramatically changing healthcare for the better. The overarching principle in our 7 Directives is to be community-driven and Nation-based as our foundation to health governance. Keywords: Indigenous, OCAP, harmonized, 7 directives, community-driven
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  • 15:45 - 16:45
    Learning Analytics, the use of ‘big data’ (including data gathered from learning systems such as D2L or Blackboard, instructor’s records, and institutional data repositories) to examine student learning, retention and outcomes, is becoming an increasingly popular methodology in the Scholarship of Teaching and Learning (SoTL). While SoTL research raises complicated ethical issues due to the power relations inherent in the dual roles of instructor / researcher and student / participant, research using administrative student data raises additional ethical issues due to the multiple modalities through which data is gathered and stored, and the multiple purposes for which the data is collected. This session will explore the ethical issues inherent in Learning Analytics SoTL research, focusing on consent and transparency, privacy and anonymity, data ownership and access, and data sharing and handling. The session will provide a review of existing international frameworks and codes of practice for the ethical use of student data in Learning Analytics research from Europe, Australia, and the UK, with a focus on the DELICATE checklist established by the European Learning Analytics Community in 2016 (laceproject.eu). Session participants will be invited to reflect upon whether and how these international specifications for ethical conduct of Learning Analytics research align with ethical guidance provided by the TCPS2 (2018). This session will provide an opportunity for CAREB members to work towards developing a set of guidelines for ethics review of Learning Analytics SoTL research in the Canadian context. Keywords: learning analytics, big data, SoTL
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  • 15:45 - 16:45
    TCSP2 (2018) Article 4.2 Women shall not be inappropriately excluded from research solely on the basis of gender or sex. Despite increased recognition by researchers, REBs, NGOs, and Government organizations of the need to increase the number of women involved in research as participants, the historical exclusion of women from research persists. This has resulted in data and practices that do not reflect women’s social situations or their medical needs. Both in my experience as a REBA, and reflected in recent literature, it is evident that women continue to be excluded from research. Researchers do not want to be responsible for interfering with pregnancy and continue to argue that women’s baseline stats interfere with results. Rather than working to include women, researchers continue to create exclusionary recruitment plans such as requiring women to take birth control for the length of a project. Motherhood and the idea of the clinical female body are still interfering with health because women are not being included in research as participants. I argue that this exclusion of women from research also happens at the institutional level, and that this has not been widely considered. In my administrative role pre-reviewing research protocols for the REB, I have reviewed multiple studies focusing on gay men or men who have sex with men (MSM). Conversely, I have not seen research focusing on lesbian or queer women. If institutions and REBs are truly applying the TCPS2 and respecting the principle of Justice they must also consider what percentage of research projects include the involvement of women. This study critically examines the extent to which women continue to be excluded as research participants through a critical analysis of relevant policy and literature with a focus on the types of research that are currently being conducted and funded. Keywords: women, exclusion, current research
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