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This is a series of inter-related webinars. The introductory webinar is designed to cover various aspects of the administrative considerations in the ethical review and oversight of Biomedical research studies. Subsequent webinars will explore specific research ethics considerations in the ethical review and oversight of biomedical research studies, including common and unique ethical issues presented by biomedical research studies. This webinar package includes each of the following topics in the “Reviewing a Research Study in the Biomedical Domain” webinar series:
Click here to access Reviewing a Research Study in the Biomedical Domain – Overall Protocol Content Review & Considerations
Webinar Objectives:
- To provide criteria for the review of the Administrative Components of a biomedical research including: Sign-offs and Attestations, Conflict of Interest Review and Management, Documentation Required for Appropriate Review, Adequacy of Resources to conduct the research, study type classification and clinical trial registration; and to address the application of appropriate ethical principles and guidelines, and regulatory criteria for the review and approval of the administrative aspects of the research.
Webinar Objectives: To provide criteria for protocol content review of a bio-medical study including: scientific merit, clinical equipoise, risk assessment and mitigation, dissemination of research findings, management of material incidental findings and the return of results, and future access to investigational agents/devices/procedures. These criteria will be covered with the intent of addressing the application of [...]
Webinar Objectives:
- To provide criteria for the review of the Participant Protection Components of a bio-medical research study including: Participant Selection; Participant Reimbursement; Informed Consent Procedures; Vulnerable Populations, Data Privacy and Confidentiality; and Data and Safety Monitoring. These criteria will be covered with the intent of addressing the application of appropriate ethical principles and regulatory criteria for the review and approval of these aspects of a biomedical research study.
Webinar Objectives:
- To highlight special considerations in the review of a bio-medical study including: considerations for studies involving new unregulated investigational interventions, studies involving investigational agents accessed through Health Canada’s Special Access Program as compared to the standard investigational testing regulatory authorization route, and therapeutic misconception from various stakeholder perspectives. These criteria will be covered with the intent of addressing the application of appropriate ethical principles for the review and approval of biomedical research studies impacted by these considerations.
Webinar Objectives:
- To assess the ethical implications of research aimed at addressing sensitive topics that threaten the safety of the researcher and demonstrate how to appropriately determine which of the existing regulations, rules and guidelines apply to risk management plans for sensitive research topics (e.g. illegal drug use, prostitution, research involving participants living in active war zones)
This webinar package includes each of the following Special and Emerging Topics webinar topics and sessions
Webinar Objectives:
- To assess the ethical implications of research aimed at addressing sensitive topics that threaten the safety of the researcher and demonstrate how to appropriately determine which of the existing regulations, rules and guidelines apply to risk management plans for sensitive research topics (e.g. illegal drug use, prostitution, research involving participants living in active war zones)