Webinar Objectives: To provide a detailed overview of the processes and activities required to develop and maintain appropriate REB standard operating procedures (SOPs) STATUS: content under development Duration: 1 hour. Date: Friday, February 26, 2021 Time: 2:00pm EST
Webinar Objectives: By the end of this webinar participants should be able to: Define the three fundamental ethical principles which need to be assessed during the review process. Assess the application for ethical issues associated with the principle of: “Respect for persons”. Ensure free and informed consent is obtained. Identify situations which may inhibit the [...]
Duration: 1.5 hours Date & Time: Thursday, November 17, 2022 from 11:00 am to 12:30 pm EST
- Assess the risks and benefits associated with a SSH protocol to ensure a favourable balance exists.
- Differentiate between the types of risks commonly found in biomedical/clinical protocols and those typically found in SSH protocols.
- Describe the five overarching responsibilities of an REB when conducting an ethical review.
- Apply the three key factors which are relevant to determining whether an application requires review by the institutional REB.
Presenter: Dr. Michelle McGinnBio: Michelle K. McGinn is Associate Vice-President, Research and Professor of Education at Brock University in St. Catharines, Canada. She holds a PhD in Education from Simon Fraser University and a certificate in Research Administration from Mohawk College. Her primary interests include research collaboration, researcher development, scholarly writing, mentorship, and ethics in academic practice for (post)graduate students and established scholars. She is a co-investigator on the nationally funded “Academic Researchers in Challenging Times” project, where she is exploring the careers, practices, and identities of social science scholars and research administrators (see arictproject.com). Major contributions to the field of research ethics include prior roles as chair of Brock’s research ethics board, member of Canada’s Social Sciences and Humanities Research Ethics Special Working Committee during the development of TCPS2, and consultant to research ethics programs in Honduras and South Africa. Connect via Twitter @dr_mkmcginn *If you are a member, please ensure you log-in as this is free with annual membership
Webinar Objectives: Critically assess an REB in order to identify issues and opportunities for improvement relating to its governance, reporting relationships, structure, resourcing and auditing of its operations. STATUS: content under development Duration: 1 hour. Date & Time: TBD
- 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 [...]
- 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.
- 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.