When research subjects’ capacity to consent is absent, diminished, or fluctuating, additional consent enhancements, safeguards, and support may be required by the IRB. AAHRPP Standard II-4 requires IRBs to provide additional protections for vulnerable subjects in research, including policies and procedures to protect subjects whose capacity to consent is potentially absent, diminished, or fluctuating. The regulations, however, are generally silent on the specifics of these additional protections. What strategies, best practices, and resources exist for HRPP professionals to address this issue on an institutional level and ensure proper safeguards? (Presented on January 18, 2018)
The University of Minnesota and Mayo Clinic recently developed and implemented robust sets of policies and procedures to enhance protections for these vulnerable subjects. During this advanced-level webinar, IRB professionals from these two institutions will discuss:
- The ethical and regulatory background regarding capacity to consent to research
- A framework for introducing new or revised policies and procedures for capacity to consent issues
- Different approaches and lessons learned regarding best practices, oversight, education and outreach, and community engagement
- How to effectively adapt strategies to your own institution’s needs and constraints
What will I learn?
After attending this webinar, you will be able to do the following regarding research with subjects who have limited capacity to consent:
- Understand the necessity for identifying additional safeguards
- Explain some of the various institutional approaches that exist
- Apply guidance and strategies to develop, implement, and monitor these policies and procedures at your own institution
- Identify ways to engage the community in the development of policies and procedures
- Identify relevant education and training activities for IRB members, staff, and the research community
Who should attend?
This advanced-level webinar will be beneficial for IRB chairs, members, and staff; institutional officials; researchers and research staff; and other compliance personnel.
Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Learn More »
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HRP Consulting Group provides expert advice to institutions seeking to develop or improve all aspects of their human research protection program. For more information, please visit www.thehrpconsultinggroup.com.
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