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On Research - with CITI Program
Discussing issues that impact scientific research monthly, from clinical research to ethical considerations. Hosted by Alexa McClellan. New episode every month. Learn more at about.citiprogram.org
On Research - with CITI Program
Understanding Exception from Informed Consent - On Research Podcast
A growing area of research involves exception from informed consent. In an emergency setting, participants can be enrolled in a trial without their consent. Mike Linke joins On Research to discuss the regulations and ethical considerations around this important area of research.
Additional Resources:
- FDA Guidance Document for EFIC studies - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/exception-informed-consent-requirements-emergency-research
- NIH Resources about EFIC studies - https://www.ninds.nih.gov/current-research/trans-agency-activities/office-emergency-care-research/research-involving-exception-informed-consent
- Learn more about CITI Program at about.citiprogram.org
- Learn more about HRP Consulting at HRP Consulting Group (thehrpconsultinggroup.com).
Guest Bio: Mike Linke is a scientist, researcher, and IRB Chair. He has been in the research industry for 30 years and serves as the StrokeNet IRB Chair and the SMART IRB Program Director for Education. Mike has extensive experience working with Exception from Informed Consent (EFIC) studies.
