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To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC 1
EXCEPTION FROM INFORMED CONSENT REQUIREMENTS for emergency research Developed by: U-MIC University of Michigan IRB Collaborative
Exception from informed consent 21 CFR 50. 24 • exception to requirement to obtain consent prior to participation o certain emergency research protocols without consent v subjects’ condition prevents them from consenting prior to participation Exception requires separate IND/IDE • even if IND/IDE for same agent already exists Developed by: U-MIC 3
Exception from informed consent Criteria from exception from informed consent • life-threatening situation • available treatments unproved or unsatisfactory • need for scientific evidence of safety/effectiveness IRB must determine that consent is not feasible because • subjects’ condition prevents them from consenting • intervention necessary before LAR can provide consent • no reasonable way to identify potential subjects in advance Developed by: U-MIC 4
Exception from informed consent IRB must determine that • research offers potential direct benefit o life-threatening condition that necessitates intervention o animal and other preclinical studies demonstrate potential direct benefit to humans o reasonable risks v v v subjects’ condition risks/benefits of standard treatment potential benefits of proposed intervention • exception is necessary in order to conduct research Developed by: U-MIC 5
Exception from informed consent Proposed research plan must define • period in which intervention is expected to be effective (therapeutic window) • how researcher will attempt to contact and obtain consent from LAR • how researcher will summarize attempts to contact and obtain consent from LAR Developed by: U-MIC 6
Exception from informed consent IRB must review and approve • informed consent document/process o for use when subject or LAR can provide consent • procedures or information for LARs and family members o to give them the opportunity to object to participation in the research Developed by: U-MIC 7
Exception from informed consent Researcher must provide additional protections of subjects’ rights/welfare • consultation with community representatives where o research will take place o subjects will be drawn • public disclosure of planned research prior to initiating • public disclosure of information after research is complete o subject demographics o study results • independent data monitoring committee Developed by: U-MIC 8
Exception from informed consent IRB must determine that procedures exist for informing subject, LAR, and family members of • • subject’s participation details about research all information addressed in consent document right to withdraw from research without penalty If subject’s condition improves • researcher must inform subject of research as soon as feasible Developed by: U-MIC 9
Exception from informed consent requirements for emergency research Developed by: U-MIC 10
THANK YOU. Brian Seabolt Robin Sedman Judy Birk IRBMED Developed by: U-MIC 11
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