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U-MIC

2. Exception from informed consent requirements for emergency research
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U-MIC
University of Michigan IRB Collaborative

3. Exception from informed consent
21 CFR 50.24
exception to requirement to obtain consent prior to participation
certain emergency research protocols without consent
subjects’ condition prevents them from consenting prior to participation
Exception requires separate IND/IDE
even if IND/IDE for same agent already exists
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U-MIC

4. 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
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U-MIC

5. Exception from informed consent
IRB must determine that
research offers potential direct benefit
life-threatening condition that necessitates intervention
animal and other preclinical studies demonstrate potential direct benefit to humans
reasonable risks
subjects’ condition
risks/benefits of standard treatment
potential benefits of proposed intervention
exception is necessary in order to conduct research
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U-MIC

6. 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
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U-MIC

7. Exception from informed consent
IRB must review and approve
informed consent document/process
for use when subject or LAR can provide consent
procedures or information for LARs and family members
to give them the opportunity to object to participation in the research
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U-MIC

8. Exception from informed consent
Researcher must provide additional protections of subjects’ rights/welfare
consultation with community representatives where
research will take place
subjects will be drawn
public disclosure of planned research prior to initiating
public disclosure of information after research is complete
subject demographics
study results
independent data monitoring committee
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U-MIC

9. 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
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U-MIC

10. Exception from informed consent requirements for emergency research
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U-MIC

11. thank you. Brian Seabolt Robin Sedman Judy Birk IRBMED Developed by:
U-MIC