"Research and Sponsored Programs"
Development of Research Ethics
"Research with humans should be..."
Common Rule and FDA Regulations Protect Human Subjects
Multiple Project Assurances (Cont.)
What do Regulations
and
Assurance Apply to?
What do Regulations
and
Assurance Apply to? (Cont.)
What do Regulations
and
Assurance Apply to? (Cont.)
Continuing IRB Responsibilities
Informed Consent Process (Cont.)
Basic Informed Consent Requirements
Basic Informed Consent Elements
Additional Informed Consent Elements
Waiving or Modifying Informed Consent Requirements
Waiving Written
Informed
Consent
Emergency Waiver of Informed Consent Conditions:
Only the IRB can waive or alter the consent process.
Principal Investigator Responsibilities
Principal Investigator Responsibilities (Cont.)
Special Protections
for
Vulnerable Populations
After Approval:
Continuing Reviews