The IRB

• Survey Results (10/2017-12/2017)
• What’s New
  


• New AID - Data Safety Monitoring Board in Phase I/II Cell and Gene Transfer Clinical Trials


• Delay of the Revised Common Rule to July 19, 2018


• Summary of the changes to Medical and Social, Behavioral, and Educational Research


• Publication of the Revised NIH Grants Policy Statement (Rev. October 2017) for FY 2018 (NOT-OD-18-005) National Institutes of Health


• Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality
  • What is a Certificate of Confidentiality (CoC)?
  • If part of my cohort was recruited prior to issuance of the Certificate do I need to re-consent them?


• Social & Behavioral (Non-medical) Research: Exempt Category 7 for research involving benign behavioral interventions.
  • Campus Announcement
  
  
• Single IRB (sIRB)
• Relying on a sIRB and sIRB SOP
• NCI CIRB - the NCI Central IRB Initiative
  


• Short Form Consent Process (updated to reflect the witness does not have to speak to participants language)


• ClinicalTrials.gov
• Revised Intake Process for Industry Clinical Trials
• Changing policies impact NIH-funded studies involving human subjects In your proposal application packet, be sure to complete the “R&R Other Project Information” form page before you complete the “PHS Human Subjects and Clinical Trials Information” form page as the first will populate the second. Please view this 9 min You Tube video: PHS Human Subjects and Clinical Trial Information Form Walk-through.
  
  
• FDA's guidance on Waiver Alteration of Informed Consent
  
  

• About the IRB (the Administrative Panels on Human Subjects Research)
  
  
• Charge to the IRBs