2009 VA IRB Chair Meeting

October 7-8, 2009 — Bethesda, MD

Power Point Slides for Download

** Unless otherwise noted, all files are in Power Point format**

• From Informed Consent to Enlightened Decision-Making - Jerry Menikoff, MD, JD
• Drawing the Lines - Determining What Needs IRB Review - Michael A. Carome, MD
• Requirements for Reporting to ORO - Tom Puglisi, PhD
  • RCO Noncompliance Reporting (92 KB, Word)
  • Reporting SAEs and UPRs to ORO, OHRP, and FDA (88 KB, Word)
  • RCO Informed Consent Audits: January 1-May 1, 2009 (246 KB, PDF)
• Role of Privacy Officer on the IRB - Stephania H. Griffin, RHIA, CIPP/G
• VA Central IRB - From Concept to Reality - K. Lynn Cates, MD
• Investigational Device Exemption (IDE) Overview for IRBs - Marian Serge, RN
• FDA IRB & Informed Consent Regulations - Kevin Prohaska, DO, MPH
• Human Specimen & Data Repositories - Marianna Bledsoe