COMMERCIAL IRBS ------------------------------------------------------------------------------------------------------------------------------------ Biomed IRB Commercial Institutional Review Board - HIMA Listing Copernicus Group IRB Hill Top Research, Inc. Independent Review Consulting (IRC) Institutional Revew Board Services New England IRB Quorum Review Schulman Associates IRB, Inc. Western Institutional Review Board (WIRB)

IRB GUIDANCE ------------------------------------------------------------------------------------------------------------------------------------ IRB Approval Periods & Continuing Review of Research Cooperative Research Emergency Use of an Investigational Drug or Biologic Expedited IRB Review--1998 Revised Categories Expedited Review FDA Institutional Review Board Inspections - FDA Info Sheet IRB Compliance- Common Findings & Guidance IRB Continuing Review IRB Discussion Forum IRB Guidebook - NIH IRB Knowledge of Local Research Context IRB Responsibilities - Assurrances for OPRR Treatment Use of Investigational Drugs Medical Devices Use of Investigational Products When Subjects Enter a Second Institution - FDA Info Sheet Emergency Use of Unapproved Medical Devices Frequently Asked Questions about IRB Review of Medical Devices List of Non Significant Risk Devices List of Significant Risk Devices Non-local IRB Review Significant Risk and Nonsignificant Risk Medical Device Studies

ASSURANCE INFORMATION FOR OPRR ------------------------------------------------------------------------------------------------------------------------------------ Assurance Information for OPRR Agreement for a Non-Institutional CPRP Investigator Assurance Documents, Purposes and Practices IRB Responsibilities Research Investigator Responsibilities