Requirements for Reporting to ORO VA Research要求上报奥罗 VA研究.pptVIP

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Requirements for Reporting to ORO VA Research要求上报奥罗 VA研究.ppt

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Requirements for Reporting to ORO VA Research要求上报奥罗 VA研究

Office of Research Oversight * Office of Research Oversight (10R) Requirements for Reporting to ORO Institutional Review Board Chairs Meeting October 7, 2009 VA has the Federal Government’s most comprehensive program of research compliance oversight Public Law 108-170 (38 USC §7307): Created VHA Office of Research Oversight (ORO) Must report directly to Under Secretary for Health Chief Officer has statutory authority to halt research Monitors / Reviews / Investigates Compliance Protection of Human Subjects Laboratory Animal Welfare Research Safety Research Lab Security Special Oversight of Biosafety Level 3 (BSL-3 ) Labs Research Information Protection Research Misconduct Federalwide Debarment for Research Impropriety Educates Facility Research Compliance Officers Recent Compliance Initiatives Mandatory Facility Research Compliance Officer (RCO) Rapid Reporting of Serious or Continuing Noncompliance Rapid SAE Reporting (5 business days) Mandatory 100% Annual Informed Consent Audits Mandatory Regulatory Audits Every 3 Years Serious or Continuing Noncompliance Apparent serious or continuing noncompliance identified by an RCO audit = Special Rapid Reporting Procedure: RCO must report to Facility Director, ACOS/R, IRB, and RD Committee within 5 business days after discovery Facility Director must report to ORO Regional Office within 5 business days after notification IRB makes official determination whether or not noncompliance is serious or continuing noncompliance IRB makes official determination of required remedial actions Facility Director must provide follow-up to ORO as directed Serious or Continuing Noncompliance Other apparent serious or continuing noncompliance = local Facility Reporting Procedure: Must be reported to ACOS/R and IRB within 5 business days after discovery IRB makes official determination whether or not noncompliance is serious or continuing noncompliance IRB makes official determination of required remedial actions IRB must notify