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Office of Research Oversight (10R) Requirements for Reporting to ORO Institutional Review Board Chairs Meeting October 7

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):

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Office of Research Oversight (10R) Requirements for Reporting to ORO Institutional Review Board Chairs Meeting October 7

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  1. Office of Research Oversight (10R) Requirements for Reporting to ORO Institutional Review Board Chairs Meeting October 7, 2009

  2. 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

  3. 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

  4. 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

  5. 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 R&D 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

  6. 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 Facility Director within 5 business days after determinations • Facility Director must report to ORO Regional Office within 5 business days after notification • Facility Director must provide follow-up to ORO as directed

  7. Local Serious Adverse Events (FDA Definition) • Must be reported to ACOS/R and IRB within 5 business days after discovery • Special review by qualified, voting IRB member required: • Action to prevent immediate hazard to subject(s)? • Serious and unanticipated and possibly related to the research? • If serious and unanticipated and possibly Related to the research => Special Rapid Reporting Procedure: • IRB must notify Facility Director within 5 business days • Facility Director must report to ORO Regional Office within 5 business days after notification • Facility Director must provide follow-up to ORO as directed

  8. Unanticipated Problems Involving Risks to Subjects or Others (OHRP Definition) • All must be reported to ACOS/R and IRB within 5 business days after discovery • Special review by qualified, voting IRB member required: • Action to prevent immediate hazard to subject(s)? • Serious and unanticipated and possibly related to the research? • If serious and unanticipated and possibly Related to the research => Special Rapid Reporting Procedure: • IRB must notify Facility Director within 5 business days • Facility Director must report to ORO Regional Office within 5 business days after notification • Facility Director must provide follow-up to ORO as directed

  9. ORO encourages local accountability for oversight of research compliance Facility self-reports of noncompliance are recognized by ORO and VHA leadership as positive indicators of a local culture of accountability New requirements for RCO informed consent and regulatory audits are expected to increase the number of facility self-reports

  10. Facility-Identified, Self-Remediated Noncompliance 200 150 100 50 201 177 A Positive, Growing Culture of Local Accountability for Research Oversight 90 68 66 49 CY03 CY04 CY05 CY06 CY07 CY08

  11. CY2008 – CY2009 Facility Self-Reported Noncompliance (New Cases: Human, Animal, Safety, IT, etc) 350 300 250 200 150 100 50 335 CY2009 123 201 CY2008 50 Q1 Q2 Q3 Q4 Cumulative Total

  12. Questions & Comments

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