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


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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, 2009

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Office of research oversight 10r requirements for reporting to oro institutional review board chairs meeting october 7 2009

Office of Research Oversight (10R)

Requirements for Reporting to ORO

Institutional Review Board Chairs Meeting

October 7, 2009


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


Office of research oversight 10r requirements for reporting to oro institutional review board chairs meeting october 7 2009

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


Office of research oversight 10r requirements for reporting to oro institutional review board chairs meeting october 7 2009

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


Office of research oversight 10r requirements for reporting to oro institutional review board chairs meeting october 7 2009

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


Office of research oversight 10r requirements for reporting to oro institutional review board chairs meeting october 7 2009

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


Office of research oversight 10r requirements for reporting to oro institutional review board chairs meeting october 7 2009

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


Office of research oversight 10r requirements for reporting to oro institutional review board chairs meeting october 7 2009

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


Office of research oversight 10r requirements for reporting to oro institutional review board chairs meeting october 7 2009

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


Office of research oversight 10r requirements for reporting to oro institutional review board chairs meeting october 7 2009

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


Office of research oversight 10r requirements for reporting to oro institutional review board chairs meeting october 7 2009

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


Office of research oversight 10r requirements for reporting to oro institutional review board chairs meeting october 7 2009

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