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Assessing the Quality of VA Human Research Protection Programs

This study examines the feasibility of using 16 Quality Indicators (QIs) to assess the quality of VA Human Research Protection Programs (HRPPs) and presents preliminary data collected from June 2009 to May 2010. The QIs focus on outcomes related to the protection of research subjects and identifying potential harm or violation of rights.

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Assessing the Quality of VA Human Research Protection Programs

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  1. Assessing the Quality of VA Human Research Protection Programs Robert Brooks, MD PhD MBA Min-Fu Tsan, MD, PhD Office of Research Oversight

  2. Quality Indicators for VA HRPPs (1) • In recent years, ORO staff have developed a set of 16 Quality Indicators, with an emphasis on assessing outcomes rather than process or compliance. • Quality Indicators were targeted at: • Whether there is an adequate system in place to protect research subjects • Results that may indicate that research subjects have been harmed or their rights have been violated • Results or factors that are likely to or may lead to harm to human subjects

  3. Quality Indicators for VA HRPPs (2) • These 16 QIs covered: • HRPP accreditation • Initial and continuing review and approval by IRB and R&DC • Informed consent requirements • HIPAA authorization requirements • Investigator compliance, qualification, and training • Serious adverse events • Research involving vulnerable subjects • International research • Training of IRB and R&DC members • Subject education (Tsan MF, Smith K, and Gao B. IRB: Ethics and Human Research. July-August 2010)

  4. VA HRPP QIs Preliminary Data • We incorporated some HRPP QIs into RCO’s Informed Consent Document (ICD) audits as well as regulatory audits of human research protocols during the period between June 1, 2009 through May 31, 2010. • Data were collected as part of ORO’s Facility Director’s Certification of Compliance in July, 2010 • Data was also collected regarding the numbers and types of open VA research protocols, and the numbers and types of audits performed • Data were available for analysis from 107 VA Medical Centers which represent 100% of VA research facilities.

  5. VA HRPP QIs Informed Consent Documents *Total Number of HIPAA Documents Required is Unknown

  6. VA HRPP QIs IRB and R&DC Approval

  7. VA HRPP QIs For-Cause Suspension/Termination

  8. VA HRPP QIs Local SAEs and Unanticipated Problems

  9. VA HRPP QIs Lapse in Continuing/Annual Reviews

  10. VA HRPP QIs Subject Case History Review

  11. VA HRPP QIs Research Personnel (Scope of Practice)

  12. VA HRPP QIs Research Personnel (Training)

  13. VA HRPP QIs International Research

  14. VISN Quality Indicator Data (1) VISN LEVEL DATA

  15. VISN Quality Indicator Data (2) VISN LEVEL DATA

  16. VISN Quality Indicator Data (3) VISN LEVEL DATA

  17. VISN Quality Indicator Data (4) VISN LEVEL DATA

  18. VISN Quality Indicator Data (5) VISN LEVEL DATA

  19. Assessing the Quality of VA HRPPs:Summary • We developed 16 QIs for assessing the quality of VA HRPPs. • Assessing the quality of VA HRPPs using these QIs appeared feasible. • Preliminary data obtained during the period between June 1, 2009, through May 31, 2010, provide some baseline data for future comparison as well as some useful information to guide future improvement of the QIs and HRPPs.

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