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ORO Issues - VHA Office of Research _ Development

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					 Office of Research Oversight


   Research Compliance
    for the 21st Century
         Tom Puglisi, PhD


Local Accountability in Research
           April 7, 2010


                                   1
        Office of Research Oversight

                   A Brief History:
US House of Representatives, Subcommittee on Oversight
     and Investigations and Subcommittee on Health
                     April 21, 1999

    Joint Hearing on Suspension of Medical Research
At West Los Angeles and Sepulveda VA Medical Facilities




                                                      2
        Office of Research Oversight

Under Secretary for Health Dr. Kenneth Kizer:
• Establish an Independent Office of Research
   Compliance and Assurance (ORCA)
    ─ Reporting Directly to USH
    ─ “Independent, Objective, Unbiased” Oversight
• Establish an External Research Accreditation Program
• Public Law 108-170 (38 USC §7307) Dec 6, 2003
  • Created VHA Office of Research Oversight (ORO)
  • Must report directly to Under Secretary for Health
  • Chief Officer has statutory authority to halt research
                                                         3
          Office of Research Oversight
• VA has the Federal Government’s most comprehensive
    program of research compliance oversight
• 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 (RCOs)      4
           Office of Research Oversight

     ORO Central Office & 5 Regional Offices
                       Midwestern
                       Hines, IL                       Northeastern
                       VISNs 11, 12, 15, 19, 23        Bedford, MA
                                                       VISNs 1, 2, 3


Western                                                    Mid-Atlantic
Loma Linda, CA                                             Washington, DC
VISNs 18, 20, 21, 22                                       VISNs 4, 5, 6, 9, 10

                                                       ▀

                                        Southern
                                        Atlanta, GA
                                        VISNs 7, 8, 16, 17
                                                                                  5
           Office of Research Oversight

             Recent VHA Compliance Initiatives
• Mandatory Facility Research Compliance Officer (RCO)
• RCO Education Program
• Mandatory Rapid Serious Adverse Event (SAE) Reporting (5 business
   days)

• Mandatory 100% Annual Informed Consent Audits
• Mandatory Regulatory Audits Every 3 Years
• Rapid Reporting of Serious or Continuing Noncompliance
• Annual Facility Director Certification of Research Compliance
• Annual Research and Development (R&D) Committee and Associate
   Chief of Staff for Research (ACOS/R) Program Reviews
                                                                      6
       Office of Research Oversight

• ORO Activities Include:
  • On-Site Reviews of Program Compliance
     • For Cause Reviews
     • Proactive Routine Inspections
     • Proactive Bio-Safety Level 3 (BSL-3) Laboratory Inspections
  • Remote Compliance Reviews
  • Facility Director Certification of Research Oversight
  • Research Misconduct Oversight
  • Adverse Event Oversight
  • Human Research Assurance Program
                                                                7
       Office of Research Oversight

• ORO’s current goal is to conduct approximately
  100 on-site program reviews annually
   • Approximately 15% are “for-cause”
   • Approximately 85% are proactive inspections
   • Issues written report of findings
   • Monitors implementation of all remedial actions
• ORO findings must be reported to House and
  Senate Veterans Affairs Committees
  • Quarterly and Annual Reports to Congress
  • Copies of ORO Reports
                                                       8
         Office of Research Oversight

                  On-Site Program Reviews –
     Routine Inspections, Follow-Up Inspections, For-Cause Reviews
  (Human, Animal, Safety, BSL-3, Information Protection, R&D Oversight)


125                                                          107
100                                         96       95

75
50                        40
                  22             33
25      19


      CY03 CY04 CY05 CY06 CY07 CY08 CY09                                  9
        Office of Research Oversight

      Remedial Action Plans Monitored by ORO –
             From Current and Prior Routine Inspections,
            Follow-Up Inspections, and For-Cause Reviews
150
125                                                        148

100                                       104    101
75
50                              59
                         54
25               49
       29

      CY03 CY04 CY05 CY06 CY07 CY08 CY09                         10
         Office of Research Oversight

        Remote Compliance Reviews (New Cases) –
 (Human, Animal, Safety, BSL-3, Information Protection, R&D Oversight)

150
                                                                160
125                    ORO begins follow-up of OI&T,
                       NSOC, OIG, and CSP reviews
100
75
                                                       84
50
25            < 20 (estimated)

      CY03 CY04 CY05 CY06 CY07 CY08 CY09
                                                                         11
         Office of Research Oversight

•   Facility self-reports of noncompliance are recognized
    by ORO and VHA leadership as positive indicators of
    a local culture of accountability
• ORO does not penalize or sanction facilities for
    self-identified, self-reported noncompliance
• Works with facilities to develop, implement, and
    monitor effective remedial action plans

•   New requirements for RCO informed consent and
    regulatory audits are expected to increase the
    number of facility self-reports

                                                            12
            Office of Research Oversight

      Facility-Identified Noncompliance (New Cases) –
600               Remediation Monitored by ORO     600
       A Positive, Growing Culture
500    of Local Accountability for
       Research Oversight
400
                    Local Accountability
                    Training Begins
300                                              201

200                                        177     RCO Audits Begin
               66        90      68
100    49

      CY03 CY04 CY05 CY06 CY07 CY08 CY09                              13
           Office of Research Oversight

        Research Compliance Officer (RCO) Audits –
 Informed Consent Documents (ICDs) Audited for 11,322 Studies
                    First Reporting Period Ending May 31, 2009
                  ICDs Obtained Within 12 Months Prior to Audit


 Studies                                 Studies
                               Studies            Studies    Total
  with     Studies   Studies               with
                                with               with     Studies
  ICDs     Lacking   Lacking              HIPAA                                  NC = NOT
                                Other               NC       with               COMPLIANT
 Missing     ICD       ICD               Missing
                                 ICD              CPRS        NC
    or     Witness    Dates                 Or
                                 NC                Entry      ICD
Unsigned                                 Unsigned
                                                                                STUDIES MAY
                                                                                  BE NC IN
  41         84       68        131        69       38       378      NUMBER      MULTIPLE
                                                                                   AREAS

                                                                       % OF
                                                                       11,322
 0.4%      0.7%      0.6%      1.2%       0.6%    0.3%      3.3%      STUDIES
                                                                      AUDITED

                                                                                            14
           Office of Research Oversight

Research Compliance Officer Informed Consent Audits –
        92,918 Informed Consent Documents (ICDs) Audited
               First Reporting Period Ending May 31, 2009
             ICDs Obtained Within 12 Months Prior to Audit


                                                           Total
  ICDs                       ICDs     HIPAA
          ICDs      ICDs                         NC        ICD,
 MISSING                     With     Missing                                     NC = NOT
         Lacking   Lacking                      CPRS      HIPAA,                 COMPLIANT
    or                       Other      Or
         Witness    Dates                       Entries   CPRS
UNSIGNED                      NC     Unsigned
                                                            NC
                                                                                 STUDIES
                                                                                   MAY
  167     4215     2851      2141     1243       607      11224     NUMBER       BE NC IN
                                                                                 MULTIPLE
                                                                                  AREAS

                                                                       % of
 0.2%     4.5%     3.1%      2.3%     1.3%      0.7%      12.1%    92,918 ICDs
                                                                    AUDITED


                                                                                        15
     Office of Research Oversight

        2009 OIG Informed Consent Audit
5933 Informed Consent Documents (ICDs) Audited
             55.3% ICDs Obtained 2006-2008
             41.3% ICDs Obtained 2000-2005
             3.4% ICDs Obtained Prior to 2000


    ICDs
              ICDs         ICDs
   Missing
             Lacking      Lacking
      or
             Witness       Dates
  Unsigned


                                                % of 5993
   1.0%      16.6%        0.9%                  AUDITED


                                            % of 367,103
   1.0%      29.2%        0.6%            ESTIMATED ICDs


                                                            16
             Office of Research Oversight
                   Deficiencies Identified – CY 2009
                     ORO Routine Inspections at 26 Facilities

                  Area of Deficiency – Lack of . . .                              Percent
1. Complete up-to-date Standard Operating Procedures (SOPs)                         95%
2. Research and Development Committee (R&DC) oversight, including                   65%
   annual program reviews
3. Documentation and tracking of required training, credentialing, privileging,     65%
   and scope of practice
4. Effective and timely communication between affiliate Research Review             65%
   Committee and VA Research Service
5. Protocol inventory controls, effective protocol tracking, and timely             58%
   continuing reviews
6. Information Security Officer (ISO), and Privacy Officer protocol reviews         46%
7. Timely reporting of adverse events and problems to ORO                           35%
8. Active involvement of Facility Leadership                                        27%   17
             Office of Research Oversight

                   Deficiencies Identified – CY 2009
           109 Facility Director Certifications of Research Oversight

                  Area of Deficiency – Lack of . . .                        Percent
1. No deficiencies identified by Facility Director                            36%
2. Documentation and tracking of required credentialing, privileging, and     30%
   scope of practice
3. Documentation, tracking, and completion of required training               21%
4. Complete, up-to-date Standard Operating Procedures (SOPs)                  20%
5. Research safety, hazardous materials, emergency response                   13%
6. Up-to-date Memoranda of Understanding (MOUs) with academic affiliates      12%
   operating Research Review Committees used by the VA facility
7. Information protection compliance and/or protocol review by the            11%
   Information Security Officer (ISO) and Privacy Officer

                                                                                    18
Office of Research Oversight




    Research Compliance
     for the 21st Century
         Tom Puglisi, PhD




                               19

				
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