Docstoc

VHA Handbook 1058.01 - VHA Office of Research _ Development

Document Sample
VHA Handbook 1058.01 - VHA Office of Research _ Development Powered By Docstoc
					    Office of Research Oversight




Office of Research and Development
    Local Accountability Meeting

            January 2009




                                     1
Office of Research Oversight




• Mission and Challenges
• VHA Handbook 1058.01:
 Reporting Research Events



                               2
         Office of Research Oversight



• Advise Under Secretary for Health
• Monitor / Review / Investigate Compliance
  – Protection of Human Subjects
  – Laboratory Animal Welfare
  – Research Safety & Research Security
  – Research Information Security
  – Research Misconduct



                                              3
                 Office of Research Oversight
                                  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




                                                                               4
              Office of Research Oversight
                  Trends in Research Compliance



• Increasing Challenges for Program Oversight (CY2006  Present)

  – Facility Director Leadership

  – Facility-Level Program Oversight

  – Auditing and Monitoring to Enhance Compliance

  – Aging Infrastructure

  – Relationships with Academic Affiliates




                                                                   5
             Office of Research Oversight
           Action Plans: Meeting Current Challenges




• Facility Director Leadership
  Leadership & Accountability Training (ORD)
    – Mandatory Attendance (January 2009)

  Annual Certification of Research Oversight (ORO)
    – Began July 1, 2007 (ORO)




                                                      6
           Office of Research Oversight
           Action Plans: Meeting Current Challenges




• Facility-Level Program Oversight
  Research Administrative Review (ORD)
    – Define Roles & Accountability for ACOS/R,
      AO/R, R&D Committee

  Leadership & Accountability Training (ORD)
    – Mandatory Attendance (January 2009)

  Facility Investigator Training Program Required


                                                      7
              Office of Research Oversight
              Action Plans: Meeting Current Challenges




• Auditing & Monitoring
 Facility Research Compliance Officer Required
     – Effective December 31. 2008 (detailed or permanent)
     – Must Report to Facility Director (Mandatory)
     – Direct Reporting of Non-Compliance to ORO
   Annual 100% Audit of Informed Consent
   Tri-Annual Regulatory Audit of all Protocols
   Audit Results Reported to ORO
   Add Audit Monitoring to ORO On-Site Reviews
   Research Compliance Officer Training (ORO)



                                                             8
             Office of Research Oversight
            Action Plans: Meeting Current Challenges



• Aging Infrastructure
 Infrastructure Review (ORD)

 Research Allocation Review (ORD, Finance, 10N)

 ORD Research Administration IT Solution Work Group




                                                       9
            Office of Research Oversight
           Action Plans: Meeting Current Challenges




• Relationships with Academic Affiliates

 AAMC – VA Working Group

 VHA – OGC – OI&T Working Group
    –   Use of Oversight Committees
    –   Research Service Responsibilities
    –   Data Ownership
    –   Data Storage and Use



                                                      10
            Office of Research Oversight
               ORO On-Site Program Reviews
              (Human, Animal, Safety, Info Sec, etc)



100
                                               97      95

 75

 50
                       45
 25                               33
       19     22


      CY03 CY04 CY05 CY06 CY07 CY08

                                                            11
            Office of Research Oversight
              Facility-Identified Noncompliance


200                                               201
                                           177


150

                     90
100                           68
             66

       49
 50


      CY03 CY04 CY05 CY06 CY07 CY08
                                                        12
             Office of Research Oversight
        VHA Handbook 1058.01: Reporting Research Events


• Replaces All Previous ORO Reporting Requirements
       – Human Research
       – Animal Research
       – Research Safety
       – Research Laboratory Security
       – Research Information Protection
•   Includes Reporting:
       – Within the Facility
       – To ORO
•   New Definitions and Reporting for Human Research
       – Unanticipated Problems / Serious Adverse Events
       – Serious of Continuing Noncompliance
                                                           13
           Office of Research Oversight
      VHA Handbook 1058.01: Reporting Research Events



                     New Definitions
Administrative Hold.
• A voluntary interruption of research enrollments
  and/or ongoing research activities.
• Does not apply to interruptions of research related to
  concerns regarding:
   – The safety, rights, or welfare of human research
     subjects, research investigators, research staff, or
     others; or
   – The safety or welfare of laboratory animals.

                                                            14
            Office of Research Oversight
      VHA Handbook 1058.01: Reporting Research Events



                     New Definitions
Serious Noncompliance.
• Failure to adhere to the laws, regulations, or policies
  governing VA research that:
   – Results in substantive harm or damage (or risk of substantive
     harm or damage) to the safety, rights, or welfare of human
     subjects, research staff or others; or
   – Results in substantive harm or damage (or risk of substantive
     harm or damage) to the safety or welfare of laboratory
     animals; or
   – Substantively compromises the integrity or effectiveness of
     research protections, either systemically or relative to a
     particular protocol or project.
                                                                     15
            Office of Research Oversight
      VHA Handbook 1058.01: Reporting Research Events


                  New Definitions
Serious AE (SAE) / Serious Problem.
• An AE or problem that involves or results in:
   – Death, a life-threatening experience, inpatient
     hospitalization, prolongation of hospitalization, persistent or
     significant disability or incapacity, congenital anomaly, or
     birth defect; or
   – Substantive harm or damage (or risk of substantive harm or
     damage) to the safety, rights, or welfare of research
     subjects, research staff; or
   – Substantive harm or damage (or risk of substantive harm or
     damage) to the safety or welfare of laboratory animals; or
   – The need for medical, surgical, behavioral, social, or other
     intervention to prevent any of the above.
                                                                       16
            Office of Research Oversight
      VHA Handbook 1058.01: Reporting Research Events


                        New Definitions
Continuing Noncompliance.
• Persistent or repeated failure to satisfy VA or other
  federal research requirements,
   – Either in the past or extending into the present.
Unanticipated Problem in Research.
• Any problem in research that is not expected
   – In terms of nature, severity, or frequency of occurrence
   – As documented in the protocol or other materials approved
     by the R&DC, IRB, IACUC, etc.
   – For human research, may include the informed consent
     document, clinical investigators’ brochure, product labeling,
     etc.
                                                                     17
          Office of Research Oversight
     VHA Handbook 1058.01: Reporting Research Events


           General Requirements
• Facility Director must report to ORO:
   – Within 5 business days of being informed of
     a reportable event
   – Report must be in writing and signed
   – Report required whether or not event has
     been resolved
   – Followup reports as required by ORO



                                                       18
              Office of Research Oversight
         VHA Handbook 1058.01: Reporting Research Events


                        Human Research
Unanticipated Problems Involving Risks (Subjects/Others):
• Must be reported to the IRB and ACOS/R within
  5 business days of discovery
• Unanticipated problems include:
   – Interruptions of research due to concerns about safety, rights, or
     welfare of subjects, research personnel, or others
   – Work-related injuries requiring more than minor medical intervention
     or lead to serious injury or death
   – Any PBM Alerts related to a facility research project
   – All Unanticipated Serious Adverse Events

                                                                      19
               Office of Research Oversight
         VHA Handbook 1058.01: Reporting Research Events


     IRB Review of Unanticipated Problems and SAEs:
• Within 5 business days of report, a designated voting IRB
    Member/Reviewer (or the convened IRB) must:
•   Determine and document whether event is related,
    possibly related, or unrelated to the research.
•   If related or possibly related, must determine that event is:
     – Not Serious, No Action Required
     – Not Serious, But Minor Changes Needed via Expedited Review.
     – Serious, Immediate Action Needed to Prevent Harm, Report to
      Facility Director within 5 business days, Refer to Convened IRB
      Review for Resolution
    – Serious, but Immediate Action Not Needed to Prevent Harm,
      Report to Facility Director within 5 business days, Refer to
      Convened IRB Review for Resolution
                                                                        20
              Office of Research Oversight
         VHA Handbook 1058.01: Reporting Research Events


           Serious or Continuing Noncompliance
• Must be reported to the IRB and ACOS/R within
    5 business days of discovery
•   If IRB determines serious or continuing noncompliance
    occurred, must be reported to Facility Director within 5
    business days.
•   If discovered during an RCO informed consent or
    regulatory audit, must be reported with 5 business days to:
     – Facility Director
     – ACOS/R
     – IRB for Review and Resolution
     – R&D Committee
                                                             21
              Office of Research Oversight
        VHA Handbook 1058.01: Reporting Research Events


                Report to ORO Regional Office
• Problems (including AEs) Involving Risks to Subjects or
  Other that are
  – Serious and Unanticipated and Related (or Possible Related) to
     the Research
• Serious or Continuing Noncompliance
   – If identified by an RCO informed consent or regulatory audit, must
     also be reported to VISN Director and CRADO
• Suspensions or Terminations of IRB approval



                                                                      22
              Office of Research Oversight
         VHA Handbook 1058.01: Reporting Research Events


                Report to ORO Central Office
               (Copy to ORO Regional Office)
•   Assurance Changes
•   IRB Changes
•   MOU Changes
•   Accreditation Problems




                                                           23
             Office of Research Oversight
        VHA Handbook 1058.01: Reporting Research Events



• Comparable Reporting Required for:
     – Animal Welfare
     – Research Safety
     – Research Laboratory Security
     – Research Information Protection
     – Alleged Research Misconduct
•   Handbook Includes Summary Tables and Decision Charts
    to aid in facility decision making
•   Local SOPs Required for All Required Internal and
    External Reporting


                                                          24
Office of Research Oversight




 http://www.1.va.gov/oro/

1717 H Street, NW, Suite 500 (10R)
     Washington, D.C. 20420
     PHONE: (202) 266-4577




                                     25

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:15
posted:3/23/2013
language:English
pages:25