ORO - VCU Office of Research

Document Sample
ORO - VCU Office of Research Powered By Docstoc
					Office of Research Oversight


           Research Issues in the
              Department of
             Veterans Affairs
                    Hot Topics

            Joan P. Porter, DPA, MPH, CIP
                     Deputy Chief Officer
                 Office of Research Oversight
                Department of Veterans Affairs
                      September 9, 2008
                                                 ORO   1
Office of Research Oversight


    Office of Research Oversight
              ORO (10R)
       The Office of Research Oversight (ORO) serves as
         the primary VHA office in advising the Under
     Secretary for Health on all matters of compliance and
    assurance regarding human subject protections, animal
      welfare, research safety and security, research data
               security, and research misconduct.

   The Office will be adding an additional function this fall —
        Education of Research Compliance Officers

                                                       ORO        2
Office of Research Oversight

            Current Organizational Chart
                                                           Chief Officer
                                                          J. Thomas Puglisi
 Assoc. Director for Research Safety                   Deputy Chief Officer                      Assoc. Director for Research
        and Animal Welfare                                 Joan P. Porter                          Integrity and Assurance
            Susan B. Harper                            Executive Assistant                                    Peter Poon
                                                         Shannon Williams
       Veterinary Medical Officer                                                                   Health Science Specialist
       Veterinary Medical Officer                         Staff Assistant                           Health Science Specialist
       Veterinary Medical Officer                           Lynda Poore                             Health Science Specialist
       Health Science Specialist                  Program Support Assistant                         Health Science Specialist
       Health Science Specialist                            Penny Powell                                Program Analyst
       Health Science Specialist




   Northeastern Regional Office                     Mid-Atlantic Regional Office                    Southern Regional Office
            Bedford, MA                                   Washington, DC                                    Decatur, GA
     Richard D’Augusta, Director                        Min-Fu Tsan, Director                           David Miller, Director
      Health Science Specialist                       Health Science Specialist                       Health Science Specialist
      Health Science Specialist                       Health Science Specialist                       Health Science Specialist
        Program Specialist                               Program Assistant                             Administrative Officer




                     Midwestern Regional Office                                   Western Regional Office
                             Hines, IL                                              Moreno Valley, CA
                          Karen Smith, Director                                    Paul Hammond, Director
                        Health Science Specialist                                 Health Science Specialist                       Dated
                        Health Science Specialist                                 Health Science Specialist                       12/10/07
                          Program Specialist                                        Program Specialist

                                                                                                                     ORO                     3
Office of Research Oversight

          Revised Organizational Chart
                                                       Chief Officer
                                                    Deputy Chief Officer
    Assoc. Director for Research                    Executive Assistant                         Assoc. Director for Research
     Safety and Animal Welfare                         Staff Assistant                            Integrity and Assurance
                                                 Program Support Assistant                         Program Analyst Officer
       Veterinary Medical Officer
       Veterinary Medical Officer                                                                  Health Science Specialist
       Veterinary Medical Officer                                                                  Health Science Specialist
       Health Science Specialist                  Asst. Director Research                          Health Science Specialist
       Health Science Specialist                  Compliance Education                             Health Science Specialist
       Health Science Specialist                  Health Science Specialist                        Health Science Specialist
                                                  Health Science Specialist
                                                      Program Analyst
                                                       Staff Assistant



   Northeastern Regional Office                  Mid-Atlantic Regional Office                   Southern Regional Office
          Bedford, MA                                  Washington, DC                                   Decatur, GA
   Richard D’Augusta, Director                       Min-Fu Tsan, Director                          David Miller, Director
                                                                                               4 Health Science Specialists
   4 Health Science Specialists                  4 Health Science Specialists
                                                                                                   Administrative Officer
       Program Specialist                             Program Assistant



                    Midwestern Regional Office                                 Western Regional Office
                         Karen Smith, Director                                   Moreno Valley, CA
                              Hines, IL                                          Paul Hammond, Director
                                                                                                                             Dated
                    4 Health Science Specialists                              4 Health Science Specialists                   8/12/08
                          Program Specialist                                       Program Specialist


                                                                                                                 ORO                   4
Office of Research Oversight


ORO prepares numerous
reports for site visits
throughout the year based on:
               • For-Cause Reviews
               • Routine Reviews
 ORO also reviews IRBs, animal programs,
 VHA reviews, informed consent, and all
 aspects of protective research.
                                     ORO   5
Office of Research Oversight


  For-Cause Reviews Conducted
             by ORO
               (January 1 – August 20, 2008)

    Human Research Protection                       Research and Development
  Programs (HRPP) – includes IRB                        Committee (R&D)

                3                                              1
                                   Animal Care and Use
                                    Program (ACUP)


   Research Information Security
                                           1         Research Safe and Security
         Program (RISP)                                   Program (RSSP)

                1                                                0
                                                     Current count for CY2008
                                                                          ORO     6
Office of Research Oversight


Routine Reviews Conducted by ORO
               (January 1 – August 20, 2008)



    Human Research Protection                       Research and Development
  Programs (HRPP) – includes IRB                        Committee (R&D)

               11                                             12
                                   Animal Care and Use
                                    Program (ACUP)


   Research Information Security
                                           6         Research Safe and Security
         Program (RISP)                                   Program (RSSP)

                6                                                6
                                                     Current count for CY2008
                                                                          ORO     7
Office of Research Oversight


    A New Future for Research
    Compliance Officers (RCOs)

     The current picture —
                Approximately 92 RCOs with
                •   varied backgrounds,
                •   functions,
                •   grades, and
                •   categories

                                             ORO   8
Office of Research Oversight

  Another Comment about hot topics in the
  Department of Veteran Affairs research
  program —
          Important concentration on
    Post-Traumatic Stress Disorder (PTSD)
                 this year —
will influence IRB considerations and other
   protection policies not only for PTSD
       research, but across the board.
                                      ORO     9
Office of Research Oversight

             Cooperative Studies
               Program #519

     ORO completed a lengthy For-Cause Review
     Report on the Cooperative Studies
     Program #519 Protocol “Integrating Practice
     Guidelines for Smoking Cessation into
     Mental Healthcare for Post-Traumatic Stress
     Disorder” in which veterans with PTSD
     were involved in 10 sites.
                                              ORO   10
Office of Research Oversight

Cooperative Studies Program #519, continued



   The purpose was not to study their reaction
   to the drugs for PTSD per se, but rather to
   compare the effectiveness of standard smoking
   cessation treatments and standard PTSD
   treatments delivered in an integrated program
   versus smoking cessation treatments and PTSD
   treatments delivered separately.

                                              ORO   11
Office of Research Oversight
 Cooperative Studies Program #519, continued




    Although generally compliant
    with the basic regulatory requirements
    for research using human subjects,
    ORO found that this protocol did not
    have sufficient safeguards for veterans
    with PTSD.

                                               ORO   12
Office of Research Oversight



               ORO Findings
       IRBs met basic Common Rule
       reviews, but their records and
       minutes were lacking documentation
       of their assessment of risks and
       benefits for persons with PTSD.


                                     ORO    13
Office of Research Oversight
 ORO Findings, continued




      • ORO recommended raising
        VHA system-wide standards
        for IRB review and approval of
        research to ensure the application
        of any needed special safeguards.



                                        ORO   14
Office of Research Oversight
 ORO Findings, continued




        • ORO also concluded that in
          annual reviews, IRBs failed to
          adequately consider whether
          serious adverse events changed
          the risks of participating in the
          research.


                                          ORO   15
Office of Research Oversight
 ORO Findings, continued




     VHA needs to
         – create system-wide standards to use
           when IRBs review serious adverse
           events and
         – Enhance and increase study
           monitors and auditing at VHA
           research sites.

                                            ORO   16
Office of Research Oversight
 ORO Findings, continued



     • Protocol research subjects taking
       the PTSD drug varenicline were
       generally not informed about a
       February 2008 Food and Drug
       Advisory on risks of the drug in a
       timely or efficient way by the
       IRBs or research offices at their
       facilities.
                                        ORO   17
Office of Research Oversight
 ORO Findings, continued



     • ORO has recommended that
       VHA establish a reliable system
       through which all VHA research
       programs and study participants
       will be notified promptly about
       any emerging medication safety
       information.

                                         ORO   18
Office of Research Oversight

                   In Summary —
  ORO recommended improving VHA standards
         to protect human subjects by:
 • Improving IRB evaluations of special safeguards for
   participants in VA research;
 • Improving IRB review of local serious adverse events in VHA;
 • Using local regulatory compliance audits of the informed
   consent process used in VHA research;
 • Setting up a notification system for alerting the VHA research
   community and study participants about new or emerging
   medication safety information.
                                                         ORO        19
Office of Research Oversight
ORO Review of Post-Traumatic Stress
Disorder (PTSD) Research Studies, continued….


    Another concentrated review in ORO:
   ORO Review of Post-Traumatic Stress
    Disorder (PTSD) Research Studies


     The Chief Officer, Office of Research
     Oversight, sent a detailed request to all
     Directors of Veterans Health Administration
     Facilities conducting research.

                                                ORO   20
Office of Research Oversight
ORO Review of Post-Traumatic Stress
Disorder (PTSD) Research Studies, continued….



  How was the review conducted?
   Each VA facility designated a special review
   panel of at least three IRB or Research and
   Development Committee members to
   • Do an intensive review, addressing detailed
     questions and
   • Report to the IRB
                                                      21

                                                ORO
Office of Research Oversight
ORO Review of Post-Traumatic Stress
Disorder (PTSD) Research Studies, continued….


    ORO analysis of IRB actions in
    PTSD research
     • Requested information on necessary IRB
       modifications of the research
     • Copies of IRB findings and actions sent to
       ORO for analysis
     • As of August 22nd slightly over 100 PTSD studies
       were reported.

                                                    ORO   22
Office of Research Oversight
ORO Review of Post-Traumatic Stress
Disorder (PTSD) Research Studies, continued….

 What questions were addressed? Did the
 investigator and/or IRB -
  • Show knowledge of/sensitivity to issues related to persons
    with PTSD?
  • Pay attention to alerts and/or warnings of FDA, sponsors?
  • Follow through on notifications of subjects?
  • Evaluate drug risks to subjects (if applicable)?
  • Show regulatory compliance with risk evaluation and
    explanation to possible subjects?
  • Adequately monitor the research?
  • Provide appropriate subject assistance?
  • Take into account any potential vulnerability of subjects?   23

                                                        ORO
Office of Research Oversight


     A New Future for Research
  Compliance Officers (RCOs) in the
   Veterans Health Administration

     The current picture —
                Approximately 92 RCOs with
                •   varied backgrounds,
                •   functions,
                •   grades, and
                •   categories
                                             ORO   24
Office of Research Oversight

    The new proposal: Research
    Compliance Officers (RCOs)
  • Reporting to Medical Center Directors and Veterans Integrated
    Service Network (VISN) Directors with research protocols;
  • Full time employees;
  • Knowledgeable of human subjects, animals, and biomedical
    research;
  • Utilizing FDA/ICH Good Clinical Practice (GCP) methods of
    review;
  • Helping ORO as well as VA facilities with ability to correct
    non-compliance quickly;
  • At least 3 year comprehensive reviews of each protocol;
  • Annual informed consent review
  • Maybe up to 150 persons??
                                                                   ORO   25
Office of Research Oversight




                  Any thoughts?

                     Questions?

           Thanks for being here.

                                    ORO   26

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:3
posted:3/22/2013
language:English
pages:26