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									The University of Miami

HSRO Strategic Plan Update
    December 2007
    Agenda
   HSRO Mission / IRB Goal
    Phase I – Regulatory Compliance
   Phase II – Operational Priorities
       Eprost Redeployment Update
       WIRB Reacquisition Process
       IRB Affairs
   AAHRPP Accreditation
    HSRO Mission
Protecting the safety, rights, and welfare of human
  research participants through:

     Collaboration and Regulatory Compliance

Collaborating with Investigators, key study personnel,
  and other supporting institutional bodies toward a
  common goal of protecting human research
  participants.
     IRB Goal and Objective
    To protect the rights and welfare of those individuals
          who contribute to the research process by
                   participating as subjects.
   In protecting the research subject, the IRB also protects the institution
    and the researcher from the potential harmful consequences of an
    inadequate consent process or the exposure of the subject to
    excessive risk.
   To review each research plan and consent process in order to
    safeguard the rights and welfare of human subjects.
   To determine that each study conforms to ethical standards including:
    A reasonable balance of risks and anticipated benefits; adequate
    provisions for informed consent; and equitable selection of subjects
       Operational Goal
                 Deliver High Quality Service
   Guiding and Supporting the development of research based on sound
    research design and strong ethical principles that contribute to scientific and
    scholarly advances in biomedical, behavioral, social and other sciences.
   Developing and Implementing human research protections training
    programs on the application of IRB policies and procedures, and Federal
    regulations and guidelines.
   Consulting with Investigators and key study personnel in the development
    of research programs to facilitate compliance with regulations, and assuring
    adherence to FDA and other regulatory guidelines, ethical considerations, and
    institutional policies related to human research protections.
   Continual Learning of Investigators and key study personnel resulting in
    an up-to-date and knowledgeable research community in human research
    protections
Regulatory Compliance
       Phase I
  Compliance Regulatory Visits
FDA Site Visit – IRB Compliance Audit
 May 17-19, 2006

Resolution – Voluntary Action Indicated
 September 2006



OHRP Site Visit – For Cause Audit
 March 13-15, 2007

Resolution
 September 14, 2007
UM
        Operational Model for Human Subjects Research Office

                                                                                 Vice Provost
               Human Subjects Research                                       Myron Rosenthal, PHD                                                        Assistant Provost
                 Protection Program
                                                                                                                                                          for IRB Affairs
                                                                                                                                                     Dr. Stephen Richman
                                                                               Executive Director
        Office Of Research Compliance Assessment
     Office of Research Training & Education, HSCOIC                  Kelly Insignares PHD, MBA, CIP
                                                                                                                                                             IRB Chairs
     Ethics Program, Privacy Office, CRIS, Technology
              Transfer , Ancillary Committees
                                                                                                                                                         Dr. Ofelia Alvarez
                                                                                                                                                         Dr. Charles Carver
                                                                                                                                                         Dr. D. Jayaweera
                                      Associate Director for                                                          Associate Director for
                                     Business and Operations                                                          Regulatory Affairs and              Dr. Thomas Sick
                                                                                                                      Educational Initiatives
                                         Zuny Fernandez                             Compliance Liaison
                                                                                        Manager                     Amanda Coltes-Rojas CIP
 Information Technology
                                                        Finance / Office              Kenia Viamonte
 Senior Systems Administrator                          Manager – Jeanette                                             Privacy & Regulatory           Educational Initiatives
         Stella Uyeno                                     Laschower                                                          Affairs
                                                                                                                                                          Assistant Director
                                                        Staff Accountant –          Marisel Valdes – Staff              Assistant Director           Marisabel Davalos CIP
                                                         Amanda Dufau                     Assistant                    Evelyne Bital CIP
Programmer - Leandro Guzman
                                                                                    Receptionist – Mireya
Business Systems Analyst – TBA                         Staff Assoc. – Paul
                                                                                     Diaz De Arce – Staff
  Help desk Tech. Sr. – Daniel                                 Neil                       Associate                                                  Education Coordinator
           Auguste                                                                  Yaslaime Fraga – Staff                                              Joey Casanova
                                                                                            Asst.



                                          Manager, Operations – Dawn Stoutt
                                                                                                             Vivienne Carrasco – Sr. Regulatory Analyst
                                    IRB Regulatory Specialist – Yoko Young Sang
                                                                                                             Meghan Stein CIP– Sr. Regulatory Analyst
                                        IRB Regulatory Specialist – Jada Rauls
                                                                                                              Natalie Francis – Sr. Regulatory Analyst
                                           IRB Specialist – Angela Guzman

                                         IRB Specialist – Cecilia Grano de Oro                           Simonnette Thompson CIP – Regulatory Analyst

                                            IRB Specialist – Patricia Duque
                                                                                                                Kimberly Dort – Regulatory Analyst
                                             IRB Specialist – Michael Paez
                                                                                                       Sonya Hadrigan CIP – Sr. Regulatory Analyst (50%)


DEC 2007
    NAIM – IRB of Record Fall 2007
   “When OHRP ends it’s investigation, the University of
    Miami’s research program will be among America’s
    strongest operations. It appears that adequate ad hoc
    checks and balances are placed around campus
    investigators. There is no indication that small violations
    are taking place. This may suggest that there is not an
    overall weakness on campus. Before the new group of
    thinkers, certified IRB executives came on board, this
    program was in need of infrastructure change. If the
    executive team remains in place, this may end up a
    model program.”
Operational Priorities
     Phase II
       Major Objectives
        Task                       Goal                    Timeframe


Redeployment of      Fully redeploy eprost across the    February 2008
Eprost               institution and complete workflow

WIRB Reacquisition   Reacquire studies from WIRB and Ongoing -
                     review them under UM IRB        December 2009

AAHRPP               Attain full AAHRPP accreditation    Ongoing –
Accreditation        for the UM HRPP                     March 2009
      Eprost Redeployment
   Will increase efficiency and provide real time information to
    the PI and study team regarding the status of the review
   Deployment of ongoing eprost training program for current
    and future eprost users in accordance to their role in eprost.
   Enhancements to increase efficiency and turnaround times
   Concurrent educational opportunities
   90% completed – current departments online
   10% left – schedule thru January 31st
    System Enhancements
   Currently developing parallel review processes thru
    eprost
   Expected January 2008 launch date - parallel
    process
   Future eprost enhancements – suggestions sent to
    lettershsro@med.miami.edu
Re-Acquisition of Studies
    WIRB Reacquisition Process
   Studies are identified three months prior to continuing
    review
   PI notified of reacquisition selection and required
    documentation
   IF a compelling reason is provided by the PI to the Vice
    Provost regarding keeping the study at WIRB – it will be
    considered
   Goal – December 2009
IRB Affairs
      Institutional Review Boards
   Social Behavioral Board - 2nd and 4th Thursday of each month,
    3:30 PM
     Dr. Charles Carver, Chair
     Dr. Victoria Mitrani, Vice Chair
     Vivienne Carrasco, Sr. Regulatory Analyst
        Institutional Review Boards
   Medical Boards
     Board A – 2nd and 4th Monday of each Month -- 1:00 PM
    Dr. Thomas Sick, Chair
    Dr. Donald Temple, Vice-Chair
    Simonnette Thompson, Sr. Regulatory Analyst
     Board B – 1st and 3rd Monday of each month, 1:00 PM

    Dr. Ofelia Alvarez, Chair
    Dr. Abdul Mian, Vice-Chair
    Meghan Stein, Sr. Regulatory Analyst
     Board C – 1st and 3rd Tuesday of each month, 1:30 PM

    Dr. Dushyantha Jayaweera, Chair
    Dr. Karin Esposito, Vice-Chair
    Natalie Francis, Sr. Regulatory Analyst
AAHRPP Accreditation
      Why Were Accreditation Programs
      Developed?

   In the late 1990s and in early 2000, non-
    compliance with the regulations for the protection
    of human subjects became front page news
    through stories such as the suspension of
    research at Duke, John Hopkins and UPenn
   The most influential case that prompted changes
    in research was the death of Jesse Gelsinger at
    the University of Pennsylvania
     What is AAHRPP?
   Association for Accreditation of Human Research
    Protection Programs, Inc. (AAHRPP)

   AAHRPP is a non-profit organization founded in
    2001 to ensure research compliance and to
    promote uniform standards for the protection of
    human research subjects
What is Accreditation?
   A set of national standards that HRPPs can
    strive to meet that can be consistently
    interpreted.

   It is not another layer of oversight.
  What Are The Possible Benefits of
  Accreditation?

Accreditation:
 Improves human research protection programs

 Builds public trust

 Reduces burden from government and industry inspection

 Improves research quality

 Attracts high-quality investigators

 Helps in recruiting participants

 Increases efficiency and reduces costs

 Assures regulatory compliance

 Makes programs more competitive
What is Involved?
   Self-assessment of our human subjects protection
    program.

   Focus on the mechanisms in place at our University
    and at the PI’s research practice to protect human
    research subjects.

   On-site evaluation by a peer panel of experts
       Interviews with HSRO staff, IRB members, PIs, research
        coordinators, staff, maybe sponsors)
       AAHRPP Council will review findings of the site visits and
        make recommendation for accreditation.
        What Organizations Have Been
        Accredited to Date?

   As of September 19, 2007, 81 organizations representing a
    total of 307 entities have been accredited.
   The most recently accredited academic institutions include:
    •   Harvard University Faculty of Medicine, Boston, MA
    •   Marshall University, Huntington, WV
    •   The Board of Regents of the University of Oklahoma,
        Oklahoma City, OK
    •   University of Kansas Medical Center, Kansas City, KS
What Are The Steps in AAHRPP
Accreditation?
   A rigorous self-assessment by the institution

   An on-site evaluation by a panel of compliance
    experts

   Council review of inspection findings

   Notification of accreditation status
What is Involved in the Self-Assessment?

   The self-assessment is performed by addressing “elements” on
    the AAHRPP evaluation instrument

   The evaluation instrument is broken down into five domains that
    include:
      The Organization (23 elements)

      The Research Review Unit (34 elements)

      The Investigator (11 elements)

      The Sponsor (7 elements)

      The Research Participant (4 elements)
What is the Basis of the Evaluation
Instrument?

   Accreditation standards are based on:
       Federal Policy Regulations – 45 CFR 46
       FDA Regulations – 21 CFC 50 & 56
       ICH Good Clinical Practice Guidelines
       “Common Sense”
How Are You Important?
   The Institution & the HSRO has different areas that
    work together to support and maintain our Institution’s
    HRPP.
   Each area is fundamental to the process.
        Will require feedback from IRB Members, principal
         investigators, study coordinators and staff, sponsors,
   Information from each area will be compiled and will
    assist in providing the necessary information on the
    self-assessment tool.
   You each contribute to this important process!
                   HSRO TIMELINE
                Self-                     Application
             Assessment                   Submission
              Complete                     Deadline                   AAHRPP
                2008                        2008                      Council
                                                                      Meeting
                                                                       2009
                           March - July
              February




                                          August




                                                                      March
                                                         January
 September




   Self-
Assessment                Application                   AAHRPP Site
  Begins                  Preparation                      Visit
   2007                      2008                          2009
     Closing Thought
“My challenge to leaders of academic medical centers,
university presidents, and everyone else involved in the
oversight of… research is to take the responsibility, and the
necessary actions, to strengthen the conduct of research at
their institutions.

Above all, [this] means providing IRBs… with the stature,
authority and resources they need to do their jobs.”
                       Donna Shalala, Secretary DHHS
                       New Engl J Med, Sept 2000

								
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