The University of Miami
HSRO Strategic Plan Update
December 2007
Agenda
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HSRO Mission / IRB Goal
Phase I – Regulatory Compliance
Phase II – Operational Priorities
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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.
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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
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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.
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Developing and Implementing human research protections training
programs on the application of IRB policies and procedures, and Federal
regulations and guidelines.
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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.
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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
Protection Program
Myron Rosenthal, PHD
Assistant Provost
for IRB Affairs
Dr. Stephen Richman
Executive Director
Office Of Research Compliance Assessment
Kelly Insignares PHD, MBA, CIP
Office of Research Training & Education, HSCOIC
IRB Chairs
Ethics Program, Privacy Office, CRIS, Technology
Transfer , Ancillary Committees
Dr. Ofelia Alvarez
Dr. Charles Carver
Associate Director for
Business and Operations
Zuny Fernandez
Compliance Liaison
Manager
Programmer - Leandro Guzman
Business Systems Analyst – TBA
Help desk Tech. Sr. – Daniel
Auguste
Finance / Office
Manager – Jeanette
Laschower
Staff Accountant –
Amanda Dufau
Staff Assoc. – Paul
Neil
Dr. Thomas Sick
Amanda Coltes-Rojas CIP
Information Technology
Senior Systems Administrator
Stella Uyeno
Dr. D. Jayaweera
Associate Director for
Regulatory Affairs and
Educational Initiatives
Kenia Viamonte
Privacy & Regulatory
Affairs
Educational Initiatives
Assistant Director
Marisabel Davalos CIP
Assistant Director
Marisel Valdes – Staff
Assistant
Receptionist – Mireya
Diaz De Arce – Staff
Associate
Yaslaime Fraga – Staff
Asst.
Evelyne Bital CIP
Education Coordinator
Joey Casanova
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
IRB Specialist – Angela Guzman
IRB Specialist – Cecilia Grano de Oro
IRB Specialist – Patricia Duque
Natalie Francis – Sr. Regulatory Analyst
Simonnette Thompson CIP – Regulatory Analyst
Kimberly Dort – Regulatory Analyst
IRB Specialist – Michael Paez
Sonya Hadrigan CIP – Sr. Regulatory Analyst (50%)
DEC 2007
NAIM – IRB of Record Fall 2007
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“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
Eprost
Fully redeploy eprost across the
institution and complete workflow
February 2008
WIRB Reacquisition
Reacquire studies from WIRB and Ongoing review them under UM IRB
December 2009
AAHRPP
Accreditation
Attain full AAHRPP accreditation
for the UM HRPP
Ongoing –
March 2009
Eprost Redeployment
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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
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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
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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
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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
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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
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AAHRPP Accreditation
Why Were Accreditation Programs
Developed?
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In the late 1990s and in early 2000, noncompliance 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?
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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?
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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?
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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
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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?
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As of September 19, 2007, 81 organizations representing a
total of 307 entities have been accredited.
The most recently accredited academic institutions include:
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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?
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A rigorous self-assessment by the institution
An on-site evaluation by a panel of compliance
experts
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Council review of inspection findings
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Notification of accreditation status
What is Involved in the Self-Assessment?
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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?
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Accreditation standards are based on:
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Federal Policy Regulations – 45 CFR 46
FDA Regulations – 21 CFC 50 & 56
ICH Good Clinical Practice Guidelines
“Common Sense”
How Are You Important?
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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.
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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
SelfAssessment
Begins
2007
Application
Preparation
2008
AAHRPP Site
Visit
2009
March
AAHRPP
Council
Meeting
2009
January
August
Application
Submission
Deadline
2008
March - July
February
September
SelfAssessment
Complete
2008
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