The University of Miami

HSRO Strategic Plan UpdateDecember 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 MissionProtecting 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 GoalDeliver 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 CompliancePhase I

Compliance Regulatory Visits

FDA Site Visit – IRB Compliance Audit May 17-19, 2006Resolution – Voluntary Action Indicated September 2006

OHRP Site Visit – For Cause Audit March 13-15, 2007Resolution September 14, 2007

Operational Model for Human Subjects Research Office

Vivienne Carrasco – Sr. Regulatory Analyst

Meghan Stein CIP– Sr. Regulatory Analyst

Natalie Francis – Sr. Regulatory Analyst

Simonnette Thompson CIP – Regulatory Analyst

Kimberly Dort – Regulatory Analyst

Sonya Hadrigan CIP – Sr. Regulatory Analyst (50%)

Finance / Office Manager – Jeanette

Laschower

Staff Accountant – Amanda Dufau

Staff Assoc. – Paul Neil

Vice Provost

Myron Rosenthal, PHD Human Subjects Research Protection Program

UM

Executive Director

Kelly Insignares PHD, MBA, CIP

Associate Director for Business and Operations

Zuny Fernandez

DEC 2007

Compliance Liaison Manager

Kenia Viamonte

Associate Director for Regulatory Affairs and Educational Initiatives

Amanda Coltes-Rojas CIP

Assistant Provost

for IRB Affairs

Dr. Stephen Richman

Marisel Valdes – Staff Assistant

Receptionist – Mireya Diaz De Arce – Staff

AssociateYaslaime Fraga – Staff

Asst.

Educational Initiatives

Assistant Director Marisabel Davalos CIP

Privacy & Regulatory Affairs

Assistant Director Evelyne Bital CIP

Manager, Operations – Dawn Stoutt

IRB Regulatory Specialist – Yoko Young Sang

IRB Regulatory Specialist – Jada Rauls

IRB Specialist – Angela Guzman

IRB Specialist – Cecilia Grano de Oro

IRB Specialist – Patricia Duque

IRB Specialist – Michael Paez

Information Technology

Senior Systems Administrator Stella Uyeno

IRB Chairs

Dr. Ofelia Alvarez

Dr. Charles Carver

Dr. D. Jayaweera

Dr. Thomas Sick

Office Of Research Compliance Assessment

Office of Research Training & Education, HSCOIC

Ethics Program, Privacy Office, CRIS, Technology Transfer , Ancillary Committees

Programmer - Leandro GuzmanBusiness Systems Analyst – TBA

Help desk Tech. Sr. – Daniel Auguste

Education CoordinatorJoey Casanova

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 PrioritiesPhase II

Major ObjectivesTask Goal Timeframe

Redeployment of Eprost

Fully redeploy eprost across the institution and complete workflow

February 2008

WIRB Reacquisition Reacquire studies from WIRB and review them under UM IRB

Ongoing - December 2009

AAHRPP Accreditation

Attain full AAHRPP accreditation for the UM HRPP

Ongoing – 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, ChairDr. Victoria Mitrani, Vice ChairVivienne Carrasco, Sr. Regulatory Analyst

Institutional Review Boards

Medical Boards Board A – 2nd and 4th Monday of each Month -- 1:00

PMDr. Thomas Sick, Chair Dr. Donald Temple, Vice-ChairSimonnette Thompson, Sr. Regulatory Analyst Board B – 1st and 3rd Monday of each month, 1:00 PMDr. Ofelia Alvarez, Chair Dr. Abdul Mian, Vice-ChairMeghan Stein, Sr. Regulatory Analyst Board C – 1st and 3rd Tuesday of each month, 1:30 PM Dr. Dushyantha Jayaweera, ChairDr. Karin Esposito, Vice-ChairNatalie 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-Assessmen

t Begins2007

Sep

tem

ber

Self-Assessment Complete

2008

Feb

ruar

y

Application Preparation

2008

Application Submission Deadline

2008

AAHRPP Council Meeting

2009M

arch

- J

uly

Au

gu

st

Jan

uar

y

AAHRPP Site Visit

2009

Mar

ch

Closing Thought“My challenge to leaders of academic medical centers,university presidents, and everyone else involved in theoversight of… research is to take the responsibility, and thenecessary actions, to strengthen the conduct of research attheir institutions.

Above all, [this] means providing IRBs… with the stature,authority and resources they need to do their jobs.”

Donna Shalala, Secretary DHHSNew Engl J Med, Sept 2000