The University of Miami

1. The University of Miami HSRO Strategic Plan Update December 2007

2. Agenda • HSRO Mission / IRB GoalPhase I – Regulatory Compliance • Phase II – Operational Priorities • Eprost Redeployment Update • WIRB Reacquisition Process • IRB Affairs • AAHRPP Accreditation

3. 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.

4. 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

5. Operational Goal Deliver High Quality Service • Guiding and Supportingthe 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 Implementinghuman research protections training programs on the application of IRB policies and procedures, and Federal regulations and guidelines. • Consultingwith 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

6. Regulatory CompliancePhase I

7. 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

8. U Operational Model for Human Subjects Research Office IRB Chairs Dr. Ofelia Alvarez Dr. Charles Carver Dr. D. Jayaweera Dr. Thomas Sick Vice Provost Myron Rosenthal, PHD Executive Director Kelly Insignares PHD, MBA, CIP Assistant Provost for IRB Affairs Dr. Stephen Richman Associate Directorfor Regulatory Affairs and Educational Initiatives Amanda Coltes-Rojas CIP M Human Subjects Research Protection Program Office Of Research Compliance Assessment Office of Research Training & Education, HSCOIC Ethics Program, Privacy Office, CRIS, Technology Transfer , Ancillary Committees Associate Director for Business and Operations Zuny Fernandez Compliance Liaison Manager Kenia Viamonte Information Technology Senior Systems Administrator Stella Uyeno Finance / Office Manager – Jeanette Laschower Staff Accountant – Amanda Dufau Staff Assoc. – Paul Neil Privacy & Regulatory Affairs Assistant Director Evelyne BitalCIP Educational Initiatives Assistant Director Marisabel Davalos CIP Marisel Valdes – Staff Assistant Receptionist – Mireya Diaz De Arce – Staff Associate Yaslaime Fraga – Staff Asst. Programmer - Leandro Guzman Business Systems Analyst – TBA Help desk Tech. Sr. – Daniel Auguste Education Coordinator Joey Casanova 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 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%) DEC 2007

9. 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.”

10. Operational PrioritiesPhase II

11. Major Objectives

12. 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

13. 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

14. Re-Acquisition of Studies

15. 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

16. IRB Affairs

17. 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

18. 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 Institutional Review Boards

19. AAHRPP Accreditation

20. 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

21. 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

22. 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.

23. 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

24. 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.

25. 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

26. 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

27. 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)

28. 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”

29. 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!

30. HSRO TIMELINE ACCREDITATION Self-Assessment Complete 2008 Application Submission Deadline 2008 AAHRPP Council Meeting 2009 March - July January August February March September Self-Assessment Begins 2007 Application Preparation 2008 AAHRPP Site Visit 2009

31. 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