The University of Miami

1. The University of Miami HSRO Strategic Plan October 20th, 2005

2. Agenda • HSRO Mission / IRB Goal • Plan Objectives • UM / HSRO Strategic Plan Highlights • Organizational Themes • HSRO Operational Plan • Regulatory Affairs, IRB Affairs, System Development, Educational and Regulatory Recruitment

3. HSRO Mission Protecting the safety, rights, and welfare of human research participants through: Collaboration 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. Plan Objectives • Align and ensure activities are compliant with regulatory, funding, and any other applicable governing / funding / regulatory bodies • Align HSRO activities with the institutional goals and objectives related to the research enterprise • Focus and apply HSRO resources on activities that advance programs for human subjects protection = the institutional vision • Implement customer support services to the institution and develop credibility as we create the “role model for IRB administration”

6. Plan Objectives • Deliver comprehensive educational training and development initiatives that proactively serve HSRO stakeholders • Develop an Integrated Research Information System that includes ancillary committees, participant tracking and protocol submissions • Build and preserve the trust of our stakeholders

7. University Strategic Plan Highlights • To develop a comprehensive Human Subjects Protection Program • Move the University of Miami to the top ranks of institutions of higher education within this decade • Top 20 nationally in terms of NIH funding in ten years • Create the synergy necessary in order to develop and maintain extramural funding • Develop translational research opportunities

8. HSRO Strategic Plan Highlights • Build a research support infrastructure within the HSRO. • An integrated research information management system: includes (eprost), consolidated research services, proactive research related educational programs, and an improved overall protocol submission system. • Designing and developing an infrastructure (operations, workflow and personnel) that will support the research mission today and in the future. • Requires recruiting and filling current open positions to support the vision - top priority

9. Organizational Themes • Systems do not employ best practices or consistently support the research enterprise • Prior lack of appropriate resources for the HSRO • Prior lack of understanding in regards to the IRB and related issues • Lack of appropriate training opportunities and support for eprost system

10. Organizational Themes • Lack of response to stakeholders • Inability to respond to requests • Unsatisfactory levels of work performance • Lack of standards • Eroded trust in the administration of the HSRO

11. Organizational Themes • Need for an integrated research systems (clinical and non-clinical) • Need for a proactive skill and competency development program for core clinical research coordinators • Develop workflows, policies and processes which are well defined and communicated • Educate staff regarding high quality customer service

12. HSRO Operational Plan • The plan highlights the department’s goals for the next 18-months • Adjustments to the plan may occur with the Vice Provost approval • Update performance against the plan to the institution’s leadership

13. Regulatory Affairs

14. Regulatory Affairs

15. Regulatory Affairs

16. Privacy and Regulatory Affairs

17. Educational Initiatives

18. IRB Affairs

19. IRB Affairs

20. IRB Affairs

21. System Development – E Prost

22. HSRO IT Team • Charlene Estevez , Database Tech Specialist • Rosemary Alvarado, Database Tech Specialist • Stella Uyeno, Software Specialist (MWS) • Eva Molina, Help Desk

23. Administration

24. 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

25. Operations

26. U Operational Model for Human Subjects Research Office Assistant Provost for IRB Affairs Dr. Stephen Richman Directorfor Regulatory Affairs and Educational Initiatives Judith Aguirre Executive Vice President and Provost Dr. Tom LeBlanc Executive Director for HSRO Business / Operations Kelly Insignares Vice Provost Myron Rosenthal, Ph.D. IRB Chairs Dr. Stephen Sapp Dr. Thomas Sick Dr. Ofelia Alvarez M Human Subjects Research Protection Program HSRO / IRB Mission Office Of Research Compliance Office of Research Training & Education Ethics Program, Privacy Office Ancillary Committees A01 – Vanessa Leyton – Mgr IV- eff. 11/1/05 A01 – Evelyn Bital - Mgr IV – eff. 11/1/05 A01 – Amanda Coltes-Rojas - Mgr IV – eff. 11/1/05 A01 – Marisabel Davalos- Asst Mgr III – eff. 7/11/05 A01 – Mike Bingham – Asst. Mgr. III – eff. 11/28/05 Educational Initiatives Associate Director IV –Julia Beutler– 11/7/05 A03 – Sr. Staff Associate Associate Director IV – TBA - 08/05 Operations and Finance PRE BOARD POST BOARD Associate Director IV – TBA - 09/05 Privacy & Regulatory Affairs Pre Board Review Manager – effective 10/05 – Z. Fernandez A01 – Coordinator IV – effective 8/05 – J. Addison A01 – Coordinator IV – V. Carrasco – effective 10/05 2 A03 – Sr. Staff Associates TBA – Sr. Staff Associate Paul Neil – Staff Associate Post Board Review Manager – effective 10/05 – S. Hadrigan A01 – Coordinator IV – L. Verdaguer – effective 8/05 A01 – Coordinator IV – TBA – effective 9/05 2 A03 - Sr. Staff Associates #027697 – Alice Nielsen #026505 – Dena McCarthy Information Technology DB Tech Spec. - C Estevez DB Tech Spec. – R. Alvarado Sr. Staff Asst. – Elvia Molina Office Manager Kenia Viamonte Marisel Valdez – Staff Asst. Daniel Auguste – Staff Asst. Receptionist – Mireya Diaz De Arce – Sr. Staff Associate A03 – Sr. Staff Associate – TBA A03 – Sr. Staff Associate – TBA- Posted 3/05 10/05

27. Pre Board Review Function • Interpreting and applying federal and state laws, regulations, institutional policies and guidelines to protect human subjects and to ensure institutional compliance • Board documentation / minute taking • Informed consent form pre review and edit, intake process, pre review (grant application, award, protocol, ICF) consistency among the various documents • IDR’s – ensure internal billing requisition is submitted and provided to the Office Manager for billing purposes • Initial record submission data entry in eprost (manual until system up), reportable events review and triage, all WIRB submissions pre review – mailings and initial tracking of the protocols.

28. Pre Board Review Team • Zuny Fernandez, Pre Board Review Manager • John Addison • Vivienne Carrasco • Paul Niel • Mireya Diaz De Arce

29. Regulatory Operations The Role of the Regulatory Analysts • To support the board with regulatory advice and manage protocol agenda • To pre-screen all protocol submissions for regulatory compliance • To facilitate regulatory compliance with investigators and their staffs

30. Regulatory Operations Team IRB Regulatory Analysts • Evelyne Bital • Amanda Coltes • Marisabel Davalos • Vanessa Leyton

31. Post Board Review Function • Interpreting and applying federal and state laws, regulations, institutional policies and guidelines to protect human subjects and to ensure institutional compliance • Board documentation / minute taking, informed consent form post review, post decision review to ensure consistency among the decision and the regulatory letter of determination • Regulatory documentation to support internal billing requisitions are to be submitted and provided to the Office Manager for billing purposes • Post decision submission data entry in eprost (manual until system up), reportable events documentation and filing, all WIRB submissions post decision documentation – regulatory documents, translations, post board determination and review of expiration dates and appropriate follow up and notification of the protocols • Responsible for status requests, suspension notices, clearance functions

32. Post Board Review Team • Sonya Hadrigan – Post Board Review Manager • Lucía Verdaguer • TBA - Coordinator • Dena McCarthy • Alice Nielsen

33. Office Management Function • Coordinate and facilitate comprehensive office management of the HSRO • Provide assistance for Human Resources Issues • Responsible for overall function and operation of protocol filing system and Front Desk area • Maintenance of IRB Member information, SOP’s and meeting minutes • Support major University-wide projects

34. Office Management Team • Kenia Viamonte - Office Manager • Daniel Auguste • Marisel Valdes • Mireya Diaz De Arce

35. Moving Forward • “Research has to be based on the highest standards of responsible conduct, based upon ethical principles by each and every individual taking part. Let me make it unmistakably clear, in case anyone has any doubts. If institutions and individuals fail to accept their responsibilities and in good faith work to achieve them, then they simply should not be permitted to engage in this [research] endeavor.” (Dr. Greg Koski, Director, DHHS OHRP, August 2000.) • “What’s at stake is the integrity of research, and public confidence in that research.” (Donna Shalala, Secretary, Department of Health and Human Services, May 2000.)

36. Closing thought The metaphor of a caterpillar transforming into a butterfly may be romantic, but the experience is an unpleasant one for the caterpillar. In the process of transformation, it goes blind, its legs fall off, and its body is torn apart, as beautiful wings emerge. Similarly, the transformation from a hierarchical bureaucracy to a flexible, self regenerating organization will be painful and requires the enormous courage of its leaders. Thanks for having the courage!