The University of Miami

1. The University of Miami HSRO Strategic Plan February 2007

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 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. 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 enhance our 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 • Develop systems that employ best practices and consistently support the research enterprise • Provide appropriate resources for the HSRO • Develop an understanding of the IRB and related regulatory issues • Develop appropriate training opportunities and support for eProst system

10. Organizational Themes • Develop a commitment to quality customer service and response to stakeholders • Develop and set high standards of performance and professionalism • Build trust in the administration of the HSRO • Design an integrated research system (clinical and non-clinical)

11. Organizational Themes • Build a training curriculum 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 internal and external stakeholders regarding regulations, requirements and policy

12. U Operational Model for Human Subjects Research Office IRB Chairs Dr. Ofelia Alvarez Dr. Charles Carver Dr. Thomas Sick Assistant Provost for IRB Affairs Dr. Stephen Richman Kelly Insignares MBA, CIM, CIP Executive Director Associate Directorfor Regulatory Affairs and Educational Initiatives Amanda Coltes-Rojas Vice Provost Dr. Myron Rosenthal M Human Subjects Research Protection Program Office Of Research Compliance Office of Research Training & Education, HSCOIC Ethics Program, Privacy Office, Ancillary Committees Associate Director for Business and Operations Zuny Fernandez Information Technology Assistant Director Adrian Boloix Office Manager Kenia Viamonte Finance Manager II - TBA Sr. Staff Associate – Amanda Dufau Staff Associate – Paul Neil Privacy & Regulatory Affairs Assistant Director Evelyne Bital Marisel Valdes –Sr. Staff Assistant Receptionist – Mireya Diaz De Arce – Sr. Staff Associate Yaslaime Fraga – Staff Assistant TBA – Staff Assistant Software Spec. - Jared Miller Software Spec. – Leandro Guzman Staff Associate – Daniel Auguste Educational Initiatives Assistant Director Marisabel Davalos TBA – IT Education Trainer IRB Regulatory Specialist – Simonnette Thompson IRB Regulatory Specialist – Dawn Stoutt IRB Regulatory Specialist – Cynthia Trebb IRB Specialist – Jose Casanova IRB Specialist – Yoko Young Sang A01 – IRB Specialist – TBA A01 – IRB Specialist – TBA A01 – IRB Specialist – TBA Vivienne Carrasco – Sr. Regulatory Analyst Sonya Hadrigan – Sr. Regulatory Analyst Meghan Stein – Sr. Regulatory Analyst Natalie Francis – Regulatory Analyst Alexis Clasca – Regulatory Analyst 3/1/07 CONFIDENTIAL February 2007

13. 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’s approval • Update performance against the plan to the Provost and institutional leadership

14. Administration

15. IRB Affairs

16. IRB Affairs

17. Regulatory Affairs • Amanda Coltes-Rojas, MPH • Associate Director for Regulatory Affairs & Educational Initiatives • Evelyne Bital, MA • Assistant Director for Privacy & Regulatory Affairs • Marisabel Davalos, M.S. ED • Assistant Director of Educational Initiatives • TBA- IT Education Trainer

18. Regulatory Affairs

19. Regulatory Affairs

20. Regulatory Affairs

21. Privacy and Regulatory Affairs

22. Privacy and Regulatory Affairs

23. Privacy and Regulatory Affairs

24. Educational Initiatives

25. Educational Initiatives

26. Educational Initiatives

27. Operations - Finance • Zuny Fernandez • Associate Director for Business & Operations • TBA- Finance Manager • Amanda Dufau • Paul Neil

28. Finance The Role of the Finance Team • Collect and record all WIRB invoices and IDR submissions into three spreadsheet databases • Reconcile invoice payments with IRB submissions and IDRs • Ensure weekly payment to WIRB • Reconcile invoice spreadsheets with weekly WIRB open invoice trial balance

29. Finance The Role of the Finance Team • Responsible for maintaining and sending bi-weekly translation summaries to each department administrator • Ensure appropriate approvals, amounts and accounts are accurately documented • Process payments and IDR submissions, reconcile payment and revenue accounts on weekly basis • Maintain files of all fees/payments to provide backup documentation and customer service

30. Finance The Role of the Finance Team • Responsible for generating eProst and DMAS financial reports • Maintain oversight of HSRO fee schedule and annual plan • Communicate fee schedule updates to HSRO staff and research community • Reconcile actual account balances to budgeted plan (four dept. accounts)

31. Finance

32. Finance

33. Operations - Business • Zuny Fernandez • Associate Director for Business & Operations • Operations & Finance Team • Office Management

34. 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

35. Operations - Business

36. Operations Review Function The Role of Operations Team includes: • Interpreting and applying federal and state laws, regulations, institutional policies and guidelines to protect human subjects and to ensure institutional compliance • Informed consent form pre review and edit, intake process, pre review (grant application, award, Clinical Trial Agreement, protocol, ICF) consistency among the various documents including regulatory requirements • Ensuring the Informed Consent form is appropriate - readability and compliance with regulations

37. Operations Team Function The Role of Operations Team includes: • IDR’s – ensure internal billing requisition is submitted and provided to the Finance Staff 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. • Board documentation / minute taking

38. Operations Review Function The Role of Operations Team includes: • Responsible for ensuring all tracking information is accurate and validated in eprost system. • Ensure appropriate approvals (ancillary committee approvals) are documented • Ensure required agreements (outside facility use and collaborator) are provided and executed prior to protocol processing • Cross Training Among Operation Functions

39. Operations Review Team • Ms. Simonnette Thompson • Ms. Dawn Stoutt • Ms. Cynthia Trebb • Mireya De Arce

40. Operations – Review Function

41. Operations – Review Function

42. Regulatory Analysts • Vivienne Carrasco, MPH – Sr. Regulatory Analyst • Sonya Hadrigan – Sr.Regulatory Analyst • Meghan Stein – Sr. Regulatory Analyst • Natalie Francis– Regulatory Analyst • Alexis Clasca– Regulatory Analyst

43. Regulatory Analysts The Role of the Regulatory Analysts • To support the board with expert regulatory advice and manage protocol agenda • To pre-screen all protocol submissions for regulatory compliance • To facilitate regulatory compliance with investigators and their staffs • To provide education and training to IRB members, internal staff and university community • To review and approve final reports and informational amendments

44. Regulatory Review Function

45. Regulatory Review Function

46. Operations Review Function The Role of Operations Team includes: • 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 Finance Staff for billing purposes

47. Operations Review Function The Role of Operations Team includes: • 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, documentation requests, suspension notices, clearance functions. • Cross training among Operation functions

48. Operations Review Team • Joey Casanova • Yoko Young Sang • TBA – IRB Coordinator • TBA – IRB Coordinator • TBA – IRB Coordinator

49. Operations – Review Function

50. Office Management Team • Ms. Kenia Viamonte • Office Manager • Mireya Diaz De Arce- Sr. Staff Associate • Marisel Valdes- Staff Associate • Yaslaime Fraga- Sr. Staff Assistant • TBA- Sr. Staff Assistant