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. Operational Model for Human Subjects Research Office 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 Finance Manager II - TBA Sr. Staff Associate – Amanda Dufau Staff Associate – Paul Neil Vice Provost Dr. Myron Rosenthal Human Subjects Research Protection Program U M Kelly Insignares MBA, CIM, CIP Executive Director Associate Director for Business and Operations Zuny Fernandez February 2007 Office Manager Kenia Viamonte Associate Director for Regulatory Affairs and Educational Initiatives Amanda Coltes-Rojas Assistant Provost for IRB Affairs Dr. Stephen Richman Marisel Valdes –Sr. Staff Assistant Receptionist – Mireya Diaz De Arce – Sr. Staff Associate Yaslaime Fraga – Staff Assistant TBA – Staff Assistant Educational Initiatives Assistant Director Marisabel Davalos Privacy & Regulatory Affairs Assistant Director Evelyne Bital 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 CONFIDENTIAL Information Technology Assistant Director Adrian Boloix IRB Chairs Dr. Ofelia Alvarez Dr. Charles Carver Dr. Thomas Sick Office Of Research Compliance Office of Research Training & Education, HSCOIC Ethics Program, Privacy Office, Ancillary Committees Software Spec. - Jared Miller Software Spec. – Leandro Guzman Staff Associate – Daniel Auguste TBA – IT Education Trainer

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 TaskGoalTimeframe Department Clinical Research Coordinators Implement an ongoing forum to update and enhance the skills of HSRO liaisons. 1 st Q 2007 CommunicationImplement a University wide communication program regarding HSRO initiatives, restructuring, services, changes, etc Ongoing – presentations, newsletter and updates on HSRO website

15. IRB Affairs TaskGoalTimeline Evaluation of IRB Member Performance Establish a yearly evaluation process that includes feedback from peers, IRB Administrators, Chairs and Assistant Provost 2 nd Q 2007 Board MembershipIdentify and appoint IRB Chairs – appoint and select board members for 3 rd Medical Board 1 st Q 2007

16. IRB Affairs TaskGoalTimeline Skills DevelopmentDevelop program to enhance Board member review skills Ongoing Education / Skills Development To develop a practical based HSRO educational program for IRB Members Ongoing – incorporated educational items as ongoing discussion item at IRB meetings IRB Board RetreatsDevelop a forum to review updates in regulations and explore options related board development 1 st Q 2007

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 TaskGoalTimeline Policy DevelopmentCommunicate and educate internal and external staff on policy / regulatory changes Ongoing – updated policies on HSRO website and HSRO eNewsletter Professional Development Develop in-service training programs to enhance staff skill set of HSRO related issues Ongoing – instituted weekly internal educational sessions on reg. topics Internal Templates and Forms Develop enhanced checklist and reviewer tools, processes, and systems Ongoing – updates implemented thru approved processes

19. Regulatory Affairs TaskGoalTimeline Policy and Procedures Develop and implement updated HSRO policies and procedures – SOPs (updates to current version) Ongoing Conflict of Interest Committee Provide administrative support to the HSCOIC. Ongoing FWA and IRB registration Management Conduct ongoing management of UM’s FWA; Update FWA/IRB registrations (when needed) Ongoing

20. Regulatory Affairs TaskGoalTimeline Quality Improvement / Assurance and Review Develop procedures to ensure quality of review and evaluation as well as consistency among the IRBs Ongoing – instituted interim QA regulatory internal check

21. Privacy and Regulatory Affairs TaskGoalTimeline HIPAA Security Program Implementation of research security related policies Draft SOP 1 st Q 2007 Completed Communication Update HSRO website with HIPAA related material Identify issues/topics to be added to education program Ongoing

22. Privacy and Regulatory Affairs TaskGoalTimeline Quality Assurance Plan Develop a program of ongoing quality assurance and quality improvement Ongoing Privacy ReviewDevelop evaluation process of the effectiveness of HSRO’s regulatory files 1 st Q 2007 Quality ImprovementPartner w/ORCA to conduct routine evaluation to determine whether investigators implement protocols as approved by the IRB Ongoing

23. Privacy and Regulatory Affairs TaskGoalTimeline Privacy/Research Education Provide web-based research related HIPAA training for researchers 1 st Q 2007 HSRO NewsletterContribute article regarding HIPAA and privacy-related topics to the HSRO eNews on a monthly basis Ongoing

24. Educational Initiatives TaskGoalTimeline StaffingRecruit IT Education Coordinator1 st Q 2007 HSRO NewsletterPlan and publish HSRO eNews on a monthly basis (3 rd week of each month) Ongoing eProstPlan training sessions for guiding users through the eProst redeployment phases Ongoing

25. Educational Initiatives TaskGoalTimeline eProstDevelop user training module for NetLearning 1 st Q 2007 External Expert Seminars Begin a series of training sessions with outside experts regarding common regulatory issues – possible via web cast delivery model Ongoing – Twice a year

26. Educational Initiatives TaskGoalTimeline Ad-Hoc Policy and Procedures Committee Develop process and chair meetings of the Ad-Hoc P&P Committee to review and provide suggestions for P&P revisions Ongoing AAHRPP Accreditation Develop plan of action for the accreditation initiative of the UM HRPP 1 st Q 2007

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 TaskGoalTimeframe Protocol Processing Fee Schedule Implement new fee schedule and fully automated cost recovery system 2 nd Q 2007 Budget Model and Revenue Generation Ensure revenue goal is met within projected 12 month period Ongoing WIRB invoicing and processing Ensure timely processing of all WIRB invoices and cost recovery Ongoing – working on non-translation invoices

32. Finance TaskGoalTimeframe WIRB Protocol Processing Re- acquisition Schedule Management of full board protocol re-acquisition from WIRB - based on study expiration timeline Ongoing WIRB Continuing Review Notification Send monthly reminder notices for protocols continuing at WIRB Ongoing CommunicationUpdate HSRO e-news with fee related announcements/finance related initiatives Ongoing

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

34. Operational Goal Deliver 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

35. Operations - Business TaskGoalTimeline Workflow and Process Design Recommend and develop workflows based on current staffing numbers and capabilities Ongoing Recruitment / Retention Fill open positions, set standards / expectations and reward high levels of performance Ongoing

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 TaskGoalTimeline Informed ConsentA process for reviewing the ICF ensuring compliance with regulatory criteria / readability / content consistency between CTA, grant, ICF, authorization, protocol 1 st Q 2007 (glossary) Data ValidationEnsure information captured in eprost is complete and appropriate justification received Ongoing (as submissions received) Turnaround TimeAny submissions received will be reviewed and triaged within 24 hours (intake acknowledgement) 4-6 weeks

41. Operations – Review Function TaskGoalTimeline Quality Control and Consistency To compare initial approved study with subsequent periodic reports / continuing reports / amendments to ensure protocol review decision is appropriate in conjunction with Assistant Director of Privacy & Regulatory Affairs Ongoing random checks

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 TaskGoalTimeline Internal IRB Regulatory Consultant Develop internal expertise by providing updates on guidance documents, regulations and current issues Ongoing EducationPartner with IRB Regulatory Specialist’s to provide guidance on exempt & expedited reviews 1 st Q 2007 (Ongoing)

45. Regulatory Review Function TaskGoalTimeline Full Board Submissions & Board Management Pre-review and prepare all submissions requiring review by the convened IRB; provide expert guidance to the IRB Ongoing Informational Amendments To review and approve informational amendments according to HSRO policy Ongoing Final ReportsTo review currently pending final reports and appropriately close the study – pending reports 1 st Q 2007 DocumentationEnsure minutes for meetings are appropriate and complete (content, determinations/ regulatory compliance) Ongoing

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

49. Operations – Review Function TaskGoalTimeline Suspension ActivityEnsure suspension letters are sent the day a study expires Ongoing

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

51. Office Management Function Coordinate and facilitate comprehensive office management of the HSRO Provide assistance in all HR matters Responsible for overall function and operation of protocol filing system and Front Desk area Maintenance of personnel files Coordinate all HSRO special events Support major University-wide projects United Way fundraising Job Fairs

52. Office Management Function Audit Component… Liaison between HSRO and ORCA Serve as point of contact for prepping protocol for directed or routine ORCA audits Maintain open line of communication between ORCA, Vice-Provost, Executive Director, Associate Director of Regulatory Affairs & Educational Initiatives & Regulatory Analysts Responsible for closing loop in audit process to ensure audit files are complete and that any/all action pending is taken

53. Office Management Function Board Management… Maintenance of IRB Member information, meeting agendas & board approved minutes, rosters Archive Board Meeting attendee lists and exempt/expedited reports Conflict of Interest (COI) component… Responsible for creating & maintaining committee member information and all relevant updates Creating and maintaining COI files as necessary

54. Operations – Office Management TaskGoalTimeline File Conversion (Phase II)New Tab/Color coded system differentiating WIRB and Internal protocol files pursuant to new file policy *COMPLETE UNIFORMITY Ongoing ScanningScanning and indexing of closed protocol files On-going

55. Operations – Office Management TaskGoalTimeline Board Maintain monthly calendar of office hours and updated member files IRB Member Compensation system- processing Boar Member evaluations-development and initial planning Ongoing 1 st Q 2007 Additional StaffingPost/recruit and hire additional Staff Support1 st Q 2007 Team DevelopmentDevelopment plan for Office Management Team (ie Continuing Education opportunities etc.) 1 st Q 2007

56. Operations - IT Team Adrian Boloix Assistant Director Information Technology, HSRO Stella Uyeno – Web Services Jared Miller– Software Specialist Leandro Guzman -Software Specialist Daniel Auguste – Staff Associate

57. Operations - IT Function Design eProst to ensure all regulatory requirements are appropriately captured and documented Develop eProst’s workflow to efficiently standardize and streamline the application and approval process to conduct human subjects research Provide ongoing user support and troubleshooting system issues Cleanup of Y drive

58. Operations - IT Function Ongoing monitoring of security policy and standards to certify that each user has appropriate rights to system features and information – new forms will assist in this endeavor Maintain eProst through 5.2 upgrades and other installations to our software and server – will transfer this process in-house; Updates/transfer to production Design and manage websites, electronic newsletter and updated content

59. System Development – E Prost TaskGoalTimeline Process / WorkflowDefine protocol system workflow- full board review, expedited, exempt and protocol processing; Ophthalmology testing Ongoing Policies/GuidelinesCommunicate updated HSRO policies and procedures to guide system validation and security 1 st Q 2007 Project Plan for E Prost Reactivation Develop a viable implementation plan, unveil project plan – including implementation team, University wide user group 1 st Q 2007

60. System Development – E Prost TaskGoalTimeline Smart formsRedesign *Smart forms *(ongoing) – initial application, continuing reports, amendments, reportable events, adverse events and final reports Ongoing-smart form development Eprost TrainingDevelop online and offline materials, customized to the various user roles – online modules and lab based training; [Sandbox-lab based training] Test - ongoing 1 st Q 2007 Meeting Management Enhancements Design and validate efficiency and effectiveness of fully electronic - online IRB meetings 1 st Q 2007

61. System Development – E Prost User Group Team Members Dr. Richard A. Williams Assistant ChairmanDepartment of Psychology Johanna Stamates R.N. Research Compliance Assessment Mary I. Ishii, Psy.D. Research Asst Professor Department of Psychiatry Lynn Healy Program Assistant III Division of Infectious Diseases Coreen Rodgers Sr. AdministratorDepartment of Ophthalmology Dr. Vinata Lokeshwar Associate Professor Department of Urology Dr. Charles CarverProfessor Department of Psychology Dr. Okhee Lee-Salwen Professor Teaching and Learning Brian Lewis LecturerEducational & Psych Studies

62. System Development – E Prost Major Milestones in the System Implementation Plan Develop new protocol, amendment, continuation, final and reportable events forms Complete new workflows Implement new meeting management features to effectively have online IRB meetings HSRO and users group evaluates new forms and workflow Ophthalmology pilots our improved system for a duration of three months IRB Boards have online board review w/Ophthalmology testing/reviewer notes Build and rollout training program for current and future eProst users in accordance to their role in eProst.

63. Moving Forward Updated Policies and Procedures Online Subcontracts Policy, International Research Policy, HSCOIC and Updates to Prior policies Updated ICF Templates – HSRO website available February 1 st Updated Fee Schedule – coming effective April 1 st Eprost Online Redeployment – Ophthalmology has been up for three months First full board online review February 12 th, 2007 Meeting with Pediatrics and Psychology for redeployment Feedback on forms and workflow Scheduling an External Expert Seminar – Marisabel Davalos Focus on COI AAHRPP Meeting in February to begin preliminary preparations