The University of Miami HSRO Strategic Plan February

The University of Miami HSRO Strategic Plan February 2007

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

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.

IRB Goal and Objective To protect the rights and welfare of those individuals who contribute to the research process by participating as subjects. n n n 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

Plan Objectives n n 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”

Plan Objectives n n n 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

University Strategic Plan Highlights n n 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 n n n 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

HSRO Strategic Plan Highlights n Build a research support infrastructure within the HSRO. n n 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. n Requires recruiting and filling current open positions to support the vision - top priority

Organizational Themes n n 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 e. Prost system

Organizational Themes n n 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)

Organizational Themes n n n 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

UM Operational Model for Human Subjects Research Office Vice Provost Human Subjects Research Protection Program Dr. Myron Rosenthal Assistant Provost for IRB Affairs Kelly Insignares MBA, CIM, CIP Office Of Research Compliance Office of Research Training & Education, HSCOIC IRB Chairs Executive Director Ethics Program, Privacy Office, Ancillary Committees Dr. Stephen Richman Dr. Ofelia Alvarez Dr. Charles Carver Associate Director for Business and Operations Zuny Fernandez Office Manager Kenia Viamonte Marisel Valdes –Sr. Staff Assistant Receptionist – Mireya Diaz De Arce – Sr. Staff Associate Yaslaime Fraga – Staff Assistant TBA – Staff Assistant Associate Director for Regulatory Affairs and Educational Initiatives Amanda Coltes-Rojas Finance Manager II - TBA Sr. Staff Associate – Amanda Dufau Staff Associate – Paul Neil Privacy & Regulatory Affairs Assistant Director Evelyne Bital Educational Initiatives Assistant Director IRB Regulatory Specialist – Cynthia Trebb IRB Specialist – Jose Casanova IRB Specialist – Yoko Young Sang A 01 – IRB Specialist – TBA February 2007 Information Technology Assistant Director Adrian Boloix Software Spec. - Jared Miller Software Spec. – Leandro Guzman Staff Associate – Daniel Auguste Marisabel Davalos TBA – IT Education Trainer IRB Regulatory Specialist – Simonnette Thompson IRB Regulatory Specialist – Dawn Stoutt Dr. Thomas Sick 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

HSRO Operational Plan n 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

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

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

IRB Affairs Task Goal Timeline Skills Development Develop program to enhance Board member review skills Ongoing Education / Skills Development To develop a practical based HSRO educational program for IRB Members Ongoing – IRB Board Retreats Develop a forum to review updates in regulations and explore options related 1 st Q 2007 incorporated educational items as ongoing discussion item at IRB meetings

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

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

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

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

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

Privacy and Regulatory Affairs Task Goal Timeline Quality Assurance Develop a program of Plan ongoing quality assurance and quality improvement Ongoing Privacy Review Develop evaluation process of the effectiveness of HSRO’s regulatory files 1 st Q 2007 Quality Improvement Partner w/ORCA to conduct routine evaluation to determine whether investigators implement Ongoing

Privacy and Regulatory Affairs Task Goal Timeline Privacy/Research Education Provide web-based research 1 st Q 2007 related HIPAA training for researchers HSRO Newsletter Contribute article regarding HIPAA and privacy-related topics to the HSRO e. News on a monthly basis Ongoing

Educational Initiatives Task Staffing HSRO Newsletter e. Prost Goal Timeline Recruit IT Education Coordinator Plan and publish HSRO e. News on a monthly basis (3 rd week of each month) 1 st Q 2007 Plan training sessions for guiding users through the e. Prost redeployment phases Ongoing

Educational Initiatives Task Goal Timeline e. Prost Develop user training module for Net. Learning 1 st Q 2007 External Expert Seminars Begin a series of training Ongoing – sessions with outside Twice a year experts regarding common regulatory issues – possible via web cast delivery model

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

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

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

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

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

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

Finance Task WIRB Protocol Processing Reacquisition Schedule WIRB Continuing Review Notification Communication Goal Management of full board protocol re-acquisition from WIRB - based on study expiration timeline Send monthly reminder notices for protocols continuing at WIRB Timeframe Ongoing Update HSRO e-news with Ongoing fee related announcements/finance

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

Operational Goal Deliver High Quality Service n 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. n Developing and Implementing human research protections training programs on the application of IRB policies and procedures, and Federal regulations and guidelines. n 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. n Continual Learning of Investigators and key study personnel resulting in an up-to-date and knowledgeable research community in human research protections

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

Operations Review Function The Role of Operations Team includes: n Interpreting and applying federal and state laws, regulations, institutional policies and guidelines to protect human subjects and to ensure institutional compliance n 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 n Ensuring the Informed Consent form is appropriate readability and compliance with regulations

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

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

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

Operations – Review Function Task Goal Timeline Informed Consent A process for reviewing the ICF 1 st Q 2007 ensuring compliance with (glossary) regulatory criteria / readability / content consistency between CTA, grant, ICF, authorization, protocol Data Validation Ensure information captured in Ongoing (as eprost is complete and appropriate submissions justification received) Turnaround Time Any submissions received will be reviewed and triaged within 24 hours (intake acknowledgement) 4 -6 weeks

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

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

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

Regulatory Review Function Task Goal Timeline Internal IRB Regulatory Consultant Develop internal expertise by providing updates on guidance documents, regulations and current issues Ongoing Education Partner with IRB Regulatory 1 st Q 2007 Specialist’s to provide guidance on (Ongoing) exempt & expedited reviews

Regulatory Review Function Task Goal Timeline 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 Reports To review currently pending final 1 st Q 2007 reports and appropriately close the study – pending reports Documentation Ensure minutes for meetings are appropriate and complete (content, determinations/ Ongoing

Operations Review Function The Role of Operations Team includes: n Interpreting and applying federal and state laws, regulations, institutional policies and guidelines to protect human subjects and to ensure institutional compliance n Board documentation / minute taking, informed consent form post review, post decision review to ensure consistency among the decision and the regulatory letter of determination n Regulatory documentation to support internal billing requisitions are to be submitted and provided to the Finance Staff for billing purposes

Operations Review Function The Role of Operations Team includes: n 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. n Responsible for status requests, documentation requests, suspension notices, clearance functions. n Cross training among Operation functions

Operations Review Team n n n Joey Casanova Yoko Young Sang TBA – IRB Coordinator

Operations – Review Function Task Suspension Activity Goal Ensure suspension letters are sent the day a study expires Timeline Ongoing

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

Office Management Function n n n n 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

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

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

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

Operations – Office Management Task Board Additional Staffing Goal n. Maintain Timeline monthly calendar of office hours and updated member files n. IRB Member Compensation systemprocessing n. Boar Member evaluationsdevelopment and initial planning Ongoing Post/recruit and hire additional Staff Support 1 st Q 2007 Team Development plan for Office Management Team (ie Continuing Education opportunities etc. ) 1 st Q 2007

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

Operations - IT Function n n Design e. Prost to ensure all regulatory requirements are appropriately captured and documented Develop e. Prost’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

Operations - IT Function n 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 e. Prost 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

System Development – E Prost Task Goal Timeline Process / Workflow Define protocol system workflowfull board review, expedited, exempt and protocol processing; Ophthalmology testing Ongoing Policies/Guidelines Communicate 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

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

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

System Development – E Prost Major Milestones in the System Implementation Plan n n n 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 e. Prost users in accordance to their role in e. Prost.

Moving Forward n n n Updated Policies and Procedures Online n 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 th n First full board online review February 12 , 2007 n Meeting with Pediatrics and Psychology for redeployment n Feedback on forms and workflow Scheduling an External Expert Seminar – Marisabel Davalos n Focus on COI AAHRPP Meeting in February to begin preliminary preparations