The University of Miami
HSRO Strategic PlanFebruary 2007
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
HSRO MissionProtecting 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 ObjectiveTo 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
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”
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
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
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
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
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)
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
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
UMKelly 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 SangA01 – IRB Specialist – TBAA01 – IRB Specialist – TBAA01 – 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 MillerSoftware Spec. – Leandro
GuzmanStaff Associate – Daniel
Auguste
TBA – IT Education Trainer
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
AdministrationTask Goal Timeframe
Department Clinical Research Coordinators
Implement an ongoing forum to update and enhance the skills of HSRO liaisons.
1st Q 2007
Communication Implement a University wide communication program regarding HSRO initiatives, restructuring, services, changes, etc
Ongoing – presentations, newsletter and updates on HSRO website
IRB Affairs
Task Goal Timeline
Evaluation of IRB Member Performance
Establish a yearly evaluation process that includes feedback from peers, IRB Administrators, Chairs and Assistant Provost
2nd Q 2007
Board Membership Identify and appoint IRB Chairs – appoint and select board members for 3rd Medical Board
1st Q 2007
IRB Affairs
Task Goal TimelineSkills Development Develop program to enhance
Board member review skillsOngoing
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 Retreats Develop a forum to review updates in regulations and explore options related board development
1st Q 2007
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 InitiativesTBA- IT Education Trainer
Regulatory AffairsTask Goal Timeline
Policy Development Communicate 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
Regulatory AffairsTask Goal Timeline
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
Regulatory AffairsTask Goal Timeline
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
Privacy and Regulatory AffairsTask Goal Timeline
HIPAA Security Program
Implementation of research security related policies
Draft SOP
1st Q 2007
CompletedCommunication Update HSRO website with
HIPAA related materialIdentify issues/topics to be added to education program
Ongoing
Privacy and Regulatory AffairsTask Goal Timeline
Quality Assurance Plan
Develop a program of ongoing quality assurance and quality improvement
Ongoing
Privacy Review Develop evaluation process of the effectiveness of HSRO’s regulatory files
1st Q 2007
Quality Improvement Partner w/ORCA to conduct routine evaluation to determine whether investigators implement protocols as approved by the IRB
Ongoing
Privacy and Regulatory Affairs
Task Goal TimelinePrivacy/Research Education
Provide web-based research related HIPAA training for researchers
1st Q 2007
HSRO Newsletter Contribute article regarding HIPAA and privacy-related topics to the HSRO eNews on a monthly basis
Ongoing
Educational InitiativesTask Goal Timeline
Staffing Recruit IT Education Coordinator 1st Q 2007
HSRO Newsletter Plan and publish HSRO eNews on a monthly basis (3rd week of each month)
Ongoing
eProst Plan training sessions for guiding users through the eProst redeployment phases
Ongoing
Educational InitiativesTask Goal Timeline
eProst Develop user training module for NetLearning
1st 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
Educational InitiativesTask Goal Timeline
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
AAHRPPAccreditation
Develop plan of action for the accreditation initiative of the UM HRPP
1st Q 2007
Operations - Finance Zuny Fernandez
Associate Director for Business & Operations TBA- Finance Manager Amanda Dufau Paul Neil
FinanceThe 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
FinanceThe 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
FinanceThe 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)
FinanceTask Goal Timeframe
Protocol Processing Fee Schedule
Implement new fee schedule and fully automated cost recovery system
2nd 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
FinanceTask Goal Timeframe
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
Communication Update HSRO e-news with fee related announcements/finance related initiatives
Ongoing
Operations - Business Zuny Fernandez
Associate Director for Business & Operations Operations & Finance Team Office Management
Operational GoalDeliver 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
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 standards / expectations and reward high levels of performance
Ongoing
Operations Review FunctionThe 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
Operations Team FunctionThe 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
Operations Review FunctionThe 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
Operations Review Team Ms. Simonnette Thompson Ms. Dawn Stoutt Ms. Cynthia Trebb Mireya De Arce
Operations – Review FunctionTask Goal Timeline
Informed Consent A process for reviewing the ICF ensuring compliance with regulatory criteria / readability / content consistency between CTA, grant, ICF, authorization, protocol
1st Q 2007(glossary)
Data Validation Ensure information captured in eprost is complete and appropriate justification received
Ongoing (as submissions received)
Turnaround Time Any submissions received will be reviewed and triaged within 24 hours (intake acknowledgement)
4-6 weeks
Operations – Review Function
Task Goal Timeline
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
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
Regulatory AnalystsThe 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
Regulatory Review Function
Task Goal TimelineInternal IRB Regulatory Consultant
Develop internal expertise by providing updates on guidance documents, regulations and current issues
Ongoing
Education Partner with IRB Regulatory Specialist’s to provide guidance on exempt & expedited reviews
1st Q 2007(Ongoing)
Regulatory Review FunctionTask 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 reports and appropriately close the study – pending reports
1st Q 2007
Documentation Ensure minutes for meetings are appropriate and complete (content, determinations/ regulatory compliance)
Ongoing
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
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
Operations Review Team Joey Casanova Yoko Young Sang TBA – IRB Coordinator TBA – IRB Coordinator TBA – IRB Coordinator
Operations – Review FunctionTask Goal Timeline
Suspension Activity Ensure suspension letters are sent the day a study expires
Ongoing
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
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
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
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
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 Scanning and indexing of closed protocol files
On-going
Operations – Office Management
Task Goal TimelineBoard Maintain monthly calendar of office hours and
updated member filesIRB Member Compensation system-processingBoar Member evaluations-development and initial planning
Ongoing
1st Q 2007
Additional Staffing Post/recruit and hire additional Staff Support 1st Q 2007
Team Development Development plan for Office Management Team (ie Continuing Education opportunities etc.)
1st Q 2007
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
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
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
System Development – E ProstTask Goal Timeline
Process / Workflow Define protocol system workflow- full board review, expedited, exempt and protocol processing; Ophthalmology testing
Ongoing
Policies/Guidelines Communicate updated HSRO policies and procedures to guide system validation and security
1st Q 2007
Project Plan for E Prost Reactivation
Develop a viable implementation plan, unveil project plan – including implementation team, University wide user group
1st Q 2007
System Development – E ProstTask 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 materials, customized to the various user roles – online modules and lab based training; [Sandbox-lab based training] Test - ongoing
1st Q 2007
Meeting Management Enhancements
Design and validate efficiency and effectiveness of fully electronic - online IRB meetings
1st Q 2007
System Development – E ProstUser Group Team Members
Dr. Richard A. Williams Assistant Chairman Department 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. Administrator Department of Ophthalmology Dr. Vinata Lokeshwar Associate Professor Department of Urology Dr. Charles Carver Professor Department of Psychology Dr. Okhee Lee-Salwen Professor Teaching and Learning Brian Lewis Lecturer Educational & Psych Studies
System Development – E ProstMajor 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.
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 1st Updated Fee Schedule – coming effective April 1st
Eprost Online Redeployment – Ophthalmology has been up for three months
First full board online review February 12th, 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