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 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

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

UM

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 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 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 – 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 Initiatives

TBA- 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 Timeline

Privacy/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