The University of Miami

HSRO Strategic PlanOctober 20th, 2005

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 Mission

Protecting the safety, rights, and welfare of human research participants through:

Collaboration

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 develop a 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

Systems do not employ best practices or consistently support the research enterprise

Prior lack of appropriate resources for the HSRO Prior lack of understanding in regards to the IRB and

related issues Lack of appropriate training opportunities and support

for eprost system

Organizational Themes

Lack of response to stakeholders Inability to respond to requests Unsatisfactory levels of work performance Lack of standards Eroded trust in the administration of the HSRO

Organizational Themes

Need for an integrated research systems (clinical and non-clinical)

Need 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 staff regarding high quality customer service

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 approval

Update performance against the plan to the institution’s leadership

Regulatory Affairs

Task Goal Timeline

Policy Development Communicate and educate internal and external staff on policy / regulatory changes

4th Q 2005

Professional Development

Develop in-service training programs to enhance staff skill set of HSRO related issues

4th Q 2005

Internal Templates and Forms

Develop enhanced checklist and reviewer tools, processes, and systems

Ongoing

Regulatory Affairs

Task Goal Timeline

Policy and Procedures Develop and implement updated HSRO policies and procedures – SOPs (new full version)

1st Q 2006

Compliance Develop procedures to respond to audits and requests for information

4th Q 2005

Participant Advocacy Recommend process for triage and response to participant questions and concerns

4th Q 2005

Regulatory Affairs

Task Goal Timeline

Procedures for Non-compliance

Develop process and appropriate triage to address non-compliance with IRB protocol, research standards and/or medical practice

4th Q 2005

Quality Improvement / Assurance and Review

Develop procedures to ensure quality of review and evaluation

2nd Q 2006

Privacy and Regulatory Affairs

Task Goal Timeline

Staffing Recruit Associate Director for Privacy and Regulatory Affairs

4th Q 2005

Privacy and Regulatory Policy / Quality Assurance Plan

Develop a program of ongoing quality assurance and quality improvement. Develop research privacy related policies and communications plan.

1st Q 2006

Educational Initiatives

Task Goal Timeline

Staffing Recruit Associate Director for Educational Initiatives – Nov.7th, 2005

COMPLETED

Course Development and Training Plan

Develop a core curriculum (HSRO training plan) for HSRO and clinical research personnel related to IRB initiatives incorporating a core clinical research team concept

1st Q 2006

IRB AffairsTask Goal Timeline

Process of Appointments and Evaluation

Develop and implement guidelines that govern membership (CV, Confidentiality agreement , conflict of interest)

COMPLETED

Compensation Develop compensation scheme and mechanism for payment for active IRB members

COMPLETED

Board Membership Identify and appoint IRB Chairs – appoint and select board members ( 2 Medical, 1 Behavioral)

Ongoing

IRB Affairs

Task Goal Timeline

Skills Development Develop program to enhance Board member review skills

4th Q 2005

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 board development

1st Q 2006

IRB Affairs

Task Goal Timeline

Update FWA with new board

Board developed to review and approve revised policies and procedures

COMPLETED

Board Meetings Start up on October 11th, 2005 COMPLETED

Evaluation of IRB Member Performance

Establish a yearly evaluation process that includes feedback from peers, IRB Administrators, Chairs and Assistant Provost

2nd Q 2006

System Development – E Prost

Task Goal Timeline

Process / Workflow and Smart forms

Define protocol system workflow, develop a viable implementation plan and revise *Smart forms* (ongoing)

COMPLETED (workflow)

Policies/Guidelines Communicate updated HSRO policies and procedures to guide system validation and security

1st Q 2006

Project Plan for E Prost Reactivation

Unveil project plan – including implementation team, University wide user group

4th Q 2005

HSRO IT Team

Charlene Estevez , Database Tech Specialist Rosemary Alvarado, Database Tech Specialist Stella Uyeno, Software Specialist (MWS) Eva Molina, Help Desk

Administration

Task Goal Timeline

Department Clinical Research Coordinators

Implement an ongoing forum to update and enhance the skills of HSRO liaisons.

2nd Q 2006

Communication Implement a University wide communication program regarding HSRO initiatives, restructuring, services, changes, etc

Ongoing

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

OperationsTask Goal Timeline

Governance AccountabilitiesStructure

Develop table of organization and office policies. Develop structure with clear accountabilities

COMPLETED

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

Operational Model for Human Subjects Research Office

A01 – Vanessa Leyton – Mgr IV- eff. 11/1/05

A01 – Evelyn Bital - Mgr IV – eff. 11/1/05

A01 – Amanda Coltes-Rojas - Mgr IV – eff.

11/1/05

A01 – Marisabel Davalos- Asst Mgr III – eff. 7/11/05

A01 – Mike Bingham – Asst. Mgr. III – eff.

11/28/05

A03 – Sr. Staff Associate – TBA

A03 – Sr. Staff Associate – TBA- Posted 3/05

Executive Vice President and Provost

Dr. Tom LeBlancHuman Subjects Research Protection

Program

HSRO / IRB Mission

UM

Executive Director for HSRO Business /

Operations

Kelly Insignares

Vice Provost

Myron Rosenthal, Ph.D.

Post Board Review Manager – effective 10/05 – S.

Hadrigan

A01 – Coordinator IV – L. Verdaguer – effective 8/05

A01 – Coordinator IV – TBA – effective 9/05

2 A03 - Sr. Staff Associates

#027697 – Alice Nielsen

#026505 – Dena McCarthy

Associate Director IV – TBA - 08/05

Operations and Finance

10/05

Office Manager

Kenia Viamonte

Director for Regulatory Affairs and Educational

Initiatives

Judith Aguirre

Assistant Provost

for IRB Affairs

Dr. Stephen Richman

Marisel Valdez – Staff Asst.Daniel Auguste – Staff Asst.

Receptionist – Mireya Diaz De Arce – Sr. Staff Associate

Educational Initiatives

Associate Director IV –Julia Beutler– 11/7/05

A03 – Sr. Staff Associate

Associate Director IV – TBA - 09/05

Privacy & Regulatory AffairsPre Board Review Manager –

effective 10/05 – Z. Fernandez

A01 – Coordinator IV – effective 8/05 – J. Addison

A01 – Coordinator IV – V. Carrasco – effective 10/05

2 A03 – Sr. Staff Associates

TBA – Sr. Staff AssociatePaul Neil – Staff Associate

PRE BOARD POST BOARD

Information Technology

DB Tech Spec. - C EstevezDB Tech Spec. – R. Alvarado Sr. Staff Asst. – Elvia Molina

IRB Chairs

Dr. Stephen Sapp

Dr. Thomas Sick

Dr. Ofelia Alvarez

Office Of Research Compliance

Office of Research Training & Education

Ethics Program, Privacy Office

Ancillary Committees

Pre Board Review Function 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 pre review and edit, intake

process, pre review (grant application, award, protocol, ICF) consistency among the various documents

IDR’s – ensure internal billing requisition is submitted and provided to the Office Manager 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.

Pre Board Review Team

Zuny Fernandez, Pre Board Review Manager John Addison Vivienne Carrasco Paul Niel Mireya Diaz De Arce

Regulatory Operations

The Role of the Regulatory Analysts To support the board with regulatory advice

and manage protocol agenda To pre-screen all protocol submissions for

regulatory compliance To facilitate regulatory compliance with

investigators and their staffs

Regulatory Operations Team

IRB Regulatory Analysts Evelyne Bital Amanda Coltes Marisabel Davalos Vanessa Leyton

Post Board Review Function 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 Office Manager for billing purposes

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, suspension notices, clearance functions

Post Board Review Team

Sonya Hadrigan – Post Board Review Manager Lucía Verdaguer TBA - Coordinator Dena McCarthy Alice Nielsen

Office Management Function Coordinate and facilitate comprehensive office

management of the HSRO Provide assistance for Human Resources Issues Responsible for overall function and operation of

protocol filing system and Front Desk area Maintenance of IRB Member information, SOP’s

and meeting minutes Support major University-wide projects

Office Management Team

Kenia Viamonte - Office Manager Daniel Auguste Marisel Valdes Mireya Diaz De Arce

Moving Forward

“Research has to be based on the highest standards of responsible conduct, based upon ethical principles by each and every individual taking part. Let me make it unmistakably clear, in case anyone has any doubts. If institutions and individuals fail to accept their responsibilities and in good faith work to achieve them, then they simply should not be permitted to engage in this [research] endeavor.” (Dr. Greg Koski, Director, DHHS OHRP, August 2000.)

“What’s at stake is the integrity of research, and public confidence in that research.” (Donna Shalala, Secretary, Department of Health and Human Services, May 2000.)

Closing thought

The metaphor of a caterpillar transforming into a butterfly may be romantic, but the experience is an unpleasant one for the caterpillar. In the process of transformation, it goes blind, its legs fall off, and itsbody is torn apart, as beautiful wings emerge. Similarly, the transformation from a hierarchical

bureaucracy to a flexible, self regenerating organization will be painful and requires the

enormous courage of its leaders. Thanks for having the courage!