the university of miami hsro strategic plan october 20 th, 2005
TRANSCRIPT
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!