Agenda. HSRO Mission / IRB GoalPlan ObjectivesUM / HSRO Strategic Plan HighlightsOrganizational ThemesHSRO Operational PlanRegulatory Affairs, IRB Affairs, System Development, Educational and Regulatory Recruitment. HSRO Mission. Protecting the safety, rights, and welfare of human research part
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1. The University of Miami HSRO Strategic Plan
October 20th, 2005
2. Agenda HSRO Mission / IRB Goal
UM / HSRO Strategic Plan Highlights
HSRO Operational Plan
Regulatory Affairs, IRB Affairs, System Development, Educational and Regulatory Recruitment
3. HSRO Mission Protecting the safety, rights, and welfare of human research participants through:
Collaborating with Investigators, key study personnel, and other supporting institutional bodies toward a common goal of protecting human research participants.
4. 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
5. 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”
6. 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
7. 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
8. 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
9. 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
10. 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
11. 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
12. 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
13. Regulatory Affairs
14. Regulatory Affairs
15. Regulatory Affairs
16. Privacy and Regulatory Affairs
17. Educational Initiatives
18. IRB Affairs
19. IRB Affairs
20. IRB Affairs
21. System Development – E Prost
22. HSRO IT Team Charlene Estevez , Database Tech Specialist
Rosemary Alvarado, Database Tech Specialist
Stella Uyeno, Software Specialist (MWS)
Eva Molina, Help Desk
24. 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
27. 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.
28. Pre Board Review Team
Zuny Fernandez, Pre Board Review Manager
Mireya Diaz De Arce
29. 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
30. Regulatory Operations Team IRB Regulatory Analysts
31. 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
32. Post Board Review Team
Sonya Hadrigan – Post Board Review Manager
TBA - Coordinator
33. 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
34. Office Management Team
Kenia Viamonte - Office Manager
Mireya Diaz De Arce
35. 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.)
36. 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 its
body 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!