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What’s New at The CITI Program

What’s New at The CITI Program. Paul Braunschweiger Ph.D. Professor Radiation Oncology University of Miami Miller School of Medicine www.citiprogram.org. Talking points. Historical perspective Organizational structure New materials through CITI New curriculum structure opportunities.

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What’s New at The CITI Program

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  1. What’s New at The CITI Program Paul Braunschweiger Ph.D. Professor Radiation Oncology University of Miami Miller School of Medicine www.citiprogram.org

  2. Talking points Historical perspective Organizational structure New materials through CITI New curriculum structure opportunities. New registration, enrollment and navigation aids New administrator utilities PRIM&R Member Access New look for 2009

  3. CITI Program is a web based bioethics education program designed to promote the responsible conduct of research. CITI Founders Karen Hansen, Fred Hutchinson Cancer Research Center, Seattle, WA., USA Paul Braunschweiger Ph.D. University of Miami Miami, Fl. USA

  4. June 2000 DHHS Mandates Training in Human Subjects Protection A. TERMS OF THE FEDERALWIDE ASSURANCE (FWA) FOR INSTITUTIONS WITHIN THE UNITED STATES. Announced Dec. 2000; implemented, 2005 • 12. Educational Training • OHRP strongly recommends that the Institution and the designated IRB(s) establish educational training and oversight mechanisms (appropriate to the nature and volume of its research) to ensure that research investigators, IRB members and staff, and other appropriate personnel maintain continuing knowledge of, and comply with, the following: relevant ethical principles; relevant federal regulations; written IRB procedures; OHRP guidance; other applicable guidance, state and local laws; and institutional policies for the protection of human subjects. Furthermore, OHRP recommends that a) IRB members and staff complete relevant educational training before reviewing human subjects research; and b) research investigators complete appropriate institutional educational trainingbefore conducting human subjects research.

  5. CITI – Program11-2008 Participating Institutions and Organizations (~1150) CITI Developer Group (~60) Founders RCR CITI Executive Advisory Committee L.A.W. CITI Editorial Board (15) Intl. HSRP GCP HIPS www.citiprogram.org CITI Administration – Office of Research Education, University of Miami

  6. CITI Support Staff

  7. CITI Program Milestones • 10 Participating Institutions in 2000. • CITI - Collaborative IRB Training Initiative • New Courses added 2004. • ~ 1150 Participating Institutions in 11- 2008. • CITI - Collaborative Institutional Training Initiative • Lab Animal Welfare Course – 5-2007 • ~ 35,000 Learners per month. 40- 60% students • >105,000 Learners since 1-1-2009. • > 12,000 Lab Animal Course learners since 1-1-2009 • >1,000,00 people have completed a CITI course since 9-1-2000. • Subscriber Profile • Universities, colleges, medical centers, community hospitals, societies, government, commercial IRBs, industry

  8. CITI Program Milestones • International Initiatives • CITI - Collaborative International Training Initiative • Multi-language Course Site. 11-2007 updated 2-2009 • Spanish • Portuguese • Chinese, Japanese, Russian, Mongolian, French, Thai

  9. CITI Worldwide Footprint World wide n > 1150 International n = 49sites / 35 countries

  10. CITI Program Courses • Human Subject Protection • Good Clinical Practice (15) • Refresher Courses • Health Information Privacy and Security (HIPS) • Basic • Refresher • The Responsible Conduct of Research. • 5 Disciplines • Text, cases, quizzes. • Laboratory Animal Welfare (L.A.W.) • Basic • Refresher

  11. RCR 12-29-07 Lab Animal Welfare Program 2004 - Collaboration between CITI and Dr, M. Fallon at the Atlanta, VA. 2007 – VA decided to close the www.ResearchTraining.org LAW course site. 5-2007 CITI offered the CITI Version of RT.org to our participating institutions. 10-2007 – CITI Lab Animal Welfare Working Group. 2008 - 2009 - Comprehensive review and updating of the course content. 2009 CITI International Collaborating Centers

  12. RCR 12-29-07 CITI L.A.W. Course Library • CITI Basic Courses. • Working with the IACUC • Essentials for IACUC Members • Special Courses • Aseptic Technique • Minimizing Pain and Distress in Rodents.

  13. RCR 12-29-07 CITI L.A.W. Course Library

  14. RCR 12-29-07 Establishing an Institutional Curriculum • Each institution can establish their own curriculum from the L.A.W. Content Library. • Curriculum can be customized according to: • Role in LAW research. • Species / models used. • Basic courses and refresher courses. • Reminder notifications

  15. CITI L.A.W Course site usage384 institutions

  16. Top 10 Institutional Users *First 3 months of 2009 ** 151 VA sites have access to the CITI Program.

  17. RCR 12-29-07 2008 CITI L.A.W. Welfare Course Usage. n=384 institutions

  18. CITI L.A.W. Working Group *CITI L.A.W. Working group leader

  19. RCR 12-29-07 L.A.W. Working Group • Review learner comments • Modify the content if appropriate. • New Content • Susan Silk MS, Director of the Division of Policy and Education, OLAW • “Using Animals in Research: Information for PHS-funded Investigators.” will provide a comprehensive overview of the regulations and guidelines for PHS-funded researchers including institutional and investigator responsibilities, applying for funding, receiving an award and post award responsibilities. • Mark Christensen, Prof. of Ethics, Lourdes College • 5 module course on the Ethics of conducting research with Lab animals. • Ethical considerations related to the use of live animal subjects in scientific research. In this module we will briefly highlight some philosophical theories about ethics and moral standing and their relation to the use of animals as research subjects. • Conducting Field Studies Responsibly. • Case based refresher course.

  20. RCR 12-29-07 L.A.W. Working Group • Recently completed updating and editing course content for: • Working With the IACUC • Essentials for IACUC Members • Quiz questions Reviewed and updated. • Feedback for all of the questions in all of the modules. • Posting in June 2009. • Antibody production • New Course on antibody production

  21. Course Site and Software Update

  22. Multilanguage Course Site

  23. RCR 12-29-07 Curriculum design • Curriculum design is institutional responsibility • Stratified Curriculum to meet educational needs. • Research Focus • Model / species specific modules. • Role in research • IO, IACUC Member / staff, PI, Investigators, research staff, students. • Institution specific modules • Policies and Procedures. • Materials not covered by CITI Courses • Special species or model systems • Field studies. • Lab Animal Research Ethics.

  24. RCR 12-29-07 Curriculum DevelopmentRequired vs. Optional vs. Elective • Required • Learner is required to complete modules in this category. • Elective • Institution can designate several “Elective” modules (e.g., 10) and require that the learner complete a specific number (e.g., 8) that are of interest. • Optional • Optional modules are made available to the learner after all required and elective modules are completed. • Passing score set by the institution • Learner must attain an aggregate score that meets the institutional requirement to get a Completion Report

  25. Curriculum design CITI Course order forms are available at www.citiprogram.org Institutional Administrator menu

  26. Curriculum Modifications CITI Course order forms are available at www.citiprogram.org Institutional Administrator menu

  27. RCR 12-29-07 Quiz Questions Utilities • Integrity Assurance. • New presentation paradigms. • Randomized questions from a pool • Using a case study as a stem. • New psychometric tools to evaluate quiz questions.

  28. Institutional Modules Developed by organizations specifically for their research community.

  29. RCR 12-29-07 Examples of Institutional L.A.W. Modules Medical Surveillance Program General Zoonotic Training Farm Animals Wild Animals Fish, Amphibians and Reptiles Introduction to Surgical Research Antibody Production Occupational Health and Safety Other models (e.g., Birds) CU Policy on the Care and Use of Animals in Research and Teaching. Conducting Potentially Painful/Distressful Procedures in Lab Animals At The University of Miami

  30. Registration, Enrollment and Navigation

  31. REGISTRATION

  32. Add Customizable fields

  33. Enrollment Questions Curriculum Selection • New page to page branching logic enrollment process • Learner self-identifies research areas. • Chooses topics • Choices determine the next series of choices

  34. Enrollment Questions • Choose the most appropriate research focus or role in research • Software then shows the next series of questions appropriate for the learner.

  35. Choose the Animal Models

  36. Special Invasive Techniques

  37. Special Course Enrollment

  38. Course Summary

  39. Learner Menu

  40. Grade BookIntegrity Statement

  41. Integrity Statement X

  42. Utilities for Learners and Administrators

  43. CITI Program Knowledge Basehttp://citiprogram.supportcenterpro.com/knowledgebase/orCITI Home Page, Contact Us The CITI Program Knowledge Base provides helpful information to assist in the use of the CITI Program website. Provide support, resources, hints, tips, links and answers to frequently asked questions about the CITI Program, all in one place. We welcome contributions and feedback from learners and CITI institutional administrators. Please use the “Submit New Ticket” ticket link to the right of the screen to share comments, questions, and feedback with the CITI Support team.

  44. CITI Program Knowledge Base Please use the “Submit New Ticket” ticket link to the right of the screen to share comments, questions, and feedback with the CITI Support team.

  45. Admin Access to User Data • All CITI Institutional administrators have access to user data • Can be restricted according to admin role. • Receive completion reports • Responsible for segments of the training program • Human subjects • RCR • Lab Animal • HIPS

  46. Institutional Administrator Menu

  47. Course listing Review a completion Report

  48. Training Data Retrieval

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