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CITI Developer Meeting

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  1. CITI Developer Meeting Human Subjects Research October 23, 2009

  2. Meeting CD

  3. CITI International Programs

  4. CITI Worldwide Footprint 9-1-09 World wide n = 1324 International n = 65sites / 38 countries

  5. CITI International • >1324 sites around the world • >65 international sites in 38 countries. (5%) • CITI Collaborating Centers • Develop sustainable CITI Programs for the international research community. • Latin America • Taiwan • Japan • Korea • India • Middle East • Canada

  6. Multilanguage Course Site • Multi-language Course Site. 11-2007 • Updated in 2008 and 2009 to accommodate UTF-8 character sets. • Languages. • English • Spanish (NAID, FIC) • Portuguese (NAID, FIC) • Chinese • Japanese • French (NIAID) • Thai (US Army) • Russian (US Army) • Korean • Kartuli (FIC) • Arabic

  7. CITI International Centers • CITI International Collaborating Centers • CITI - India Anil Sharma, MD • CITI - Korea - B.I. Chou Ph.D. • Caribbean/Latin America/South America – Sergio Litewka , MD • CITI -Taiwan – Benjamin Kuo, MD /Paul Braunschweiger Ph.D. • CITI - Japan – Iekuni Ichikawa, MD • CITI - Canada – Karen Arts, MS - Ontario Institute of Cancer Research.

  8. CITI India Anil Sharma MD

  9. Initial Workshop • November 24,25,26 • SRU- Sri Ramachandra University • Prominent University in Chennai • More than 43,000 students • Has Medical, Pharmacy, Nursing and Dental Schools. • Affiliated with Harvard Medical International

  10. Organizing Committee INDO - US WORKSHOP "PROMOTING RESEARCH ETHICS EDUCATION IN INDIA"Organized by Sri Ramachandra University, India andCITI Program, University of Miami, USANovember 24th to 26th 2009 http://srmc.edu/indo_us_2010/index.htm • Paul Braunschweiger • Mansoor Ahmed • Ram Agarwal • Anil Sharma • S.P. Thyagarajan • Melody Lin • Chiu Lin • Jerry Castellano

  11. 3 Day seminar • Researchers from Academia and industry are invited to discuss content development. • Over 100 researchers attending 3 day meeting. • Guest speakers include ICMR officials.

  12. OHRP grant • We thank OHRP for their generous support to help start CITI India.

  13. CITI International Centers • Update on Collaborations since October 2008– Paul Braunschweiger • CITI International Cooperative Centers • CITI - India Anil Sharma, MD • CITI - Korea - B.I. Chou Ph.D. • Caribbean/Latin America/South America – Sergio Litewka , MD • CITI -Taiwan – Benjamin Kuo, MD /Paul Braunschweiger Ph.D. • CITI - Japan – Iekuni Ichikawa, MD • CITI - Canada – Karen Arts, MS - Ontario Institute of Cancer Research.

  14. CITI-Korea B.I. Chou Ph.D.

  15. Caribbean/Latin America/South America Sergio Litewka , MD

  16. CITI - Taiwan Benjamin Kuo

  17. HSP progress in Taiwan  Benjamin I. Kuo, MD, DrPHCIP Secretariat, Joint Institutional Review Board

  18. Chinese version of CITI

  19. Statistics of Taiwan CITI usersupdated Sep.3 2009

  20. Future plan • Enhancement of CITI Chinese version to be more friendly for non-scientific IRB members. • Translation of Responsible Conduct Research (RCR) in CITI. • Set up of Humans Subject Protection Association in Taiwan (HuSPAT) – PRIM&R Taiwan version.

  21. CITI - Japan Iekuni Ichikawa, MD

  22. CITI – Canada Karen Arts, M.S.

  23. CITI Developer Meeting Human Subjects Research October 23, 2009

  24. Physiology Break 10:00 – 10:30

  25. Course Updates HSR BioSafety International public access Lab Animal RCR Course.

  26. CITI Bio-safety & Bio-security Course

  27. Bio-Safety and Bio-SecurityBen Fontes, Yale University • Emergency Procedures • BBP • NIH rDNA Guidelines • Human gene transfer • Bio-security • Shipping* • Animal Biosafety • Select Agents, Bioterrorism Overview Lab acquired infections Risk Assessment Risk Management Work Practices PPE Engineering Controls Lab Design

  28. Bio-safety and Bio-Security Course Reviewers • Eric Cook - Dartmouth U • Michael Spath - CUNY • Andy Cockburn - U. West Virginia • Marcia Finucane - U. Kentucky • Norma Epley - ECU • Jairo Betancourt - U of Miami • Paul Braunschweiger - U. Miami Reviews are due back to the office by 10-1-09. Course - ready for the PRIM&R meeting.

  29. Bio-Safety and Bio-SecurityBen Fontes, Yale University • Emergency Procedures • BBP • NIH rDNA Guidelines • Human gene transfer • Bio-security • Shipping* • Animal Biosafety • Select Agents, Bioterrorism Reviews are due back to the office by 10-1-09. Course - ready for the PRIM&R meeting. Overview Lab acquired infections Risk Assessment Risk Management Work Practices PPE Engineering Controls Laboratory Design

  30. International public access course • www.irbtrainining.org • Training for non-US collaborators on Us funded projects. • Developed in 2003-2004 through NIH funded “IRB enhancement grants” • Platform, translation tools and translations. • Materials in English, Spanish, Portuguese, Chinese and French languages • Move training database CITI platform

  31. Lab Animal Welfare Course Mike Mann Ph.D.

  32. Responsible Conduct of Research Course Paul Braunschweiger Ph.D. Funded by CITI and the ORI / DHHS.

  33. CITI Program Content Library • RCR • Biomedical • Social and Behavioral Research* • Physical Sciences • Humanities* • Engineering • RCR and Science Administrators

  34. New additions to the Program • The RCR with lab animals • Paul Braunschweiger Ph.D. • The RCR with human subjects. • Jason Borenstein Ph.D. • RC of scholarly activities in the humanities • Sharon Shriver Ph.D. • RCR in the social and behavioral sciences • Dan Vasgird Ph.D.

  35. Content Editing • Hired a science and technology editor to resolve outstanding issues in the CITI RCR modules. • Comments regarding typos in the modules • Grammatical errors • Poor quiz question. • Deliver is November 14. • Reviewed and reconciled by December 1, 2009. • Implemented by 1-1-10

  36. RCR Course Site Usage

  37. RCR Course Completion Reports (C.R.) awarded * 1-1-09 to 10-1-09, public access and institutional RCR set-ups * 86 new institutional RCR set-ups, 2009 10-1-09

  38. RCR Course Completion Reports (C.R.) Awarded via The Public Access Portal. * 1-1-09 to 10-1-09

  39. RCR Learner feedback RCR Satisfaction Survey

  40. I believe that it is very important that the entire research team (PI, Investigators, staff, students and administrators) and not just the PI, should have a clear understanding of the responsible conduct of research, to insure that the data is collected and distributed with integrity and to the highest ethical standards. Strongly disagree strongly agree

  41. Having completed the CITI Course in the Responsible Conduct of Research and gained a better understanding of how damaging research misconduct can be to students, to the institutions and to other investigators, I am now more likely to report a clear act of research misconduct to an appropriate person at my organization. Strongly disagree strongly agree

  42. Rate the course. RCR L.A.W. Poor outstanding Poor outstanding H.S.P Poor outstanding

  43. Research Survey Mentoring and Mentoring Experiences Participation in Human Subjects Research

  44. New Modules Karen Hansen

  45. Acknowledgements Karen, Paul, Sally and Susan

  46. CITI Support Staff Not shown Pablo Velascelo and Ryan Roelans

  47. The CITI HSR Program Contents Software updates Usage Learner Feedback

  48. CITI Program Content Library • Human subjects • Biomedical • Community Member • ESCRO • Social and Behavioral • Good Clinical Practice • English • Spanish • Portuguese • Chinese • Thai • French, not posted. • HIPS

  49. CITI Program Content Library • RCR • Biomedical • Social and Behavioral Research* • Physical Sciences • Humanities* • Engineering • RCR and Science Administrators • Bio-safety and Bio-security