CITI Collaborative Institutional Training Initiative

1. CITI Collaborative Institutional Training Initiative Building Integrity in the Research Enterprise Paul Braunschweiger Ph.D. Professor, Radiation Oncology CITI Co-Founder University of Miami www.citiprogram.org

2. Integrity in Human Subjects Research is The Key to Success • Reduces risks to subjects. • Conserves Resources. • Promotes acceptance of the research. • Minimizes the time for implementation of new affective therapies. • Preserves the Public Trust.

3. Recent Violations of the Public Trust • 2005 Woo Suk Hwang, fabricated and falsified Stem Cell lines. • 8-2006, Advanced Cell Technology “Ethical Stem Cells” report misleading and false. • 2005 Eric Poehlman fabricated and falsified data from clinical aging studies. • June 28, 2006, Eric Poehlman was sentence to 366 days in jail. • 8-2006 40 Ohio U Engineering grad students accused of plagiarism. • Revocation of degrees • 8-2006 Ward Churchill, CU Professor of Ethnic Studies. • Fired for Research Misconduct. • 9-1-06 Elizabeth Goodwin. falsification and fabrication. • Resigned -Science September 1, 2006. • 9-10-06 NIH Thomas Walsh >$100,000 from Pharma.

4. Violation of the Public Trust is Nothing New • Isaac Newton (1642) & Gregor Mendel (1822-1884) • Data too good, may have altered original data to fit the model • Louis Pasteur 1822 -1895 • May have plagiarized the work of others • May have been less than candid about how his anthrax vaccine was prepared.

5. Violation of the Public Trust is Nothing New Antoine Lavoisier 1778 • Failed to credit Scheele and Priestly for prior discovery of O2. • Piltdown Man • Fraud by Charles Dawson went undiscovered for 40 years. • >500 doctoral theses written on the subject. By J.L. David

6. The Public Trust • Research with human subjects is a privilege and not an entitlement. • Society trusts investigators to conduct research ethically. • The Regulations – because the public trust was violated. • Public Trust must be protected. • Public trust maintained through accountability. • Accountability is accomplished through documentation of ethical conduct. • Federal Regulations specifically require documentation of ethical behavior. • Regulatory requirements to document are designed to: Preserve the Public Trust in research.

7. Preserving the Public Trust Through Education • Why does scientific misconduct occur? • Mental disorder. • Powerful and increasing professional pressure to publish studies. • $$$$$$$$$$$$$$$$$$ • Inadequate mentoring. • Ignorance of the rules. • Poor ethical decision skills. • Ill prepared to “do the right thing”. • Cultural differences in ethical standards. • Research Ethics Education

8. The Ethical Foundations for Trust are Based in Education. • Mentoring of students and young investigators. • Classroom courses. • Web based instruction. • CITI is positioned to help meet the educational needs of the human subjects research community.

9. Talking Points • Background • The CITI program. • The CITI Developer Group • Course Content • Course Site Usage • All participants • SUNY • The CITI International Program. • Demo new CITI courses. • GCP • HIPS • RCR • Demo course site utilities • Summary

10. Participating Institutions and Organizations (~660) RCR CITI Developer Group (~50) CITI Editorial Board (15) Intl. GCP CITI – Organization 9-2006 CITI Administration – Office of Research Education, University of Miami

11. CITI Developers Group has semiannual meetings • Provide oversight to the Program • Review CITI user feedback. • Develop and review new content. • Plan new initiatives.

12. Resolve learner problems Registrations Technical Issues Institution set up support Learner Groups Program Curriculum Institutional page setup Adding institutional content Coordinator Support Changes in contact information Implement Modifications. Report Utilities CITI “Help Desk” 305 243-7970 citisupport@med.miami.edu

13. CITI – Startup Organizations9-2000 • University of Miami • Paul Braunschweiger,Ph.D., Ken Goodman, Ph.D. • Fred Hutchinson Cancer Research Center • Karen Hansen, BA • Albany Medical Center • Jeff Cooper, MD • Children's Hospital-Boston • Susan Kornetsky, MPH • Dartmouth College • Liz Bankert, MA • University of Kentucky • Ada Sue Selwitz, MA, Norma Epley, MS • The National Comprehensive Cancer Network • Diane Paul, MS • University of Nebraska • Bruce Gordon, MD, Ernie Prentice, Ph.D. • Group Health Cooperative • Barbara Young, Ph.D., Janelle Erickson, MPH • University of Washington • Helen McGough, MS

14. SUNY CITI Member Site SUNY and CITI http://www.suny.edu/student/campuses_map.cfm

15. CITI Course Materials • Basic course human subjects protection • 12 modules for biomedical research investigators. • 11 modules for social & behavioral research investigators • 5 general interest modules. • Human Subjects Refresher courses • 2 Biomedical • 2 Social & Behavioral • Institutional Modules • Institutional Policies • Specific procedures • Special Interest HSR modules.

16. New CITI Course Materials • Good Clinical Practice (GCP) and ICH (summer 2006) • 12 modules for investigators and staff • Health Information Privacy and Security • 18 content modules

17. New CITI Course Materials Responsible Conduct of Research (Fall 2006) • Scientific Misconduct • Data Management • Conflict of Interest • Collaborative Science • Responsible Authorship • Mentoring • Peer Review • Lab Animal Welfare • Human Subjects Protection

18. The CITI Target Audience

19. The Clinical Investigator The Anatomy Lecture of Dr. Nicolaes Tulp, Rembrandt 1632

20. The Social & Behavioral Scientist “The Psychologist” by Charles Bragg www.charlesbragg.com

21. The Basic Science Investigator Florescence In Situ Hybridization

22. Students “The Student” by Rembrandt

23. The IRB Frans Hals, Regents of the St Elizabeth Hospital of Haarlem - 1641

24. The IRB Coordinator The Tribunal of the Brabant Mint in Antwerp 1594, by Marten de Vos 1523 – 1603Justice triumphs over deceit and violence

25. Chair of the IRB Hans HOLBEIN, the Younger, Henry VIII and the Barber Surgeons c. 1543

26. The Institutional Official

27. CITI Course Site Usage

28. CITI PARTICIPANTS 2000 TO 2006 700 600 500 400 PARTICIPATING ORGANIZATIONS 300 200 100 0 1-Sept-06 1-Aug-00 1-Aug-05 17-Aug-01 15-Aug-02 13-Aug-03 15-Aug-04 CITI Program Growth * *

29. Monthly Usage Registrants 20000 18000 >89% Completion Rate 16000 14000 12000 NEW LEARNERS 10000 Completion Reports 8000 6000 Basic course = 79% Refresher course = 21% 4000 2000 0 6-06 8-06 5-05 7-05 1-05 3-05 9-05 1-06 11-05

30. CITI Cumulative Registrations 500 450 400 350 300 Thousands Version 6 250 200 150 Registrations 100 Version 5 Version 3 Version 4 50 Ver 1 & 2 0 Jun-01 Jun-02 Jun-03 Jun-04 Jun-05 Oct-00 Oct-01 Oct-02 Oct-03 Oct-04 Oct-06 Jan-06 Feb-01 Apr-01 Feb-02 Feb-03 Apr-03 Feb-04 Feb-05 Nov-05 Apr-02 Apr-04 Apr-05 Dec-00 Dec-01 Dec-02 Dec-03 Dec-04 Aug-00 Aug-01 Aug-02 Aug-04 Aug-05 Aug-03 Aug-06 Mar-06 June-06

31. Participating Organizations * Increased since 9-05

32. Course Site Usage by SUNY Learners 18 16 14 12 10 8 Thousands of Learners 6 4 2 0 July July July April April April January January October October 2004 2005 2006

33. CITI Usage per SUNY Site

34. New CITI Features • International participation. • New Human subjects Research materials. • New CITI Modules • IRB Member • Students in Research • Refresher Materials • GCP Content • HIPS • Responsible Conduct of Research Course.

35. Data from January 2006 International Access

36. CITIInternational

37. International Human Subject Research • US Regulations regarding training pertain to international collaborators on NIH funded projects. • CITI International www.irbtraining.org • Spanish • French • Portuguese • Chinese • Arabic • Used by foreign investigators collaborating on NIH funded projects. IRB enhancement grants to KH @FHCRC and to PB @ U of Miami.CITI is committed will maintain and update this course site.

38. CITI International Program • International Demonstration Projects • Caribbean • Taiwan • Costa Rica • South America • International “mini” Site • www.IRBtraining.org • International participants at: • www.citiprogram.org

39. New CITI Modules

40. New Courses • Good Clinical Practice & ICH • HIPS • Responsible Conduct of Research https://www.citiprogram.org Register as Responsible Conduct of Research orARENA / PRIM&R

41. CITI Good Clinical Practice Course

42. HIPS Course

43. HIPS Curriculum

44. The Responsible Conduct of Research • Research Misconduct • Data Management • Conflict of Interest • Collaborative Science • Responsible Authorship • Mentoring • Peer Review • Lab Animal Welfare (1-1-07) • Human Subjects Protection DHHS, Office of Research Integrity

45. CITI RCR Course Biomedical Sciences Social & Behavioral Sciences Physical Sciences Arts & Humanities

46. CITI RCR Course for the Biomedical Sciences • Basic foundation text for each RCR topic • Discipline specific case studies for each RCR topic. • Case studies are embedded in the text or presented as stand alone modules after the text. • Quizzes • Totally customizable by institution or instructor. • Can be used “top down” or “bottom up.” www.citiprogram.org Responsible Conduct of Research

47. CITI Course Site and Admin Tools

48. CITI Course Site and Admin Tools

49. In Summary • New Modules • IRB Member • Student Researcher • IRB Coordinator (1-1-07) • Public Health Research (1-1-07) • New courses • GCP, • HIPS • RCR • Lab animal welfare • Utilities • Order forms provided • Help Desk available to help you use the program.