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. September 18, 2006 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.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 O 2. 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. CITI – Organization 9-2006 CITI Administration – Office of Research Education, University of Miami Participating Institutions and Organizations (~660) CITI Developer Group (~50) CITI Editorial Board (15) Intl. GCP RCR

11. September 18, 2006 CITI Developers Group has semiannual meetings Provide oversight to the Program Review CITI user feedback. Develop and review new content. Plan new initiatives.

12. September 18, 2006 CITI “Help Desk” 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 305 243-7970 citisupport@med.miami.edu

13. CITI – Startup Organizations 9-2000 University of MiamiUniversity of Miami –Paul Braunschweiger,Ph.D., Ken Goodman, Ph.D. Fred Hutchinson Cancer Research CenterFred Hutchinson Cancer Research Center –Karen Hansen, BA Albany Medical CenterAlbany Medical Center –Jeff Cooper, MD Children's Hospital-BostonChildren's Hospital-Boston –Susan Kornetsky, MPH Dartmouth CollegeDartmouth College –Liz Bankert, MA University of KentuckyUniversity of Kentucky –Ada Sue Selwitz, MA, Norma Epley, MS The National Comprehensive Cancer NetworkThe National Comprehensive Cancer Network –Diane Paul, MS University of NebraskaUniversity of Nebraska –Bruce Gordon, MD, Ernie Prentice, Ph.D. Group Health CooperativeGroup Health Cooperative –Barbara Young, Ph.D., Janelle Erickson, MPH University of WashingtonUniversity of Washington –Helen McGough, MS

14. September 18, 2006 SUNY and CITI http://www.suny.edu/student/campuses_map.cfm SUNY CITI Member Site

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. September 18, 2006 The Clinical Investigator The Anatomy Lecture of Dr. Nicolaes Tulp, Rembrandt 1632

20. September 18, 2006 The Social & Behavioral Scientist “The Psychologist” by Charles Bragg www.charlesbragg.comwww.charlesbragg.com

21. September 18, 2006 The Basic Science Investigator Florescence In Situ Hybridization

22. September 18, 2006 Students “The Student” by Rembrandt

23. September 18, 2006 The IRB Frans Hals, Regents of the St Elizabeth Hospital of Haarlem - 1641

24. September 18, 2006 The IRB Coordinator The Tribunal of the Brabant Mint in Antwerp 1594, by Marten de Vos 1523 – 1603 J ustice triumphs over deceit and violence

25. September 18, 2006 Chair of the IRB Hans HOLBEIN, the Younger, Henry VIII and the Barber Surgeons c. 1543

26. September 18, 2006 The Institutional Official

27. CITI Course Site Usage

28. September 18, 2006 CITI Program Growth 0 100 200 300 400 500 600 PARTICIPATING ORGANIZATIONS 1-Aug-00 17-Aug-01 15-Aug-0213-Aug-0315-Aug-04 1-Aug-05 CITI PARTICIPANTS 2000 TO 2006 1-Sept-06 700 * *

29. September 18, 2006 Monthly Usage 0 2000 4000 6000 8000 10000 12000 14000 16000 18000 20000 1-053-05 5-057-05 9-05 11-05 1-06 NEW LEARNERS Basic course = 79% Refresher course = 21% Registrants Completion Reports >89% Completion Rate 6-06 8-06

30. September 18, 2006 CITI Cumulative Registrations 0 50 100 150 200 250 300 Aug-00 Oct-00 Dec-00 Feb-01 Apr-01 Jun-01 Aug-01 Oct-01 Dec-01 Feb-02 Apr-02 Jun-02 Aug-02 Oct-02 Dec-02 Feb-03 Apr-03 Jun-03 Aug-03 Oct-03 Dec-03 Feb-04 Apr-04 Jun-04 Aug-04 Oct-04 Dec-04 Feb-05 Apr-05 Jun-05 Aug-05 Thousands Registrations Nov-05 Jan-06 350 Version 6 Version 5 Version 4 Version 3 Ver 1 & 2 400 Mar-06 June-06 500 450 Aug-06 Oct-06

31. September 18, 2006 Participating Organizations Category%Number Universities / Colleges33%*215 VA23%152 Research Medical Centers17%*110 Government9%*58 HealthCare Systems8%55 Industry4%27 Foundations3%17 International Sites2%16 Total100%650 * Increased since 9-05

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

33. CITI Usage per SUNY Site SUNY Site Learners University at Stony Brook 3672 University at Albany 2859 Upstate Medical University 2456 College at Brockport 1510 Health Science Center at Brooklyn 1483 College at Plattsburgh 987 College at Fredonia 676 College at Cortland 543 New Paltz 497 College at Potsdam 496 SUNY Site Learners Binghamton University 425 SUNY SPServices 119 University at Buffalo 118 College of Optometry 101 Buffalo State 96 Empire State College 51 Purchase College 16 Canton8 College at Oneonta 6 Total 9-12-06 16,119

34. September 18, 2006 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. CITI International

37. September 18, 2006 International Human Subject Research US Regulations regarding training pertain to international collaborators on NIH funded projects.US Regulations regarding training pertain to international collaborators on NIH funded projects. CITI International www.irbtraining.orgCITI International www.irbtraining.orgwww.irbtraining.org SpanishSpanish FrenchFrench PortuguesePortuguese ChineseChinese ArabicArabic –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. September 18, 2006 CITI International Program International Demonstration Projects –Caribbean –Taiwan –Costa Rica –South America International “mini” Site –www.IRBtraining.orgwww.IRBtraining.org International participants at: –www.citiprogram.orgwww.citiprogram.org

39. September 18, 2006 New CITI Modules

40. September 18, 2006 New Courses Good Clinical Practice & ICH HIPS Responsible Conduct of Research https://www.citiprogram.org Register as Responsible Conduct of Research or ARENA / PRIM&R

41. September 18, 2006 CITI Good Clinical Practice Course

42. September 18, 2006 HIPS Course

43. September 18, 2006 HIPS Curriculum

44. September 18, 2006 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. September 18, 2006 CITI RCR Course Biomedical Sciences Social & Behavioral Sciences Physical Sciences Arts & Humanities

46. September 18, 2006 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.orgResponsible Conduct of Research

47. September 18, 2006 CITI Course Site and Admin Tools

48. September 18, 2006 CITI Course Site and Admin Tools

49. September 18, 2006 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.