1. Johns Hopkins Bloomberg School of Public Health Institutional Review Board Brown Bag Series February 7, 2007 CITI – What is It & Why Do I have to Do It? www.citiprogram.org

2. JHSPH IRB What is CITI? The Collaborative Institutional Training Initiative Maintained by the University of Miami Content developed by a national consortium Contains modules on topics like informed consent, vulnerable populations, ethical principles & IRB regulations Each module has short quiz at the end to assess understanding.

3. JHSPH IRB Effective January 1, 2007, CITI replaced the former CHR computer based human subjects training module –Regulations on human research change, however the CHR web based training module had not been updated since 2001 –CITI is currently used by over 600 institutions and organizations and is well known and respected for its balanced information

4. JHSPH IRB All faculty, research staff and students who have not been trained since 2004 or before are required to complete the CITI training by April 30, 2007. If an investigator completed training in 2005, he/she has until January 1, 2008 to complete the CITI training. The CITI program must be completed prior to submitting to the IRB for initial review of a protocol, or for continuing review or amendment of a previously approved protocol. Effective April 30, 2007, the IRB will check all persons listed on a new application, progress report or amendment request to ensure that each person has met the training requirements.

5. JHSPH IRB

12. Good Clinical Practice (GCP) and ICH module is required for all clinical investigators listed on an IRB application (in addition to basic course) –Consists of 13 modules –Cannot access until completion of basic course (Biomedical Research Investigators)

13. JHSPH IRB

16. How will the IRB know I have completed my training? –Print and save a copy of the completion report –Upload a copy of the training certificate via your PHIRST account –You will not be able to submit a new application via PHIRST until a copy of a human subjects training certificate has been uploaded via PHIRST –If you are submitting a hard-copy amendment or continuing review request, please submit a copy of HST certificate for each investigator listed on the project

17. JHSPH IRB How do I upload a copy of my HST certificate to my PHIRST account?  Log-in  Click on your name located at the top right hand corner of the study workspace (next to the My Home icon)  Upload the required information (including a Biosketch/CV or Resume)  Click Apply

18. JHSPH IRB Does the CITI certification expire? –Yes. All CITI certificates expire 3 years from the completion date. –After 3 years, you must complete a refresher course –CITI will automatically contact you to remind you that it is time to take the refresher course

19. JHSPH IRB How much time will it take to complete the modules? –Depends on your experience with human research issues –Most modules take 10-20 minutes complete for a total of 4-6 hours for the basic course –You do not have to complete all the modules at once

20. JHSPH IRB What is a passing course on the quizzes? –You must receive a total passing score of 80% –If you do not obtain a total passing score of 80% you can return to the modules and retake the quizzes

21. JHSPH IRB I forgot my CITI password. What do I do? –Log onto CITI www.citiprogram.org.www.citiprogram –Go to “Forgot Username and Password” –CITI will provide you with the necessary information

22. JHSPH IRB I completed CITI at another institution. Do I have to take it again? –Yes – provided that it was completed in the last 3 years.

23. JHSPH IRB Are non-JHU researchers/collaborators required to complete CITI? –No – as long as they can provide training from another institution and it was completed or updated within the last 3 years

24. JHSPH IRB Is CITI available in any languages other than English? –Yes. Spanish, French, Portuguese and Chinese –Modules in Russian should be available soon –Available at www.irbtraining.org or contact CITI at citisupport@med.miami.eduwww.irbtraining.orgcitisupport@med.miami.edu

25. 0% 10% 20% 30% 40% 50% 60% % of Responders 10987654321 Very easy Difficult Mean = 8.9 Learner survey data 2-14-05 to 4-01-05; N=1103 Rate the ease of the registration procedure. CITI User Survey

26. 0% 10% 20% 30% 40% 50% 60% % of Responders 10987654321 Very Easy Difficult Mean = 9.2 Learner survey data 2-14-05 to 4-01-05; N=1123 Rate the ease of navigating the course.

27. CITI User Survey0% 10% 20% 30% 40% 50% 12345678910 TOTALLY UNNECESSARY ABSOLUTELY VITAL On a scale of 1 - 10, how necessary is the requirement that all key personnel engaged in human subjects research must participate in a human subjects protection educational program? Learner survey data 5-1-04 to 4-01-05; N=6559 Mean = 8.4 % of Responders

28. 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% % of the Responders YesNo Now that you have finished the course, do you think that you learned something that you didn’t already know or understand regarding protecting human subjects in research? UM Only All Data N=6233 All Data N = 57 UM CITI User Survey

29. 0% 5% 10% 15% 20% 25% % of Responders 10987654321 Strongly agree Strongly Disagree The time I spent completing this course (4-5 hrs) is well justified. Learner survey data 2-14-05 to 4-01-05; N=1003 Mean = 7.7

30. 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% % of Responders AudioVideoClassroomPaper No Change Delivery Platform Assuming a similar time commitment, would you prefer any of the following to this web-based program? Learner survey data 2-14-05 to 4-01-05; N = 1145

31. 0% 5% 10% 15% 20% 25% 30% 35% % of Responders 10987654321 Strongly Agree Strongly Disagree Having completed the course, I now have a clearer understanding of human research subjects protection. Mean = 8.5 Learner survey data 2-14-05 to 4-01-05 ; N= 1176

32. 0% 5% 10% 15% 20% 25% % Responders 10987654321 Strongly agree Strongly disagree Having completed the CITI course, I am now more capable of advising a colleague on issues regarding human subjects protection. Mean = 7.7 Learner survey data 2-14-05 to 4-01-05 ; N=1170

33. 0% 5% 10% 15% 20% 25% 30% % of Responders 10987654321 Strongly Agree Strongly Disagree Now that I have completed the CITI Course, I realized that I may have observed unacceptable risks to human research subjects. 17% 58% Mean 3.4 Learner survey data 2-14-05 to 4-01-05; N=1136

34. 0% 5% 10% 15% 20% 25% 30% % of Responders 10987654321 Outstanding Poor How would you rate the CITI Course, overall? Mean = 8.1 Learner survey data 2-14-05 to 4-01-05; N=1122

35. 0% 10% 20% 30% 40% 50% 60% 70% % of Responders Yes, definitely No, I don’t think so. Maybe, but not sure Do you think the Course that you just completed will help you do better Science? UM All Data N=6325 All Data N= 58 UM

36. 0.0%5.0%10.0%15.0%20.0%25.0%30.0% % of The Survey Responders Student PI Clinical Investigator Other Research Assistant Study coordinator or Study nurse Interviewer IRB Member or Coordinator Lab Researcher Administrator Data manager Social Worker What is Your Role in Human Subjects Research Learner survey data 2-14-05 to 4-01-05, n=1130 CITI – Learner Demographics

37. International Members

38. JHSPH IRB HELP! Whom do I contact? If you are having problems with the CITI site or course, contact CITI at citisupport@med.miami.edu 305-243-7970 If you have questions about the JHSPH IRB requirements, contact the IRB office at irboffice@jhsph.edu irboffice@jhsph.edu 410-955-3193