Johns Hopkins Bloomberg School of Public HealthInstitutional Review BoardBrown Bag SeriesFebruary 7, 2007

CITI What is It & Why Do I have to Do It?

www.citiprogram.org

JHSPH IRBWhat is CITI?The Collaborative Institutional Training Initiative Maintained by the University of MiamiContent developed by a national consortiumContains modules on topics like informedconsent, vulnerable populations, ethical principles & IRB regulations Each module has short quiz at the end to assess understanding.

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

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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.

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JHSPH IRBGood 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)

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JHSPH IRBHow will the IRB know I have completed my training?Print and save a copy of the completion reportUpload a copy of the training certificate via your PHIRST accountYou will not be able to submit a new application via PHIRST until a copy of a human subjects training certificate has been uploaded via PHIRSTIf 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

JHSPH IRBHow 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

JHSPH IRBDoes the CITI certification expire?

Yes. All CITI certificates expire 3 years from the completion date.After 3 years, you must complete a refresher courseCITI will automatically contact you to remind you that it is time to take the refresher course

JHSPH IRBHow much time will it take to complete the modules?Depends on your experience with human research issuesMost modules take 10-20 minutes complete for a total of 4-6 hours for the basic courseYou do not have to complete all the modules at once

JHSPH IRBWhat 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

JHSPH IRBI forgot my CITI password. What do I do?

Log onto CITI www.citiprogram.org .Go to Forgot Username and PasswordCITI will provide you with the necessary information

JHSPH IRBI completed CITI at another institution. Do I have to take it again?

Yes provided that it was completed in the last 3 years.

JHSPH IRBAre 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

JHSPH IRBIs CITI available in any languages other than English?

Yes. Spanish, French, Portuguese and ChineseModules in Russian should be available soonAvailable at www.irbtraining.org or contact CITI at citisupport@med.miami.edu

CITI User Survey0%10%20%30%40%50%60%% of Responders10987654321Very easy DifficultMean = 8.9Learner survey data 2-14-05 to 4-01-05; N=1103Rate the ease of the registration procedure.

CITI User Survey0%10%20%30%40%50%60%% of Responders10987654321Very Easy DifficultMean = 9.2Learner survey data 2-14-05 to 4-01-05; N=1123Rate the ease of navigating the course.

CITI User SurveyLearner survey data 5-1-04 to 4-01-05; N=6559Mean = 8.4% of Responders

0%10%20%30%40%50%60%70%80%90%100%% of the RespondersYesNoNow that you have finished the course, do you think that you learned something that you didnt already know or understand regarding protecting human subjects in research?UM OnlyAll DataN=6233 All Data N = 57 UMCITI User Survey

0%5%10%15%20%25%% of Responders10987654321Strongly 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=1003Mean = 7.7

0%10%20%30%40%50%60%70%80%90%% of RespondersAudioVideoClassroomPaperNo ChangeDelivery PlatformAssuming 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

0%5%10%15%20%25%30%35%% of Responders10987654321Strongly Agree Strongly DisagreeHaving completed the course, I now have a clearer understanding of human research subjects protection. Mean = 8.5Learner survey data 2-14-05 to 4-01-05 ; N= 1176

0%5%10%15%20%25%% Responders10987654321Strongly agree Strongly disagreeHaving completed the CITI course, I am now more capable of advising a colleague on issues regarding human subjects protection.Mean = 7.7Learner survey data 2-14-05 to 4-01-05 ; N=1170

0%5%10%15%20%25%30%% of Responders10987654321Strongly Agree Strongly Disagree

Now that I have completed the CITI Course, I realized that I may have observed unacceptable risks tohuman research subjects. 17%58%Mean 3.4Learner survey data 2-14-05 to 4-01-05; N=1136

0%5%10%15%20%25%30%% of Responders10987654321Outstanding PoorHow would you rate the CITI Course, overall?Mean = 8.1Learner survey data 2-14-05 to 4-01-05; N=1122

N=6325 All DataN= 58 UM

CITI Learner DemographicsLearner survey data 2-14-05 to 4-01-05, n=1130

International Members

JHSPH IRBHELP! Whom do I contact?

If you are having problems with the CITI site or course, contact CITI atcitisupport@med.miami.edu305-243-7970If you have questions about the JHSPH IRB requirements, contact the IRB office at irboffice@jhsph.edu 410-955-3193