johns hopkins bloomberg school of public health
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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. JHSPH IRB. What is CITI? The Collaborative Institutional Training Initiative - PowerPoint PPT PresentationTRANSCRIPT
Johns Hopkins Bloomberg School of Public Health
Institutional Review BoardBrown Bag Series
February 7, 2007
CITI – What is It & Why Do I have to Do It?
www.citiprogram.org
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.
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
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.
JHSPH IRB
JHSPH IRB
JHSPH IRB
JHSPH IRB
JHSPH IRB
JHSPH IRB
JHSPH IRB
JHSPH IRB
• 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)
JHSPH IRB
JHSPH IRB
JHSPH IRB
JHSPH IRB
• 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
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
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
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
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
JHSPH IRB
• I forgot my CITI password. What do I do?
– Log onto CITI www.citiprogram.org .
– Go to “Forgot Username and Password”
– CITI will provide you with the necessary
information
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.
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
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
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1010 99 88 77 66 55 44 33 22 11
Very easy DifficultVery easy Difficult
Mean = 8.9Mean = 8.9
Learner survey data 2-14-05 to 4-01-05; N=1103
Rate the ease of the registration procedure.
CITI User Survey
CITI User Survey
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1010 99 88 77 66 55 44 33 22 11
Very Easy DifficultVery Easy Difficult
Mean = 9.2Mean = 9.2
Learner survey data 2-14-05 to 4-01-05; N=1123
Rate the ease of navigating the course.
CITI User Survey
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11 22 33 44 55 66 77 88 99 1010
TOTALLY UNNECESSARY TOTALLY UNNECESSARY ABSOLUTELY VITALABSOLUTELY VITAL
On a scale of 1 - 10, how necessary is the requirement that all key On a scale of 1 - 10, how necessary is the requirement that all key personnel engaged in human subjects research must participate in a personnel engaged in human subjects research must participate in a
human subjects protection educational program? human subjects protection educational program?
Learner survey data 5-1-04 to 4-01-05; N=6559
Mean = 8.4Mean = 8.4
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YesYes NoNo
Now that you have finished the course, do you think that you Now that you have finished the course, do you think that you learned something that you didn’t already know or understand learned something that you didn’t already know or understand
regarding protecting human subjects in research?regarding protecting human subjects in research?
UM Only
All Data
N=6233 All DataN = 57 UM
CITI User Survey
0%0%
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1010 99 88 77 66 55 44 33 22 11
Strongly agree Strongly DisagreeStrongly agree Strongly Disagree
The time I spent completing this course (4-5 hrs) is The time I spent completing this course (4-5 hrs) is well justified. well justified.
Learner survey data 2-14-05 to 4-01-05; N=1003
Mean = 7.7Mean = 7.7
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AudioAudio VideoVideo ClassroomClassroom PaperPaper No ChangeNo Change
Delivery PlatformDelivery Platform
Assuming a similar time commitment, would you prefer Assuming a similar time commitment, would you prefer any of the following to any of the following to this web-based program?this web-based program?
Learner survey data 2-14-05 to 4-01-05; N = 1145
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1010 99 88 77 66 55 44 33 22 11
Strongly Agree Strongly DisagreeStrongly Agree Strongly Disagree
Having completed the course, I now have a clearerHaving completed the course, I now have a clearerunderstanding of human understanding of human research subjects protection. research subjects protection.
Mean = 8.5Mean = 8.5
Learner survey data 2-14-05 to 4-01-05 ; N= 1176
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1010 99 88 77 66 55 44 33 22 11Strongly agree Strongly disagreeStrongly agree Strongly disagree
Having completed the CITI course, I am now more Having completed the CITI course, I am now more capable of advising a colleague on issues regardingcapable of advising a colleague on issues regarding
human subjects protection.human subjects protection.
Mean = 7.7Mean = 7.7
Learner survey data 2-14-05 to 4-01-05 ; N=1170
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1010 99 88 77 66 55 44 33 22 11
Strongly Agree Strongly DisagreeStrongly Agree Strongly Disagree
Now that I have completed the CITI Course, Now that I have completed the CITI Course, I realized that I may have observed unacceptable risks toI realized that I may have observed unacceptable risks to
human research subjects. human research subjects.
17%17% 58%58%
Mean 3.4Mean 3.4
Learner survey data 2-14-05 to 4-01-05; N=1136
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1010 99 88 77 66 55 44 33 22 11
Outstanding PoorOutstanding Poor
How would you rate the CITI Course, overall?How would you rate the CITI Course, overall?
Mean = 8.1Mean = 8.1
Learner survey data 2-14-05 to 4-01-05; N=1122
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Yes, definitelyYes, definitely No, I don’t think so.No, I don’t think so. Maybe, but not sureMaybe, but not sure
Do you think the Course that you just completed will help you do Do you think the Course that you just completed will help you do better Science?better Science?
UM
All Data
N=6325 All DataN= 58 UM
0.0%0.0% 5.0%5.0% 10.0%10.0% 15.0%15.0% 20.0%20.0% 25.0%25.0% 30.0%30.0%
% of The Survey Responders% of The Survey Responders
StudentStudent
PIPIClinical InvestigatorClinical Investigator
OtherOther
Research AssistantResearch Assistant
Study coordinator or Study nurseStudy coordinator or Study nurseInterviewerInterviewer
IRB Member or CoordinatorIRB Member or Coordinator
Lab ResearcherLab Researcher
AdministratorAdministratorData managerData manager
Social WorkerSocial Worker
What is Your Role in Human Subjects ResearchWhat is Your Role in Human Subjects Research
Learner survey data 2-14-05 to 4-01-05, n=1130
CITI – Learner Demographics
International Members
JHSPH IRB
• HELP! Whom do I contact?
If you are having problems with the CITI site or course, contact CITI at
305-243-7970
If you have questions about the JHSPH IRB
requirements, contact the IRB office at
410-955-3193