Office of Regulatory Research Compliance
Howard University
HU Research Bldg 1
1840 7th Street, NW
Suite 309
Washington, D.C. 20001
Phone: (202) 865-8597
Fax: (202) 232-5286
ORRC is located directly across from the Howard University Shaw Metro on 7th Seventh St.(Georgia Ave) on the third floor of the Howard University Research Building-1.
TRAINING & EDUCATION
For a complete list of OHRP Training Videos, go here.
Required Education
Collaborative Institutional Training Initiative (CITI) – Required human subjects protection education
CITI can be accessed at www.citiprogram.org.
Basic CITI
required for all new investigators, research staff, students
Refresher CITI
required for investigators, research staff, and students who have taken Basic CITI once it expires.
More questions and answers
Basic CITI
Required for all new investigators, research staff, and students.
What is CITI?
HU requires investigators and key personnel to complete the Collaborative Institutional Training Initiative (CITI) Basic Course in either Biomedical or Social-Behavioral Research as baseline entry into human subjects research at HU. The course and exam are web-based and can be accessed at www.citiprogram.org. All the modules listed for HU must be completed. There is a short quiz after most modules. An aggregate passing score of 80% is required. New protocols (including ‘exempt’), continuing reviews, and change to research submissions will be forwarded for IRB review only after the principal investigator’s completion of the required CITI Biomedical or Social-Behavioral Course has been verified. The CITI Refresher course does not qualify as a Basic course. Make sure you take the Basic course if you have not yet done so at HU or another institution.
Who takes CITI?
All key study personnel, including the principal investigator, sub-investigators, study coordinators, and students, are required to complete the Basic CITI human subjects protection education in either Biomedical or Social-Behavioral Research. Key personnel are persons involved with the research protocol through interacting or intervening with research participants or their identifiable data. Those obtaining informed consent from a study participant, or having access to identifiable data, are considered key personnel. Upon request by the investigator, the IRB may consider alternate training arrangements for certain kinds of research (such as community engaged research) involving key personnel. IRB members and staff are expected to take both Basic Courses.
How long does it take and when does it expire?
Depending on your experience with human subjects research, the Basic CITI course can take 4 to 6 hours to complete. It does not have to be completed in one sitting. Verification of completion is sent to you immediately. Print off a copy and retain in your files. The Basic course expires 2 years after completion. CITI generates a reminder email 30 days before the Basic course expires. The Basic CITI course must be completed before qualifying for the Refresher course.
Registration for CITI
CITI can be accessed at www.citiprogram.org. Closely follow the directions for first time registration. Write down your user name and password and save it. Use this same username/password for all subsequent entry into CITI. Indicate your affiliation with Howard University in order for HU to obtain your record. When completing the Registration Profile as a first-time CITI participant, DO NOT indicate prior completion of another human subjects protection course. To take the Basic Course, choose a Learner Group that is appropriate to your activities in human research. The program will automatically select the modules you are required to complete. Follow the instructions and links on the Learner’s Menu to begin the Basic course. Use the “View/Update your Learner Group” link on the Learner’s Menu to select or change groups for the Basic Course. Retain the username and password used to create the CITI account and complete the Basic course. DO NOT take the Refresher course if you have not previously taken the Basic course at HU or another institution.
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Refresher CITI
Required for investigators, research staff, and students who have taken Basic CITI
Continuing Education requirement: The CITI Biomedical or Social-Behavioral Refresher course is required every 2 years for all investigators and key personnel who have completed the CITI Basic course.
Who takes the CITI Refresher course?
All key study personnel, including the principal investigator, sub-investigators, study coordinators, and students, are required to complete the Refresher CITI human subjects protection education in either Biomedical or Social-Behavioral Research after their Basic expires. IRB members and staff are expected to take the Refresher course that is relevant to their IRB Panel (or their research, if investigators) as well as the IRB Learner Group Refresher course. Use the same username and password for the Refresher course as was used for the Basic course.
When is the Refresher course required?
To find out when you took the Basic or Refresher CITI, check a printed copy of the completion certificate or go to the CITI website. Enter the user name and password that was used to complete the Basic or Refresher course. On the Learner’s Menu scroll down to ‘Previous Coursework Completed’ and click. Go to 'Coursework completed.’ Check your course completion status. If you do not know your username and password, either contact CITI directly using the “Forgot username or password” retrieval tool on CITI’s home page (www.citiprogram.org).
How long does the Refresher course take and when does it expire?
The Refresher course takes about 2 hours to complete. It does not have to be completed in one sitting. Verification of completion is sent to you immediately. Print off a completion certificate and retain in your files. CITI generates a reminder email 30 days before the Basic or Refresher course expires. The Basic CITI course must be completed at HU or another institution before qualifying for the Refresher course. Use the same username and password for the Refresher as was used for the Basic course.
The Refresher course will expire 2 years after it is completed. In some cases, a sponsor may require an earlier completion. Using the same username and password, enter CITI and take the Refresher course at any time. The completion dates will be updated.
How do I know which modules are required for the Refresher course?
When you enter CITI using the same username and password used for the Basic course, you will be automatically routed to the Refresher course. Take the Refresher course in the Learner Group most relevant to your research activities – Biomedical or Social-Behavioral Research. Note that you can change your learner group. Depending on the learner group, some modules are required for everyone. In addition, you can choose from a selection of elective modules to total 12. Refresher course completion requires taking a total of 12 modules. The required total number for the Refresher course must be completed before any optional courses are available.
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More questions and answers
I completed the CITI Basic course in October of either 2009 or 2010, when does it expire?
The Basic course expires 2 years after the month/date it was taken. If you completed the Basic course on October 15, 2009, it expired on October 16, 2011. If you completed the Basic course on October 15, 2010, it expires on October 16, 2012. You will need to take the CITI Refresher course to keep your human research protections training current. Use the same username and password for the Refresher as was used for the Basic course.
I completed the CITI Refresher course February 14, 2010, when does it expire?
Your CITI Refresher course will expire on February 15, 2012. You will need to take the Refresher course by that date to keep your human research protections training current.
How do I find out if I am due for the Refresher course and how do I log on?
To find out when you took the Basic CITI, check a printed copy of the completion certificate or go to the CITI website. Enter the user name and password that was used to complete the Basic course. On the Learner’s Menu scroll down to ‘Previous Coursework Completed’ and click. Go to 'Coursework completed.’ Check your Basic course completion. If you do not know your username and password, either contact CITI directly using the “Forgot username or password” retrieval tool on CITI’s home page (www.citiprogram.org).
What happens if my Basic CITI course expires and I have not taken the Refresher course?
New protocols (including ‘exempt’), continuing reviews, and change to research submissions will be forwarded for IRB review after the principal investigator’s completion of the CITI Biomedical or Social-Behavioral Refresher Course has been verified. Investigators and key personnel must have taken the Basic course before qualifying for the Refresher course.
Public Responsibility in Medicine & Research ( PRIM&R) Training:
Good Clinical Practice (GCP) Training:
To ensure a well-trained professional workforce in clinical research and enhance our human subject protection program, the Howard University's (HU) Office of Regulatory Research Compliance (ORRC) now mandates the Good Clinical Practice (GCP) course for relevant research personnel.
Institutional Review Board (IRB)
Office of Regulatory Research Compliance
U.S. Food and Drug Administration (FDA):
It's a federal agency of the US Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through regulation and supervision of food safety, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, medical devices, cosmetics, animal foods & feed, blood transfusions, medical devices, biopharmaceuticals, electromagnetic radiation emitting devices (ERED), and veterinary products.
