Human Subjects Research Training Course

All researchers doing non-exempt research using human subjects are required to pass the online research training course offered by CITI. This includes not only the principal investigator but also all co-investigators, research technicians, research assistants, or student assistants who have contact with the research subjects.

Researchers doing exempt research are also strongly encouraged to complete the training.

Within a week after submission of your research protocol, the IRB will categorize your protocol as exempt or non-exempt and notify you.  If non-exempt, you must then complete the training before approval may be granted.

The CITI course takes 2-3 hours to complete and offers tracks in social/ behavioral/educational or biomedical research.  You should complete the track which is most appropriate for your field of research.  You may also complete elective modules in other areas if you wish.  The CITI course is online and available 24/7.

If any of the non-affiliated researchers do not have access to CITI, free training is available on the U.S. Department of Health and Human Services websites. 

 

Instructions:

  1. Go to the CITI website.
  2.  Log in (if already registered) or click on “Register” in the upper right hand corner of the page. 
  3. On the CITI Learner Registration page, Step 1, For CSUEB students/staff/faculty, click on “Select Your Organization Affiliation”, type in the search bar “California State University, East Bay”, agree to the terms and conditions, and affirm that you are affiliated with the university. Click on “Create a CITI Program Account”. Note if you are from a partner organization, you should log onto CITI through your home institution CITI account.
  4. In Step 2, enter your name and preferably use your CSUEB email address (horizon email if a student), so an admin may find your CITI ID in case there is an error.  Enter a second email address if you wish, and click on “Continue”.
  5. In Step 3, create a username and password, and set up the security question. Click on “Continue”. 
  6. In Step 4, type “USA” in the search box, select “United States”, and click on “Continue”. 
  7. You will next be asked if you want to pay for Continuing Education Unit (CE). Select “No”.
  8. The next page you will see should be the “Affiliate with an Institution” page. Here you will provide the information requested by Cal State East Bay. You only need to provide information if there is a red asterisk.
  9. Under “Institutional email address” provide your CSUEB email address (or horizon email for students). (You will need to do this twice).
  10. Under the section “Which Course do you plan to take?” make sure you select either “Basic Human Subjects - Social & Behavioral” or “Basic Human Subjects - Biomedical”.
  11. You should now be at the “Select Curriculum” page. ONLY ANSWER “Question 1”. Please DO NOT answer the other questions.
  12. The answer to “Question 1” should be either “Social & Behavioral Research” or "Biomedical Reserach". 
  13. Scroll to the bottom, and hit “Submit”.
  14. For the pull down menu that asks “Which course do you plan to take?”, please select “Basic Human Subjects - Social & Behavioral Focus”.

Note that you need not complete the entire course in one sitting.  The CITI site will remember which modules you have completed and you may pick up where you left off.

Your initial training is valid for 3 years. Before the 3 years expire, you must complete the refresher course. For researchers completing the refresher course, choose “I have completed the Basic Course” in Section 2, and then the appropriate choice in Section 3.

You must achieve an 80% success rate in the module tests to complete the courses.  You may retake tests until you have achieved the necessary success rate.  A course completion report will be issued upon completion of either course. The report should be printed out and submitted with the protocol materials. The Office of Research and Sponsored Programs will maintain a database listing investigators who have completed the training.  The reports are valid for 3 years from the date of issue.  If you continue conducting research, every 3 years, a refresher course, also offered through CITI, must be completed. 

Note that you may choose additional study modules if desired as well as the optional courses in Good Clinical Practice (GCP) and Responsible Conduct of Research (RCR).

If you have completed a human subjects training course elsewhere, such as the NIH course, email or bring the completion certificate to the ORSP, and it will be accepted.