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- Protocol Guidelines
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- Issues of Special Concern
- Complete Protocol Package
- Elements of Voluntary Informed Consent
- Guidelines for Obtaining Assent from Minors
- Human Subjects Research Training Course
- Forms & Templates
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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.
- Go to the CITI website.
- Log in (if already registered) or click on “Register” in the upper right hand corner of the page.
- On the CITI Learner Registration page, Step 1, type "East Bay" in the search box, choose "California State University, East Bay", agree to the terms and conditions, and affirm that you are affiliated with the university. Click on "Continue."
- In Step 2, Enter your name and CSUEB email address (horizon email if a student.) Enter a second email address if you wish, and click on "Continue."
- In Step 3, create a username and password, and set up the security question. Click on "Continue."
- In Step 4, type "USA" in the search box, select "United States", and click on "Continue."
- In Step 5, choose "No" regarding earning Continuing Education credits, and answer the last two questions regarding CITI contacts as you wish. Click on "Continue."
- In Step 6, enter your language preference, your CSUEB email address again, your gender, and highest degree. For "Role in Human Subjects Research", choose "Student Researcher" with appropriate degree level if you are a student, "Principal Investigator" if faculty, or "IRB Member" if a member of the IRB. Fill in your phone number for "Office Phone" and choose the course you intend to complete. Almost all investigators at CSUEB should take the course "Basic Human Subjects - Social and Behavioral Focus." If you are a faculty member or student doing Biomedical research, you may take the course "Basic Human Subjects - Biomedical." You will actually specify the courses you want to take in the next step. Click on "Continue."
- In Step 7, do not select any boxes under Laboratory Animal Welfare. Under "Human Subjects Research," almost all researchers should identify themselves as "Social & Behavioral Research Investigators" which will select the basic Social and Behavioral research course. If you are a faculty member or student doing Biomedical research, select "Biomedical Research Investigators." If you are an IRB member, select "IRB Members." Select the button if you have completed the basic training course before. In the next section, only select a button if you have already completed the basic course and would like to take the refresher course. Choose the appropriate button. You may select to take the "Responsible Conduct of Research" or other courses if you wish, but these are not required. Click on "Complete Registration."
- On the next page, click on "Finalize Registration."
- Expand the "California State University, East Bay Courses" tab to see the courses now available to you.
- Select "Social & Behavioral Research - Basic/Refresher" course or other course you have chosen.
- Complete the Integrity Assurance Statement by selecting "agree" and clicking on "Submit."
- Click on the first course module, read the material, take the mini-test at the end and repeat until all course modules have been completed.
- From the Main Menu, under My Courses, click on “Print” under Completion Report in order to print out your completion report.
- You may then log out of the CITI site.
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, mail or bring the completion certificate to the ORSP, and it will be accepted.