Human Subjects Required Education and Training
All faculty, staff, students, and others who interact with human subjects in the performance of research and assisting in research must complete a required educational program on the protection of human subjects before the Institutional Review Board (IRB) may approve a proposal.
This certification process must be completed and documented with the IRB every three years.
A new protocol will not be accepted by the IRB until all members of the research team have completed the appropriate training and the training is documented in the iRIS system.
To provide a comprehensive educational program on human subjects’ protection, Georgia State University has joined the Collaborative IRB Training Initiative (CITI). This comprehensive program is web-based and hosted by the University of Miami. The website is available at www.citiprogram.org.
CITI certification from other institutions is acceptable provided the certification was obtained within the last three years. If CITI training is obtained at another Institution, the completion report must be provided to the Georgia State IRB. Instructions on how to obtain the completion report can be found BELOW. Non-Georgia State personnel can provide certifications of human research protections programs that may have been required at another institution. However, Georgia State personnel are required to complete the CITI training.
The CITI program will allow you to exit and enter the site if all the modules cannot be completed. The time required to complete each module is largely dependent upon one’s knowledge base on the protection of human subjects. You should allow between two and six hours for completion.
After completing all required modules, please go to the institutional homepage in CITI (Georgia State University). From here, you will be able to download a Course Completion Report. This report will provide a detailed record of your accomplishments. A copy of this file will also be sent to the Georgia State Office of Research Integrity.
A mastery score of at least 80 percent is required for the training to be considered complete.
Each user of the system must register and create his or her own username and password for the system. Step-by-step instructions on how to register for the CITI course provided below. If you forget your password, you must go through the CITI program to retrieve it: go to the CITI homepage and click the link “Forgot login information.” The university’s IRB staff cannot look-up the password for you. Please be sure to use your GSU E-mail account when registering with CITI.
How to Register for the CITI Course
Go to www.citiprogram.org.
In the right-hand side of the screen, you will see “Create an account”. Click on “Register.”
Step number one states, “Select your organization affiliation”. Under “Search for Organization” enter full or partial name in text box. Then scroll down to step number 2.
Step number two states, “you must enter your personal information”. Type your first name, last name, and email address. Verify your e-mail and if you have a secondary e-mail, you’re welcome to enter that information, but it is not required. When you are done, click on “Continue to step 3.”
Step three asks you to, “Select Your Username and Password”. You may choose your own username and password. We have no regulations on what you used for either of these. It is strongly suggested that you use something memorable. Please also choose and answer a security question, then click “Continue to step 4.”
Step 4 asks you to enter your demographic information. Once you’re done, click “Continue to step 5.”
- Step number five asks if you want to receive CEU credits. This is optional. When you are done, click “Continue to step 6.”
- On the next page type in all of your information. The headings with a red asterisk by them are required. When you are done, click on “Continue to step 7.”
For question number one select the group that is most appropriate for the research that you will be completing. Group 1 for medical studies or Group 2 for social and behavioral studies. The IRB Reference group will require you to complete both groups.
For question number two, choose the box that applies based on your answer for question 1. Please note that RCR training is a university requirement; the training is not a requirement to be in good standing with the IRB.
For question number three, conflict of interest is required. Please select, “Yes.”
- Questions number four and five are optional. Click the “Complete Registration” button.
Click on “Finalize Registration” and you will see the message, “Your registration has been completed successfully.”
In the middle of the screen, you will see the heading ‘Course’. Directly under that are the courses listed that you have selected. Please click the link.
On the next page, you will see “Complete the Integrity Assurance Statement before beginning the course” Click on this link.
Read through the statement. Once at the bottom, be sure you agree with the first statement under the heading “Select the appropriate statement then click the Submit button:” Be sure the circle next to the first option is filled in and click the ‘Submit’ button.
You will then see a listing of all of the required courses. To begin, click on the word ‘Introduction’. This will begin the courses.
Read through the section. The Introduction does not have a quiz, but the other modules will. Click the link to ‘Go to the next module’ to continue with the courses.
- Read each module and complete the quiz at the end. A passing score is required for each of the modules.
Instructions for Locating and Completing International Research Module CITI Program
- Go to www.citiprogram.org
- On the right-hand side of the screen enter your “Username” and “Password” that you previously created, and click the “Log In” button
- On the Main Menu page you will see your Institution’s course listing, with the following headings: Course, Status, Completion Report, CE Eligibility, and Survey. Under the “Course” heading, scroll down to your selected “Group“: Group 1-Biomedical or “Group 2-Social Behavioral” and click on it.
- Once on your selected “Group”, “Group-1 Biomedical” or “Group 2- Social Behavioral-Basic Course” page, you will see the following headings: Modules, Already Taken? Score, and CE Eligible. Under the “Module” heading, scroll down to “International Research-SBE (ID: 509)” and click on it.
- You are now on the International Research- SBE module
- Once you have finished reading the International Research module, you can take the quiz.
- To get to the quiz, scroll to the bottom of the screen and click on “Take the quiz for International Research.”
- Once you have answered all of the questions on the quiz, click the “Submit” button on the bottom of the screen to register your answers.
Instructions for Locating and Completing Good Clinical Practice (GPC) Modules CITI Program
- Go to www.citiprogram.org
- On the right-hand side of the screen enter your Username and Password that you previously created, and click the Log In button.
- On the Main Menu page you will see My Learner Tools for Georgia State University. Select Add a Course.
- For Question 1, Human Subjects Research, you may add any of the courses listed or you may select Not at this time.
- For Question 2, Good Clinical Practice (GCP), you must select GCP – Social and Behavioral Research Best Practices for Clinical Research.
- For Question 6, Biosafety/Biosecurity Course, you may add any of the courses listed or you may select Not at this time.
- Scroll to the bottom of the page and click on Submit.
- Next click on GCP – Social and Behavioral Research Best Practices for Clinical Research to start and complete the 9 module course.
- Complete the Integrity Assurance Statement
- Start with Module 1, complete each module and associated quiz.
- When all modules and quizzes are complete, print a copy of the completion report.
Your CITI Training
To ensure your CITI training is imported correctly into iRIS you need to ensure your e-mail address you associated with your CITI account is the one in iRIS. It is recommended that you use your Georgia State University E-mail Account. To check what e-mail address you have associated to your account in IRIS you should select “My Assistant” from the left navigation menu inside of iRIS and then select “My Account Information”. Here you can update your e-mail address. For step-by-step instructions please see the How to Update/Add an E-mail Address document.
For certain studies you may need to add users who are external to Georgia State University. In iRIS this can only be done if they have an account within the system. In order to accomplish this you must fill out the Account Request Form.
In order to send the IRB a copy of your completion report, follow the steps below:
- Log-in to your CITI account at: http://www.citiprogram.org/
- Click on View course completion history for <institution> and print completion certificates.
- Click on Print Completion Report on the right side of the screen.
- A print window will open and you can click cancel on that window.
- In the Menu bar, click File then Save As. Save the document somewhere you will remember it.
- You can then attach the file to an email.
The CITI program allows the user to choose between three learner groups or modules: Biomedical Research, Social/Behavioral Research and IRB Reference. Biomedical Research involves any type of clinical research studies, including those that involve drugs and/or devices, investigational or marketed. Social/behavioral research (SBR) is typically characterized by data collection methods such as questionnaires, interviews, focus groups, direct observation and non-invasive physical measurements. The IRB Reference modules require the completion of all courses in the biomedical and social and behavioral modules. The user should choose which learner group is most appropriate for his or her research or field of study. The principal investigator should ensure that the research team for each study has completed the appropriate training.
In addition, if research involves a topic that is not included in the basic course, an additional, optional course should be added. For example, research conducted via the Internet or research conducted outside of the United States (international research) would require that the researcher complete those modules as well.
After three years, the training will expire and researchers are required to complete the refresher course. This course should not take as long to complete as the original basic course. Each researcher is responsible for maintaining an active training certification. If a researcher’s training has expired, the IRB cannot accept any new studies, amendments, or renewals that list that researcher as personnel. Failure to complete the training or the refresher course could result in revocation of your protocol approval for research or other action(s) deemed appropriate by IRB.