Required Education and Training

Required educational program on the protection of human research subjects

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.

All researchers, 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 CITI training and the training is documented in the iRIS system.

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 here. Non-Georgia State personnel can provide certifications of human research protections programs that may have been required at another institution. Georgia State personnel are required to complete the CITI training.

Registration

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 are available. 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

Learner groups

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 appropiate 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.

Responsible conduct in research

To meet the IRB requirement, the IRB Basic Course must be completed. The Responsible Conduct in Research (RCR) training utilizes the same CITI platform, but completing the RCR course does not meet the requirement for human subjects training. The completion certification that is received at the end of the training must say “IRB Basic Course.” For more information on the RCR required training, please see http://ursa.research.gsu.edu/ursa/responsible-conduct-in-research/

Helpful information

The CITI program will allow you to exit and enter the site if all the modules cannot be completed.

The time reuired 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 (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.

Refresher course

After three years, the training will expire and researchers are required to complete the refresher course. This course should not take as long as the original basic course. Each researcher is responsible for maintaining an active training certification. If a researchers’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.

http://www.citiprogram.org