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New Human Subjects Research Education Requirement:
Collaborative Institutional Training Initiative (CITI)

June 25, 2010 -The Office of Research Administration (ORA) and the IRB Executive Committee are pleased to announce that the IU Institutional Review Board (IRB) will begin using the educational programs of the Collaborative Institutional Training Initiative (CITI) to meet the educational requirements for conducting research with human subjects effective October 1, 2010.

CITI is a web-based tutorial and testing site that is frequently updated to reflect changes in human subject law and regulation. With the continual changes taking place in human subjects research, a more robust, complete, and up-to-date program is needed beyond the in-house program currently in place. CITI users can affiliate with more than one participating institution, which allows for cross-institutional transferability and prevents duplication of education efforts by investigators.

The CITI training meets the federal requirements for basic training for the use of human subjects in research. Additionally CITI is used by over 830 participating institutions and facilities around the world. Of the 830 institutions, other Big 10 schools currently using CITI modules include: Purdue University, Ohio State University, Northwestern, University of Wisconsin-Madison, University of Michigan, Pennsylvania State University, Michigan State University, and University of Illinois.

All Indiana University IRB investigators, IRB members, and Human Research Protection Program staff members will be required to complete IRB education provided by the Collaborative Institutional Training Initiative (CITI). This new initiative will replace the current, in-house Human Subjects Protection Test and will fulfill the NIH certification requirement.

Principal Investigators, co-investigators, and non-affiliated investigators on all open studies who were previously required to pass the IU Human Subjects Protection Test, will be required to complete the CITI program. This requirement will need to be completed at the time of continuing review for all continuing reviews due after October 1, 2010.

Additionally, principal investigators, co-investigators, and non-affiliated investigators directly interacting or intervening with subjects on new study submissions, or being added to open studies, after October 1, 2010, will be required to complete the CITI education program.

Upon successful completion of the course, a certificate is issued which can be used as confirmation that the required training has been completed. Individuals will be able to log into the system and retrieve their certificate at anytime. Completion information will also be captured by the CITI database and will be accessible to authorized Human Research Protection Program staff. Learners can register with multiple institutions as needed and readily meet curricula requirements for each institution to avoid duplication of efforts.

Completion of the CITI program will be required of investigators every three years. Once the initial CITI modules are completed, users will complete refresher courses every three years. CITI offers an automated alert system to remind learners, by email, that refresher or recertification training is due.

To register, please visit Educational Opportunities CITI page and follow the instructions. Once you have created an account, select the modules appropriate for your discipline and research activities.

If you are an IU employee that has completed CITI courses at a previous institution, check your CITI account to see if IU is listed as an institution.

For non-affiliated investigators that have an existing CITI account with another institution or organization, log-in through the main CITI site with your CITI username and password: www.citiprogram.org. When you are logged in to your account, on the Main Menu you can choose to “Affiliate with another institution”. Choose to affiliate with the IU campus on which you will be conducting research. After you finish registering with your IU campus the modules that you need to take will be listed under the IU campus’ “My Courses” section.

CITI Program Details:

The training can be taken in several sections, rather than all at once. The system will remember what quizzes have been taken and the score. It is available to users to print some or all of the materials as needed. Users will still need to return to the course site to complete the quiz associated with each module.

CITI offers a user-friendly interface where learners can complete the modules customizable to their discipline categories:

  • Biological/Biomedical Sciences
  • Social Sciences
  • Research with Prisoners
  • Research with Children
  • Genetic Research
  • International Research
  • Students in Research, and more.

All investigators will be required to complete, within their discipline category, chapters and pass tests covering core areas. It is estimated that this should take between one and a half to three hours to complete. Examples of some of the core areas are listed below:

  • CITI Course Introduction and Belmont Report
  • History and Ethical Principles
  • Regulatory Overview
  • Informed Consent
  • HIPAA and Human Subjects Research
  • Conflicts of Interest

Many institutions and organizations are beginning to accept completion of identified CITI modules as continuing education (CE) credits. SoCRA will recognize six hours of CE for the basic course “Protection of Human Research Subjects” and four hours of CE for the “Good Clinical Research Practice” course. Appropriate completion certificates are required to be retained for audit purposes by SoCRA members who are re-certifying for the CCRP designation.

CITI is a volunteer organization whose goal is to develop and distribute high quality, peer reviewed educational resources designed to raise awareness to the Responsible Conduct of Research for all members of the research team. CITI provides “Help Desk” support for users available during normal business hours to help learners with any problems they may have: 305-243-7970 or citisupport@med.miami.edu