IRB Training Requirements

Educational Requirements

Federal Regulations require that key personnel in studies involving human subjects undergo training to improve research subject safety. Key personnel are all individuals responsible for the design and conduct of the study. This includes the PI, Co-PI’s, Supervisors and other personnel who will be interacting with the human subject or that will be handling data (even if they do not interact with the human subjects).

Important Notice: As of January 2, 2013, FIU will only accept human subject training through the Collaborative IRB Training Initiative Program (CITI). This new requirement applies to all new IRB protocol submissions and when adding project personnel onto an existing IRB-approved protocol. Investigators with active IRB protocols will need to ensure that all project personnel have satisfied this new IRB training requirement when submitting for their next IRB continuing review.

Required CITI IRB Online Training for All Researchers (Initial Training)

Please follow the directions below to sign up for an account on the CITI website:

  1. Go to http://www.citiprogram.org
  2. As a “new” user, you will need to click “Register”.
  3. Select “Florida International University” from the Participating Institutions.
  4. Complete the required registration fields and contact information and click submit.
  5. You will need to select “Human Subjects Research” from the CITI Enrollment web page and click next.
  6. Select the “Biomedical Human Research Investigators Course” or the “Social & Behavioral Human Research Investigators Course” and click submit.
  7. A table will be displayed listing the course(s) you are enrolled in. You can begin the course by clicking on the course name.

You will have the opportunity to print a Training Certificate Completion Report upon completion of the training course and exam. Please save a copy of this report for your records. The FIU IRB Office does not issue certificates of CITI training completion.

Required CITI IRB Online Training for All Researchers (Refresher Training)

Training reports are valid for a period of three years and must be renewed at the end of that three year period by taking a Refresher Course through the CITI website. Please follow the directions below to complete the refresher course:

  1. Go to http://www.citiprogram.org
  2. Log in with your existing user name and password, which will take you to the main menu.
  3. For FIU users, CITI will automatically add the “Refresher” course to your list of courses 90 days before your CITI Training expires. The refresher course should list a status of “Not started” or “Incomplete”. You can begin the course by clicking on the course name.
  4. Begin your course by clicking on the red link “Incomplete Re-Enter”.
Additional CITI IRB Online Training (Required Depending on the Type of Study)

CITI Good Clinical Practice (GCP) Training:

All researchers that are engaged in conducting one or more of the following types of research studies are also required to complete online GCP training (in addition to the regular CITI IRB training):

  1. An NIH funded clinical trial (one or more human subjects are prospectively assigned to one or more interventions, which may include placebo or other control, to evaluate the effects of those interventions on health related biomedical or behavioral outcomes); or
  2. An FDA regulated clinical trial involving drugs, devices, or biologics.

GCP training can be completed through the CITI Program website.  GCP training reports are valid for a period of three years and must be renewed at the end of that three year period.

CITI Health Information Privacy and Security (HIPS) Training:

All researchers that are engaged in conducting research involving the use of Protected Health Information (PHI) are also required to complete the online CITI HIPS training (in addition to the regular CITI IRB training).

If you have taken CITI Training at another institution

Investigators that have completed the CITI IRB Training at another institution can link up their training records with FIU by completing the steps outlined below:

  1. Go to http://www.citiprogram.org
  2. Log in with your existing user name and password, which will take you to the main menu.
  3. You will need to click on the following link: “Click here to affiliate with another institution”.
  4. Select Florida International University from the list of institutions.
  5. Select your courses as applicable and then click submit.
  6. A table will then be displayed listing the course(s) you are enrolled in. You can begin the course by clicking on the course name.
  7. Complete any modules that were not previously completed at your prior institution, but are required by FIU (non-transferable).
Questions about CITI Online Training

Please review the CITI IRB Online Training FAQs for additional information and answers to commonly asked questions about the CITI IRB Training requirements.

If you are having technical difficulties in signing up or in navigating the CITI Program website, please visit the CITI Program Support web page.