IRB Training

Collaborative IRB Training Initiative (CITI)

Welcome to the training page for the Institutional Review Board (IRB).

Collaborative Institutional Training Initiative

Ethical considera ons are essen al in planning and implemen ng any research study involving humans. The UT Tyler has a formal agreement known as the Federal Wide Assurance (FWA) with the Department of Health & Human Services that states UT Tyler will be responsible in protec ng the rights and welfare of human subjects involved in research through adherence to related principles regarding research conducted with human subjects. These principles are opera onalized through established policies and procedures that are re ected in the UT Tyler IRB Handbook.

Of utmost importance is the knowledge and skills required to do human subjects research within a solid ethical framework. In order to facilitate mee ng this standard of knowledge, the UT Tyler has purchased a license to the Collabora ve Ins tu onal Training Ini a ve (CITI), a comprehensive educa onal program that is used na onally and world-wide “...to provide educa onal content that promotes the quality of and public trust in the research enterprise” (Mission statement: CITI). The main website for CITI can be accessed at https://www.ci program.org/

Principal Inves gators, Co-inves gators, and any student or other assistant who will be involved with sample recruitment and other sampling procedures, data collec on and iden able (via direct or indirect iden ers) data and/or data analyses are required to take the training and send completed before submission of research.

Requirements for Socio-Behavioral Researchers: (Active link to open to list below)

Socio-Behavioral Course: 9 modules.

  • Belmont Report and CITI Course Introduction
  • History and Ethical Principles
  • Defining Research with Human Subjects
  • The Federal Regulations
  • Assessing Risk
  • Informed Consent
  • Privacy and Confidentiality
  • Unanticipated problems and Reporting Requirements in Social and Behavioral Research
  • Populations in Research Requiring Additional Considerations and/or Protections
  • Additional supplemental course(s) may be required if a special population is used, i.e., cognitively impaired or research in primary/secondary schools, or special method is used, i.e., internet or community-based participatory action research.

*Please submit the applicable CITI Training Completion Certificates for ALL team members with your IRB application.

Requirements for Biomedical Researchers: (Active link to open to list below)

Bio-Medical Course: 9 modules.

  • Belmont Report and CITI Course Introduction
  • History and Ethics of Human Subjects Research
  • Basic Institutional Review Board (IRB) Regulations and Review Process
  • Informed Consent
  • Social and Behavioral Research (SBR) for Biomedical Researchers
  • Records-Based Research
  • Research and HIPAA Privacy Protections
  • Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research
  • Populations in Research Requiring Additional Considerations and/or Protections
  • Additional supplemental course(s) may be required if a special population is used, i.e., cognitively impaired or research in primary/secondary schools, or special method is used, i.e., internet or community -based participatory action research.

*Please submit the applicable CITI Training Completion Certificates for ALL team members with your IRB application.

Requirements for Student Research Assistants (RA)

  • Those individuals, i.e., student research assistants (RA), who are handling de-identified data for data analysis purposes are exempt from these requirements under the condition that the PI accepts responsibility for oversight and monitoring of the student RA for the ethical conduct of research as described in the required training for the PI and research team. The PI may require the student to take any of the CITI modules as it relates to their functions on the research team.

Timing, Frequency and Documentation of CITI training:

  • Individuals who have protocols currently in place will not need to complete required CITI training un l the protocol is up for renewal. At that me, required modules will need to be completed before the renewal or continuing review is approved. The research protocol will be suspended un l training has been completed.
  • Protocols submitted from first day of classes, August 29, 2016, will be approved only a er required CITI training has been completed.
  • CITI training must be completed at least every three years, or more often as required per protocol.
  • Once CITI training has been completed, the PI must submit documentation of training for self and research team at 
the me the protocol and related materials are submitted to the IRB Chair for review.

*Please submit the applicable CITI Training Completion Certificates for ALL team members with your IRB application.

CITI REGISTRATION PROCESS

CITI FAQ’s