UT Tyler

IRB Training

Collaborative IRB Training Initiative (CITI)

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

Collaborative Institutional Training Initiative

Ethical considerations are essential in planning and implementing any research study involving humans. 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 protecting the rights and welfare of human subjects involved in research through adherence to related principles regarding research conducted with human subjects. These principles are operationalized through established policies and procedures that are reflected 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 meeting this standard of knowledge, UT Tyler has purchased a license to the Collaborative Institutional Training Initiative (CITI), a comprehensive educational program that is used nationally and worldwide “... to provide educational 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.citiprogram.org/

Principal investigators, co-investigators, and any student or other assistant who will be involved with sample recruitment and other sampling procedures, data collection and identifiable (via direct or indirect identifiers) data and/or data analyses are required to take the training and send completed before submission of research.

Requirements for Socio-Behavioral Researchers

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

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 until the protocol is up for renewal. At that time, required modules will need to be completed before the renewal or continuing review is approved. The research protocol will be suspended until training has been completed.
  • Protocols submitted from first day of classes, Aug. 29, 2016, will be approved only after 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 time 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