Human Subjects Research Training

Human Subjects Research Training

 

All SU researchers and advisers must complete the CITI Human Subjects Research training program (scroll down for details) and include current completion certification with expedited and full-board protocol submissions. (You do not need to submit training certification with applications for exemption.)

Notes: 

Training requirements have been revised as of September 2018.   Certification now lasts for four years (an increase from three years)! The required human subject research training modules from CITI have been streamlined for SU researchers, and now several modules are considered supplementary (all module titles are shown below). Note that when a supplementary module is directly applicable to the proposed research project, the IRB may require the completion of one or more specific modules before approval may be granted. NIH Human Subjects Research Training is no longer an option because the website was discontinued in September 2018.

** If you have completed either NIH or CITI training within the past four years, you do not need to complete this CITI training until your current certification expires.

If you will submit related grant proposal(s), consult with the Office of Sponsored Projects regarding training requirements because some funding organizations require certain training modules from specific certification sites, such as Responsible Conduct in Research and Human Subjects Research modules from CITI.

Co-investigators or key personnel from other institutions are not required to demonstrate evidence of human subjects research training as part of an SU IRB protocol submission. However, as an SU PI, you are responsible for maintaining high ethical standards among researchers involved in a protocol and must report any violations. In special circumstances (such as community-based research endeavors), SU researchers may choose to informally train key personnel in human subjects protections. Contact the IRB if you would like to discuss special accommodations or specific circumstances.

 

CITI Certification

For IRB requirements, complete the CITI Human Subjects Research course. Registration instructions:

       Note: The IRB requires this course: "Human Subjects Research for IRB (Faculty, Staff, and Student)."  The IRB does not require the Responsible Conduct in Research (RCR) courses at CITI; these courses may be required for OSP or other research endeavors.  

  • If you already have a CITI account, choose "Log In" and proceed.
  • If you have not yet accessed CITI, click "Register," then enter Seattle University for "Select Your Organization Affiliation" and check appropriate boxes before clicking "Continue ..."  If you have not completed CITI certification before, do NOT select "Log In Through My Institution."
  • Enter first and last name, and your SU email address (CITI will not accept any other email addresses).
  • After you answer the questions provided, the system will tell you that you are registered.
  • After registered, you can click View Courses for Seattle University.
  • Select the "Human Subjects Research for IRB (Faculty, Staff, and Student)" training course.**  
  • For IRB certification, complete the four required modules offered in the Human Subjects Research course. You may save at any time and return to the training.
  • Additional modules of training may be required or desired depending on your project.  See below.

   *Save a screen shot or PDF that shows your certification completion.  You will include it with your IRB protocol submission.

 

   **If this course title is not displayed in your list of courses, then scroll to the bottom of the "Courses" screen, select "Add a course," and answer the questions regarding your interest in human subject research training.  

 

CITI Training Modules:

The required CITI modules for IRB submissions of expedited and full-board research protocols are:

  • History and Ethical Principles
  • Assessing Risk
  • Informed Consent
  • Privacy and Confidentiality

The supplementary CITI modules are shown below and are accessible after completing the required modules. One or more of these modules may be required by the IRB for approval of expedited and full-board research protocols. Faculty may opt to make one or more of these modules required for their students.

  • Consent and Cultural Competence
  • Ethical and Practical Considerations in Community-Engaged Research (CEnR)
  • International Research
  • Internet-Based Research
  • Research with Children
  • Research with Decisionally Impaired Subjects
  • Research with Older Adults
  • Research with Persons who are Socially or Economically Disadvantaged
  • Research with Prisoners
  • Research in Public Elementary & Second Schools
  • Vulnerable Subjects – Workers/Employers

 https://www.citiprogram.org/