Educational requirement for human subject research at UNTHSC

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When submitting a protocol for IRB review (both new and continuing review), the Principal Investigator must include written verification that each of the key personnel has successfully completed the appropriate educational tutorial/program designated by the UNTHSC Office of Research Compliance (OReC) through the CITI (Collaborative Institutional Training Initiative) Course in the Protection of Human Subjects, with links located on the UNTHSC
IRB web site. This is now the basic standard training requirement for all faculty, staff, and students engaged in research involving human subjects.

At UNTHSC, CITI training is valid for three years. A refresher course can be taken through the CITI website to renew CITI certification every three years. Expiration of this educational training requirement can jeopardize any current or newly submitted research protocol.

CITI Training Requirements

 

Note that the various “Refresher Courses” offered through CITI (Biomedical- Clinical, Social-Behavioral, Interdisciplinary, etc.) are NOT a substitute for the HUMAN SUBJECT RESEARCH Basic Course for first time CITI learners.    The Refresher courses are only allowed for persons who have already successfully completed the HUMAN SUBJECT RESEARCH Basic course(s) required by the UNTHSC IRB. 

 

Additionally, completion of the CITI Good Clinical Practice (GCP) Course or any other CITI course (such as Responsible Conduct of Research – RCR)  is NOT a substitute for the HUMAN SUBJECT RESEARCH Basic Course.  While completion of the GCP and RCR courses may be required by other departments or units at the UNT Health Science Center, these courses do not meet the basic “entry level” requirement of the OReC/IRB for human subjects research.

 

Please note that selecting and completing an inappropriate CITI training course may delay OReC and IRB review and approval of the protocol/application.