Human Subjects Research & CITI Training

CITI Online Human Research Curriculum

All investigators, faculty advisors and research staff are required to complete the appropriate CITI online training module on Human Subject’s Protection within 48 months before the application date, and to submit the certificate of completion to the IRB with their application (please see below for guidance on completing the appropriate CITI training). Applications are considered incomplete without this training and will not be processed or reviewed until this requirement has been fulfilled. Additionally, so long as an approved protocol is active, investigators must update their qualifications at least every 48 months. This qualification must be maintained in order for investigators to continue ongoing research activities. 

If an investigator, faculty advisor, or member of research staff has completed CITI training through affiliation with another university, institution, organization, etc. within the last 48 months, then a completion certificate must accompany the application. Only CITI training will be accepted. 

NOTE: Investigators using Protected Health Information (PHI) in their research involving human subjects must also complete UNE HIPAA educational requirements and submit evidence of completion with their IRB application. If you are unsure whether or not your research involves PHI or have any questions about fulfilling UNE HIPAA educational requirements or questions regarding HIPAA policies, please contact the UNE HIPAA Privacy Officer, Dora Anne Mills at dmills2@une.edu

Required CITI Coursework

Please see below for guidance on completing the appropriate CITI training for conducting research with human subjects at the institution. 

TO REGISTER: CITI training is provided free of cost to users at UNE. When creating an account on the CITI homepage, DO NOT select 'Log in via SSO' under 'Log in through my institution'; UNE does not use the SSO system. Select 'Register' under 'Create an account'; throughout the process you will be prompted to affiliate with UNE. 

Social & Behavioral Research Investigators 

Complete the Social & Behavioral Research Investigators Course in it's entirety if you are a principal or co-investigator, student, faculty advisor, or research staff conducting social/behavioral research with human subjects. Examples of these research activities include studying individual or group characteristics or behavior employing surveys, interviews, and/or focus groups and educational research in an academic setting. 

NOTE: If the proposed social/behavioral research is PHS-funded, all principal or co-investigators, students, faculty advisors and/or research staff on the project must also complete the Social & Behavioral Responsible Conduct of Research Course in it's entirety. This training is encouraged for all non-PHS-funded investigators and staff as well, but it is not required. 

Biomedical Research Investigators

Complete the Biomedical Research Investigators Course in it's entirety if you are a principal or co-investigator, student, faculty advisor, or research staff conducting biomedical research with human subjects. Examples of these research activities include research studying movement, coordination and exercise protocols involving physical measures (pedometers, physical sensors, etc.), medical research on drugs and research involving the collection of biological specimens (saliva, blood, etc.). 

NOTE: If the proposed biomedical research is PHS-funded, all principal or co-investigators, students, faculty advisors and/or research staff on the project must also complete the Biomedical Responsible Conduct of Research Course in it's entirety. This training is encouraged for all non-PHS-funded investigators and staff as well, but it is not required. 

Financial Conflicts of Interest Course

All PHS-funded "Investigators" must complete online Financial Conflicts of Interest Course prior to the expenditure of funds on any newly-funded projects, including noncompeting continuation awards. Training must be completed at least every four years. Current PHS awards (pre-8/2012) are not subject to these new requirements until the noncompeting continuation award. However, we encourage investigators to take the FCOI training to fulfill this mandatory requirement. The definition of an "investigator" includes the Principal Investigator (PI) and any other person (regardless of title or position) that the PI identifies as independently responsible for the design, conduct, or reporting of the research. While this online training is required for PHS-funded investigators, it is encouraged for all non-PHS-funded investigators as well. Please see the Office of Sponsored Programs page for more information on UNE's Financial Conflicts of Interest Policy.