IRB Education Requirements (CITI)

CITI Training                       HIPAA Training                           ORSPA Training

ETSU utilizes the Collaborative Institutional Training Initiative (CITI) Program, a web-based program designed to provide research ethics and compliance training courses to ETSU and Quillen VAMC researchers for free. CITI Program was created by the University of Miami and is now operated by the Biomedical Research Alliance of New York (BRANY).

Ethics and Compliance Education Requirements

All study staff engaged in the conduct of human subject research are required to complete an ETSU/VA approved course in the ethical conduct of research involving human subjects prior to receiving IRB approval. The IRB utilizes the courses provided by CITI to fulfill the educational needs of our reserachers. Education certificates are valid for a 3-year period and must remain current while study staff is engaged in research.  IRB approval will not be granted until the HRPP staff verify all required ethics and compliance training for each study staff member. In addition to human subject protection (HSP) education, study staff may be required to complete additional educational courses depending on the type of study being conducted.

Please note: Registering for CITI does not create your account with OneAegis (formerly IRBManager); this must be done separately. Please refer to the OneAegis instructions here.

Additional Information:

• Instructions

  Below are links to instructions for logging into CITI and completing the appropriate courses:

  • Instructions for mandatory CITI training for IRB-approved studies
  • Instructions for optional Students in Research course
    • Note: The Students in Research course do NOT fulfill the IRB education requirement.
• Check status of CITI training

  You can check the status of your and your study staff's CITI training before submitting a new study or modification to add study staff. The IRB cannot approve study staff that have not completed the required CITI  human subjects protection course. 
• Trouble with CITI account

  The ETSU IRB does not operate the CITI Program, so if you experience issues with your CITI account, please contact the CITI Program Support CenterCITI is a third party vendor operated by BRANY, and they employ a team of support staff to assist you with any issues.
  
  
• Accessing your CITI completion report

  From the CITI website:

  1. Log into your CITI Program account.
  2. Click on "East Tennessee State University courses" in the Main Menu.
  3. Click on "View Previously Completed Coursework."

  You will see your completed courses, and you can print or save any certificate or completion report.

• Non-ETSU Study Staff

  If you are collaborating with non-ETSU study staff (including the VA and Ballad Health), the collaborating investigators are expected to complete the human subject training requirements of their institution. If the non-ETSU study staff are not affiliated with an institution that provides their own training, you can recommend the following training options:

  • DHHS Human Research Protection Training
  • ACRP Ethics and Human Subject Protection
  • NIH Protecting Human Research Participants (PHRP)

FAQs

• Who must complete Human Subject Protection (HSP) education?

  All ETSU and VA Principal Investigators and study staff must complete CITI Human Subjects Protection education. The CITI educational course also must be completed prior to final approval of any new study, continuing review, administrative check-in or modification adding new study staff.
• How long does the CITI HSP course take?

  For most individuals, the CITI HSP course takes about 2-4 hours to complete. The course involves several modules that cover various human research ethics and regulatory requirements, and there are videos, supplemental materials, and quizzes throughout. You can stop and start at anytime. Be sure to save your progress before exiting.
• Can I take CITI courses if I am not on an IRB study?

  If you are an ETSU employee or student, you can sign up using the ETSU CITI Subscription and complete any courses or modules that interest you. Some instructors require students to complete CITI training as part of class requirements, and there is a course specifically for this purpose (see instructions above).  Additionally, CITI offers other training courses and modules relevant to the conduct of research that may be required by other ETSU offices/departments. For example, sponsored research may require completion of the CITI Conflict of Interest course.
• What if I have completed CITI courses at another institution?

  If you have completedCITII courses at another institution, you can affiliate with ETSU in your CITI Program profile to receive credit for the training at ETSU.

  1. Go to the CITI Program website and log in to your existing account (even if at created another institution).
  2. On the My Courses page, under Institutional Courses, you will see a link to "add an affiliation."
  3. Click the link and locate East Tennessee State University in the search bar.
  4. Click the affirmations and agree to Terms of Service to continue.
  5. Complete the Profile and continue.
  6. Select the courses you need to complete.

  Your account will affiliate with ETSU during this process, and your already completed courses will transfer to ETSU. If ETSU requires additional modules to be completed, you will need to complete those to receive credit.

• Are there additional training requirements for IRB approval?

  Principal Investigators are responsible for training study staff to complete their assigned roles or tasks on the study, and researchers should be qualified to conduct the proposed research. All researchers and study staff conducting research with PHI (or HIPAA data) must complete HIPAA Training. Researchers using PHI for research from ETSU/ETSU Health must complete ETSU HIPAA training available on the HIPAA Compliance website. Researchers coming into contact with biohazardss (i.e., blood, human waste, microorganisms) may also be required to complete appropriate Environmental Health & Safety (EH&S) training such as bloodborne pathogens training. More information is available on the EH&S website.

  In addition to the CITI HSP course, researchers and study staff on NIH-funded clinical trials must complete Good Clinical Practices (GCP) training, which is available in CITI as well as other programs. Other sponsor requirements for training may exist, and it is the researcher's responsibility to comply. For example, NSF may require Responsible Conduct of Research training, and DoD may require other training. The Office of Research & Sponsored Programs Administration (ORSPA) can assist with sponsored research training requirements.