The Collaborative IRB Training Initiative (CITI)

Overview of the GWU CITI Training Program

All GWU investigators and non-GWU investigators conducting research under the authorization of the GWU Institutional Review Board (IRB) must demonstrate and maintain sufficient knowledge of the ethical principles and regulatory requirements for protecting human subjects, through the completion and periodic renewal of the web-based human subject protection training called Collaborative Institutional Training Initiative (CITI) (www.citiprogram.org). This training must be completed prior to submission of all new human research study applications and maintained throughout the life of the study. Below is a list of Frequently Asked Questions (FAQs) that will help orient you to CITI training.

Who do I contact with questions?

If you have any questions regarding CITI training requirements for human subjects research or if you have forgotten your username or password, please contact the GWU Office of Human Research (OHR) at (202) 994-2715 or ohrirb@gwu.edu. For technical questions regarding the CITI webpage, please contact the CITI support desk at (305) 243-7970 or email citisupport@med.miami.edu. For questions regarding departmental or course-specific CITI training requirements, please contact the department or course instructor.

Who has to take CITI training?

CITI training must be completed by all GWU investigators (and study staff) and non-GWU investigators (and study staff) conducting human subjects research under the authorization of the GWU IRB, to include research determined to be “exempt,” who are either:

1. Interacting with potential or enrolled subjects, to include but not limited to consenting, recruiting, data collection and intervention, or
2. Viewing, obtaining, analyzing or otherwise handling identifiable research data, to include coded data which links to subject identity via a key linking subject identity and data.

Which CITI courses do I need to complete for human subjects research?

The training modules available to investigators are as follows (Note: The Responsible Conduct of Research Modules do not satisfy these training requirements):

1. Either the Social-Behavioral or Biomedical “Basic Course"
   
Required

You should select the basic course that is relevant to your research. For example, biomedical research includes studies designed primarily to increase the scientific base of information about normal or abnormal physiology and development and studies primarily intended to evaluate the safety, effectiveness or usefulness of a medical product, procedure or intervention.

2. “CITI Health Information Privacy and Security (HIPS)”

Required if obtaining, viewing or otherwise handling Protected Health Information (e.g. reviewing medical records)

3. “Data and Specimens”

May be completed instead of #1 if the researcher’s only activity is data or specimen analysis or handling.

How do I access the CITI website, create a new account, or renew my CITI training?

See CITI Registration Instructions.

How do I know if I passed the Basic Course?

Researchers must correctly answer 75% of the questions in a course section’s exam to successfully pass.  If a course section is failed, the researcher will immediately be given the opportunity to retake that section’s exam.

How often do I need to renew my CITI training?

To participate in ongoing research activities, the Social-Behavioral Basic, Biomedical Basic or Data and Specimens module must be renewed every 2 years by taking the corresponding Refresher Course.  Modifications, renewals and other mid-research submissions will not be approved without verification of up-to-date researcher training.

Health Information Privacy & Security (HIPS) training does not require renewal--it only needs to be taken once.

* New to IRB Forum attendees: Reseachers may attend this monthly OHR outreach to receive one Human Subject Protections training credit. Two credits may be applied to future CITI Refreshers Course requirements.

What should I do if I forgot my user name or password?

Please contact the GWU Office of Human Research (OHR) at (202) 994-2715 or ohrirb@gwu.edu for assistance. If you have affiliated your account with GWU, the OHR staff will be able to view your user name and password. If you have taken CITI at another institution and have not affiliated with GWU, you will need to contact the CITI support desk at (305) 243-7970 or email citisupport@med.miami.edu.

What should I do if I completed human subject protections training at another institution?

If you have taken CITI training or some other form of human subject protections training at another institution, please submit documentation of training (e.g., certificate, etc.) to the GWU Office of Human Research (OHR). The GWU OHR will review the completed training, when it was last completed, and if  found to meet GWU training requirements, it may be accepted in lieu of GWU’s customized CITI training program.

If CITI training was completed through another institution, we recommend that you “Affiliate” your CITI account with GWU through your account’s home page so that GWU OHR staff can view your completed training directly.