Frequently Asked Questions
Do I have to take Human Subject Protection training?
Yes. Successful completion of Human Subject Protection (HSP), HIPAA Research, and Conflict of Interest (COI) training is required for all research personnel listed on your eIRB study. If the protocol is a clinical trial, it is also necessary to complete Good Clinical Practice (GCP) training.
Please note that if the research personnel are employed outside of the UT Southwestern Medical Center system, they must submit record of their research training from that entity or self-register in CITI and complete the UT Southwestern Research courses. It is the responsibility of the Principal Investigators to ensure non-UT Southwestern research personnel collaborating with UT Southwestern investigators are in compliance with UT Southwestern training policies.
What is covered in each CITI IRB required training module?
- Human Subject Protection: Human Subject Protection (HSP) training is mandatory for all research personnel who are involved in a research study that involves human subjects. HSP training presents common concepts, principles, and issues related to the protection of human research participants, including principles of bioethics and basic regulatory standards.
- Research HIPAA: Research HIPAA training is required for all study personnel who are involved in a research study that involves human subjects. This training presents information about The Privacy Rule as well as other issues related to obtaining, using, and/or disclosing Protected Health Information (PHI).
- Good Clinical Practice: Good Clinical Practice (GCP) training is required for all research personnel who are involved in a research study involving human subjects in a clinical trial. GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials. GCP practices provide assurance that the data and reported results are credible and accurate; and the rights, integrity and confidentiality of the trial subjects are protected.
- Conflict of Interest: Each covered individual* must complete Conflict of Interest (COI) Training before engaging in research at UT Southwestern Medical Center and at least once every four years thereafter. A covered individual new to UT Southwestern must complete the training before engaging in research, or must provide evidence of having completed the training at another UT System institution within the last four years. A covered individual must complete the training immediately if it is found that the covered individual is not in compliance with this policy or a management plan, or if the policy is revised in a manner that affects the covered individual’s duties.
*Covered Individual – Any person who is required to submit a statement of financial interests, including: faculty members; study team members (including students and post-graduate trainees); individuals who may influence the negotiation or execution of research or technology licensing agreements; Institutional Review Board (IRB) members; Institutional Animal Care and Use Committee (IACUC) members; and Conflict of Interest Committee (COI Committee) members.
Do I get a certificate of completion?
Yes. A personalized certificate is generated for training courses. The user should keep a copy for their records since the IRB does not keep copies of training certificates.
How long does the training take?
HSP and GCP training can take the user up to 3 hours, depending on the level of experience with human subject’s research. HIPAA Research can take up to 30 minutes and COI training typically takes 10 to 15 minutes.
Can I complete CITI training in several sessions?
Yes. You can leave and come back to the website using your CITI username and password.
Note: If you ever forget your password or user name, you can go to “Forgot login information” at the home webpage to retrieve the information.
How do I get a copy of my completion certificate?
You can view and print a copy of your completion certificate by logging into the CITI home page with the username and password you selected when you first registered. Upon successful login, you will be at the "Learner's Menu" screen:
If under the Status heading it says "passed," then you will see Print Report under the next column heading – Completion Report. Click on Print Report to open a PDF version of the certificate which may be printed or saved to your desktop.
If under the Status heading it says "Not Started" or "Incomplete," you will need to click on the name of the course to complete the training module before the completion report may be printed or saved.
What if I have a certificate from another training program?
Training requirements can currently be met by showing completion from a variety of sources. If you have already completed a training program, send a copy of the certificate of completion to the IRB office who will determine if it meets the necessary course requirements. It may be sent through interoffice mail code 8843, faxed to 214-648.2171, or emailed to email@example.com
Where do I send my training certificates of completion?
The IRB Office automatically receives notification of all training taken at CITI Program and the training will automatically populate in eIRB if “University of Texas Southwestern Medical Center” was selected as the Participating Institution and the institutional email address was used as the primary email address. Therefore, it is not necessary to send the training reports to the IRB unless requested by the IRB office.
What is a Learner Group and which should I select for my training?
There are several Learner Groups to choose from, with each group reflecting a different training curriculum. It is important to choose the correct Learner Group as this “assigns” the correct courses to you. Please choose Group I “IRB Protocol Training” and answer “Yes” to Question 2 regarding Conflict of Interest Training.
Can I take additional modules beyond the above courses?
Absolutely. Once you complete the basic course(s), you can choose to take additional optional modules.
How do I find my “Person Number”? (Applicable only to UT Southwestern Employees)
To find your UT Southwestern person number, please do the following: Log into PeopleSoft by clicking on the PeopleSoft link at the top right-hand corner at MyUTSW, enter your UTSW User ID and password (the same one you use to log into Outlook for email), select “PeopleSoft HCM”, “Self Service”, and “Compensation History.” It is listed as the Employee ID.
The grants officer requires a statement of the research training I have taken. Where can I get such a letter?
The request for documented training form will need to be completed and returned to the IRB office. The form can be sent through interoffice mail code 8843, faxed to 214-648-2171, or emailed to firstname.lastname@example.org.