The UT Southwestern IRB office staff provides education and training on the ethical and regulatory standards for human subject protection. IRB policy requires all study team members (including offsite collaborators) listed on a UT Southwestern IRB protocol application to complete training before conducting research involving human subjects. Successful completion of training is required prior to granting final approval of a new protocol. Both Human Subject Protection (HSP) and HIPAA Research are required for all research personnel listed on the NR1. If the protocol is industry sponsored, it is also necessary to complete Good Clinical Practices (GCP) training.
Likewise, new study personnel cannot be added to an approved protocol until they have completed all required training. Information about the required training and answers to frequently asked questions are listed below.
For any questions related to training, please contact the IRB Senior Coordinators:
All required training is provided as a web-based tutorial offered through the Collaborative Institutional Training Initiative (CITI Program). After finishing the required training(s), please keep a copy of each document for your records.
Human Subject Protections
Health Insurance Portability and Accountability Act (HIPAA)
Good Clinical Practice
Training Instructions – UT Southwestern Employees
Training Instructions – Other Affiliates
Additional Educational Opportunities
FAQs
HUMAN SUBJECT PROTECTIONS (HSP)
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.
An alternative to completing the Human Subject Protections training online is to attend a class. This training class is held on select Tuesday afternoons. Also offered during this time is certification of completion for HIPAA research. For specific dates and room numbers please see our schedule.
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HEALTH INSURANCE PORTABILITY and ACCOUNTABILITY ACT (HIPAA), Research Course
The Research HIPAA course is required for all UT Southwestern Medical Center at Dallas (including Zale Lipshy and St Paul hospitals), Parkland and Children's Hospital's research personnel listed on the NR1. Topics covered include access and use of protected health information for research purposes, authorization and waiver of authorization, and data security.
An alternative to completing the Research HIPAA training online is to attend a class. This training is held on select Tuesday afternoons. Also offered during this time is certification of completion for Human Subject Protections training. For specific dates and room numbers please see our schedule.
If the research personnel are employed outside of the UT Southwestern Medical Center at Dallas system, and employed by a HIPAA covered entity, they must submit record of their HIPAA research training from that entity or self register in CITI and complete the UT Southwestern Research HIPAA course.
It is the responsibility of the Principal Investigators to ensure non-UT Southwestern research personnel collaborating with UT Southwestern investigators are in compliance with the UT Southwestern HIPAA policies and procedures. These are available at www.utsouthwestern.edu/hipaa. Training documents for HIPAA and Research Activities are available at HIPAA Research Training Content. Please note: These training documents are made available for informational purposes only. A training certificate will only be issued for those completing the on-line or classroom training.
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Good Clinical Practice
Good Clinical Practice training is required for all research personnel performing an industry sponsored study involving human subjects. 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.
Any questions regarding the required training can be directed to the IRB office at 214-648-3060.
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Training Instructions:
UT Southwestern Employees (Faculty or staff who has an active person number and a Southwestern ID) Note: The CITI Course site is best viewed with Microsoft Internet Explorer or Firefox.
IMPORTANT: Before you begin, please have your Person Number available since you will be asked to enter it into the registration form. If you do not know your person number, click here to visit the FAQ for instructions
- Go to: http://www.citiprogram.org/.
- If you are a new user, click on “Register Here”. This will open a new window that contains the Registration Form.
- Fill out the Registration Form by completing the following fields:
- Select your institution or organization
Important: Select “UT Southwestern Medical Center” in order to be able to view our courses
- Select your Username and Password
Important: Recommend using your UT Southwestern MedNet ID.
- Enter your name
Important: Use your full name. Providing a nickname or an abbreviated name may cause delay in verifying your training.
- Enter your email address
Important: Use your UT Southwestern e-mail address as your preferred address.
- Click Submit.
- Complete the following fields:
Fields marked with an * are required fields
- Gender
- Date of Birth
- Person Number (only for UT Southwestern employees)
- Department
- What is your job title?
- Office Phone
- Mail Code
- Home Phone
- May we re-contact you to complete a course survey?
- Click Submit.
To sign in again later:
- Go to: http://www.citiprogram.org/
- Enter your User Name 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.
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Other Affiliates (Employees of Children’s, Parkland, Texas Scottish Rite Hospital, Retina Foundation or other off-site collaborators who do not have a UT Southwestern person number)
IMPORTANT: You must select “UT Southwestern Medical Center” as the Participating Institution in order to view the appropriate courses.
- Go to: http://www.citiprogram.org/.
- If you are a new user, click on “Register Here”. This will open a new window that contains the Registration Form.
- Fill out the Registration Form by completing the following fields:
- Select your institution or organization
Important: Select “UT Southwestern Medical Center
- Select your Username and Password
- Enter your name
Important: Use your full name. Providing a nickname or an abbreviated name may cause delay in verifying your training
- Enter your email address
- Click Submit.
- Complete the following fields:
Fields marked with an * are required fields
- Gender
- Date of Birth
- Person Number (only for UT Southwestern employees)
- Department
- What is your job title?
- Office Phone
- Mail Code
- Home Phone
- May we re-contact you to complete a course survey?
- Click Submit.
To sign in again later:
- Go to: http://www.citiprogram.org/.
- Enter your User Name 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.
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ADDITIONAL EDUCATIONAL OPPORTUNITIES
To further promote a solid foundation for the conduct of human subjects research, additional educational and training opportunities are available through the IRB office. These include, but are not limited to:
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TRAINING SESSION
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COURSE DESCRIPTION
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Research Matters
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Monthly presentations regarding specific topics relating to human participant protections and research. Available to all research personnel. Registration is not required.
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Individualized training and education
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Training on all aspects of human research protections and IRB processes is available at the request of departments or investigators.
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IRB Website and Listserv
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Links to regulatory websites, as well as pertinent reference materials, IRB policies and guidance, and IRB forms and templates. The Listserv also provides subscribers with important IRB announcements, including changes in IRB forms and processes, and updates on regulatory issues. Available to faculty, staff, students and the research community. To subscribe click here.
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FAQ
Do I have to take this training?
Yes. Both HSP and HIPAA Research are required for all research personnel listed on the NR1. If the protocol is industry sponsored, it is also necessary to complete GCP training.
Do I get a certificate of completion?
Yes. A personalized certificate is generated training courses. It is recommended that the user keep a copy for their records.
How long does the training take?
HSP training can take the user from one-half to one hour, depending on the level of experience with human subjects research. HIPAA Research can take up to one-half hour.
Can I complete CITI training in several sessions?
Yes. You can leave and come back to the site 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 under the next column heading - Completion Reports - click on the print link. This will display a table and the last column of the table is headed Print Completion Report - click on the print completion report link in this column to print the certificate.
If under the Status heading it says "Not Started - Enter" or "Incomplete - Re-enter", click on Previous Coursework Completed link, then click on See coursework completed for UT Southwestern University since... . This will display a table and the last column of the table is headed Print Completion Report - click on the print completion report link in this column to print the certificate.
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, interoffice mail code 8843 or fax 214.648.2171.
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, interoffice mail code 8843 or fax 214.648.2171.
Where do I send my training certificates of completion?
These should be sent to the IRB office, .via interoffice mail code 8843 or fax 214.648.2171. If the certificate is in PDF format it can be emailed to: anne.clark@utsouthwestern.edu
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. Group descriptions are for each selection. Please choose a Learner Group that best reflects the area of research and responsibilities for you.
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, including the Responsible Conduct of Research (RCR) Courses.
What is GCP Training?
Good Clinical Practices training is required for all industry sponsored clinical trials. It takes about one hour to complete.
The grants officer requires a statement of the research training I have taken. Where can I get such a letter?
The form "Documented Training in the Protection of Human Subjects in Research" will need to be completed, signed by the primary investigator and returned to the IRB office. After all dates of training are checked and the form is signed by the IRB Manager, it can be picked up at the IRB office.
Any questions regarding training or compliance?
Please direct questions to:
How to I find my “Person Number”?
To find your UT Southwestern person number, open GroupWise and click send a new email. Your name should be displayed in the ‘from’ field. In the ‘To’ field type your own name. This will display your personal information from Human Resources. Please note the field titled Person Nbr. This is the information that CITI will request.
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