The UT Southwestern IRB office staff provide education and training on the ethical and regulatory standards for human subject protection. In accordance with regulatory requirements, all study team members (including offsite collaborators) listed on a UT Southwestern IRB protocol application must complete training before conducting research involving human subjects. The IRB will not grant final approval of a new protocol unless required training has been completed. 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:
Human Subject Protections
Health Insurance Portability and Accountability Act (HIPAA)
FAQs
After finishing the required training(s), please print the documentation verifying completion. Keep a copy of each document for your records and send a copy to the IRB Office, mail code 8843, or fax to 214.648.2171.
Note: Good Clinical Practice training is only required for industry sponsored Clinical Trials. This training is offered by the Clinical Trials Office. Click here for more information or you may contact LuAnn Muck in the CTO at 214-648-3957.
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 |
Monthly presentations regarding specific topics relating to human participant protections and research. Available to all research personnel, group size limited.
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| Individualized training and education |
Training on all aspects of human research protections is available at the request of departments or investigators. |
| IRB Website and Listserv |
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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HUMAN SUBJECT PROTECTIONS (HSP)
On March 1, 2008, the NIH Office of Extramural Research (OER) on-line tutorial Protecting Human Research Participants (http://phrp.nihtraining.com) replaced the NCI Human Participant Protections Education for Research Teams course. The NCI course will no longer be available as of March 1, 2008. Like the previous course, the OER tutorial is a free, web-based course that presents information about protections for human participants in research. The tutorial is designed for the conduct of research involving human participants. It satisfies the NIH human subjects training requirement for obtaining NIH awards, but it is not the only way to satisfy this requirement.
The tutorial presents common concepts, principles, and issues related to the protection of human research participants, including principles of bioethics and basic legal standards.
Upon completion the on-line tutorial, a certificate of completion should be printed by the user and a copy sent to the IRB office, mail code 8843 or fax, 214.648.2171.
An alternative to completing the Human Subject Protections training online is to attend a class. This training class is held every other Tuesday afternoon. 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 Module
The HIPAA Research module 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. It is a web-based tutorial offered through the UT Southwestern (UTSW) Medelearn system and can be accessed with a Southwestern user ID and password. Topics covered include access and use of protected health information for research purposes, authorization and waiver of authorization, and data security.
This web based training can be found by visiting the HIPAA Research section of the Medelearn system. If you require an ID, please contact John Morris, 214.645.6787 or john.morris@utsouthwestern.edu.
An alternative to completing the HIPAA training online is to attend a class. This training is held monthly. 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 training from that entity.
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.
Questions can be directed to the IRB office.
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FREQUENTLY ASKED QUESTIONS:
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.
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.
Do I get a certificate of completion?
Yes. A personalized certificate is generated for the HSP and HIPAA Research training. It is recommended that the user keep a copy for their records and forward a copy to the IRB office. This can be done via interoffice mail code 8843, or fax 214.648.2171.
What is GCP Training?
Good Clinical Practices training is required for all industry sponsored clinical trials. The GCP training is offered by the Clinical Trials Office (CTO) and takes about one hour to complete. A certificate of completion is issued by the CTO upon successful completion of the test. For more information about how to get the GCP training, please contact LuAnn Muck in the CTO at 214-648-3957.
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.
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:
pat.myrick@utsouthwestern.edu or anne.clark@utsouthwestern.edu
Any questions regarding training or compliance?
Please direct questions to:
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