Training (CITI, Biosafety, IMedris, Clinical)
CITI Training
UTGSM IRB requires that everyone involved in human subject's research complete a computer- based training course in human subjects' protection through the Collaborative Institutional Training Initiative (CITI -Unless you have completed the NIH Human Subjects Protection Course in the last 3 years).
Anyone working directly with human subjects or with identifiable patient protected health information (PHI) data or patient-derived specimens (e.g., tissue, blood, serum) for research purposes under UTGSM auspices must complete the training. Investigators, research nurses, coordinators, students, technicians working with identifiable data, and faculty advisors all need to obtain CITI certification. You may also need to do human subjects training that is specific for a particular granting agency. If you have never taken a CITI Course before, please follow the instructions below for New Users. If you have completed a CITI course at another institution, please skip down to the second set of instructions for affiliating that account with the UT Health Science Center, Knoxville.
Basic Clinical Research Training
The University of Tennessee Health Science Center (Memphis) has developed a series of basic research training modules in the following areas:
- Research History and Background, Evolution of Regulations and Guidance
- Phases of Clinical Research and Study Types
- Good Clinical Practice, ICH Guidelines, Compliance, FDA Regulations
- Standard Operating Procedures
- Role and Responsibilities of the IRB, Sponsor, CRO, Principal Investigators, and Key Study Personnel
- Informed Consent / Assent and Documentation of the Informed Consent Process
These training modules offer further education on why we conduct research under the umbrella of Good Clinical Practice (GCP) and comply with local and federal regulating agencies. If you are actively engaging in clinical research on our campus, it is highly recommended that you review these training modules.
Modules can be accessed by following this link:
https://www.uthsc.edu/research/human-subjects-research/hsr-training.php
UTHSC Memphis also has a training series (18 sessions) to prepare clinical researchers for the SOCRA CCRP (Certified Clinical Research Professional) or the ACRP CCRC (Certified Clinical Research Coordinator) certification exam. This course also serves as an additional orientation for anyone interested in learning about clinical research.
Animal Training
Prior to writing an animal protocol, you will need to receive training from the Institutional Animal Care and Use Committee - IACUC or the veterinarians at OLAC. The IACUC is a federally mandated committee, qualified through the experience and expertise of its members, which oversees its institution's animal program, facilities, and procedures. It provides a framework for compliance with federal policies, guidelines and principles related to the use of animals in research, teaching and testing. There is a wealth of information on the IACUC website regarding all aspects of the appropriate use of animals in research projects.
You will also need to complete the CITI Training for people working with animals and registering with the UTHSC Knoxville location.
At a minimum, the principal investigator and anyone working on a protocol will need to complete the online training: The American Association for Laboratory Animal Science (AALAS): Working with the UT Knoxville IACUC Course. Depending on the research goals, it may also be necessary to complete additional training. Detailed information of these requirements can be found on the IACUC website. IACUC training, for all personnel named on an active animal protocol, will need to be renewed annually.
Additionally, all personnel on a protocol will need to enroll in the Occupational Health Program and complete yearly updates.
If you do not have any experience is the techniques you plan to perform as part of your research, the OLAC veterinarians offer periodic training laboratories and can assist with personalized one-on -one training in specialized techniques if needed and/or refer you to an experienced researcher.
Biosafety Training
The UTK Office of Biological Safety provides training to all University of Tennessee faculty, staff, and students working in laboratories on the Knoxville area campuses on a variety of topics both in person and online for your convenience. Anyone working with human bloodborne pathogens or processing any type of hazardous material will need to complete several training modules (highlighted in red), which can all be found at:https://biosafety.utk.edu/biosafety-program/training/.
Modules outlined in red must be completed by any GSM Research Coordinator.
UTK contacts for anything relating to biosafety or environmental health:
Brian S. Ranger, Director of Biological Safety and Biosafety Officer
branger@utk.edu, Phone: (865) 974-1938
Jennifer Ferris, MS, GSM, Laboratory Safety Advocate
jferris@utmck.edu, Phone: (865) 305-7975
Radiation Safety Training
The mission of the Radiation Safety Department is to support research compliance. This office strives to ensure safety for faculty, staff, students, and the public in regard to radioactive materials, x-ray devices, and Class IIIB and IV laser systems.
Training
Any person who will handle or work near ionizing radiation is required to receive training regarding hazards and safe practices. Training is required before you are working with the items. Radiation and laser safety training programs require a periodic refresher -on an annual basis. You must complete the requirements for the refresher trainings so you will remain authorized to use or work around ionizing radiation. Some of the training programs are completed online. Contact the radiation safety office for your training requirements. In addition to training, all workers are required to be enrolled in the UTK dosimetry program and receive the appropriate dosimeter badges. NOTE: Even if you are enrolled in the UTMC dosimetry program as part of your employment duties you are required to enroll in the UTK dosimetry program (and obtain a separate dosimeter badge) when working with radiation and laser as part of your non-clinical research projects.
Open Source Training Class
The open source general radiation safety training is scheduled once a month. This training is for everyone working in a lab setting with open/loose sources of radioactive materials (powders, liquids, gases). The training schedule is available here. If you need training and cannot make one of the scheduled times listed, contact the radiation safety office: radiationsafety@utk.edu or at 865-974-5580. The training usually takes 3 hours to complete. It covers radiation hazard information, exposure monitoring, safe use practices, instrumentation, and basic procedures for radiation workers on campus. After the lecture and exercises, you will take an examination on the training material.
Online Training Several of our initial and annual refresher training programs are available online through UT Canvas Software. These include Radioactive Sealed Source, X-ray Machine, and Radiation Safety Training for the Veterinary Teaching Hospital. To gain access to these trainings, you must be registered by the Radiation Safety department. At present, UTGSM faculty have not been transferred the to the Canvas system and training will be supplied using PDF copies until such time as this changes.
Access Training
If your job requires you to enter areas that are posted for radioactive materials or x-ray machines, contact the Radiation Safety department for access and applicable training requirements. NOTE: Other approvals or exceptions to these rules may apply to UTMC employees who routinely work with radioactivity or lasers as part of the hospital duties. If you need clarification or assistance please contact the Office of Research Support jferris@utmck.edu , who serves as a liaison to the compliance offices.
Authorizations to possess radioactive materials or X-ray units
Appropriate forms must be completed and submitted to the Radiation Safety Department. Authorization for radioactive materials and some x- ray units must be approved by the Radiation Safety Committee. If you have any questions when completing these documents, contact the radiation safety office or the Radiation Safety director, Marsha Smith, mmsmith@utk.edu.
New x-ray devices or tubes must be registered with the State of Tennessee, Division of Radiological Health within 10 days of installation. If that deadline is passed, we risk monetary fines. It is important to keep the Radiation Safety Department informed of any changes regarding research x- ray machines.