RESEARCH TRAINING REQUIREMENTS FOR
LSUHSC-NO AND EXTERNAL INVESTIGATORS
Any employee, faculty, staff or student of LSUHSC-NO and external researchers engaged in LSUHSC-NO associated research who are considered to be a key personnel in human subjects research (HSR) OR engaged in the conduct of HSR are required to complete IRB mandated research training prior to the initiation of research. IRB approval of a research study will not be issued until all training requirements are met. Individuals who are not key personnel AND not engaged in HSR are exempt from training requirements described below
Key Personnel: any individual responsible for the design, conduct, or publication/presentation of research results.
Engaged: an individual who intervenes or interacts with living individuals for research purposes, or obtains individually identifiable private information for research purposes.
Beginning January 1, 2027, the LSUHSC-NO IRB will implement updated human subjects research training requirements. These changes will streamline protocol processing, reduce administrative burden on investigators, and maintain compliance with applicable federal regulations.
What’s changing?
- CITI training will be the standard: Required human subjects research training will be fulfilled through the designated CITI courses.
- Training Requirements will be the same for both LSUHSC-NO and external investigators engaged in a LSUHSC-associated study.
- CATS training will no longer be monitored by the IRB, with the exception of Shipping of Biological Materials, which remains required for personnel who ship biospecimens.
- Current training requirements will remain in effect through December 31, 2026. Researchers should complete the newly required CITI courses by this date to prepare for the transition.
Additional guidance:
- The new FDA-focused GCP course replaces other GCP-related courses for the applicable studies listed above.
- Researchers conducting international research may also be required by sponsors to complete GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus).
- Personnel involved in shipping biospecimens may fulfill this requirement with the Mayo Clinic IATA Dangerous Goods Shipping training.
Renewal Reminders
CITI sends email notifications when a course is within 30 days of expiration. Researchers should monitor these reminders and ensure their required training remains current.
IRB Required Training
LSUHSC-NO has selected the Collaborative Institutional Training Initiative (CITI Program) as the provider of online courses necessary to fulfill the initial and continuing training on human subject protection. The required courses and the frequency of training are listed in the table below.
Instructions for creating a CITI account and affiliating with LSUHSC-NO are provided by the CITI Program. CITI Program -
Important for LSU Health-NO Investigators: Once your account is created, log in to CITI using your LSU Health-NO credentials through Single Sign-On (SSO), following the steps in this document. Logging in through SSO ensures your CITI training records automatically sync with Kuali.
Training Course |
Frequency |
Training Provider |
Required for All Personnel Involved in Research |
|
Biomedical Research Basic - |
Every 3 years |
CITI |
Biomedical research |
|
Social & Behavioral Research Basic -Initial OR Refresher |
Every 3 years |
CITI |
Social and Behavioral research |
|
Good Clinical Practice (GCP) Drug and Device, FDA |
Every 3 Years | CITI | NIH-funded clinical trials or FDA-regulated drug or device studies |
|
Conflict of Interest |
Every 4 years | CITI | All research |
|
HIPAA for Education and Research |
Every 3 years | CITI | All research |
Institution-Required Disclosure
LSUHSC-NO, under the purview of the Office of Compliance Programs and the Office of Research, requires additional training for individuals involved in research. The Office of Research is responsible for confirming compliance with the training and disclosure requirements for all HSC investigators including those listed in the initial application and those added after study approval through an amendment request. The required areas of training and disclosure relevant to the conduct of HSR are listed in the table below.
Annual COI disclosures are submitted through the Kuali Research COI module. Information about COI disclosure and access to Kuali Research COI module is found here.
Institutional Biosafety Committee Training
Institutional Biosafety Committee (IBC) Oversight? HSR studies involving the manipulation of biological specimens or the use of biohazardous materials and/or recombinant or synthetic nucleic acids for research, require IBC approval. Please refer to the IBC webpage or consult with the IBC Office (IBCoffice@lsuhsc.edu) regarding the submission process and additional training requirements.