RESEARCH TRAINING REQUIREMENTS FOR LSUHSC-NO INVESTIGATORS


Any employee, faculty, staff or student of LSUHSC-NO (HSC) considered to be a “key personnel“ in a human subject research (HSR) project OR “engaged” in the conduct of HSR is required to complete HRPP- and institution-mandated research training prior to the initiation of research. IRB approval of a research study, or the involvement of individual researchers in the study, will not be issued until all training requirements are met.

A key personnel is any individual responsible for the design, conduct, or reporting of research.

An individual is engaged in HSR when he/she:

  1. intervenes or interacts with living individuals for research purposes; or
  2. obtains individually identifiable private information for research purposes.

Individuals who are not key personnel AND not engaged in HSR, are exempt from the training requirements described below.

Training requirements for external investigators – non-HSC personnel engaged in a HSC-associated HSR study – are described here.
 

HRPP 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.
 

Training Course

Frequency

Training Provider

Required for Personnel Involved in

Biomedical Research Basic -
Initial & Refresher

Every 3 years

CITI

Biomedical research

Social & Behavioral Research Basic -Initial & Refresher

Every 3 years

CITI

Social and behavioral research

Good Clinical Practice - 
Initial & Refresher

Every 3 Years CITI NIH-funded clinical trials or FDA-regulated drug or device studies


Instructions for creating a CITI account and affiliating with LSUHSC-NO are provided by CITI Program. Once an account is created, HSC investigators may log in to CITI using HSC credentials (single sign-on) and select training courses as described in this document.
 

Institution-Required Training & 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.
 

Training Course/Disclosure

Frequency

Training Provider

Required for 

Conflict of Interest in Research Disclosure Annual Kuali Research All HSR studies
Conflict of Interest in Research Training Every 4 years KDS All HSR studies
HIPAA Privacy - Research Annual KDS All HSR studies
Bloodborne Pathogen Annual (high risk) or
every 5 years (low risk)
KDS All HSR studies
Shipping Biological Materials Every 2 Years KDS

Individuals shipping biospecimens in any HSR study


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.

Knowledge Delivery System (KDS) is a web-based training program managed by the Office of Compliance Programs (OCP). For more information about institutional training requirements and to access KDS, please visit the OCP website. Instructions for requesting addition of training module(s) to your personal KDS profile are found here.

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.

 

Submitting a Protocol for IRB Review

KDS and CITI training records are continuously updated in the Kuali Research system so the HSC investigator does not have to provide completion of training documents when submitting a protocol in Kuali Research for IRB review. CITI records are updated ONLY if the investigator has at least once signed in to CITI using Single Sign-On as instructed in this document. The HRPP staff will contact you through the Kuali sustem if there are any issues with, or deficiencies in, the training records.