RESEARCH TRAINING REQUIREMENTS FOR EXTERNAL INVESTIGATORS

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An external investigator (EI) is any individual who is not a LSUHSC-NO employee, faculty or student, but is engaged in a HSC-associated human subjects research (HSR) study or is a key personnel in the study.

When the LSUHSC IRB is not the IRB of Record for the EI, the only documentation requirement is the IRB approval letter from their home institution. Their training and COI disclosure requirements are evaluated by their own institution.

This page describes the documentation requirements for EIs when the LSUHSC IRB serves as their IRB of Record. Under this circumstance, an IRB authorization agreement may also be required.

Training Requirements

The specific training courses, the conditions under which they are required and the frequency at which they must be completed are listed in the table below. Alternatives to the preferred courses are described after the table.

Human Research Subject Protection Training

LSUHSC-NO has selected the Collaborative Institutional Training Initiative (CITI Program) as the provider of online courses necessary to fulfill initial and continuing training on human subject protection for HSC investigators. External investigators are also encouraged to complete the appropriate CITI courses to meet training requirements, although comparable courses from the EI's home institution or other providers may be acceptable.

EIs who already have a CITI account, either as independent learners or through their home institution, may complete the necessary courses through that account and submit a copy of the certificate of completion as part of the protocol submission process in Kuali Research. If necessary, EIs may also affiliate with LSUHSC-NO to access courses, such as the COI Basic and Refresher courses, that may not be available in their existing account. EIs who do not have a current CITI account may register at CITI Program and should affiliate with LSUHSC-NO at the time of registration. Instructions for creating an account, affiliating with an institution, selecting courses, and starting modules, are provided by CITI Program.
 

Conflict of Interest Training & Disclosure

An external investigator whose home institution is listed in the Financial COI Clearinghouse on the Federal Demonstration Partnership platform is exempt from LSUHSC's COI training and disclosure requirements as his/her institution has already certified that they are compliant with Public Health Service/NIH Financial Conflict of Interest (FCOI) rules and regulations. Listing in the FCOI Clearinghouse is verified by the Human Research Protection Program (HRPP) staff for each external investigator listed on the study.

If the EI's home institution is not listed in the FCOI Clearinghouse and DOES NOT have a comparable COI training and disclosure policy, the EI should take the CITI COI Basic course following the instructions provided above. Additionally, HRPP staff will provide instructions to the EI  for accessing and completing COI in Research Disclosure module in Kuali Research.

If the EI's home institution is not listed in the FCOI Clearinghouse but DOES HAVE comparable COI training and disclosure policies and procedures, please see below under "Alternative Training."
 

Compliance and Training System ("CATS")

Compliance and Training System ("CATS") is a web-based training program managed by the LSUHSC-NO Office of Compliance Programs (OCP). Research related trainings are set up so that employees, staff, students, and affiliates can self-assign these trainings in CATS as necessary. More information can be found on the OCP website and the self-assign user guide. 

                                                                                                                                                                                                                                                                Alternative Training

In most cases, alternative national programs or training programs developed by the external investigator's home institution may be substituted for the preferred courses listed in the table above as long as the content is comparable. If you are interested in using this option, please contact the IRB Office (IRBoffice@lsuhsc.edu) to discuss the documentation needed to determine the suitibility of the alternative program(s). 
 

Submitting a Protocol for IRB Review

When submitting a protocol in Kuali Research, please attach all relevant completion of training documents for each EI participating in the research study