RESEARCH TRAINING REQUIREMENTS FOR EXTERNAL INVESTIGATORS


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

This page describes the training and documentation requirements for EIs when the HSC IRB serves as their IRB of Record. Under this circumstance, an IRB authorization agreement is also required as described here.

Training and documentation requirements for when the HSC IRB is NOT the IRB of Record for the EI is found on this page.
 

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.

Training Topic

Preferred Training Course/Disclosure

Preferred Provider

Frequency

Required for the Following Studies

Human Subject Protection

Biomedical Research Basic -  Initial & Refresher

CITI

Every 3 years

Biomedical research studies

Human Subject Protection

Social & Behavioral Research Basic -  Initial & Refresher

CITI

Every 3 years

Social and behavioral research studies

Human Subject Protection

Good Clinical Practice -  Initial & Refresher

CITI

Every 3 years

NIH-funded clinical trials or FDA-regulated drug or device studies

Conflict of Interest (COI)

COI in Research Disclosure

Kuali Research

Annual

All HSR studies (but see below for exemptions)

Conflict of Interest 

COI Basic & Refresher

CITI

Every 4 years

All HSR studies (but see below for exemptions)

Privacy

HIPAA Privacy in Research

KDS

Annual

HSR studies in which external investigator is accessing protected health information from LSUHSC or LSU Health medical records

Infection Control

Bloodborne Pathogen

KDS

Annual (high risk) or Every 5 years (low risk)

HSR studies in which external investigator is carrying out research on LSUHSC facilities

 

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."
 

Knowledge Delivery System (KDS)

Knowledge Delivery System (KDS) is a web-based training program managed by the LSUHSC-NO Office of Compliance Programs (OCP). HRPP staff will submit requests to OCP for assignment of required KDS training for external investigators as necessary.
 

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 (and the appropriate, fully-executed Authorization Agreement) for each EI participating in the research study.