RESEARCH TRAINING REQUIREMENTS FOR EXTERNAL INVESTIGATORS


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An external investigator is any individual who is not a LSUHSC-NO employee, faculty or student, but is "engaged" in a LSUHSC-NO-associated human subjects research (HSR) study or is a "key personnel" in the study. The training requirements vary depending on which IRB serves as the IRB of Record for the external investigator.

Tip: An IRB of Record is the IRB that has agreed to assume authority for IRB review and oversight of the research project and/or individual study team members.

 

An IRB of the External Investigator’s Home Institution is the IRB of Record

In this circumstance, the study is reviewed by both the LSUHSC-NO IRB AND an IRB of the external investigator’s home institution (or its designee, such as a commercial IRB). The external investigator will complete the training required by his/her home institution.

What Should be Submitted to the LSUHSC-NO IRB?

  • An approval letter for the study and its investigator(s) from the home institution’s IRB
  • Certificate of completion by the external investigator of his/her home institution’s required human research subject protection training 

 

The LSUHSC-NO IRB Serves as the IRB of Record for the External Investigator

NOTE: The LSUHSC-NO IRB will serve as the IRB of Record for an external institution or individual only after execution of an appropriate reliance agreement, either an IRB authorization agreement (IAA) or an Individual Investigator Agreement (IIA). Use this decision tree to determine which agreement is most approproiate for your research study. Templates for the IAA and the IIA are found here and here, respectively. Follow these instructions to complete the reliance agreements. 

Once the appropriate reliance agreement has been executed, and the LSUHSC-NO IRB agrees to serve as the IRB of Record, the external investigator(s) will be responsible for fulfilling the education and disclosure requirements noted in the table below. Alternatives to the preferred courses are discussed at the end of the page.

 

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

CoI Risk Manager

Annual

All HSR studies (but see below for exemptions)

Conflict of Interest (COI)

COI in Research Training

KDS

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 the LSUHSC campus

 

Human Research Subject Protection Training

LSUHSC-NO has selected the Collaborative Institutional Training Initiative (CITI Program) as the provider of the online courses necessary to fulfill the initial and continuing training on human subject protection. CITI training modules of another institution may be accepted in lieu of the LSUHSC-specific CITI courses. Registering with CITI does not require an LSUHSC-NO server user ID. Individuals create their own user accounts. Individuals also can transfer CITI credits from one institution to another by adding affiliations to their account. Click here for instructions on how to create a CITI account and select courses.

 

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 external investigator’s home institution is not listed in the FCOI Clearinghouse and does not have a comparable COI training and disclosure policy, HRPP staff will provide instructions to the investigator for completing LSUHSC’s COI training and disclosure.

 

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).