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.
The EI may participate in the research if the IRB of the EI’s home institution (or its designee, such as a commercial IRB) has independently reviewed and approved the study. Alternatively, the HSC IRB may agree to serve as the IRB of Record for the EI under certain conditions.
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.
Before the HSC IRB will assume oversight of an EI and approve a protocol in which an EI is a study member, one of the following authorization agreements must be fully executed:
Use this decision tree to determine which agreement (IAA or IIA) is most appropriate for the EI(s) in your research study.
Download and complete the appropriate template and, if necessary, obtain the signature of the authorized representative of the EI’s institution. Then submit the partially executed agreement to the IRB Office (IRBOffice@LSUHSC.edu) for HSC institutional signature and final execution.
Submitting a Protocol for IRB Review
When submitting a protocol in Kuali Research, please include the appropriate document(s) for the EI as described below:
|IRB of Record||Required Documents|
|EI Home Institution IRB or Designee||IRB approval letter|
|LSUHSC IRB||Fully executed IIA or IAA* &|
|Training completion reports as described here|
*If an executed Master IAA is already on file with the HSC IRB, you only need to provide the signed attestation page for any new EI.