EXTERNAL INVESTIGATORS
An external investigator (EI) is any individual who is not a LSUHSC-NO (HSC) employee, faculty or student, but is “engaged” in HSC-associated human subjects research study or is listed as 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. These include:
- EIs intending to conduct human subjects research at affiliated local sites (e.g., University Medical Center, East Jefferson General Hospital, West Jefferson Medical Center, Touro, Our Lady of the Lakes/FMOLHS) with established master service agreements designating HSC IRB to serve as the IRB of Record
- EIs serving as sub-investigators or research personnel (non-Primary Investigator) on Expedited or Full Board research protocols
An IRB of Record is the IRB that has agreed to assume responsibility for initial review and continued oversight of a research project on behalf of one or more relying institutions and their investigators.
For Exempt research protocols, the HSC IRB provides oversight of EIs only when the EI’s affiliated institution or health center has an established master service agreement with HSC IRB designating it as the IRB of Record. In all other cases, EIs will need to seek IRB review and approval from their own institution or another appropriately designated external IRB prior to engaging in research activities. The HSC IRB does not require documentation verifying external IRB approval for the EI.
The EI may qualify for LSUHSC-NO external affiliate status. Contact the Compliance Office for further guidance. If external affiliation status is granted, the EI should be added to the Kuali submission with their lsuhsc.edu email address and complete LSUHSC-NO training and conflict of interest requirements.
Authorization Agreements
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 authorization agreements found on the Agreements Template page must be fully executed.
Use this decision tree to determine which Reliance arrangement 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 home institution. Then submit the partially executed agreement to the IRB Office (IRBOffice@LSUHSC.edu) for HSC institutional signature and final execution.