INSTITUTIONAL BIOSFETY COMMITTEE REQUIREMENTS FOR HUMAN SUBJECTS RESEARCH


Requirement of an IBC Application is determined by the collection or use of biological samples.  If an IBC is not required, the IRB will serve as the sole registration of the research project with the ORS. Along with the required IRB training, all study personnel must be current with Bloodborne Pathogen training to receive IRB approval.

Select examples of human subject research studies that DO, or DO NOT, require an IBC application are listed below. The IRB and IBC has final decision if an IBC application will be required.  If you have any questions about applicability, please contact the IBC Office at IBCOffice@lsuhsc.edu. Instructions for submitting an IBC Application can be found on the IBC Webpage.

REQUIRES IBC APPLICATION

DOES NOT REQUIRE IBC APPLICATION

Human gene transfer studies (including naked DNA or RNA, virus based vectors or genetically modified cells)

Retrospective or prospective “chart”  reviews

Studies that collect or use pathological or diagnostic specimens (e.g. cadaver, discarded teeth) by any research study personnel including the PI 

Studies that may have human contact but do not collect any biological, pathological or diagnostic specimens (e.g. questionnaire, surveys, medical treatment or physical therapy comparison study)

Studies where LSUHSC research personnel, including the PI, collect, process, test (e.g., blood metabolite levels, urine pregnancy test), storage and/or shipping of human blood, bodily fluids, or tissue samples regardless of the performance site

Studies where the collection, processing, testing, and/or shipping of human blood, bodily fluids, or tissue samples are performed off campus and by hospital/clinical lab personnel who are NOT research study personnel

Vaccine studies that contain biological material with recombinant or synthetic nucleic acid molecules

 

Xenotransplants or xenografts

 

Therapeutic approaches that involve the use of biological agents