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 |
|---|---|
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Human gene transfer studies (including naked DNA or RNA, virus based vectors or genetically modified cells) |
Retrospective or prospective “chart” reviews |
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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) |
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Studies where LSUHSC research personnel, including the PI, manipulate (e.g., DNA or RNA isolation, preparing extracts or tissue sections, running assays, etc.) beyond "minimal manipulation" or store for future use human blood, bodily fluids, or tissue samples in a lab at LSUHSC. |
Studies where LSUHSC research personnel, including the PI, collect biospecimen but where the biospecimen: will not be stored long-term in the researcher's laboratory for furture use; will not be processed, extracted, assayed or otherwise manipulated in the researcher's laboratory to answer a research question as part of the study; and, will be delivered or shipped without or with minimal processing (minimal manipulation), to a testing laboratory (e.g., UMC clinical lab, sponsor-designated central lab) for analysis. Examples of minimal manipulation are centrifugation and transferring supernatant to new tubes; aliquoting liquids; or dissecting tissues into multiple samples. |
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Vaccine studies that contain biological material with recombinant or synthetic nucleic acid molecules |
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 |
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Xenotransplants or xenografts |
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Therapeutic approaches that involve the use of biological agents |