Federal regulations (45 CFR 46 and 21 CFR 50) state that research involving human subjects, directly or through the use of records, tissues, or other means, must receive IRB review and approval prior to implementation. At Ochsner these regulations are met by submitting a new study application to the IRB. If the IRB deems the activity to meet the definition of “research” involving “human subjects”, then the protocol will be reviewed and approved in one of the following three ways: Exempt, Expedited (non-Full Board review), Full Board. Below you will find research decision trees posted by the Office of Human Research Protections (OHRP) to assist investigators and IRB's in making research determinations.
In addition, the IRB office has created a number of 1-page guidance documents to assist the research community on various research topics.