SUBMIT AN INITIAL APPLICATION TO THE IRB
The IRB reviews human subjects research studies using one of several mechanisms depending on the nature of the study and the level of risk to the subject participating in that study. The risk level is compared to “minimal risk” as defined by the federal regulations:
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45.CFR.46.102(j))(Common Rule).
Greater than minimal risk studies require full committee review, while minimal risk studies may be eligible for expedited review or exempt certification.
Select one of the applications below that is most appropriate for your research study. If you are unsure about which application or review level is needed, please contact the IRB Office (IRBOffice@lsuhsc.edu; Tel: 504-568-4970).
These studies are reviewed by the IRB Committee at a convened meeting. Use this application for greater than minimal risk studies OR studies that are minimal risk, but do not fit in any of the expedited review categories.
Examples of studies requiring full committee review include:
- randomized treatment studies
- studies using investigational drugs and/or devices
- behavioral studies involving risky interventions, observations of illegal behavior or very sensitive data/questions
To qualify for an expedited review, research must fall into one or more of nine (9) federally-defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects.
Some examples of expedited research are:
- studies involving collection of hair, saliva or dental plaque samples,
- studies of blood samples from healthy volunteers,
- analyses of voice recordings
- studies of existing pathological specimens with patient identifiers.
Studies deemed appropriate for expedited review will be evaluated by the IRB Chair and/or designee rather than by the entire committee.
More detailed information about the expedited categories is available in the Expedited Categories Tool.
To qualify, research must fall into one of 8 (eight) federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects. At LSUHSC, only 6 (six) Exempt categories are allowed in total. Specifically, exempt categories 7 and 8 currently are not used at LSUHSC. These categories are for the research storage, maintenance and use of samples and/or data originally collected under a broad consent. Currently, the appropriate infrastructure does not exist at LSUHSC to track which specimens or data a participant has allowed (or has not allowed) for research use or ensure that participants are not (re)approached should they decline an initial broad consent.
Some examples of exempt research are:
- anonymous or identifiable surveys or interviews
- passive observation of public behavior with or without the collection of identifiers
- secondary analyses of identifiable private information or biospecimens
- retrospective and prospective medical chart reviews (see below)
More detailed information about the exemption categories is available in the Exempt Categories Tool.
A “medical chart” is a record of a patient’s clinical data and medical history, including but not limited to their demographics, vital signs, diagnoses, medications, treatment plans, visit records, test results, patient complaints, and physician’s findings and impressions. Records in a chart may be physical paper or electronic health records that include videos, voice files, or other media containing health record information. Medical chart reviews are research studies that directly review these medical charts and are a specialized category of exempt research.
Use one of these applications ONLY when an external IRB serves as the IRB of record for a study and the LSUHSC IRB has agreed to be the relying IRB through an executed reliance agreement. If the LSUHSC-NO IRB will serve as the lead/primary IRB (the IRB of record) in a multicenter study, then use one of the standard applications described above. Access relevant application forms and more information regarding the use of external IRBs here.