IRB APPLICATION FORMS & SUBMISSION INSTRUCTIONS
Submit One of the Following IRB Application Forms
Click on How to Submit for instructions on how to start the application process and for clarification for which version of the following IRB Application is appropriate for your research.
Exempt Research Application – “Exempt” refers to research activities in which the only involvement of human subjects will be in one or more of the exemption categories (as designated in the revised Common Rule) and involve only minimal risk to subjects. More detailed information about the exemption categories is available in the Exempt Categories Tool. Exempt research applications are now submitted through IRBManager. Please go to the IRBManager main page for instructions.
DO NOT move forward with an Exempt application if your proposed research:
► Intentionally targets a prisoner population or includes children in categories with limitations/exclusions; or
► Involves activities outside of the scope of the exemption categories; or
► Presents greater than minimal risk to subjects.You must submit a regular application to the IRB Office if it does not meet the definition of exempt research.
You must submit a regular application to the IRB Office if your research activity does not meet the regulatory definition of exempt research.
For exempt category research that involves interaction with human participants, LSUHSC institutional standards require researchers to uphold the ethical principle of respect for persons by providing a brief description of the research that includes the basic elements of informed consent. This typically is accomplished via an information sheet/cover letter or an oral script. Instructions for preparing, and an exampe of, an information sheet are provided below:
Medical Chart Review Only Application
- 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. Medical Chart Review applications are now submitted through IRBManager. Please go to the IRBManager main page for instructions.
DO NOT move forward with this application if your proposed research includes:
- Review of health information contained elsewhere, such as a limited data set or secondary research
- Other research activities in addition to the chart review.
- You must submit a regular application to the IRB Office if it does not meet the definition of a Medical Chart Review ONLY
- Minimal Risk (Expedited) Research Application - The researcher must demonstrate in the application how the proposed activities fall into one or more of the categories eligible for expedited review. Studies deemed appropriate for Expedited Review will be considered by the Chair and/or designee.
- Greater than Minimal Risk (Full Board Review) Research Application - Greater than minimal risk as defined in 45CFR46 and 21CFR50. These applications require review by the full committee at a convened meeting.
- External IRB Application - Utilize when the LSUHSC-NO IRB will be the RELYING IRB for a study involved in a LSUHSC-NO acknowledged consortium or CIRB program (SmartIRB, IRBchoice, PETAL...). This application should not be used for NCI CIRB onocolgy studies. If the LSUHSC-NO IRB will be considered as the Lead/Primary IRB, use the standard application listed above as 1,2, 3 or 4.
Submit Both of the Following Required Forms with the IRB Application*
- Use during approval process only. AFTER study is approved, use post-approval Change in Personnel Form.
COI Team Member Form
- required for every study*.
*Neither the demographic form nor the COI Team Member form is required to be submitted with the External IRB Reliance Application or with any application that can be submitted through IRB Manager (e.g., exempt, medical chart review).
Other IRB and HIPAA Forms That May be Required During the Application Process
ICF Cover Page Template (Required for ALL studies requiring consent forms approved after January 21, 2019)
Informed Consent Form (ICF) Template
(click here for instructions for completing the ICF)
Informed Consent Guidance Tool for Unspecified Future Research
- Non-English Speaking Subjects Short Informed Consent Form Templates: (click here for instructions for non-English speaking subjects Short-ICF)
Waiver of Informed Consent, Waiver of HIPAA Authorization, and Waiver of Documentation of Informed Consent
HIPAA and Research: Guidelines and Forms
to document HIPAA Authorization
Device Review Sheet
- Use if the device is the purpose of the investigation and will be used to evaluate the safety or effectiveness in the diagnosis of disease or other conditions; or the cure mitigation, treatment, or prevention of disease; use for minimal risk or greater than minimal risk studies.
- Supplemental Application for International Research