Preparing Your IRB Protocol for Submission

This page provides a general overview for the requirements of initial submissions of IRB protocols.  Studies vary widely and some of the information below may not be applicable, or more information may be required.  It generally takes approximately two to three weeks from initial submission to approval, depending on the nature of the study and revisions requested. Studies referred to the full board will be discussed at the next convening of the board, which occurs on the second Friday of every other month. Contact the LSU IRB with any questions you may have.

 

Access GeauxGrants

Access to GeauxGrants is provided automatically to LSU employees (faculty, staff, and students who have an assistantship or are otherwise employed) and that information is provided by Human Resources.  If you do not have access, you will need to request a New Campus Profile.  It can take up to two weeks to obtain access.

 

Develop Your Project

Work with your research team, faculty advisor, etc. to develop your project as much as possible before submitting to the IRB for review. When submitting your project to the IRB, you should be prepared to provide the details of your project, including: participant inclusion/exclusion criteria, potential risks/benefits to participants, consent forms/scripts, instruments (e.g., surveys/questionnaires, interview questions, devices, etc.), data security plans (how your data will be securely stored, especially if you're collecting potentially identifiable or sensitive data), recruitment materials, etc.  The IRB must review anything/everything that participants will encounter over the course of their engagement with the study and all materials must be approved prior to beginning any part of the project.  (Note: IRB approval is not required at the time of proposal submission, in most cases.  However, some sponsors or funding agencies may require IRB approval prior to full development of the study, a project may consist of multiple phases that are not fully developed, or certain elements of the study may need to change or be revised.  Not fully developed studies or multi-phase projects should be noted on the application and in the project description. Updates may be submitted at a later time to finalize materials via an amendment.  Changes may not be implemented until after IRB has approved the amendment.) 
Resources: Guide for Submitting an IRB Initial Application, Guide To Informed Consent, Consent Templates

 

Human Subjects Research Training

All LSU researchers must complete the CITI training before IRB approval.  The Basic/Refresher for either Biomedical Research Investigators or Social & Behavioral Research Investigators is required. 
Resources:  CITI Training Page. 
Note: LSU IRB does not accept Responsible Conduct of Research, Conflicts of Interest, IRB Chair, Signatory/Institutional Official, etc. for human subjects training. 

 

Data Security

Researchers may find guidance on data security and mangement practices by reviewing ORED Data Management Plans, LSU ITS Data Management resource and LSU policy statement, PS-124 Data Management. 

It is recommended to use resources that are supported by LSU institutional security licenses for data collection and storage. Resources include, but are not limited to: 

Survey Platforms: Qualtrics, MS Forms

Virtual Meeting Platforms: MS Teams, Zoom

Cloud Storage: Zoom, Box, MS OneDrive, MS Teams

 

 

Supporting Materials

In addition to your project description/abstract, your IRB protocol needs to include anything that particiants will encounter during their engagement with the study. Be sure that all of your information is consistent throughout the application and in each attachment.  Inconsistencies can cause delays in the review process, as multiple revisions may be required.   

Common Supporting Materials

Project Description/Abstract - This should provide a thorough summary of your project, including participant population, methods, instruments, etc. If there are mutliple phases, multiple researchers, and/or collaborating institutions, the roles of each should be clearly defined.

Pre-Screener - “Pre-screening” describes optional activities that occur before obtaining informed consent.  These may be used to determine initial eligibility for and interest in a study. Pre-screening cannot include any research procedures or collect any research data.  Not all studies require a pre-screener.

Informed Consent - As one of the priciples of research ethics, Informed Consent provides information to potential participants/participants that allows them to enter into a research project freely, with all of the information necessary for them to decide whether or not to take part.  They must give consent before they decide to participate.  

Parental Consent - If enrolling minors/under-age participants (typically under age 18), one or both parents or a guardian must be provided with the information ordinarily required for informed consent, so that they may decide whether to allow the child to participate, 

Child Assent - A child should provide affirmative agreement to participate in research, if able to do so.  Failure to object cannot be construed as assent.  They must actively display willingness, not just compliance with directions. 

Adminstrator/Institutional Consent - Organizations have the right to approve or reject human subjects research activities at their organization. LSU IRB requires researchers to submit documentation of permission/consent from an appropriate organizational administrator before commencing any human subjects research activities at that organization. 

Instruments - Anything used to gather data, such as: Surveys/Questionnaires, Interview/Focus Group Questions, Conversation/Discussion Guides, Observation Sheets, Curriculum/Training Materials, Images of Devices, etc. 

Stimuli - Anything that will be used to evoke responses, reactions, etc. from participants, such as: Images, Photographs, Videos, Interventions, Environment, etc.  

Human Subjects Research Training Certificate - Researchers should provide a valid human subjects research training certificate.  If you do not have one already, LSU IRB accepts the Basic/Refresher CITI training for either Biomedical Research Investigators or Social & Behavioral Research Investigators. Click here for CITI Training instructions.

Recruitment Materials - Any recruitment materials, email correspondence, social media posts, flyers, verbal scripts, anything that will be used to solicit participation.

Instructions - Any instructional materials, verbal/written directions, etc.

Other - Anything else that participants may encounter during their engagement with your study.