IRB Application Walkthrough

IRB Application Walkthrough

Welcome to the IRB Application Walkthrough. On this page you'll learn about the submission and review process, complete with links to the resources that you'll need every step of the way.

Before You Begin

Prior to beginning your IRB application, it is important to make sure that you have all of your papers in order. On this page you'll learn about the submission and review process, complete with links to the resources that you'll need every step of the way. Welcome to the IRB Application Walkthrough. On this page you'll learn about the submission and review process, complete with links to the resources that you'll need every step of the way. Welcome to the IRB Application Walkthrough. On this page you'll learn about the submission and review process, complete with links to the resources that you'll need every step of the way. Welcome to the IRB Application Walkthrough. On this page you'll learn about the submission and review process, complete with links to the resources that you'll need every step of the way. 

Tasks to complete

Complete your CITI Training

Final IRB submission and approval requires you to have completed research ethics training through CITI. Be sure to download a copy of your completion certificate for upload to the IRB form system.

Evaluate expedited review and exempt review options

Many research projects are eligible for expedited review, which allows researchers to have their IRB applications approved outside of a meeting of the full IRB. Some projects are also eligible for exempt review, which if approved allows research to be carried out without continuing review, unless a change in the project has occurred.

For more information about expedited review and exempt review, or for help in determining whether or not your research is eligible for either of these categories, please consult the IRB FAQ, or contact Sharla Miles.

Preparing Your Application

SHSU has several different IRB forms to choose from, depending on the purpose of your research and the degree to which the IRB will need to evaluate your proposal for ethical and safety concerns. The six forms are similar in appearance and the process for completing each of them is similar as well, but there are several important things you'll want to keep in mind.

Tasks to complete

Choosing Your Form

You have four IRB options to choose from:

IRB Application (Thesis/Dissertation) - Non-Exempt Human Subjects Research

Who can complete this application? Any student conducting non-exempt Human Subjects research and the goal is completing the research for a Thesis or Dissertation. 

IRB Application (Regular Initial) - Non-Exempt Human Subjects Research

Who can complete this application? (1) all faculty and staff conducting non-exempt Human Subjects research; (2)Any student conducting non-exempt Human Subjects research for publication/conference presentation, but the goal is not completing the research for a Thesis or Dissertation. 

IRB Exempt Application (Thesis/Dissertation)

Who can complete this application? Any student conducting research involving Human Subjects that is exempt from IRB review*, and the goal is completing the research for a Thesis or Dissertation. 

IRB Exempt Application (Regular Initial)

Who can complete this application? (1) all faculty and staff conducting research involving Human Subjects that is exempt from IRB review*; (2)Any student conducting research involving Human Subjects that is exempt from IRB review* for publication/conference presentation, but the goal is not completing the research for a Thesis or Dissertation.

*Institutional policy requires that the IRB must determine whether or not a study qualifies for an exemption based on federal regulations (45 CFR 46.101(2)(b)).

Filling out Your Form

Each IRB form has a list of sections which must be completed; for example, the IRB Application (Regular Initial) has sections for you to disclose information about the personnel conducting the study, research funding, and protocols for participant selection and recruitment, among other things. Simply click each item in the list and answer the questions that appear on your screen, making sure to attach any supplemental documentation that is needed to satisfactorily answer those questions. Failure to immediately disclose important information related to your research project and protocols may result in delays in the evaluation and approval of your application.

After filling out a section, you may select the Save button to return to the form's home screen, or the Save & Continue button to continue on to the next section. You may also choose the Skip & Continue button to proceed to the next section in the form without saving any information in this section. When you reach the final section of the form, clicking Save & Continue or Skip & Continue will prompt you to submit the full form to the IRB for approval. 

Approval & Routing Process

What You'll Need

Once you've submitted your form to the IRB, the routing process for approval begins. Your specific approval chain will depend on the type of IRB form you are submitting, but all forms require multiple approvals; please check the IRB Application Approval Chain chart for more information. During the approval & routing process, the information that you submitted in your form will be evaluated in order to ensure your proposed research meets institutional standards on research ethics and safety. 

The IRB Forms system that you used to submit your application is also used to check on the status of your application, to add and review notes written by you or members of your approval chain regarding your application, and to make requested corrections to your application if it is returned to you. 

Tasks to complete

Make Corrections To Your Application (if applicable)

If changes are needed to your form, it will be returned to you by a member of your approval chain. Most of the time, a returned form will be accompanied by a note describing the reasons for the return and the changes that need to be made to your application. 

After You Submit Your Application

As you progress through your research project, you will need to ensure that you continue to meet institutional compliance standards. The IRB conducts continuing review of previously approved research on a periodic basis, which requires you to complete a form documenting any changes to your project, including changes related to personnel and funding. You may also expedite the continuing review process by updating the IRB when significant changes to your research occur by completing an amendment application. 

Tasks to complete

Complete Your Final Report Form

Once your research project has been concluded according to the terms set forth in your IRB documentation, you will need to complete a final report form explaining the reasons for the conclusion of your project, as well as any additional issues that may need to be disclosed.   


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