IRB Approval Process

Understanding IRB Approval

Before anyone begins research at Aurora Health Care, an institutional review board (IRB) must review and approve the proposed project. The Aurora application process requires a written research proposal that outlines the scope of research, funding and participants.

The IRB may approve research, request modifications, defer a decision to a later date or disapprove a project. Our application process helps you create a thorough proposal that meets all regulations and guidelines to give you the best opportunity for success.

The length of IRB review varies depending on the risk level of the research. The convened board must review research studies of the greatest risk level.

The Aurora IRB meets twice monthly. Applications are due about a month before the meeting where we review them. See our IRB member rosters and meeting dates, or learn more about the Aurora RSPP/IRB.

An IRB Chair or designated IRB member can review studies that meet the regulatory criteria for exempt determination or expedited approval.

How to Apply for IRB Approval

Sometimes, obtaining approval from an IRB can feel almost as daunting as research itself. Our RSPP has created this website to provide the forms, operating procedures, and information you need to submit a research proposal to the IRB.

We are here to help you comply with regulations and documentation related to research using human subjects, their data and their biospecimens.

Here are the steps you must follow to apply for IRB approval:

1. Checking if IRB oversite is needed: Some research does not require IRB oversight and the RSPP office can help you determine if IRB review is needed. To find out if your research requires IRB review see:
   1. SOP 1 – Initial Submission Requirements & Processes [PDF]
   2. SOP 2 – Review of Initial Submission [PDF]
2. Understanding external IRBs: Many research sponsors require researchers to use a single IRB. If you are working with researchers from other institutions, you might defer oversight to an external IRB. Learn more about ceded research.
3. Training and approval: Before beginning research, you will need to complete researcher training and apply for research approval. See:
   1. SOP 1 – Initial Submission Requirements & Processes [PDF]
   2. SOP 2 – Review of Initial Submission [PDF]
   Then, find the forms you’ll need when starting a research application.
4. Post-approval: Once your research is approved, you’ll need to keep in touch with the IRB to meet certain benchmarks and timelines. Learn how in RSPP SOPs 2-4:
   1. SOP 2 – Review of Initial Submission [PDF]
   2. SOP 3 – Post-Approval Responsibilities & Submissions [PDF]
   3. SOP 4 – Review of Post-Approval Submissions [PDF]
   If your study is under the oversight of the Aurora IRB, and you need to make changes, disclose conflicts of interest or report on results, use our IRB forms and templates.
5. Expanded access: Some cases require an exception to use an investigational treatment, device or medication outside a research context. Find the forms and guidance you need for research involving:
   • Compassionate use: In some cases, patients can qualify for investigational treatment when they don’t qualify for a clinical trial. Find forms for compassionate use.
   • Emergency use: In cases of emergency use, you need to meet certain conditions and submit a report to the IRB within five days.
6. Humanitarian use devices: The FDA approves humanitarian use devices for use in treating patients in limited situations (under the device’s approved indications). The FDA requires IRB oversight of HUDs. Learn how to apply for IRB approval for humanitarian use devices.