Frequently Asked QuestionsAbout CyberIRB

Overview

What Is CyberIRB?

Aurora Health Care uses an electronic process for submitting research applications to the institutional review board (IRB).

Electronic submissions to our IRB are accomplished via CyberIRB. This system, also known as Cyber:

  • Streamlines the submission process
  • Enables you to monitor the status of your submission
  • Provides a consistent experience to all researchers

This page includes answers to the most frequently asked questions about CyberIRB. If your question is not answered here, please contact Aurora RSPP/IRB.

Sign in to CyberIRB

Format Questions

Understanding the CyberIRB Format

Are this program and the server behind it Title 21 CFR 11 compliant?

Title 21, Part 11 of the Food and Drug Administration (FDA) Code of Federal Regulations establishes guidelines for managing documents that relate to electronic records and electronic signatures. The FDA’s biggest concern pertaining to Cyber was to ensure that the electronic signature is performed by the person signing the document.

This consideration is why we require the principal investigator (PI) to sign documents using their unique username and password. Each PI should have received their own unique ID and password. These tools verify the PI’s identity and permissions for a particular document. By requiring users to follow these steps, we ensure Title 21 CFR 11 compliance throughout the lifespan of an electronic submission.

Process Questions

FAQs About the Submission Process & CyberIRB

Do I need to use CyberIRB now? When will paper no longer be accepted?

We encourage you to become proficient on Cyber now. Our system eventually will become fully electronic, and paper submissions will no longer be accepted.

What if my PI takes too long to submit?

The PI is ultimately responsible for the content of each item submitted for IRB approval. It is up to you, the submitter, to develop a system with your investigator(s) to ensure that they have reviewed what is being submitted to our IRB. Our IRB does not have control over PI review. The IRB review process will not begin until the signature from the PI has been obtained.

Can I make modifications to studies that were originally approved outside of Cyber?

Yes. For any study that has already received IRB approval, you can submit:

  • Modifications
  • Significant new findings
  • Violations
  • Continuing reviews

Cyber contains all IRB-approved studies. If you do not see a particular study listed that should be available to you, please contact Angela Carpenter.

Contact the RSPP/IRB Office

We’re here to answer your research documentation questions.

Starting a Research Application

Learn how to get started with research training and approval.

Resources & Forms

Download templates for IRB application, informed consent and more.

Policies & Procedures

Want to know about our research policies and procedures?