Downloads for IRB Submission

Forms for IRB Review

Finding the Forms You Need for IRB Review

Performing human subject research or requesting the use of a humanitarian use device (HUD) or expanded access of an investigational agent requires you to submit certain forms for institutional review board (IRB) review. This website provides a repository for all forms maintained by Aurora Health Care’s Research Subject Protection Program (RSPP).

You’ll find forms and templates for:

  • General use: Forms for most IRB submissions are on the forms page.
  • Informed consent: Find templates to obtain informed consent for research on human subjects.
  • Ceded research: A ceded review means research oversight is deferred to an external IRB. Download IRB forms and standard operating procedures for ceded research.
  • Humanitarian use devices: Using a humanitarian use device (per approved indication) to treat a patient on a non-research, non-emergency basis requires an application for humanitarian use.
  • Expanded access: Requesting approval to provide an investigational agent outside of clinical trials requires approval from our IRB and the Food and Drug Administration (FDA). Find forms for compassionate use.
  • Emergency use: Doctors may provide an investigational agent to patients in an emergency situation. After emergency use, you must report to our IRB within five days.

Please note that our IRB submission application processes also use an electronic format through CyberIRB. Find answers to CyberIRB FAQs.

More Information

Other Important Information Relating to IRB Forms

Our RSPP maintains a complete list of Standard Operating Procedures (SOPs) that explain our guidance and rationale for IRB review. Learn more about our RSPP SOPs.

Our forms, SOPs and guidance documents use specific language, terminology and acronyms that you may be unfamiliar with. Reference our glossary for assistance.

Contact the RSPP/IRB Office

We’re here to answer your research documentation questions.

IRB Approval of Research

Find out the steps you need to take to get IRB approval of research.

Starting a Research Application

Learn how to get started with research training and approval.

Policies & Procedures

Want to know about our research policies and procedures?