Research Forms

What to Know Before Applying for IRB Review

Before beginning research at Aurora, you’ll need to apply for institutional review board (IRB) review. Visit the Starting a Research Application page for guidance about:

• Research administrative pre-authorization (RAP)
• Initial research requirements
• Human subject determination
• Researcher training
• Disclosure of conflicts of interest
• Nursing research
• Additional forms for non-research department administrators

The RSPP Investigator Manual [PDF] covers every aspect of the research process, from choosing a research topic to how long to keep records after research is complete.

To clarify common terms and acronyms used in Aurora’s research forms, please refer to the glossary [PDF].

Forms to Submit a Research Protocol Application

After you have completed researcher training and secured RAP, you can prepare to submit your research application. Download the forms you need:

• Delegation of Authority Log [DOC]
• Exempt Protocol Submission Application [DOCX]
• IRB Protocol Submission Application [DOCX]
• Representation for Research Involving Decedents' Information Review (502.2) [DOCX]
• Representation for Reviews Preparatory to Research (502.1) [DOCX]
• Waiver or Alteration of Authorization Request (502.3) [DOCX]

Forms for Research Already Underway

Several research forms help you report to our IRB on ongoing research studies or completed research. Download forms for ongoing work:

• Application for Continuing Review [DOCX]
• Continuing Review for Review of Medical Records, Repositories and/or Databases for Research Purposes [DOCX]
• Final Report [DOCX]

Forms to Manage Problems, Revise Research & Obtain Waivers

Clinical research sometimes requires changes. We help you maintain regulatory compliance and protect human research subjects. Document changes using these research forms:

• Addition of Aurora Facility [DOC]
• Changes in Exempt Research [DOCX]
• Changes in Key Personnel in Ceded Research [DOCX]
• Changes to Previously Approved Human Subject Research [DOCX]
• Noncompliance Reporting [DOCX]
• Significant New Information Reporting [DOC]
• Unanticipated Problem Reporting [DOC]

Ceded Research & Special Situations

Some research involves special circumstances. Find Aurora Health Care forms and more information about:

• Ceded research (research deferred to an external IRB)
• Humanitarian use devices (access to investigational devices under the device’s approved indications)
• Compassionate use (research approved on a compassionate basis)
• Emergency use (using investigational methods for lifesaving purposes)