Starting a Research Application

Overview

Getting Started With Research at Aurora

Aurora Health Care has an established process to support researchers as they initiate research. On this page, you’ll find forms and information to help you obtain approval as an Aurora researcher and remain compliant throughout your research project.

As your research evolves, you may need to revisit this page for recertification or to renew research approval. Or you might be bringing on a new researcher or looking into potential conflicts of interest that arise over a research project’s lifespan. Use these resources to guide you throughout your research.

Before You Start

Step One: Research Administrative Pre-Authorization (RAP)

Prior to submitting ANY research proposal to our IRB or any Aurora-approved external IRB, you are required to obtain Research Administrative Pre-Authorization (RAP).

You must have RAP before accessing Aurora data or specimens for research purposes or conducting any research activities at Aurora.

RAP should not be misinterpreted as IRB approval. You must submit your RAP with any submission to the Aurora Research Subject Protection Program (RSPP). The IRB is part of the RSPP, the department that protects the safety of human research subjects. If your submission does not include RAP, the IRB review process will not begin.

Please email research.preauthorization@aurora.org to begin the RAP process through the Aurora Research Institute.

Step Two: Understand Initial Research Requirements

Before beginning your IRB submission application, it is vital to understand the requirements and whether your research needs IRB review. Please review these RSPP standard operating procedures:

Human Subject Research Determination

Human subject research is research that involves humans or their identifiable data or biospecimens. If you are uncertain whether research qualifies as human subject research, our RSPP can help.

To receive a determination, complete the Human Subject Research Determination [DOCX] form. You will find submission instructions on the form.

Step Three: Review RSPP Investigator Manual

Before you submit research for approval by our RSPP and IRB, you will most likely have a lot of questions. We answer most of them in the RSPP Investigator Manual [PDF].

The manual covers every aspect of the research process — from choosing a research topic to how long to keep records after research is complete. If you have additional questions after reviewing our manual, please contact us.

Human Subject Research Training

CITI Training

To conduct research at Aurora, all researchers must first register with the Collaborative Institutional Training Initiative (CITI). CITI provides peer-reviewed education in research ethics, regulatory oversight, responsibility and other topics.

Depending on the type of research you will conduct, you can complete biomedical or social/behavioral CITI courses. The type of course you complete must match the type of research you will conduct.

This means that if you complete the biomedical course, and your research project is social/behavioral in nature (or vice versa), your project will not be reviewed by the Aurora IRB or considered for ceding to an external IRB until you complete the proper course. This requirement applies to any key personnel listed on your application.

Renewing CITI Training

Researchers must renew their training every three years. Download Renewal Instructions for CITI Training [PDF].

Research Conflicts of Interest

Conflicts of Interest: Disclosures & Training

All individuals listed as key personnel on a research study conducted at Aurora must complete the Significant Interest questionnaire.

  • Read Aurora’s policy: Learn more about what constitutes a conflict of interest and the details of our policy. Aurora Policy 269: Conflicts of Interest in Research — Individual [PDF]
  • Learn more about conflicts of interest: Gain an overview of what significant interests (SIs) are and what conflicts must be disclosed. Download the training session, Understanding Conflicts of Interest in Research [PDF].
  • Disclose significant interests: Whether or not you believe you have a conflict of interest, you must complete the Significant Interest questionnaire within PolicyTech. If you are not an Aurora employee, you may need to obtain an “N” number to access the questionnaire.

Our RSPP office will not review any research submission until all key personnel have completed their questionnaires.

Have questions? Please contact us at ResearchCOI@aurora.org.

Nursing Research

Special Approval for Nursing Research

Nursing research requires approval from the Center for Nursing Research & Practice before you submit your proposal to our IRB. Learn more:

For Department Administrators

Administrative Considerations for Research

Most research at Aurora is managed by the Department of Clinical Research. But occasionally, research occurs outside this department.

In these cases, administrators — those who oversee a department, laboratory, unit or clinic — are asked to evaluate the research study’s impact in their area of responsibility.

Evaluating Research in Your Area

Our RSPP provides a questionnaire to guide your administrative evaluation. This questionnaire, known as the Administrative Tool, is formally titled Administrative Considerations for Research. Download the Administrative Considerations for Research [DOC] form.

Our Administrative Tool provides a checklist to help gauge the impact of proposed research in your area of responsibility. The form’s checklist guides you through questions about:

  • Protecting patients’ safety, rights, privacy and confidentiality
  • Resources that may be needed to conduct a study
  • Whether research will have adequate facilities and staffing

Administrative review is just one aspect of IRB approval. Before granting IRB approval to a research study, we consider many additional items. Learn more about the IRB approval process.

After Completing the Administrative Tool

The Administrative Tool is intended to facilitate your evaluation. It does not need to be returned to our RSPP’s office. If you would like to bring specific issues to our attention, please contact us at irb.office@aurora.org. Please reference the title of the research study in your email.

In most cases, the RSPP will require some form of written acknowledgement that you are aware that research will be conducted in your area/department/unit. Research teams will request that you provide one of the following:

  • Your signature on the IRB Application [DOC]
  • A letter or email attesting to your acceptance of the research study in your area/department/unit

Contact the RSPP/IRB Office

We’re here to answer your research documentation questions.

Ceded Research

Learn what to do when an external IRB oversees your research.

Resources & Forms

Download templates for IRB application, informed consent and more.

Policies & Procedures

Want to know about our research policies and procedures?