Guidance Documentation

Overview

Answers for Your Human Subject Research Questions

Any human subject research is subject to specific policies and procedures. However, you may have questions about topics like informed consent, enrolling non-English-speaking subjects and the research process.

To help guide your research study, Aurora Health Care has developed several Research Subject Protection Program (RSPP) guidance documents. This guidance documentation is intended to give you more information about clinical research involving human subjects.

Conflict of Interest

Protecting Aurora & Yourself

In some situations, the financial and non-financial interests of Aurora or investigators may affect human subject research. Our RSPP guidance documentation about conflict of interest helps protect you and our organization:

To find additional documents and policies related to conflict of interest, visit our starting a research application page.

The Research Process

Administrative Information

The following policies and procedures cover general administrative and organizational tasks performed by our RSPP and institutional review board (IRB):

Using Patient Records for Research

Learn more about using patient records and confidential information in your human subject research:

Reporting Noncompliance

Download this guidance on subject noncompliance vs. reportable noncompliance [PDF] to learn what constitutes noncompliance and when you should report this event in your study materials.

You may also find out what’s new with this RSPP SOPs: noncompliance and unanticipated problems [PDF] guide to get the latest information.

External IRBs

Guidance for Ceded Research

In some cases, external IRBs approve and review research studies involving human subjects. Learn more about ceded research, including process details and who you should contact: Guidance on the deferral/ceding of Aurora IRB oversight to an external IRB [PDF]

To find additional documents and policies related to external IRBs, visit our ceded research page.

Planning Your Research

Algorithms for Human Subject Research

Use these algorithms to help prepare your research study and screen and recruit human subjects:

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.

Resources & Forms

Download templates for IRB application, informed consent and more.

Policies & Procedures

Want to know about our research policies and procedures?