Studies testing potential treatments in human volunteers to see whether they should be approved for wider use in the general population are regulated by the Food and Drug Administration (FDA). A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy.

Resources

We recommend reviewing the following documents from the Human Research Protection Program (HRPP) Toolkit Library:

• Drugs and Biologics (HRP-306, Worksheet)
  Used by IRB staff who are reviewing research involving drugs.

• Devices (HRP-307, Worksheet)
  Used by IRB staff who are reviewing research involving devices.

• Emergency Use (HRP-322, Worksheet)
  Used by researchers conducting an emergency use of unapproved drug, biologic, or device in a life-threatening situation, and to provide support to IRB staff reviewing such uses.

• Compassionate Use of an Unapproved Medical Device (HRP-325, Worksheet)
  Used by researchers conducting non-emergency individual patient/small group expanded access for an unapproved medical device and to provide support to IRB staff reviewing such uses.

FDA Regulated Research Oversight Program Overview

The FDA Regulated Research Oversight Program is charged with drafting policies and establishing guidance for UW-Madison researchers conducting FDA regulated research. In addition, the Oversight Program registers and tracks investigator held INDs and IDEs, performs routine audits of all FDA regulated research studies to verify investigator compliance with FDA requirements, and ensures timely and appropriate communications with the FDA.

Visit the FDA Regulated Research Oversight Program for additional resources.