In this section
Exempt research determinations
"Exempt" research are human subjects studies that present no greater than minimal risk to subjects and fit into one or more exempt categories. Individual investigators do not have the authority to determine that a research project qualifies as exempt. This determination must be made by HRPP staff, upon review of a Human Subject Research Determination Form submitted by the investigator.
Expanded access is a potential pathway to investigational drugs. This page will provide basic information on expanded access programs and the process to submit a request for emergency use at Children's Wisconsin.
Frequently asked questions (FAQs)
In this section, you will find answers to frequently asked questions about human subject research.
Human subject research determinations
This page helps study teams determine if their proposed project meets the definition of human subject research. The responsibility for initial determination of whether an activity constitutes “research” rests with the individual who has primary responsibility for the activity.
Local guidance and SOPs
Institutional Review Board (IRB) guidance and standard operating procedures (SOPs) that detail our institutional commitment, review of research, vulnerable population protections, reliance practices, and more.
Regulations and guidance
This section provides information on regulations that may apply to your research from the Office for Human Research Protections (OHRP), Food and Drug Administration (FDA), National Institutes of Health (NIH), and others.