About This Form
Not Human Subjects Research (NHSR) inquiries are used to determine if a project meets the regulatory definition of human subjects research. If the IRB determines that a project does not meet the regulatory definitions, we will send you a determination letter that states IRB approval is not required for your project. If the IRB determines the project does meet the regulatory definition of human subjects research, you will need to submit a new full study application in Cayuse to obtain IRB approval.
NHSR review is not provided for the following projects, which need to be submitted as a new protocol in Cayuse:
- Projects that involve coded data or specimens
- Projects involving FDA regulated products
- Any other projects that meet the regulatory definition of human subjects research
If you would like to submit an NHSR inquiry, please answer the questions on the following pages.
Not Human Subjects Research (NHSR) inquiries are used to determine if a project meets the regulatory definition of human subjects research. If the IRB determines that a project does not meet the regulatory definitions, we will send you a determination letter that states IRB approval is not required for your project. If the IRB determines the project does meet the regulatory definition of human subjects research, you will need to submit a new full study application in Cayuse to obtain IRB approval.
NHSR review is not provided for the following projects, which need to be submitted as a new protocol in Cayuse:
- Projects that involve coded data or specimens
- Projects involving FDA regulated products
- Any other projects that meet the regulatory definition of human subjects research
If you would like to submit an NHSR inquiry, please answer the questions on the following pages.