What is Human Research?
Guidance for determining whether an activity is Human Research is within the “Use this document for guidance as to whether an activity meets either the U.S. Department of Health and Human Services (DHHS) or U.S. Food and Drug Administration (USFDA) definition of Human Research, keeping in mind that the IRB Office makes the ultimate determination as to whether research activity constitutes Human Research subject to IRB oversight.
- You are responsible for obtaining appropriate IRB review and approval before conducting Human Research. The IRB will only review research before the initiation of research activities.
- If you have questions about whether an activity is Human Research, contact the IRB Office. If you wish to have a written determination, submit a new study in eIRB+ using the “FORM: Human Research Determination Form (HRP-503)” in place of a protocol.
- See “WORKSHEET: Exempt Determination (HRP-312)” for activities that are exempt from IRB regulatory requirements. Note that “exempt” does not mean you do not need IRB review. It means it is no greater than minimal risk human research exempt from further regulatory review but still subject to IRB Office ethics review and approval.
- In certain scenarios, Human Research may be reviewed and approved by an External IRB. See “Will Northwestern University or its affiliates rely on an external IRB?” below for those scenarios. Even if your research does fit into one of the described scenarios, your Human Research must still be submitted to and approved by the IRB Office.