Human Subject Research Determination
Confirm if your project is considered Human Subject Research
A project that meets the definition of Human Subject Research is subject to IRB review. If you are not sure if your project meets the definition, we recommend that you submit a Human Subject Research Determination (HSRD) Request.
The HSRD Form may be used by faculty, staff, and students who are not sure if their activity requires IRB review. The HSRD Form will isolate elements of your project so the IRB Office can make a quick and accurate determination.
If you are confident that your project meets the definition of Human Subjects Research, do not fill out and submit an HSRD request.
Consider what data you plan to collect!
The IRB cannot establish for certain whether questions/interactions/data collected do not ask anything that would be considered private or identifiable data without clarification of the proposed study. As such, providing documentation of interviews, survey questions, or any other methods of data collection should be included along with the HSRD form. Unfortunately, it is difficult to determine risk and whether definitions are or are not fulfilled without a bit more information. Unless it is obvious that no human subjects or their data are involved or the study is not for research purposes, the IRB will usually need additional detail for IRB/ human subjects research determinations.
The IRB Office will review and decide as to whether an IRB Application is required due to the protocol meeting the definition of human subject research or if the protocol does not meet the definition of human subject research.
If the IRB Office determines that your protocol meets the definition of human subject research and requires IRB review, you will be notified via email to submit an Initial Application. If your project is determined not to require further IRB review, a determination letter will be sent to you.
The purpose of the HSRD form is to establish whether your study meets the definition of human subjects research and, therefore, requires IRB review. It is not meant as a preliminary review or to determine whether CITI Training is required.
