Is My Project Human Subjects Research?
The Code of Federal Regulations: Title 45, Public Welfare, Part 46, Protection of Human Subjects, specifies that human subjects research may not begin until it has been authorized by the university HSIRB. These pages contain the instructions and materials you need to prepare and submit your HSIRB protocol for review.
As of August 27, 2018, CSUB HSIRB transitioned from the Qualtrics system to the Cayuse HSIRB system for submission of protocols. There are no longer multiple protocol application forms. Every new project will have the same initial submission process. Completing this initial form will also let you know if your project meets the definition of human subjects research, and therefore must be reviewed and authorized by the HSIRB before it is conducted, and if so, which kind of HSIRB protocol to submit.
"Key personnel" in research projects involving human subjects or data containing personal identifiers must be certified in Human Subjects Protection Training (HSPT) for HSIRB authorization of their protocols. Key personnel are the principal investigator and any other people -- co-investigators and research assistants -- who would interact with human subjects in data collection or obtaining informed consent, or have access to data with personal identifiers.
Note: CSUB Faculty and Staff can gain access automatically by using their CSUB NetId & Password. CSUB Students and External Investigators will need to contact Gwen Parnell to request access to the Cayuse system, (this process takes 48 hours).