Faculty, students, staff, and other campus employees that engage in human subjects research without CSUSB IRB approval or an exempt determination can result in disciplinary action and a investigation under CSUSB's University Policy on Misconduct in Research and Authorship. Engaging in human subjects research without prior IRB approval or exempt determination is non-compliance with the protection of human subjects in research. Incidents of non-compliance are reported to the Office of Human Research Protections (OHRP) under the U.S. Department of Health and Human Services (DHHS) which may warrant further investigation by the federal agency.
Reportable incidents under the OHRP regulations include:
1. Any unanticipated problems involving risks to subjects or others:
2. Any serious or continuing non-compliance with OHRP policy or the requirements or determinations of the IRB; and
3. Any suspension or termination of IRB approval.