All faculty, students, and staff involved in activities that fall under the federal definitions of Human Subjects Research are required to comply with federal and state laws as well as CSS policies and procedures for the protection of human research subjects. All CSS faculty and students who are PIs conducting human subjects research must submit an application to the CSS IRB and receive approval before collecting or analyzing data for the project. Consistent with OHRP recommendations, the IRB reserves the authority to determine whether a study qualifies as human subject research and whether human subject research is exempt from IRB review.
The IRB utilizes the definitions listed in the revised Common Rule (45 CFR ยง46.102) to determine whether a proposed study meets the criteria for human subject research.