Human Research Protection Program

Investigator Responsibilities in Research Involving Human Subjects (SBE)

A. Investigators must comply with all applicable federal regulations, as well as UT policies regarding research with human subjects.

B. Investigators must provide a copy of the UT IRB-approved informed consent document to each subject, unless the IRB has specifically waived this requirement.

C. All documents and study records are to be retained for at least 3 years after the study has been terminated/closed/expired in a manner approved by the UT IRB. Investigators must also follow all additional records retention guidance (HIPAA, State laws, Sponsor requirements, etc.) as applicable to their research.

D. Investigators will promptly report to the IRB any injuries or other unanticipated problems involving risks to subjects or others.

E. Investigators must submit proposed changes/amendments to IRB approved human subject research studies for IRB review. The proposed changes must be approved by the IRB before the changes can be initiated, except where necessary to eliminate apparent immediate hazards to the subjects.

F. Investigators are responsible for complying with the continuing review/annual report requirements as prescribed by the IRB. The continuation of research after expiration of IRB approval is a violation of federal regulations. If IRB approval has expired, all research activities (recruitment, enrollment, data collection, data analysis) must stop.

G. Investigators are responsible for submitting a Final Report Form within 30 days of study expiration or within 30 days of cessation of all study activity, whichever date occurs first. This includes IRB approved studies for student research projects.

Last Updated: 6/27/22