Principal Investigator IRB Responsibilities
Once the IRB has approved a study; Principal Investigators (PI) are responsible for ensuring:
- that before any change to the study plan is implemented, researchers must request an additional review of the revised plan;
- all investigators, key personnel, and Faculty Advisors involved in research with human subjects maintain current training in human subjects research through the CITI course: IRB: Human Subject Research (Investigators, Advisors). If there is any change to the study staff, investigators must update the IRB and provide copies of new study staff’s CITI Completion Certificates for required trainings;
- that study materials that participants will see include the IRB issued Study Number. This number can be found on the approval letter;
- if research activities will continue beyond the expiration date of the approval, a request for review will be needed;
- that current IRB approval is maintained for the life of a sponsored project for research with human subjects; and
- if there is an unanticipated problem involving risks to subjects or others related to the study procedures, the Office of Regulatory and Research Compliance is contacted once you become aware of the problem. Contact Terrell D. Rabb M.A., Interim Director,
518-437-3850 or via e-mail at [email protected].
Submit personnel updates and requests for review of human subject research activities to: [email protected]
Failure of a Principal Investigator to fulfill the above responsibilities may result in a determination of non-compliance and suspension of the study.