Responsibilities for Principal Investigator for Ongoing Protocol

1. Report immediately to the IRB any severe adverse reaction or serious problem, whether anticipated or unanticipated.
2. Report any significant findings that become known in the course of the research that might affect the willingness of subjects to continue to take part.
3. Insure that only persons formally by the IRB enroll subjects.
4. Use only a currently approved consent form (remember approval periods are for 12 months or less).
5. Protect the confidentiality of all personally identifiable information collected and train your staff and collaborators on policies and procedures for ensuring confidentiality of this information.
6. Submit for review and approval by the IRB all modifications to the protocol or consent form(s) prior to the implementation of the change.
7. Submit a Continuing Review Report for continuing review by the IRB. Federal regulations require IRB review of on-going projects no less than once a year (a Continuing Review Report from and reminder letter will be sent to you 2 months before your expiration date). Please note, however, that if you do not receive a reminder from this office about your upcoming continuing review, it is the primary responsibility of the PIT not to exceed the expiration date in collection of any information. Finally, it is the responsibility of the PI to submit the Continuing Review Report before the expiration period.
8. Notify the IRB when the study has been completed and complete the Final Report Form.
9. Please help us help you by including the above protocol number on all future correspondence relating to this protocol.