Requests to change the Principal Investigator (PI) of an active study must be forwarded within an Amendment Form for review on an expedited basis by the IRB chair or IRB-designee. If the Chair-designee believes that review by the convened IRB is required, the request shall be forwarded to the IRB for its review. Such request shall include a letter from the current PI indicating the change in responsibility and its rationale and a letter from the new PI accepting responsibility for the research. If the PI has left the University or is unable to provide an explanatory letter, the amendment/request to change the PI may come from the chair of the academic department or the director of the institutional research center that provides the administrative support and oversight to the study.
If the PI requesting the change within an active study holds an IND or IDE for the study, he/she must decide whether to continue to hold the IND/IDE or to transfer the IND/IDE to the new PI. In the latter case, the current PI (the IND/IDE holder) must inform the FDA in writing that he/she is turning over the IND number and responsibilities to the new PI; and the new PI must inform the FDA in writing of acceptance of the responsibility for the IND number and that all documents relating to the IND have been transferred to him/her.
Co-Investigators provide additional leadership to a study and may bring to the study similar or complementary expertise required for study conduct. Requests to change (or remove) a Co-Investigator may be reviewed and approved by an IRB Chair or designee through the expedited process. The IRB Chair or designee will ensure that the change or removal of the Co-Investigator does not lead to increased risk to the subjects and is made in accordance with prior IRB determinations related to the study. If the Chair believes that review by the convened IRB is required, the request shall be forwarded to the IRB for its review.
Additionally, any absence by the PI expected to last 30 calendar days or more requires the submission of a notification to the IRB detailing how the study will be conducted during this absence and who will provide oversight of the study conduct during the PI's absence from the institution (i.e. leave, sabbatical, etc.)