The IRB review is over. You’ve been given the approval, the green light, to conduct a human subject research study naming you as the “Principal Investigator” (PI). But what, exactly, does being a PI mean? What responsibilities to the research project does a PI have? To help answer these questions, below are several areas of responsibility assumed by the PI and those others involved in the research protocol. Should you have additional questions, please do not hesitate to contact the IRB office at ext. 6364.
What many PIs fail to realize (especially new PIs) is interaction/communication with the IRB does not end after the IRB protocol is approved. Perhaps the most important direct responsibility a PI has is to provide ongoing communication about their project to the IRB during the entire life of the study. Ongoing communications include, but are not limited to, amendment requests, annual continuations, reporting non-compliance, adding or deleting research personnel, etc.
Sole Principal Investigator
It is the policy of the NEOMED IRB that each approved human subjects protocol has a single PI who is responsible for its design and conduct. The designation of multiple PI’s or Co-PI’s is not recognized by the IRB.
Conduct of the Project
It is the PI’s responsibility to ensure the project is conducted in accordance with the NEOMED IRB approved protocol, including the recruitment and consent procedures. If you intend to diverge from the protocol, the PI must either submit an amendment or addendum, or a new protocol, depending on the extent of the changes to be made. No changes may be implemented until the IRB approves the changes in writing.
Responsibility for Research Staff
Though research responsibility may be delegated to research staff member (investigators, consultants, student investigators, project managers, etc.), the PI must maintain oversight and retains ultimately responsibility for the conduct and possible non-compliance of those to whom they delegate responsibility. The research staff is also responsible for reporting to the PI any known non-compliance or misconduct encountered during the study and must document their efforts to report non-compliance to the study’s PI. If the issue is not resolved, research staff must report non-compliance directly to the Institutional Review Board chair.
Changes to Research Activities (Amendments)
The PI is responsible for ensuring that no changes to the approved protocol are made without the prior approval of the IRB. To request an amendment to an approved protocol, complete the “Amendment Request Form” found on the IRB website.
IRB records must be retained for a minimum of three years. Records include a copy of the approved protocol with the approval memo, all amendment requests with approval memos, all consent forms (if signed maintain in a secure, locked cabinet), non-compliance notifications, corrective action plans, and all other official correspondence from the IRB. It is the PI’s responsibility for maintaining all required records and to make them available upon request to the IRB or any other regulatory body.
Continuing Review & Study Termination
Federal regulation and NEOMED Policy require continuing review and reports of progress at least annually on all research projects reviewed under “expedited” or “full board” procedures. (Requirement does not apply to “exempt” research.) It is the PI’s responsibility to know when approval of their protocol expires and to submit the required “Continuation Form” or “Closure Form” with enough time for the study to be reapproved by the expiration date.
Mentoring of Student Researchers
The PI is responsible for explaining the process of writing an IRB protocol, submitting it for approval, and conducting the approved protocol. Faculty should not expect students to conduct the research without any guidance; if a student is non-compliant with federal, state or institutional guidelines, the PI is responsible. Students must be trained in the consent process if consenting participants. Students should also be informed about the possibility of adverse reactions or problems that may arise throughout the informed consent process and during the study and how to report them to the PI.
Reporting Non-Compliance & Unanticipated Events
It is the PI’s responsibility to report any unanticipated problems, adverse events, protocol violations and protocol deviations to the NEOMED IRB chair. Adverse events (AE) may be defined as follows:
- Any subject injuries or adverse reactions associated with the study procedures, and/or problems involving the conduct of the study that may occur during the course of the research project;
- Any possible breach of human subject protection in any research activities of which the investigator may become aware. This includes loss of confidentiality and/or emotional hardship.