Responsibilities of the Primary Investigator (PI)
The "primary investigator" or the "principal investigator" (PI), the lead researcher in a study that collects data from human subjects, is entrusted with the responsibilities to uphold the proposed protocol and the terms & conditions imposed by the IRB. If the PI is a student, then the responsibility to provide oversight falls on the faculty advisor (FA) to ensure the student PI follows ethical practices in dealing with the human participants and the information generated from the subjects. .
Personally conduct or supervise the project by enforcing the current protocol as approved by the IRB;
Protecting the rights and welfare of the human subjects
Lead by example - comply with all applicable MTSU policies & procedures, and federal regulations. The PI, or the FA if the PI is a student, has to maintain detailed record on training and other activities of all co-investigators
Ensure all of the investigators are qualified (e.g., training, education, expertise) to perform procedures and duties assigned to them during the study;
Updating the Office of Compliance with any changes to the protocol including the list of study personnel;
Prepare and submit reports of adverse events in a timely manner and modifications to the protocol prior to implementing these changes;
Recruit study participants by following appropriate guidelines
- all recruitment materials, such as flyers, email scripts, verbal inducement, etc., must be approved by IRB before they can be used for correspondences
- it is the PI's responsibility to ensure there is no undue coercion or influence when obtaining consent from participants
- Important study information such as potential risks, inconveniences, time commitments and etc., must be disclosed during recruitment. Also included must be any exclusion criteria to be used so participants, especially if any inducement compensation is promised in the recruitment.
Maintain records, including signed consent documents, for at least three years AFTER the protocol has been closed by submitting a final report
Submit Progress Reports and Final Reports to the Committee
- In addition, there may be other study-specific responsibilities that the PI must be aware of. Especially when special population, such as minors, vulnerable participants, sensitive subjects, and etc., are involved, the PI will have more responsibilities to ensure the safety and welfare of the subjects is treated as paramount.
The PI's responsibilities are not limited to the post-approval segment of the protocol; the PI would be the point person to ensure the protocol is designed and followed in a manner such that the information collected from the subjects and the human participants themselves are adequately protected.
- Protocol Application: The PI must ensure the application packet is fully completed by collecting and providing all the information required for IRB approval. The protocol application must be accurate and the PI must also ensure that the co-investigators, including FA, have all met the CITI Training requirements prior to submitting the application. All of the necessary supporting materials, such as, data collection instruments (surveys, questionnaires, tests, interviews, and etc.), recruitment scripts, informed consent templates, official permission letters when applicable, online links when conducting/corresponding over the internet, and additional supporting documents must be carefully inspected before submission. Students must submit their IRB applications through their faculty advisor who would be supervising the research project (NOT necessarily the academic advisor).
- Post-Approval Requests: The above requirements apply for all of the post approval requests, such as protocol amendments, continuing reviews and other types of requests for IRB actions..
- Post-Approval Responsibilties: The PI must make every effort to protect the safety and welfare of the participants and immediately report any adverse events or harms incurred by the research subjects to the IRB. Inadvertent deviations and other changes to the protocol must also be notified imediately. The PI must function diligently to ensure data protection.
- Supervisor Responsibilities: PIs with supervisory authority, such as faculty and staff, must exhibit competence and professionalism through the execution of the project to ensure highest standards are met with intervening with the subjects. The PI must be aware of all the activities within the project, especially when student interns who may not have the experience serve as co-investigators. The PI is responsible for training such students or interns in appropriate research methods in addition to ensuring they have other IRB-required training. The IRB also recommends that PIs with supervisory authority meets with the team on a regular basis to discuss any deficiencies and make appropriate plans to address such deficiencies. The PI must also maintain records for such meetings.