What are the responsibilities of a PI of a human subject study?


The "principal investigator" or the "primary investigator" (PI) 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.   

As the primary beneficiary of the academic outcome of the study, the PI (or the faculty advisor) is responsible for all of the activities in a project.  The following is a list of typical responsiblities of a PI.  The co-investigators also share the same burden of the PI in executing the following responsibilities.  
  1. Personally conduct or superve the project by enforing the current protocol as approved by the IRB;
  2. Protecting the rights and welfare of the human subjects
  3. Lead by example - comply with all applicable MTSU policies & procedures, and federal regulations.  The PI, or the faculty advisor if the PI is a student, has to maintain detailed record on training and other activities of all co-investigators of a study
  4. Ensure all of the investigators are qualified (e.g., training, education, expertise) to perform procedures and duties assigned to them during the study;
  5. Updating the Office of Compliance with any changes to the protocol including the  list of study personnel;
  6. Prepare and submit reports of adverse events in a timely manner and modifications to the protocol prior to implementing these changes;
  7. Recruit study participants by following appropriate guidelines
    1. all recruitment materials must be approved by IRB prior to postingto the Committee for review.
    2. it is the PI's responsibility to ensure there is no undue coercion or influence when obtaining consent from participants.
  8. Maintain  records, including signed consent documents, for at least three years AFTER the completion of the research;
  9. Submit Progress Reports and Final Reports to the Committee.  



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