Post Approval Responsibilities

 

Responsibilities of the PI or the faculty advisor if the PI is a student

For IRB purposes, PI is defined as a researcher who is responsible for the conduct of the study.  In most instances, the PI of an IRB protocol is also the beneficiary of the academic output of the study.  The special case is when the PI is a student.  Since the students of MTSU cannot share the institutional responsibility, an MTSU faculty member or a staff member has to serve as the institutional authority.  Therefore, the PI, or the faculty advisor if the PI is a student, is main contact person who is also responsible for all of the activities in an approved protocol.  The following is a list of typical responsibilities of a PI (faculty advisor).  The co-investigators also share the same burden of the PI in executing the responsibilities.  It is important to be aware that several protocols may impose additional responsibilities to the investigators depending on the type of study.  
  1. Personally conduct or supervise the project by enforcing the protocol as approved by the IRB;  The PI/faculty advisor should ensure that no deviations take place from the approved protocol and will immediately report such deviations to the Office of COmpliance within 48 hours
  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/faculty advisor MUST maintain detailed record on training and other activities of all of the co-investigators of the approved study
  4. Ensure all of the investigators are qualified (e.g., training are up-to-date, education, expertise) to perform the approved 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 the approved guidelines
    1. all recruitment materials must be approved by IRB prior to posting. 
    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, co-investigator information, recruitment, participant size and other types of documents, for at least three years AFTER the completion of the research;
  9. Submit Progress Reports and Final Reports to the Office of Compliance.  

 

POST APPROVAL PROCEDURES & OBLIGATIONS 

The recipient (PI or the faculty advisor (if the applicant is a student) must assume full responsibility that the study will be conducted in the guidelines listed by the research team's approved protocol.  Any alteration to the protocol can be done only after obtaining written approval from the IRB or the Office of Compliance.  Starting from August, 2015, major changes to the procedures and the instruments may be restricted and the researchers may be be directed to complete a new application.  The following are a few procedures and obligations for the researchers in order to keep the protocol active.  Depending on the type of protocol, additional restrictions and obligations may be imposed.

 Data Storage

The PI or the faculty advisor (if the PI is a student) has to take responsibility of the data collected during the study.  All confidential materials need to be secured as proposed in their application.  The researchers have to notify the Office of Compliance if there are any breaches or any change of storage location is anticipated.  A suitable course of action would be determined upon the researche