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• The NIH PI may assign responsibility for specific aspects of the conduct of the research to appropriately qualified individuals consistent with the IRB-approved protocol and the requirements. However, at all times the PI retains overall responsibility for the conduct of the research and must ensure both the protocol and the research team's actions are compliant with law, regulation, and policy.
• The PI must ensure that the staff is trained and able to perform their roles/duties.
• Required Documentation:
  • Documentation Required for IRB Review:
    • NIH PIs must designate those individuals who are conducting human subjects research as investigators on the protocol and list them on the IRB applicationStudy Information Form.
  • A Delegation Log should be kept, which lists the members of the study team and indicates tasks the PI has delegated to each individual person, including those individuals not listed in the protocol.
    • These may be referred to by a number of terms such as the Delegation of Authority Log, Delegation of Responsibilities Log, Delegation of Duties Log, or Delegation of Study-Related Tasks Log etc.

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