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What is the role of the Principal Investigator/Institution in clinical research?

The institution or organization who receives the grant or contract award is responsible for fulfilling all financial and administrative aspects of the award. The Principal Investigator ( PI ) is the individual responsible for the scientific or technical aspects of the clinical trial or study and for day-to-day scientific management of the project or program. The Principal Investigator works closely with the institution or organization to meet all the applicable requirements and terms of the grant.

The PI’s responsibilities include, but are not limited to, the following:

  • Design and implement ethical research
  • Comply with applicable federal human subject protection regulations and obtain a Federal Wide Assurance (FWA)
  • Comply with NIH, State and Local regulations
  • Ensure investigators and research staff complete human subjects protection training
  • Ensure that research involving human subjects is approved by the appropriate IRB
  • Comply with IRB policies, procedures, decisions, conditions, and requirements
  • Implement research as approved and obtain prior IRB approval for changes
  • Create and implement a Data and Safety Monitoring Plan
  • Document informed consent and assent per Federal regulations and as approved by the IRB
  • Report progress of approved research to the IRB, as often as and in the manner prescribed by the IRB
  • Report to the IRB and NIH any injuries, adverse events, or other unanticipated problems involving risks to subjects or others
  • Retain signed consent documents and IRB research records according to regulations
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