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• The NIH PI has overall responsibility for the design, conduct, reporting and scientific integrity of the research.
• PI is responsible for designating other investigators appropriately such as Medical Advisory Investigators (MAI), Lead Associate Investigator (AI), Associate Investigators (AIs) and Adjunct PI.
• PIs conducting research regulated by the Food and Drug Administration (FDA) must comply with FDA requirements and NIH policy as well as 45 CFR 46.
• PIs are accountable for the following, as applicable:
  • Ensuring sufficient resources are allocated to the research.
  • Complying with the determinations of the Reviewing IRB.
  • Obtaining all required ancillary and institutional approvals.
  • Obtaining all necessary agreements with outside entities such as sponsors and collaborators including Material Transfer Agreement (MTA), Memorandum of Understanding (MOU) or collaboration agreement, Clinical Trial Agreement (CTA), Cooperative Research and Development Agreement (CRADA).
  • Protecting identifiable private information and/or biospecimens as well as subjects' privacy and confidentiality in compliance with relevant laws, regulations, policies, and the terms of the informed consent or other documents.
  • Ensuring proper arrangements for IRB oversight when conducting non-exempt human subjects research at a non-NIH site including when seeking single IRB review for multi-site research. This is usually via a reliance agreement. See the Reliance and Single (sIRB) Resources page on the OHSRP website for additional information on this topic.
  • Submitting required documentation to the IRB in a timely manner:
    • Continuing Reviews
    • Reportable Events
    • Amendments
    • New Information Reports
    • Protocol ModificationsProgress Reports
  • Maintaining a regulatory file with current and accurate records of all study documentation as required by applicable regulatory requirements.
  • Cooperating with NIH oversight entities, authorized federal regulatory agencies, and sponsors for: investigations, monitoring, audits, and required actions.
  • Ensuring an orderly transfer of research responsibilities prior to leaving NIH.

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