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NIH Investigator Manual for Human Subjects Research

Chapter 2 - Roles and Responsibilities of the Principal Investigator

Overview

Key Points

  • The NIH Principal Investigator (PI) has overall responsibility for the design, conduct, reporting and scientific integrity of the research.

  • The NIH PI may assign responsibility for specific aspects of the conduct of the research to appropriately qualified individuals. However, at all times the PI retains overall responsibility for the conduct of the research and must assure both the protocol and the research team's actions are compliant with law, regulation, and policy.
What are the basic principles that inform the conduct of ethical human subjects research?
  • The Belmont Report principles of respect for persons, beneficence and justice are the basis for the ethical conduct of human subjects research and are the foundation for the federal regulations for the Protection of Human Subjects (45 CFR 46, HHS Common Rule).

  • All investigators are expected to conduct themselves according to the highest standards of professional conduct and integrity and to adhere to the ethical principles that address the protection of human subjects in research.

  • All NIH investigators will comply with federal law, regulation and policy, including NIH policy, and will conduct the research in compliance with the IRB approved protocol.
    • When the NIH IRB is the Reviewing IRB, all investigators will follow the policies of the NIH IRB which are called the NIH HRPP policies.
    • When an external IRB is the Reviewing IRB, in addition to NIH policies, NIH investigators will also comply with the applicable policies and procedures of the external IRB.
What is required to become a PI?
  • NIH PIs must be approved by IC leadership. The IC leadership will determine if the PI is qualified on the basis of education, training and experience to conduct the proposed research.

  • Only the following investigators may be PIs on NIH protocols per Policy 300, Investigator Responsibilities:
    • NIH Federal Employees, including Commissioned Corp Officers, assigned to the NIH;
    • Non-NIH Federal Employees with the concurrence of NIH Institute/Center (IC) Leadership and the approval of the NIH Institutional Official.

  • Required Training:
    • NIH requirements for human subjects research training are described in Policy 103, Education Program.
    • The Collaborative Institutional Training Initiative (CITI) updated its content related to the revised Common Rule January 21, 2019. All investigators must complete the revised basic training course (CITI Biomedical Basic course and/or CITI Social-Behavioral-Educational Basic course) based on the type of research that the investigator conducts.
    • Those investigators conducting non-exempt HSR are also required to complete Good Clinical Practice (GCP) training (i.e. CITI GCP (US FDA focus) that can be accessed via OHSRP CITI Training link) and, as applicable, additional training commensurate with their roles and responsibilities.
What are the general responsibilities of the PI?
  • 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 New Information Reports
      • Protocol Modifications
    • 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.
What are the requirements for PI's regarding delegation of responsibilities?
  • 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 Study 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.
Where can I find additional information about PI responsibilities?

Chapter 3 - Obtaining and Preparing Required Documents for IRB Initial Review