PI Roles & Responsibilities

The Belmont Report principles of respect for persons, beneficence, and justice guide ethical human subjects research (HSR) and form the foundation for federal regulations. As an investigator, you are expected to conduct yourself with the highest standards of professional conduct and integrity, adhering to ethical principles for protecting human subjects in research. You must comply with federal law, regulations, and NIH policies and conduct research according to the IRB-approved protocol.

• When the NIH IRB is the Reviewing IRB, follow NIH Human Research Protections Program (HRPP) policies.
• When an external IRB is the Reviewing IRB, comply with both NIH policies and the external IRB’s policies and procedures.

NIH PIs must be approved by their Institute and Center (IC) leadership, who will determine if you are qualified based on education, training, and experience. Only certain investigators can be PIs on NIH protocols:

• NIH Federal Employees, including Commissioned Corps Officers assigned to the NIH.
• Non-NIH Federal Employees with IC Leadership concurrence and NIH Institutional Official (IO) approval.

• Follow NIH requirements for HSR training as described in the following policy:

• Complete the revised basic training course (CITI Biomedical Basic course and/or CITI Social-Behavioral-Educational Basic course) based on your type of research.
• If conducting non-exempt HSR, complete Good Clinical Practice (GCP) training (e.g., CITI GCP (US FDA focus)) and any additional training as required by your role.

As a PI, you have overall responsibility for the design, conduct, reporting, and scientific integrity of the research. You are responsible for selecting your study team. If your research is regulated by the Food and Drug Administration (FDA), you must comply with FDA requirements and NIH policy.

You are accountable for:

• Allocating sufficient resources to the research.
• Complying with Reviewing IRB determinations.
• Obtaining all required ancillary and institutional approvals.
• Securing necessary agreements with outside entities with the assistance of your IC Technology Transfer Office.
• Protecting identifiable private information and biospecimens, as well as subjects' privacy and confidentiality.
• Arranging for IRB oversight when conducting non-exempt HSR at a non-NIH site, often via a reliance agreement.
• Reviewing study progress with the research team during routine meetings.
• Ensuring informed consent is obtained and documented according to regulations and institutional policies.
• Addressing subject concerns and complaints.
• Submitting required documentation to the IRB in a timely manner (e.g., Continuing Reviews, Protocol Modifications, Reportable New Information Reports).
• Maintaining a regulatory file with accurate records of all study documentation.
• Cooperating with NIH oversight entities, federal regulatory agencies, and sponsors for investigations, monitoring, audits, and required actions.
• Developing and following a data safety monitoring plan.
• Completing required training related to HSR and ensuring your study personnel meet training requirements.
• Disclosing conflicts of interest and inventor status for any intellectual property involved in the investigation.
• Ensuring an orderly transfer of research responsibilities before leaving NIH.

As a PI, you may assign specific research tasks to qualified individuals, consistent with the IRB-approved protocol and requirements. However, you retain overall responsibility and must ensure compliance with laws, regulations, and policies. Ensure your staff is trained, qualified, and able to perform their roles. You must designate individuals conducting HSR as investigators on the protocol and list them in the eIRB system, PROTECT.

Keep a Delegation Log listing study team members and the tasks you have delegated to each person. Update the log if staff changes occur. This log may be referred to as the Delegation of Authority Log, Delegation of Responsibilities Log, Delegation of Duties Log, or Delegation of Study-Related Tasks Log.

OHRP: Investigator Responsibilities FAQs

FDA: Good Clinical Practice