The Principal Investigator (PI) of a research project is responsible for the content of the eResearch (HawkIRB) application and the conduct of all study activities conducted by the PI and all research team members. The HawkIRB system only recognizes one PI for a project. The PI is the person who submits the HawkIRB New Project form or for whom the New Project form is submitted by a HawkIRB Delegate. When Co- or Sub-Investigators are added as research team members, they can be named as Contact Persons for the project, if applicable.

UI faculty, staff, trainees, students (IRB-01, Biomedical; IRB-02, Behavioral Science), and VA Health Care System (VAHCS) employees can be the PI of a project. The PI must have the background, training, and expertise to oversee and conduct the research. Students cannot be the PI at the VA Health Care System (VAHCS), IRB-03.

Emeritus Faculty may serve as the PI of a project but must provide rationale of how they can provide oversight for a project while holding an emeritus appointment. Adjunct Faculty cannot serve as the PI of a project.

Students, Residents and Postdoctoral Fellows must have a Faculty Advisor who is named on the research team and oversees the project.

The PI is responsible for the conduct of the research study, the content of the HawkIRB New Project application, record storage, and all forms submitted in HawkIRB after IRB approval. These forms include:

Note that even if a HawkIRB delegate prepares forms on behalf of the PI, the PI is ultimately responsible for the content of these forms. When a PI prepares a New Project Application, they must sign an Assurance Document, a list of agreements with the IRB about the oversight and conduct of the research. For background information and regulatory references for the Assurances, see PI Assurances and Applicable References.

The PI must also ensure that research team members are fully trained and informed about conducting the research as approved by the IRB. This includes making sure they:

  • Know how to access IRB approved consent documents and other materials
  • Are trained to conduct the consent process and study procedures as described in the HawkIRB application
  • Maintain appropriate research records and documents

For clinical research of drugs, biological products and medical devices, the PI is responsible for:

  • Ensuring that research is conducted according to the signed investigator statement
  • Protecting the rights, safety and welfare of research subjects
  • Controlling drugs, biological products and investigational devices

For additional information, see the FDA Guidance Document, “Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects.” There are additional requirements for investigators to ensure compliance with International Conference on Harmonization – Good Clinical Practice (ICH-GCP) Guidelines.

PIs and Key Personnel must disclose conflicts of interest annually in the University eCOI system. The annual disclosure period is January through April. For additional information, visit the Conflict of Interest in Research website.

The PI is required to maintain certain records related to a research project. IRB record storage requirements are outlined in the UI IRB Standard Operating Procedures and Researcher Guide (Section II, Part 23) The PI must maintain records of all IRB submissions and notices of approval (which are stored in HawkIRB), and all signed informed consent documents. Study data must be stored according to the confidentiality protections described in Section X of the HawkIRB application.

All records of human subject research are subject to inspection by federal authorities and the University of Iowa IRB. When leaving the UI, the PI should leave the signed consent documents at the institution for the time period specified in the UI policy or according to the sponsor or FDA requirements.

The University of Iowa owns the primary research results generated from all research, development, and related activities conducted under its jurisdiction. Therefore, when a Principal Investigator (PI) plans to leave the University and wants to take the original data to the new institution, the transfer of the original data must proceed according to established guidelines. Follow these steps to share data with non-UI researchers or take data from the UI:

  1. Obtain permission from your Department Executive Officer (DEO) or Department Head.
  2. Submit a HawkIRB Modification form to describe data sharing or taking data when you leave the UI (Section X.4 and X.5-6).
  3. Consult with the Division of Sponsored Programs (DSP) about establishing a Data Use Agreement or Materials Transfer Agreement.

IMPORTANT NOTE: It is best to initiate this process at least one month prior to the planned data sharing or transfer.

The Division of Sponsored Programs (DSP) has an online Researcher Handbook; an electronic guide to help researchers navigate the complex research environment at The University of Iowa. The Handbook provides instructions for getting started, securing the required approvals, and conducting research that is compliant with relevant government laws and regulations and UI policies and procedures.

Faculty and Research Scientists can access the Research Navigation Tool to connect with the Research Compliance and other units for assistance with getting started with research at the University of Iowa.