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Principal Investigator Responsibilities, Eligibility, and Permissions

A Principal Investigator (PI) or Co-Investigator (Co-I) is defined as the project director or principal or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, reporting of research, or proposed for such funding, which may include, for example, collaborators or consultant. PIs and Co-Is should never be designated as ‘study team member’ in the eIRB+ application and students cannot be listed as PI or Co-I.

Principal Investigator Responsibilities

Every research study requires a Principal Investigator (PI). A PI is the individual who has the primary responsibility for ensuring the ethical conduct of the research study and assumes full responsibility for the conduct of the research.  This includes:

  • protecting human participants’ rights, safety and welfare;
  • protocol compliance;
  • adherence to institutional, state, and federal regulations and guidance;
  • ensuring informed consent is appropriately obtained from each participant;
  • appropriately maintaining study records;
  • complying with the financial, administrative policies, and regulations associated with associated federal awards;
  • overall fiscal management of the project;
  • disclosure of conflict of interest;
  • possess the expertise, time, and commitment to conduct the research;
  • provide the necessary oversight for all aspects of the study; and
  • must accept full responsibility for the study.

Every research study requires a Principal Investigator and this person takes full responsibility for the conduct of the study. As study PI, you must adhere to the obligations to serve as an investigator as outlined in the Investigator Manual (HRP-103) and as defined on the Office for Research's Principal Investigator Research Roles and Responsibilities webpage.  The Principal Investigator leads a project and accepts overall responsibility for its direction, financial oversight, responsible conduct of research, adhering to research compliance and regulatory requirements, and adhering to the financial terms and conditions of the relevant award, relevant Northwestern University and sponsor policies.

Principal Investigator Eligibility & Permissions

Individuals who are trainees or students, including undergraduate and graduate students, research assistants, residents, fellows, or Masters or Doctoral Candidates, may not serve as the study’s PI.

If, based on University status or title, you fall into the “case-by-case” category, please contact the Associate Vice President for Research via email to request permission for such faculty.  When submitting the request to serve as a Principal Investigator of a study, you must include the following information in the request:

  • Include the name of the person requesting permission to serve as the PI in the email subject line.
  • An explanation for requesting PI status. The explanation should reflect the requester’s current appointment, percent of time that will be allocated to the project, funding source/ agency supporting the research, and the protocol start and end date.
  • A copy of your CV.
  • A copy of your research protocol.
  • Letter of support from your department chair / division chief.

As part of each new protocol submission, the department chair, division chief, school dean, unit director or hospital system supervisor must attest that the individual is qualified by training and experience to serve as the Principal Investigator providing oversight for the proposed research and for the required clinical procedures. Such requests should be submitted only for a particular project with a specified project period. If the Associate Vice President of Research grants approval, upload a PDF of the confirmation email into the Supporting Documents section of your eIRB+ application.

Incoming Principal Investigators with Ongoing Research

If you are joining Northwestern University from another institution and you plan to continue an existing research study initiated elsewhere:
  • Email irbreliance@northwestern.edu to discuss your ongoing research, determine whether the research requires formal review by the Northwestern IRB, and determine whether reliance agreements between Northwestern and another entity are required.
  • Email MTA@northwestern.edu if you intend to bring data or specimens with you to Northwestern so you can establish the appropriate agreements.

Outgoing Principal Investigators

If you are leaving and intend to stay engaged in a human research study you must submit a modification in eIRB+. Please see the Principal Investigator Transfer of Responsibility Guidelines webpage for more information.

Additional Information

  • An individual’s status as PI may be withdrawn for just cause. Such a decision may be appealed to the Vice President for Research.
  • Outside collaborators (non-Northwestern personnel) may not be listed as PIs or co-PIs on Northwestern University proposals. An outside collaborator is not a Northwestern University faculty member and does not “automatically” have PI status nor an on-going contractual relationship with institution.