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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 agree to adhere to the obligations to serve as an investigator as outlined in the Investigator Manual (HRP-103).  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

Individuals who are trainees or students, including undergraduate and graduate students, research assistants, residents, fellows, Masters or Doctoral Candidates, or Postdoctoral Researchers 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.

Principal Investigators Permissions

Principal Investigators who leave the institution are responsible for notifying the IRB well in advance of their departure so that he or she can make arrangements to either close their study or name another appropriately qualified individual who is currently at the institution to serve as the study’s PI. However, there may be instances where the PI of an active IRB approved study may have their faculty status changed from regular to adjunct and request to retain their Principal Investigator role for their existing IRB approved study or studies.

When their status changes, the Principal Investigator must obtain permission from the Associate Vice President for Research to continue to serve as the Principal Investigator for each of their active studies.  In such cases, please contact the Associate Vice President for Research via email to request permission to continue to serve in the capacity of Principal Investigator. The email must include the following:

  • An explanation for your request to retain your PI role
  • A current copy of the PI’s CV
  • Copy of the IRB approved protocol and most recent initial or continuing review approval letter
  • A letter of support from the PI’s department chair, division chief, school dean, unit director, or hospital supervisor
  • A supplemental document that contains the PI’s plan to manage the study, provide oversight, communicate with study team members and participants, and adhere to other compliance obligations.

If approval is granted you, as the study’s PI, must submit a modification application to inform the IRB of the appointment change. The submission must also include the management plan submitted to the Associate Vice President for Research and a PDF copy of the confirmation email. These materials should be uploaded into the “Supporting Documents” section of the corresponding eIRB+ submission.

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.