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.
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:
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.
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:
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.
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.