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Principal Investigator (PI)

Overall Role/Responsibility

Direct and oversee all research activities and foster a culture of research integrity. Responsible for fiscal and administrative management of research. Conduct research in an objective and unbiased manner in compliance with policies and regulations. While the PI may delegate responsibility for some project activity to others, the PI is ultimately responsible for compliance with all applicable regulations and policies and for ensuring a safe research environment, meaning one that is inclusive and free from any form of discrimination or harassment.

Northwestern University researchers can use this chart to pre-determine Principal Investigator eligibility to serve on an IRB protocol, IACUC protocol or a Sponsored Research proposal/award.

Administration

  • Manage research staff, including co-investigators, post-doctoral trainees, fellows, students, technicians and lab managers
  • Oversee the training and mentoring of post-doctoral trainees, fellows, and students
  • Assure that all key research personnel have met training requirements
  • Coordinate with school, department, and central administration to ensure that sponsored research activities are in accordance with all applicable regulations, policies, and procedures
  • Ensure appropriate resources for research conduct
  • Review, prepare, and submit results for publication and register publication, as required by sponsor

Proposals and Awards

Pre-Award

Proposal Submission
  • Review funding opportunity announcements
  • Prepare technical and/or scientific proposal
  • Develop and coordinate budgets, administrative elements, and materials, including materials for subcontracts
  • Coordinate large proposals with the Office of Research Development (ORD)
  • Understand and comply with institutional limited submission process
  • Complete proposal application and submissions by required deadlines
Pre-Award Set-Up
  • Ensure pre-spending (at-risk/advance) accounts are requested from Sponsored Research
  • Complete “Just In Time” documentation requests from sponsor
  • Provide estimate of sponsored project effort percentage
  • Modify project scope and coordinate all administrative items, including budget, as necessary

Post-Award

  • Direct all technical and administrative activities
  • Review and confirm notice of award and award setup, including budget reconciliation
  • Request issuance of subcontracts
  • Review and approve any revisions to project scope, budget or changes in effort or other activities that may require prior approval from sponsor
  • Monitor expenditures regularly to ensure that funds are managed in compliance with sponsor terms and conditions and only expended to directly support and benefit the project
  • Ensure the accurate and timely submission of all required reports throughout the life of the award
  • Confirm that all award records and data are maintained accurately and consistently over the award life cycle and through the sponsor and University’s records retention period
  • Monitor subrecipient and consultant activity, including review and approval of invoices
  • Responsible for deficits and disallowances incurred against an award
  • Oversee confirmation and monitoring of program income
  • Coordinate with the Accounting Services for Research and Sponsored Programs (ASRSP) office for all financial matters including fiscal compliance, cash application, financial audits, and effort reporting
  • Communicate plans to transfer a grant to the sponsor, Sponsored Research, and other institutions

Material Transfer Agreements (MTA)

  • Initiate a request to Sponsored Research for an MTA prior to any materials being sent to collaborators

Closeout

  • Review and approve all project expenses to ensure completion and compliance, including financial reports, final invoices, program income, and subrecipient performance
  • Oversee completion of closeout documentation and ensure that all reporting requirements are met
  • Confirm that all periodic and final technical and invention reports are submitted
  • Work with ASRSP to resolve sponsored funds collection issues
  • Certify budget statements at the end of the award

Effort Reporting

  • Complete effort commitment profile
  • Complete salary planning and distribution
  • Disclose existence of appointments at other institutions to departmental chair
  • Disclose and notify chair and dean when proposing cost share for proposal submission
  • Fulfill and manage effort commitments of project members
  • Certify effort by the required deadline
  • Resolve effort discrepancies
  • Ensure appropriate training of project staff

Research Conduct

Human Research Participants

  • Ensure the protection of the rights and welfare of human research participants
  • Oversee submission to, and approval by, the Institutional Review Board (IRB) and confirm protocol/grant congruency
  • Ensure the IRB approves the protocol prior to initiation
  • Conduct all human participant research according to the approved protocol, relevant regulations, laws, institutional policies, and the Investigator Manual (HRP-103)
  • Obtain IRB approval prior to the initiation of modifications to a study, except for those changes that are implemented to eliminate immediate hazards to participants
  • Respond to all compliance issues, including participating in post-approval monitoring
  • Confirm and monitor that the research team is trained and in compliance with IRB policies and procedures, federal and state regulations, and other relevant University policies
  • Promptly suspend or terminate research, as appropriate, and submit reports of these actions and other reportable events to the IRB via Reportable New Information (RNIs) submissions

Clinical Trials

  • Ensure clinical trials are conducted in accordance with Good Clinical Practice (GCP)
  • Work with staff to prepare and submit case report forms for clinical trials
  • Follow required closeout procedures (see ASRSP)
  • Maintain current and accurate records in the Clinicaltrials.gov database

Animal Subjects

  • Oversee animal study protocol submission to, and approval by, the Institutional Animal Care and Use Committee (IACUC) and provide a full copy of grant for protocol/grant congruency
  • Ensure that the animal study protocol is IACUC approved prior to implementing animal work and that all aspects of animal care and use are conducted according to the approved protocol
  • Ensure each grant has a separate approved animal study protocol
  • Review/confirm animal charges and reconcile with the Center for Comparative Medicine (CCM)
  • Confirm and monitor that research team is trained and qualified for the procedures they will perform, including compliance with all Occupational Health and Safety enrollment requirements
  • Comply with all federal, state and local regulatory and institutional inspections and compliance investigations
  • Inform the IACUC Office when custom antibodies or tissues are obtained from a third party
  • Notify the IACUC Office of external collaborations involving animal work
  • Notify the IACUC Office of animal work supported by funds from another institution
  • Participate in Post-Approval Monitoring (PAM) visits
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Research Safety

  • Model, demonstrate and enforce safety and health compliance
  • Mentor trainees and lab staff in relation to safety issues
  • Register lab with Research Safety and keep research profile current
  • Ensure consistent use of proper protective clothing and usage of materials
  • Report any incidents that occurred during the performance of laboratory work activities that resulted in or could have led to injury or damage to property.
  • Ensure that all lab members leaving the lab have cleaned up their assigned spaces before they depart

Research Integrity

  • Conduct research in an ethical and compliant manner
  • Ensure integrity of all research activities and data
  • Uphold secure and ethical data use, data confidentiality, and compliant data management, sharing, ownership, and retention practices
  • Supervise and ensure the integrity of the research of all trainees and research staff
  • Ensure Responsible and Ethical Conduct of Research (RECR) training for NSF supported undergraduate students, graduate students, and post-doctoral fellows as well as all trainees, participants, and scholars supported through applicable NIH awards
  • Implement and follow responsible authorship practices, including adherence to discipline-specific guidelines

Conflict of Interest (COI)

  • Meet initial and ongoing Conflict of Interest (COI) training and disclosure requirements
  • Identify which individuals on the study team meet the definition of "investigator" and are subject to the COI requirements
  • Adhere to the requirements of COI management plans
  • Adhere to COI policies and processes and to all federal, state, and local regulations and sponsoring agency policies and procedures

Patents and Inventions

  • Promptly disclose all inventions to the Innovation and New Ventures Office (INVO) using the on-line Inventor Portal must be completed at least 3-4 weeks prior to public disclosure)
  • Provide accurate sources of funding on the Invention Disclosure form
  • Communicate timely information to INVO, such as chartstring and/or account information, confidentiality agreements, technology development updates, etc.

Export Controls & International Compliance