Principal Investigator Roles and Responsibilities

Position Role
Sponsored Program Administration
Financial Management
Effort Reporting
Conflicts of Interest
Human Research Participant Protection
Animal Welfare
Environmental Health and Safety
Human Gene Transfer
Patents and Inventions
Export Controls

Position Role

The Principal Investigator (PI) is charged to conduct objective research that generates independent, high quality, and reproducible results. The Principal Investigator is responsible for the management and integrity of the design, conduct, and reporting of the research project and for managing, monitoring, and ensuring the integrity of any collaborative relationships. Additionally, the Principal Investigator is responsible for the direction and oversight of compliance, financial, personnel, and other related aspects of the research project and for coordination with school, department, and central administration personnel to assure research in is conducted in accordance with federal regulations and university and sponsoring agency policies and procedures.

The Principal Investigator reports to a designated official such as a dean, department head, or division chief.

General Administrative

  • Coordinates with school, department, and central administration personnel to help ensure that sponsored research and related activities are in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Administers and oversees research and all related activities.
  • Assures that all key personnel involved in sponsored program administration have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Supports and endorses cooperation with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office.

Preparation of Scientific Proposal

  • Obtains or coordinates with department administrator to obtain appropriate internal approvals and assure that proposals meet federal regulations and university and sponsoring agency policies and procedures prior to submitting proposal to sponsoring agency.

Proposal Budget

  • Develops budget justification in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Makes key budgetary decisions and verifies that appropriate budgets and cost projections are prepared to deliver the proposed project scope.
  • Prepares or coordinates with department administrator to prepare categorized budget and justification and confirm accuracy and completeness of budgeted costs.

Protocol Preparation and Review

  • Prepares and submits scientific protocol(s) or changes in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Submits any proposed changes to the protocol for approval as required and assures that changes are not implemented prior to approval.
  • Reviews protocol at inception and as required thereafter for completeness, accuracy, and improvement opportunities.

Award Acceptance (Terms and Conditions)

  • Recognizes the University as the recipient of awards.
  • Reviews and signs award agreement in accordance with University policies and procedures.
  • Complies with and implements award terms and conditions and subcontract scope of work.
    Prepares or coordinates with department administrator to prepare a revised categorized budget based on the actual award and the specific needs of the project.
  • Complies with terms of award acceptance in accordance with federal regulations and university and sponsoring agency policies and procedures.

Conduct of Research

  • Oversees the conduct of research in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Oversees the research team to help ensure ethical conduct in all aspects of the research process including but not limited to the treatment of human and animal subjects, conflicts of interest, data acquisition, management, sharing and ownership, publication practices, responsible authorship, and collaborative research and reporting.
  • Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Washington University’s Research Integrity Policy and other misconduct as described in Washington University’s Code of Conduct.

Facilities and Administrative Cost Rate

  • Identifies program type to allow determination of correct facilities and administrative (F&A) cost rate.
  • Coordinates with school, department, and central administration personnel to verify that the correct F&A cost rate is applied to sponsored project budgets.

Space Management

  • Uses allocated space appropriately and efficiently and reports correct use of space to the department.

Equipment Management

  • Obtains, maintains, and safeguards equipment used to conduct research in accordance with federal regulations and university and sponsoring agency policies and procedures.

Service Centers

  • Develops, monitors, and administers service center rates in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Provides general oversight for operation of specialized service centers in accordance with federal regulations and university and sponsoring agency policies and procedures.

Reporting

  • Complies with technical, progress, and compliance reporting requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.

Project Closeout

  • Submits accurate and timely closeout documents to applicable Federal agencies, University entities, and the sponsoring agency in accordance with federal regulations and university and sponsoring agency policies and procedures.

Financial Management

General Administrative

  • Oversees administration of project funds.
  • Coordinates with school, department, and central administration personnel to determine whether the project charges are allowable and allocable in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Verifies the authenticity and accuracy of expended funds.
  • Assures that all key personnel involved in financial management have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Supports and endorses cooperation with University compliance and monitoring efforts related to financial management and reports instances of noncompliance to the appropriate compliance office.

Cost Sharing

  • Coordinates with school, department, and central administration personnel to identify and authorize cost sharing obligations and expenditures.

Cost Transfer

  • Reviews and authorizes cost transfers a timely manner in accordance with federal regulations and university and sponsoring agency policies and procedures.

Reporting

  • Complies with technical, progress, and compliance reporting requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.

Project Closeout

  • Submits accurate and timely closeout documents to applicable Federal agencies, University entities, and the sponsoring agency in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Supervises and approves the posting of project expenses to the fund in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Coordinates with school, department, and central administration personnel to initiate resolution to any cost overruns.
  • Coordinates with departmental administrator and/or Sponsored Projects Accounting (SPA) to complete and submit appropriate final closeout or transfer forms.

Effort Reporting

  • Reviews, adjusts, and legally certifies the accuracy of personal activity reports (PARs) for all applicable personnel.
  • Completes PARs for unavailable personnel within deadlines and in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Returns signed PARs to Sponsored Projects Accounting in accordance with University policy.
  • Assures that all key personnel involved in effort reporting have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Supports and endorses cooperation with University compliance and monitoring efforts related to effort reporting and reports instances of noncompliance to the appropriate compliance office.

Conflicts of Interest

  • Takes appropriate steps to avoid conflicts of interest, or the appearance of conflicts of interest, between financial or other personal interests and the goals and policies of the University.
  • Complies with and assures personnel comply with applicable School, University, and sponsoring agency conflict of interest policies and procedures.
  • Discloses all significant financial conflicts of interest to the appropriate Disclosure Review Committee (DRC) and complies with recommended management strategies.
  • Supports and endorses cooperation with University compliance and monitoring efforts related to conflicts of interest and reports instances of noncompliance to the appropriate compliance office.

Human Research Participant Protection

General Administrative

  • Protects the rights and welfare of human research participants in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Assures that all key personnel involved in human research complete and comply with the required education for the protection of human participants in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Acts as liaison between the Human Research Protection Office (HRPO) and the sponsor.
  • Supports and endorses cooperation with University compliance and monitoring efforts related to human participant research and reports instances of noncompliance to the appropriate compliance office.

Preparation of Scientific Proposal

  • Performs a comprehensive review of background and scientific literature prior to preparing the scientific proposal.
  • Provides or coordinates with department administrator to provide accurate human research participant approval information for all submissions and correspondence to the sponsoring agency.
  • Discloses and details use of human participants in the scientific proposal.
  • Verifies that the protocol and proposal for funding are identical.

Proposal Budget

  • Verifies that the proposal budget provides sufficient funds for compliance with federal regulations and university and sponsoring agency policies and procedures.
  • Pays research participants and/or covers their expenses as approved by the HRPO Committee.

Protocol Preparation and Review

  • Prepares and submits human research protocols or changes in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Submits any proposed changes to the protocol for approval as required and assures that changes are not implemented prior to approval.
  • Reviews protocol at inception and as required thereafter for completeness, accuracy, and improvement opportunities.

Informed Consent

  • Prepares and maintains all documents related to the informed consent process.
  • Submits informed consent documents to HRPO for review and approval.
  • Completes the consent process as approved, including obtaining all on-going re-consent documentation.
  • Assures accurate execution of the informed consent process.

Award Acceptance (Terms and Conditions)

  • Verifies that protocol complies with the terms and conditions of the award and that HRPO protocol approval is in place prior to the acceptance of the award and the start of research.

Conduct of Research

  • Oversees the conduct of research in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Conducts research in accordance with current, approved human studies protocol for the duration of the project.
  • Adheres to all recommendations and conditions placed upon the research by HRPO for the duration of the research.
  • Responds to Human Studies Research Quality Assurance / Quality Improvement (HSR QA/QI) Committee review findings and implements corrective measures suggested.
  • Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Washington University’s Research Integrity Policy and other misconduct as described in Washington University’s Code of Conduct.

Protected Health Information

  • Adheres to and supports all federal regulations and university policies and procedures instituted to safeguard protected health information (PHI).
  • Assures that all personnel complete the appropriate level of training regarding the access, use, and disclosure of PHI in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Supports and endorses cooperation with University compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.

Unanticipated Problems

  • Promptly reports any unanticipated problems involving risks to research participants or others to the HRPO Committee (Washington University’s IRB).

Reporting

  • Complies with technical, progress, and compliance reporting requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.

Project Closeout

  • Submits accurate and timely closeout documents to applicable Federal agencies, University entities, and the sponsoring agency in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Secures and maintains or coordinates with department administrator to secure and maintain all documentation for the study in accordance with federal regulations and university and sponsoring agency policies and procedures.

Animal Welfare

General Administrative

  • Oversees the humane care and use of animals involved in research in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Assures that all key personnel involved in animal research complete the required education for the humane care and use of animals and laboratory safety and radioactive materials in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
  • Supports and endorses cooperation with University compliance and monitoring efforts related to animal welfare and reports instances of noncompliance to the appropriate compliance office.

Preparation of Scientific Proposal

  • Provides or coordinates with department administrator to provide accurate animal studies approval information for all submissions and correspondence to sponsoring agencies.
  • Discloses and details use of animal subjects in the scientific proposal.
  • Verifies that the protocol and proposal for funding are identical.

Proposal Budget

  • Verifies that the proposal budget provides sufficient funds for compliance with federal regulations and university and sponsoring agency policies and procedures.

Protocol Preparation and Review

  • Prepares and submits animal studies protocols or changes in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Submits proposed changes to the protocol for approval as required and assures that changes are not implemented prior to approval.
  • Reviews protocol at inception and as required thereafter for completeness, accuracy, and improvement opportunities.

Award Acceptance (Terms and Conditions)

  • Verifies that protocol complies with the terms and conditions of the award and that Institutional Animal Care and Use Committee (IACUC) protocol approval is in place prior to acceptance of award and the start of research.

Conduct of Research

  • Oversees the conduct of research in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Conducts research in accordance with current, approved animal studies protocol for the duration of the sponsored project.
  • Adheres to all recommendations and conditions placed upon the study by the IACUC, Division of Comparative Medicine (DCM) veterinary staff, and other University entities as appropriate for the duration of the project.
  • Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Washington University’s Research Integrity Policy and other misconduct as described in Washington University’s Code of Conduct.

Serious Adverse Events

  • Reports serious violations of approved protocol to the IACUC particularly any that may affect animal safety.

Reporting

  • Complies with technical, progress, and compliance reporting requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.

Project Closeout

  • Submits accurate and timely closeout documents to applicable Federal agencies, University entities, and the sponsoring agency in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Secures and maintains or coordinates with the department administrator to secure and maintain all documentation for the study in accordance with federal regulations and university and sponsoring agency policies and procedures.

Environmental Health and Safety

General Administrative

  • Adheres to all federal, state, and local regulations and university and sponsoring agency policies and procedures instituted to protect the health and safety of research participants, personnel, and the environment.
  • Assures that individuals handling hazardous or regulated materials are well trained in proper safety procedures and complete the required environmental health and safety education in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
  • Establishes and monitors or coordinates with department administrator to establish and monitor safety programs for department, center, or project in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
  • Supports and complies with all Stop Work decisions.
  • Supports and endorses cooperation with University compliance and monitoring efforts related to environmental health and safety and reports instances of noncompliance to the appropriate compliance office.

Preparation of Scientific Proposal

  • Provides or coordinates with the department administrator to provide accurate environmental health and safety information for all submissions and correspondence to the sponsoring agency.
  • Verifies that facilities and resources can be provided to adequately and safely implement the research proposal.

Proposal Budget

  • Verifies that the proposal budget provides sufficient funds for compliance with federal, state, and local regulations and university and sponsoring agency policies and procedures.

Protocol Preparation and Review

  • Identifies hazards associated with project activities.
  • Prepares and submits environmental health and safety protocols or changes in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
  • Submits and proposed changes to the protocol for approval as required and assures that changes are not implemented prior to approval.
  • Reviews protocol at inception and as required thereafter for completeness, accuracy, and pollution prevention and health and safety improvement opportunities.

Award Acceptance (Terms and Conditions)

  • Verifies that protocol complies with the terms and conditions of the award and that applicable environmental health and safety protocol approvals are in place prior to acceptance of award and the start of research.

Conduct of Research

  • Oversees the conduct of research in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
  • Conducts research in accordance with current, approved environmental health and safety protocols for the duration of the project.
  • Coordinates with department administrator and/or Environmental Health and Safety (EHS) to implement appropriate safety procedures and practices for the research project and to assure the availability of engineering controls and safety equipment prior to the start of the research.
  • Adheres to all recommendations and conditions placed upon the research by EHS and assures that safety and compliance procedures are adhered to by all personnel for the duration of the project.
  • Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Washington University’s Research Integrity Policy and other misconduct as described in Washington University’s Code of Conduct.

Serious Adverse Events

  • Reports promptly all on-the-job accidents, illnesses, unlawful environmental releases, and/or potential exposures in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
  • Takes immediate and appropriate corrective actions and implements measures to prevent future occurrences.

Reporting

  • Complies with technical, progress, and compliance reporting requirements in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.

Project Closeout

  • Submits accurate and timely closeout documents to applicable federal, state, and local agencies, university entities, and the sponsoring agency in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
  • Complies with laboratory decommissioning and safety guideline requirements in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.

Human Gene Transfer

General Administrative

  • Adheres to all federal, state, and local regulations and university and sponsoring agency policies and procedures governing human gene transfer.
  • Assures that all key personnel involved in human gene transfer research have met training requirements in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
  • Supports and endorses cooperation with University compliance and monitoring efforts related to human gene transfer and reports instances of noncompliance to the appropriate compliance office.

Preparation of Scientific Proposal

  • Performs a comprehensive review of background and scientific literature prior to preparing the scientific proposal.
  • Provides or coordinates with department administrator to provide accurate human gene transfer approval information for all submissions and correspondence to sponsoring agencies.

Proposal Budget

  • Verifies that the proposal budget provides sufficient funds for compliance with federal, state, and local regulations and university and sponsoring agency policies and procedures governing human gene transfer research.

Protocol Preparation and Review

  • Prepares and submits human gene transfer protocols or changes in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
  • Submits and proposed changes to the protocol for approval as required and assures that changes are not implemented prior to approval.
  • Reviews protocol at inception and as required thereafter for completeness, accuracy, and improvement opportunities.
  • Submits relevant protocol information to Federal agencies as required in accordance with Federal regulations governing human gene transfer research.

Award Acceptance (Terms and Conditions)

  • Verifies that protocol complies with the terms and conditions of the award and that appropriate human gene transfer protocol approvals are in place prior to the acceptance of the award and the start of research.

Conduct of Research

  • Oversees the conduct of research in accordance with federal and state regulations and university and sponsoring agency policies and procedures governing human gene transfer research.
  • Conducts research in accordance with current, approved human gene transfer protocols for the duration of the research.
  • Adheres to all recommendations and conditions placed upon the research by EHS and HRPO.
  • Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Washington University’s Research Integrity Policy and other misconduct as described in Washington University’s Code of Conduct.

Unanticipated Problems

  • Promptly reports any unanticipated problems related to human gene transfers in accordance with federal and state regulations and university and sponsoring agency policies and procedures governing human gene transfer research.

Reporting

  • Complies with technical, progress, and compliance reporting requirements in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.

Project Closeout

  • Submits accurate and timely closeout documents to applicable federal, state, and local agencies, university entities, and the sponsoring agency in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.

Patents and Inventions

General Administrative

  • Coordinates with department administrator and/or the Office of Technology Management (OTM) to disclose and report patent and invention information in accordance with federal regulations and university and sponsoring agency policies and procedures.
  • Reports all inventions promptly to OTM to assure proper patent protection.
  • Coordinates with OTM on the preparation and prosecution of patents.
  • Supports and endorses cooperation with University compliance and monitoring efforts related to patents and inventions and reports instances of noncompliance to the appropriate compliance office.

Preparation of Scientific Proposal

  • Provides written confirmation of invention in accordance with federal regulations and university and sponsoring agency policies and procedures.

Export Controls

General Administrative

  • Remains aware of and adheres to federal regulations and university policies and procedures related to export controls.
  • Assures that key personnel are well trained in federal regulations and university policies and procedures related to export controls.
  • Discloses international exchanges of information, items, and/or activities as requested and complies with recommended management strategies and restrictions.
  • Discloses international exchanges of information, items, and/or activities as requested and complies with recommended management strategies and restrictions.