Office of Research

Principal Investigator Responsibilities

The Principal Investigator (PI) is the individual with primary responsibility for:

  • The scientific integrity and management of the project.
  • The financial management of project funds, including recovery of indirect costs.
    • Full cost recovery is necessary to support the university’s physical and administrative capacity to perform extramural projects.
  • Adherence to all university and sponsor policies.

Further details on PI roles through the proposal lifecycle can be found on the page Roles & Responsibilities for Managing Sponsored Projects.

Proposals

There are several offices on campus dedicated to supporting proposal submission, including Research Development, the Proposal Administration team, IBE Hub, and Foundation Relations. However, the content of a grant proposal is ultimately the responsibility of the PI. During the proposal process, the PI is responsible for:

  • Reviewing the solicitation and/or sponsor guidelines.
  • Notifying and maintaining timely communication with the UCSC Office of Sponsored Projects to ensure each proposal submission is reviewed and institutionally endorsed.
  • Identifying budgetary needs for a proposed project.
  • Securing cost share resources and letters of support. 
  • Ensuring the accuracy, content, and completeness of the Cayuse record and the final proposal package.
  • Ensuring all relevant campus offices have reviewed and approved the proposal prior to submission.
  • Ensuring all related training and certification requirements are met.

Award Management

The PI has primary responsibility for financial management and stewardship of project funds and for the scientific management, technical progress, and integrity of the sponsored project. This includes:

  • Adhering to university and sponsor policies and procedures
  • Performing the activities for which the award is issued.
  • Complying with the terms and conditions of the award, and adhering to life of the award compliance responsibilities.
  • Establishing a budget that supports project activities, and managing the resulting budget and expenditures through the life of the project.
  • Ensuring award expenditures are allowable and allocable per the award terms and conditions, and approving award expenditures.
  • Monitoring subrecipient performance, and approving or denying invoices.
  • Meeting deadlines for any technical, financial, compliance and other reports required by the award, including for award closeout.
  • Working with the Office of Sponsored Projects to address any change in scope of work, change in PI, or other issues requiring prior approval by a sponsor.

Human Subjects Research

PIs are responsible for:

Protecting the safety and welfare of research participants
  • Conducting the study in an ethical manner, including protecting the rights and welfare of human subjects who are involved in the research project.
  • Ensuring that the resources necessary to protect participants are present before conducting the research study.
  • Reporting to the IRB any unanticipated problems or significant new findings that develop during the course of research that may affect the risks and benefits to subjects.
  • Reporting protocol violations and research-related incidents to the IRB according to the UCSC HRPP reporting guidance.
  • Reporting any correspondence to or from a regulatory agency regarding matters of regulatory compliance (e.g., FDA audit findings, PI audit response letter) to the IRB.
  • Responding to participants’ complaints/concerns or requests for information and reporting to the IRB any significant participant complaints/concerns.
  • Designing and carrying out the research study with adequate data and safety monitoring, when appropriate.
  • Assuring that the protected health information (PHI) requested, if any, is the minimum necessary to meet the research objectives, and that PHI is not reused or disclosed to any parties other than those described in the IRB-approved protocol, except as required by law.
Training and supervising collaborating faculty and staff
  • Ensuring that all engaged investigators observe pertinent laws, regulations, and institutional policies and guidelines.
  • Ensuring that engaged investigators complete IRB-required training, are qualified, and adhere to the provisions of the IRB-approved protocol.
Adherence to regulatory and IRB requirements and guidance
  • Ensuring that all research involving human subjects receives IRB review and approval before commencement of the research, including screening or recruitment.
  • Seeking IRB guidance when in doubt about whether proposed research requires IRB review.
  • Complying with all IRB decisions, conditions and requirements.
  • Obtaining IRB review and approval before changes are made to approved protocols or consent forms (IRB modification request), except where necessary to eliminate apparent immediate hazard to the subject..
  • Ensuring that no human subject is involved in the research prior to obtaining their consent.
  • Ensuring the adequacy of the informed consent process.
  • Ensuring that protocols receive continuing IRB review and approval at the appropriate interval.
  • Providing financial disclosure information or any other potential conflicts of interest that might affect the relationship with the research participant or the outcome of the research.
  • Obtaining any necessary ancillary approvals, independent of IRB review, before beginning research (including Conflict of Interest review, Embryo and Stem Cell Research review, and the Institutional Biosafety review).

Research involving animals

PIs are responsible for:

Protecting the safety and welfare of research animals
  • Conducting the study in an ethical manner, including protecting animal welfare.
  • Reporting unexpected or serious adverse events.
  • Reporting protocol violations and research-related incidents.
  • Reporting any correspondence to or from a regulatory agency regarding matters of regulatory compliance (e.g., FDA audit findings, PI audit response letter) to the IACUC.
Training and supervising participating personnel
  • Ensuring that all participating personnel observe pertinent laws, regulations, and institutional policies and guidelines.
  • Ensuring that personnel are appropriately trained and have met clearance requirements.
Adherence to regulatory requirements and guidance
  • Submitting completed protocol documents to the IACUC for review, including protocol applications, modifications, and annual updates.
  • Ensuring that all research involving animals receives IACUC review and approval before commencement of the research.
  • Seeking guidance when in doubt about whether proposed research requires IACUC review.
  • Complying with all IACUC decisions, conditions and requirements.
  • Ensuring that protocols receive continuing review and approval at the appropriate interval.
  • Providing financial disclosure information or any other potential conflicts of interest.

Intellectual property

PIs are responsible for:

  • Understanding the terms of the UC Patent Policy as well as the UC Patent Acknowledgment.
  • Assuring that they and all individuals they supervise disclose all inventions, whether they believe them to be invented at the UC or not, to Innovation Transfer. 
  • Understanding the intellectual property terms of their sponsored awards.
  • Ensuring that all inventions conceived or reduced to practice in their lab with support from sponsored awards are promptly disclosed to Innovation Transfer, including accurate reporting of the funding source. 

Conflict of interest (COI)

PIs are responsible for:

  • Meeting initial and ongoing Conflict of Interest (COI) training, disclosure, and reporting requirements.
  • Identifying individuals as project investigators if, at any point during the life of a project, they directly or materially influence the research, or are responsible for the design, conduct, or reporting of records. Project investigators are required to disclose their significant financial interests, and each disclosure must be reviewed before funds may be spent. 
  • Adhering to all relevant university and sponsor processes and policies related to COI.
  • Adhering to the requirements of COI management plans resulting from positive disclosures.

Responsible conduct of research (RCR)

PIs are responsible for:

  • Ensuring the professional and ethical conduct of research, and promoting and maintaining an environment that encourages intellectual honesty and integrity.
  • Completing RCR training through CITI, and ensuring training compliance for all personnel named on relevant awards.
  • Including RCR training plans in proposals where required. 

Research integrity

PIs are responsible for:

Principal Investigators

Last modified: May 13, 2024