Principal Investigator PDF

What is the Principal Investigator of a Research Project? • A principal investigator, also known as the PI, is the holder of an independent grant administered by a university or research organization and the lead researcher for the grant project, usually in the sciences, such as a laboratory study o...

What is the Principal Investigator of a Research Project? • A principal investigator, also known as the PI, is the holder of an independent grant administered by a university or research organization and the lead researcher for the grant project, usually in the sciences, such as a laboratory study or a clinical trial. The phrase is also often used as a synonym for "head of the laboratory" or "research group leader.“ • In the United States federal funding from agencies such as the NIH or the NSF, the PI is the person who takes direct responsibility for completion of a funded project, directing the research and reporting directly to the funding agency. • For small projects (which might involve 1-5 people) the PI is typically the person who conceived of the investigation, but for larger projects the PI may be selected by a team to obtain the best strategic advantage for the project. • In the context of a clinical trial a PI may be an academic working with grants from NIH or other funding agencies, or may be effectively a contractor for a pharmaceutical company working on testing the safety and efficacy of new medicines. Life of a Principal Investigator • A PI spends 24/7 living and breathing research. • When not at the bench conducting research, the PI is reading research papers. • A PI spends about 85-90% effort on the research project therefore it would be difficult for a PI on a project to teach 50% effort or to spend more than 50% effort in the clinic seeing patients. • In contrast, a collaborator would spend just 1015% effort on a project helping out but they would be responsible for other things. • A collaborator may have the role of a consultant on a project with minimum project responsibilities. Role Of The Principal Investigator • The Principal Investigator has the primary responsibility for achieving the technical success of the project, while also complying with the financial and administrative policies and regulations associated with the award. • Although Principal Investigator's may have administrative staff to assist them with the management of project funds, the ultimate responsibility for the management of the sponsored project award rests with the Principal Investigator. • These fundamental responsibilities of the Principal Investigator during the post-award phase of a sponsored project award include: -Execute the project as outlined in the funded proposal, using sound management techniques -Carry out the project's financial plan as presented in the funded proposal, or make changes to the plan following a prescribed set of policies and procedures-Report project progress to the sponsor as outlined in the terms of the grant award -Maintain an accurate record of project related expenses -Comply with policies and procedures related to project management and personnel practices -Comply with all applicable sponsor rules, regulations and/or terms and conditions of the award Research Mentor and the Mentor-Mentee Relationship • The Research Mentorship is a formal or informal relationship in which an experienced mentor offers professional development advice and guidance to a lesser experienced mentee. • Before entering a mentor-mentee relationship: • • • • • Know mentor’s time availability Know mentor’s preferred form of communication (email, phone, in-person meeting) Role and responsibility of the mentor The resources the mentor agrees to provide (funding, access to lab, computing…) Expectations the mentor has of the mentee Once the relationship is established, there are many things a mentee can do to ensure a productive partnership: Communicate often, Ask questions, Complete assigned tasks on time Maintain meticulous records Express gratitude for contributions of the supervisor The Research Team From The Top Down • When conducting human subjects research there are certain expectations that the research team must meet. The roles of the research team and their corresponding responsibilities are absolutely critical for the success of any research project. • The Study coordinators serve to aid in the coordination, management and conduct of clinical research under the supervision of a designated physician/ Principal investigator. • Principal Investigator: As covered earlier, the Principal Investigator (PI) bears ultimate responsibility for all activities associated with the conduct of a research project, including compliance with federal, state and local laws, institutional policies and ethical principles. • The PI remains ultimately responsible even when some aspects of the research are delegated to other members of the study team. The Research Team • Co-Investigator: Co-Investigators (Co-Is) are a subset of Key Personnel who have special responsibilities on research projects. Co-Is are obligated to ensure that the project is designed and conducted in compliance with applicable laws and regulations and institutional policy governing the conduct of human subjects research. • Each Co-I must explicitly acknowledge to the Institutional Review Board (IRB) their participation as a Co-Investigator on the study and will be asked to acknowledge their addition to or deletion from any existing IRB-approved study. The Research Team • Sub-investigator: Sub-investigator is a term specific to FDA-regulated studies. It identifies study team members who make critical clinical trial-related procedures and/or to make important trial-related decisions. • Generally, these are also study Co-Is but may also include study team members with critical and important trial-related roles. • Faculty Advisor (FA): All research conducted by students/trainees, including postdoctoral fellows, must include a Faculty Advisor (FA) as a member of the study team. • In addition to the expectation that the FA provide active mentorship to the student during the conduct of the research, the FA shares responsibility with the student/trainee researcher for the ethical conduct of the research and is institutionally accountable for the study. The Research Team • Other Key Personnel: include individuals who contribute to the scientific development or execution of a study in a substantive, measurable way. Typically, these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level are sometimes considered Key Personnel depending on their involvement in a project. • Research fellows, residents, associates and consultants may be Key Personnel. • Students/Trainees: Supervision by faculty members is required for any research performed by students/trainees in any role, to ensure the proper conduct of research and protection of subject rights and welfare. Principal Investigator Obligations Before IRB Approval • The PI is responsible for the content of all submissions (e.g., initial review, continuing review, adverse event reporting, ORIO reporting, progress reports) to the IRB and other review units and for ensuring that those documents are submitted in a timely manner, as required by the IRB or other review unit. • The PI must include on the IRB application all key personnel who contribute to the scientific development or execution of a study in a substantive, measurable way. Personnel can be added even after approval of the IRB. • To assist the IRB in fulfilling its responsibilities, researchers must provide all information requested by the IRB in a timely fashion PI is in charge of: Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs) Principal Investigator Obligations After IRB Approval • Adhering to Approved Protocol: Researchers, under the direction of the PI, must conduct research as specified in the IRB-approved protocol and must comply with all IRB determinations, including directives to terminate participation in designated research activities. • Changes to Research: Any proposed changes in the research must be submitted to the IRB via an amendment application and approved in advance by the IRB unless necessary to eliminate apparent immediate hazards to subjects. • Similar requirements apply for other review units (e.g., Investigational Drug Service, Radiation Safety Committee, etc.) responsible for oversight of research activities. • Investigators (PI) must promptly report to the IRB any additional risks that are identified during the course of the research project. Principal Investigator Obligations After IRB Approval • Continuing Review: PIs are responsible for monitoring their approval periods and submitting a continuing review application in a timely manner so as to permit the IRB to review and issue an approval prior to expiration of the study. • Lapse of IRB Approval: If IRB approval for a study lapses for any reason, even if the investigator submitted an application for review in a timely manner and promptly responded to any requests for clarifications or changes, the research must stop until the IRB issues its formal approval or determines that it is in the best interest of individual subjects to continue participating in the research interventions or interactions.