Principal Investigator

 

Who can be a principal investigator: 

Animal welfare:

  • Obtains IACUC approval for research use of animals
  • Obtains other committee approval as necessary
  • Adheres to all federal, state and local laws, as well as all institutional policies and procedures related to research use of animals
  • Ensures that all staff on project are adequately trained and certified in order to assure humane care and use of animals
  • Reports any violations of animal care and use regulations to IACUC office
  • Completes periodic training to remain current on federal, state, and local regulations, institutional policies and procedures, and animal care and use technology

Biosafety/Recombinant and Synthetic DNA Molecules:

  • Obtains all necessary reviews and approvals for project
  • Obtains all necessary training (e.g. microbiological, safety and clinical practices) and/or certifications
  • Ensures that personnel follow required policies and procedures
  • Ensures that project personnel participate in relevant training
  • Requests operational and/or technical support as necessary
  • Ensures completion and timely submission of the Biological Materials Registration Form
  • Submits information requested in NIH Guidelines for Research with recombinant and synthetic DNA molecules to Institutional Biosafety Committee (IBC), IRB and NIH OBA/RAC
  • Develops Human Gene Transfer Research Plan
  • Obtains other approvals as necessary
  • Is trained in appropriate microbiological, safety and clinical practices
  • Makes initial determination of biosafety level and other appropriate precautions for the research
  • Reports adverse events to the Institutional Biosafety Committe (IBC), IRB, FDA, NIH and DSMBs, as required by the policies of these organizations
  • Reports problems, violations and staff accidents/illnesses to the Institutional Biosafety Committe (IBC) and/or OBA as soon as possible but no later than 30 days after occurrence

Conflict of interest:

  • Files Annual Financial Disclosure (AFD) form with chair/director
  • Files project-based Conflict of Interest Form when necessary
  • Participates in development of Management, Monitoring and Implementation Plan ("plan") if necessary
  • Complies with Management, Monitoring and ImplementationPlan ("plan") to manage any conflict of interest

Data and safety monitoring:

  • Audits the research process on a regular basis, and documents this audit, as relevant
  • Reports adverse events to the IRB according to institutional policy and IRB procedures, and to DSMBs, sponsors and appropriate federal agencies as required

Education and training:

  • Completes periodic training to remain current on federal, state, and local regulations, institutional policies and procedures, and animal care and use technology
  • Ensures that all staff on project are adequately trained and certified in order to assure humane care and use of animals
  • Participates in training on financial administration of sponsored projects
  • Completes periodic training to remain up-to-date on federal regulations, UU policies and procedures and compliance expectations for animal welfare
  • Ensures that all personnel complete periodic training to remain up-to-date on federal regulations, UU policies and procedures and compliance expectations for animal welfare
  • Obtains all necessary environmental health and safety, and biosafety training and/or certifications
  • Ensures that all personnel complete necessary environmentalhealth and safety, and biosafety training
  • Participates in OSP training regarding University policies, compliance issues, proposal improvement, and agency specific issues
  • Participates in radiation protection training
  • Ensures that all personnel participate in radiation protection training

Environmental health and safety:

  • Provides safe and healthy environments for areas and personnel assigned to their project(s)
  • Initiates and enforces necessary preventive measures to control hazards
  • Consults with the Department of Environmental Health and Safety regarding appropriate practices and facilities to conduct research safely and in compliance with regulatory requirements
  • Requests operational and/or technical support as necessary
  • Ensures that personnel follow required policies and procedures
  • Ensures necessary support such as personal protective equipment, occupational medical examinations, local exhaust ventilation, etc. are in place
  • Participates in relevant training and education
  • Ensures that project personnel participate in relevant training and education
  • Ensures completion of the University of Utah Registration of Materials Potentially Infectious to Humans form, as necessary
  • Ensures injuries and illnesses are reported to the Worker's Compensation Office
  • Serves as focal point for safety and health concerns

Financial management of research:

  • Determines financial charges that are allocable to the sponsored project
  • Attests to the allowability and reasonableness of all expenditures when initiated
  • Reviews and approves/resolves monthly/quarterly accounting statements
  • Responsible for completion, accuracy and timeliness of technical reports
  • Responsible for hiring/assignment of personnel on project
  • Initiates and approves subcontract agreements and payments
  • Participates with department/center financial administrative officer in process of documenting cost sharing/matching costs.
  • Initiates requests for re-budgeting of costs on the project
  • Initiates and proposes resolution of any cost overrun occurring on the project
  • Identifies and allocates any program income
  • Ensures compliance with all applicable financial regulations and UU policies and procedures by project personnel and reports instances of non-compliance
  • Participates in training in financial administration as necessary; ensures that relevant project personnel participate in training in financial administration as necessary

Human gene transfer:

  • Registers and obtains approval for new, continuing or modified Human Gene Transfer protocols with the Institutional Biosafety Committe (IBC) and IRB
  • Submits information requested in Appendix M of the NIH Guidelines for Research with recombinant and synthetic DNA molecules to the Institutional Biosafety Committe (IBC), IRB and NIH OBA/RAC as required by the policies of these organizations
  • Develops Human Gene Transfer plan as required by Institutional Biosafety Committe (IBC)
  • Obtains other approvals as necessary
  • Is trained in appropriate microbiological, safety and clinical practices
  • Assures that research staff are trained in appropriate microbiological, safety and clinical practices
  • Makes initial determination of biosafety level and other appropriate precautions for the research
  • Reports adverse events to the Institutional Biosafety Committe (IBC), IRB, FDA, NIH and DSMBs, as required by the policies of these organizations
  • Reports problems, violations and staff accidents/illnesses to the Institutional Biosafety Committe (IBC) and/or OBA as soon as possible but no later than 30 days after occurrence

Human subjects:

  • Adheres to federal regulations, state and local laws, institutional policies and IRB procedures regarding the safety and protection of human subjects
  • Assures the performance of the Informed Consent process
  • Reports adverse events to the IRB according to institutional policy and IRB procedures, and to DSMBs, sponsors and appropriate federal agencies as required
  • Audits the research process on a regular basis, and documents this audit
  • Acts as a liaison between the IRB and the sponsor
  • Maintains documents as required by federal, state and UU policies/procedures
  • Ensures that the IRB protocol is identical to the proposal for funding for extramural or intramural support, informs the IRB of any updates or modifications to the protocol and ensures that they are in compliance with federal, state and University of Utah regulations and policy
  • Completes periodic training to remain up-to-date on federal regulations, University of Utah policies and procedures and compliance expectations
  • Ensures that all personnel on the sponsored project complete all required human subjects training, as necessary

Human tissue samples:

  • Assures that consent is obtained for banking of samples, with options for banking with no identifiers, banking with identifiers, or banking with identifiers but future use contingent on donor's consent
  • Assures that potential for financial gain is specified in consent

Patents and inventions:

  • Discloses nature and background of new intellectual property to the Technology Transfer Office by filling out and signing an Invention Disclosure Form
  • Assigns new intellectual property to the University of Utah
  • Maintains written documentation of each technology
  • Assists TTO with estimation of size and nature of potential markets
  • Ensures compliance with university technology transfer policy by project personnel
  • Discloses to TTO relevant funding sources and any pre-existing obligations to funding sponsors or providers of proprietary materials; maintains records on same
  • Provides information on "prior art"; assists TTO in preparation and prosecution of patent applications; executes assignment to the University of Utah and other formal documents associated with patenting
  • Maintains appropriate confidentiality when dealing with intellectual property
  • Initiates Material Transfer Agreements regarding transfer of University of Utah materials to others by contacting the Technology Transfer Office and assists TTO in the processing of same
  • Completes invention portion of Continuing Grant Applications and Final Invention Report

Radiation safety:

  • Serves as "Responsible User" (generally)
  • Ensures that the "Responsible User" is approved by RSO and RSC, if "Responsible User" is not Principal Investigator
  • Provides a detailed plan to RSC for proposed use
  • Acknowledges and accepts in writing responsibility for compliance with all Radiological Health policies and procedures
  • Ensures that all project personnel participate in radiation training as necessary

Sponsored projects administration:

  • Submit grant proposals in a timely manner to allow for necessary review and processing
  • Manages the technical/programmatic aspects of the project by
    • providing all deliverables that may be required in the agreed upon time frame, not deviating from the scope of work for the project unless changes are agreed upon by the sponsor;
    • overseeing the work of students and other personnel utilized on the project
  • Manages the logistical/physical aspects of the project by
    • understanding contract/grant terms and conditions, including any special or unusual conditions
    • assuring that the contractual conditions are met
    • appropriately managing and utilizing any space and instrumentation needed to complete the project;
    • assuring appropriate laboratory management
  • Exercises responsible fiscal control, ensures that funds are spent appropriately and within the sponsor and university/state guidelines
  • Assures regulatory compliance with policies such as Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), Biosafety, recombinant DNA, Radiological Safety and FDA policies regarding clinical trials
  • Conducts the project using the highest ethical standards following the policies relating to integrity in research (Misconduct Policy) and declares any potential conflict of interest for themselves or any individual involved with the project that falls within the University Conflict of Interest Policy.
  • Completes all close out and intellectual property requirements of the university and the sponsor; including but not limited to all interim and final technical reports, submission of invention disclosures and other reports as required
  • Participates in OSP training regarding University policies, compliance issues, proposal improvement, and agency specific issues

Last updated: 09/09/2004