| PRINCIPAL INVESTIGATOR
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| Animal welfare:
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- 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
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| Biosafety/recombinant
DNA: |
- 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 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
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| 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 Implementation
Plan ("plan") to manage any conflict of interest
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| Data and safety monitoring:
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- 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
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| Education and training:
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- 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 environmental
health 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
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| 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
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| 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
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| Human gene transfer:
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- 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 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
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| Human subjects:
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- 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
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| Human tissue samples:
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- 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
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| Patents and inventions:
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- 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
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| Radiation safety:
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- 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
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| 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
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Last updated: 09/09/2004 |
