A. General Responsibilities of Principal Investigators
The principal investigator (PI) is responsible for personally
conducting or supervising the conduct of human-subjects research and for protecting
the rights, safety, and welfare of the subjects enrolled in the research. The
PI must ensure that all human-subjects research is conducted in an ethical
manner and in accordance with all federal, state, and local laws and
regulations, institutional policies, and requirements or determinations of the
PHRC.
1. Supervising the conduct of human-subjects research
The PI may delegate study-related tasks, but must adequately supervise
study personnel to whom tasks are delegated. When supervising the conduct of
human-subjects research, the PI must ensure that:
Study personnel are qualified by training and experience to perform
study-related tasks that have been delegated to them;
Study personnel have an adequate understanding of the research; and
Study personnel follow the IRB-approved protocol, including the
recruitment and consent procedures described in the protocol summary.
The PI should have a plan for supervision and oversight of the
research. The intensity of the supervision should take into consideration the
study personnel conducting the research, the nature of the research, and the
subject population. For more information refer to PHRC guidance Principal
Investigators and Delegation of Study-related Tasks to Co-investigators and
Study Staff.
2. Protecting the rights, safety, and welfare of research subjects
The PI or other identified qualified individual(s) must be available to
provide study subjects with reasonable medical care for any medical problems
that arise during participation in the research that are, or could be, related
to the research. Additionally, when participation in the research might impact
the subject’s health and/or medical care, the PI should inform the subject’s
primary care physician about the subject’s participation in the research if the
subject has a primary care physician and if the subject agrees to the primary
care physician being informed.
When protecting the rights, safety, and welfare of research subjects,
the PI must ensure that:
S/he or other identified, qualified individual(s) provides study
subjects with reasonable medical care for any adverse events, including
clinically significant laboratory values, related to the research;
S/he or another specific qualified individual is available to study
subjects to answer questions or provide care during the conduct of the
research; and
S/he and all research staff conducting the study adhere closely to the
research plan, such as inclusion/exclusion criteria, safety assessments, safety
monitoring and reporting of unanticipated problems, and procedures to protect
privacy of subjects and confidentiality of identifiable data, in order to
minimize risks to subjects.
The PI should not commence the research without adequate resources to
protect subjects participating in the research and should stop the research if
the resources necessary to protect subjects become unavailable. These resources
might include research personnel, space, equipment, time, and availability of
medical or psychological care for problems that arise during participation in
the research.
B. More Specific Responsibilities of Principal Investigators
The PI must ensure that:
PHRC approval is obtained prior to initiation of the research;
The research is conducted in accordance with the PHRC-approved
protocol, including, when applicable, the approved recruitment and consent
procedures;
When informed consent is required, informed consent is obtained prior
to the initiation of any study-related procedures;
When written informed consent is required, informed consent is obtained
and documented using the current PHRC-approved research consent form;
When drugs, biological products, and devices are being investigated or
used, they are managed and controlled as required by institutional policy and,
when applicable, FDA regulations 21 CRF 312 and 21 CFR 812;
Changes to the PHRC-approved protocol and/or the research consent form
are not initiated without prospective PHRC approval unless necessary to
eliminate apparent immediate hazards to the subject;
Unanticipated problems involving risks to subjects or others (including
adverse events) are reported promptly to the PHRC in accordance with PHRC
policy
When applicable, Data and Safety Monitoring Board/Data Monitoring
Committee or other monitoring group reports are submitted promptly to the PHRC
for review;
Continuing review is conducted prior to expiration of PHRC approval in
accordance with PHRC Policy;
Should PHRC approval lapse, research procedures, such as recruitment
and enrollment of subjects, study procedures on currently enrolled subjects,
review of health/medical records, collection of tissue or other samples, or
analysis of data, are not conducted until the PHRC re-approves the research or
until special permission is obtained from the PHRC to continue previously
enrolled subjects because it is in their best interests to do so;
When the research has been completed or is being closed out prior to
completion, a final continuing review report is submitted to the PHRC;
Adequate and accurate research records are kept and retained as
required by the PHRC and, when applicable, by the sponsor or FDA; and
Research records are made available to the PHRC, Partners Quality
Improvement Program (QI Program), the sponsor, and when applicable, the Office
for Human Research Protections (OHRP), and the Food and Drug Administration
(FDA) upon request for monitoring and oversight of the research.
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.
Sponsored Program Administration
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 Animal Studies Committee (ASC) 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 ASC, 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 ASC 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.
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