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Principal Investigator Roles and Responsibilities

 

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 Institute Director.

 

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 Â鶹ԭ´´F’s Research Ethics Policy.

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.

Purpose:

This process ensures proper oversight and compliance when the Principal Investigator (PI) is unavailable to review subaward invoices. It outlines the delegation of invoice review responsibilities and establishes the requirement to process and pay subaward invoices within 30 days of receipt, in compliance with 2CFR200.305, which mandates timely payment to subrecipients for allowable costs incurred under a federal award. The subaward review delegation form can be found here.

Scope:
This instruction applies when the PI is unavailable, and a delegated individual is required to review subaward invoices.

Process Steps:

1.    Identify Delegate:
In the event the PI is unavailable, a qualified individual (e.g., Co-Investigator, Project Administrator, or designated staff) should be appointed to review subaward invoices. The delegate must have sufficient knowledge of the project scope and budget.

2.    Documentation of Delegation:
The PI must formally notify the designated delegate and document the delegation of responsibilities. This documentation should include the duration of the delegation and the scope of the review.

3.    Department Record-Keeping:
A copy of the delegation form should be kept in the department’s files for future reference and compliance purposes.

4.    Review Process:
The delegated individual will review the subaward invoice for the following:

o    Accuracy of billed costs in relation to the subaward agreement.

o    Allowability and reasonableness of charges in accordance with the project’s budget and terms.

o    Compliance with sponsor guidelines and applicable regulations.

5.    Approval and Sign-off:
Once the delegated individual completes the review, they will approve the invoice for payment by signing off on the invoice or providing written confirmation of review.

6.    Copy to Accounts Payable (AP):
A copy of the delegation form must be submitted to Accounts Payable (AP) when the delegate approves the invoice. This ensures that AP has the necessary documentation for processing the invoice.

7.    Timely Payment Requirement:
Invoices must be paid within 30 days from the receipt of the invoice, in compliance with 2CFR200.305, which requires prompt payment of subawards and invoices to avoid late fees or penalties.

8.    PI Review upon Availability:
When the PI becomes available, they must review and confirm any invoices approved by the delegate to ensure ongoing oversight and accuracy.

9.    Record Keeping:
A record of the delegated review (including the name of the delegate, review notes, and approval) must be maintained in the department’s project documentation for future reference.

Responsibilities:

·&²Ô²ú²õ±è;&²Ô²ú²õ±è;PI: Ensure delegation is documented and the review process is followed.

·&²Ô²ú²õ±è;&²Ô²ú²õ±è;Delegate: Review and approve subaward invoices in the absence of the PI, ensuring compliance with the project’s terms.

·&²Ô²ú²õ±è;&²Ô²ú²õ±è;Department Administration: Maintain records of all invoice reviews and approvals.

·&²Ô²ú²õ±è;&²Ô²ú²õ±è;Accounts Payable (AP): Retain a copy of the delegation form for AP processing when the delegate approves the invoice.

 

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 OGCA to complete and submit appropriate final closeout or transfer forms.

Effort Reporting

• Reviews, adjusts, and legally certifies the accuracy of Effort Certification Statements (ECS) for all applicable personnel.
• Completes ECSs for unavailable personnel within deadlines and in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Returns signed ECSs to OGCA 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 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 Office of Research Integrity (ORI) 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 ORI 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 ORI 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 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 for the duration of the research.
• Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Â鶹ԭ´´F’s Research Ethics Policy.

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 ORI.

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 Institutional Animal Care and Use Committee (IACUC) 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 IACUC,) 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 Â鶹ԭ´´F’s Research Ethics Policy.

Serious Adverse Events

• Reports serious violations of approved protocol to the IACUC 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 Â鶹ԭ´´F’s Research Ethics Policy

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.

 

Patents and Inventions

 

General Administrative

• Coordinates with OGCA and/or the Office of Intellectual Property and Commercialization (OIPC) 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 OIPC to assure proper patent protection.
• Coordinates with OPIC 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.

Department/Unit Administrator Roles and Responsibilities

 

Position Role

Department/Unit administrators are administrative staff that work at the departmental level and coordinate with the department head, Principal Investigators, and school, department, and central administration personnel to support and provide guidance on the administration of compliance, financial, personnel, and other related aspects of research projects.

Department administrators report to supervisors in the department such as a department head, business manager, division administrator, or Principal Investigator.

 

Sponsored Program Administration

 

General Administrative

• Coordinates with Principal Investigator, department head, and 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.
• Assists Principal Investigator and department head in administration and oversight of research and related activities.
• Assists Principal Investigator to assure 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.
• Cooperates 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

• Assists Principal Investigator in obtaining appropriate internal approvals and assures that proposals meet federal regulations and university and sponsoring agency policies and procedures prior to submitting proposal to sponsoring agency.

Proposal Budget

• Assists the Principal Investigator to prepare a categorized budget and justification and to confirm the accuracy and completeness of budgeted costs.

Protocol Preparation and Review

• Assists Principal Investigator to prepare, submit, or modify scientific protocol in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assists Principal Investigator to review protocol at inception and as required thereafter for completeness, accuracy, and improvement opportunities.
• Assists the department head in providing oversight for research protocols.

Award Acceptance (Terms and Conditions)

• Reviews the terms and conditions and accuracy of the award.
• Assists Principal Investigator to comply with and implement award terms and conditions and subcontract scope of work.
• Assists the Principal Investigator to prepare a revised categorized budget based on the actual award and the specific needs of the project.

Conduct of Research

• Assists Principal Investigator and department head to help ensure that research is conducted ethically and in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Â鶹ԭ´´F’s Research Ethics Policy..

Facilities and Administrative Cost Rate

• Coordinates with Principal Investigator, school, department, and central administration personnel to verify that the correct facilities and administrative (F&A) cost rate is applied to sponsored project budgets.

Space Management

• Assists Principal Investigator to appropriately and efficiently use space and to report the correct use of space to the department.
• Oversees renovation of research space and maintains and updates Space System data.

Equipment Management

• Assists Principal Investigator to obtain, maintain, and safeguard property used to conduct research in accordance with federal regulations and university and sponsoring agency policies and procedures.

Service Centers

• Assists Principal Investigator to develop, monitor, and administer service center rates in accordance with federal regulations and university and sponsoring agency policies and procedures.

Reporting

• Assists the Principal Investigator to comply with technical, progress, and compliance reporting requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.

Project Closeout

• Assists the Principal Investigator to submit 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

• Coordinates with school, department, and central administration​n personnel to assist Principal Investigator regarding the financial administration of project funds.
• Coordinates with Principal Investigator and school, department, and central administration personnel to determine whether project charges are allowable and allocable in accordance with Federal regulations and University and sponsoring agency policies and procedures.
• Assists the Principal Investigator to verify the authenticity and accuracy of expended funds.
• Processes financial transactions and reviews and analyzes sponsored projects financial reports.
• Reviews and approves financial transactions and other financial charges on projects to verify that costs are reasonable and transactions represent an appropriate allocation of costs in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assists Principal Investigator to assure 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.
• Cooperates with university compliance and monitoring efforts related to financial management and reports instances of noncompliance to the appropriate compliance office.

Cost Sharing

• Coordinates with Principal Investigator and school, department, and central administration personnel to identify and authorize appropriate cost-sharing obligations and expenditures.
• Processes and reviews cost sharing and cost matching transactions and documents funds sources.

Cost Transfer

• Assists Principal Investigator to determine whether cost transfer requests are allowable and allocable in accordance with federal regulations and university and sponsoring agency policies and procedures.

Reporting

• Assists Principal Investigator to comply with technical, progress, and compliance reporting requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.

Project Closeout

• Assists Principal Investigator to submit 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.
• Assists Principal Investigator to post project expenses to the fund in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Coordinates with Principal Investigator and school, department, and central administration personnel to initiate resolution to any cost overruns.
• Coordinates with the Principal Investigator and OGCA to complete and submit appropriate final closeout or transfer forms.

Effort Reporting

• Assists Principal Investigator to review, adjust, and certify Effort Certification Statements (ECSs) for all applicable personnel.
• Returns signed ECSs to OGCA in accordance with university policy.
• Assists Principal Investigator to assure 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.
• Cooperates 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 applicable school, university, and sponsoring agency conflict of interest policies and procedures.
• Discloses all significant financial conflicts of interest to the appropriate supervisor.
• Cooperates 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

• Assists Principal Investigator to protect the rights and welfare of human research participants in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assists Principal Investigator to assure 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.
• Cooperates 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

• Coordinates with Principal Investigator to provide accurate human research participant approval information for all submissions and correspondence to sponsoring agencies.
• Assists Principal Investigator to assure that any use of human research participants is disclosed and detailed in the scientific proposal.

Proposal Budget

• Assists Principal Investigator to verify that the proposal budget provides sufficient funds for compliance with federal regulations and university and sponsoring agency policies and procedures.
• Assists Principal Investigator to pay human research participants and/or cover their expenses as approved by the Human Research Protection Office (HRPO) Committee.

Protocol Preparation and Review

• Assists Principal Investigator to prepare and submit human research protocol or changes thereto in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assists Principal Investigator to obtain and maintain an approved human research protection protocol for the duration of the project.
• Documents accurate human studies protocol approval information.
• Assists Principal Investigator to review protocol at inception and as required thereafter for completeness, accuracy, and improvement opportunities.

Informed Consent

• Assists Principal Investigator to prepare and maintain all documentation related to the informed consent process.
• Assists Principal Investigator to submit informed consent documents to HRPO for review and approval.

Award Acceptance (Terms and Conditions)

• Assists Principal Investigator to verify that the 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

• Assists Principal Investigator to adhere to federal regulations and university and sponsoring agency policies and procedures.
• Assists Principal Investigator to conduct research in accordance with current, approved human studies protocol for the duration of the project.
• Assists Principal Investigator to adhere to all recommendations and conditions placed upon the research by ORI as required for the duration of the research.
• Assists Principal Investigator to respond to IRB Committee review findings and implement corrective measures suggested.
• Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Â鶹ԭ´´F’s Research Ethics Policy.

Protected Health Information

• Adheres to and supports all federal regulations and university policies and procedures instituted to safeguard protected health information (PHI).
• Assists Principal Investigator to assure 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.
• Cooperates 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

• Assists the Principal Investigator to promptly report any unanticipated problems involving risks to research participants or others to ORI (Â鶹ԭ´´F’s IRB).

Reporting

• Assists Principal Investigator to comply with technical, progress, and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures.

Project Closeout

• Assists Principal Investigator to submit 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.
• Coordinates with Principal Investigator 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

• Assists Principal Investigator to oversee the humane care and use of animals involved in research in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assists Principal Investigator to assure that all key personnel involved in animal research have completed the required education for the humane treatment of animals and laboratory safety and radioactive materials in accordance with federal, state, and local regulations, as well as university and sponsoring agency policies and procedures.
• Cooperates with university compliance and monitoring efforts related to animal welfare and reports instances of noncompliance to the appropriate compliance office.

Preparation of Scientific Proposal

• Coordinates with Principal Investigator to provide accurate animal studies approval information for all submissions and correspondence to sponsoring agencies.
• Assists Principal Investigator to assure that the use of animal subjects is disclosed and detailed in the scientific proposal.

Proposal Budget

• Assists Principal Investigator to verify that the proposal budget provides sufficient funds for compliance with federal regulations and university and sponsoring agency policies and procedures.

Protocol Preparation and Review

• Assists Principal Investigator to prepare animal studies protocol or changes thereto in accordance with Federal regulations and University and sponsoring agency policies and procedures.
• Assists Principal Investigator to obtain and maintain an approved animal studies protocol for the duration of the project.
• Documents accurate animal studies protocol approval information.
• Assists Principal Investigator to review protocol at inception and as required thereafter for completeness, accuracy, and improvement opportunities.

Award Acceptance (Terms and Conditions)

• Assists Principal Investigator to verify that the protocol complies with the terms and conditions of the award and that Institutional Animal Care and Use Committee (IACUC) protocol approval is in place prior to the acceptance of the award and the start of research.

Conduct of Research

• Assists Principal Investigator to adhere to federal regulations and university and sponsoring agency policies and procedures.
• Assists Principal Investigator to conduct research in accordance with current, approved animal studies protocol for the duration of the project.
• Assists Principal Investigator to adhere to all recommendations and conditions placed upon the study by the IACUC, 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 Â鶹ԭ´´F’s Research Ethics Policy.

Serious Adverse Events

• Assists Principal Investigator to report serious violations of approved protocol to the IACUC particularly any that may affect animal safety.

Reporting

• Assists Principal Investigator to comply with technical, progress, and compliance reporting requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.

Project Closeout

• Assists Principal Investigator to submit 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.
• Coordinates with Principal Investigator 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

• Assists Principal Investigator to adhere to all federal and state regulations and university and sponsoring agency policies and procedures instituted to protect the health and safety of research participants, personnel, and the environment.
• Assists Principal Investigator to assure that individuals handling hazardous or regulated materials are well trained in proper safety procedures and have completed required environmental health and safety education in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Assists department head in establishing and monitoring safety programs for department, center, or project.
• Assists Principal Investigator to support and comply with all Stop Work decisions.
• Cooperates 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

• Coordinates with Principal Investigator to provide accurate environmental health and safety information for all submissions and correspondence to sponsoring agencies.
• Assists Principal Investigator to verify that facilities and resources can be provided to adequately and safely implement the research proposal.

Proposal Budget

• Assists Principal Investigator to verify 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

• Assists Principal Investigator to identify hazards associated with project activities.
• Assists Principal Investigator to prepare environmental health and safety protocol in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Assists Principal Investigator to obtain and maintain an approved environmental health and safety protocols for the duration of the project.
• Assists Principal Investigator to review protocol at inception and as required thereafter for completeness, accuracy, and pollution prevention and health and safety improvement opportunities.

Award Acceptance (Terms and Conditions)

• Assists Principal Investigator to verify that the protocol complies with the terms and conditions of the award and that applicable environmental health and safety protocol approvals are in place prior to the acceptance of the award and the start of research.

Conduct of Research

• Assists Principal Investigator to adhere to all federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Assists Principal Investigator to conduct research in accordance with current, approved environmental health and safety protocol for the duration of the project.
• Coordinates with Principal Investigator and 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.
• Assists Principal Investigator to adhere to all recommendations and conditions placed upon the study by EHS and to assure 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 Â鶹ԭ´´F’s Research Ethics Policy.

Serious Adverse Events

• Assists Principal Investigator to promptly report 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.
• Assists Principal Investigator to take immediate and appropriate corrective actions and implement measures to prevent future occurrences.

Reporting

• Assists Principal Investigator to comply 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

• Assists Principal Investigator to submit 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.
• Assists Principal Investigator to comply with laboratory decommissioning and safety guideline requirements in accordance with federal and state local regulations and university and sponsoring agency policies and procedures.

 

Patents and Inventions

 

General Administrative

• Coordinates with Principal Investigator and/or the Office of Intellectual Property and Commercialization (OIPC) to disclose and report patent and invention information in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assists the Principal Investigator to promptly report all inventions to OIPC to assure proper patent protection.
• Assists the Principal Investigator to coordinate with OIPC on the preparation and prosecution of patents.
• Cooperates 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

• Verifies that the Principal Investigator has written confirmation of invention in accordance with university and sponsoring agency requirements.

 

Export Controls

 

General Administrative

• Assists the Principal Investigator to remain aware of and adhere to federal regulations and university policies and procedures related to export controls.
• Assists the Principal Investigator to assure that key personnel are well trained in federal regulations and university policies and procedures related to export controls.
• Assists Principal Investigator to disclose international exchanges of information, items, and/or activities as requested and to comply with recommended management strategies and restrictions.
• Cooperates with university compliance and monitoring efforts related to international exchanges of information, items, and/or activities and reports instances of noncompliance to the appropriate compliance office.