Investigator Responsibilities

• Coordinate with unit staff and Research & Graduate Studies (RGS) personnel to help ensure that research and sponsored project activities are conducted in accordance with federal regulations and PSU and sponsor policies and procedures

• Administer and oversee research project activities and ensure the scientific integrity of the project

• Assure that all key personnel involved in the project have met training requirements in accordance with federal regulations, PSU and sponsor policies and procedures

• Oversee the project 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

• Support and endorse cooperation with research compliance and monitoring efforts and report instances of noncompliance to the appropriate office

• Adhere to record retention policy for all financial and scientific documentation

• Take 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

• Disclose potential conflicts of interest and conflicts of commitments in accordance with PSU and sponsor requirements

• Disclose project inventions and comply with University intellectual property policy

• Adhere to all federal, state, and local regulations and university and sponsor policies and procedures instituted to protect the health and safety of research participants, personnel, and the environment

• Attend offered trainings and outreach sessions

• Seek and maintain approvals to adhere to applicable compliance requirements related to research activities

• Prepare and submit protocols for research involving human subjects, animal use, and biosafety hazards to the appropriate PSU oversight program & committee:

  • Human Research Protection Program (HRPP) & Institutional Review Board (IRB)

  • Animal Care & Use Program & Institutional Animal Care & Use Committee (IACUC)

  • Biosafety Program & Institutional Biosafety Committee (IBC)

Human Subjects Research

• Comply with the Code of Federal Regulations regarding the protection of human subjects and PSU Policy

• Protect the rights and welfare of all human subjects and conduct all research according to the approved protocol

• Retain all data and signed consent documents for at least 3 years beyond the completion of the research (or longer if required by funding agency)

• Ensure that each potential participant understands the nature of the research and ensure that the correct procedures are followed to gain informed consent from each person prior to participation

• Provide each participant with a copy of the HRPP-approved consent document, unless waived by the IRB

• Ensure all research personnel, including faculty advisors, have completed required CITI training and the certificate of completion is current (within the last three years)

• Promptly report any unanticipated problems involving risks to research participants or others to the HRPP

Animal Care & Use

• Ensure any proposed animal research is not unnecessarily duplicative

• Oversee the humane care and use of animals involved in research in accordance with federal regulations and PSU and sponsor policies and procedures

• Report serious violations of approved protocol to the Animal Care and Use Program or IACUC, particularly any that may affect animal safety

• Ensure all animal research personnel are properly trained prior to working with animals in all areas relevant to their assigned work

• Discomfort of animals will be limited to that which is unavoidable and analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize pain and discomfort

• Notify the IACUC of any unexpected results that adversely impact research animals and report any unanticipated pain or distress, morbidity or mortality the the Consulting Veterinarian

• Request IACUC approval for the changes PRIOR to implementation; failure to report significant changes may be a violation of regulations and may result in suspension of animal activities

• Assure all procedures described in the approved protocol are consistent with the grant statement of work, if funded

International Research Security

• Disclose international exchanges of information, items, and/or activities as requested

• Understand and comply with the terms and conditions of agreements related to Export Controls, publication restrictions, and foreign national participation

• Consult with PSU's Export Control Officer prior to engaging in activities that may trigger export controls and cooperate with efforts to determine the applicability of export controls

• Consult PSU's Export Control Officer when an export is contemplated

• Comply with recommended management strategies, export controls or other restrictions

• Report suspected violations of export controls

Data Security

• Be aware of and comply with PSU's Information Security Policy

• Seek out authorized parties in RGS to execute data use agreements and similar instruments

• Comply with any requirements of applicable data use agreements and similar instruments

• Carry out the requirements of applicable PSU Data Security Plans

Biological Safety

• Conduct research involving rDNA, infectious agents or other biological hazards in accordance with federal regulations and PSU and sponsor policies and procedures

• Maintain a current record of any transfer of recombinant DNA, vectors, or host strains containing recombinant DNA or infectious agents between investigators at this or other institutions

• Follow federal requirements to ensure all laboratory personnel have received required training related to shipping biological materials, as applicable

• Ensure all laboratory and support personnel are properly trained in the practices and techniques required for safety, and supervise the safety performance of personnel to affirm that required safety practices and techniques are employed

• Inform Institutional Biosafety Program if changes will be made to approved experiments involving biohazards

Proposal Development & Submission

• Notify Sponsored Projects Administration (SPA) at the onset of the proposal development process and work with SPA to develop proposals in accordance with sponsor, PSU, and other applicable policies (no later than 3 weeks/15 working days) prior to sponsor deadline or target date

• Read program solicitation and work with SPA to adhere to sponsor proposal requirements

• Work with SPA to adhere to general timeline and specific deadlines required in order to meet general and special submission requirements, develop and compile proposal components

• Provide reasonable estimates of percent of effort and other expenses necessary to carry out the proposed project, including effort related to cost sharing commitments

• Make key budgetary decisions and verify that budgets and cost estimates are sufficient to carry out the proposed project scope

• Identify subrecipients and review and approve subrecipient proposals included in PSU's proposal submitted to the sponsor

• Prepare and compile required proposal components and forms and either submit to SPA or upload in sponsor's electronic system

• Secure resource commitments and required internal approvals following PSU’s process prior to submission of the proposal

• Prepare and compile information requested from the sponsor prior to issuance of award (i.e. "Just-In-Time requests" for updated current & pending support forms, compliance certification letters, etc.) and submit to SPA for review and submission

Sponsored Award Management

• Recognize Portland State University as the recipient of awards

• Read award document and materials provided by SPA related to sponsor policies and regulations, special requirements, and/or restrictions

• Comply with terms of award, corresponding federal regulations, and university and sponsor policies and procedures and oversee administration of project funds

• Oversee the project 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

• Communicate with SPA staff for guidance regarding special terms and conditions, adherence to the award terms and conditions, as well as sponsor and PSU policy

• Coordinate with staff that place orders for sponsored project expenses [orders can be placed directly with vendor, p-card, purchase order or formal procurement process]

• Review and approve payroll documents and purchase requests in PSU approval systems and authorize payment of invoices [expenditure transaction types include but are not limited to: letters of offer, labor distributions, travel authorizations/reimbursements, consulting agreements (PSCs), purchase orders, supply orders, etc.]

• Approve outgoing subrecipient agreements and related invoices

• Coordinate with unit heads and SPA to identify and authorize cost sharing obligations and expenditures

• Review monthly reports of budget and expenditure activity to verify the authenticity and accuracy of expended funds and communicate identified errors to SPA

• Coordinate with SPA staff to determine whether the project charges are allowable and allocable in accordance with federal regulations, PSU, and sponsor policies and procedures

• Prepare and submit program/technical reports, deliverables, and other required reports

• Review effort reports to determine if actual effort reasonably corresponds to payroll distribution charges

• Work with SPA to obtain appropriate sponsor prior approvals for significant changes as required by award terms and sponsor regulations

• Submit accurate and timely closeout information, reports, and documents to SPA and sponsor in accordance with PSU and sponsor policy