Export Control (Included when any of the following questions are "Yes" on the "Export" tab:

• "Will the project require access to classified facilities or classified information?"
• "Is the sponsor or prime sponsor a foreign entity?"
• "Does the project include payment to any foreign subrecipients or foreign consultants?"
• "Will there be any foreign visitors or unpaid foreign collaborators associated with this project?"
• "Other than technical reports, will the project involve the delivery of goods, materials or services to a foreign location or a foreign individual?"

Responsible Office: Office of Sponsored Programs (OSP)
Your responsibilities: Federal law prohibits or restricts the transfer of certain technology, materials, biologicals, software, technical data and/or services (collectively “Controlled Content”) to any foreign person or persons unless licensed, excepted or exempt for Export Control purposes. Such restrictions may apply to sharing or providing Controlled Content to any foreign sponsors, foreign collaborators, foreign subcontractors, or foreign participants (including internal PSU participants who are foreign persons under the law). If this project is funded, an export compliance review will be required due to the indication of certain export control triggers in the proposal materials. Additional review may be required as a result of the inclusion of certain export control triggers in the award terms. Prior to acceptance of the award agreement and any commencement of work under this proposal, you will be required to work with an OSP Export Specialist to determine if any additional restrictions or mitigation efforts are required on the operation of this project. Such efforts may effect both project personnel and/or performance spaces where project efforts can be performed. In some cases, it may be necessary to obtain either a license from the Government and/or prepare an internal security plan (Technology Control Plan – TCP) prior to commencement of efforts under this project. In particular, foreign visitors, foreign deliverables (other than technical reports), research performed abroad and/or other contractual based export compliance triggers are subject to review and approval by OSP at the time of award. Award acceptance will not be completed until all required export compliance items are resolved pursuant to University policies and guidelines.

Human Subjects (included when "Does this research involve interaction or intervention with human subjects or the use of identifiable private human subjects data?" is "Yes" on the "Human Subjects" tab)

Responsible Office: Office for Research Protections (ORP), Human Research Participant Protection Program
Your Responsibilities: You indicated that human subjects are involved in this project. Before Penn State will accept your award and you can begin your proposed research project, you must have an active, approved study or exemption by the Centralized Application Tracking System (CATS IRB). Prior to accepting your award, ORP will ensure that a study is active and applicable for your research. Information about IRB requirements, including training requirements, can be found in the Investigator Manual located in the General Tab of the Library within CATS IRB.

Animals (included when "Does this research involve interaction or intervention with animal subjects?" is "Yes" on the "Animal/Biosafety" tab)

Responsible Office (COM) : Institutional Animal Care and Use Committee (IACUC)
Responsible Office (UP and other campuses): Office for Research Protections (ORP), Institutional Animal Care and Use Committee (IACUC)

Before Penn State will accept your award and you can begin your proposed research project, the work must be covered under an approved Institutional Animal Care and Use Committee (IACUC) protocol (per RP04). If you have an active, approved protocol and your funding source is not listed on your IACUC protocol, use the activity “Create Amendment” in CATS IACUC to modify your protocol and add your funding source. “Submit” the amendment for review when ready. If the planned work is not yet covered by an approved IACUC protocol, please contact the IACUC Administrative Office for your campus to determine how to proceed:

• • For researchers at the College of Medicine/Hershey Medical Center, contact IACUC@pennstatehealth.psu.edu
  • For researchers at University Park and Other Campuses, orp-iacuc@psu.edu

Important Notice for Researchers at Penn State College of Medicine/Hershey Medical Center:
The IACUC now allows more than one grant per IACUC protocol, with the exception of DOD-funded work, as long as the scope of work is similar across grants. Please notify the IACUC Office of intent to associate multiple grant awards prior to combining on IACUC protocols, so that guidance can be provided.

Biosafety (included when "Does this research involve the use of any Biohazardous Materials as defined in Penn State Policy SY24, Use of Regulated and Biohazardous Materials in Research and Instruction?" is "Yes" on the "Animal/Biosafety" tab)

Responsible Office: Office for Research Protections (ORP), Animal, Biosafety, and Isotope Research Protection Program
Your Responsibilities: Before Penn State will accept your award and you can begin your proposed research project, you must have an approved study or exemption by the Institutional Biosafety Committee (IBC). If you have an active, approved study, there is nothing more to do. If you do not, to fill out the application, visit this page.

Radioactive Isotopes (included when "Does this research involve the use of radioactive materials?" is "Yes" on the "Radiation/Lab Safety" tab)

Responsible Office: Office for Research Protections (ORP), Animal, Biosafety, and Isotope Research Protection Program
Your Responsibilities: Before Penn State will accept your award and you can begin your proposed research project, you must have an approved study or exemption by the University Isotope Committee (UIC). If you have an active, approved study, there is nothing more to do. If you do not, to fill out the application, visit this page.

Conflict of Interest (included when the "Significant Financial Interests" question is "Yes" on the "Investigators" tab)

Responsible Office: Office for Research Protections (ORP), Conflict of Interest Program
Your responsibilities: Before your proposal was submitted, you should have confirmed that you have disclosed all significant financial interests related to your institutional responsibilities via the Financial Disclosure Form on the Conflict Of INterest System (COINS). Your Financial Disclosure will be reviewed by the University and, if the University determines a financial conflict of interest exists with the proposed research, then the conflict must also be managed or eliminated, and you must agree in writing to the management or elimination of the conflict, before Penn State can accept the award. Depending on the nature of the conflict, it may be necessary to implement a management plan, which can include provisions such as reporting the conflict and the agreed upon management to the sponsor (and other relevant parties), research monitoring and/or divestiture of certain significant financial interests.

Intellectual Property (included when the "Does the project require the use of any Penn State background intellectual property?" question is "Yes" on the "Investigators" tab)

Responsible Office:Office of Sponsored Programs (OSP)
Your responsibilities:If a project involves use of previously developed intellectual property (i.e., Background IP), it may be necessary to secure licenses prior to beginning work on the project. If project personnel are interested in retaining ownership of newly developed intellectual property (i.e., Foreground IP), it will be necessary to assert such rights prior to signing a contract. More information on this process can be found here.

Duplicate Proposals (included when the "Is this proposal currently pending with another sponsor?" question is "Yes" on the "Investigators" tab)

Responsible Office: Office of Sponsored Programs (OSP) or your College Research Office
Your Responsibilities: All sponsors must be informed of duplicative submissions. In many cases, a sponsor will not consider a proposal if it is being considered for funding by another sponsor. Contact the responsible office if you are notified that one of the duplicate proposals is funded. It is generally necessary to withdraw one of the duplicate proposals if the other proposal is funded.

Export Control (Included when any of the following questions are "Yes" on the "Export" tab:

• "Will the project require access to classified facilities or classified information?"
• "Is the sponsor or prime sponsor a foreign entity?"
• "Does the project include payment to any foreign subrecipients or foreign consultants?"
• "Will there be any foreign visitors or unpaid foreign collaborators associated with this project?"
• "Other than technical reports, will the project involve the delivery of goods, materials or services to a foreign location or a foreign individual?"

Responsible Office: Office of Research Affairs (ORA)
Your responsibilities: Federal law prohibits or restricts the transfer of certain technology, materials, biologicals, software, technical data and/or services (collectively “Controlled Content”) to any foreign person or persons unless licensed, excepted or exempt for Export Control purposes. Such restrictions may apply to sharing or providing Controlled Content to any foreign sponsors, foreign collaborators, foreign subcontractors, or foreign participants (including internal PSU participants who are foreign persons under the law). If this project is funded, an export compliance review will be required due to the indication of certain export control triggers in the proposal materials. Additional review may be required as a result of the inclusion of certain export control triggers in the award terms. Prior to acceptance of the award agreement and any commencement of work under this proposal, you will be required to work with an OSP Export Specialist to determine if any additional restrictions or mitigation efforts are required on the operation of this project. Such efforts may effect both project personnel and/or performance spaces where project efforts can be performed. In some cases, it may be necessary to obtain either a license from the Government and/or prepare an internal security plan (Technology Control Plan – TCP) prior to commencement of efforts under this project. In particular, foreign visitors, foreign deliverables (other than technical reports), research performed abroad and/or other contractual based export compliance triggers are subject to review and approval by OSP at the time of award. Award acceptance will not be completed until all required export compliance items are resolved pursuant to University policies and guidelines.

Human Subjects (included when "Does this research involve interaction or intervention with human subjects or the use of identifiable private human subjects data?" is "Yes" on the "Human Subjects" tab)

Responsible Office: Human Subjects Protection Office (HSPO)
Your Responsibilities: You indicated that human subjects are involved in this project. Before Penn State will accept your award and you can begin your proposed research project, you must have an active, approved study or exemption by the Centralized Application Tracking System (CATS IRB). Prior to accepting your award, HSPO will ensure that a study is active and applicable for your research. Information about IRB requirements, including training requirements, can be found in the Investigator Manual located in the General Tab of the Library within CATS IRB.

Animals (included when "Does this research involve interaction or intervention with animal subjects?" is "Yes" on the "Animal/Biosafety" tab)

Your Responsibilities: You indicated that animal subjects are involved in this project. Before Penn State will accept your award and you can begin your proposed research project, the work must be covered under an approved Institutional Animal Care and Use Committee (IACUC) protocol (per RP04). If you have an active, approved protocol and your funding source is not listed on your IACUC protocol, use the activity “Create Amendment” in CATS IACUC to modify your protocol and add your funding source. “Submit” the amendment for review when ready. If the planned work is not yet covered by an approved IACUC protocol, please contact the IACUC Administrative Office for your campus to determine how to proceed:

• For researchers at the College of Medicine/Hershey Medical Center, contact IACUC@pennstatehealth.psu.edu
• For researchers at University Park and Other Campuses, contact orp-iacuc@psu.edu

Important Notice for Researchers at Penn State College of Medicine/Hershey Medical Center:
Please be reminded that there is a one IACUC protocol per grant policy. A new IACUC protocol must be submitted for association with a new funding source if the current IACUC protocol is already associated with a different external funding award. Please include associated award documents to the Funding Sources page of the protocol. Contact the IACUC Administrative Office with any questions.

Biosafety (included when "Does this research involve the use of any Biohazardous Materials as defined in Penn State Policy SY24, Use of Regulated and Biohazardous Materials in Research and Instruction?" is "Yes" on the "Animal/Biosafety" tab)

Responsible Office: Research Quality Assurance (RQA)
Your Responsibilities: Before Penn State will accept your award and you can begin your proposed research project, you must have an active, approved study or exemption by the Biosafety and Recombinant DNA Subcommittee. Prior to accepting your award, RQA will ensure that the study is active and applicable for your research.

Radioactive Isotopes (included when "Does this research involve the use of radioactive materials?" is "Yes" on the "Radiation/Lab Safety" tab)

Responsible Office: Subcommittee on Human Use of Radioisotopes (HUIC)
Your Responsibilities: You indicated that radioactive isotopes are involved in this project. Before Penn State will accept your award and you can begin your proposed research project, you must have an approved study or exemption by the University Isotope Committee (HUIC). Prior to accepting your award, HUIC will ensure that the study is active and applicable for your research.

Conflict of Interest (included when the "Significant Financial Interests" question is "Yes" on the "Investigators" tab)

Responsible Office: Office of Administration, Conflict of Interest Program
Your responsibilities: Before your proposal was submitted, you should have confirmed that you have disclosed all significant financial interests related to your institutional responsibilities via the Financial Disclosure Form on the Conflict Of INterest System (COINS). Your Financial Disclosure will be reviewed by the University and, if the University determines a financial conflict of interest exists with the proposed research, then the conflict must also be managed or eliminated, and you must agree in writing to the management or elimination of the conflict, before Penn State can accept the award. Depending on the nature of the conflict, it may be necessary to implement a management plan, which can include provisions such as reporting the conflict and the agreed upon management to the sponsor (and other relevant parties), research monitoring and/or divestiture of certain significant financial interests.

Duplicate Proposals (included when the "Is this proposal currently pending with another sponsor?" question is "Yes" on the "Investigators" tab)

Responsible Office: Office of Research Affairs (ORA)
Your Responsibilities: All sponsors must be informed of duplicative submissions. In many cases, a sponsor will not consider a proposal if it is being considered for funding by another sponsor. Contact the responsible office if you are notified that one of the duplicate proposals is funded. It is generally necessary to withdraw one of the duplicate proposals if the other proposal is funded.