Common use of Radioactive Materials Clause in Contracts

Radioactive Materials. Research Project Awardees shall assure compliance with the provisions of Title 10 CFR 21. This regulation establishes procedures and requirements for implementation of Section 206 of the Energy Reorganization Act of 1974. Recombinant DNA. By signing the award or accepting funds under the award, you assure that all work involving the use of recombinant DNA will be in compliance with guidance provided at ▇▇▇▇▇://▇▇▇.▇▇.▇▇▇.▇▇▇/biotechnology/biosafety-and-recombinant-dna-activities/ Environmental Liability. The Research Project Awardee is responsible for achieving compliance with all environmental laws applicable to the work performed under this Agreement, including but not limited to any licenses and permit applications required under Federal, State, or local laws or regulations. The Research Project Awardee shall not name the United States, the Department of Army (DA), or any other Government agency, instrumentality or employee as an owner, operator or in any other capacity on any license or permit application required under environmental laws unless written consent is first obtained from an authorized agent of the Federal agency or instrumentality to be named. Prohibition of Use of Human Cadavers. Research, development, testing and evaluation (RDT&E), education or training activities involving human cadaveric specimens (with the exception of activities solely using established/existing human cadaveric cell lines) under a Research Project Award shall not begin until approval is granted in accordance with the Army Policy for Use of Human Cadavers for RDT&E, Education, or Training, November 2019 (▇▇▇▇▇://▇▇▇▇.▇▇▇▇▇▇.▇▇▇/assets/docs/orp/Army_Policy_for_Use_of_Human_Cadavers.pdf ). The USAMRDC Office Human and Amimal Research Oversight (OHARO) is the Action office for this policy. Approval must be obtained from the USAMRDC OHARO. Research Project Awardees must coordinate with the supporting/funding Army organization to ensure that proper approvals are obtained. OHARO will issue written approvals to begin under separate notification to the Research Project Awardee, a copy of which shall be provided to the appointed SOTR. Written approval to proceed from the USAMRDC OHARO is also required for any subaward that will use funds from a Research Project Award to conduct RDT&E, education or training involving human cadaveric specimens. The Research Project Awardee must promptly report problems related to the conduct of the activity involving cadavers or the procurement, inventory, use, storage, transfer, transportation, and disposition of cadavers to the appointed SOTR who informs USAMRDC OHARO. The Research Project Awardee must maintain complete records of the activity. The USAMRDC or designees must be permitted to observe the activity upon request and/or audit activity records to ensure compliance with the approved protocol or applicable regulatory requirements. Non-compliance with these terms and conditions may result in withholding of funds and/or the termination of the award. Prohibition of Use of Human Subjects. Research under this Agreement or Research Project Awards involving the use of human subjects, to include research involving the secondary use of human biospecimens and/or human data, cannot begin until the USAMRDC’s Office of Human Research Oversight (OHRO) provides authorization that the research may proceed. The USAMRDC OHRO will issue written approval to begin research under separate notification to the Research Project Awardee, a copy of which shall be provided to the appointed SOTR. Written approval to proceed from the USAMRDC OHRO is also required for any Research Project Awardee (or lower tier subawards) that will use funds from this award to conduct research involving human subjects, human biospecimens, and/or human data. *This prohibition does not apply to research under this award that solely uses only one or more of the following types of human biospecimens to accomplish its aims: (1) established/existing commercially available human cell lines; (2) established/existing patient-derived xenograft (PDX) models; (3) commercially available human organoids; (4) commercially procured pooled human biospecimens. The USAMRDC OHRO conducts site visits as part of its responsibility for compliance oversight. Recipients and subrecipients must comply with all applicable human research protections requirements. Accurate and complete study records must be maintained and made available to representatives of the USAMRDC as a part of their responsibility to protect human subjects in research. Research records must be stored in a confidential manner so as to protect the confidentiality of subject information. The Research Project Awardee and any lower tier subawardees are required to adhere to the following reporting requirements: Submission of study documents to the USAMRDC OHRO for review and approval and provide the following reports: substantive modifications to the approved protocol, continuing review documentation (if applicable), and the final report as outlined in the USAMRDC OHRO approval memorandum. Unanticipated problems involving risks to subjects or others, in the research, clinical holds (voluntary or involuntary), and suspension or termination of this research by the IRB, the institution, the Sponsor, or regulatory agencies, must be promptly reported to the USAMRDC OHRO, copying the CM and SOTR. Change in subject status when a previously enrolled human subject becomes a prisoner must be promptly reported to the USAMRDC OHRO. The report must include actions taken by the institution and the IRB. The knowledge of any pending compliance inspection/visits by the FDA, OHARO, or other government agency concerning this clinical investigation or research, the issuance of Inspection Reports, FDA Form 483, warning letters or actions taken by any Regulatory Agencies, and any instances of serious or continuing noncompliance with regulatory requirements (federal regulations or IRB requirements) that relate to this clinical investigation or research, must be reported immediately to the USAMRDC OHARO. Non-compliance with these terms and conditions may result in withholding of funds and/or the termination of the award. Submission instructions and investigator guidance on DoD requirements for human subjects research, including 32 CFR Part 219, DoD Instruction 3216.02, and USAMRDC Office of Human Research Oversight (OHRO) submission instructions can be accessed at ▇▇▇▇▇://▇▇▇▇.▇▇▇▇▇▇.▇▇▇/▇▇▇▇▇.▇▇▇/collaborate/research_protections/hrpo. Prohibition of Use of Animals Notwithstanding any other terms and conditions contained in this Agreement or incorporated by reference herein, Research Project Awardees (or lower tier subawards) are expressly forbidden to use laboratory animals in any manner whatsoever without the express written approval of the USAMRDC, Animal Care and Use Review Office (ACURO). Written authorization to begin research under the applicable protocol(s) proposed for Research Project Award(s) will be issued in the form of an approval letter from the USAMRDC ACURO. Furthermore, modifications to already approved protocols require approval by ACURO to the Research Project Awardee(s), a copy of which shall be provided to the appointed SOTR. Furthermore, modifications to already approved protocols require approval by ACURO prior to implementation. For each fiscal year, the Research Project Awardee must maintain, and upon request from ACURO, submit animal usage information. The Research Project Awardee must promptly inform the USMRDC ACURO of adverse events regarding animals under applicable protocol(s) associated with this agreement. These requirements are defined in the approval letter from the USAMRDC ACURO. Non-compliance with any of these terms and conditions may result in withholding of funds and/or the termination of the Research Project Award. The Animal Care and Use Office requirements can be accessed at ▇▇▇▇▇://▇▇▇▇.▇▇▇▇▇▇.▇▇▇/▇▇▇▇▇.▇▇▇/collaborate/research_protections/acuro Principal Investigator. Each Research Project Award shall identify a Principal Investigator. This individual shall be continuously responsible for the conduct of the research project. The Research Project Awardee, through the CM, shall obtain the AO’s approval to change the Principal Investigator or to continue the research work during a continuous period in excess of three months without the participation of an approved Principal Investigator. Each Research Project Award is based upon the Principal Investigator devoting a defined percentage of effort to the project over the term of the Research Project Award. The Research Project Awardee shall advise the AO if the Principal Investigator will, or plans to, revise the level of effort estimated in the Research Project Proposal. A curriculum vitae shall be provided for professional associates added to the research project or substituted during the course of work.

Radioactive Materials. Research Project Awardees shall assure compliance with the provisions of Title 10 CFR 21. This regulation establishes procedures and requirements for implementation of Section 206 of the Energy Reorganization Act of 1974. Recombinant DNA. By signing the award or accepting funds under the award, you assure that all work involving the use of recombinant DNA will be in compliance with guidance provided at ▇▇▇▇▇://▇▇▇.▇▇.▇▇▇.▇▇▇/biotechnology/biosafety-and-recombinant-dna-activities/ Environmental Liability. The Research Project Awardee is responsible for achieving compliance with all environmental laws applicable to the work performed under this Agreement, including but not limited to any licenses and permit applications required under Federal, State, or local laws or regulations. The Research Project Awardee shall not name the United States, the Department of Army (DA), or any other Government agency, instrumentality or employee as an owner, operator or in any other capacity on any license or permit application required under environmental laws unless written consent is first obtained from an authorized agent of the Federal agency or instrumentality to be named. Prohibition of Use of Human Cadavers. Research, development, testing and evaluation (RDT&E), education or training activities involving human cadaveric specimens (with the exception of activities solely using established/existing human cadaveric cell lines) under a Research Project Award shall not begin until approval is granted in accordance with the Army Policy for Use of Human Cadavers for RDT&E, Education, or Training, November 2019 20 April 2012 (▇▇▇▇▇://▇▇▇▇.▇▇▇▇▇.▇▇▇▇.▇▇▇/assets/docs/orp/Army_Policy_for_Use_of_Human_Cadavers.pdf ▇▇▇▇▇.▇▇▇?pageid=research_protections.overview ). The USAMRDC Office Human and Amimal Research Oversight (OHARO▇▇.▇▇▇▇@▇▇▇▇.▇▇▇) is the Action office for this policy. Approval must be obtained from the USAMRDC OHAROORP. Research Project Awardees must coordinate with the supporting/funding Army organization to ensure that proper approvals are obtained. OHARO ORP will issue written approvals to begin under separate notification to the Research theResearch Project Awardee, a copy of which shall be provided to the appointed SOTR. Written approval to proceed from the USAMRDC OHARO ORP is also required for any subaward that will use funds from a Research Project Award to conduct RDT&E, education or training involving human cadaveric specimens. The Research Project Awardee must promptly report problems related to the conduct of the activity involving cadavers or the procurement, inventory, use, storage, transfer, transportation, and disposition of cadavers to the appointed SOTR who informs USAMRDC OHAROORP. The Research Project Awardee must maintain complete records of the activity. The USAMRDC or designees must be permitted to observe the activity upon request and/or audit activity records to ensure compliance with the approved protocol or applicable regulatory requirements. Non-compliance with these terms and conditions may result in withholding of funds and/or the termination of the award. Prohibition of Use of Human Subjects. Research under this Agreement or Research Project Awards involving the use of human subjects, to include research involving the secondary use of human biospecimens and/or human data, cannot begin until the USAMRDC’s Office of Human Research Oversight (OHRO) ORP provides authorization that the research may proceed. The USAMRDC OHRO ORP will issue written approval to begin research under separate notification to the Research Project Awardee, a copy of which shall be provided to the appointed SOTR. Written approval to proceed from the USAMRDC OHRO ORP is also required for any Research Project Awardee (or lower tier subawards) that will use funds from this award to conduct research involving human subjects, human biospecimens, and/or human data. *This prohibition does not apply to research under this award that solely uses only one or more of the following types of human biospecimens to accomplish its aims: (1) established/existing commercially available human cell lines; (2) established/existing patient-derived xenograft (PDX) models; (3) commercially available human organoids; (4) commercially procured pooled human biospecimens. The USAMRDC OHRO ORP conducts site visits as part of its responsibility for compliance oversight. Recipients and subrecipients must comply with all applicable human research protections requirements. Accurate and complete study records must be maintained and made available to representatives of the USAMRDC as a part of their responsibility to protect human subjects in research. Research records must be stored in a confidential manner so as to protect the confidentiality of subject information. The Research Project Awardee and any lower tier subawardees are is required to adhere to the following reporting requirements: Submission of study documents to the USAMRDC OHRO for review and approval and provide the following reports: substantive modifications to the approved protocol, continuing review documentation (if applicable)documentation, and the final report as outlined in the USAMRDC OHRO ORP approval memorandum. Unanticipated problems involving risks to subjects or others, subject deaths related to participation in the research, clinical holds (voluntary or involuntary), and suspension or termination of this research by the IRB, the institution, the Sponsor, or regulatory agencies, must be promptly reported to the USAMRDC OHRO, copying the CM and SOTR. ORP Change in subject status when a previously enrolled human subject becomes a prisoner must be promptly reported to the USAMRDC OHRO. The report must include actions taken by the institution and the IRBORP HRPO. The knowledge of any pending compliance inspection/visits by the FDA, OHAROORP, or other government agency concerning this clinical investigation or research, the issuance of Inspection Reports, FDA Form 483, warning letters or actions taken by any Regulatory Agencies, and any instances of serious or continuing noncompliance with regulatory requirements (federal regulations or IRB requirements) that relate to this clinical investigation or research, must be reported immediately to the USAMRDC OHAROORP. Non-compliance with these terms and conditions may result in withholding of funds and/or the termination of the award. Submission instructions and investigator guidance on DoD requirements for human subjects research, including 32 CFR Part 219, DoD Instruction 3216.02, and USAMRDC Office of ORP Human Research Oversight (OHRO) Protection Office submission instructions can be accessed at ▇▇▇▇▇://▇▇▇▇.▇▇▇▇▇.▇▇▇▇.▇▇▇/▇▇▇▇▇.▇▇▇/collaborate/research_protections/hrpo?pageid=research_protections.hrpo. Prohibition of Use of Laboratory Animals Notwithstanding any other terms and conditions contained in this Agreement or incorporated by reference herein, Research Project Awardees (or lower tier subawards) are expressly forbidden to use laboratory animals in any manner whatsoever without the express written approval of the USAMRDC, Animal Care and Use Review Office (ACURO). Written authorization to begin research under the applicable protocol(s) proposed for Research Project Award(s) will be issued in the form of an approval letter from the USAMRDC ACURO. Furthermore, modifications to already approved protocols require approval by ACURO to the Research Project Awardee(s), a copy of which shall be provided to the appointed SOTR. Furthermore, modifications to already approved protocols require approval by ACURO prior to implementation. For each fiscal year, the a Research Project Awardee must maintain, and upon request from ACURO, submit animal usage information. The Research Project Awardee must promptly inform the USMRDC ACURO of adverse events regarding animals under applicable protocol(s) associated with this agreement. These requirements are defined in the approval letter from the USAMRDC ACURO. Non-compliance with any of these terms and conditions may result in withholding of funds and/or the termination of the Research Project Award. The Animal Care and Use Office requirements can be accessed at ▇▇▇▇▇://▇▇▇▇.▇▇▇▇▇.▇▇▇▇.▇▇▇/▇▇▇▇▇.▇▇▇/collaborate/research_protections/acuro Principal Investigator. Each Research Project Award shall identify a Principal Investigator. This individual shall be continuously responsible for the conduct of the research project. The Research Project Awardee, through the CM, shall obtain the AO’s approval to change the Principal Investigator or to continue the research work during a continuous period in excess of three months without the participation of an approved Principal Investigator. Each Research Project Award is based upon the Principal Investigator devoting a defined percentage of effort to the project over the term of the Research Project Award. The Research Project Awardee shall advise the AO if the Principal Investigator will, or plans to, revise the level of effort estimated in the Research Project Proposal. A curriculum vitae shall be provided for professional associates added to the research project or substituted during the course of work?pageid=research_protections.acuro.

Radioactive Materials. Research Project Awardees shall assure compliance with the provisions of Title 10 CFR 21. This regulation establishes procedures and requirements for implementation of Section 206 of the Energy Reorganization Act of 1974. Recombinant DNA. By signing the award or accepting funds under the award, you assure that all work involving the use of recombinant DNA will be in compliance with guidance provided at ▇▇▇▇▇://▇▇▇.▇▇.▇▇▇.▇▇▇/biotechnology/biosafety-and-recombinant-dna-activities/ Environmental Liability. The Research Project Awardee is responsible for achieving compliance with all environmental laws applicable to the work performed under this Agreement, including but not limited to any licenses and permit applications required under Federal, State, or local laws or regulations. The Research Project Awardee shall not name the United States, the Department of Army (DA), or any other Government agency, instrumentality or employee as an owner, operator or in any other capacity on any license or permit application required under environmental laws unless written consent is first obtained from an authorized agent of the Federal agency or instrumentality to be named. Prohibition of Use of Human Cadavers. Research, development, testing and evaluation (RDT&E), education or training activities involving human cadaveric specimens (with the exception of activities solely using established/existing human cadaveric cell lines) under a Research Project Award shall not begin until approval is granted in accordance with the Army Policy for Use of Human Cadavers for RDT&E, Education, or Training, November 2019 20 April 2012 (▇▇▇▇▇://▇▇▇▇.▇▇▇▇▇.▇▇▇▇.▇▇▇/assets/docs/orp/Army_Policy_for_Use_of_Human_Cadavers.pdf ▇▇▇▇▇.▇▇▇?pageid=research_protections.overview ). The USAMRDC Office Human and Amimal Research Oversight (OHARO▇▇.▇▇▇▇@▇▇▇▇.▇▇▇) is the Action office for this policy. Approval must be obtained from the USAMRDC OHAROORP. Research Project Awardees must coordinate with the supporting/funding Army organization to ensure that proper approvals are obtained. OHARO ORP will issue written approvals to begin under separate notification to the Research theResearch Project Awardee, a copy of which shall be provided to the appointed SOTR. Written approval to proceed from the USAMRDC OHARO ORP is also required for any subaward that will use funds from a Research Project Award to conduct RDT&E, education or training involving human cadaveric specimens. The Research Project Awardee must promptly report problems related to the conduct of the activity involving cadavers or the procurement, inventory, use, storage, transfer, transportation, and disposition of cadavers to the appointed SOTR who informs USAMRDC OHAROORP. The Research Project Awardee must maintain complete records of the activity. The USAMRDC or designees must be permitted to observe the activity upon request and/or audit activity records to ensure compliance with the approved protocol or applicable regulatory requirements. Non-compliance with these terms and conditions may result in withholding of funds and/or the termination of the award. Prohibition of Use of Human Subjects. Research under this Agreement or Research Project Awards involving the use of human subjects, to include research involving the secondary use of human biospecimens and/or human data, cannot begin until the USAMRDC’s Office of Human Research Oversight (OHRO) ORP provides authorization that the research may proceed. The USAMRDC OHRO ORP will issue written approval to begin research under separate notification to the Research Project Awardee, a copy of which shall be provided to the appointed SOTR. Written approval to proceed from the USAMRDC OHRO ORP is also required for any Research Project Awardee (or lower tier subawards) that will use funds from this award to conduct research involving human subjects, human biospecimens, and/or human data. *This prohibition does not apply to research under this award that solely uses only one or more of the following types of human biospecimens to accomplish its aims: (1) established/existing commercially available human cell lines; (2) established/existing patient-derived xenograft (PDX) models; (3) commercially available human organoids; (4) commercially procured pooled human biospecimens. The USAMRDC OHRO ORP conducts site visits as part of its responsibility for compliance oversight. Recipients and subrecipients must comply with all applicable human research protections requirements. Accurate and complete study records must be maintained and made available to representatives of the USAMRDC as a part of their responsibility to protect human subjects in research. Research records must be stored in a confidential manner so as to protect the confidentiality of subject information. The Research Project Awardee and any lower tier subawardees are is required to adhere to the following reporting requirements: Submission of study documents to the USAMRDC OHRO for review and approval and provide the following reports: substantive modifications to the approved protocol, continuing review documentation (if applicable)documentation, and the final report as outlined in the USAMRDC OHRO ORP approval memorandum. Unanticipated problems involving risks to subjects or others, subject deaths related to participation in the research, clinical holds (voluntary or involuntary), and suspension or termination of this research by the IRB, the institution, the Sponsor, or regulatory agencies, must be promptly reported to the USAMRDC OHRO, copying the CM and SOTR. ORP Change in subject status when a previously enrolled human subject becomes a prisoner must be promptly reported to the USAMRDC OHRO. The report must include actions taken by the institution and the IRBORP HRPO. The knowledge of any pending compliance inspection/visits by the FDA, OHAROORP, or other government agency concerning this clinical investigation or research, the issuance of Inspection Reports, FDA Form 483, warning letters or actions taken by any Regulatory Agencies, and any instances of serious or continuing noncompliance with regulatory requirements (federal regulations or IRB requirements) that relate to this clinical investigation or research, must be reported immediately to the USAMRDC OHAROORP. Non-compliance with these terms and conditions may result in withholding of funds and/or the termination of the award. Submission instructions and investigator guidance on DoD requirements for human subjects research, including 32 CFR Part 219, DoD Instruction 3216.02, and USAMRDC Office of ORP Human Research Oversight (OHRO) Protection Office submission instructions can be accessed at ▇▇▇▇▇://▇▇▇▇.▇▇▇▇▇▇.▇▇▇/▇▇▇▇▇.▇▇▇/collaborate/research_protections/hrpo. Prohibition of Use of Animals Notwithstanding any other terms and conditions contained in this Agreement or incorporated by reference herein, Research Project Awardees (or lower tier subawards) are expressly forbidden to use laboratory animals in any manner whatsoever without the express written approval of the USAMRDC, Animal Care and Use Review Office (ACURO). Written authorization to begin research under the applicable protocol(s) proposed for Research Project Award(s) will be issued in the form of an approval letter from the USAMRDC ACURO. Furthermore, modifications to already approved protocols require approval by ACURO to the Research Project Awardee(s), a copy of which shall be provided to the appointed SOTR. Furthermore, modifications to already approved protocols require approval by ACURO prior to implementation. For each fiscal year, the Research Project Awardee must maintain, and upon request from ACURO, submit animal usage information. The Research Project Awardee must promptly inform the USMRDC ACURO of adverse events regarding animals under applicable protocol(s) associated with this agreement. These requirements are defined in the approval letter from the USAMRDC ACURO. Non-compliance with any of these terms and conditions may result in withholding of funds and/or the termination of the Research Project Award. The Animal Care and Use Office requirements can be accessed at ▇▇▇▇▇://▇▇▇▇.▇▇▇▇▇▇.▇▇▇/▇▇▇▇▇.▇▇▇/collaborate/research_protections/acuro Principal Investigator. Each Research Project Award shall identify a Principal Investigator. This individual shall be continuously responsible for the conduct of the research project. The Research Project Awardee, through the CM, shall obtain the AO’s approval to change the Principal Investigator or to continue the research work during a continuous period in excess of three months without the participation of an approved Principal Investigator. Each Research Project Award is based upon the Principal Investigator devoting a defined percentage of effort to the project over the term of the Research Project Award. The Research Project Awardee shall advise the AO if the Principal Investigator will, or plans to, revise the level of effort estimated in the Research Project Proposal. A curriculum vitae shall be provided for professional associates added to the research project or substituted during the course of work?pageid=research_protections.hrpo.