Common use of Prohibition of Use of Human Subjects Clause in Contracts

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 USAMRMC’s ORP provides authorization that the research may proceed. The USAMRMC 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 USAMRMC 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. The USAMRMC ORP conducts site visits as part of its responsibility for compliance oversight. Accurate and complete study records must be maintained and made available to representatives of the USAMRMC 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 is required to adhere to the following reporting requirements: Submission of substantive modifications to the protocol, continuing review documentation, and the final report as outlined in the USAMRMC 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 USAMRMC ORP Change in subject status when a previously enrolled human subject becomes a prisoner must be promptly reported to the USAMRMC ORP HRPO. The knowledge of any pending compliance inspection/visits by the FDA, ORP, 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 that relate to this clinical investigation or research, must be reported immediately to the USAMRMC ORP. Non-compliance with these terms and conditions may result in withholding of funds and/or the termination of the award. DoD requirements for human subjects research, including 32 CFR Part 219, DoD Instruction 3216.02, and USAMRMC ORP Human Research Protection Office submission instructions can be accessed at xxxxx://xxxx.xxxxx.xxxx.xxx/xxxxx.xxx?pageid=research_protections.hrpo.

Prohibition of Use of Human Subjects. (NOVEMBER 2015) Research under this Agreement or Research Project Awards award involving the use of human subjects, to include research involving the secondary use of human biospecimens and/or human data, cannot begin until the USAMRMC’s ORP Office of Research Protections (ORP) provides authorization that the research may proceed. The USAMRMC 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 SOTRyou. Written approval to proceed from the USAMRMC ORP is also required for any Research Project Awardee (or lower tier subawards) subrecipient that will use funds from this award to conduct research involving human subjects. The USAMRMC ORP conducts site visits as part of its responsibility for compliance oversight. Accurate and complete study records must be maintained and made available to representatives of the USAMRMC 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 recipient is required to adhere to the following reporting requirements: Submission of substantive modifications to the protocol, continuing review documentation, and the final report as outlined in the USAMRMC 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 USAMRMC ORP ORP. Change in subject status when a previously enrolled human subject becomes a prisoner must be promptly reported to the USAMRMC ORP HRPO. The knowledge of any pending compliance inspection/visits by the FDA, ORP, 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 that relate to this clinical investigation or research, must be reported immediately to the USAMRMC ORP. Non-compliance with these terms and conditions may result in withholding of funds and/or the termination of the award. DoD requirements for human subjects research, including 32 CFR Part 219, DoD Instruction 3216.02, and USAMRMC ORP Human Research Protection Office submission instructions can be accessed at xxxxx://xxxx.xxxxx.xxxx.xxx/xxxxx.xxx?pageid=research_protections.hrpo.

Prohibition of Use of Human Subjects. Research under this Agreement or Research Project Awards award involving the use of human subjects, to include research involving the secondary use of human biospecimens and/or human data, cannot begin until the USAMRMC’s ORP Office of Research Protections (ORP) provides authorization that the research may proceed. The USAMRMC 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 SOTRyou. Written approval to proceed from the USAMRMC ORP is also required for any Research Project Awardee (or lower tier subawards) subrecipient that will use funds from this award to conduct research involving human subjects. The USAMRMC ORP conducts site visits as part of its responsibility for compliance oversight. Accurate and complete study records must be maintained and made available to representatives of the USAMRMC 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 recipient is required to adhere to the following reporting requirements: Submission of substantive modifications to the protocol, continuing review documentation, and the final report as outlined in the USAMRMC 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 USAMRMC ORP ORP. Change in subject status when a previously enrolled human subject becomes a prisoner must be promptly reported to the USAMRMC ORP HRPO. The knowledge of any pending compliance inspection/visits by the FDA, ORP, 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 that relate to this clinical investigation or research, must be reported immediately to the USAMRMC ORP. Non-compliance with these terms and conditions may result in withholding of funds and/or the termination of the award. DoD requirements for human subjects research, including 32 CFR Part 219, DoD Instruction 3216.02, and USAMRMC ORP Human Research Protection Office submission instructions can be accessed at xxxxx://xxxx.xxxxx.xxxx.xxx/xxxxx.xxx?pageid=research_protections.hrpo.

Prohibition of Use of Human Subjects. Research under this Agreement or Research Project Awards Clinical Trial involving the use of human subjects, to include research involving the secondary use of human biospecimens and/or human data, cannot begin until the USAMRMCUSAMRDC’s ORP provides authorization that the research may proceed. The USAMRMC USAMRDC ORP will issue written approval to begin research under separate notification to the Research Project AwardeeNetwork Site, a copy of which shall be provided to the appointed SOTRAOTR. Written approval to proceed from the USAMRMC USAMRDC ORP is also required for any Research Project Awardee Network Site (or lower tier subawards) that will use funds from this award to conduct research involving human subjects. The USAMRMC USAMRDC ORP conducts site visits as part of its responsibility for compliance oversight. Accurate and complete study records must be maintained and made available to representatives of the USAMRMC 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 Coordinating Center is required to adhere to the following reporting requirements: Submission of substantive modifications to the protocol, continuing review documentation, and the final report as outlined in the USAMRMC USAMRDC 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 USAMRMC ORP USAMRDC ORP. Change in subject status when a previously enrolled human subject becomes a prisoner must be promptly reported to the USAMRMC USAMRDC ORP HRPO. The knowledge of any pending compliance inspection/visits by the FDA, ORP, 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 that relate to this clinical investigation or research, must be reported immediately to the USAMRMC USAMRDC ORP. Non-compliance with these terms and conditions may result in withholding of funds and/or the termination of the award. DoD requirements for human subjects subject’s research, including 32 CFR Part 219, DoD Instruction 3216.02, and USAMRMC USAMRDC ORP Human Research Protection Office submission instructions can be accessed at xxxxx://xxxx.xxxxx.xxxx.xxx/xxxxx.xxx?pageid=research_protections.hrpo.