Prohibition of Use of Human Subjects Sample Clauses

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 ins...
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Related to Prohibition of Use of Human Subjects

  • Protection of Human Subjects The Recipient agrees to comply with the requirements of the National Research Act, as amended, 42 U.S.C. §§ 289 et seq., and U.S. DOT regulations, “Protection of Human Subjects,” 49 C.F.R. Part 11, pertaining to protections for human subjects participating in or involved in research, development, and activities related to the Project.

  • PROHIBITION OF UNILATERAL ACTION The Employer will not take any actions affecting wages, hours and other terms and conditions of employment as defined in Section 8(d) of the National Labor Relations Act which violate the terms of this Agreement or are otherwise inconsistent with its obligations under law.

  • PROHIBITION OF STRIKES Section 1. Strike Definition

  • Human Trafficking Prohibition Pursuant to Section 2155.0061 of the Texas Government Code, PSP certifies that it is not ineligible to receive this agreement and acknowledges that this Agreement may be terminated and payment withheld if PSP’s certification in this matter is inaccurate. TFC may not award a contract, including a contract for which purchasing authority is delegated to a state agency, that includes proposed financial participation by a person who, during the five-year (5) period preceding the date of the award, has been convicted of any offense related to the direct support or promotion of human trafficking.

  • Prohibition on Unauthorized Use or Disclosure The Business Associate will neither use nor disclose the Covered Entity’s Protected Health Information, except as permitted or required by this Addendum or in writing by the Covered Entity or as Required by Law. This Agreement does not authorize the Business Associate to use or disclose the Covered Entity’s Protected Health Information in a manner that will violate Subpart E of 45 CFR Part 164 if done by the Covered Entity.

  • Limitation of Use The parties agree that this Agreement shall not be proffered by either party in another jurisdiction as evidence of any concession or as a waiver of any position taken by the other party in that jurisdiction or for any other purpose.

  • ANTI DISCRIMINATION AND ANTI HARASSMENT Contractor and/or any subcontractor shall not unlawfully discriminate against or harass any individual including, but not limited to, any employee or volunteer of the County of Marin based on race, color, religion, nationality, sex, sexual orientation, age or condition of disability. Contractor and/or any subcontractor understands and agrees that Contractor and/or any subcontractor is bound by and will comply with the anti discrimination and anti harassment mandates of all Federal, State and local statutes, regulations and ordinances including, but not limited to, County of Marin Personnel Management Regulation (PMR) 21.

  • Certification Regarding Prohibition of Boycotting Israel (Tex Gov. Code 2271) If (a) Vendor is not a sole proprietorship; (b) Vendor has ten (10) or more full-time employees; and (c) this Agreement or any agreement with a TIPS Member under this procurement has value of $100,000 or more, the following certification shall apply; otherwise, this certification is not required. Vendor certifies, where applicable, that neither the Vendor, nor any affiliate, subsidiary, or parent company of Vendor, if any, boycotts Israel, and Vendor agrees that Vendor and Vendor Companies will not boycott Israel during the term of this Agreement. For purposes of this Agreement, the term “boycott” shall mean and include refusing to deal with, terminating business activities with, or otherwise taking any action that is intended to penalize, inflict economic harm on, or limit commercial relations with Israel, or with a person or entity doing business in Israel or in an Israeli-controlled territory but does not include an action made for ordinary business purposes. When applicable, does Vendor certify? Yes

  • Certification Regarding Prohibition of Certain Terrorist Organizations (Tex Gov. Code 2270) Vendor certifies that Vendor is not a company identified on the Texas Comptroller’s list of companies known to have contracts with, or provide supplies or services to, a foreign organization designated as a Foreign Terrorist Organization by the U.S. Secretary of State. Does Vendor certify? 3 Yes

  • Rights Protection Mechanisms and Abuse Mitigation ­‐ Registry Operator commits to implementing and performing the following protections for the TLD:

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