HUMAN MATERIALS/ASSURANCE Sample Clauses

HUMAN MATERIALS/ASSURANCE. It is understood that the acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States and that no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material. The Subontractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this subcontract, by collaborating sites, or by subcontractors identified under this subcontract, were obtained with prior approval by the Office for Human Research Protections (OHRP)of an assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved assurances, whether domestic or foreign, and compliance must be ensured by the Subcontractor. The Subcontractor shall provide to BBI-Biotech a properly completed Optional Form 310 certifying IRB review and approval of the protocol from which the human materials were obtained. The human subject certification can be met by submission of a self designated form, provided that it contains the information required by the Optional Form 310.
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