Common use of HUMAN MATERIALS Clause in Contracts

HUMAN MATERIALS. The acquisition and supply of all human specimen material (including fetal material) used under this Agreement shall be obtained by Subcontractor in full compliance with applicable Federal, State and Local laws and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material. The Subcontractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this Agreement, by collaborating sites, or by lower tier Subcontractors identified under this Agreement, 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. Provision by the Subcontractor to AstraZeneca of a properly completed “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly Optional Form 310), certifying IRB review and approval of the protocol from which the human materials were obtained constitutes the written documentation required. The human subject certification can be met by submission of a self-designated form provided that it contains the information required by the “Protection of Human Subjects Assurance Identification/IRB Certification/ Declaration of Exemption”, Form OMB No. 0990-0263(formerly Optional Form 310).