Common use of HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE Clause in Contracts

HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE. 17.2.1 The acquisition and supply of all human specimen material (including fetal material) used under this Agreement shall be obtained by the Project Awardee 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. 17.2.2 The Project Awardee 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 sub-tier awardees, 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 Project Awardee. 17.2.3 Provision by the Project Awardee to the HHS OTAO, through the CMF, 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).

HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE. 17.2.1 The acquisition and supply of all human specimen material (including fetal material) used under this Agreement shall be obtained by the Project Awardee 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. 17.2.2 The Project Awardee 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 sub-tier awardees, 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 Project Awardee. 17.2.3 Provision by the Project Awardee to the HHS OTAO, through the CMF, 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 0990-0263 (formerly Optional Form 310).

HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE. 17.2.1 1. The acquisition and supply of all human specimen material (including fetal material) used under this Agreement OTA shall be obtained by the Project Awardee Recipient in full compliance with applicable Federal, state State and local Local laws and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material. 17.2.2 2. The Project Awardee Recipient shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this AgreementOTA, by collaborating sites, or by subSub-tier awardeesrecipients identified under this OTA, were obtained with prior approval by the Office for Human Research Protections (OHRP) 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 Project AwardeeRecipient. 17.2.3 3. Provision by the Project Awardee Recipient to the HHS OTAO, through the CMF, ’s of a properly completed “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0990- 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 0990-0263 (formerly Optional Form 310).

HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE. 17.2.1 1. The acquisition and supply of all human specimen material (including fetal material) used under this Under This Agreement shall be obtained by the Project Awardee Recipient in full compliance with applicable Federal, state State, and local laws and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material. 17.2.2 2. The Project Awardee Recipient shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this Under This Agreement, or by collaborating sites, or by sub-tier awardeesidentified 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 Project AwardeeRecipient. 17.2.3 3. Provision by the Project Awardee Recipient to the HHS OTAO, through the CMF, OTAO 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 0990-0263 (formerly Optional Form 310).. 29