Common use of Mutual Terms Clause in Contracts

Mutual Terms. This Agreement is to set forth the respective authorities, roles, and responsibilities of each party when a Ceded Review is accepted by the Designated IRB Institution in accordance with the process set forth herein. For purposes of this Agreement, “Research” means any non-exempt human subjects research within the meaning of the Federal Policy for the Protection of Human Subjects or within the meaning of any other federal human subject research regulations or policies. As used in this Agreement, Research may reference a specific study or protocol in which there will be a UM and relying party operating pursuant to the terms of this Agreement, or collectively the studies subject to Ceded Review under this Agreement. Both the Designated IRB and the Relying Institution agree that review and approval of human subjects research under this Agreement shall be conducted in compliance with the federal regulations as codified in 45 CFR 46 and 21 CFR 50 & 56 (as applicable), other pertinent federal regulations, state and local laws, and all applicable human research protection program (HRPP) policies at the Designated IRB’s Institution. Both the Designated IRB and the Relying Institution agree that they are primarily responsible for safeguarding the rights and welfare of research participants and that the rights and welfare of participants must take precedence over the goals and requirements of the research. Both the Designated IRB and the Relying Institution agree that the obligations and liabilities of the Designated IRB are limited to its regulatory review and oversight of Research covered by this Agreement and that the Designated IRB will ensure its reviews and determinations are in accordance with all applicable federal regulations and human subjects protection requirements, state and local laws, and institutional policies and procedures. Both the Designated IRB and the Relying Institution agree to develop or maintain standard operating procedures (“SOPs”) consistent with this Agreement. This Agreement does not preclude the Relying Institution or its researchers from taking part in research not covered by this Agreement, or from participating in any other IRB authorization or reliance agreements. This Agreement meets federal requirements for the designation of another institution’s IRB as the reviewing IRB, as set forth in the Office for Human Research Protections (“OHRP”) document Terms of the Federalwide Assurance.. This signed Agreement will be kept on file at each signatory institution and will be provided to OHRP or other federal agencies upon request.