Common use of Institutional Responsibilities Clause in Contracts

Institutional Responsibilities. All institutions are responsible for ensuring that their personnel (i.e., the Institutional Official, the IRB, IRB office staff, investigators and research staff, and any other personnel supporting research covered under this Agreement) act in accordance with all applicable federal, state and local laws and regulations (e.g., Title 32 Code of Federal Regulations Part 219 (32 CFR 219); Title 10 United States Code Section 980 (10 USC 980); DoD Directives and Instructions (e.g., DoDD 3216.02); 45 CFR Part 46 (Subparts B, C, and D as made applicable by DoDD 3216.02); DoD Component policies; and the Food and Drug Administration regulations and guidance (e.g., 21 CFR Parts 50, 56, 312, and 812) where applicable in addition to the terms and conditions of the organizations’ DoD Assurance and/or their DHHS FWA. Specific DoD Component requirements are stated in Part 3 of this document. All institutions will permit, upon request, the inspection of any facilities used in support of the activities described in the “Scope” and other research areas by federal agencies responsible for oversight of human research protection and proper management of the research within the scope of this agreement.

Institutional Responsibilities. All institutions are responsible for ensuring that their personnel (i.e., the Institutional Official, the IRB, IRB office staff, investigators and research staff, and any other personnel supporting research covered under this Agreement) act in accordance with all applicable federal, state and local laws and regulations (e.g., Title 32 Code of Federal Regulations Part 219 (32 CFR 219); Title 10 United States Code Section 980 (10 USC 980); DoD Directives and Instructions (e.g., DoDD XxXX 3216.02); 45 CFR Part 46 (Subparts B, C, and D as made applicable by DoDD 3216.02); DoD Component policies; and the Food and Drug Administration regulations and guidance (e.g., 21 CFR Parts 50, 56, 312, and 812) where applicable in addition to the terms and conditions of the organizations’ DoD Assurance and/or their DHHS FWA. Specific DoD Component requirements are stated in Part 3 of this document. All institutions will permit, upon request, the inspection of any facilities used in support of the activities described in the “Scope” and other research areas by federal agencies responsible for oversight of human research protection and proper management of the research within the scope of this agreement.

Institutional Responsibilities. All institutions are responsible for ensuring that their personnel (i.e., the Institutional Official, the IRB, IRB office staff, investigators and research staff, and any other personnel supporting research covered under this Agreement) act in accordance with all applicable federal, state and local laws and regulations (e.g., Title 32 Code of Federal Regulations Part 219 (32 CFR 219); Title 10 United States Code Section 980 (10 USC 980); DoD DOD Directives and Instructions (e.g., DoDD XXXX 3216.02); 45 CFR Part 46 (Subparts B, C, and D as made applicable by DoDD XXXX 3216.02); DoD DOD Component policies; and the Food and Drug Administration regulations and guidance (e.g., 21 CFR Parts 50, 56, 312, and 812) where applicable in addition to the terms and conditions of the organizations’ DoD DOD Assurance and/or their DHHS FWA. Specific DoD DOD Component requirements are stated in Part 3 of this document. All institutions will permit, upon request, the inspection of any facilities used in support of the activities described in the “Scope” and other research areas by federal agencies responsible for oversight of human research protection and proper management of the research within the scope of this agreement.