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., 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. A. The Institutional Official of the Engaged Institution Relying on the IRB will: 1. Ensure that all institutional personnel involved in the research (covered within the scope of this agreement) have completed education and training requirements. 2. Verify that scientific review of the research protocol has been conducted and that the IRB considered the feedback from the scientific review. 3. Verify that the IRB has reviewed the research protocol in accordance with DoD requirements, including those identified in the research contract or agreement. 4. Ensure institutional personnel comply with requirements and oversight established by the IRB. 5. Ensure institutional personnel follow the approved research protocol. 6. Ensure institutional personnel report to the IRB and DoD: (a) unanticipated problems involving risks to subjects or others; (b) serious or continuing non-compliance;

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., XxXX 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. A. The Institutional Official of the Engaged Institution Relying on the IRB will: 1. Ensure that all institutional personnel involved in the research (covered within the scope of this agreement) have completed education and training requirements. 2. Verify that scientific review of the research protocol has been conducted and that the IRB considered the feedback from the scientific review. 3. Verify that the IRB has reviewed the research protocol in accordance with DoD requirements, including those identified in the research contract or agreement. 4. Ensure institutional personnel comply with requirements and oversight established by the IRB. 5. Ensure institutional personnel follow the approved research protocol. 6. Ensure institutional personnel report to the IRB and DoD: (a) unanticipated problems involving risks to subjects or others; (b) serious or continuing non-compliance;; (c) suspension or termination of IRB approval; and (d) any other events or circumstances requiring notification. 7. Ensure institutional personnel maintain current copies of the IRB approved research protocol (initial review, continuing review, amendments, adverse event reports, and final report), all communications with the IRB, this Agreement, and other relevant information in accordance with DoD record keeping requirements. 8. Verify the IRB has the expertise and policies and procedures needed to review and oversee the research submitted by the institution (in accordance with 32 CFR219.107, §.103(b)(3), and §.115).

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., XxXX 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. A. The Institutional Official of the Engaged Institution Relying on the IRB will: 1. Ensure that all institutional personnel involved in the research (covered within the scope of this agreement) have completed education and training requirements. 2. Verify that scientific review of the research protocol has been conducted and that the IRB considered the feedback from the scientific review. 3. Verify that the IRB has reviewed the research protocol in accordance with DoD DOD requirements, including those identified in the research contract or agreement. 4. Ensure institutional personnel comply with requirements and oversight established by the IRB. 5. Ensure institutional personnel follow the approved research protocol. 6. Ensure institutional personnel report to the IRB and DoD: DOD: (a) unanticipated problems involving risks to subjects or others; (b) serious or continuing non-compliance;; (c) suspension or termination of IRB approval; and (d) any other events or circumstances requiring notification. 7. Ensure institutional personnel maintain current copies of the IRB approved research protocol (initial review, continuing review, amendments, adverse event reports, and final report), all communications with the IRB, this Agreement, and other relevant information in accordance with DOD record keeping requirements. 8. Verify the IRB has the expertise and policies and procedures needed to review and oversee the research submitted by the institution (in accordance with 32 CFR 219.107, §.103(b)(3), and §.115).

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., 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. A. The Institutional Official of the Engaged Institution Relying on the IRB will: 1. Ensure that all institutional personnel involved in the research (covered within the scope of this agreement) have completed education and training requirements. 2. Verify that scientific review of the research protocol has been conducted and that the IRB considered the feedback from the scientific review. 3. Verify that the IRB has reviewed the research protocol in accordance with DoD requirements, including those identified in the research contract or agreement. 4. Ensure institutional personnel comply with requirements and oversight established by the IRB. 5. Ensure institutional personnel follow the approved research protocol. 6. Ensure institutional personnel report to the IRB and DoD: (a) unanticipated problems involving risks to subjects or others; (b) serious or continuing non-compliance;