GCP Course for Clinical Trials Involving Investigational Drugs (International /ICH Focus) Student Researchers should select Students - Class projects The IRB will accept human subject protection trainings from other institutions on a case-by-case basis. A copy of the certificate or a confirmation from the other institution IS REQUIRED. It is the responsibility of the PI to ensure that all key staff possess a current and valid training certificate. If an individual's training certificate expires before completion of the study, that individual must be removed from the study, or all study activities must cease until an updated training certificate can be obtained. The IRB requires that all investigators and key personnel receive training before the submission of grant proposals for approval. Proof of such training should be submitted with each grant proposal and protocol review request. OVERVIEW OF DOD REQUIREMENTS Guidance on Additional Requirements for Protocols Conducted by DOH and Sponsored by a Department of Defense (DoD) Component Regulations and directives that specifically address the protection of human subjects in research sponsored by any component of the US DoD include DoD Directive 3216.02 (dated March 25, 2002); Section 980 of title 10, USC; 32 CFR Part 219; and DoD Directive 6200.2 (dated August 1, 2000), and others. Identification of DoD Sponsored Research When submitting an HSP to the DOH IRB, the Principal Investigator must identify the research as sponsored or funded by a DOD component (as defined in Department of Defense Directive 3216.02). The Principal Investigator is responsible for identifying DOD component requirements specified in the application guidelines and for advising the IRB staff and IRB of the requirements. DOD components include, but are not limited to: Navy and Academy • Office of Research • US Naval Observatory • Army • US Army Corps of Engineers • Military Academy (West Point) • Air Force and Air Force Academy • Marines • Coast Guard and Coast Guard Academy • National Guard • Missile Defense Agency • Defense Advanced Research Projects Agency (DARPA) • Pentagon Protection Agency • Defense Intelligence Agency • National Geospatial-Intelligence Agency • National Security Agency •
GCP Course for Clinical Trials Involving Investigational Drugs (International /ICH Focus) Student Researchers should select Students - Class projects The IRB will accept human subject protection trainings from other institutions on a case-by-case basis. A copy of the certificate or a confirmation from the other institution IS REQUIRED. It is the responsibility of the PI to ensure that all key staff possess a current and valid training certificate. If an individual's training certificate expires before completion of the study, that individual must be removed from the study, or all study activities must cease until an updated training certificate can be obtained. The IRB requires that all investigators and key personnel receive training before the submission of grant proposals for approval. Proof of such training should be submitted with each grant proposal and protocol review request. OVERVIEW OF DOD REQUIREMENTS Guidance on Additional Requirements for Protocols Conducted by DOH and Sponsored by a Department of Defense (DoD) Component Regulations and directives that specifically address the protection of human subjects in research sponsored by any component of the US DoD include DoD Directive 3216.02 (dated March 25, 2002); Section 980 of title 10, USC; 32 CFR Part 219; and DoD Directive 6200.2 (dated August 1, 2000), and others. Identification of DoD Sponsored Research When submitting an HSP to the DOH IRB, the Principal Investigator must identify the research as sponsored or funded by a DOD component (as defined in Department of Defense Directive 3216.02). The Principal Investigator is responsible for identifying DOD component requirements specified in the application guidelines and for advising the IRB staff and IRB of the requirements. DOD components include, but are not limited to: • Navy and Academy • Office of Research • US Naval Observatory • Army • US Army Corps of Engineers • Military Academy (West Point) • Air Force and Air Force Academy • Marines • Coast Guard and Coast Guard Academy • National Guard • Missile Defense Agency • Defense Advanced Research Projects Agency (DARPA) • Pentagon Protection Agency • Defense Intelligence Agency • National Geospatial-Intelligence Agency • National Security Agency
irbguidelines_v_4.docx