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
Part 5: Other Determinations The project the New York State Department of Health’s ethical standards (e.g., acceptable risk-benefit relationship, equitable selection, informed consent where appropriate, protections of privacy interests of participants and the confidentiality of their data (under state law) where appropriate, transparency about the process, proportionality, and where applicable community involvement in quality improvement efforts. Part 6: Engagement in Research DOH is engaged in research (when any of the following are true): Insufficient information to determine; return for additional information Comments Signed
(b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.”? REVIEWER’S COMMENTS (Include here or attach additional sheet): Reviewer’s signature Date APPENDIX 28: EXPEDITED REVIEW WORKSHEET FOR CONTINUING REVIEW New York State Department of Health Institutional Review Board Reviewer’s Expedited/Continuing Review Checklist Study Title: IMPORTANT ISSUES FOR YOU REVIEW ARE: That the to subjects are still minimized. That the risks to subjects are still reasonable in relation to anticipated benefits. That the number of subjects initially requested and approved has not been exceeded. Any protocol revisions that have been approved by the IRB since the last continuing review. Any request for protocol revision at the time of continuing review. Determine if the study appears to be progressing as planned. If unexpected events, toxicity, or complications have occurred that may indicate a need for a change in the protocol or consent. If the subjects registered any complaints about the study. Whether the consent document that is currently in use contains all previous revisions. Review a current report from the data-monitoring mechanism (Principal Investigator, Data-Monitoring Committee, or Data Safety Monitoring Board) to determine that study events are being evaluated relative to the appropriate stopping or modification rules. (It is appropriate for the IRB to require a INVESTIGATOR: