Additional Requirements For Research Involving the Department of Defense (Do. D)Background. In 2. Department of the Defense (Do. D) enhanced its human subject protection requirements, including the application of those requirements to extramural performers. UCI has signed an addendum with the Do. D which requires that UCI apply Do. D regulations and policies for the protection of human research participants when conducting, reviewing, approving, overseeing, supporting or managing Do. D supported human subject research. The addendum is recognized by all branches of the Do. D: the Navy, Army and Air Force. Each branch of the Do. D may have their own specific requirements for reviewing research protocols that they support, and these requirements must be followed. For specific branch requirements see below or contact your program officer. The information in this guidance is for investigators involved in human subjects research supported by or in collaboration with Do. D. View the Do. D Directive 3. Copy of the Do. D Addendum to UCI's Federalwide Assurance. A copy of the Do. D Addenum to UCI's Federalwide Assurance is available should you be required to provide it. What Qualifies as Do. D Research. Human Subject Research involves the Do. D when any of the following apply: The research is funded by a component of the Do. D (e. g.; Navy, Army, Air Force)The research involves cooperation, collaboration, or other type of agreement with a component of Do. DThe research uses property, facilities, or assets of a component of Do. DThe subject population will intentionally include personnel (military or civilian) from a component of Do. DNote: Do. D policies and requirements do not apply when Do. D personnel incidentally participate as subjects in research that is not supported by Do. D, and Do. D personnel are not an intended population of the research. Instructions for all Do. D Research. When Investigators conducting, reviewing, approving, overseeing, supporting or managing Do. D supported research with human subjects (including research that qualifies for exempt status) submit a study to the UCI IRB, the Do. D requires that the institution meet the following: EDUCATION: In addition to completing the UCI HRP education requirements, conduct initial and continuing research ethics education for personnel who are engaged in human subject research. This training must be completed by all study team members initially and on a continuing basis every three years. Documentation of this completion must be uploaded with the e- IRB application. For the Department of Navy (Do. N), completion of the CITI Training + 4 Additional Modules is required. For information on Do. N education requirements, refer to the attached documents and links. Department of Navy - Instructions for Principal Investigator education and training Step by Step - Instructions on How to Access the Do. N Training Requirements. Step by Step - Instructions on how to Access the Do. N CITI Refresher Course. This page is about the meanings of the acronym/abbreviation/shorthand DON HRPP in the Governmental field in general and in the Military terminology in particular. News and Comment on the Protection of Human Subjects in Navy ResearchDON HRPP: Getting in Front of the AircraftHRPP Head VillasanteCommunications. Do. N Education and Training Policy for Research Ethics and the Responsible Conduct of Research. Research under the purview of the Under Secretary of State (Personnel and Readiness): Requires annual training on human subject protections for all investigators and research staff directly involved in human subject research. Be prepared to document how annual human subject protection training is maintained. For other military branches (e. Army, Air Force), contact your program officer for specific information about their respective education requirements. SCIENTIFIC MERIT: New research and substantive scientific amendments to approved research shall undergo scientific review and the review is considered by the IRB. Upload evidence of this approval with your e- IRB application (scientific review and approval by PRMC or by the IRB through BERD does suffice for this requirement but must occur prior to IRB review). In the absence of an external review or an established internal review mechanism, you should make arrangements with your chair or dean for an ad hoc scientific review. Information on Do. N requirements regarding Sec. Nav Instruction 3. D are available online. For other military branches (e. Army, Air Force), contact your program officer for specific information about their respective scientific merit requirements. MEDICAL MONITOR: Appoint a medical monitor when appropriate for studies involving more than minimal risk to subjects. Additional Requirements For Research Involving the Department of Defense. Documentation requirements for Department of Navy Human Research Protection Program. / ~/~-DEPARTMENT OF THE NAVY 7; ~ OFFICE OF THE SECRETARY 1000 NAVY PENTAGON WASHINGTON DC 20350-1000 SECNAVINST 3900.39D. DON Human Research Protection Program. DON HRPP HANDBOOK 1 DEPARTMENT OF THE NAVY HUMAN RESEARCH PROTECTION PROGRAM (DON HRPP) HANDBOOK 1. SCOPE 1.1 Scope. This handbook provides guidance. Human Research Protection Program: In SECNAVINST 3900.39D, dated 6 November 2006, the Secretary of the Navy delegated the sole authority and responsibility for. DON Human Research Protection Program Activities that are NOT Research Involving Humans Subjects under DoDI 3216.02 • Compliance Assessment.Research Protections. The Office of Naval Research (ONR) Research Protections Division, a component of the Department of the Navy (DoN) Human Research Protection. DON Human Research Protection Program DON Human Research Protection Program What’s New 14 November 2006 DoD Training Day Washington, DC. DoD Human Research Protection Training. Ph.D. Director, Department of the Navy Human Research Protection Program. “Navy senior leadership is extremely. See page 4 of the Do. D Directive for specific guidance related to this requirement. INTERNATIONAL RESEARCH: Safeguard for research conducted with international populations. Information on Do. N requirements regarding Sec. Nav Instruction 3. D are available online. For other military branches (e. Army, Air Force), contact your program officer for specific information about their respective requirements. VULNERABLE POPULATIONS: Protect pregnant women, prisoners and children. Ensure additional protections for military research subjects to minimize undue influence. COGNITIVE IMPAIRMENT: If research involves cognitively impaired adults, there is a direct benefit to the subject. LEGALLY AUTHORIZED REPRESENTATIVE: Comply with Do. D limitations on research where consent by legally authorized representatives is proposed. WAIVER OF CONSENT: Comply with Do. D limitations on exceptions from informed consent. If the research involves interventions or interactions with subjects the research does not involve a waiver of consent or parental permission unless a waiver is obtained from the Secretary of Defense. Information on Do. N requirements regarding Sec. Nav Instruction 3. D are available online. For other military branches (e. Army, Air Force), contact your program officer for specific information about their respective requirements. COMPENSATION: Comply with limitations on dual compensation for U. S. military personnel. SURVEY RESEARCH: Follow Do. D requirements for additional review for Do. D- sponsored survey research or survey research within Do. D. Research involving the administration of surveys to, or interviews of, Do. D personnel (military or civilian) may require Do. D approval of the surveys or interview questions. This involves research where Do. D personnel and civilian personnel (working with the Do. D) are asked to complete surveys; not when researchers funded by the Do. D are conducting survey on non- Do. D personnel. Survey requirements are different depending on the branch of the Do. D. For Air Force requirements, contact your program officer. Please follow the below specific guidance, as applicable. Army: Request for Approval to Survey Department of Army Form. Obtaining Approval for a Survey of U. S. Army Personnel. Navy: Navy Survey Policy Do. D Wide: Do. D Instruction on Surveys of Military Personnel (surveys across branches of the Do. D)COMPLIANCE AND MISCONDUCT: Address and report allegations of non- compliance with human research protections. Address and report allegations of research misconduct. Support oversight by the sponsoring Do. D component. CONFLICT OF INTEREST: Follow procedures for addressing financial and other conflicts of interest. POWS: Prohibit research with Prisoners of War (POW). This includes any person captured, detained, held or otherwise under the control of the Do. D personnel (military and civilian or contractor employee). Including; enemy prisoners, civilian internees, retained persons and lawful and unlawful combatants. Such persons do not include Do. D personnel being held for law enforcement purposes. DRUGS, DEVICES AND BIOLOGICS: Comply with all provisions for research with human subjects using investigational test articles (drugs, device and biologics). DOCUMENTATION: Follow recordkeeping requirements (see below). Document determination by a designated Institutional Official (other than the investigators) whether research meets the criteria for exemption. INJURY AND ADVERSE EVENTS: Explain to subjects any provisions for medical care for research- related injury. Report unanticipated problems, adverse events, research- related injury and suspensions or terminations of research. All new UCI IRB applications for research that involves the Do. D must include this Supplement Form as an attachment. The Supplement Form includes additional submission requirements so please review this form thoroughly and complete any additional required information as needed. Lead Researcher and Co- investigator CVs. Data Collection Forms/Case Report Forms. FDA letter for IND or IDEFDA Form 1. FDA Form 1. 57. 2Post- Approval Instructions. Documentation. Principal Investigators (PIs) and the UCI HRP are responsible for maintaining certain documentation in their files. PIs are also responsible for submitting documentation to Do. D prior to starting an IRB- approved study and upon subsequent reviews by the IRB (addenda, continuing reviews, etc.). Do. D uses such documentation to conduct a "headquarters- level administrative review." Do. D HRPP requires certain IRB documentation that is not maintained by the PI (such as IRB meeting minutes). These items will be sent directly from the UCI HRP to Do. D. UCI HRP will notify the PI when these documents are sent. For instance, the Department of Navy (Do. N) has documentation requirements. For other military branches (e. Army, Air Force), contact your program officer for specific information about their respective requirements. For more information on Do. N documentation requirements, refer to the following links: IRB Reporting Requirements. The IRB may be required to notify Do. N and the sponsor (if there is a non- Do. N sponsor) of serious adverse events, non- compliance, unanticipated problems involving risks to subjects or other and protocol deviations and actions taken regarding the reports. The Do. N must be notified of any audits, investigations or inspections of Do. N – supported research. The IRB will report such inspections to Do. N only when the IRB conduct or are aware of the inspection. Do. N HRPP requires certain IRB documentation that is not maintained by the PI (e. IRB meeting minutes).
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