PURPOSE This guidance outlines the additional obligations of investigators conducting DOD research. GUIDANCE Training and education All personnel who conduct, review, approve, oversee, support, or manage human subjects research are required to undergo initial and continuing research ethics education. may be specific DOD educational requirements or certification required. DOD may evaluate the organization’s education policies to ensure the personnel are qualified to perform the research, based on the complexity and risk of the research. As the investigator, you must be aware of the specific requirements contained in DOD regulations and requirements and educated about these requirements when appropriate. Scientific Review The IRB must consider the scientific merit of the research. The IRB may rely on outside experts to provide an evaluation of the scientific merit. International Research You or the organization must obtain permission to conduct research in that country by certification or local ethics review. You must follow all local laws, regulations, customs, and practices. Reporting: The following findings in DOD-supported research must be reported to the DOD human research protection officer within 30 days: Determinations of Serious Noncompliance or Continuing Noncompliance Significant changes to the research protocol that are approved by the IRB The results of the IRB continuing review Change of reviewing IRB When the organization is notified by any Federal department, agency or national organization that any part of an HRPP is under investigation for cause requirements Unanticipated Problems Involving Risk to Subjects or Others Suspension of IRB approval Termination of IRB approval Survey Approval Surveys performed on DOD personnel must be submitted, reviewed, and approved by the DOD after the research protocol is approved by the IRB. Multisite Research When conducting multi-site research, a formal agreement between organizations is required to specify the roles and responsibilities of each party. Definition of Minimal Risk The definition of the minimal risk based on the phrase encountered in “ordinarily daily life or during the performance of routine physical or physiological examinations or tests” must not be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For example, the risks imposed in research involving human subjects focused on a special population
PURPOSE This guidance outlines the additional obligations of investigators conducting DOD research. GUIDANCE Training and education All personnel who conduct, review, approve, oversee, support, or manage human subjects research are required to undergo initial and continuing research ethics education. may be specific DOD educational requirements or certification required. DOD may evaluate the organization’s education policies to ensure the personnel are qualified to perform the research, based on the complexity and risk of the research. As the investigator, you must be aware of the specific requirements contained in DOD regulations and requirements and educated about these requirements when appropriate. Scientific Review The IRB must consider the scientific merit of the research. The IRB may rely on outside experts to provide an evaluation of the scientific merit. International Research You or the organization must obtain permission to conduct research in that country by certification or local ethics review. You must follow all local laws, regulations, customs, and practices. Reporting: The following findings in DOD-supported research must be reported to the DOD human research protection officer within 30 days: Determinations of Serious Noncompliance or Continuing Noncompliance Significant changes to the research protocol that are approved by the IRB The results of the IRB continuing review Change of reviewing IRB When the organization is notified by any Federal department, agency or national organization that any part of an HRPP is under investigation for cause requirements Unanticipated Problems Involving Risk to Subjects or Others Suspension of IRB approval Termination of IRB approval Survey Approval Surveys performed on DOD personnel must be submitted, reviewed, and approved by the DOD after the research protocol is approved by the IRB. Multisite Research When conducting multi-site research, a formal agreement between organizations is required to specify the roles and responsibilities of each party. Definition of Minimal Risk The definition of the minimal risk based on the phrase “ordinarily encountered in daily life or during the performance of routine physical or physiological examinations or tests” must not be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For example, the risks imposed in research involving human subjects focused on a special population