International Research Research Involving Children.ppt

International Research Research Involving Children K. Lynn Cates, MD Assistant Chief Research Development Officer Office of Research Development Department of Veterans Affairs International Research All subjects must be provided appropriate protections in accord with those given to subjects in the U.S. Research must reflect understanding and respect for the community, the group, the culture, and the environment International Research VHA Directive 2005-050, “Requirements for Conducting VA-Approved International Research Involving Human Subjects, Human Biological Specimens, or Human Data,” Nov. 4, 2005 “…requires permission be granted by the Chief Research and Development Officer (CRADO), or designee, prior to initiating or conducting Department of Veterans Affairs (VA)-approved international research involving human subjects, human biological specimens, or human data.” International ResearchDefinition of “International Research” “…any VA-approved human subjects research conducted at international sites (not within the United States (U.S.), its territories, or Commonwealths) or any VA–approved research using either human biological specimens or human data originating from international sites.” International ResearchMulti-site Studies Covered only if VA is the sponsor VA functions as the coordinating center VA subcontracts to a foreign site The PI for the total project is a VA investigator International ResearchMedical Center Director’s Responsibilities Approving the PI’s request for permission to conduct international research before it is sent to the CRADO for action Providing a memorandum to the CRADO indicating he/she approves the study Ensuring permission has been obtained from the CRADO before the PI initiates the project International ResearchInvestigator’s Responsibilities Conducting research in compliance with all applicable VHA and other Federal regulations and policies Obtaining permission from the CRADO Reporting all unexpected or ad