{"created":"2023-05-15T14:42:16.322391+00:00","id":57942,"links":{},"metadata":{"_buckets":{"deposit":"126d73e7-a610-4959-9b3c-2a25df85042e"},"_deposit":{"created_by":1,"id":"57942","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"57942"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00057942","sets":["11"]},"author_link":["582517","582516"],"item_10004_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2011-07","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"1","bibliographicPageEnd":"62","bibliographicPageStart":"31","bibliographicVolumeNumber":"39","bibliographic_titles":[{"bibliographic_title":"臨床評価"}]}]},"item_10004_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"Objectives:To identify characteristics of compensation frameworks for research-related injuries of human\nsubjects of clinical trials, in Japan and other parts of the world, and clarify future perspectives.\nMethod:Narrative, non-systematic review of regulations and literature concerning compensation\nprograms for research-related injuries of Japan, United States (US), and European, Asian, and African\ncountries, and additional interview surveys.\nResults:(1) There is a substantial diversity in the national frameworks for compensation for researchrelated\ninjuries. (2) Analysis of cost-effectiveness and feasibility of insurance program is difficult when it is\nmanaged as a private and/or voluntary system. (3) The compensation guidelines of the Japan\nPharmaceutical Industry Legal Affairs Association provide a high level of human subject protection\ncompared with the world situation. The compensation guidelines of the Association of British\nPharmaceutical Industries, which is similar to the Japanese guidelines, seem to work as global standards to\nsome extent. On the other hand, the compensation policy development and implementation is insufficient\nin comparison with the international standards and those in the US and other Asian countries.\nConclusion:A publicly established framework would work better for cost-effective analysis toward\nfairness of compensation for research-related injuries. Additionally, a global consensus for fairness and\nequality of compensation should be reached through more international discussion on this topic.","subitem_description_type":"Abstract"}]},"item_10004_source_id_9":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"0300-3051","subitem_source_identifier_type":"ISSN"}]},"item_access_right":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"metadata only access","subitem_access_right_uri":"http://purl.org/coar/access_right/c_14cb"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"栗原, 千絵子"}],"nameIdentifiers":[{"nameIdentifier":"582516","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"栗原 千絵子","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"582517","nameIdentifierScheme":"WEKO"}]}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"jpn"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"研究対象者の権利と補償：−グローバル臨床試験を視野に入れた国際比較と今後の課題","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"研究対象者の権利と補償：−グローバル臨床試験を視野に入れた国際比較と今後の課題"}]},"item_type_id":"10004","owner":"1","path":["11"],"pubdate":{"attribute_name":"公開日","attribute_value":"2011-07-27"},"publish_date":"2011-07-27","publish_status":"0","recid":"57942","relation_version_is_last":true,"title":["研究対象者の権利と補償：−グローバル臨床試験を視野に入れた国際比較と今後の課題"],"weko_creator_id":"1","weko_shared_id":-1},"updated":"2023-05-15T22:21:31.933885+00:00"}