{"created":"2023-05-15T14:40:51.473037+00:00","id":56034,"links":{},"metadata":{"_buckets":{"deposit":"c668cc0e-2a17-4c00-ae88-cda3eabdf832"},"_deposit":{"created_by":1,"id":"56034","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"56034"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00056034","sets":["7"]},"author_link":["573384","573383","573385"],"item_10004_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2016-01","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"2","bibliographicPageEnd":"28","bibliographicPageStart":"613","bibliographicVolumeNumber":"43","bibliographic_titles":[{"bibliographic_title":"臨床評価"}]}]},"item_10004_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"Purpose：To provide an explanatory overview of the draft revision of International Ethical Guidelines for\nBiomedical Research Involving Human Subjects submitted by the CIOMS (Council for International\nOrganizations of Medical Science) for public consultation from September 2015 to March 1, 2016.\nMethods：Narrative, non-systematic review of literature on research ethics.\nResults：We identified nine topics where major changes were proposed in the draft: (1) social value of\nresearch; (2) choice of control in clinical trials; (3) biobank and data archive; (4) treatment and\ncompensation for research-related harms; (5) research in disaster situations; (6) implementation research;\n(7) use of online information; (8) research ethics committees and review; and (9) public accountability.\nDiscussion and Conclusion：Though logical constructions and ethical considerations of this proposed\ndraft are still premature, there are significant changes worth noting. These changes shall provide the\nethical foundation for research aiming at global health, focusing on critical issues of public health, such as\nan Ebola outbreak; earthquakes; tsunamis; and military conflicts, as well as research using new\ntechnologies for the analysis of large amounts of data or whole genome sequence. Most importantly,\nCIOMS argues that ethical justification of health-related research involving human subjects is derived from\nits social value, which must be generated only from scientifically valid research; and that placebo control is\nethically acceptable when it does not cause more than a minor increase above minimal risk. Both of these\narguments are in marked contrast to the 2013 version of the Declaration of Helsinki as CIOMS raises the\nante of science and ethics as well as requiring researchers to balance science and ethics, involving a more\ndifficult trade off.","subitem_description_type":"Abstract"}]},"item_10004_source_id_9":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"0300-3501","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":"573383","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"齊尾武郎"}],"nameIdentifiers":[{"nameIdentifier":"573384","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"栗原 千絵子","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"573385","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":"CIOMS生物医学研究指針の改訂 ─ グローバル・ヘルスと研究の価値 ─","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"CIOMS生物医学研究指針の改訂 ─ グローバル・ヘルスと研究の価値 ─"}]},"item_type_id":"10004","owner":"1","path":["7"],"pubdate":{"attribute_name":"公開日","attribute_value":"2017-04-25"},"publish_date":"2017-04-25","publish_status":"0","recid":"56034","relation_version_is_last":true,"title":["CIOMS生物医学研究指針の改訂 ─ グローバル・ヘルスと研究の価値 ─"],"weko_creator_id":"1","weko_shared_id":-1},"updated":"2023-05-15T22:42:33.904340+00:00"}