The Establishment of Approval System with the Unified Form of Explanation/Consent Documents for Providing Understandable Information

  • NAGAI Yayoi
    Office KAZE NO MICHI / Former Chief of Medical Quality and safety management center, Gunma University Hospital
  • CHIGIRA Yoshiko
    Medical information management center, Gunma University Hospital
  • SUGANO Kyohei
    Medical information management center, Gunma University Hospital
  • SAITO Shigeru
    Department of Anesthesiology, Gunma University Hospital
  • YOSHIMOTO Yuhei
    Department of Neurosurgery, Gunma University Hospital

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Other Title
  • インフォームド・コンセント充実のための統一書式の説明同意文書承認体制の構築
  • インフォームド ・ コンセント ジュウジツ ノ タメ ノ トウイツ ショシキ ノ セツメイ ドウイ ブンショ ショウニン タイセイ ノ コウチク

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Abstract

Among the medical accident issues at Gunma University Hospital, it was a significant issue that extremely poor contents for the explanation/consent form were found in the medical record. In medical practice, there are some items or contents required to be kept on record after explaining them to patients. The approval system with the unified form of explanatory document was established from October 2014 for clearly indicating the above-mentioned descriptions to medical professionals and also reliably enabling those professionals to use the form with required items in the entire hospital. Mainly for surgery, the documents have been prepared for 480, 675, and 765 cases after 1, 2, and 3 years (as of the end of September 2017) respectively. The explanatory documents such as for chemotherapy or specific disorders were also prepared in addition to the invasive medical practice. Moreover, we also conduct questionnaire surveys along with renewal contents and a question for an easy-to-understand level by patients. The documents are also provided to other facilities. We need to deal with further issues so that we can provide necessary information as being more easily understandable when a patient makes a decision for his/her own course of treatment with the full understanding.

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