研究公正に関する自己記述式尺度における質問文の検討 : 尺度作成における議論を通して

京都府立医科大学大学院医学研究科医学生命倫理学人文・社会科学教室京都府立医科大学大学院医学研究科生物統計学教室京都府立医科大学大学院保健看護学研究科東京医科歯科大学臨床医学教育学開発分野新潟大学創生学部日本医科大学医療管理学京都府立医科大学大学院医学研究科生命基礎数理学教室京都府立医科大学大学院医学研究科医療フロンティア展開学九州大学病院ARO次世代医療センター群馬パース大学教養部AMED研究公正高度化モデル開発支援事業「学際的アプローチによる研究倫理教育のモデル評価プログラムの開発と検証」（瀬戸山班）では、研究活動に関する倫理的意思決定を測定する尺度を開発している。本論文では、この開発中の尺度の質問文に着目し、自己記述式尺度が抱える問題点を克服するため、質問文の作成において検討した内容や、この質問文のオリジナリティ、課題について述べる

研究活動における「隠れたカリキュラム」の可視化の試み : 重回帰分析による分析と考察

京都府立医科大学大学院医学研究科医学生命倫理学人文・社会科学教室京都府立医科大学大学院医学研究科生命基礎数理学教室京都府立医科大学大学院医学研究科生物統計学教室京都府立医科大学大学院保健看護学研究科東京医科歯科大学臨床医学教育学開発分野新潟大学創生学部日本医科大学医療管理学京都府立医科大学大学院医学研究科医療フロンティア展開学九州大学病院ARO次世代医療センター群馬パース大学教養部本稿では，医学教育分野で注目されている「隠れたカリキュラム（hidden curriculum）」を，医学研究の倫理分野において倫理的意思決定やそれに影響を与える組織の環境に応用し，研究倫理に関する規範意識・行動様式を問う情意領域問題の測定尺度を作成したものを用いて，「あなたならばどう行動するか」と「あなたの周りの人ならばどう行動すると考えるか」についてそれぞれ質問を行い，その得点差を見ることで隠れたカリキュラムの影響を可視化することを試みた。その結果，全体及びすべてのカテゴリーにおいて「あなたならばどう行動するか」の得点が高いこと，属性との関連について調べたところ，一部のカテゴリーと性別，人に関わる研究の有無で有意な得点差がみられた

Development and Use of Gene Therapy Orphan Drugs—Ethical Needs for a Broader Cooperation Between the Pharmaceutical Industry and Society

Gene therapy orphan medicinal products constitute a unique group of new drugs which in case of hereditary diseases are usually administered only once at an early age, in the hope to provide sufficient gene product to last for the entire life of the patients. The combination of an exceptionally large single payment and the life-long clinical follow-up needed for understanding the long-term benefits and safety of gene therapy, represent new types of scientific, financial, social and ethical challenges for the pharmaceutical industry, regulators and society. With special consideration of the uniqueness and importance of gene therapy, the authors propose a three points plan for a close cooperation between the pharmaceutical industry and society to develop orphan gene therapy. (1) In fully transparent health technology negotiations a close and long-lasting, contractually fixed cooperation should be established between the manufacturers and local health-care stakeholders for sharing the medical and scientific benefits, the financial risks as well as the burdens of the post-authorization clinical and regulatory development. (2) The parties should agree on a fair, locally affordable drug price without the usually very high premium price calculated to compensate for the low number of patients. In case of high manufacturing costs, the companies should offer prolonged, 15–20 years long payment by installment with risk-sharing, especially considering that the late outcome of the treatment is unknown. Society should assist scientifically and financially organizing a specific patient registry, treatment in specialized hospitals and adequate long-term follow-up of patients, the coordinated management of financial transactions related to the risk sharing program. (3) The post-authorization treatment and prolonged observation of additional new cases coordinated by society should provide real world data needed for the modern complex regulatory evaluation of gene therapy products by the competent authorities. We assume that fair sharing of the benefits and risks as well as a well-organized cooperation of society with the industry in collecting real world evidence might result in better drug evaluation and improved accessibility due to lower prices. The outlined concept might support gene therapy more efficiently than the presently requested outstandingly high prices

Linking the Declarations of Helsinki and of Taipei: Critical Challenges of Future-Oriented Research Ethics

Expansion of data-driven research in the 21st century has posed challenges in the evolution of the international agreed framework of research ethics. The World Medical Association (WMA)’s Declaration of Helsinki (DoH) has provided ethical principles for medical research involving humans since 1964, with the last update in 2013. To complement the DoH, WMA issued the Declaration of Taipei (DoT) in 2016 to provide additional principles for health databases and biobanks. However, the ethical principles for secondary use of data or material obtained in research remain unclear. With such a perspective, the Working Group on Ethics (WGE) of the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) suggests a closer scientific linkage in the DoH to the (Declaration of Taipei) DoT focusing specifically on areas that will facilitate data-driven research, and to further strengthen the protection of research participants