著者
栗原 千絵子 松本 佳代子 石光 忠敬
出版者
公益社団法人 日本薬学会
雑誌
YAKUGAKU ZASSHI (ISSN:00316903)
巻号頁・発行日
vol.123, no.3, pp.91-106, 2003-03-01 (Released:2003-03-26)
参考文献数
102
被引用文献数
1 1

The Japanese Pharmaceutical Law was revised at the end of July 2002. The important features of this revision are the postmarketing safety scheme, especially for biological products, and reconstruction of the legislation for effective pharmaceutical development. This is based on the national policy to foster life sciences such as genetic research and regenerative medicine for both healthcare improvement and industrial promotion. Such research requires study participants who donate human tissue including abandoned embryos or aborted fetuses, which may touch the human dignity. In particular, fetal stem cell research appears to have unpredictable risks not only to women who undergo abortions but also to societal epistemology. The authors conducted risk-benefit assessment of fetal stem cell research, reviewing the scientific, ethical, legal, and social aspects, including a case study of critical appraisal on a report of the double-blind, sham surgery-controlled trial of implantation of fetal tissues in patients with Parkinson's disease conducted in the USA. It is concluded that risk-benefit assessment with a wide, profound perspective is necessary for advanced biotechnology. Some types of research should not be assessed based only on such utilitarian viewpoints as risk and benefit. Conscientious reflection is necessary to reach a public consensus on which types of human material can be utilized as research or pharmaceutical resources.
著者
栗原 千絵子
出版者
一般社団法人 日本臨床薬理学会
雑誌
臨床薬理 (ISSN:03881601)
巻号頁・発行日
vol.45, no.2, pp.41-51, 2014-03-31 (Released:2014-04-16)
参考文献数
64

The latest revision of the Declaration of Helsinki was adopted by the World Medical Association (WMA) in October 2013. The year 2014 is the 50th anniversary since the first adoption of the Declaration in 1964, which was based on strong reflection over the unethical human experimentation conducted by doctors during World War II. Subsequently, the WMA has continuously elaborated the Declaration with the goal to prevent abuse of human dignity, and to guide physicians worldwide toward the conduct of ethically and scientifically sound research involving human subjects, to adhere to their duty of working for the patients' best interest.The most remarkable points discussed toward this 2013 revision are: (1) adding subheadings; (2) creating a provision to assure compensation and treatment for subjects harmed as a result of research; (3) clarifying the provisions of comparators e.g., placebo; (4) clarifying the provisions of protecting vulnerable populations and post-study arrangement; (5) adding the concept of biobank in the provision of research using human material and/or data; (6) strengthening the function of research ethics committees; (7) expanding the range of research to be registered in public database; and (8) clarifying the provision of the use of unproven intervention.There remain pros and cons of the principles in the revised Declaration; however, it is important to understand the historical background and continuing debates regarding the Declaration as a "living document". In this paper, the author describes such discussions that are believed to promote profound understanding of this document, which are necessary for the research communities in the world to conduct ethically and scientifically sound research involving human subjects.
著者
栗原 千絵子
出版者
日本保健物理学会
雑誌
保健物理 (ISSN:03676110)
巻号頁・発行日
vol.54, no.1, pp.19-28, 2019-04-18 (Released:2019-09-03)
参考文献数
26
被引用文献数
2

The International Commission on Radiological Protection (ICRP) issued in February 2018 the Publication 138, titled “Ethical foundation of radiological protection system.” Although the ICRP has longtime recognized that ethics is an essential component of their radiological protection system, they have rarely described explicitly about the ethical foundation of the system. For this reason, the Commission established in 2012 the task group 94 to clarify and describe the ethical foundation of the system. As the result, the publication shows the process of evolution of the radiological protection system through 20th century until now, which leads to the identification of four core ethical values underpinning the system: beneficence and non-maleficence; prudence; justice; and dignity, along with related procedural values: accountability; transparency; and inclusiveness (stakeholder participation). As one of the authors of this publication, I will briefly introduce the developing process and the outlines of it, and additionally will provide a short summary of my experience of discussion through the workshops worldwide, concerning the nuclear accident of the Fukushima Daiichi Nuclear Power Station, as well as commonalities and diversities of Western and Asian perspectives of ethical core values.
著者
高田 恵子 森 淑江 辻村 弘美 宮越 幸代 栗原 千絵子 長嶺 めぐみ
出版者
北関東医学会
雑誌
北関東医学 (ISSN:13432826)
巻号頁・発行日
vol.60, no.1, pp.31-40, 2010-02-01 (Released:2010-03-17)
参考文献数
11

【目 的】 国際看護協力を行う際の問題点の一つとして, 派遣された国における看護に関する考え方や看護技術の日本との違いが挙げられる. 開発途上国に対する効果的な看護協力のために, ラオスで活動した青年海外協力隊看護職隊員の面接調査と活動報告書を分析し, 看護の差異を明らかにすることを目的とする. 【方 法】 看護職隊員14名の活動報告書, 5名の隊員に面接調査を実施し, 作成された逐語録から日本と異なる看護に関する記述を抽出し,「看護技術/助産技術到達目標」(厚生労働省2003) を参考に分類した. 【結 果】 日本と異なる看護の記述は「感染予防の技術」,「症状・生態機能管理技術」,「与薬の技術」に関する内容が多く, 患者の身の回りの世話は家族が行っていた. 助産技術は分娩期, 妊娠期についての記述が多かった. 【結 語】 ラオスと日本の看護の違いが明確化された. それらは, 今後の国際看護協力活動において多大に寄与するものと考える.
著者
澤口 聡子 加茂 登志子 米山 万里枝 滝口 清昭 坂本 慎一 大脇 敏之 多木 崇 栗原 千絵子 加藤 則子 佐藤 啓造 京相 雅樹 平澤 恭子 加茂 登志子 杉山 登志朗 森 友久
出版者
国立保健医療科学院
雑誌
挑戦的萌芽研究
巻号頁・発行日
2014-04-01

解離性同一性障害における複数人格を音声録音しSOFTware PRAATの基本周波数分析で人格識別することが可能であった。PRAATの関係する要因を用いた個人を対象とする(nested)多値logistic回帰分析および一般線形モデルを構築し、前者において0.5<odds ratio<1.0、後者において尤度比・LR統計量>0.05を一つの目安として、専門医にアクセスする対応方針で臨床研究をすすめ得る。薬剤使用時の客観指標としてMetaRNA(複数のRNA・mRNA分子種)測定モデルを作成し治療や研究の潜在的なnavigationを与え得る。anticiper de ja saisirを推唆。