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Practical approach for collection study of human biomaterials on intractable skin diseases

山口医学 Volume 62 Issue 4 Page 199-204
published_at 2013-11-01
B030062000402.pdf
[fulltext] 1.53 MB
Title
ヒト生体試料を利用した医学研究への実践的対応
Practical approach for collection study of human biomaterials on intractable skin diseases
Creators Muto Masahiko
Source Identifiers
Creator Keywords
ヒト生体試料 研究資源 品質管理 知的財産権の保護 バンク事業
稀少かつ難治な7つの皮膚疾患(天疱瘡,表皮水疱症,先天性魚鱗癬様紅皮症[非水疱型先天性魚鱗癬様紅皮症],膿疱性乾癬,神経線維腫症(Ⅰ・Ⅱ),色素性乾皮症,結節性硬化症の7疾患の生体試料(血液由来の遺伝子,血清および皮膚組織)の収集を厚生労働科学研究費補助金事業の一環として2009年度に着手した.その永続的な管理運営体制の構築に向けて,乗り越えなければならない問題点を探索した.その結果,(1)生体試料は一体誰のものか,(2)研究成果物の知的財産権の帰属先はどこか,ということが問題点として浮上してきた.それに対して,現行のインフォームド・コンセント法理をもってしても不十分であり,社会への利益還元の方策を解決すること,そして配分的正義に基づく研究者間での利益分配の思想の導入の必要性を主張した.
Our research project was to collect human biomaterials, as a part of the Research on Measures for Intractable Diseases of the Ministry of Health, Labour and Welfare, Japan, including human blood and skin tissue from the patients who are affected in 7 different intractable skin diseases. The seven diseases consisted of pemphigus, epidermolysis bullosa, congenital ichthyosiform erythroderma, generalized pustular psoriasis, neurofibromatosis(I・II),xeroderma pigmentosum, and tuberous sclerosis(Bourneville-Pringle diseases).We are trying to develop bio bank for a continuous medical research for the intractable skin diseases. In order to carry out the study plan, we have the two major problems;first, who has the property for the corresponding human bio materials? Second, who has an official right based on patent law? To resolve the above problems, between patients including their family members and doctors, there should be fiducial qualities on thinking informed consent, based on freedom of choice from the patient side and fairness. Moreover some practical laws including material transfer agreement should be present in Japan.
Subjects
医学 ( Other)
Languages jpn
Resource Type journal article
Publishers 山口大学医学会
Date Issued 2013-11-01
File Version Version of Record
Access Rights open access
Relations
[ISSN]0513-1731
[NCID]AN00243156
Schools 大学院医学系研究科(医学)