胎児組織の研究利用問題に関するメモ
（2000年12月31日バージョン）
自分のメモとしてまとめたものですので、十分なものではありません。案外、基本的な資料がぬけていたりするかもしれません。まとめかたも不統一です。大きな間違い等がありましたら、玉井真理子（mtamai@gipac.shinshu-u.ac.jp）までご一報いただければ幸いです。
【胎児組織研究利用に関連する指針等】
＜国や国際機関の指針等[１]＞
■イギリス保健社会保障省の助言者集団による「胎児および胎児性試料の研究利用、助言者集団による報告書（ピール報告書）」
Department
of Health and Social Security (1972) The use of fetuses and fetal material for
research, report of the advisory group (Peel report) Her Majesty's Stationary
Office, London
■フランス・生命科学と保健に関する国家倫理諮問委員会による「治療、診断、科学的目的での死亡胎児組織および胚組織の利用についての勧告」
National
Consultative Ethics Committee for Life Sciences and Health (CNESVS) (1984)
Recommendation on the use of embryo tissue as well as tissue of dead foetuses
for therapeutic, diagnostic and scientific purposes.
■オランダ保健審議会の委員会による「胎児組織およびその他の中絶残余物を科学的目的のために提供および利用する際の助言」
Committee
of the Netherlands Health Council (1984) Advice on donation and use of fetuses,
fetal tissue and other remains of abortion for scientific purposes (Kuitert
report), Health Council of The Netherlands, Den Haag, no 19
■ヨーロッパ審議会による「ヒト胚と胎児の診断、治療、科学、工業、商業目的での利用について」
Parliamentary
Assembly of the Council of Europe (1986) On the use of human embryos and
foetuses for diagnostic, therapeutic, scientific, industrial and commerical
purposes. Council of Europe, Strasbourg, Recommendation 1046
■ヨーロッパ審議会の科学技術委員会による「ヒト胚および胎児に関連する科学研究についての報告書」
Committee
on Science and Technology (1988) Report on scientific research relating to the
human embryo and foetus (Rapporteur: A. Palacios). Parliamentary Assembly of
Council of Europe, Strasbourg, Doc 5943
■アメリカ保健およびヒューマンサービス省による「ヒト胎児組織移植研究検討会報告書」
US
Department of Health and Human Services. Public Health Services and National
Institutes of Health (1988) Report of the Human Fetal Tissue Transplantation
Research Panel. US Government Printing Office
このPanelを作るようにNIHに指示したHHS保健次官補ウィンダムの手紙はこちら
■ヨーロッパ審議会による「ヒト胚と胎児の科学研究目的での利用について」
Parliamentary
Assembly of the Council of Europe (1989) On the use of human embryos and
foetuses for scientific research. Council of Europe, Strasbourg, Recommendation
1100
■イギリス保健社会保障省による「胎児および胎児性試料の研究と利用についての指導の概観（ポーキングホーン報告書）」[２]
Department
of Health and Social Security (1989) Review of the guidance on the research and
use of fetuses and fetal material (Polkinghorne report), Her Majesty's
Stationary Office, London, Cm 762
■オランダ・医学研究に関する倫理的側面に関する委員会の年次報告書
Dutch
Committee on Ethical Aspects of Medical Research (1993) Annual Report 1991 and
1992. Health Council of The Netherlands, Den Haag, publication K93/01
＜専門家集団による指針等＞
■世界医師会の胎児組織移植に関する声明
WMA
(1990) World Medical Association Statement on Fetal Tissue Transplantation http://www.wma.net/e/policy/17-t_e.htmlで参照可
■イギリス医師会の指針
BMA
guidelines on the use of fetal tissue (1988) The Lancet I: 1119
■アメリカ医師会の立場
American
Medical Association (1990) Medical applications of fetal tissue
transplantation. JAMA 263: 565-570
■ヨーロッパ中枢神経系移植・修復ネットワーク(NECTAR) [３]による指針
Boer,
G. J., on behalf of the Network of European CNS Transplantation and Restoration
(NECTAR) (1994) Ethical guidelines for the use of human embryonic or fetal
tissue for experimental and clinical neurotransplantation and research, Journal
of neurology 242: 1-13
http://www.nesu.mphy.lu.se/nectar/eth.1.htmlで参照可（日本語訳はこちら）
【アメリカでの胎児組織研究利用に関連する法律・規則・通知など】
■ 統一死体提供法（Uniform
Anatomical Gift Act）
http://www.law.upenn.edu/bll/ulc/fnact99/uaga87.htm
■公法103-43、国立保健研究改訂1993年法（Public
Law 103-43, National Institute of Health Revitalization Act of 1993）
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/publiclaw103-43.htm
■合衆国規則の被験者保護のセクション（45 CFR §46
Subpart B）
【ネット上で読める論文・論文抄録・記事など―国外】
■Martin DK, Maclean H, Lowy FH, Williams
JI, Dunn EV. Fetal tissue
transplantation and abortion decisions: a survey of urban women. CMAJ. 1995 Sep
1;153(5):545-52.
http://collection.nlc-bnc.ca/100/201/300/cdn_medical_association/cmaj/vol-153/issue-5/0545.htm
■Gillam L. The 'more-abortions' objection to fetal tissue
transplantation. J Med Philos. 1998 Jun;23(4):411-27.
http://www.szp.swets.nl/szp/journals/jm234411.htm
■Schrock P. Fetal Tissue Transplantation
http://www.hsc.missouri.edu/~shrp/radsci/fetal/fetal1.html
■Oldham R. Fetal Tissue Transplantation Research
http://www.pillowrock.com/ronnie/fetalresearch.htm
■アメリカ家族計画協会（Planned
Parenthood Federation of America） Donating Fetal Tissue for Medical Treatment and Research,
2001
http://www.plannedparenthood.org/library/facts/fetaltis_010600.html
【その他の資料―国外】
■胚および胎児研究に関するアメリカ各州法の比較（State Embryonic and Fetal
Research Laws）
http://www.ncsl.org/programs/health/genetics/embfet.htm
■オーストラリア・シドニー大学医学部倫理委員会提供のヒト胎児組織利用のためのインフォームドコンセント書式サンプル(Patient Information
Document, Use of Human Fetal Tissue for Medical Research)
http://www.usyd.edu.au/ethics/human/sample/dloads/Sample%201.pdf
■アメリカ・連邦議会Subcommittee on Health & Environmentでのヒアリング
■アメリカ・連邦議会Senate Committee on Governmental Affairsでのヒアリング：S.
Hrg. 107-73 -- Tissue Banks: Is the Federal Government's Oversight Adequate?,
May 24, 2001
http://www.access.gpo.gov/congress/senate/senate12sh.html
■講義案？：胎児組織移植の法的側面（Legal Aspects of Fetal Tissue
Transplantation）
http://www.accessexcellence.org/AE/AEPC/WWC/1992/fetaltissue_legal.html
■アメリカ・アリゾナ州の胎児組織利用禁止法が違憲？
http://www.nctimes.net/news/123000/h.html
■イギリスの報告書：Independent Review Group on Retention of
Organs at Post-Mortem: Final Reportのなかの死亡胎児からの組織採取に関する記述
http://www.show.scot.nhs.uk/scotorgrev/Final%20Report/ropm-20.htm
■パーキンソン病患者に胎児組織を移植する研究をしているアメリカのカート・フリード氏について
・ 物議をかもした二重盲検プラセボ対象試験の結果を発表した論文
http://content.nejm.org/cgi/content/abstract/344/10/710
・ フリード氏の履歴、業績など
http://www2.uchsc.edu/pharm/faculty/freed.asp
・ フリード氏が所属するコロラド大学健康科学研究センター薬理学教室
http://www2.uchsc.edu/pharm/default.asp
■胎児組織移植研究をしているスウェーデンのグループのリーダーであるオレ・リンドバル氏について
・ 論文：
Lindval O., Hagell P. Cell Therapy and transplantation in Parkinson's disease.
Clin Chem Med 2001; 39(4): 356-61.
Lindval O. Stem cell transplanation. Lancet 2001; sup. 358: S47-8.
Lindval O, Bjorklund A. First step towards cell therapy for Huntington's disease.
Lancet 2000; 356: 1944-5.
・ リンドバル氏の履歴、業績など
http://www.neurol.lu.se/srn/olle/olle.html
・ リンドバル氏が所属するランド大学神経修復研究所
http://www.neurol.lu.se/srn/index.html
■胎児組織研究利用擁護派のDorothy Vawterについて
http://www.stkate.edu/mnethx/bios.html#dorothy
【雑情報―国内】
■京都大学医学部先天異常標本解析センター
http://www.kyoto-u.ac.jp/Official/guide/2-8.htm
＜紹介文より抜粋＞当センターは，「ヒトの胎児医学と先天異常の予防」に関する研究を目的として，昭和50年（1975）４月に設立された。当センターには，過去約35年間にわたって収集されたヒト胚子と胎児の標本並びにそのデータが保存され，標本数はこの種のコレクションとしては世界最大規模の約４万３千例に上っている。うち約1,000例は，全身の連続組織標本として整えられている。
■パーキンソン病治療の総説
http://square.umin.ac.jp/massie-tmd/pdtrtrev.html
Olivier Rascol,
Christopher Goetz, William Koller, Werner Poewe, Cristina Sampaio. Treatment
interventions for Parkinson's disease: an evidence based assessment. Lancet
2002; 359: 1589-98.の日本語の解説。胎児組織の移植に関しては、まだ評価が定まっていないとの記述あり。
■水頭症研究班の報告書
http://www.onh.go.jp/ns/yamasaki_hancho/ah11seika.doc
＜抜粋＞この研究には、多施設からの患者ＤＮＡを中心とした生体資料を集積するバンクを形成すること、遺伝子解析を行うこと、正常胎児脳（流産あるいは中絶胎児脳）を研究に用いることなどいくつかの倫理的配慮を要する点が含まれている。臨床研究を行っていく上での医学倫理問題について見識を深め、平成１１年9月30日国立大阪病院医学倫理委員会に「先天性水頭症の分子生物学的メカニズム解明と治療法開発」研究における倫理審査を申請し、10月18日に院外学識者３名を含む医学倫理委員会が開催され、４時間にわたる審議を経て、11月17日承認された。また研究班では、独自の『先天性水頭症患児・家族に対する研究協力についてのインフォームドコンセント』および『同意書』、『中絶された胎児・家族に対する研究協力についてのインフォームドコンセント』および『同意書』を作製し、研究協力におけるインフォームドコンセントの徹底には、細心の注意を払っている。
■中絶胎児組織移植研究をあつかった漫画
「SUN」（五味裕子）：モーニング新マグナム増刊、講談社、2000年2月、NO.13
http://www5b.biglobe.ne.jp/~skm/magnum.htm
＜上記サイトより抜粋＞提起されるものは非常に重い。どこまでが遺体でどこまでが廃棄物か、死体（生な言い方ですいません）利用としての臓器移植がありなら胎児の利用はありなのかなしなのか。利用して病を直し命をつなぐことはありなのかなしなのか。そういう倫理は努力して確立するのか、ほっといてなるようになるのを待つのか。きれいごとではおさまんないし、置かれた立場によって意見も大きく分かれるだろうし。‥というようなことを読者が考えるとして、そういう意味で貴重なまんがでしょう。
■厚生科学審議会科学技術部会ヒト幹細胞を用いた臨床研究の在り方に関する専門委員会での議論
◇中絶胎児問題がはじめて話題にされた、第５回議事録
http://www.mhlw.go.jp/shingi/2002/10/txt/s1031-1.txt
◇第10回委員会直前に出された意見書
「ヒト幹細胞を用いた臨床研究に関する情報」として、http://mi-net.org/rights/ に掲載されている。
・
ヒト幹細胞を用いた臨床研究の在り方に関する専門委員会への意見書および質問状（社民党３議員）
・
「ヒト幹細胞等を用いる臨床研究に関する指針案」への要望（優生思想を問うネットワーク）
・
死亡した胎児の利用についての要求（soshiren女(わたし)のからだ）
◇ジャーナリスト粥川準二氏の専門委員会傍聴記（日誌の一部、12/12、12/18、12/26、12/27など）
http://www2.diary.ne.jp/user/91038/
◇専門委員会での議論も含めて最近の動きを扱ったものとして
・ 毎日新聞社説、2002年12月13日、「死亡胎児利用まだまだ議論が足りない」 http://www.mainichi.co.jp/eye/shasetsu/200212/13-2.html
・ ばんぶう（日本医療企画社刊）、栗原千絵子、再生医療は「夢の医療」か？連載第１回：幹細胞臨床研究の指針と「中絶胎児資源化」の是非、2003年1月号、pp.62-67 http://www.jmp.co.jp/zasshi/banbu/mokuji0301.html
■中絶胎児組織を使わない移植研究の可能性について論じた総説
◇神経幹細胞の移植. 岩本範顕(慶応義塾大学 整形外科),
最新医学(0370-8241)57巻1号
Page90-93(2002.01)
＜アブストラクト＞障害された中枢神経系の再生は困難であるが,動物実験では胎児組織の移植が有用であると報告されている.しかし,胎児組織の移植ではその供給が不十分なうえ,倫理面でも問題があり,臨床応用は厳しいと考えられる.最近,胎児組織に代わる移植材料の候補として神経幹細胞が注目されている.神経幹細胞は自己複製能と多分化能を有する未分化な細胞で,選択的培養法により無尽蔵に増殖するので,十分なドナーの供給が可能である.
◇神経幹細胞を用いたParkinson病治療の可能性. 澤本和延(大阪大学 医系研究 神経機能),
岡野栄之, 医学のあゆみ(0039-2359)201巻5号
Page325-329(2002.05)
＜アブストラクト＞近年,胎児中脳組織に含まれる未分化な前駆細胞やドパミンニューロンをin
vitroで作製する技術が開発されつつあり,Parkinson病に対する胎児脳に代わる有望な移植材料として期待を集めている.しかし,分化誘導後の培養細胞集団の中には未知の細胞が多数含まれているため,必要な細胞を選択的に分離・濃縮して用いることが必要である.著者等は,Parkinson病の治療に有用であると思われる細胞種に発現する遺伝子のプロモーター制御下で蛍光蛋白質遺伝子を発現させ,FACSを用いて分離する方法を開発した.分離した細胞をParkinsonモデルラットの脳へ移植したところ,効率よく症状を回復させた.
【胎児（中絶胎児であるかどうかは不明）組織利用研究の国内例】
いずれも、医学中央雑誌（http://www.jamas.gr.jp/）で検索したもの
◇胎児組織移植研究◇
胎児胸腺・肝細胞移植を行った短四肢小人症を伴う免疫不全症の1例 1985年
Author：井関幹郎(慶応義塾大学),
番場正博, 倉辻忠俊
Source：日本臨床免疫学会会誌(0911-4300)8巻2号
Page117-122(1985.04)
シソーラス用語：小人症(合併症); 四肢奇形-先天性;
免疫不全症候群(合併症,外科的療法)
チェックタグ：ヒト
Abstract：短四肢小人症を伴う免疫不全症(Gatti-Lux症候群)の5歳女児に胎児胸腺・肝細胞を腹腔内に移植した.移植2週後より発熱,発疹,腹部膨満の増強,肝機能障害などが現れ,graft
versus host (GVH)反応と思われた.4 1/2ヵ月後に患児リンパ球に新しいHLA抗原の出現を認め,移植細胞が生着したと判断した.免疫学的検査所見および臨床症状は改善しなかった.患児は5ヵ月後に間質性肺炎により死亡した
T細胞欠損による複合型免疫不全症の患者における照射胎児胸腺の移植の1例(英語) 1993年
Author：Higuchi
Shigenori(熊本大免疫医研), Yanabe Yasuhide, Tsuchiya Hiroyuki, 他
Source：Acta
Paediatrica Japonica(0374-5600)35巻1号
Page39-44(1993.02)
論文種類：原著論文/症例報告
シソーラス用語：胸腺(移植); 免疫不全症候群(治療);
リンパ球(異常)
チェックタグ：ヒト; 乳児(〜2);
男
Abstract：生後6ヵ月男児。T細胞欠損による複合型免疫不全症で,T細胞数の減少,末梢血のB細胞数の増加,血清IgG濃度の低下があり,CTスキャンとMRIで胸腺像を認めなかった。胸腺ホルモンのチモシン投与によりT細胞機能は部分的に回復したが,T細胞数は正常化しなかった。生後26ヵ月に,妊娠16週の女性胎児から得た胸腺を照射後に移植した。移植後にT細胞数(主にCD4+細胞)は50-70%に増加した。軽度の移植片宿主相関反応が生じ,数種の免疫抑制剤を投与した。染色体分析では,T細胞は46XYと46XXの2つの核型をもち,一方,B細胞は46XYの核型のみであった。細胞免疫性と血清IgG濃度は低いままであった。しかし,定期的γ-グロブリンと経口的抗真菌剤の投与により,患者は現在6歳3ヵ月で,ほとんど異常なく生活している。骨髄移植の適当な提供者が得られない場合には,照射胸腺の移植は有効な方法であった
T細胞減少を伴う免疫不全症男子例における胸腺ホルモンおよび放射線処理胎児胸腺移植の治療効果 1991年
Author：樋口重典(熊本大学 小児科),
柳辺安秀, 中村倫恵, 他
Source：小児科(0037-4121)32巻8号
Page851-858(1991.08)
論文種類：原著論文/症例報告
シソーラス用語：胸腺(移植); 胸腺ホルモン(治療的利用);
免疫不全症候群(合併症,治療);
T細胞; リンパ球減少症(合併症)
チェックタグ：ヒト; 乳児(〜2);
男
abstract：なし
胎児胸腺移植が成功したDi George症候群の一例 1987年
Author：久下順子(京都大学 小児科),
他
Source：日本小児科学会雑誌(0001-6543)91巻2号
Page374(1987.02)
論文種類：会議録/症例報告
シソーラス用語：DiGeorge症候群(治療);
胸腺; 臓器移植
チェックタグ：ヒト; 乳児(〜2);
男
abstract：なし
◇基礎研究◇
無胸腺ヌードラットの眼に異種移植したヒト胎児脊髄:生存,超微細構造的分化,神経膠反応及び血管相互作用(英語) 1994年
Author：Inoue
Hiroshi K.(群馬大学 脳神経外科), Henschen Andreas, Olson
Lars
Source：Journal
of Electron Microscopy(0022-0744)43巻1号
Page1-9(1994.02)
論文種類：原著論文
シソーラス用語：異種移植; 血管; 神経膠;
脊髄(超微構造); 前眼房;
移植片
チェックタグ：ヒト; ラット; 動物;
胎児
Abstract：無胸腺ヌードラットの前房に異種移植したヒト胎児脊髄の超微細構造を検討した。移植片は長期間生着し,正常ヒト脊髄の数個の臓器典型的特徴を発現した。異なる大きさ(小,中間,大)の三つの細胞型,及び有髄軸索を持つ,或いは持たない二つの異なる型の神経線維網が中心細胞層に認められた。小ニューロンの間及び周りに無ミエリン領域が形成されており,多数の無髄線維及び微細軸索束より成っていた。宿主-移植片界面,特に宿主紅彩からの血管周囲は,星状膠細胞突起及び基底膜の著明な交互嵌合を示した。多数の線維性星状細胞及び多数の神経膠突起を含む厚い表在神経膠層も中間軸索及び中心細胞層の両者に認められた。薄壁血管は中心層で群れをなしており,それらの血管周囲腔はコラーゲン線維を含有していた。中枢神経系型血管は認められなかった
二分脊椎の遺伝と疫学 遺伝的因子による機序 1999年
Author：岡明(鳥取大学 脳神経小児科),
難波栄二, 竹下研三
Source：厚生省精神・神経疾患研究10年度研究報告書 難治性の脊髄空洞症と二分脊椎症に伴う脊髄機能障害の治療と予防に関する研究 Page109-113(1999.03)
論文種類：原著論文
シソーラス用語：疫学; 遺伝学; 脊髄癒合不全(発生学・遺伝学,疫学)
チェックタグ：人
Abstract：マウスPax3又はヒトPax3遺伝子の障害が二分脊椎の病因と推定されている.本報では早期ヒト胎児組織にPax3の発現の有無を検討するため,Pax3のリボ検体とヒト胎児脊髄検体の生体内交離を行った.Pax3のmRNAはヒトのリンフォイド細胞mRNAからRT-PCRにより求め,digoxigenineラベルのリボ検体とした.胎生9〜15週のヒト胎児脊髄の固定検体と反応させると,antisense検体で反応し,sense検体では反応しなかった.この所見はヒト神経管形成にPax3遺伝子の翻訳因子が関連することを推測させる
ヒト胎児組織における17β-hydroxysteroid
dehydrogenase type 1とtype 2,及びEstrogen
receptorの発現に関する検討 2000年
Author：武山淳二(東北大学 病理診断),
鈴木貴, 原田信広, 笹野公伸
Source：日本内分泌学会雑誌(0029-0661)76巻1号
Page185(2000.04)
論文種類：会議録
シソーラス用語：Estrogen Receptors; 17-Hydroxysteroid
Dehydrogenases; 組織; 胎児;
ヒト
チェックタグ：人
abstract：なし
ヒト胎児組織における17β-hydroxysteroid
dehydrogenase活性の検討 1999年
Author：武山淳二(東北大学 病理診断),
笹野公伸, 鈴木貴, 飯沼一宇,
中村純二, AnderssonStefan
Source：日本内分泌学会雑誌(0029-0661)75巻1号
Page190(1999.04)
論文種類：会議録
シソーラス用語：Hydroxysteroid Dehydrogenases; 酵素検査;
17-Hydroxysteroid Dehydrogenases(生化学); 組織;
胎児; ヒト
チェックタグ：人; 胎児; in vitro
abstract：なし
成人及び胎児組織における分化とアポトーシス関連遺伝子の局在 新規に作製されたモノクローナル抗体を用いた研究(英語) 1998年
Author：Sano
Makoto(慶応義塾大学 病理), 他
Source：Acta
Histochemica et Cytochemica(0044-5991)31巻2号 Page151(1998.04)
論文種類：会議録
シソーラス用語：モノクローナル抗体; 遺伝子;
組織; 胎児; 成人;
細胞分化; アポトーシス
医中誌フリーキーワード：EAT遺伝子
チェックタグ：人; 胎児; 成人(19〜44)
abstract：なし
マウス受精卵ならびにヒト胎児組織における細胞死抑制分子EATの発現 1999年
Author：佐野誠(慶応義塾大学 病理),
梅澤明弘, 鈴木淳, 本田貴宏,
下田耕二, 秦順一
Source：日本組織細胞化学会第40回記念総会・学術集会講演プラグラム・予稿集 Page185(1999.12)
論文種類：会議録
シソーラス用語：細胞死; 組織; 胎児;
ヒト; 受精卵; マウス;
遺伝子発現
医中誌フリーキーワード：EAT遺伝子
チェックタグ：人; 鼠; 動物
abstract：なし
ホルマリン及びアルコール固定胎児組織からのDNA分析 1998年
Author：安積順一(札幌医科大学),
他
Source：日本法医学雑誌(0047-1887)52巻Suppl.
Page116(1998.03)
論文種類：会議録
シソーラス用語：DNA(分析・検出); 組織;
胎児; Alcohols; Formaldehyde; 組織固定
医中誌フリーキーワード：分析; 性別の判定
チェックタグ：人
abstract：なし
ヒト胎児組織に発現する扁平上皮関連抗原の免疫組織化学的研究 2000年
Author：山内進(東海大学 医技短大),
見常多喜子
Source：東海大学短期大学紀要(0386-8664)33号
Page91-95(2000.02)
論文種類：原著論文
シソーラス用語：免疫組織化学; 腫瘍抗原(病理学);
扁平上皮癌(病理学); モノクローナル抗体;
胎児; ヒト
チェックタグ：人
Abstract：独自に開発した扁平上皮癌関連モノクローナル抗体(YM抗体)を用い,扁平上皮癌関連抗原(YM抗原)がヒト胎児の何週齢のどの臓器・組織に出現するかを検索した.また同一週齢の胎児凍結切片標本に対して最近扁平上皮癌診断用モノクローナル抗体として市販されている幾つかの抗体を使用し,YM抗体による検索結果と比較した.YM抗原が陽性を示したのは概して各種臓器・組織の上皮基底層を形成する増殖期の細胞であった.使用抗体別にみると,それぞれの抗体が認識する抗原物質の分子量は異なっているがそれぞれの抗原は相互の接近した位置にほぼ同時に出現するものや,特定の抗原のみ出現するものなど多彩であった
中高年妊婦の人工妊娠中絶胎児の染色体の検索(英語) 1990年
Author：Hoshi Nobuhiko(北海道大学 産婦人科),
YamagamiYukiko, HanataniKaoru, 他
Source：Asia-Oceania Journal of Obstetrics and
Gynaecology(0389-2328)16巻3号
Page275-281(1990.09)
Abstract：ヒトにおいて母性年齢が高まるにつれ染色体的に,また身体的に異常な児が生まれる頻度が増加すること,また妊孕能が低下することはよく知られた事実である.今回の研究は卵巣機能が低下傾向に向かう35歳以上の女性の可及的多数の人工妊娠中絶胎児を対象として染色体異常のタイプならびに出現頻度を明らかにすることを目的とした.35〜48歳の中高年齢妊婦の計934例の中絶児を染色体の面から観察した.最終月経の第1日から計算した妊娠週数は平均7.6±2.0週であった.また母体の平均年齢は39.6±2.7歳であった.染色体学的に異常の存在を認める胎児の頻度はこれら中絶児では高く,その頻度は母体年齢の増加につれて著明に上昇した.すなわち35〜39歳では9.6%(40/418),40〜44歳では20.7%(100/484),そして45〜48歳では43.8%(14/32)で平均16.5%であった.染色体異常の実態をより明らかにするためには,同じ中高年妊婦の自然流産児の同様な染色体観察をさらに行うことが必要と考える
中絶胎児組織利用のモラトリアムが解除されたときのNIHからの通知（1993年）
http://grants.nih.gov/grants/guide/notice-files/not93-235.html
公法103-43・国立保健研究所改訂1993年法の規定改正に伴う治療的ヒト胎児組織移植研究の実施と援助のための暫定指針の廃止
WITHDRAWAL
OF INTERIM NIH GUIDELINES FOR THE SUPPORT AND CONDUCT OF THERAPEUTIC HUMAN
FETAL TISSUE TRANSPLANTATION RESEARCH IN LIGHT OF SUPERSEDING PROVISIONS OF
PUBLIC LAW 103-43, THE NATIONAL INSTITUTES OF HEALTH REVITALIZATION ACT OF 1993
NIH
GUIDE, Volume 22, Number 32, September 3, 1993
P.T. 34
Keywords:
Human
Subjects Policy, Abortion (Induced), Biological Resources, National Institutes
of Health
要約：国立保健研究所は、公法103-43・国立保健研究所改訂1993年法の改正に伴う治療的ヒト胎児組織移植研究の実施と援助のための暫定指針の廃止を発表するものである。法の適切な規定の概要は以下のとおりである。
SUMMARY:
The National Institutes of Health (NIH) is announcing the withdrawal of its
interim guidelines for the support and conduct of therapeutic human fetal
tissue transplantation research because of the superseding provisions of P.L.
103-43, the National Institutes of Health Revitalization Act of 1993. A summary
of pertinent provisions of the Act is provided below.
背景
Background
1993年1月22日、クリントン大統領は、保健およびヒューマンサービス省の長官（Secretary of Health and Human Services）に対して５年間のモラトリアムを終了するように指示した。人工妊娠中絶胎児から採取されたヒト胎児組織を用いる移植治療の研究に連邦の資金を拠出することについてのモラトリアムである。
On
January 22, 1993, President Clinton issued a directive to the Secretary of
Health and Human Services ending a five-year moratorium on Federal funding of
therapeutic transplantation research that uses human fetal tissue derived from
induced abortions.
保健およびヒューマンサービス省の長官であるドナ・E・シャララは、国立保健研究所（NIH：National Institutes of Health）に大統領のこの意向を伝えた。かくして、1993年の２月１日をもってモラトリアムは正式に取り消されたのである。
Secretary
of Health and Human Services Donna E. Shalala notified the National Institutes
of Health (NIH) of the President's action, and then formally revoked the moratorium
on February 1, 1993.
同時に、長官は、健康局の長官実務補佐（the Acting Assistant Secretary
for Health）を通して、NIHに当座の指針（interim guidelines）を策定するように指示した。ヒト胎児組織移植の研究に連邦資金を拠出することは中絶の選択を助長するものではないことを明確にするために、1988年のヒト胎児組織移植研究検討会（the 1988 Human Fetal Tissue Transplantation Research Panel）の勧告に基づいた指針を策定するように指示したのである。
At
the same time, the Secretary, through the Acting Assistant Secretary for
Health, directed the NIH to develop interim guidelines based on the
recommendations of the 1988 Human Fetal Tissue Transplantation Research Panel
to ensure that Federal funding of human fetal tissue transplantation research
does not encourage the choice of abortion.
これにより、NIHが準備し、そして健康局の長官実務補佐が間に入るかたちで、1988年のヒト胎児組織移植研究検討会とNIH所長への助言委員会の勧告に基づいた当座の政策指針が示された。
Accordingly,
the NIH prepared, and transmitted to the Acting Assistant Secretary for Health,
interim policy guidelines based on the recommendations of the 1988 Human Fetal Tissue
Transplantation Research Panel and the Advisory Committee to the Director, NIH.
この当座のNIH指針は、1993年の5月に、研究助成のためのNIHガイド第22巻11号（the
NIH Guide for Grants and Contracts, Vol. 22, No. 11）の中に示された。
Those
interim guidelines were published in the NIH Guide for Grants and Contracts on
March 19, 1993 (Vol. 22, No. 11).
Action
1993年6月10日に施行された公法103-43の規定の大幅改正にともなってヒト胎児組織移植治療研究の実施と援助のためのNIH暫定指針をここに廃止するものである。最終的な指針がこの先示されることはない。
The
NIH Interim Guidelines for the Support and Conduct of Therapeutic Human Fetal
Tissue Transplantation Research are hereby withdrawn in light of the
comprehensive and superseding provisions of P.L. 103-43, enacted June 10, 1993.
Final guidelines will not be issued.
Additional
Information
公法103-43・国立保健研究所改訂1993年法によって加えられた公衆衛生法のセクション498Bに関心を向けなければならない。胎児組織移植に関するそのセクションの規定は以下のように要約される。
Attention
is directed to section 498A of the Public Health Service Act (42 U.S.C. 289g-1)
added by P.L. 103-43, the NIH Revitalization Act of 1993. The provisions of
that section pertinent to research on transplantation of fetal tissue are
summarized as follows:
・Human fetal tissue means tissue or cells
obtained from a dead human embryo or fetus after a spontaneous or induced
abortion, or after a stillbirth.
・Human fetal tissue may be used regardless
of whether the tissue is obtained pursuant to a spontaneous or induced abortion
or pursuant to a stillbirth.
・The Secretary of Health and Human
Services may conduct or support research on the transplantation of human fetal
tissue for therapeutic purposes.
・The woman donating the human fetal tissue
must sign a statement declaring that the tissue is being donated for
therapeutic transplantation research, the donation is being made without any restriction
regarding the identity of individuals who may be the recipients of
transplantations of the tissue, and the donation is being made without her (the
donor) having been informed of the identity of those individuals who may be the
recipients.
・The attending physician must sign a
statement declaring that the tissue has been obtained in accord with the
donor's signed statement and that full disclosure has been made to the donating
woman of (1) the attending physician's interest, if any, in the research to be
conducted with the tissue, and (2) any known medical risks to the donor or
risks to her privacy that might be associated with the donation of the tissue and
are in addition to the risks associated with the woman's medical care. In the
case of tissue obtained pursuant to an induced abortion, the attending physician's
statement must also declare that the consent of the woman for the abortion was
obtained prior to requesting or obtaining consent for donation, the abortion
was conducted in accord with applicable State Law, and no alteration of the
timing, method, or procedures used to terminate the pregnancy was made solely
for the purposes of obtaining the tissue.
・The individual with the principal
responsibility for conducting the research must sign a statement declaring that
the individual is aware that the tissue is human fetal tissue donated for
research purposes and may have been obtained pursuant to a spontaneous or
induced abortion or pursuant to a stillbirth; that the principally responsible
researcher has provided such information to other individuals with responsibilities
regarding the research; that the principally responsible researcher will
require, prior to obtaining the consent of a person to be a recipient of a
transplantation of the tissue, written acknowledgment of receipt of the
foregoing information by such recipient; and that the principally responsible
researcher has had no part in any decisions as to the timing, method, or
procedures used to terminate the pregnancy made solely for the purposes of the
research.
・Human fetal tissue may be used only if
the head of the agency or other entity conducting the research involved
certifies to the Secretary of Health and Human Services that the statements
required herein will be available for audit by the Secretary [HHS].
・Research involving the transplantation of
human fetal tissue for therapeutic purposes must be conducted in accord with
applicable State law and the Secretary may not provide support for such
research unless the applicant for assistance agrees to so conduct the research.
The conduct of such research by the Secretary must be in accord with applicable
State and local law.
公法103-43・国立保健研究所改訂1993年法によって加えられた公衆衛生法のセクション498Bの公布は以下のように要約できる。
The
provisions of section 498B of the Public Health Service Act (42 U.S.C 289g-2),
added by P.L. 103-43, the NIH Revitalization Act of 1993, are summarized as
follows:
・It shall be unlawful for any person to knowingly
acquire, receive, or otherwise transfer any human fetal tissue for valuable
consideration if the transfer affects interstate commerce. (Valuable
consideration does not include reasonable payments associated with the transportation,
implantation, processing, preservation, quality control, or storage of human
fetal tissue.)
・It shall be unlawful for any person to
solicit or knowingly acquire, receive, or accept a donation of human fetal
tissue for the purpose of transplantation of such tissue into another person if
the donation affects interstate commerce, the tissue will be or is obtained
pursuant to an induced abortion, and (1) the donation will be or is made pursuant
to a promise to the donating individual that the donated tissue will be
transplanted into a recipient specified by such individual; (2) the donated
tissue will be transplanted into a relative of the donating individual; or (3)
the person who solicits or knowingly acquires, receives, or accepts the
donation has provided valuable consideration for the costs associated with such
abortion. (Valuable consideration does not include reasonable payments
associated with the transportation, implantation, processing, preservation,
quality control, or storage of human fetal tissue.)
・Any person who violates these provisions
shall be (1) fined in accordance with Title 18 United States Code, except that
the fine shall be not less than twice the amount of any valuable consideration received,
(2) imprisoned for not more than 10 years, or (3) penalized as described in
both (1) and (2).
INQUIRIES
Written
comments may be mailed or delivered (between 9 a.m. and 5 p.m. weekdays).
Comments received may be inspected at the same location during these hours.
F.
William Dommel, Jr., J.D.
Senior
Policy Advisor
Office
for Protection from Research Risks
Building
31, Room 5B63
Bethesda,
MD 20892
Telephone:
(301) 496-7005
NIH研究者によるヒト胎児組織の研究利用に関する条件の要約（2000年）
http://www1.od.nih.gov/oir/sourcebook/oversight/human-tissue-use.htm
Summary
of Federal Provisions Pertaining to Research Use of Human Fetal Tissue by NIH
Investigators
(In
addition to those required by 45CFR Part 16, Subparts A,C, and/or D)
If
you conduct research that involves transplantation of human fetal tissue, you
should follow:
http://grants.nih.gov/grants/guide/notice-files/not93-235.html
(NIH
Guide, Volume 22 #22, September 3, 1993, "Withdrawal of Interim NIH
Guidelines for the Support and Conduct of Therapeutic Human Fetal Tissue
Transplantation Research in Light of Superseding Provisions of Public Law
103-43, The NIH Revitalization Act of 1993"). This guidance summarizes
provisions on the acquisition and use of human fetal tissue for
transplantation.
If
you conduct basic research that uses human fetal tissue, with no transplantation, the following provisions
apply to your acquisition and use of fetal tissue:
No
profits should be involved:
42
USC 289g-2 Provides that it is "unlawful for any person to knowingly acquire,
receive, or otherwise transfer any human fetal tissue for valuable
consideration in interstate commerce. Human fetal tissue means tissues or cells
obtained from a dead human embryo or fetus after a spontaneous or induced
abortion or after a stillbirth. Valuable consideration does not include
reasonable payments associated with the transportation, implantation,
processing, preservation, quality control, or storage of human fetal
tissue."
Researchers
should have no involvement in the termination of pregnancy:
45CFR
46.206(a)(3) Individuals who use fetal tissue in their research "will have
no part in (i) any decisions as to the timing, method, and procedures used to
terminate the pregnancy, and (ii) determining the viability of the fetus at the
termination of the pregnancy" that generates the tissue they use.
The
tissue must be obtained in accordance with state and local law:
45CFR
46.210: "Activities involving the dead fetus, macerated fetal material, or
cells, tissue, or organs excised from a dead fetus shall be conducted only in
accordance with any applicable State or local laws regarding such
activities."
If you conduct any type of research on
human fetal tissue, you should consult with the Office of Human Subjects
Research (Alan Sandler, 301-402-3444) and then with your Institute's
Institutional Review Board (IRB).
September
20, 2000
合衆国規則：被験者保護（45CFR46, 2001年）
CODE
OF FEDERAL REGULATIONS
TITLE
45 PUBLIC WELFARE
DEPARTMENT OF HEALTH AND HUMAN
SERVICES
NATIONAL INSTITUTES OF HEALTH
OFFICE FOR PROTECTION FROM RESEARCH RISKS
PART
46 PROTECTION OF HUMAN SUBJECTS
Revised November
13, 2001 (Effective December 13, 2001)
Subpart
B Additional Protections for Pregnant
Women, Human Fetuses and Neonates Involved in Research
Source:
Federal Register: November 13, 2001 (Volume 66, Number 219), Rules and
Regulations, Page 56775-56780, from the Federal Register Online via GPO Access
[wais.access.gpo.gov] [DOCID:fr13no01-9].
§46.201
To what do these regulations apply?
(a)
Except as provided in paragraph (b) of this section, this subpart applies to
all research involving pregnant women, human fetuses, neonates of uncertain
viability, or nonviable neonates conducted or supported by the Department of
Health and Human Services (DHHS). This includes all research conducted in DHHS
facilities by any person and all research conducted in any facility by DHHS
employees.
(b) The exemptions at Sec. 46.101(b)(1) through
(6) are applicable to this subpart.
(c) The provisions of Sec. 46.101(c) through (i)
are applicable to this subpart. Reference to State or local laws in this
subpart and in Sec. 46.101(f) is intended to include the laws of federally
recognized American Indian and Alaska Native Tribal Governments.
(d) The requirements of this subpart are in
addition to those imposed under the other subparts of this part.
§46.202
Definitions.
The definitions in Sec. 46.102 shall be
applicable to this subpart as well. In addition, as used in this subpart:
(a) Dead fetus means a fetus that exhibits
neither heartbeat, spontaneous respiratory activity, spontaneous movement of
voluntary muscles, nor pulsation of the umbilical cord.
(b) Delivery means complete separation of the
fetus from the woman by expulsion or extraction or any other means.
(c) Fetus means the product of conception from
implantation until delivery.
(d) Neonate means a newborn.
(e) Nonviable neonate means a neonate after
delivery that, although living, is not viable.
(f) Pregnancy encompasses the period of time
from implantation until delivery. A woman shall be assumed to be pregnant if
she exhibits any of the pertinent presumptive signs of pregnancy, such as
missed menses, until the results of a pregnancy test are negative or until
delivery.
(g) Secretary means the Secretary of Health and
Human Services and any other officer or employee of the Department of Health
and Human Services to whom authority has been delegated.
(h) Viable, as it pertains to the neonate, means
being able, after delivery, to survive (given the benefit of available medical
therapy) to the point of independently maintaining heartbeat and respiration.
The Secretary may from time to time, taking into account medical advances,
publish in the Federal Register guidelines to assist in determining whether a
neonate is viable for purposes of this subpart. If a neonate is viable then it
may be included in research only to the extent permitted and in accordance with
the requirements of subparts A and D of this part.
§46.203
Duties of IRBs in connection with research involving pregnant women, fetuses,
and neonates.
In addition to other responsibilities assigned
to IRBs under this part, each IRB shall review research covered by this subpart
and approve only research which satisfies the conditions of all applicable
sections of this subpart and the other subparts of this part.
§46.204
Research involving pregnant women or fetuses.
Pregnant women or fetuses may be involved in
research if all of the following conditions are met:
(a) Where scientifically appropriate,
preclinical studies, including studies on pregnant animals, and clinical
studies, including studies on nonpregnant women, have been conducted and
provide data for assessing potential risks to pregnant women and fetuses;
(b) The risk to the fetus is caused solely by
interventions or procedures that hold out the prospect of direct benefit for
the woman or the fetus; or, if there is no such prospect of benefit, the risk
to the fetus is not greater than minimal and the purpose of the research is the
development of important biomedical knowledge which cannot be obtained by any
other means;
(c) Any risk is the least possible for achieving
the objectives of the research;
(d) If the research holds out the prospect of
direct benefit to the pregnant woman, the prospect of a direct benefit both to
the pregnant woman and the fetus, or no prospect of benefit for the woman nor
the fetus when risk to the fetus is not greater than minimal and the purpose of
the research is the development of important biomedical knowledge that cannot
be obtained by any other means, her consent is obtained in accord with the
informed consent provisions of subpart A of this part;
(e) If the research holds out the prospect of
direct benefit solely to the fetus then the consent of the pregnant woman and
the father is obtained in accord with the informed consent provisions of
subpart A of this part, except that the father's consent need not be obtained
if he is unable to consent because of unavailability, incompetence, or
temporary incapacity or the pregnancy resulted from rape or incest.
(f) Each individual providing consent under
paragraph (d) or (e) of this section is fully informed regarding the reasonably
foreseeable impact of the research on the fetus or neonate;
(g) For children as defined in Sec. 46.402(a)
who are pregnant, assent and permission are obtained in accord with the
provisions of subpart D of this part;
(h) No inducements, monetary or otherwise, will
be offered to terminate a pregnancy;
(i) Individuals engaged in the research
will have no part in any decisions as to the timing, method, or procedures used
to terminate a pregnancy; and
(j) Individuals engaged in the research
will have no part in determining the viability of a neonate
§46.205
Research involving neonates.
(a) Neonates of uncertain viability and
nonviable neonates may be involved in research if all of the following
conditions are met:
(1) Where scientifically appropriate,
preclinical and clinical studies have been conducted and provide data for
assessing potential risks to neonates.
(2) Each individual providing consent
under paragraph (b)(2) or (c)(5) of this section is fully informed regarding
the reasonably foreseeable impact of the research on the neonate.
(3) Individuals engaged in the research
will have no part in determining the viability of a neonate.
(4) The requirements of paragraph (b) or
(c) of this section have been met as applicable.
(b)Neonates of uncertain viability. Until
it has been ascertained whether or not a neonate is viable, a neonate may not
be involved in research covered by this subpart unless the following additional
conditions have been met:
(1) The IRB determines that:
(i) The research holds out the prospect
of enhancing the probability of survival of the neonate to the point of
viability, and any risk is the least possible for achieving that objective, or
(ii) The purpose of the research is the
development of important biomedical knowledge which cannot be obtained by other
means and there will be no added risk to the neonate resulting from the
research; and
(2) The legally effective informed consent
of either parent of the neonate or, if neither parent is able to consent
because of unavailability, incompetence, or temporary incapacity, the legally
effective informed consent of either parent's legally authorized representative
is obtained in accord with subpart A of this part, except that the consent of
the father or his legally authorized representative need not be obtained if the
pregnancy resulted from rape or incest.
(c) Nonviable neonates. After delivery nonviable
neonate may not be involved in research covered by this subpart unless all of
the following additional conditions are met:
(1) Vital functions of the neonate will not be artificially
maintained;
(2) The research will not terminate the heartbeat or
respiration of the neonate;
(3) There will be no added risk to the neonate resulting
from the research;
(4) The purpose of the research is the development of
important biomedical knowledge that cannot be obtained by other means; and
(5) The legally effective informed consent of both parents
of the neonate is obtained in accord with subpart A of this part, except that
the waiver and alteration provisions of Sec. 46.116(c) and (d) do not apply.
However, if either parent is unable to consent because of unavailability,
incompetence, or temporary incapacity, the informed consent of one parent of a
nonviable neonate will suffice to meet the requirements of this paragraph
(c)(5), except that the consent of the father need not be obtained if the
pregnancy resulted from rape or incest. The consent of a legally authorized
representative of either or both of the parents of a nonviable neonate will not
suffice to meet the requirements of this paragraph (c)(5).
(d)
Viable neonates. A neonate, after delivery, that has been determined to be
viable may be included in research only to the extent permitted by and in
accord with the requirements of subparts A and D of this part.
§46.206 Research involving, after delivery, the placenta, the dead
fetus or fetal material.
分娩後の、胎盤、死亡胎児、胎児由来試料を利用する研究
(a) Research involving, after delivery, the placenta; the dead
fetus; macerated fetal material; or cells, tissue, or organs excised from a
dead fetus, shall be conducted only in accord with any applicable Federal,
State, or local laws and regulations regarding such activities.
(b) If information associated with material described in paragraph
(a) of this section is recorded for research purposes in a manner that living
individuals can be identified, directly or through identifiers linked to those
individuals, those individuals are research subjects and all pertinent subparts
of this part are applicable.
§46.207 Research not otherwise
approvable which presents an opportunity to understand, prevent, or alleviate a
serious problem affecting the health or welfare of pregnant women, fetuses, or
neonates.
The
Secretary will conduct or fund research that the IRB does not believe meets the
requirements of Sec. 46.204 or Sec. 46.205 only if:
(a)
The IRB finds that the research presents a reasonable opportunity to further
the understanding, prevention, or alleviation of a serious problem affecting
the health or welfare of pregnant women, fetuses or neonates; and
(b)
The Secretary, after consultation with a panel of experts in pertinent
disciplines (for example: science, medicine, ethics, law) and following
opportunity for public review and comment, including a public meeting announced
in the Federal Register, has determined either:
(1) That the research in fact satisfies the conditions of
Sec. 46.204, as applicable; or
(2) The following:
(i) The research presents a
reasonable opportunity to further the understanding, prevention, or alleviation
of a serious problem affecting the health or welfare of pregnant women, fetuses
or neonates;
(ii) The research will be conducted in accord with sound
ethical principles; and
(iii) Informed consent will be obtained in accord with the
informed consent provisions of subpart A and other applicable subparts of this
part.
2001年版には46.208から46.211がない（1991年版にはある）のは改訂されたから？
合衆国規則：被験者保護（45CFR46, 1991年）
Revised
June 18, 1991 (Effective August 19, 1991)
Subpart
B Additional Protections Pertaining to
Research, Development, and Related Activities Involving Fetuses, Pregnant
Women, and Human in vitro Fertilization
[SOURCE:
40 FR 33528, August 8, 1975, unless otherwise noted.]
§
46.201 Applicability.
- The regulations in this subpart are
applicable to all Department of Health and Human Services grants and
contracts supporting research, development, and related activities
involving: (1) the fetus, (2) pregnant women, and (3) human in vitro fertilization.
- Nothing in this subpart shall be
construed as indicating that compliance with the procedures set forth
herein will in any way render inapplicable pertinent State or local laws
bearing upon activities covered by this subpart.
- The requirements of this subpart are
in addition to those imposed under the other subparts of this part.
§ 46.202 Purpose.
It is the purpose of this subpart to provide
additional safeguards in reviewing activities, to which this subpart is
applicable, to assure that they conform to appropriate ethical standards and
relate to important societal needs.
§ 46.203 Definitions.
As used in this subpart:
- Secretary means the Secretary of
Health and Human Services and any other officer or employee of the
Department of Health and Human Services, to whom authority has been
delegated.
- Pregnancy encompasses the period
of time from confirmation of implantation (through any of the presumptive
signs of pregnancy, such as missed menses, or by a medically acceptable
pregnancy test), until expulsion or extraction of the fetus.
- Fetus means the product of conception from
the time of implantation (as evidenced by any of the presumptive signs of
pregnancy, such as missed menses, or a medically acceptable pregnancy
test), until a determination is made, following expulsion or extraction of
the fetus, that it is viable.
- Viable as it pertains to the fetus means
being able, after either spontaneous or induced delivery, to survive
(given the benefit of available medical therapy) to the point of
independently maintaining heart beat and respiration. The Secretary may
from time to time, taking into account medical advances, publish in the FEDERAL
REGISTER, guidelines to assist in determining whether a fetus is viable
for purposes of this subpart. If a fetus is viable after delivery, it is a
premature infant.
- Nonviable fetus means a fetus ex
utero, which, although living, is not viable.
- Dead fetus means a fetus ex
utero, which exhibits neither heartbeat, spontaneous respiratory
activity, spontaneous movement of voluntary muscles, nor pulsation of the
umbilical cord (if still attached).
- In vitro fertilization means any fertilization
of human ova, which occurs outside the body of a female, either through
admixture of donor human sperm and ova, or by any other means.
[40 FR 33528, August 8, 1975, as amended at 43
FR 1759, January 11,1978]
§ 46.204 Ethical Advisory Boards.
- One or more Ethical Advisory Boards
shall be established by the Secretary. Members of these board(s) shall be
so selected, that the board(s) will be competent to deal with medical,
legal, social, ethical, and related issues, and may include, for example,
research scientists, physicians, psychologists, sociologists, educators,
lawyers, and ethicists, as well as representatives of the general public.
No board member may be a regular, full-time employee of the Department of
Health and Human Services.
- At the request of the Secretary, the
Ethical Advisory Board shall render advice consistent with the policies
and requirements of this part as to ethical issues, involving activities
covered by this subpart, raised by individual applications or proposals.
In addition, upon request by the Secretary, the Board shall render advice
as to classes of applications or proposals and general policies,
guidelines, and procedures.
- A Board may establish, with the
approval of the Secretary, classes of applications or proposals which: (1)
must be submitted to the Board, or (2) need not be submitted to the Board.
Where the Board so establishes a class of applications or proposals, which
must be submitted, no application or proposal within the class may be
funded by the Department or any component thereof, until the application
or proposal has been reviewed by the Board, and the Board has rendered
advice as to its acceptability from an ethical standpoint.
[40 FR 33528, August 8, 1975, as amended at 43
FR 1759, January 11, 1978; 59 FR 28276, June 1, 1994]
§ 46.205 Additional duties of the Institutional
Review Boards in connection with activities involving fetuses, pregnant women,
or human in vitro fertilization.
- In addition to the responsibilities
prescribed for Institutional Review Boards under Subpart A of this part,
the applicant's or offeror's Board shall, with respect to activities
covered by this subpart, carry out the following additional duties:
- Determine that all aspects of the
activity meet the requirements of this subpart;
- Determine that adequate
consideration has been given to the manner in which potential subjects
will be selected, and adequate provision has been made by the applicant
or offeror for monitoring the actual informed consent process (e.g.,
through such mechanisms, when appropriate, as participation by the
Institutional Review Board or subject advocates in: (i) overseeing the
actual process by which individual consents required by this subpart are
secured, either by approving induction of each individual into the
activity, or verifying, perhaps through sampling, that approved
procedures for induction of individuals into the activity are being
followed, and (ii) monitoring the progress of the activity and
intervening as necessary, through such steps as visits to the activity
site, and continuing evaluation to determine if any unanticipated risks
have arisen);
- Carry out such other
responsibilities, as may be assigned by the Secretary.
- No award may be issued until the
applicant or offeror has certified to the Secretary that the Institutional
Review Board has made the determinations required under paragraph (a) of
this section, and the Secretary has approved these determinations, as
provided in §46.120 of Subpart A of this part.
- Applicants or offerors seeking
support for activities covered by this subpart must provide for the
designation of an Institutional Review Board, subject to approval by the
Secretary, where no such Board has been established under Subpart A of
this part.
[40 FR 33628, August 8, 1975, as amended at 46
FR 8386, January 26, 1981]
§ 46.206 General limitations.
- No activity, to which this subpart
is applicable, may be undertaken, unless:
- Appropriate studies on animals and
nonpregnant individuals have been completed;
- Except where the purpose of the
activity is to meet the health needs of the mother or the particular
fetus, the risk to the fetus is minimal and, in all cases, is the least
possible risk for achieving the objectives of the activity;
- Individuals engaged in the activity
will have no part in (i) any decisions as to the timing, method, and
procedures used to terminate the pregnancy, and (ii) determining the
viability of the fetus at the termination of the pregnancy; and
- No procedural changes, which may
cause greater than minimal risk to the fetus or the pregnant woman will
be introduced into the procedure for terminating the pregnancy, solely in
the interest of the activity.
- No inducements, monetary or
otherwise, may be offered to terminate pregnancy for purposes of the
activity.
[40 FR 33628, August 8, 1975, as amended at 40
FR 51638, November 6, 1975]
§ 46.207 Activities directed toward pregnant
women as subjects.
- No pregnant woman may be involved as
a subject in an activity covered by this subpart, unless: (1) the purpose
of the activity is to meet the health needs of the mother, and the fetus
will be placed at risk only to the minimum extent necessary to meet such
needs, or (2) the risk to the fetus is minimal.
- An activity permitted under
paragraph (a) of this section may be conducted, only if the mother and
father are legally competent and have given their informed consent after
having been fully informed regarding possible impact on the fetus, except
that the father's informed consent need not be secured, if: (1) the
purpose of the activity is to meet the health needs of the mother; (2) his
identity or whereabouts cannot reasonably be ascertained; (3) he is not
reasonably available; or (4) the pregnancy resulted from rape.
§ 46.208 Activities directed toward fetuses in
utero as subjects.
- No fetus in utero may be
involved as a subject in any activity covered by this subpart, unless: (1)
the purpose of the activity is to meet the health needs of the particular
fetus, and the fetus will be placed at risk only to the minimum extent
necessary to meet such needs, or (2) the risk to the fetus imposed by the
research is minimal, and the purpose of the activity is the development of
important biomedical knowledge which cannot be obtained by other means.
- An activity permitted under
paragraph (a) of this section may be conducted, only if the mother and
father are legally competent and have given their informed consent, except
that the father's consent need not be secured, if: (1) his identity or
whereabouts cannot reasonably be ascertained; (2) he is not reasonably
available, or (3) the pregnancy resulted from rape.
§ 46.209 Activities directed toward fetuses ex
utero, including nonviable fetuses as subjects.
- Until it has been ascertained
whether or not a fetus ex utero is viable, a fetus ex utero
may not be involved as a subject in an activity covered by this subpart,
unless:
- There will be no added risk to the
fetus resulting from the activity, and the purpose of the activity is the
development of important biomedical knowledge, which cannot be obtained
by other means, or
- The purpose of the activity is to
enhance the possibility of survival of the particular fetus to the point
of viability.
- No nonviable fetus may be involved
as a subject in an activity covered by this subpart, unless:
- Vital functions of the fetus will
not be artificially maintained;
- Experimental activities, which of
themselves would terminate the heartbeat or respiration of the fetus,
will not be employed; and
- The purpose of the activity is the
development of important biomedical knowledge, which cannot be obtained
by other means.
- In the event the fetus ex utero
is found to be viable, it may be included as a subject in the activity,
only to the extent permitted by and in accordance with the requirements of
other subparts of this part.
- An activity permitted under
paragraph (a) or (b) of this section may be conducted, only if the mother
and father are legally competent and have given their informed consent,
except that the father's informed consent need not be secured, if: (1) his
identity or whereabouts cannot reasonably be ascertained; (2) he is not
reasonably available; or (3) the pregnancy resulted from rape.
[40 FR 33528, August 8, l975, as amended at 43
FR 1759, January 11, 1978]
§ 46.210 Activities involving the dead
fetus, fetal material, or the placenta.
死亡胎児、胎児由来試料、胎盤を利用する研究活動
Activities involving the dead fetus,
macerated fetal material, or cells, tissue, or organs excised from a dead fetus
shall be conducted, only in accordance with any applicable State or local laws
regarding such activities.
§ 46.211 Modification or waiver of specific
requirements.
Upon the request of an applicant or offeror
(with the approval of its Institutional Review Board), the Secretary may modify
or waive specific requirements of this subpart, with the approval of the
Ethical Advisory Board after such opportunity for public comment, as the
Ethical Advisory Board considers appropriate in the particular instance. In
making such decisions, the Secretary will consider whether the risks to the
subject are so outweighed by the sum of the benefit to the subject, and the
importance of the knowledge to be gained, as to warrant such modification or
waiver, and that such benefits cannot be gained except through a modification
or waiver. Any such modifications or waivers will be published as notices in
the FEDERAL REGISTER.
アメリカの新聞・雑誌より
■タイム（TIME）記事 1988年2月1日
A
Balancing Act of Life and Death
New
uses of fetuses and brain-absent babies trouble doctors
BY CHRISTINE GORMAN
After
years of research, doctors feel they are ready to try to alleviate many
incurable conditions, ranging from congenital heart defects to degenerative
nerve diseases, through the transplanting of organs and tissues. Their pioneering triumphs, however, have
created a Faustian dilemma. Each year in the U.S. hundreds of infants die who could
have been saved by a new heart; literally millions of people with diseases like
Parkinson's and Alzheimer's may eventually benefit from tissue implants. Should
physicians manipulate the definitions of life and death to meet this growing
demand for donor tissue? The...
（以下、ネット上では有料）
http://www.time.com/time/archive/preview/from_redirect/0,10987,1101880201-148514,00.html
（文献入手済み）
■ワシントンタイムス（WASHINGTON TIMES）記事 2000年10月3日
HILL WITNESS TERMED UNRELIABLE ON SALE OF
FETAL TISSUE TO LABS
The
first congressional hearing on possible selling of fetal body parts ended with
one witness being called unreliable and a contempt of Congress resolution
approved for another witness who failed to appear. Members of the House Commerce subcommittee on health and
environment have also called for the FBI and Justice Department to investigate
allegations, including ones reported in magazines and on the ABC news program
"20/20" on Wednesday night, that aborted fetuses are being dissected
and sold to
（以下、ネット上では有料）
http://www.milnet.com/milnet/domestic/backup/abortion08-89-2001.htm
（文献未入手）
■ニューヨークタイムス（NY Times）記事 2001年3月8日
Parkinson's
Research Is Set Back By Failure of Fetal Cell Implants
By GINA KOLATA
A carefully controlled study that tried
to treat Parkinson's disease by implanting cells from aborted fetuses into
patients' brains not only failed to show an overall benefit but also revealed a
disastrous side effect, scientists report.
In about 15 percent of patients, the
cells apparently grew too well, churning out so much of a chemical that
controls movement that the patients writhed and jerked uncontrollably.
The researchers say that while some
patients have similar effects from taking too high a dose of their Parkinson's
drug, in this case the drugs did not cause the symptoms and there is no way to
remove or deactivate the transplanted cells.
On the researchers' advice, six patients
who enrolled in the study but who had not yet had the implantation operation
have decided to forgo it.
The results, reported today in The New
England Journal of Medicine[４],
are a severe blow to what has been considered a highly promising avenue of
research for treating Parkinson's disease, Alzheimer's disease and other
neurological ailments.
The study indicates that the simple solution of injecting fetal cells into a
patient's brain may not be enough to treat complex diseases involving nerve
cells and connections that are poorly understood. Some say it is time to go
back to the laboratory and to animals before doing any more operations on
humans.
（後略）
■ニューヨークタイムス（NY Times）記事 2001年3月9日
A Setback in Parkinson's Research
(NYT) Editorial
Late Edition - Final, Section A, Page 18, Column
1
ABSTRACT ----- Editorial says disappointment over
disheartening results of recently published study to determine whether fetal
nerve cells can help patients with Parkinson's disease will be even greater if
vocal opponents of this kind of research succeed in blocking further study
■ニューヨークタイムス（NY Times）記事 2001年3月12日
When
Not to Grasp at a Cure
By
Jerome Groopman
Late
Edition - Final , Section A , Page 15 , Column 1
ABSTRACT
- Prof Jerome Groopman Op-Ed article on disagreement between researchers at
Columbia University and University of Colorado over continuing use of fetal
cells in treating Parkinson's disease, with former calling for halt to
experiments and latter opting to continue experimentation; examines ethics of
giving license to human experiments that appear to have done little good, or of
denying desperate patients procedure if they are informed of new data on risk
and choose to take it; drawing (M) Thirty years ago, one of my favorite uncles
noticed that his hands trembled even when they were at rest. He was in his 60's,
still robust and proud of his prowess as a champion handball player in the
Bronx. The trembling was the first sign of Parkinson's disease. My uncle's
course was typical. Although drugs helped for a while, the disease proved
unrelenting as cells in his brain died and he was deprived of dopamine, an
essential chemical. His warm smile was replaced by the blank mask of largely
immobile facial muscles. His trembling hands spilled food. Walking was a
struggle of shuffling and the terror of falling.
■ニューヨークタイムス（NY Times）記事 2001年7月27日
Stem
Cells Hint at Promise For Inborn Brain Diseases
By NICHOLAS WADE
In further testimony to the medical
promise of stem cells, biologists have found that human neural stem cells can
become incorporated in a fetal monkey's brain and share in its development,
suggesting a novel way of correcting inborn brain diseases.
The human stem cells were injected into
the brains of monkeys in the womb, and helped not only to construct the
monkeys' brains but also to form the reservoir of stem cells from which new
brain cells are generated throughout adult life.
The experiment, being published
electronically by Science magazine today, was performed by Dr. Evan Y. Snyder,
an expert on brain stem cells at Harvard Medical School; Dr. Curt R. Freed of
the University of Colorado, a researcher who uses fetal brain cells to treat
Parkinson's disease; and their colleagues.[５]
（後略）
■ニューヨークタイムス（NY Times）記事 2002年6月21日
Progress
Is Reported on Parkinson's Disease
By
NICHOLAS WADE
Scientists working with human
embryonic stem cells have converted them into the type of brain cell that is
lost in Parkinson's disease, and have shown that the equivalent cells in mice
alleviate Parkinson-like symptoms in rodents.
''What we are showing here is
that we absolutely, definitely have the right cell,'' said Dr. Ron McKay, a
stem cell biologist who works at the National Institutes of Health.
The cells produce a
neuron-to-neuron signalling chemical called dopamine. The loss of dopamine is
believed to cause many of the symptoms of Parkinson's disease. Dr. McKay hopes
that the cells he has developed will one day be used to treat the disease,
after he has spent two years testing how they work in monkeys. Indeed a surgeon
could put them in patients quite quickly ''but they wouldn't know what they
have done,'' Dr. McKay said.
The need for caution is
apparent in his own experiments, in which he injected the dopamine-producing
mouse cells into the brains of rats. The dopamine-producing cells on one side
of the rats brains had previously been destroyed with a special chemical. So
the rats, suffering Parkinsons-like effects on one side of their brains, tended
to move in circles.
In the article published today
in Nature, Dr. McKay and his colleagues describe how they injected their
dopamine-producing cells into the damaged sides of the rat brains[６].
The cells wired themselves up to other cells in the brain and behaved just like
dopamine-making cells, helping the rat's walking behavior.
（後略）
文献の内容紹介
イギリスでの意識調査報告：Anderson,
Fionn, et al. (1994). "胎児組織研究に対する女性たちの態度Attitudes
of Women to Fetal Tissue Research." Journal of Medical Ethics,
20: 36-40.
http://www.plannedparenthood.org/library/facts/fetaltis_010600.html（米国家族計画協会サイト）には上記論文の内容が次のように紹介されている。
イギリスの600人あまりの女性を対象にして調査を行った。彼女らのほとんどは実際に中絶を経験したことはなかった。94％の女性が胎児組織研究を支持すると答えた。その調査のなかで、女性たちは胎児組織を提供してもいいかと問われたわけではなかったが、ほとんどが、そのような提供には好意的な態度を示すだろうと予想した（アンダーソンら、1994年）。 In a survey
of more than 600 women in the United Kingdom — most of whom had never had an
abortion — 94 percent said they supported fetal tissue research. Although the
women were not asked in the survey to donate their own fetal tissue, most
predicted that they would be willing to make such a donation (Anderson et
al., 1994)
1993年までの胎児組織研究利用規制を概観した論文：Coutts,
Mary Carrington. (1993). "胎児組織研究Fetal Tissue Research." Kennedy
Institute of Ethics Journal, 3(1): 81-101.
http://www.plannedparenthood.org/library/facts/fetaltis_010600.html（米国家族計画協会サイト）には上記論文を参考にして次のようにまとめられている。
In 1974, the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research was
established within HEW, the former U.S. Department of Health, Education, and
Welfare (now the Department of Health and Human Services). Its mission was to
examine the study of fetuses. Less than a year later, HEW issued regulations on
research involving the fetus, stipulating that research involving dead fetuses
or their tissues be permitted in accord with state law (Coutts, 1993).…中略…Medical research with
embryonic and fetal tissue progressed steadily from the mid-1970s to the
mid-1980s, until 1987, when the New England Journal of Medicine reported
the successful transplantation of fetal neural tissue into the brains of two
young patients with Parkinson's disease. The successful procedure led to
requests for government funding of similar procedures. It also led to a heated
outcry from anti-abortion activists. Their inflammatory and alarmist
misinformation campaign soon led to a Reagan administration moratorium in 1988
on all federally funded research involving the transplantation of tissue from
induced abortions into humans (Coutts, 1993). …中略…Despite the conclusions of the 1988 NIH Fetal
Tissue Transplantation Research Panel supporting embryonic tissue
transplantation research as "acceptable public policy," the U.S.
Department of Health and Human Services refused to lift the moratorium on federally
funded fetal tissue research. During the administration of President George
Bush (1989-1993), the moratorium was extended indefinitely. In February 1993,
his first full month in office, President Bill Clinton lifted the moratorium
(Coutts, 1993). As of August 2001, the moratorium has not been reinstated.
文献
【NECTAR指針 http://www.nesu.mphy.lu.se/nectar/eth.1.html
の参考文献より抜粋した18篇】
Burnell
GM, Norfleet MA (1987)
中絶に対する反応についての女性自身の報告
Women's
self-reported responses to abortion.
J
Psychol 121: 71-76
Burtchaell
JT (1988)
University
policy on experimental use of aborted fetal tissue.
IRB:
A Review of Human Subject Research 10: 7-11
Faria
G, Barett E, Goodman LA (1985)
Women
and abortion: attitudes, social networks, decision-making.
Social
Work in Health Care 11: 85-99
Gareth
Jones D (1991)
Fetal
neural transplantation: placing the ethical debate within the context of
society's use of human material.
Bioethics
5: 23-43
Garry
DJ, Caplan AL, Vawter DE, Kearney W (1992)
Are
there really alternatives to the use of fetal tissue from elective abortions in
transplantation research?
New
Engl J Med 327: 1592-1595
Greely
HT, Hamm T, Johnson R, Price CR, Weingarten R, Raffin T, The Stanford
University Medical Center Committee on Ethics (1989)
The ethical
use of human fetal tissue in medicine.
New
Engl J Med 320: 1093-1096
スタンフォード大学医療センター（アメリカ）倫理委員会からの提案
Hansen
JT, Sladek Jr JR (1989)
Fetal
research.
Science
246: 775-779
Hoffer
BJ, Olson L (1991)
Ethical
issues in brain-cell trans-plantation.
TINS
14: 384-388
King
P, Areen J (1988)
Legal
regulation of fetal tissue transplantation.
Clin
Res 36: 205-208
MacDonald
AS (1990)
Foetal
neuroendocrine tissue transplantation for Parkinson's disease: an institutional
review board faces the ethical dilemma.
Transplant
Proc 22: 1030-1032
Mahowald
MB (1988)
Placing
wedges along a slippery slope: use of fetal neural tissue for transplantation.
Clin
Res 36: 220-222
Nolan
K (1990)
The
use of embryo or fetus in transplantation: what there is to lose.
Transplant
Proc 22: 1028-1029
Robertson
JA (1988)
Rights,
symbolism and public policy in fetal tissue transplants.
Hastings
Center Report 6: 5-12
Robertson
JA (1990)
The
ethical acceptability of fetal tissue transplants.
Transplant
Proc 22: 1025-1027
Sladek
Jr JR, Shoulson I (1988)
Neural
transplantation: a call for patience rather than patients.
Science
240: 1386-1388
Walters
L (1988)
Ethical
issues in fetal research: a look back and a look forward.
Clin
Res 36: 209-214
【その他MEDLINEで検索したものなど―未整理】
Annas
GJ, Elias S.
ヒト胎児組織移植をめぐる政治
The
politics of transplantation of human fetal tissue.
N
Engl J Med. 1989 Apr 20; 320(16):1079-82.
Baker HW.
生殖補助医療の規制をめぐる問題：臨床医の視点
Problems with the regulation of assisted reproductive technology:
a clinician's perspective.
J Law Med. 2002 May; 9(4):457-69. Review.
Barnes DW, Stevenson RE. Meeting report: human fetal tissue transplantation research panel.In Vitro Cell Dev Biol. 1989 Jan; 25(1):6-8.
Bridges KM.
黒人女性の身体のcommodification
について：胎児組織譲渡の重大な意味
On the commodification of the black female body: the
critical implications of the alienability of fetal tissue.
Columbia Law Rev. 2002 Jan; 102(1):123-67.
Burtchaell
JT.
The
use of aborted fetal tissue in research: a rebuttal.
IRB.
1989 Mar-Apr; 11(2):9-12.
Burtchaell
JT.
University policy on experimental use of aborted fetal tissue: case study.
IRB.
1988 Jul-Aug; 10(4):7-11.
Caplan
AL.
Bioethics
1987 Apr; 1(2):119-40
Should
foetuses or infants be utilized as organ donors?
Childress JF. Ethics, public policy, and human fetal tissue transplantation research.Kennedy Inst Ethics J. 1991 Jun; 1(2):93-121.
Childress JF
Deliberations of the Human Fetal Tissue Transplantation
Research Panel. in Biomedical politics, Hanna KE ed. pp.215-257, National
Academy Press, 1991
http://books.nap.edu/books/0309044863/html/215.html
Clark
PA. (2002)
パーキンソン病へのプラセボによる外科治療：利益は不利益を上回るのか？
Placebo
surgery for Parkinson's disease: do the benefits outweigh the risks?
J Law
Med Ethics 30(1): 58-68
Coutts,
Mary Carrington. (1993).
Fetal
Tissue Research.
Kennedy Institute of Ethics Journal, 3(1) (March), 81-101.
Culliton
BJ.
Science
1988 Dec 23; 242(4885): 1625-6
Panel
backs fetal tissue research.
Culliton
BJ.
Science
1988 Sep 16; 241(4872): 1423
White
House wants fetal research ban.
Dafler
CE.
胎児組織移植：倫理と情緒はいかに相互に関連するか
Transplanting
fetal tissue: how ethics and emotions interact.
Colo
Med. 1989 Sep; 86(15): 264-5.
Edwards BE, Gearhart JD, Wallach EE. The human pluripotent stem cell: impact on medicine and society.Fertil Steril. 2000 Jul; 74(1): 1-7. Review.
English V.
イギリスにおける胚性幹細胞研究の規制
Regulating embryonic stem cell research in the United
Kingdom.
J Law Med. 2002 May; 9(4): 380-1. No abstract available.
Freedman
B.
The
ethics of using human fetal tissue -- a response to Burtchaell: I.
IRB.
1988 Nov-Dec; 10(6): 1-4.
Fung
CHK, Lo JW.
人工妊娠中絶された胎児の組織を利用するのではない別な選択
Alternatives
to using fetal tissue from induced abortions.
JAMA.
1990 Jul 4; 264(1): 34.
Gershon D. Fetal tissue research. New panel for ethical issues.Nature. 1991 Jan 17; 349(6306): 184.
Gillam
L.
胎児組織移植に対する「中絶の増加」という反対
The
'more-abortions' objection to fetal tissue transplantation.
J Med
Philos. 1998 Jun; 23(4): 411-27.
http://www.szp.swets.nl/szp/journals/jm234411.htm
Gold RB, Lehrman D. Fetal research under fire: the influence of abortion politics.Fam Plann Perspect. 1989 Jan-Feb; 21(1): 6-11, 38.
Gorman
C.
生と死に関する法のバランス：胎児や脳のない赤ちゃんの新しい利用法が医師を悩ませる
A
balancing act of life and death. New uses of fetuses and brain-absent babies trouble
doctors.
Time.
1988 Feb 1; 131(5): 49.
Grisolia JS.
中枢神経幹細胞移植：臨床的および倫理的視点
CNS stem cell transplantation: clinical and ethical
perspectives.
Brain Res Bull. 2002 Apr; 57(6): 823-6. Review.
Haimes E.
When transgressions become transparent: limiting family
forms in assisted conception.
J Law Med. 2002 May; 9(4): 438-48. Review.
Kassirer
JP, Angell M.
パーキンソン病研究におけるの胎児組織の利用
The
use of fetal tissue in research on Parkinson's disease.
N
Engl J Med. 1992 Nov 26; 327(22): 1591-2.
Leary WE. U.S. panel backs research use of fetal tissue from abortions.NY Times (Print). 1988 Sep 17;:1, 10.
Levin
R (1988)
Could
over Parkinson’s therapy.
Science,
240:390-392
Madrazo I, Drucker-Colin R, Diaz V, Martinez-Mata J, Torres
C, Becerril JJ. (1987)
Open microsurgical autograft of adrenal medulla to the right
caudate nucleus in two patients with intractable Parkinson's disease.
N Engl J Med, 316(14): 831-834
Madrazo
I, Leon V, Torres C, Aguilera MC, Varela G, Alvarez F, Fraga A, Drucker-Colin
R, Ostrosky F, Skurovich M, et al. (1988)
Transplantation
of fetal substantia nigra and adrenal medulla to the caudate nucleus in two
patients with Parkinson's disease.
N
Engl J Med, 318(1): 51
Mahowald
MB.
Neural
fetal tissue transplantation: scientific, legal, and ethical aspects.
Clin
Res. 1988 Apr; 36(3): 187-8.
Mahowald
MB.
Neural
fetal tissue transplantation. Should we do what we can do?
Neurol
Clin. 1989 Nov; 7(4): 745-57.
Mahowald
MB, Silver J, Ratcheson RA.
The
ethical options in transplanting fetal tissue.
Hastings
Cent Rep. 1987 Feb; 17(1): 9-15.
Markowitz MS. Human fetal tissue: ethical implications for use in research and treatment.AWHONNS Clin Issues Perinat Womens Health Nurs. 1993; 4(4): 578-88. Review.
Martin, Douglas K. (1993).
中絶と胎児組織移植
Abortion and Fetal Tissue Transplantation.
IRB, (15)
3 (May-June), 1-3.
Martin
DK, Maclean H, Lowy FH, Williams JI, Dunn EV.
胎児組織移植と中絶の決定：都市部の女性を対象にした調査
Fetal
tissue transplantation and abortion decisions: a survey of urban women.
CMAJ.
1995 Sep 1; 153(5): 545-52.
http://collection.nlc-bnc.ca/100/201/300/cdn_medical_association/cmaj/vol-153/issue-5/0545.htm
Milos N, Bamforth S, Bagnall K. (1999)
カナダにおける研究の倫理：ヒト胎児組織バンクを運営するグループの経験
Research ethics in Canada: experience of a group operating a
human embryo and fetal tissue bank.
Ann R Coll Physicians Surg Can. Apr; 32(3): 161-8.
「胎児組織の採取に携わる者は、その組織を用いた研究論文の共著者になってはいけない」という規定のあるカナダのガイドラインを紹介している
Nippert I.
The pros and cons of human therapeutic cloning in the public
debate.
J Biotechnol. 2002 Sep 11; 98(1): 53-60.
Petersen K.
Regulating human embryo research in Australia: recent
developments.
J Law Med. 2002 May; 9(4): 381-2.
Reardon L.
胎児組織移植研究の倫理：レビュー
The ethics of fetal tissue transplant research: a review.
Linacre Q. 1999 Aug; 66(3): 21-34.
Reiss MJ.
治療的クローニングの倫理的次元
Ethical dimensions of therapeutic human cloning.
J Biotechnol. 2002 Sep 11; 98(1): 61-70.
Robertson
JA.
Fetal
tissue transplant research is ethical -- a response to Burtchaell: II.
IRB.
1988 Nov-Dec; 10(6): 5-8.
Rohter
L.
NY
Times (Print) 1988 Jan 7;:B13
Implanted
fetal tissue aids Parkinson's patients.
Scott A.
生殖技術におけるいくつかの新しい展開に対する法的責任
Legal responses to some of the new developments in
reproductive technologies. Part 1.
Hum Reprod Genet Ethics. 2001; 7(2): 28-37.
Siep L, Ach JS, Quante M.
臓器移植の倫理―ドイツにおける議論の特徴
The ethics of organ transplantation -- features of the
German discussion.
J Int Bioethique. 1999 Nov; 10(4): 29-34.
Sparks RC.
胎児組織移植の倫理的問題：研究、調達、そして中絶との連座(?)
Ethical issues of fetal tissue transplantation: research,
procurement, and complicity with abortion.
Annu Soc Christ Ethics. 1990;:199-221.
Strong C. Fetal tissue transplantation: can it be morally insulated from abortion?J Med Ethics. 1991 Jun; 17(2): 70-6.
Tang
FI, Sheu SJ, Chen CH, Wang Y, Lin SZ. (2002)
胎児組織移植後のパーキンソン患者に関する予備的心理社会的研究
A
preliminary psychosocial study of Parkinson's patients after fetal tissue transplantation.
J
Nurs Res 10(1): 1-14.
Vawter
DE, Caplan A. (1992)
奇妙な醸造物：合衆国における胎児組織研究をめぐる政治と倫理
Strange
brew: the politics and ethics of fetal tissue transplant research in the United
States.
J Lab
Clin Med. Jul; 120(1): 30-4.
Vawter,
Dorothy E. and Gervais, Karen, G. (1993).
胎児組織移植と中絶についてのコメント
Commentary
on 'Abortion and Fetal Tissue Transplantation'.
IRB,
(15) 3. (May-June), 4-5.
胎児組織の提供が中絶を助長するということはないという主張
Weijer C. (2002)
I need a placebo like I need a hole in the head.
J Law Med Ethics. Spring; 30(1): 69-72.
de WG, Berghmans RL, Boer GJ, Andersen S, Brambati B,
Carvalho AS, Dierickx K, Elliston S, Nunez P, Osswald W, Vicari M. (2002)
ヒト胚および胎児組織移植についての倫理指針：ヨーロッパの概観
Ethical guidance on human embryonic and fetal tissue
transplantation: a European overview.
Med Health Care Philos. 5(1): 79-90.
Zoloth L.
幹細胞研究：焦点となる論文の収集
Stem cell research: a target article collection: Part
I--Jordan's banks, a view from the first years of human embryonic stem cell
research.
Am J Bioeth. 2002 Winter; 2(1): 3-11, 30. Review.
■1987年3月25日に、メキシコでのパーキンソン病患者への副腎移植が国内で報道されたときの新聞記事。朝日、毎日、読売の各紙が報じたが、内容はほぼ同じ。
朝日新聞夕刊
最終修正日 2003年1月31日