胎児組織の研究利用問題に関するメモ

20001231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

この検討会の21人のメンバーはこちら

■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

http://com-notes.house.gov/cchear/hearings106.nsf/a317d879d32c08c2852567d300539946/b6d2cf13cc0435ad8525689d00160363?OpenDocument

■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930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、1018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、1117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、20002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(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、12/1212/1812/2612/27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、20021213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、20031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)571 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)2015 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

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)82 Page117-122(1985.04)

論文種類:原著論文

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)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(英語) 1993

AuthorHiguchi Shigenori(熊本大免疫医研), Yanabe Yasuhide, Tsuchiya Hiroyuki,

SourceActa Paediatrica Japonica(0374-5600)351 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);

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)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46XY46XX2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63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

Author:樋口重典(熊本大学 小児科), 柳辺安秀, 中村倫恵,

Source:小児科(0037-4121)328 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);

abstract:なし

胎児胸腺移植が成功したDi George症候群の一例 1987

Author:久下順子(京都大学 小児科),

Source:日本小児科学会雑誌(0001-6543)912 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);

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

AuthorInoue Hiroshi K.(群馬大学 脳神経外科), Henschen Andreas, Olson Lars

SourceJournal of Electron Microscopy(0022-0744)431 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(,中間,)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

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.Pax3mRNA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915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 1type 2,及びEstrogen receptorの発現に関する検討 2000

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)761 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

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)751 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

AuthorSano Makoto(慶応義塾大学 病理),

SourceActa Histochemica et Cytochemica(0044-5991)312 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(1944)

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

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; ; 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

Author:安積順一(札幌医科大学),

Source:日本法医学雑誌(0047-1887)52Suppl. 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

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 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
Author
Hoshi Nobuhiko(北海道大学 産婦人科), YamagamiYukiko, HanataniKaoru,
Source
Asia-Oceania Journal of Obstetrics and Gynaecology(0389-2328)163 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.3548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3539歳では9.6%(40/418),4044歳では20.7%(100/484),そして4548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

 

1993122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(NIHNational 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2211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

 

1993610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.

  1. 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.
  2. 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.
  3. 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Nonviable fetus means a fetus ex utero, which, although living, is not viable.
  6. 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).
  7. 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.

  1. 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.
  2. 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.
  3. 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.

  1. 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:
    1. Determine that all aspects of the activity meet the requirements of this subpart;
    2. 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);
    3. Carry out such other responsibilities, as may be assigned by the Secretary.
  2. 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.
  3. 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.

  1. No activity, to which this subpart is applicable, may be undertaken, unless:
    1. Appropriate studies on animals and nonpregnant individuals have been completed;
    2. 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;
    3. 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
    4. 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.
  2. 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.

  1. 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.
  2. 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.

  1. 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.
  2. 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.

  1. 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:
    1. 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
    2. The purpose of the activity is to enhance the possibility of survival of the particular fetus to the point of viability.
  2. No nonviable fetus may be involved as a subject in an activity covered by this subpart, unless:
    1. Vital functions of the fetus will not be artificially maintained;
    2. Experimental activities, which of themselves would terminate the heartbeat or respiration of the fetus, will not be employed; and
    3. The purpose of the activity is the development of important biomedical knowledge, which cannot be obtained by other means.
  3. 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.
  4. 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 198821

 

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 2000103

 

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 200138

 

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)

全文はこちら

 

■ニューヨークタイムス(NY Times)記事 200139

 

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 2001312

 

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 2001727

 

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)

全文はこちら

 

 

■ニューヨークタイムス(NY Times)記事 2002621

 

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)

全文はこちら

 


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)

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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.
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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.

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Should foetuses or infants be utilized as organ donors?

 

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Childress JF

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Stem cell research: a target article collection: Part I--Jordan's banks, a view from the first years of human embryonic stem cell research.

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1987325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 2003131



[1])いずれもNECTAR指針を紹介したBoer論文(1994http://www.nesu.mphy.lu.se/nectar/eth.1.htmlからの引用

[2] 国内では、西九州大学図書館が所蔵している。

[3] http://www.neurofederatie.nl/nectar2002/program.htmに、NNECTAR2002年第13回大会プログラムが掲載されている。

[4] コロラド大学(http://www2.uchsc.edu/pharm/default.asp)のカート・フリード(http://www2.uchsc.edu/pharm/faculty/freed.asp)らの二重盲検プラセボ対象臨床試験は、Freed CR, et. al. Transplantation of embryonic dopamine neurons for severe Parkinson’s disease. NEJM 2001; 344(10): 710-9.として発表された(http://content.nejm.org/cgi/content/abstract/344/10/710)。そもそも、このフリードらの研究がNIHに申請されたときの反応としては、Cohen J. New fight over fetal tissue grafts. Science 1994; 263(4): 600-1. Thompson L. Fetal tissue research on the rebound. Science 1994; 263(4): 601. Widner H. (Letters) NIH neural transplantation funding. Science 1994; 263(4): 737. Breeze RE, Wells TH, Freed DR. Implantation of fetal tissue for the management of Parkinson’s disease: A technical note. Neurosurgery 1995; 36(5): 1044-8.などがある。また、彼らの研究がプラセボ対照であったことについては、2001年に結果が発表される前から、Freeman TB, Vawter DE, Godbold JH, et al. Use of placebo surgery in controlled trials of a cellular-based therapy for Parkinson’s disease. NEJM 1999; 341: 988-92. Maclin R. The ethical problem with sham surgery in clinical research. NEJM 1999; 341: 992-5. Weiner WJ. (Correspondence) Placebo surgery in trials of therapy for Parkinson’s disease. NEJM 2000; 342(5): 353. Weiner WJ, Burris JF, Freed CR, Horisberger J, Freeman TB, Macklin R. (Correspondence) Placebo surgery in trials of therapy for Parkinson’s disease. NEJM 2000; 342(5): 353-5. など、賛否両論があった。研究結果発表後は、Vogel G. Fetal cell transplant trial draws fire. Science 2001; 291: 2060-1. Gillet GR. Unnecessary holes in the head. IRB: ethics and human research 2001; 23(6): 1-6.などが問題点を論じている。

[5] Ourednik V, Ourednik J, Flax JD, Zawada WM, Hutt C, Yang C, Park KI, Kim SU,
Sidman RL, Freed CR, Snyder EY. Segregation of human neural stem cells in the developing primate forebrain. Science, 2001, 293(5536): 1820-4 (Published online July 26, 2001)

[6] Kim JH, Auerbach JM, Rodriguez-Gomez JA, Velasco I, Gavin D, Lumelsky N, Lee SH, Nguyen J, Sanchez-Pernaute R, Bankiewicz K, McKay R. Dopamine neurons derived from embryonic stem cells function in an animal model of Parkinson's disease. Nature, 2002, 418(6893): 50-6 (published online 20 June 2002). Comment in: Nature, 2002, 418(6893): 1., Nature, 2002, 418(6893): 25-7. http://www.nature.com/cgi-taf/DynaPage.taf?file=/nature/journal/v418/n6893/abs/nature00900_fs.html&dynoptions=doi1041422879