# 医療法 / Medical Care Act — 第十六条の四 (Article 16-4)

- Law: 医療法 (Medical Care Act), 昭和二十三年法律第二百五号
- English title "Medical Care Act": Ministry of Justice translation
- Kind: Act — the distinction between 法律 (Act), 政令 (Cabinet Order), 省令 (Ministerial Order) and 条例 (local ordinance) decides who may issue it and what it may say.
- Provision: 第十六条の四 (Article 16-4) — address `art-16-4`
- Text in force since: 2026-10-01
- URL (the page that opens at this provision): https://japanlaw.org/ja/medical-care-act/art-16-4
- Permanent URL (e-Gov law ID, never renamed): https://japanlaw.org/l/323AC0000000205/art-16-4
- Every provision below carries its address and both URLs on the line under it.
- Japanese text: e-Gov 法令検索, Digital Agency (デジタル庁). English: as marked on each line below.

Only the Japanese as published by the government has legal effect; the text
below is a copy of it. Every English rendering below is a translation and
says which kind: the Ministry of Justice's translation, or this
site's machine translation, whose model and date the Sources list names.
They are never merged and never substituted for one another.

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### 第十六条の四
<sup>art-16-4 · https://japanlaw.org/ja/medical-care-act/art-16-4 · https://japanlaw.org/l/323AC0000000205/art-16-4</sup>

  **第一項**  臨床研究中核病院の管理者は、厚生労働省令の定めるところにより、次に掲げる事項を行わなければならない。
  <sup>art-16-4/par-1 · https://japanlaw.org/ja/medical-care-act/art-16-4/par-1 · https://japanlaw.org/l/323AC0000000205/art-16-4/par-1</sup>
  The administrator of a core hospital for clinical research, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, must carry out the following particulars:
  <sup>Ministry of Justice translation — Japanese Law Translation Database System</sup>

    **一**  特定臨床研究に関する計画を立案し、及び実施すること。
    <sup>art-16-4/par-1/item-1 · https://japanlaw.org/ja/medical-care-act/art-16-4/par-1/item-1 · https://japanlaw.org/l/323AC0000000205/art-16-4/par-1/item-1</sup>
    to develop and implement a plan concerning specified clinical research;
    <sup>Ministry of Justice translation — Japanese Law Translation Database System</sup>

    **二**  他の病院又は診療所と共同して特定臨床研究を実施する場合にあつては、特定臨床研究の実施の主導的な役割を果たすこと。
    <sup>art-16-4/par-1/item-2 · https://japanlaw.org/ja/medical-care-act/art-16-4/par-1/item-2 · https://japanlaw.org/l/323AC0000000205/art-16-4/par-1/item-2</sup>
    when conducting specified clinical research jointly with other hospitals or clinics, to play a leading role in the implementation of specified clinical research;
    <sup>Ministry of Justice translation — Japanese Law Translation Database System</sup>

    **三**  他の病院又は診療所に対し、特定臨床研究の実施に関する相談に応じ、必要な情報の提供、助言その他の援助を行うこと。
    <sup>art-16-4/par-1/item-3 · https://japanlaw.org/ja/medical-care-act/art-16-4/par-1/item-3 · https://japanlaw.org/l/323AC0000000205/art-16-4/par-1/item-3</sup>
    to provide consultation, necessary information, advice and other assistance to other hospitals or clinics concerning the implementation of specified clinical research;
    <sup>Ministry of Justice translation — Japanese Law Translation Database System</sup>

    **四**  特定臨床研究に関する研修を行うこと。
    <sup>art-16-4/par-1/item-4 · https://japanlaw.org/ja/medical-care-act/art-16-4/par-1/item-4 · https://japanlaw.org/l/323AC0000000205/art-16-4/par-1/item-4</sup>
    to provide training on specified clinical research;
    <sup>Ministry of Justice translation — Japanese Law Translation Database System</sup>

    **五**  第二十二条の三第三号及び第四号に掲げる諸記録を体系的に管理すること。
    <sup>art-16-4/par-1/item-5 · https://japanlaw.org/ja/medical-care-act/art-16-4/par-1/item-5 · https://japanlaw.org/l/323AC0000000205/art-16-4/par-1/item-5</sup>
    to systematically manage the various records listed in items (iii) and (iv) of Article 22-3; and
    <sup>Ministry of Justice translation — Japanese Law Translation Database System</sup>

    **六**  その他厚生労働省令で定める事項
    <sup>art-16-4/par-1/item-6 · https://japanlaw.org/ja/medical-care-act/art-16-4/par-1/item-6 · https://japanlaw.org/l/323AC0000000205/art-16-4/par-1/item-6</sup>
    other particulars specified by an Order of the Ministry of Health, Labour and Welfare.
    <sup>Ministry of Justice translation — Japanese Law Translation Database System</sup>

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## Cites
- art-16-4/par-1/item-5: 第二十二条の三第三号 → 医療法 第二十二条の三第一項第三号 (Article 22-3, paragraph (1), item (iii)), art-22-3/par-1/item-3 — https://japanlaw.org/ja/medical-care-act/art-22-3/par-1/item-3 · https://japanlaw.org/l/323AC0000000205/art-22-3/par-1/item-3
- art-16-4/par-1/item-5: 第四号 → 医療法 第二十二条の三第一項第四号 (Article 22-3, paragraph (1), item (iv)), art-22-3/par-1/item-4 — https://japanlaw.org/ja/medical-care-act/art-22-3/par-1/item-4 · https://japanlaw.org/l/323AC0000000205/art-22-3/par-1/item-4

## Cited by

2 provisions cite this one. No official source publishes this direction.

- 医療法 第十七条第一項 — https://japanlaw.org/ja/medical-care-act/art-17/par-1 · https://japanlaw.org/l/323AC0000000205/art-17/par-1
- 医療法 第二十九条第五項第四号 — https://japanlaw.org/ja/medical-care-act/art-29/par-5/item-4 · https://japanlaw.org/l/323AC0000000205/art-29/par-5/item-4

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## Sources

- e-Gov 法令検索, Digital Agency (デジタル庁) — 医療法 — the text in force from 2026-10-01 (https://laws.e-gov.go.jp/law/323AC0000000205/20261001_507AC0000000087), retrieved 2026-10-19
- Japanese Law Translation Database System, Ministry of Justice (法務省) — Medical Care Act — Ministry of Justice translation (https://www.japaneselawtranslation.go.jp/en/laws/view/4006/tb), retrieved 2026-10-19
- This site's parser, version 210 — 医療法 — structure, counts, cross-references and defined terms, computed 2026-10-19