投稿アカデミー（6） 倫理的配慮と同意書 COI

ヘルシンキ宣言+倫理的承認と同意書の例文

（和文）
ヘルシンキ宣言の原則に基づき、AA倫理委員会の承認をへて（承認番号xxx）、研究ボランティアには 実験の目的、方法、安全配慮、危険性などについて事前に口頭で説明し、同意を得た上で参加した。

This study was conducted according to the principles of the Declaration of Helsinki, and was approved by the Ethics Committee of AA (Approval No. xxx). The research volunteers were given oral explanations and gave consent in advance regarding the purpose, method, safety considerations, and risks of the experiment.

ヘルシンキ宣言+倫理承認の例文

1.The study adhered to the Declaration of Helsinki and was approved by the Ethics Committee of AA (Approval No. xxx).
2.All procedures followed the Helsinki protocols and were approved by the Ethics Committee of AA (Approval No. xxx).
3.This study was conducted following the ethical principles of the Declaration of Helsinki, and with the approval of the Ethics Committee of AA (Approval No. xxx).
4.This study was carried out in accordance with the principles of the Declaration of Helsinki, and with the approval of the Ethics Committee of AA (Approval No. xxx).

倫理的配慮（大学倫理委員会の承認）のみの例文

1.We obtained approval from the Institutional Ethics Committee of the KK University (Approval number: xxxx).
2.This study has been approved by the research ethics committee (or institutional review board) of KK University (Approval number: xxxx).

参加の同意書を得たという例文

1.All participants signed an informed consent statement prior to participation in the study.
2.All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
3.Informed consent was obtained from all participants and/or their legal guardians.

同意書のサンプルのURL（英語版）

https://web.stanford.edu/group/ncpi/unspecified/student_assess_toolkit/pdf/sampleinformedconsent.pdf

同意書が免除される研究もあります（参照URL）

https://irb.ucsf.edu/waiving-informed-consent
被験者へのリスクが最小限の場合
緊急医療やそのほかの限定された状況下など

同意書：治験の説明項目（例文）

1.An explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental. 研究の目的、参加予定期間、守るべきこと、手順
2.Description of any reasonably foreseeable risks or discomforts to the subject.予測される不利益
3.Description of any benefits to the subject or to others which may reasonably be expected from the research. 予測される利益
4.Disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. 代替処置やその他の治療方針があれば、その開示
5.Confidentiality of records identifying the subject will be maintained. 個人情報の保護
6.The participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. 参加は自発的なものであり、中止、撤回は自由