Yamamoto, Makiko
Kimura, Akio
Takii, Kento
Otake, Naruaki
Matsuda, Wataru
Uemura, Tatsuki
Sato, Takunori
Kobayashi, Kentaro
Sasaki, Ryo
Hagiwara, Akiyoshi
Fujitani, Junko
Funding for this research was provided by:
National Center for Global Health and Medicine Clinical Research (No. 29-2001)
Article History
Received: 23 March 2018
Accepted: 23 August 2018
First Online: 14 September 2018
Ethics approval and consent to participate
: This study will be conducted in accordance with the Declaration of Helsinki (2013), and the Ethical Guidelines for Medical and Health Research Involving Human Subjects (2017) issued by the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labour and Welfare of Japan. All investigators involved in this study are responsible for adhering to the above ethical guidelines.This study was approved by the Research Ethics Committee of the National Center for Global Health and Medicine (NCGM-G-002374-00).The physician in charge will provide a detailed oral explanation supported by a written document to the patient or their legal representative and will then ascertain the patient’s understanding of the study. When the patient or their legal representative consents to participate in the study, the physician providing the explanation will enter the date and their name and that of the patient (or their legal representative) and the physician will sign the form. The physician will hand a copy of the signed consent form to the patient or their representative and store a copy (in electronic image format) in the electronic health record. The principal investigator will keep the original signed document. Withdrawal of consent will not disadvantage the patient or affect patient care.Process of withdrawal of consentParticipation in this study is voluntary, and participants can withdraw from the study at any time during the study as they wish. Non-participation will not cause any disadvantage to patients. The patient (or their legal representative) will confirm intent to withdraw by signing a withdrawal form. The physician in charge will countersign the withdrawal form.
: Not applicable.
: The authors declare that they have no competing interests.
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