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- About the NTT Medical Center Tokyo Ethical Review Board
- Bylaws of the NTT Medical Center Tokyo Ethical Review Board
- About Us
- President Greetings
- Philosophy and basic policy
- Hospital overview
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- In-hospital / Ward
- About the Ethics and Medical Audit Committee
- Disclosure of Medical Records
- Regarding Informed Consent
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Bylaws of the NTT Medical Center Tokyo Ethical Review Board
June 18, 2020
NTT Medical Center Tokyo
Bylaws of the NTT Medical Center Tokyo Ethical Review Board
Philosophy of the NTT Medical Center Tokyo
- Article 1
- As the symbol of the social contribution of NTT East Corporation, through the provision of medical care, we are dedicated to ensuring the happiness of all people who use the hospital and all who work at the hospital.
- Article 2
- At NTT Medical Center Tokyo, when conducting medical practice related to any of the following points 1 to 5, based on the advice of the hospital director, deliberations will be conducted to determine whether ethical considerations are addressed in accordance with the intent of the Declaration of Helsinki and the Declaration of Lisbon.
- When conducting medical research and its clinical application (excluding clinical trials)
- When addressing issues related to the sanctity of life such as the patient’s own living will
- When there are doubts about the fairness of medical care from the perspective of conflict of interest
- When there are issues with cooperation with medical care due to intellectual impairment, dementia, or psychiatric disorders and there is no agreement between the patient (or their legal representative) and the physician, which may impact the patient’s vital prognosis
- When there are other potential ethical issues with regards to medical care
Establishment of the Ethical Review Board
- Article 3
- The NTT Medical Center Tokyo Ethical Review Board (“the Committee”, hereafter) shall be established in order to achieve the above purpose
- Article 4
- The Committee shall comprise a chairperson and the following committee members commissioned by the hospital director.
Internists (2 or more)
Surgeons (2 or more)
Physician from Central Clinical Services (1 or more)
Pharmacist (1 or more)
Nurses (2 or more)
Administrative personnel (1 or more)
Expert in the humanities and social sciences such as a specialist in ethics and law (1 or more)
Individual with academic experience in an area other than the medical field who is not a hospital employee (1 or more)
The Committee shall consist of both male and female members
Term of Office
- Article 5
- In principle, the term of office for committee members shall be two years, and reappointment shall not be precluded.
In the case of a vacancy, the term of office of the successor committee member shall be the remaining term of office of the predecessor.
Obligations of the Applicant and Duties of the Committee
- Article 6
- All implementation plans for important matters related to research or medical ethics other than those in regular daily medical practice shall be subject to deliberation, and individuals planning to implement them should submit an application to the Committee.
The applicant shall submit the designated ethical review application in advance, submitting and explaining the materials at the time of review.
If there are any changes in the continuation of the protocol including discontinuation or completion, the applicant must submit a report.
Upon receiving the application, the chairperson shall contact the committee members, and if the chairperson or a majority of the committee members determine that a committee meeting should be held, a committee meeting will be convened.
The Committee shall deliberate the contents of the application, taking into account the intent of the Declaration of Helsinki and the Declaration of Lisbon with attention to the following
- Protection of the human rights of the individual in question
- How to obtain the consent and understanding of the parties in question
- Benefits and risks to individuals and medical significance of the research, etc.
- Contribution to society
If determined to be necessary, progress reports may be requested after deliberation while the research is being conducted, or the contents of the application may be re-reviewed.
Written and Expedited Reviews
- Article 7
- For clinical research applications that meet the following requirements, committee members may make a decision in writing at the discretion of the chairperson.
- Reviews of research plans that are joint research projects where the research plans have been approved by the ethics committee of the main institution and will be implemented as a joint research institution
- Reviews of research that does not involve invasiveness or intervention; however, if committee members determine the necessity of an in-person review, a committee meeting will be convened.
- Minor changes to the research approval
Request for Collective Review
- Article 8
- If requested by the representative research institution, the ethics review may be outsourced.
Upon submission of the notice of ethics review results and research approval, etc., to the secretariat, the research plan will be considered approved by the chairperson of the NTT Medical Center Tokyo Ethical Review Board and the hospital deliberation without deliberation.
In addition, addressees and contacts may be changed on the various formats as needed.
Application for Review
- Article 9
- Personnel applying for review must complete the required sections of the ethics review application and submit it to the secretariat.
Education and Training on Research Ethics
- Article 10
- Principal investigators, co-investigators, and personnel engaged in supporting tasks must receive education and training on skills and knowledge related to the implementation of the research in question once per year as needed as well as on research ethics prior to conducting the research.
- Article 11
- The applicant must submit a report to the secretariat every year from the start date of clinical research involving intervention. However, for applications related to the off-label use of pharmaceuticals and medical devices, a report shall be submitted for every five cases.
Conditions for Committee Quorum
- Article 12
- The chairperson shall convene and chair the committee meeting.
A committee meeting cannot be held unless a majority of the committee members and an expert from fields other than medicine are in attendance.
The chairperson may temporarily call academic experts considered to be particularly necessary (however, they may not participate in the decision).
Depending on the circumstances, the chairperson may designate a committee member to serve as their proxy.
- Article 13
- Review decisions shall be made upon agreement of all committee members in attendance other than the applicant.
Resulting decisions will either be approval, conditional approval, recommendation for changes, rejection, or not applicable, and the results will be communicated to the applicant along with the reason for the decision.
The secretariat will keep minutes and promptly obtain confirmation from all committee members after the end of the committee meeting.
The results will be reported to the hospital director, and the secretariat will conduct the necessary administrative processing.
- Article 14
- In principle, the minutes will be kept private. If the minutes need to be disclosed, this will be deliberated at a separate committee meeting.
Committee members, expert committee members, and those involved with the Committee in question shall not leak information obtained in the course of their duties without due reason.
The same shall apply to those who have left their positions.
Adverse Event Report / Completion Report
- Article 15
- If the applicant becomes aware of a serious adverse event or malfunction related to the research, the applicant must immediately report this to the chairperson.
*In the event of a serious adverse event including death, the facts must be promptly reported to the IRB, and the principal investigator must explain the background to the IRB.
(If urgent, an extraordinary meeting of the IRB will be convened)
- Article 16
- The Committee secretariat shall be Administration. The contact person shall be General Affairs (6651) during daytime hours, and after hours it shall be the chief physician on call or the night/holiday nurse manager (PHC7119), who will contact the hospital director and chairperson of the NTT Medical Center Tokyo Ethical Review Board in the case of an emergency.
- Article 17
- In English, the Committee shall be referred to as the NTT Medical Center Tokyo Ethical Review Board
Any matters necessary related to Committee operations or the revision or abolition of these Bylaws shall be conducted upon deliberation by the Committee.