Graduate School of Biomedical Sciences, Health Science Courses,
Ethics Committee Bylaws
Faculty of Medicine, School of Health Sciences Committee(Enacted: January 21, 2016)
Faculty of Medicine, School of Health Sciences Committee(Amended: February 21, 2016)
Faculty of Medicine, School of Health Sciences Committee(Amended: April 20. 2017)
Faculty of Medicine, School of Health Sciences Committee(Amended: September 28, 2017)(Purposes)
Article 1
These bylaws in accordance with Article 26 of the Nagasaki University Graduate School of Biomedical Sciences
Ethics Committee Rules (Graduate School of Biomedical Sciences Rules 2005 hereafter, the “Ethics CommitteeRules” rule No. 1) have been established to set forth the necessary items in respect of the organization andoperations of the Graduate School of Biomedical Sciences, Health Science Courses, Ethics Committee (hereafter,the “Committee”).
(Role of the Committee)
Article 2
The Committee shall perform reviews of research, study, etc. that have been submitted to the Committee pursuant
to Article 13.5 of the Ethics Committee Rules whether within Japan or overseas that directly involve humanparticipants.
(Organization)
Article 3
The members referred to in Article 6.5 (1)(2)(3)(4)(5) of the Ethics Committee Rules shall be recommended
by the Dean of the School of Health Sciences and the members referred to in Article 3.1(1) (2) shall be appointed
by the Dean of the Graduate School of Biomedical Sciences, and for Article 3.1(3) (4) (5) shall be commissionedby the Dean of Graduate School of Biomedical Sciences.
(Recommendation of the member of the Committee to the Nagasaki University Graduate School of BiomedicalSciences Ethics Committee)
Article 4
The Dean of the School of Health Sciences shall in respect of the members of the Committee stipulated in Article
6.2.3 of the Ethics Committee Rules recommend the Committee Chairperson to the Dean of the Graduate Schoolof Biomedical Sciences. However, where the concerned Committee Chairperson is not a professor of the Health1

Science Courses, the Dean of the School of Health Sciences shall make the selection and recommend that
selection to the Dean of the Graduate School of Biomedical Sciences.
(Review of the graduate theses, etc. of students of the School of Health Sciences, and Graduate School ofBiomedical Sciences, Health Science Courses)
Article 5
5.1 The Principal Investigator for graduate theses, etc. conducted by students of the School of Health Sciences,and the Graduate School of Biomedical Sciences, Health Science Courses, shall supervise and be responsible for
conducting the research, etc.
5.2 Applications for graduation theses, etc. made by a student shall be dealt with in accordance with the appended
Form No.1-1-2.
5.3 The student of the School of Health Sciences and the Graduate School of Biomedical Sciences, Health Science
Course, may be present at the concerned Committee meeting as an applicant, to provide explanations and state
their opinions in respect of the contents of that application.
(Review of the Institutional Review Board of Nagasaki University Hospital)
Article 6
6.1 The principal investigator for the concerned research conducted by faculty members and students of theGraduate School of Biomedical Sciences, Health Science Courses and students of the School of Health Sciences,submitted an application for the review in respect of research, etc. including in patients/ out patients of theNagasaki University Hospital, and non-patients as study control as study participant or participants in theconcerned research, shall be reviewed by the Institutional Review Board of Nagasaki University Hospital
6.2The research conducted by the students of the graduate School of Biomedical Sciences, Health Science Courses
and students of the School of Health Sciences to be reviewed by the Institutional Review Board of Nagasaki
University Hospital, the principal investigator must use the application format which is stipulated by theInstitutional Review Board of Nagasaki University Hospital.
(Amendment and Repeal of Bylaws)
Article 7
Any amendments to or repeal of these bylaws shall be made based upon resolutions passed at meetings of theCommittee of Faculty of Graduate School of Biomedical Sciences, Health Science Course.
(Administrative Duties)
Article 8
Administrative duties shall be dealt with by the General Affairs Division (Research Support Section), Nagasaki
University Graduate School of Biomedical Sciences.
(Additional Matters)
Article 9
In addition to the matters stipulated in these bylaws, the Committee shall separately set forth those othermatters required for the operation of the Committee.

2Supplementary
These bylaws have been amended on July 13, 2017, and enacted on September 28, 2017.

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