Conference OutlineOverview of the society
Rules of the Research Ethics Review Committee
(Preamble)
The purpose of the Japan Academy of Nursing Science (hereafter referred to as "the Society") is to promote the development of nursing science and the exchange of knowledge widely, thereby contributing to the health and welfare of people. The importance of nursing research in the creation of nursing knowledge and skills goes without saying.
In nursing research involving human subjects, consideration for the human rights of the subject must take precedence over scientific and social interests. This Code is rooted in the ethical standards set forth in the Nuremberg Code and the Declaration of Helsinki, which advocate respect for human rights in health care. Of fundamental importance is that the safety of subjects is adequately guaranteed, and that subjects cooperate with research of their own free will, having been fully informed and having a good understanding of the purpose, methods, and safety of the research.
The Society hereby establishes the Rules of the Research Ethics Review Committee, taking the position that nursing research involving human subjects conducted by Society members must meet these basic requirements.
(Purpose)
Article 1.
The purpose of this committee is to review whether nursing research involving human subjects conducted by regular members is conducted with ethical considerations, taking into account the "Ethical Guidelines for Medical Research Involving Human Subjects (Ministry of Education, Culture, Sports, Science and Technology and Ministry of Health, Labor and Welfare)" and the "Ethical Guidelines for Nursing Research (Japan Nursing Association)".
(Subject to review)
Article 2.
Research ethics review is limited to research where there is no research ethics review committee at the member's institution, etc., or where the research does not deal with nursing research, and where the active member is the principal investigator.
2 It is a prerequisite for review that you plan to submit your work to the Society.
3 In principle, the provisions of the preceding two paragraphs shall not apply to research in the activities of the Committee of the Society.
(Committee positioning)
Article 3.
The Research Ethics Review Committee ("Committee") shall be established separately from the Nursing Ethics Review Committee.
(Composition of committee members)
Article 4.
Members shall be appointed by the Board of Directors for a term of two years, without prejudice to reappointment, and half of the members shall change every two years.
2 The six committee members shall consist of three experts in the fields of nursing, healthcare, and medicine, one expert in another field, one expert in the field of law, and one person who can reflect the opinions of the general public, at least two of whom shall be non-academic members, and shall be of both genders.
3 The chairperson is elected by the committee members from among themselves, and the chairperson appoints the vice chairperson.
(Examination)
Article 5.
Screening shall be conducted in two ways: "Simplified Screening" and "Regular Screening".
2 "Expedited review" refers to a research protocol in which it is clear that the direct risk to the subject in research collaboration is extremely minimal, as in the case of an anonymous questionnaire survey, and that the subject's free will and anonymity in research collaboration are ensured.
(Application Procedure)
Article 6.
The applicant shall submit one original and seven copies of the research plan together with the application form (Forms 1 and 2) to the office of the Society by "registered mail".
2 The research protocol shall include the research topic, research organization, objectives, methods, subjects, information to be used, ethical issues in the research, documentation of informed consent, research funding, and requests to review committee members.
(Quick screening)
Article 7.
Approval" is granted when the chairperson and vice chairperson deem the submitted research protocol appropriate in a simplified review.
2 Research protocols that do not receive "approval" or "approval with conditions" at the expedited review will be reviewed at the regular review.
3 The chairperson shall report the results of the expedited review judgment to the committee members on an annual basis.
(Normal screening)
Article 8.
The normal review process shall consist of two stages: an "e-mail review" and a "review by convening the committee members".
2 In any review, the decision of "approval," "approval with conditions," "recommendation of change (reapplication required)," or "disapproval" is based on the agreement of at least 2/3 of the committee members.
3 Each committee member conducts an e-mail review and reports to the chair (Form 3).
4 The chairperson reports the results of the e-mail review decision to the committee members (Form 4).
5 If 2/3 or more of the committee members cannot reach a consensus through an e-mail review, the committee will convene a meeting of the committee members for a review.
(Results of screening)
Article 9.
The chairperson submits the results of approval, approval with conditions (confirmation required), recommendation for change (reapplication required), or disapproval to the President (Form 5). In the case of approval, the President shall assign an approval number.
Article 10.
The President shall notify the applicant of the results within 4 weeks from the date of application receipt for the simplified assessment and within 2 months for the regular assessment (Form 6).
(Confirmation in case of conditional approval)
Article 11.
The application for modification of conditional approval shall be submitted within three months from the date of notification of results (date of notification of receipt). The applicant shall clearly indicate the modifications/changes by means of a comparison sheet, etc., and submit one original and three copies of the research plan together with the application form (Forms 1 and 2) to the office of the Society by mail.
2 "Approval" is determined when the submitted research protocol is deemed appropriate by the chairperson and vice-chairperson's review.
(Application for reexamination)
Article 12.
The application for re-examination shall be filed within three months from the date of notification of results (the date of receipt notification). The applicant shall submit one original and seven copies of the application form (Forms 1 and 2) along with the research plan, clearly indicating any modifications or changes by means of a comparison chart or other means, to the office of the Society by mail.
2 The submitted research protocols will be reviewed again at the discretion of the chair and vice-chair for expedited or regular review.
(Objection)
Article 13.
Appeals shall be filed within two weeks of the notification of results (date of notification of receipt). The applicant shall send to the President a letter of appeal (any format) stating the specific reasons for the appeal and the required documents.
2 The objection shall be referred to the Nursing Ethics Review Committee for deliberation. The Nursing Ethics Review Committee shall hear from the Committee and the objector, as necessary, and report the results of its deliberations to the President.
3 The President makes a decision on the complaint based on the report.
(Expenses)
Article 14.
The necessary transportation expenses for the committee members will be paid at their actual expense.
2 External committee members shall be paid an honorarium, the amount of which shall be stipulated separately.
(Confidentiality)
Article 15.
Members of the committee and related parties shall not divulge to others any matters concerning the research of others that they have learned through the committee.
2 Committee members and related persons shall not use matters concerning the research of others obtained through the committee for their own research.
(Revision of Rules and Regulations)
Article 16.
Revisions to these Rules shall be made by resolution of the Board of Directors.
Supplementary Provisions
These regulations shall go into effect on February 22, 2009.
Supplementary Provisions
Notwithstanding the provisions of Article 4, the term of office of those who were members of the Committee as of the effective date of these Rules shall expire at the conclusion of the Ordinary General Meeting of Members for the first fiscal year ending after their assumption of office.
Supplementary Provisions
The amendments to these Rules and Regulations shall go into effect on August 8, 2010.
Supplementary Provisions
The amendments to these Rules and Regulations shall go into effect on February 21, 2016.
Supplementary Provisions
The amendments to these Rules and Regulations shall go into effect on September 10, 2017.
Supplementary Provisions
The amendments to these Rules and Regulations shall come into effect as from October 23, 2024.
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