(Outline)
The Public Interest Corporation, Japan Academy of Nursing Science (hereinafter ‘the Academy’) aims to promote nursing science, work for widespread exchange of knowledge, and contribute to the health and welfare of people. The importance of nursing research in the creation of nursing science knowledge and technique is fundamental.
In nursing research involving human subjects, the rights of participants must be given priority over scientific and social benefits. These regulations are founded on ethical standards presented in the Nuremberg Code and the Helsinki Declaration that advocate respect for human rights in medical treatment. Of fundamental importance are concerns such as that the safety of human subjects is fully guaranteed, that participants have received a full explanation of the research aims, methods and safety concerns, and that participants are cooperating with research of their own free will with a thorough understanding of the consequences.
The ethical standpoint of the Academy is that nursing research involving human subjects conducted by Academy members must fulfill these basic ethical requirements, and have established these Research Ethics Review Committee Regulations.
(Purpose)
Article 1 .
The purpose of the Research Ethics Review Committee is to review whether or not nursing research conducted by Academy members involving human subjects pays due concern to all ethical considerations and complies with the Ethical Guidelines Relating to Clinical Research (Ministry of Health, Labour and Welfare) and the Ethical Guidelines for Nursing Research (Japanese Nursing Association).
(Evaluation target)
Article 2 .
The Research Ethics Review Committee will only review research when an Academy member is one of the main researchers, and there is no ethics review board at the institution attended by the Academy member belongs, or the institution does not deal with nursing research.
2. Reviews will only apply to research planned for submission to the Academy.
(Positioning of Research Ethics Review Committee)
Article 3 .
The Research Ethics Review Committee (hereinafter called ‘the Committee’) shall be established separately from the Nursing Ethics Committee.
(Committee member composition)
Article 4 .
Committee members shall be appointed by the Board of Directors for a term of 2 years, but reappointment is permitted. In the organizational changeover each 2 years, half of the Committee members shall be eligible for replacement.
2. The Committee shall comprise 6 members: three specialists from the fields of nursing, health and medicine, one specialist from other fields, one specialist from the legal field, and one person who can represent opinions of society in general. Of the 6 Committee members, 2 or more members shall not be Academy members, and the Committee shall comprise both male and female members.
3. The Committee Chairperson shall be elected by mutual election amongst the Committee members, and the Committee Chairperson shall nominate the Vice Chairperson.
(Review)
Article 5 .
Reviews may be either a ‘simple review’ or a ‘standard review’.
2. A ‘simple review’ will be applied to a research protocol where it is clearly the case that there is extremely low direct risk to participants from participating in a study such as an anonymous self-answered written questionnaire survey, where the participant is cooperating with the study of their own free will and anonymity is guaranteed.
(Review application procedure)
Article 6.
Review applicants shall apply for a ‘simple review’ or a ‘standard review’ by the specified application submission deadline date.
Article 7.
The application date shall be the application submission deadline date.
Article 8.
Along with the research protocol document, the review applicant shall provide the application form (Form 1, 2), and send 1 original of each and 7 copies of each by registered mail to the Academy Office.
2. The research protocol document shall include the research issue, the research organization, aims, methods, participants, information used, ethical issues involved in the research, statements relating to informed consent, source(s) of research grant capital, and items requested of the Nursing Research Ethics Committee.
(Simple review)
Article 9.
If the Committee Chairperson and Vice Chairperson evaluate the submitted research protocol document as appropriate after a Simple review, the research protocol is ‘Approved’.
2. If the research protocol is not ‘Approved’ in Simple review, it will be evaluated in Standard review.
3. The Committee Chairperson will report the Simple review result to the Committee members.
(Standard review)
Article 10.
Standard review can be conducted by ‘Email Review’ and ‘Review by Committee Meeting’.
2. A judgment of ‘Approval’, ‘Conditional approval’, ‘Changes recommended (Resubmission required)’ or ‘Not approved’ shall be applied based on agreement of 2/3 majority or more of the Committee.
3. Each member will report the result of their Email Review using Form 3.
4. If agreement is not reached on an Email Review by a 2/3 majority or more, the Committee will meet to make a Review decision.
5. The Committee Chairperson will report the judgment result of the Email Review to the Committee members (using Form 4).
(Review result)
Article 11.
The Committee Chairperson will inform the Chairperson of the Board of Directors whether the result was ‘Approval’, ‘Conditional approval’, ‘Changes recommended (Resubmission required)’ or ‘Not approved’ (using Form 5).
Article 12.
The Chairperson of the Board of Directors will send the review applicant the Result Notification within 2 weeks of the application receipt date in the case of a Simple review, and within 1 month of the application receipt date in the case of a Standard review (using Form 6).
(Application for resubmission)
Article 13.
An application for resubmission must be made within 3 months of the Result Notification (Receipt Notification Date). The applicant must indicate the amended and changed parts in a comparison table etc, and attach the application form (Form 1, 2) to the research protocol document, and send 1 original of each and 7 copies of each by mail to the Academy Office.
(Lodging a protest)
Article 14.
Protests must be lodged within 2 weeks of Results Notification (Receipt Notification Date). The applicant must lodge the Chairperson of the Board of Directors with a Protest form (no fixed format) specifying concrete reasons for the Protest, together with the necessary documents.
2. Judgment of the Protest shall be entrusted to the Nursing Ethics Committee, who shall as necessary listen to the opinions of the Committee members and the Protest applicant, then report the judgment result to the Chairperson of the Board of Directors.
3. The Chairperson of the Board of Directors will make a decision about the protest based on the report.
(Costs)
Article 15.
When the Committee meets, incurred transportation costs will be paid to the Committee members.
2. An honorarium will be paid to non-Academy Committee members, the honorarium amount to be decided separately.
(Preservation of confidentiality)
Article 16.
Committee members and related parties are not permitted to reveal knowledge of the applicant’s research gained through the Committee to any other party.
2. Committee members and related parties must not use knowledge of the applicant’s research gained through the Committee in their own research.
(Revision of regulations)
Article 17.
Revision of these regulations can only be made after a motion is passed by the Nursing Ethics Committee and approved by the Chairperson of the Board of Directors.
Supplementary Provisions
These Regulations take effect from February 22, 2009.
Supplementary Provisions
Irrespective of Article 4, the term of office of Committee members on the date of implementation of these regulations shall extend until the conclusion of the Councilors meeting for the first fiscal year after the Committee members are appointed.
Supplementary Provisions
Revision of these regulations takes effect from August 8, 2010.
