Internal Regulations Concerning the Implementation of Research on Human Beings in the Hokkaido University Faculty of Engineering and Graduate School of Information Science and Technology

Enacted as of April 9, 2010

(Purposes)
Article 1. These internal regulations shall prescribe necessary matters regarding the implementation of research that may raise ethical issues (excluding research that is under the provisions prescribed in other laws or guidelines) in relation to research on human beings in the Hokkaido University Faculty of Engineering and Graduate School of Information Science and Technology, and shall also prescribe the organization and operating standards of the Ethical Review Board Concerning Research on Human Beings in Hokkaido University Engineering (hereinafter referred to as the “Board”).

(Research Implementation)
Article 2. When wishing to implement the research under the preceding paragraph, the head researchers shall apply to and gain approval from the Director of the Faculty or the Director of the Graduate School (hereinafter referred to as “the Director of the Faculty and other relevant person”) to whom the head researchers belong, using the Application for Ethical Review Regarding Research for Human Beings form (appended form 1).
2. In the case of the application for research under the preceding paragraph, the Director of the Faculty and other relevant person shall initiate a review by the Board to determine whether or not to approve the research.
3. When having determined whether to approve or not, the Director of the Faculty and other relevant person shall notify the head researchers of the approval using the Notification of the Results of the Review of Applications for Research on Human Beings form (appended form 2).

(Responsibility)
Article 3. The head researchers shall assume responsibility for injury suffered by research subjects caused by the relevant research conducted under the approval (hereinafter referred to as the “relevant research”).

(Report of Research Completion)
Article 4. When the relevant research is completed, the head researchers shall report it to the Director of the Faculty and other relevant person using the Report on the Results of Research on Human Beings form (appended form 3) without delay.

(Confidentiality)
Article 5. The head researchers and co-researchers shall not unveil secrets which were obtained during the relevant research.
2. When having to unveil secrets which were obtained during the relevant research as a witness or an appraiser based on the law, permission should be granted by the Director of the Faculty and other relevant person.
3. The provisions in the preceding paragraphs shall apply even after dismissal or severance.

(Establishment of the Board)
Article 6. The Board shall be jointly established by the Faculty of Engineering and the Graduate School of Information Science and Technology.

(Duties of the Board)
Article 7. The Board shall conduct screening through the examination of documents or examinations by interview if deemed necessary with regard to the following items, and report the results to the Director of the Faculty and other relevant person using the Report on the Screening Results of Research on Human Beings form (appended form 4).

  • (1) Matters regarding consideration for human rights protection of research subjects;
  • (2) Matters regarding methods for seeking understanding and gaining agreements from research subjects;
  • (3) Matters regarding the potential harm of and risks for research subjects as a result of research and the usage of research results; and
  • (4) Other necessary matters regarding research on human beings.

(Organization)
Article 8. The Board shall be composed of the following members.

  • (1) The Director of Research Planning, Faculty of Engineering
  • (2) The Director of Research Planning, Graduate School of Information Science and Technology
  • (3) Three persons selected from among full-time professors or associate professors in the Faculty of Engineering and designated by the Director of the Faculty of Engineering.
  • (4) One person selected from among full-time professors or associate professors in the Graduate School of Information Science and Technology and designated by the Director of the Graduate School of Information Science and Technology.

2. Notwithstanding the provisions of Items 3 and 4 of the preceding paragraph, the Director of the Faculty of Engineering and the Director of the Graduate School of Information Science and Technology may, when deeming it to be especially necessary for the operation of the Board, designate rehired specially appointed professors or associate professors as the Board members.

(The Term of Office)
Article 9. The term of office for the members pursuant to Items 3 and 4 of Paragraph 1 in the preceding article shall be for two years and members may be reappointed for subsequent terms. However, in the case of filling a vacant member’s position, the term of office for a member who fills a vacancy shall be the remainder of the former member’s term of office.

(Chair and Vice Chair of the Board)
Article 10. A Chair and Vice Chair shall be appointed to the Board. The Chair shall be filled by the Director of Research Planning, Faculty of Engineering, and Vice Chair by the Director of Research Planning, Graduate School of Information Science and Technology.
2. The Board shall be hosted by the Chair.
3. If the Chair is unable to carry out his/her duties, the Vice Chair shall carry out the duties on the Chair’s behalf.

(Proceedings)
Article 11. The Board may not commence proceedings unless at least a half of its members are in attendance.
2. The Board members who are involved in the research taken up in a review may not participate in the review and resolution of said research.
3. The Chair may, when deeming it to be necessary, request the Board member in the preceding paragraph to attend the Board meeting, and solicit explanations or opinions from the member.
4. Decisions of the Board shall be made by a majority of members in attendance and when there is a split decision, the Chair shall have the deciding vote.

(Attendance of Those other than the Board Members)
Article 12. The Chair may, when deeming it to be necessary, request persons other than the Board members to attend the Board meeting, and solicit explanations or opinions from them.

(General Affairs)
Article 13. General affairs regarding the implementation of research on human beings and the Board shall be managed by the General Affairs Division in cooperation with the General Affairs Section of the Graduate School of Information Science and Technology.

(Miscellaneous provisions)
Article 14. In addition to those prescribed in these internal regulations, necessary matters regarding the implementation of research on human beings shall be separately prescribed by the Director of Faculty of Engineering and the Director of the Graduate School of Information Science and Technology after deliberation by them.
2. In addition to those prescribed in these internal regulations, necessary matters regarding the Board shall be separately prescribed by the Board.

Supplementary Provisions

  1. These internal regulations will come into effect from April 9, 2010 and apply from April 1, 2010.
  2. The Internal Regulations Concerning the Implementation of Research on Human Beings in the Hokkaido University Faculty and Graduate School of Engineering and the Hokkaido University Graduate School of Information Science and Technology (enacted as of October 9, 2008) will be abolished.

Supplementary Provisions
These internal regulations will come into effect from April 1, 2011.

Supplementary Provisions
These internal regulations will come into effect from April 8, 2011 and apply from April 1, 2011.

Appended form 1 (related to Article 2, Paragraph 1)
(Form omitted)

Appended form 2 (related to Article 2, Paragraph 3)
(Form omitted)

Appended form 3 (related to Article 4)
(Form omitted)

Appended form 4 (related to Article 7)
(Form omitted)

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