Group Research Ethics Examination Committee Regulations [Created: 2004/06/18] [Revised: 2017/06/15] (Objectives) Article 1 In accordance with the Ethics Regulations on Clinical Research and Development and Human Genome and Genetic Analysis Research ( Research Ethics Regulations ) these regulations provide for the establishment, structure and operation of the Research Ethics Examination Committee (the Committee ), to provide advice to the heads of research institutions of Sysmex Corporation and Sysmex Corporation s subsidiaries (collectively referred to as Group companies ), to examine the appropriateness of research plans from the perspective of personal dignity and respect for the human rights of subjects and from an ethical and scientific perspective. The objective of these regulations is to ensure the transparency and adequacy of research in accordance with government guidelines, and to obtain societal approval of research results. (Classification of regulations) Article 2 1. These regulations apply to Group companies as Group regulations comprising common standards for the execution and management of Group operations. 2. Subsidiaries provided for in Article 1 are as follows: Sysmex International Reagents Co., Ltd. (Scope of application) Article 3 These regulations apply to examinations as to whether the conduct of research performed under Research Ethics Regulations and research related to commercial activities is appropriate and whether committee operations are appropriate regarding the disclosure of examinations. Research that is based on or complies with the Pharmaceutical and Medical Device Act, medical device GCP, pharmaceutical product GCP or ICH-GCP is outside this scope. 1 / 7
(The Committee s responsibilities) Article 4 If the heads of research institutions ask for advice, the Committee must state in writing its opinion as to the appropriateness of research plans based on the Research Ethics Regulations of research plans based on personal dignity and respect for the human rights of the subjects and from a research ethics and scientific perspective. (Composition of Committee members) Article 5 1. The Committee shall comprise six or more members, including members from within and outside the Company. 2. The Committee shall be composed of members with the following three standpoints. (1) Expert in the natural sciences (2) Expert in the humanities or social sciences, including ethics and law (3) Persons with a general perspective Committee members may not fill multiple standpoints concurrently. 3. Three or more Committee members shall be from outside the Company. 4. At least two members shall be men and at least two shall be women. 5. The tenure of Committee members shall be two years, and members may be reappointed at the end of this term. (Appointment and dismissal of Committee members) Article 6 1. Committee members from the Company shall be appointed by the president of Sysmex Corporation. 2. Committee members from outside the Company shall be nominated by the executive vice president of the R&D Strategic Planning Division, and appointed by the president of Sysmex Corporation. 3. The Committee chair and deputy Committee chair shall be appointed by the president of Sysmex Corporation. (Investigation) Article 7 The Committee may conduct investigations to ensure the appropriateness and reliability of research being conducted. 2 / 7
(Confidentiality) Article 8 Neither Committee members nor personnel conducting related office work may disclose information obtained in the course of their duties. This provision shall apply after such duties have ended. (Operating standards) Article 9 1. The Committee must perform fair and neutral evaluations by people from diverse standpoints. 2. During deliberations and voting, at least two Committee members from outside the Company must be present. 3. Neither the heads of research institutions, people responsible for the research subject being evaluated, nor the people in charge of conducting that research may be present during voting. These parties may be present during deliberations to provide explanations, if requested by the Committee. 4. The Committee chair shall convene and preside over the Committee meeting. 5. If the Committee chair is absent, his or her duties shall be assumed by the deputy Committee chair. 6. A Committee meeting may not be held unless all of the following conditions are met. (1) Attendance by members with standpoints (1) through (3) of Article 5, Paragraph 2 (2) Attendance by multiple Committee members from outside the Company (3) Attendance by both male and female Committee members (4) Attendance by at least five committee members (Research planning documents) Article 10. 1. To evaluate the appropriateness of conducting research, research planning documents shall be prepared and submitted to the Committee in the name of the head of the research institution. 2. The heads of research institutions shall ensure that all people in charge of conducting research comply with items included in research planning documents approved by the Committee. (Resolution method) Article 11. 1. In principle, Committee resolutions should be determined unanimously by all members 3 / 7
present. However, in the event that opinion is divided, resolutions shall be determined by agreement of two-thirds of the members present. In this event the dissenting opinions shall be submitted to the heads of research institutions. 2. Decisions shall be of the following five types. (1) Not applicable: Outside the scope of evaluation (2) Approval: Approved per the application (3) Conditional approval: Approved, but with conditions attached (4) Non-approval: Not approved (5) Re-evaluation: To be evaluated again following revision of the plan (Reporting evaluation results) Article 12. 1. The Committee chair must report the Committee s evaluation results to the heads of research institutions without delay. 2. The heads of research institutions must respect the Committee s decisions and make necessary decisions on items pertaining to the conduct of research in accordance with these decisions. The heads of research institutions may not perform research that the Committee has deemed inappropriate. (Saving of evaluation records) Article 13 Evaluation records shall be created by the secretariat, approved by the Committee chair and stored by the secretariat for five years following the date of the meeting. However, evaluation materials related to intervention in research that is invasive (excluding minimally invasive) shall be stored for a period of five years following the date of reporting the completion of such research. (Items related to disclosure) Article 14 1. Items related to the Committee s organization and operation must be disclosed. Items related to parliamentary proceedings must also in principle be disclosed. 2. Organization-related items to be disclosed are as follows: (1) Composition of the Committee (including subordinate organizations) (2) Names, affiliations and standpoints of Committee members 3. The content of parliamentary proceedings must be disclosed specifically and in a manner that clarifies their content. 4. The Committee may elect not to disclose certain information out of concern for 4 / 7
infringing the rights of people providing specimens, the originality of research, intellectual property rights or the preservation of trade secrets of Group companies. In this event, the committee must disclose the reason for its non-disclosure. 5. The disclosure method shall in principle be via the Sysmex Corporation website and the Institutional Review Board Reporting System established by the Ministry of Health, Labour and Welfare, or by other methods as determined by the Committee. (Expedited evaluation) Article 15 1. The Chairman may, with the Committee s approval, establish expedited evaluation procedures. Expedited evaluation results must be reported in writing to all Committee members. 2. Items for evaluation that may be handled under expedited evaluation procedures are as follows: (1) Evaluations of minor revisions to research plans (2) Evaluations of research plans related to research planning documents already approved by the Committee (3) In joint research, the evaluation of research plans in the event that the research plans of the principal institution conducting research have already been approved by the Committee (4) In joint research, evaluations to confirm that conditions are being satisfied with respect to research plans for which evaluation results of the principal institution conducting the research have been conditionally approved by the Committee (5) Evaluation related to research that is not invasive and does not involve intervention (6) Evaluation related to research that is minimally invasive and does not involve 3. The following items must be recorded in evaluation applications for research plan revision for expedited evaluation procedures: (1) The reason revisions are necessary (2) Item numbering related to revisions and revised items (specification of pre- and post-revision) (3) The approval number and approval date 4. In the event of an application received for any of the preceding items, if the Committee chair determines that the items qualify for expedited evaluation, the Committee chair shall confer with at least two Committee members, including one external or internal Committee member. In this case, the application shall be approved or evaluated by the Committee. 5. For applications for which expedited evaluation is possible according to the preceding 5 / 7
items, the items for which changes are preliminarily approved by the Committee shall be evaluated by the Committee chair. The evaluation decision in this event shall be either for approval or expedited evaluation. 6. Committee members who receive reports of the results of expedited evaluations may request a re-evaluation by the Committee, if they supply their reasons to the Committee chair within 14 days of the date the report is issued. In this case, if the Committee chair judges there to be adequate cause, the chair must promptly convene the Committee and re-evaluate the item in question. 7. In the event of expedited evaluation results and in the absence of a Committee meeting in regard to the preceding items, the determination and the reasons shall be disclosed in accordance with Article 14. 8. Articles 12 through 14 shall apply in the case of an expedited evaluation. (Handling revision items not requiring evaluation or expedited evaluation) Article 16 In the event of minor revisions to research plans as indicated in item 1 of the preceding article, the revisions may be handled by reporting items to Committee members without conducting an evaluation or expedited evaluation if revisions are solely to the composition of researchers. In this event, Committee members who have received such a report may request a re-evaluation of such items by the Committee by submitting their reasons to the Committee chair within 14 days of the date of the report s issuance. In this case, the Committee chair must promptly convene the Committee to conduct a re-evaluation of the relevant item. (Primary evaluation) Article 17 Prior to the Committee s evaluation of the research plan, the Committee chair may request the opinion of internal experts regarding the scientific and ethical appropriateness of a research plan. (Collective examinations) Article 18 The head of the research institution may request a collective examination by the ethical review board of an institution that has received advance committee approval of research plans on research carried out in collaboration with other research institutions. In this event, the head of the research institution must report the results of the review to the committee. 6 / 7
(Secretariat) Article 19 1. The Committee shall establish a secretariat to perform clerical work for the Committee. 2. The secretariat shall be located in the R&D Strategic Planning Division. 3. The receipt and dissemination of documents for the Committee, other than those provided for separately by these regulations, shall be handled via the secretariat. 4. The Committee s documents shall be in electronic form, and may be disseminated by email. (Education and training) Article 20 Prior to the conduct of evaluations or related clerical work, members of the Committee and personnel performing clerical activities must undergo any necessary education and training to gain the knowledge necessary to perform evaluations from an ethical and scientific perspective. In addition, the personnel shall undergo further education and training on an ongoing basis, as appropriate. (Other) Article 21 With regard to the Committee s operations, items not provided for in these regulations shall be determined by the Committee. (Disclosure) Article 22 These regulations shall be disclosed in accordance with national government guidelines. Bylaws (Effective date) Article 1 These regulations are effective as of May 30, 2017. Article 2 Detailed procedures and models are provided separately. 7 / 7