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National Taiwan Normal University Guidelines for the Research Ethics Review Committee
2012.10.3 Passed during the 337th Administrative Meeting 2013.11.27 Amendments passed during the 342nd Administrative Meeting 2014.11.26 Amendments passed during the 346th Administrative Meeting 2015.3.18 Amendments passed during the 347th Administrative Meeting 2015.5.20 Amendments passed during the 348th Administrative Meeting 2015.11.25 Amendments passed during the 350th Administrative Meeting 2018.11.28 Amendments passed during the 362nd Administrative Meeting 2019.5.29 Amendments passed during the 364th Administrative Meeting 2019.11.27 Amendments passed during the 366th Administrative Meeting
Article 1 National Taiwan Normal University (NTNU) established the NTNU Research Ethics Review Committee (hereinafter referred to as the "Ethics Review Committee") and these Guidelines in accordance with the Human Subjects Research Act, in order to properly conduct research activities involving human subjects, ensure protection of participants and researchers' rights, and supervise conformity with ethics and laws.
Article 2 Committee members and organization:
I. The Ethics Review Committee shall have 15 to 21 members, including a chairperson. Committee members shall comprise at least one legal expert and a credit-worthy, independent third-party; at least half of the Committee must comprise members with academic background in biomedical science, human culture, social science or behavioral science.
Committee members shall comprise no less than one-third from each gender.
II. The chairperson shall be appointed by the President from full-time instructors graded associate professor or above (inclusive) of NTNU, and handle in accordance with Article 8 of the Guidelines. The appointment conditions and qualifications may be separately prescribed.
III. Committee members shall be appointed by the President from full-time instructors graded assistant professor or above (including assistant researcher) and doctoral students of NTNU, or external person with conditions of being Review Committee member. The appointment shall be reported to the competent authority for future reference.
IV. Non-NTNU members shall comprise at least two-fifths of the Committee.
V. All chosen members are required to sign confidentiality agreements and be briefed on their duties. NTNU may also announce publicly the names
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and occupations of the Committee members and their relationships with NTNU.
VI. The Committee members shall serve a term of two years and may be reappointed at the end of the term. If Committee members are to be replaced at the end of the term, the number of replacements shall not exceed half of the revised committee size.
VII. The list of Committee members will be submitted to the MOE for approval. The same shall apply to reappointment, additional appointment, or change, and the list shall be announced.
Article 3 NTNU may dismiss Committee members from their duties if they exhibit any one of the following:
I. Absence in three consecutive meeting sessions without valid reasons or missing more than one-third of total meetings held.
II. Having been found directly responsible for delays in three of the cases assigned for review.
III. Members who severely violate rules regarding conflict of interest.
Article 4 The Ethics Review Committee may commence its meetings only with the presence of at least half of its members. Resolutions are made only if voted in favor by at least two-thirds of those present at the meeting. No proxy attendance is allowed in meetings. Committee members who concurrently act as the host or supervisor of the project being reviewed must recuse themselves from the review. These members are excluded from the required number of members needed to proceed with meetings and resolutions.
Article 5 The Ethics Review Committee shall convene monthly meetings. The chairperson may also convene extraordinary meetings when deemed necessary.
Article 6 I. The Ethics Review Committee may establish review guidelines, fee standards, and review fee payment standards and procedures to guide its research ethics reviews.
II. The Ethics Review Committee's tasks and responsibilities are as follows:
1. Conducts ethics reviews for human subject research and human research projects. Human body research: refers to research involving obtaining, investigating, analyzing, or using human specimens or an individual person's biological behavior, physiological, psychological, genetic or medical information.
2. Supervise, management, inspect, investigate, and take disciplinary measures against human body research projects in
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accordance with the law. Research projects may be ordered to be suspended and make improvements within a specified period or terminated, and related units and the competent authority must be notified in accordance with the law to protect the rights and interests of research subjects.
Article 7 The Ethics Review Committee may hire several contract workers as needed.
The hired staff must be trained and asked to sign confidentiality agreements as required by law, and the recruitment, performance evaluation, reward and discipline of the hired staff shall comply with NTNU Contract Personnel Management Guidelines.
Article 8 The Ethics Review Committee shall conduct all reviews anonymously, and Vice President of Office of Research and Development or above shall not be the chairperson of the Research Ethics Review Committee or influence the review of committee members and any decision made in the review meetings to ensure the independence of review. The review of the Ethics Review Committee is not improperly influenced by affiliated research institution, project hosts, and sponsor.
Article 9 The Guidelines have been implemented after approval by an Administrative Meeting. The same shall apply to all subsequent amendments.
