國立成功大學人類研究倫理治理架構暫行辦法

The Provisional Regulations of Governance Framework for Human Research Ethics of National Cheng Kung University

100.11.23第164次行政會議通過

101.05.09第165次行政會議修正通過

102.09.18第169次行政會議修正通過

103.09.24第173次行政會議修正通過

105.11.16第183次行政會議修正通過

Approved by 164th Administrative Meeting on 23 November 2011

Amendment approved by 165th Administrative Meeting on 9 May 2012

Amendment approved by 169th Administrative Meeting on 18 September 2013

Amendment approved by 173rd Administrative Meeting on 24 September 2014

Amendment approved by 183rd Administrative Meeting on 16 November 2016

第一條　國立成功大學（以下簡稱本校）為妥善執行人類研究，並保障研究參與者之權益，於本校研究暨學術倫理中心設置辦法未制定前，由本校人文社會科學中心負責推動相關業務，特訂定本校人類研究倫理治理架構暫行辦法（以下簡稱本辦法）。本辦法不適用於本校醫學院附設醫院之人體試驗委員會。

Article 1     The National Cheng Kung University (hereinafter the “University”) has established the Provisional Regulations of Governance Framework for Human Research Ethics of the University (hereinafter these “Regulations”) to duly perform human research and to protect the interest of the research participants.  The Research Center for Humanities and Social Sciences is responsible for conducting the relevant activities before the establishment of the Regulations for Establishment of Research and Academic Ethics Center of the University.  These Regulations are not applicable to the Institutional Review Board under National Cheng Kung University Hospital.

第二條　本辦法所稱人類研究，係指下列情形之一者：

一、人體研究法所稱從事取得、調查、分析、運用人體檢體或個人之生物行為、生理、心理、遺傳、醫學等有關資訊之人體研究。

二、指行為科學研究以個人或群體為對象，使用介入、互動之方法，或是使用可資識別特定當事人之資料，而進行與該個人或群體有關之系統性調查或專業學科的知識性探索活動者。

Article 2     “Human research” mentioned in these Regulations refers to one of the following:

1.Human subject research referred to in the Human Subjects Research Act involving obtaining, investigating, analyzing, or using human specimens or an individual person’s biological behavior, physiological, psychological, genetic or medical information.

2.Behavioral scientific research means that individuals or colonies are used as targets and knowledge exploratory activities about systematic investigative or professional disciplines related to these individuals or colonies through the use of intervention or interactive methods or through the use of personally identifiable information.

第三條　本校為保障研究參與者之權益，設下列委員會，其任務如下：

一、研究倫理諮議委員會：擬訂推動研究倫理之方針與維護研究參與者權益之政策。

二、研究倫理審查委員會：規劃及辦理研究倫理審查與執行等事宜，得依照審查需求設一個以上之研究倫理審查委員會；為討論共同標準或相關事項，可定期召開聯席會議或主任委員聯席會議。

三、研究倫理監督委員會：

(一)實地訪查及調查人類研究計畫有無依照倫理審查通過之內容執行。

(二)受理研究參與者申訴。

(三)受理未通過倫理審查者之申覆。

(四)協助研究倫理審查委員會對於相關查核業務之後續處理。

前項各款各委員會之設置要點另訂之。

Article 3     The University has established the committees below with missions to protect the interest of the research participants as following:

1. Research Ethics Advisory Committee: To establish guidelines for promoting research ethics and policies for protecting the interest of the research participants.

2. Research Ethics Committee: To plan and carry out research ethics review and execution matters.  More than one research ethics review committee may be established as required for the review.  For discussing common standards or relevant matters, joint meetings or chairmen’s joint meetings may be held regularly.

3.Research Compliance Committee:

(1)Onsite visit and investigation on whether human research projects are carried out in accordance with the approved details of ethics review.

(2)Process complaints from research participants.

(3)Process appeals from those who did not pass ethics reviews.

(4)Assist the Research Ethics Committee with subsequent handling of relevant audit affairs.

The guidelines for the establishment of the above committees shall be separately stipulated.

第四條　為執行研究倫理諮議委員會之決議，本校得由人文社會科學中心支援各研究倫理委員會與研究倫理監督委員會，並得視業務需要聘用具有博士學位之研究人員從事審查、教育訓練、諮詢等之相關研究工作，及配置專任行政事務人員辦理相關業務。

前項所列之人員，每年應接受人類研究倫理相關教育訓練課程九小時以上。

Article 4     To execute the resolutions of the Research Ethics Advisory Committee, the University may support each Research Ethics Committee and Research Ethics Supervision Committee through the Research Center of Humanities and Social Sciences.  As required, researchers with doctoral degrees may be hired to perform research related work such as review, educational training and advisory activities. And full-time administrative staff may be arranged to carry out relevant affairs.

                   The staff under the previous paragraph shall accept at least 9 hours of human research ethics related educational training courses every year.

第五條　為執行本辦法所規定任務，人文社會科學中心應製作本校人類研究倫理治理架構手冊，手冊內容須包含中心協助推動之作業程序辦法及研究倫理審查委員會作業程序辦法。

前項所列之作業程序辦法訂定原則及程序，如涉及本辦法所規定事項或各委員會之設置規定，皆應提送本校行政會議通過，其餘則送至研究倫理審查委員會討論通過。修正時亦同。

Article 5     To execute the missions provided in these Regulations, the Research Center of Humanities and Social Sciences shall prepare a Manual of Human Research Ethics Governance Framework of the University.  Such manual shall contain the operating procedural regulations for which the Center shall provide assistance and the procedural regulations for the operation of the Research Ethics Committee.

                   If the principles and procedures established under the procedural regulations mentioned in the previous paragraph relating to any matter provided in these Regulations or the regulations about the establishment of any committee, such principles and procedures shall be submitted to the Administrative Meeting of the University for approval. The rest shall be submitted to the Research Ethics Committee for discussion and approval.  The same shall be applicable to any amendment.

第六條　本辦法所需經費，由人類研究計畫所編列倫理審查費用、委託相關費用或本校其他自籌經費等支應，並以自給自足為原則。

Article 6     The funding required under these Regulations shall be paid out of the ethics review cost budgeted for human research projects, relevant commission fees and other funds sourced by the University under the principle of self-sustainability.

第七條　有關違反學術倫理案件，依本校學術倫理審議委員會設置及審議辦法辦理之。

Article 7     Any case in breach of academic ethics shall be governed by the Regulations for Establishment and Review of Academic Ethics Review Committee of the University.

第八條　本辦法經行政會議通過後實施，修正時亦同。

Article 8     These Regulations, including any amendment hereto, are implemented following the approval by the Administrative Meeting.