法規內容

下載法規原始檔

 

國立成功大學人類研究倫理監督委員會設置要點
Guidelines for Establishment of Human Research Compliance Committee of the National Cheng Kung University

101.11.21第166次行政會議通過

102.09.18第169次行政會議通過

國立成功大學人類研究倫理監督委員會設置要點

Guidelines for Establishment of Human Research Compliance Committee of the National Cheng Kung University

 

101.11.21第166次行政會議通過

102.09.18第169次行政會議修正通過

Approved by 166th Administrative Meeting on 21 November 2012

Amendment approved by 169th Administrative Meeting on 18 September 2013

 

一、 國立成功大學(以下簡稱本校)依本校人類研究倫理治理架構暫行辦法第三條規定,設「人類研究倫理監督委員會」(以下簡稱本會),並訂定本要點。

National Cheng Kung University (hereinafter the “University”) has established the Human Research Compliance committee (hereinafter the “Committee”) and these Guidelines in accordance with Article 3 of the Provisional Regulations of Governance Framework for Human Research Ethics of the University.

二、 本會任務如下:

(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)受理研究參與者之申訴及調查案。

(三)受理人類研究計畫之申覆案。

(四)協助評估人類研究倫理治理架構之施行成效。

(五)協助評鑑與提昇相關研究倫理審查委員會審查品質與效率。

(六)協助研擬研究倫理規範之具體執行方案與教育訓練事宜。

(七)  其他與人類研究計畫之權益相關事宜。

2. The Committee has the following missions:

(1)Onsite visit and investigation as to whether human research projects are executed in accordance with the approved details of ethics review.

(2)Process complaints and investigation cases from research participants.

(3)Process appeal cases of human research projects.

(4)Assistance with evaluations of performance results of Human Research Ethics Governance Framework.

(5)Assistance with appraisal and improvement of quality and efficiency of review by relevant research ethics review committee.

(6)Assistance with preparing the draft of specific execution proposals of research ethics regulations and educational training matters.

(7)Other matters related to the interests of human research projects.

三、 本會委員應為熟諳人類研究倫理治理架構施行理念或曾擔任人類研究倫理審查委員之校內外研究人員,且校外委員、任一性別委員應佔委員總數三分之一以上。任期為二年,期滿得續聘之。連聘得連任。

3. The members of the Committee shall be researchers from inside or outside the University who are familiar with the implementation ideas of Human Research Ethics Governance Framework or who have served as members of human research ethics committees. The number of members from outside the University and the number of members of each gender shall represent at least 1/3 of all members. The terms of members are 2 years and may be renewed upon expiry. The same member may serve again if re-hired.

四、 本會置委員三至五人,其中一人為主任委員。主任委員由人文社會科學中心主任就校內符合前點規定之專任教師薦請校長聘兼之,其餘委員由主任委員提名薦請校長聘任之。

4. The Committee has 3 to 5 members, one of the members shall be the Chairman. The Director of the Research Center of Humanities and Social Sciences shall recommend the President of the University to hire the candidate of the Chairman from among full-time teachers of the University who meet the requirements under the previous article. The other members shall be nominated by the Chairman and hired by the President of the University.

五、 本會就審查通過且現在執行中之人類研究計畫,得進行實地訪查。其訪查分為:

(一)主動訪查:根據研究參與風險高低,定期依比例隨機抽查相關研究計畫以進行實地訪查。

(二) 被動訪查:依研究倫理審查委員會、人文社會科學中心、計畫主持人及研究團隊、計畫執行機構、計畫經費補助單位或計畫執行機構之中央目的事業主管機關等之請求,實地訪查相關研究計畫。

5. The Committee may conduct onsite visits to human research projects that have been approved and under execution. The visits are divided into the following:

(1)Active visits: Depending on the level of risk in research participation, relevant research projects are regularly and randomly selected on a proportional basis to conduct onsite visits.

(2)Passive visits: Onsite visits to relevant research projects pursuant to the request by the Research Ethics Committee, the Research Center for Humanities and Social Sciences, the principal investigators and research teams, the project execution institutions, the project funding entities or the government authority in charge of subject industry of the project execution institutions.

六、 本會得依研究倫理審查委員會請求,進行調查疑似侵害研究參與者權益之申訴案件,於二個月內完成調查,並將調查結果交由研究倫理審查委員會為後續處理。

6. As requested by the Research Ethics Committee, the Committee may conduct an investigation on complaint cases about the suspected breach to the interests of research participants. The investigation shall be completed within 2 months and the results of the investigation shall be provided to the Research Ethics Committee for further handling.

七、 凡已向研究倫理審查委員會提出重為審查,仍對其決定不服之計畫主持人,得二個月內以書面向本會提出申覆。申覆案件審議程序另訂之。

7. If a request for reconsideration has been filed with the Research Ethics Committee and the principal investigator still objects to the decision, a written appeal may be filed with the Committee within 2 months. The review procedure for appeal cases shall be separately stipulated.

八、 本會委員皆為無給職,但非由本校人員兼任者,得依規定支給審查費、出席費及差旅費。

8. There is no remuneration for members of the Committee. However, members who are not staff of the University may be paid review fee, attendance fee and transportation fee.

九、 本要點經行政會議通過後實施,修正時亦同。

9. These Guidelines, including any amendment hereof, are implemented following approval by the Administrative Meeting.