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

101.11.21第166次行政會議修正通過

102.09.18第169次行政會議修正通過

103.02.26第171次行政會議修正通過

103.03.13第102-3次校務基金管理委員會修正通過

103.09.24第173次行政會議修正通過

104.03.19第103-2次校務基金管理委員會修正通過

104.05.13第176次行政會議修正通過

104.11.18第178次行政會議修正通過

107.09.26第192次行政會議修正通過

國立成功大學人類研究倫理審查委員會設置與審議要點

Guidelines for Establishment and Review of Human Research Ethics Committee 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

101.11.21第166次行政會議修正通過

102.09.18第169次行政會議修正通過

103.02.26第171次行政會議修正通過

103.03.13第102-3次校務基金管理委員會修正通過

103.09.24第173次行政會議修正通過

104.03.19第103-2次校務基金管理委員會修正通過

104.05.13第176次行政會議修正通過

104.11.18第178次行政會議修正通過

107.09.26第192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 166th Administrative Meeting on 21 November 2012

Amendment approved by 169th Administrative Meeting on 18 September 2013

Amendment approved by 171st Administrative Meeting on 26 February 2014

Amendment approved by 102-3rd School Affairs Fund Management Committee on 13 March 2014

Amendment approved by 173rd Administrative Meeting on 24 September 2014

Amendment approved by 1023-2nd School Affairs Fund Management Committee on 13 May 2015

Amendment approved by 176th Administrative Meeting on 13 May 2015

Amendment approved by 178th Administrative Meeting on 18 November 2015

Amendment approved by 192nd Administrative Meeting on 26 September 2018

一、 國立成功大學（以下簡稱本校）為妥善執行人類研究，維護研究參與者權益，規劃、審查及追蹤相關研究執行之倫理事宜，特依本校人類研究倫理治理架構暫行辦法第三條規定，得設一個以上人類研究倫理審查委員會（以下簡稱倫審會，英文名稱為Human Research Ethics Committee，簡稱HREC），並訂定本要點。

National Cheng Kung University (hereinafter the “University”) has established these Guidelines in accordance with Article 3 of the Provisional Regulations of Governance Framework for Human Research Ethics of the University which stipulates that more than one human research ethics review committee may be established (hereinafter the “Ethics Committee”, short for HREC) in order to duly execute human research, protect the interest of the research participants and plan, review and follow up on the ethics matters in the performance of the relevant research.

二、 倫審會任務如下：

訂定人類研究倫理之審查範圍、內容及要點。

訂定人類研究倫理之審查作業基準。

審核、評估人類研究倫理之合理性、可行性及定期追蹤。

審議攸關研究參與者權益之倫理及法律事宜。

其他涉及研究參與者權益之相關事宜。

以上事項由主任委員定期召開所有倫審會委員總人數半數以上出席之聯席會議訂定之。

The Ethics Committee has the following missions:

Establish the scope, details, and guidelines for the review of human research ethics.

Establish the basis of review procedure for human research ethics.

Review and evaluate the reasonableness, feasibility and regular follow-up of human research ethics.

Review ethics and legal matters related to the interest of the research participants.

Other relevant matters involving the interest of research participants.

The above matters shall be determined by joint meetings regularly organized by the chair attended by the majority of all members of all the Ethics Committees.

三、 倫審會依送審計畫所涉及研究倫理程度，分為推定符合倫理之免除審查案件、書面審查之簡易審查案件及採取會議審查之一般審查案件等三種，其審查標準與程序另訂之。

According to the level of research ethics involved in the projects submitted for review, the Ethics Committee divides the cases into three types - cases exempt from ethics review (which is presumed to be in accordance with the ethics) cases for expedited review and full-committee review. The review standards and procedures shall be separately stipulated.

四、 各倫審會為進行審查，置委員七至二十一人；另置書面審查專家（以下簡稱書審專家）若干人。

To perform reviews, the respective Ethics Committees shall have 7 to 21 members, as well as several experts to perform written reviews (hereinafter “written review experts”).

五、 倫審會置主任委員一人，各倫審會另置副主任委員ㄧ至二人。主任委員由校長就本校曾擔任研究倫理審查委員一年以上、通過國際研究倫理組織之專業資格認證或對研究倫理有學術或實務經驗之專任教師聘兼之，其餘委員及書審專家由主任委員薦請校長聘任之。

The Ethics Committee shall have one Chair, and the each Ethics Committees shall have 1 to 2 Deputy Chair. The President of the University shall hire the Chair from full-time teachers who have served as a member of the Ethics Committee of the University for one year or longer, who have been certified with professional qualifications by international research ethics organizations or who have academic or practical experience in research ethics.  The other members and written review experts shall be recommended by the Chair and hired by the President of the University.

六、 各倫審會組成應有法律專家、社會公正人士或研究權益相關團體之代表；委員中二分之一以上具人類研究之專業學術背景，五分之二以上非任職於本校，且任一性別委員應佔該倫審會委員總數三分之一以上。

Each Ethics Committee shall include legal experts, righteous gentlemen in the society or representatives of research interest related organizations.  At least 1/2 of the members shall possess a professional academic background in human research and at least 2/5 shall not be employed in this University. Furthermore, each gender shall represent at least 1/3 of all members of the respective Ethics Committees.

七、 各倫審會委員及書審專家任期為二年，期滿得續聘之。惟各委員會每次改聘委員人數，以不超過該委員會委員總人數之半數為原則。

The members and Written Review Experts of each Ethics Committee shall serve terms of 2 years. The term may be renewed upon expiry. However, the number of members that are re-appointed to different positions each time shall not exceed half of the total number of members in the committee in principle.

八、 倫審會委員之遴選聘用資格及專業資歷等資格條件，由本校明定並公布之。倫審會委員經遴選聘用後應簽署保密協定並接受講習，且其姓名、職業、專長及與本校之關係應予公開。

The University shall establish and announce clear hiring requirements about the Ethics Committee members, including selection and hiring qualifications and professional credentials, etc. Upon hiring, members of the Ethics Committee shall sign confidentiality agreements and accept training. Their names, occupations, expertise, and relationships with the University shall be announced.

九、 各倫審會委員有下列情形之一者，得予以終止聘任：

無正當理由缺席會議，累計三次以上或超過應出席次數三分之一以上者。

負責審查案件，因可歸責事由致有所延宕，累計三次以上者。

(三)  違反保密或利益迴避規定者。

Any member of the Ethics Committee with any of the below conditions shall be dismissed:

Absences from attendance for 3 or more meetings, or the absent times over 1/3 or more of the required meetings without justification.

For reasons attributable to the member that causes failure to timely review cases for 3 or more times.

Breach of confidentiality or interest recusal rules.

十、 各倫審會應定期召開審查會議，必要時得召開臨時審查會議。審查會議由主任委員召集，並為主席；主任委員因故未能出席時，由主席指定一位副主任委員代理之。審查會議應有該倫審會全體委員半數以上出席，且出席委員應包括機構外未具生物醫學科學背景委員一人以上；若出席委員均為單一性別時，不得進行會議。

Each Ethics Committee shall hold review meetings regularly and extraordinary review meetings may be held as required. The review meetings shall be convened and chaired by the chair. If the chair cannot attend the meeting due to any reason, the chair shall appoint one deputy chair to act on his/her behalf.

Review meetings shall be attended by the majority of all members of the relevant Ethics Committee. The attending members shall include at least one member outside the organization without the background in biomedical science. No meeting shall proceed if all attending members are of the same gender.

十一、 各倫審會召開審查會議時，得視需要請送審計畫主持人、機關、團體代表或專家學者列席說明或提供意見。

研究人員與研究生得經主任委員同意並簽署保密及利益迴避書後，以觀察員身分列席會議。

In holding review meetings, each Ethics Committee may invite the principal investigators of the projects submitted for review, representatives of institutions or organizations, experts or scholars as required sitting in meetings and providing explanations or comments.

The researchers and graduate students may sit in meetings as observers after approval by the chair and after signing confidentiality and interest recusal letters.

十二、 各倫審會審查會議決議，以該倫審會出席委員無記名投票過半數行之，會議記錄應記載正、反意見及表決結果。

Resolutions of review meetings of each Ethics Committee shall be approved by the majority of anonymous votes which cast by members of the relevant Ethics Committee attending the meeting.  The positive and negative comments and the results of the voting shall be specified in the meeting records.

十三、 倫審會在致力促進符合研究倫理之前提下，應就送審計畫是否符合下列研究倫理之要求進行審查與持續追蹤：

肯定每個人之生存價值與尊嚴，同等關懷與尊重所有研究利害關係人。

尊重研究參與者之參與意願與研究過程中之自主性，不得強制、脅迫、操控、惡意欺瞞或提供不當誘因。

主動向研究參與者揭露研究計畫主持人與研究團隊是否涉及利益衝突。

在切合各研究領域之知識探索目的與專業訓練下，以關切研究參與者之福祉為優先考量，盡力避免研究參與者受到傷害。

尊重研究參與者之隱私，避免個資洩漏。

研究之設計與執行，應恪遵學術倫理規範與相關專業倫理守則，以追求學術研究誠信並獲取研究參與者及公眾之信賴為目標。

(七)  研究結果應避免研究參與者與所屬群體遭受歧視或被污名化。

Under the condition of dedication to the promotion of research ethics, the Ethics Committee shall conduct the review and continued follow-up on whether the projects submitted for review are consistent with the below requirements of research ethics:

Acknowledgement of each individual’s value of life and dignity.  Equal care and respect for all interested parties of the research.

Respect for the participating intentions of the research participants and their autonomy in the process of the research, without any force, threat, manipulation, malicious cheating or provision of undue enticement.

Voluntary disclosure to the research participants as to whether there is a conflict of interest with principal investigator of the research project and the research team.

In consistency with the purpose of knowledge exploration in each research field and under professional training, give priority consideration to the concerns for the welfare of the research participants and avoid harm to the research participants to the maximum extent possible.

Respect the privacy of the research participants and avoid disclosure of personal information.

With the objective of pursuing good faith in academic research and obtaining the trust from the research participants and the general public, the design and execution of the research shall be in accordance with academic ethics and integrity norms and related professional ethics guidelines.

The research results shall not create discrimination or stigma for the research participants and their community.

十四、 倫審會審查結果分為通過、修正後通過、修正後再議及不通過等四種，於作成審查結果前，應通知送審計畫主持人為適當之說明。審查結果應以書面通知送審計畫主持人。

送審計畫主持人如對審查結果不服，得提具理由，請求原倫審會重為審查，但以一次為限。如對重為審查結果仍不服者，得向本校人類研究倫理監督委員會提出申覆。

The review results by the Ethics Committee are divided into 4 types – approval, approval following amendment, reconsideration following amendment and disapproval. Before accomplishing the review results, a notice shall be given to the principal investigator of the project submitted for review with proper explanation.  The review results shall be provided to the principal investigator in writing.

If the principal investigator of the project submitted for review objects to the review results, he/she may submit specific grounds to seek reconsideration by the original Ethics Committee.  No more than one reconsideration will be conducted.  If the objection continues against the results of reconsideration, an appeal may be filed with the Human Research Compliance Committee of the University.

十五、 倫審會委員應獨立行使審查職權，不受任何干涉。

Members of the Ethics Committee shall exercise their review duties in an independent manner without any intervention.

十六、 倫審會對於經審查通過之計畫，自開始執行起，至該計畫全部執行完畢為止，應持續追蹤審查，以協助計畫主持人確保計畫之執行符合研究倫理規範。

Projects approved by the Ethics Committee following review shall be subject to continuous follow-up review from the start of their execution until the full completion of the projects, in order to help principal investigator of the project ensure that the project execution is consistent with research ethics norms.

十七、 倫審會委員與書審專家皆為無給職，校外委員及書審專家得支給審查費、出席費及交通費；校內委員及書審專家則得支給審查費及出席費。

委員出席審查會議，得支給出席費，每次不超過新臺幣貳仟元。擔任書面審查者，得支給審查費，每件不超過新臺幣貳仟元；但得視案件複雜情形，酌予調整審查費，以不超過新臺幣肆仟元為限。

前二項所須經費由自籌收入支應，其經費項目或額度如有修正時，應另行提送校務基金管理委員會審議通過。

There is no remuneration for members of the Ethics Committee and the Written Review Experts. Members and Written Review Experts from outside the University may receive review fees, attendance fees and transportation fees.  Members and Written Review Experts from inside the University may receive review fees and attendance fees.

An attendance fee of NT$2,000 or less may be paid to members attending review meetings each time. Review fee of NT$2,000 or less may be paid for written review for each case. However, the review fee may be adjusted depending on the level of complexity of the case and shall not exceed a maximum of NT$4,000.

The funds required under the previous two paragraphs shall be paid out of self-generated income.  In case of a change in the funding item or amount, the further submission shall be made to the School Affairs Fund Management Committee for review and approval.

十八、 倫審會得置執行秘書一人，承主任委員之命，處理日常事務；工作人員若干人，受執行秘書之指揮監督，辦理會內事務。

The Ethics Committee may have one Executive Secretary, who is responsible for the Chair’s requests and who handles daily affairs.  There may be several staff under the direction and supervision of the Secretary to handle affairs within the Committee.

十九、 本要點經行政會議通過後實施，修正時亦同。

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