法規內容

下載法規原始檔

 

國立成功大學人類研究倫理審查辦法
Regulations for Human Research Ethics Review of National Cheng Kung University

國立成功大學人類研究倫理審查辦法

Regulations for Human Research Ethics Review of National Cheng Kung University

 

101.05.09第165次行政會議通過

102.09.18第169次行政會議通過

105.11.16第183次行政會議通過

106.09.20第186次行政會議通過

Approved by 165th Administrative Meeting on 9 May 2012

Approved by 169th Administrative Meeting on 18 September 2013

Approved by 183rd Administrative Meeting on 16 November 2016

Approved by 186th Administrative Meeting on 20 September 2017

 

第一條  國立成功大學(以下簡稱本校)為推動本校人類研究申請倫理審查,特依本校人類研究倫理治理架構暫行辦法,訂定本辦法。

Article 1    National Cheng Kung University (hereinafter the “University”) has established these Regulations in accordance with the Provisional Regulations of Governance Framework for Human Research Ethics of the University in order to promote applications for human research ethics review by the University.

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 use of personally identifiable information.

第三條  本辦法適用對象,為尚未執行之人類研究,並符合下列情形之一者:

一、本校獲得經費補助之人類研究。

二、本校人員擔任計畫主持人、共同主持人、協同主持人或研究團隊之人類研究。

三、本校人員負責研究參與者招募工作或解說研究內容之人類研究。

四、本校人員取得可辨識研究參與者身分之研究資料以分析或使用之人類研究。

前項所稱本校人員,係指本校專任教學研究人員(含編制外)、職員(含校聘)、專案工作人員、學生;獲有本校人類研究經費補助者,得視為本校人員。

前二項於下列情形,且適用人體研究法,應逕送本校醫學院附設醫院人體試驗委員會或校外研究倫理審查委員會審查:

一、適用醫療法第八條所稱之人體試驗。

二、取得、調查、分析、運用人體基因,但利用臺灣人體生物資料庫資料之研究計畫,不在此限。

三、以醫院之病人及其家屬作為研究對象。

四、直接使用醫院之儀器、影像或病歷及類似性質之未去連結資料。

Article 3    The target of application of these Regulations is human research that is not yet executed and that meets one of the following situations:

1.Human research that is funded by the University.

2.Human research of which the principal investigator, co-principal investigator, sub-investigator or research team is the staff of the University.

3.Human research in which staff of the University is responsible for recruitment of research participants or explanation of research details.

4.Human research in which the staff of the University acquires personally identifiable research data of the research participants for analysis or use.

Staff of the University under the previous paragraph means full-time teaching researchers (including contracted researchers/staff), staff (including University employees), project staff and students of the University.  Any person receiving human research funding from the University may be deemed the staff of the University.

In the following projects mentioned in the previous two paragraphs and if the Human Subjects Research Act is applicable, the projects shall be submitted to the Institutional Review Board of National Cheng Kung University Hospital or the research ethics committee outside the University for review:

1.Human subject research defined under Article 8 of the Medical Care Act.

2.Acquisition, investigation, analysis and use of human genes, excluding research project using data from the database of Taiwan Biobank.

3.Use of hospital patients or their family members thereof as research targets.

4.Direct use of the hospital’s instruments, images, medical histories or other linked data of similar nature.

第四條  符合前條規定之計畫主持人應檢具下列文件,向本校人類研究倫理審查委員會(以下簡稱倫審會)提出申請:

研究倫理審查申請表(請登入線上申請審查系統https://rec.chass.ncku.edu.tw/login,首次申請者請與倫審會聯繫)及申請表中所列之相關附件。

人類研究計畫書。

倫審會接獲申請,應向本校研究發展處確認相關計畫後正式受理。其他送審須知,依倫審會網站https://rec.chass.ncku.edu.tw/所公布資訊為準。

Article 4    The principal investigator whose project is in accordance with the previous two articles shall file an application with the Human Research Ethics Committee of the University (hereinafter the “Ethics Committee”) through submission of below documents:

1.Research Ethics Review Application Form (please log into online application review system https://rec.chass.ncku.edu.tw/login; please contact the Ethics Committee for first-time application) and relevant attachments listed in the application form.

2.Human research proposal.

Upon receipt of the application, the Ethics Committee shall verify the relevant project with the Office of Research and Development of the University before official acceptance of the case.

Other review instructions shall be in accordance with the information announced on the website of the Ethics Committee https://rec.chass.ncku.edu.tw/.

第五條  人類研究之倫理審查程序,依倫審會設置與審議要點規定進行。

Article 5    The ethics review procedure for human research shall be in accordance with the Guidelines for Establishment and Review of Ethics Committee.

第六條  人類研究之倫理審查時,得視需要邀請申請人列席說明。

Article 6    During ethics review of human research, the applicants may be asked to sit in meetings to provide explanations as required.

第七條  倫審會依據研究參與者可能受到傷害之風險審查經驗,並考量研究參與者本人及其族群之特殊或易受傷害性質,得視申請審查之人類研究計畫,採取下列處理程序:

一、免送審查或核發免審證明之免除審查程序。

二、採取書面審查之簡易審查程序。

三、採取書面與會議審查兼備之一般審查程序。

前項第一、二款情形者,免除及簡易審查程序之研究案件範圍,倫審會得依教育部及行政院衛生福利部之公告為依據。

Article 7    In accordance with the review experience about the risk of harm that the research participants may suffer and in consideration of the special nature or vulnerability of the research participants and their colonies, the following procedures may be undertaken based on the human research project application:

1.Procedure for review waiver where a review is exempt or a certificate of review waiver is issued.

2.Expedited review procedure with a written review.

3.Full-committee review procedure with both written and meeting reviews.

The Ethics Committee may determine the scope of research cases for which review exemption or expedited review procedure may be applicable under subparagraphs 1 and 2 above based on public announcements made by the Ministry of Education and the Ministry of Health and Welfare, Executive Yuan.

第八條  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,應通知送審之人類研究計畫主持人為適當說明。審查結果應附具理由,並以書面通知計畫主持人。

Article 8    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 human research project to provide proper explanations. The review results shall be supported by specific grounds and shall be provided to the principal investigator in writing.

第九條  依據人體研究法第五條規定,倫審會審查結果不通過之人體研究計畫,本校不得同意該計畫之執行。

Article 9    If a human research project is disapproved by the Ethics Committee in accordance with Article 5 of the Human Subjects Research Act, the University shall not agree to the execution of such this project.

第十條  送審之人類研究計畫主持人如對審查結果不服者,得提具理由,請求重為審查,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,以一次為限。

Article 10  If the principal investigator of the human research project submitted for review objects to the review results, he/she may provide grounds to seek reconsideration. There shall be no more than one reconsideration. If the principal investigator still objects to the result of reconsideration, an appeal may be filed with the Human Research Ethics Compliance Committee of the University. There shall be no more than one appeal.

第十一條、 倫審會於相關計畫經審查通過且開始執行後,至計畫已完成可辨識研究參與者之資料分析為止,應持續追蹤並協助確保相關計畫之執行符合研究倫理要求。

Article 11  After the relevant project is reviewed and approved and starting from its execution, the Ethics Committee shall continue to follow up and help ensure that the execution of the relevant project is consistent with research ethics requirements until accomplishing the analysis of the research participants’ identifiable data.

第十二條、 倫審會得就申請審查案件,向相關計畫主持人收取審查服務費用。收費標準由倫審會另定之。

Article 12  The Ethic Committee may charge a review service fee from the relevant project principal investigator for case review. The fee schedule shall be separately stipulated by the Ethics Committee.

第十三條、 本辦法經行政會議通過後實施,修正時亦同。

Article 13  These Regulations, including any amendment hereto, are implemented following approval by the Administrative Meeting.