:::

Center for Research Ethics

:::

Description of Research Ethics Reviews

 Description of Research Ethics Reviews

Notices on Submissions for Research Ethics Review

 

► NTNU established the Research Ethics Center and Research Ethics Review Committee on December 6, 2013, to review and follow up the ethics of research projects, and also carry out education and training.

 

1.  The Research Ethics Review Committee received Ministry of Education Announcement Tai-Jiao-Gao(5)-Zi No. 1030194197 dated January 6, 2015, which announced that the Committee had passed the inspection, and the Committee began to conduct research ethics reviews for human subject research and human body research projects starting on January 12, 2015, at 12:00 P.M. The Center began to accept applications on January 12, 2015. Please download necessary forms from “Downloads” on this webpage. After preparing documents according to the Checklist of Documents Submitted for Review on the first page of the application form, send the electronic files to the Center’s e-mail: ntnurec@gmail.com, and deliver paper documents (one copy bound together by a binder clip or staples) to the Center (Jheng Building 402B). The Center will submit the documents for review after verifying the paper documents are complete.

 

 

2.  The National Taiwan Normal University Research Ethics Review Committee Service Fee Standards took effect on June 15, 2015 (Monday) at 12:00 P.M. For research projects submitted for review after this time, complete payment according to the standards and documentary proof that the case was accepted will be issued after verification by the Research Ethics Center. For details, please see http://140.122.64.63/7news/news.php?Sn=2143

 

3.  Project personnel must provide certificates of ethics related training in accordance with NTNU regulations for the Research Ethics Review Committee. The project host must provide documentary proof of receiving 2 hours of ethics related training each year or 6 hours over 3 years. Co-hosts and assistants must provide documentary proof of receiving 1 hour of ethics related training each year or 3 hours over 3 years. If personnel received insufficient training, they must receive the necessary hours of training before approval is issued for the research project. After personnel submit the documentary proof to the Administrative Center and the documentary proof is verified, the letter of approval stating that the research project passed the review will be issued. For information on upcoming education and training courses, please see http://140.122.64.63/7page3/actnews.php?classes=7101

 

4.  The project's nature and recommendations for review applications

(1)A plan must be formulated before conducting human body research, and the research project must pass the review of   the Research Ethics Review Committee before it may be implemented. (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)If it is a human subject research project, since there are no mandatory requirements in the law, it is recommended to submit an application and pass the Committee’s review before implementing the research project.
(3)In order to protect research participants and promote academic research and development, it is recommended to pass the review by the Research Ethics Review Committee before implementing research projects that involve the    following matters:

A.  Research projects that recruit participants
B.  Research projects that use personal information that can be used to directly or indirectly identify participants
C.  Research results will be submitted to an international academic journal
D.  Regulations of the organization providing subsidies (e.g., MOST, MOHW) or data (e.g., National Health  Insurance Research Database) are submitted for review

[Laws & Regulations]
●        Human Subjects Research Act:http://goo.gl/BpCsw5
●        Supplementary description of human subject research and provisions on review exemptions announced by the MOST:http://www.acad.ntnu.edu.tw/files/archive/968_4873fbc9.pdf
●        MOST Guidelines for Research Project Subsidies:http://www.acad.ntnu.edu.tw/files/archive/967_72f7ff9e.pdf

5. Outsourcing review to an external institution and application method
(1)   Pursuant to NTNU regulations for the Research Ethics Review Committee, the Committee may commission a qualified external institution to conduct reviews of research projects involving human trials.
(2)   Human trials: Refers to experimental research of new medical technologies, new medicaments, new medical implements, or the bioavailability and bioequivalence of generic drugs conducted by medical care institutions on human beings based on medical theory.
(3)  If the research project involves human trials: Please fill out an NTNU-Form-34 Commissioning Research Ethics Reviews of Human Trial Projects and submit it along with other review application documents to the Research Ethics Center, which will then deliver the documents to the external review institution.
(4)   External review institutions for human trial projects of NTNU are as follows:

 
Review institution
Taipei Medical University Office of Human Research
http://ohr.tmu.edu.tw/main.php
Tri-Service General Hospital Institutional Review Board
http://wwwu.tsgh.ndmctsgh.edu.tw/tsghirb/index.aspx
Cathay General Hospital Institutional Review Board:
https://www.cgh.org.tw/tw/content/depart/IRB/
 
6. If you have any questions or needs, please contact the Research Ethics Center (extensions 1394, 1395)


cron web_use_log