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Center for Research Ethics

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Description of Research Ethics Reviews

 Description of Research Ethics Reviews

 

Notices on Submissions for Research Ethics Review 

1.       The Research Ethics Review Committee received Ministry of Education Announcement (臺教高(5)No. 1030194197), 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. 

(1)      Since August 1, 2020, the new application via online system.

(2)      Since August 1, 2021, the student shall be the principal investigator and the advisor shall be co-investigator for the application of review.

2.       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. 

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. 

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

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:

Taipei Medical University Office of Human Research

Tri-Service General Hospital

Cathay General Hospital

 

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