Adopted by the 1702nd Administrative Council on 03 DEC 2014
The present Operational Guidelines Governing Human Subject and Humanity Research Ethics Submissions (“the present Guidelines”) are prescribed by the Chinese Culture University (“the University”) to promote its faculty members and students to safeguard the rights and interests of participants while executing research projects in compliance with the “Human Subjects Research Act,” the “Operational Guidelines for Grants to Thematic Research Projects” of the Ministry of Science and Technology, and other relevant regulations.
For the purpose of the present Guidelines, human subject research referred herein is either of the following types:
- Human subject research: refers to research involving acquisition, investigation, analysis, or use of human specimens or an individual person’s biological behavior, physiological, psychological, genetic or medical information; and,
- Humanity research: refers to research having an individual or group as the subject and using observation, intervention, and interaction methods or using personal data delinked from personal identifier without the individual’s approval to engage, in relation to the individual or group, in systematic investigations or knowledge exploration activities in any professional discipline.
For research projects requiring research ethics review per the “Human Subjects Research Act,” the “Operational Guidelines for Grants to Thematic Research Projects” of the Ministry of Science and Technology or journal requirements, eligibility of reviewing institutions is limited to the list of qualified research ethics review committees for that year as promulgated by the Government, and project moderators may select one among the listed reviewing institutions according to respective review categories to apply for a review.
Prior to filing of the application for a research project or commencing execution of same, relevant data for the reviewing process shall be furnished by the project moderator in accordance to the provisions of the reviewing institution, while the research project may be executed only upon approval of the research ethics review.
In order to assist faculty members and students of the University in applying for review, the Office of Research and Development may enter into cooperation agreements with the qualified reviewing institutions promulgated by the Government.
Project moderators shall bear the review fees and are allowed to prepare project budgets for such outlays to be written off.
From the commencement to the completion of the execution of a project, the project moderator shall comply with the provisions of the reviewing institution so as to ensure that the execution process is in compliance with principles of research ethics.
The present Guidelines and any amendment thereto shall be implemented upon being adopted by the Administrative Council.
- In case of any discrepancies between the Chinese original and this translation, the Chinese original shall prevail.