ANS：
"In the case of human body research, a plan should be drawn up before the research is carried out, and it can only be carried out after being approved by this committee. (Human body research: referring to the acquisition, investigation, analysis, and use of human body samples or personal biological behavior, physiology, research on information related to psychology, genetics, medicine, etc.)
In the case of human research, since there are no mandatory regulations, it is recommended that a proposal be submitted to this committee for review before the research plan is carried out.
In view of protecting research participants and promoting the development of academic research, it is suggested that those whose research plans involve the following matters apply to the committee for review before implementation:
I.Recruitment of study participants to participate in the study
II.Use of personally identifiable data in research
III.Submission to international academic journals in the future
IV.Submit for review according to the research plan funding unit (for example: National Science Council (formerly Ministry of Science and echnology), Ministry of Health and Welfare) or data provider (for example: Center for Health and Welfare Data Science, Ministry of Health and Welfare). "
I、 Research Ethics Review
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Q1：Does my research proposal need to be submitted for review?
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Q2：The research proposal has been completed, and the journal asked to attach the "certificate of review and approval" when submitting. Can it be submitted for review afterwards? Or will the committe issue a certificate?
ANS：
The committee can only review plans that have not yet been implemented in order to conduct risk assessment, evaluate various issues related to research ethics, and communicate with the investigator for relevant revisions. The approval certificate can only be issued after the review is completed, and the principal investigator also needs to carry out the research according to the documents that have passed the review. If the research has been completed, and the research risks have occurred, then "retrospective review" is no longer possible. Therefore, please apply for review before the implementation of the project (before recruiting research participants, or before contacting participants). -
Q3：What is "Exempt Review", "Expedited Review" and "Full Board Review"?
ANS：
"These three categories are categories classified according to research risk.
Exempt: Refers to research cases where the research risk is almost zero. Human research must comply with the relevant regulations of the Ministry of Health and Welfare and the Ministry of Human Research Science and Technology. Cases that are exempt do not need to be sent to committee members for review, but still need to be sent to the Research Ethics Review Committee for decision. Approval certificates will also be issued to cases eligible for exemption from review.
Expedited Review: The implementation of the research plan means that the probability of causing physical, psychological, and social danger or discomfort to the research subjects is not higher than the risk of daily life encounters or routine medical treatment. Human research must comply with the relevant regulations of the Ministry of Health and Welfare. It needs to be reviewed by 2 committee members and submitted to the committee after approval.
Full-Board Review: Those who do not meet the exempt and expedited review need to be transferred to full-board review. Two committee members will examine the relevant documents of the project in detail and report the details to the committee. After all the committee members discuss and reach a consensus, a majority vote is adopted to form a review resolution. " -
Q4：How much time will it take for the review process?
ANS：
The number of days may be increased or decreased according to the reply days of each project review and trial conductor. See detailed review procedures of each risk category for details, please refer to standard operational procedures of NTNU review committee. To avoid delay of project schedule, please submit the project for review earlier.
The review period in average (from complete document preparation date to approval date):
Exemption of review: about 2~9 days
Minimum risk review: about 30 days. The project will be reviewed upon reception, approval of two members is required. The time will be different based on the number and time of reply between review members and trial conductor.
General review: about 30~60 days. In addition to submission to two members for preliminary review first, the resolution of review meeting once every month is required for the project subject to general review.
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Q5：These three categories are categories classified according to research risk.
ANS：
After checking that the materials submitted for trial are complete and that the review fee has been paid, the case acceptance certificate can be obtained. The acceptance certificate is an electronic letter and will be sent to the applicant's email address. -
Q6：If the research ethics educational training hours is required for the application of research ethics review? How many hours is required? Except for principal investigator, if the hours of research team members are required? What courses are available for the calculation?
ANS：
According to the regulations of this Committee, the project related persons need to provide certificates of relevant training hours. The principal investigator needs 2 hours one year or 6 hours three year of ethics related trainings; co/ associate-principal of investigator, assistant needs 1 hours one year or 3 hours three year of ethics related trainings.
All seminar hours issued by NTNU or external research ethics trainings institutions could be calculated without limitation on subjects. -
Q7：Are the training hours provided by the Chinese/English online courses of the "Taiwan Academic Ethics Education Resource Center" of the Ministry of Education included in the research ethics education?
ANS：
"In response to the rise of knowledge sharing and online learning, research ethics online courses are gradually being offered. This committee accepts the Chinese/English online course study certificate approved by the ""Taiwan Academic Ethics Education Resource Center"" of the Ministry of Education. The study course units currently accepted by the committee are listed below, and those who pass the test for each unit will receive 20 minutes.
0101 Introduction to Research Ethics: Definition and Content
0102 Professional Norms and Personal Responsibility in Research Ethics
0103 Government Regulations and Policies in Research Ethics
0113 Basic Concepts of the Personal Data Protection Act
0114 Basic Concepts of Privacy
0115 Principles and Practice of Research Participants Protection
0116 Overview of Research Data Management
0201 Conflict of Interest in Research
0204 Case Study in Conflict of Interest
0205 Case Study in Management of Research Data
0301 Case Analysis of Inappropriate Research Behavior (Part 1)
0302 Case Analysis of Inappropriate Research Behavior (Part 2)
0303 Informed Consent in Research
0304 Ethical Issues in Research on Vulnerable Subjects (I)
0305 Ethical Issues in Research on Vulnerable Subjects (II)
0306 Roles and Functions of Research Ethics Committee (REC/IRB) (I)
0307 Roles and Functions of Research Ethics Committee (REC/IRB) (II)
0308 Magnetic Resonance Imaging (MRI) Research Safety and Ethics
0401 Community Consent Mechanism for Research on Indigenous Peoples
0501 Ethical Issues in Psychological and Educational Research Involving Infants
0502 Protection of Vulnerable Population in Research of Clinical Psychology: Patients with Psychological Trauma
0503 Ethical Issues in Psychological and Educational Research Involving Preschoolers
0504 Disclosure and Disposition of Conflicts of Interest in Clinical Psychology Research: Case Studies
0601 Right of Collective Consent among the Indigenous People in Response to Scientific Research (Ainu in Japan)
0602 Academic Perplexity and Ethical Anxiety—on the Dilemma of Conducting Research of Taiwan Indigenous Peoples Today
0603 Field Research Ethics in the Third World—Targeting Laos
0604 Multidimensional Ethnographies and the Ethical Principles
0605 Academic Affairs and Human Rights— the Mosher's Case in Perspectives
0606 Forever Ethical Dilemma—on a Well-known Disgraceful Anthropological Event in Amazon Rainforest
0607 Academic and Ethical Encounters between Native Americans and Anthropologists
0608 On Ethical Dilemma in Anthropological Fieldwork in China
0609 On the Key Element of Ethics in Socio-cultural Anthropology
0610 Radically-operated Culture: on Ethnographical Study in Highly-sensitive Underground Social Groups
0707 Introduction to Behavioral and Social Sciences Research Ethics
0708 Introduction to Social Science Research Ethics
0709 Atypical Methods of Obtaining Informed Consent in Behavioral and Social Sciences Research
0801 Ethical Issues in Internet Behavior Research
0802 Predicament of Ethical Review and Informed Consent in Internet Behavior Research: A Case Study of Encore
0803 Ethical Issues in Crowdsourcing Research
0804 Information Technology and New Approaches to Informed Consent
0805 Protecting People Involving in Engineering Research
0806 The Research Ethics of Human Factors and Ergonomics
0807 Black Box and Guinea Pig: The Ethics of Artificial Intelligence Research
0808 The Ethics of Generating Datasets in Artificial Intelligence Research
0901 Ethical Considerations in Linguistic Studies Based on Spoken Data
0902 Ethics in Foreign Language Teaching Research
0903 Academic Ethics in Human Linguistics : Case of China Fansub and Intellectual Property Rights
0904 Ethical Considerations in Interdisciplinary Reseach between Linguistics and Medicine
0905 Diversity of Ethics Review Processes in Interdisciplinary Research between Linguistics and Medicine
0906 Linguistics and MRI: Ethics in Research with Human Sucjects
0907 Academic Ethics in Internet Ethnography: An Online Community Case Study of China Fansub
1101 Research Ethics Involving Large Databases
1102 Ethical Issues in Statistical Analysis and Consulting
1103 Ethical Issues in Surveys and Follow-up Studies
1104 Ethics in Community-Based Intervention Research
1201 Ethical Issues of the Authority Relationship in Sports Science Research
1301 Suggestion and FAQ for Ethical Review in Non-Biomedical Research
1302 The Evolution and Current Development of Universities' Research Ethics Committees in Our Country
1402 Analysis of domestic and foreign research ethics cases in recent years
1501 Ethical Issues of Clinical Research Among Psychiatric Patients: Informed Consent
1502 The Ethical Issues in Child Maltreatment Research: Respect for Autonomy and Nonmaleficence
1601 The Ethics of Social Work Research: Types of Potential Harms and the Principles of the Assessment
1801 Ethics Issues in Geospatial Information Science and Technology
9901 Supplementary Materials for Academic Ethics in the Field of Biomedicine at NYCU -
Q8：Is there a restricted format for the proposal?
ANS：
Currently, there is no standard format restriction. Applicants can use the format of proposals for the National Science and Technology Council (formerly the Ministry of Science and Technology), the Ministry of Health and Welfare, etc. to submit for review, but please add the version date when submitting for review (you can add it in the system remarks column). If it is a human body research project, applicants are reminded that according to the human body research law, the project should include the following items:
Project name, principal investigator, and research institution.
Project abstract, research objects and implementation methods.
Plan scheduled progress.
The protection of the rights and interests of research subjects, the method and content of consent.
Study manpower and related equipment requirements.
Research funding needs and their sources.
Expected outcomes and key benefits.
Ownership and utilization of R&D results.
Disclosure of researchers' conflicts of interest. -
Q9：Is there any format limitation or need to add version date for the documents submitted for review such as informed consent form and questionnaire?
ANS：
The committee provides a template of the informed consent form for reference; applicants can design it according to the needs of the researchas well. Please indicate the version date. For other research-related documents submitted for review, except for the proposal, which can be marked with the version and date in the remarks column of the system, the rest of the documents must be marked with the version and date in the text for review and identification. -
Ｑ10：The informed consent form has a signature field; should it be submitted for review after signing?
ANS：
The research plan needs to apply for review before execution (before recruiting research participants), so please do not recruit participants or ask participants to sign the informed consent before submitting the review, and do not send the signed consent of the participants during the review. -
Ｑ11：The plan is a multi-year plan; why is the validity period of the review not multi-year?
ANS：
If the program is a multi-year program, it will be fully reviewed when the new case is submitted for review. According to the Human Body Research Act, the review committee should review an approved project at least once a year. Therefore, the validity period of cases approved by the committee is at most one year. If it is a multi-year project, please submit a continuous application (submit a mid-term report) 6 weeks before the expiration date recorded on the "Certificate of Approval of Research Ethics Review". The continuous review data is mainly the brief report of the implementation and enrollment status in the previous year, and the content of the proposal will not be re-reviewed. After the continuous review is passed, the validity period of the review will be extended according to the original follow-up inspection frequency. In addition, if the project ends early, the case closure procedure can also be handled earlier. -
Ｑ12：If the project applied forNational Science and Technology Association subsidy does not go through, should the project proceed? How are research ethics review fees handled?
ANS：
The research project can continue by applying for a change of funding source, and the review fee can be reimbursed under the funds of other projects currently in progress. If a plan that is still under review for a new case is determined not to be implemented, an application for withdrawal of the case can be made in accordance with the rules of this committee (no further review). If the plan that has been reviewed is not implemented for some reason, please apply for closing the case or terminating the review in accordance with the committee's regulations.