I、 Research Ethics Review

  • Q1：Does my research proposal need to be submitted for review?

    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). "

  • 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.

  • 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.

    01. 0101 Definition and Connotation of Research Ethics
    02. 0102 Research Ethics Professional Code and Personal Responsibility
    03. 0103 Government norms and policies on research ethics
    04. 0113 Basic Concepts of Personal Data Protection Law
    05. 0114 Basic Concepts of Privacy
    06. 0115 Subject Protection Principles and Practices
    07. 0116 Overview of Research Data Management
    08. 0201 Conflict of Interest in Research
    09. 0204 Case Studies
    10. 0301 Case Analysis of Inappropriate Research Behavior (Part 1)
    11. 0302 Case Analysis of Inappropriate Research Behavior (Part 2)
    12. 0303 Informed Consent in Research
    13. 0304 Ethical Issues in Research on Vulnerable Groups (1)
    14. 0305 Ethical Issues in Research on Vulnerable Groups (2)
    15. 0306 The Role and Function of the Research Ethics Review Board (IRB) (Part 1)
    16. 0307 The Role and Function of the Research Ethics Review Board (IRB) (Part 2)
    17. 0401 Community Consent Mechanism for Indigenous Ethnic Groups
    18. 0501 Ethical Issues of Infant Participation in Psychology and Pedagogy Research
    19. 0502 Clinical Psychology Research on the Protection of Vulnerable Groups - Post-Disaster Trauma Syndrome
    20. 0503 Ethical Issues of Preschool Children Participating in Psychology and Pedagogy Research
    21. 0504 Disclosure and handling of conflicts of interest in clinical psychology research - case
    22. 0601 Enlightenment of Indigenous Peoples Exercising the Right to Collective Consent
    23. 0602 Research Mazes and Ethical Anxiety - Observations from Today's Aboriginal Academic World in Taiwan
    24. 0603 Third World Field Research Ethics - Laotian Field
    25. 0604 Multifaceted Ethnography and Entry and Exit Ethics
    26. 0605 Academics, academic degrees and rights protection - the whole story and follow-up of Mao Sidi's anti-research ethics incident
    27. 0606 Half a century of entanglements - academic research ethics of indigenous peoples in the Amazon rainforest of South America
    28. 0607 The Grievances between North American Indian Groups and Anthropologists
    29. 0608 The Ethical Confusion in the Wild Fields of China
    30. 0609 The Key to the Rhythm of Sociocultural Anthropology Research Ethics
    31. 0610 Exploration of Extreme Culture: An Ethnographic Study of Highly Sensitive Illegal Communities
    32. 0707 Introduction to Behavioral and Scientific Research Ethics
    33. 0708 Introduction to social science research ethics
    34. 0709 Abnormal forms of informed consent in behavioral and social science research
    35. 0801 Ethical Issues in Internet Use Behavior Research
    36. 0802 Difficulties in implementing ethical review and informed consent in Internet use behavior research - taking the Encore project as an example
    37. 0803 Ethical issues of using crowdsourcing for academic research
    38. 0804 Information Technology and New Types of Informed Consent
    39. 0805 Protection of personnel rights and interests in engineering technology research
    40. 0806 Research Ethics of Human Factors Engineering
    41. 0807 Black Boxes and White Mice: Ethical Issues in Artificial Intelligence Research
    42. 0808 Research Ethics in Development of Artificial Intelligence Research Datasets
    43. 0901 Ethical Considerations in Oral Language Research
    44. 0902 Ethical Issues in Foreign Language Teaching Research
    45. 0903 Academic Ethics of Human Linguistics - Cases of Intellectual Property Rights of Chinese Subtitle Group
    46. 0904 Research Ethical Considerations in Linguistics across Medical Fields
    47. 0905 Linguistics cross-medical research entry threshold
    48. 0906 Language and MRI Research - Research Ethics of Human Subjects
    49. 0907 Academic Ethics of Ethnography: A Case Study of Chinese Subtitle Groups in Internet Communities
    50. 1101 Ethics of using large databases for research
    51. 1102 Ethics of Statistical Analysis and Statistical Consulting
    52. 1103 Ethics of survey and follow-up research
    53. 1104 Community Intervention Research Ethics
    54. 1201 Ethical Issues of Power Relations in Sports Field Research
    55. 1301 Administrative advice and related questions on application for ethical review of non-biomedical research projects
    56. 1302 History and Current Situation of the Establishment of Chinese University Ethics Review Committee
    57. 1402 Analysis of domestic and foreign research ethics cases in recent years
    58. 1501 Ethical Issues in Clinical Research of Mental Illnesses: Informed Consent
    59. 1502 Ethical issues in research involving abused children: respect for autonomy and non-harm
    60. 1601 Social Work Research Ethics: Types of Potential Research Ethical Risks and Countermeasures
    61. 1801 Ethical Issues in Spatial Information Technology Research
    62. 9901 Supplementary Textbooks for Academic Ethics and Biomedicine of Yangming University"

     

  • 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.