According to the Human Subjects Research Act, if the research involves humans (i.e., humans are considered the research subjects) and is related to humans, it must be submitted for review.
Human-related research is research that involves obtaining, investigating, analysing, or using human specimens or an individual’s biological behaviour or physiological, psychological, genetic, or medical information. (Subparagraph 1, Article 4 of the Human Subjects Research Act).
Human research is behavioural science research in which individuals or groups are used as research subjects and interventions, interactive methods, or data that can be used to identify a particular subject are used to conduct systematic investigations or intellectual inquiries in professional disciplines related to that individual or group (further explanation provided in Official Document No. 1040003540 issued by the Ministry of Science and Technology, Taiwan).
This act was formulated on December 28, 2011 to regulate the right protection of human research subjects.
Studies involving human subjects should respect the autonomy of the subjects and ensure a balance of the risks and benefits of the research, minimise the invasiveness to the human subjects, and ensure a fair distribution of the research burdens and results while protecting the human subjects’ rights.
Delinkage refers to the operation of permanently disabling encoded biological specimens, data, and information from being linked to or matching them with the subjects personal data or information.
(Article 4 of the Human Subjects Research Act).
Please refer to the review submission checklist in the Institutional Review Board review system (NYCUeIRB), fill in the required information, and submit the required documents for review.
Research proposals do not have formatting restrictions. Applicants can use the proposal formatting required by the National Science and Technology Council or the Ministry of Health and Welfare when submitting a proposal for review. However, the content of the proposal must include the following items in accordance with the Human Subjects Research Act:
1. Protocol title, principal investigator, and research entity.
2. Abstract of the protocol, research subjects and experimental methods.
3. Estimated timetables.
4. Ways and content of human subject protection and consent obtaining.
5. Research personnel and equipment requirements.
6. Research funding requirements and sources.
7. Expected results and primary benefits from the research.
8. Attribution of research results and uses thereof.
9. Disclosure of any conflicts of interest affecting research personnel.
Reviews of research projects are divided into standard review procedures and expedited review procedures on the basis of the level of risk in a project. Standard procedures are applied for cases that are not eligible for expedited review and review exemption. To determine whether a study qualifies for an expedited review, please refer to the scope of human research cases that ethics review committees are allowed to review using a expedited procedure. To determine whether a study qualifies for review exemption, refer to the scope of human research cases exempted from review by an ethics review committee (a certificate of exemption issued by the Human Research Ethics Review Committee is required).
The principal investigator must determine whether a review category is appropriate for the project’s risk level, and after the project is submitted for review, the Institutional Review Board (IRB) will make its judgement on the basis of the project’s risk (Article 4 of the Human Subjects Research Act).
Please prepare the documents required to apply for a standard review, expedited review, or review exemption in accordance with the regulations of the University’s Human Research Ethics Review Board and upload the relevant documents to the Institutional Review Board review system (NYCUeIRB ). NYCUeIRB will send a Certificate of Research Ethics Review Submission to the Principal investigator through email.
To ensure their research project can be executed as quickly as possible, principal investigator and the research teams are recommended to reserve the numbers of days listed as follows for the completion of the review process. The duration of the review process is determined by the length between and number of responses between the reviewers and principal investigator for each case and, therefore, may be longer or shorter than indicated in the following. To obtain details regarding the procedures used for each risk category, please refer to the standard operating processes of the University’s IRB.
Exemption from review: Approximately 14 working days;
Expedited review: Approximately 30 working days;
Standard review: Approximately 45–60 working days (such reviews are included in review meetings, which are held once every 2 months, and must be discussed at the IRB meeting).
Prior to conducting a research, the principal investigator should draft a research plan. The research can only be completed after the research plan has been submitted to the Ethics Review Committee (hereinafter referred to as the “review committee”) and approved.
The review discussed in the preceding paragraph shall be conducted by a review committee established by the research institution in which the research is conducted. However, if the research institution does not have a review committee, the ethics review can be entrusted to another review committee (Article 5 of the Human Subjects Research Act).
For the faculty members, staff, and students of the University, the research projects in which they serve as the principal investigators should be submitted to the University’s research ethics review committee for review. Such research projects will be subject to the University’s management and supervision.
IRB and REC education and training do not have to be completed on campus. All IRB and REC education and training offered by major IRBs and RECs in Taiwan are acceptable (please refer to the Education and Training Section of the Center for Ethical Governance of Human and Behavioral Research).
1. The principal investigator and co-(sub-)investigator must have received 6 hours of IRB training within 2 years.
2. Personnel obtaining informed consent must have had 4 hours of IRB training within 2 years.
3. Student researchers must have received 6 hours of IRB training within 2 years.
Individuals who have not yet received education and training related to human research or have insufficient hours of education and training should sign a letter of commitment. In such cases, the principal investigator and co-(sub-)investigator can only obtain a Certificate of Approval for Human Research from the IRB after they submit proof of the individual’s education and training hours. Individuals obtaining informed consent are required to complete their education hours prior to the project’s execution.
According to the University’s Human Research Ethics Review Board regulations, when a student research project is submitted for review, the student’s supervisor should be made the principal investigator to ensure the rights and interests of the research subjects are protected. If circumstances permit, a student can be listed as the co-investigator or sub-investigator of the research project. However, these students are required to complete the required IRB or REC education and training hours.
According to University regulations, faculty members whose projects are not subsidised or who conduct self-funded research projects may request a review fee waiver from the Director of the Governance Center (this is not applicable for cases reviewed outside of the University).
The validity period for approval by the University’s IRB is, at most, 1 year. For research projects that span several years, an extension should be applied (by submitting an extension report) 6 weeks prior to the expiration of the validity period indicated on the Certificate of Approval for Human Research.
To ensure the rights and interests of both the research team and the research subjects/participants are protected, the research subjects/participants and the researchers (those who are obtaining informed consent) must sign and date research subject/participant consent forms in person.
To verify that the version of the consent form that is being used has been approved by the IRB and to ensure the rights of the research subjects/participants are protected, the IRB prints a perforation seal on the approved version of subject/participant consent forms, which the research team can make photocopies from.
Failure to use the approved version of the research subject/participant consent form is considered a violation of University rules and will be subject to disciplinary action taken by the University’s IRB (e.g., requirement for additional education and training or suspension of new applications).
To adjust or change the content of the research project, an alteration application must be submitted to the NYCUeIRB in accordance with the University’s IRB specifications. After the alteration is approved, the changes can be implemented according to the approved specifications.
According to the University’s Human Research Ethics Review Board regulations, if the project is still under review, a project withdrawal should be applied for; if the project has passed the review, a project closure should be applied for.
According to the University’s IRB specifications, such processes are completed within approximately 10 working days. The duration of the process is determined by the length between and number of responses between the reviewers and principal investigator of each case and, therefore, may be longer or shorter than the aforementioned period.
Suspend the execution of the research project; applying unauthorised corrections is prohibited. Contact the Center for Ethical Governance of Human and Behavioral Research’s staff-in-charge immediately to inquire about the appropriate follow-up process for the situation.
Please refer to the review submission checklist on the Institutional Review Board review system (NYCUeIRB), complete the form, and submit it for review.