NYCU REC

Does my research require a research ethics review?

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.

What is human-related research?

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).

What is the Human Subjects Research Act?

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.

What is delinkage?

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).

What documents do I need to prepare for a research ethics review?

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.

Must the information in the research proposal be the same as that provided in the National Science and Technology Council Proposal?

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.

How do I determine the research project review category?

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).

How do I obtain a Certificate of Research Ethics Review Submission?

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.

How long does the review take?

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).

Can the University’s on-campus research project apply for an off-campus IRB review?

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.

If I wish to obtain IRB or Research Ethics Committee (REC) education and training hours, is it necessary for me to attend the education and training sessions organised by the University?

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).

How many hours of IRB or REC education and training are required before members are allowed to participate in a review?

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.

What do students need to be aware of when their project must be submitted for research ethics review?

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.

If the project is not funded or is a self-funded research project, is the fee for review different?

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).

What is the length of validity for the approval provided by the IRB for a research project that spans several years?

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.

Must the subject/participant consent form be signed in person by the principal investigator?

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.

Can a research subject/participant consent form without a perforation seal be used to obtain informed consent?

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).

Do I need to apply to the IRB to alter my research project (e.g., replacement of research team members, adjustments to research methods, increase in the number of research subjects, and revisions or changes to the project content)?

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.

If the research project is not implemented for some reason, am I required to withdraw or close the project?

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.

How long does it take for a project to be extended, changed, withdrawn, or reviewed?

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.

What should I do if I encounter adverse events and deviations in the execution of the research project?

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.

What documents do I need to submit for the final report?

Please refer to the review submission checklist on the Institutional Review Board review system (NYCUeIRB), complete the form, and submit it for review.

FAQ 01. Research Ethics Review guidelines