| Simplified Review Process | Application Submission → Administrative Review → Ethics Committee Review → Approval Certificate Issued → Follow-up/Amendments → Project Completion |
| Preparing for Review | This stage includes three steps:
|
| Review and Approval | The Ethics Committee reviews applications based on regulations and potential risks:
|
| Project Execution & Reporting | Usually includes:
|
| Progress & Follow-up Review | Approved projects require at least one annual review. The office sends a reminder one month before the due date. The principal investigator must submit a "Progress Report" for review. |
| Project Suspension/Termination | If the project is suspended or terminated by the principal investigator, the committee, or regulatory agencies, a suspension/termination report must be submitted. |
| Project Completion | Upon project completion, the principal investigator must submit a final report. The office sends a reminder one month before the due date, and the final report must be submitted within three months. |
| Exempt Review | Research may qualify for exemption if it meets the following criteria: The study does not involve minors, detainees, Indigenous peoples, pregnant women, individuals with disabilities, psychiatric patients, or those under coercion or unable to provide free consent. Additionally, the study must meet one of the following conditions, and after approval by the Committeeto, will receive an exemption certificate from the Human Research Ethics Committee:
|
| Expedited Review | Applicable to studies involving minimal risk. Research must not pose a higher probability or severity of physiological, psychological, or social harm than routine daily activities or standard medical procedures. For more details, please visit the Research Ethics Website. |
| Full-Board Review | Studies that do not qualify for Exempt Review or Expedited Review under regulations set by the central competent authority (Ministry of Health and Welfare or other relevant agencies) fall under Full-Board Review. |
| Principal Investigator and Research Team Qualifications | The principal investigator and research team must have the necessary expertise and experience to manage potential issues in data collection and processing. |
| Relevance of Research Design and Objectives | The research design should align with its objectives, minimizing unnecessary risks to participants. |
| Protection of Vulnerable Populations | If participants are from vulnerable groups, measures must be in place to safeguard their privacy and safety, ensuring no undue pressure or coercion during recruitment. |
| Care, Support, and Compensation for Participants | The research should have contingency plans to address potential issues and provide appropriate care, support, or compensation for participants. |
| Reasonableness of Expected Benefits and Risks | The risks should be justified by the expected benefits, including contributions to academia, knowledge, and society, as well as the importance to participants. |
| Minimization of Research Risks | The research process should be designed to reduce unnecessary risks to participants. |
| Protection of Participant Data and Privacy | Adequate measures must be taken to protect the personal data and privacy of research participants. |
| Informed Consent Process | Participants should receive clear and appropriate information. An ethics committee-approved consent form must be used to explain key details, obtaining consent from the participant or an authorized representative. In specific cases, consent requirements may be waived or modified if approved by the ethics committee. |
| Participant Selection and Recruitment | Selection criteria should ensure fairness and protect the rights of both participants and non-participants. |
| Adequacy of Safety Monitoring | Effective monitoring mechanisms should ensure data accuracy and participant safety throughout the study. |
| Composition of the Review Committee | The committee consists of 7 to 21 members appointed by the university president, including one chairperson and one vice chairperson. Members must meet at least one of the following qualifications:
|
| Valid Decision-Making Criteria | Meetings require the attendance of more than half of the committee members to make valid decisions. At least one external member with a non-biomedical background must be present. Meetings cannot proceed if all attendees are of the same gender. |
| Conflict of Interest Policy | Committee members must sign a conflict of interest and non-disclosure agreement before their term begins to ensure confidentiality and impartiality in the review process. |
| Research Ethics Review Application | All human research projects must comply with relevant regulations and professional ethical guidelines. Researchers must adhere to the ethical principles outlined in the Belmont Report and obtain research ethics approval before starting the research. Researchers should retain all documents related to the ethics review, including certificates and data. |
| Informed Consent | Participants must receive study information in an understandable manner and be given adequate time to decide whether to participate. Coercion or undue influence is prohibited. Only ethics-approved consent forms should be used. |
| Incident Reporting | Any events that pose a risk to participants, affect their rights or safety, or impact research procedures must be reported immediately to the Human Research Ethics Committee. |
| Amendments & Extensions | Approved projects requiring modifications (e.g., changes in consent forms, methods, participants, recruitment materials, or funding sources) must submit an amendment request and obtain approval before proceeding. For extensions, researchers must submit a request to the ethics committee. |
| Data Protection & Consultation | Researchers must protect participant data and establish accessible communication channels, allowing participants or the ethics committee to inquire via mail, email, or phone. |
| Project Closure | Upon study completion, researchers must submit a "Final Report" along with relevant documents for review by the Human Research Ethics Committee. |
| Does Research Ethics Review Restrict Academic Freedom? | The review process protects both research participants and researchers. The ethics committee evaluates potential risks from the participants' perspective, ensuring no unnecessary harm. This helps prevent researchers from overlooking risks due to urgency or blind spots. Ethical concerns can significantly impact research and participant trust, potentially hindering academic progress. The review focuses only on participant protection, not academic content. The committee respects researchers' expertise, and all members sign non-disclosure agreement to safeguard research details. |
| What If My Submission Is Rejected? | Possible alternatives include: - If an "Exempt Review" is denied, it may be resubmitted for expedited or full-board review. - If an "Expedited Review" is denied, it may be resubmitted for full-board review. - If a "Full-Board Review" is denied, it may be appealed. |
| What If a Participant Wants to Withdraw? | Participants may withdraw at any time without penalty. Researchers cannot demand compensation or reclaim any provided care, support, or reimbursement. Researchers may discuss concerns with the participant but must not pressure or unduly influence them to continue. |
| Who Can I Contact for Ethics-Related Issues? | If have any research ethics concerns, please contact the researcher or their affiliated institution using the details on the consent form. Alternatively, also can contact the Research Ethics Office during service hours (9:00 AM - 12:00 PM; 2:00 PM - 5:00 PM).
|