IRB (Institutional Review Board) ethics review decision tree and Taiwan process guide. Used by the ethics_review_agent to determine whether research involves human subjects, and by the research_architect_agent to plan IRB review during methodology design.
Does your research collect, use, or analyze data from humans?
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├── No → Does not involve human subjects, no IRB review needed
│ (e.g., pure theoretical research, literature review, secondary analysis of public statistics)
│
└── Yes → Is the data personally identifiable?
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├── No → Is the data publicly available public data?
│ │
│ ├── Yes → Typically exempt from review
│ │ But must still submit an exempt review application to IRB for confirmation
│ │
│ └── No → Proceed to "Review Level Determination" below
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└── Yes → Does the research involve direct interaction with subjects?
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├── No → Only uses existing data/specimens
│ │
│ ├── Data already de-identified → May apply for exempt review
│ └── Data contains identifiable information → Expedited or full board review
│
└── Yes → Proceed to "Review Level Determination" below
Applicable Conditions (any one of the following): - [ ] Uses publicly available, de-identified datasets - [ ] Research on educational practices in normal educational settings - [ ] Involves only anonymous surveys (no sensitive topics) - [ ] Observation of public behavior (no identifiable information recorded) - [ ] Uses government public statistical data
Note: Exempt review does not mean exempt from application — you must still submit to IRB to confirm exempt status.
Applicable Conditions (all must be met): - [ ] Research risk is no greater than risks ordinarily encountered in daily life (minimal risk) - [ ] Does not involve vulnerable populations - [ ] Research methods are on the expedited review category list
Common Categories: - Surveys (containing sensitive but not high-risk topics) - Interviews (general topics) - Teaching intervention research (non-invasive) - Audio/video recording (with consent) - Secondary analysis of previously collected clinical data
Applicable Conditions (any one of the following): - [ ] Greater than minimal risk - [ ] Involves vulnerable populations (children, prisoners, pregnant women, individuals with cognitive impairments) - [ ] Involves sensitive topics (sexual behavior, illegal behavior, mental health) - [ ] Uses deception - [ ] May cause psychological or social harm
| Authority | Jurisdiction | Legal Basis |
|---|---|---|
| National Science and Technology Council (formerly MOST) | NSTC-funded projects involving human research | "NSTC Guidelines for Research Grant Applications" |
| Ministry of Health and Welfare | Human research, clinical trials, human biobanks | "Human Subjects Research Act" (2011) |
| Ministry of Education | Research ethics in educational settings | Institutional regulations |
| Regulation | Scope | Key Requirements |
|---|---|---|
| Human Subjects Research Act | Research involving human subjects (surveys, interviews, observations, interventions) | Prior review, informed consent, personal data protection |
| Personal Data Protection Act | Collection, processing, and use of personal data | Notification obligation, purpose limitation, security maintenance |
| Regulations Governing Human Trials | Drug/medical device clinical trials | GCP compliance, subject insurance |
1. Write research proposal
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2. Determine whether human subjects are involved
↓ (Involved)
3. Confirm review level (Exempt / Expedited / Full Board)
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4. Submit application to institutional IRB
- Research proposal
- Informed consent form
- Questionnaire/interview guide
- Researcher qualification documentation (CITI or equivalent training)
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5. IRB review (timeline: Expedited 2-4 weeks, Full Board 4-8 weeks)
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6. Research may only begin after receiving approval letter
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7. Periodic progress reports (typically annual)
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8. Final report
| Platform | Description | URL |
|---|---|---|
| AREC (Academic Research Ethics Committee) | Multi-institutional joint ethics review committee | Institutional IRB websites |
| Institutional IRB systems | Online application systems within universities | Institutional R&D office websites |
| CITI Program | Online research ethics training course | citiprogram.org |
| Taiwan Research Ethics Education Resource Center | Research ethics education materials | Institutional teaching development centers |
| Research Scenario | Involves Human Subjects | Recommended Review Level | Notes |
|---|---|---|---|
| MOE public statistical data analysis | No | Exempt | Already publicly available de-identified data |
| Institutional research (IR) data analysis | Depends | Exempt/Expedited | Depends on whether data is de-identified |
| Student learning outcome survey | Yes | Expedited | Anonymous surveys typically qualify for expedited review |
| Teacher interviews (general teaching experience) | Yes | Expedited | Non-sensitive topics |
| Teaching experiment (A/B teaching method comparison) | Yes | Expedited/Full Board | Depends on whether it affects students' grades/rights |
| Student mental health survey | Yes | Full Board | Sensitive topic |
| Vulnerable student population study | Yes | Full Board | Vulnerable population protection |
| Student learning portfolio analysis | Depends | Expedited | Contains identifiable information requiring expedited review |
| Classroom observation (no personal data recorded) | Yes | Exempt/Expedited | Public setting observation |
| Graduate career tracking survey | Yes | Expedited | Contains personal data requiring expedited review |
| HEEACT accreditation data analysis | Depends | Exempt/Expedited | Publicly available portions exempt from review |
| University faculty salary/labor conditions survey | Yes | Expedited/Full Board | May involve institutional power dynamics |
| Situation | Additional Requirements |
|---|---|
| Online survey | Electronic consent (clicking "I agree" constitutes consent); must state that IP addresses will not be recorded |
| Audio/video recording | Separate checkbox item: consent to audio/video recording |
| Minors | Legal guardian consent + subject assent |
| Cross-national research | Comply with local IRB requirements + Taiwan IRB requirements |
| Indigenous research | Community consent (tribal consent) + individual informed consent |
Research Participation Consent Form
1. Research Project Title: [ ]
2. Principal Investigator: [ ] / Institution: [ ]
3. Research Purpose: [ ]
4. Research Methods and Procedures:
You will be invited to [specific description of what the subject will do],
estimated to take [ ] minutes.
5. Potential Risks or Discomfort: [ ]
6. Potential Benefits: [ ]
7. Confidentiality Measures:
Your data will be processed using codes; research results will only be
presented in aggregate form, and your personal identity will not be
disclosed. Data will be destroyed after [X] years.
8. Voluntary Nature of Participation:
You are free to decide whether to participate in this study and may
withdraw at any time without any adverse consequences.
9. Contact Information:
Principal Investigator: [Name] [Phone] [Email]
IRB Contact: [Institution Name] [Phone] [Email]
□ I have read and understood the above explanation and agree to participate
in this research.
Subject Signature: __________ Date: __________
Researcher Signature: __________ Date: __________
| Strategy | Description | Applicable Scenario |
|---|---|---|
| Anonymization | Complete removal of all identifiable information, irreversible | Final data publication |
| Pseudonymization | Replace with codes, retain a linkage table | Need to track during research process |
| Data generalization | Convert precise values to ranges (e.g., age → age group) | Statistical analysis |
| Data masking | Hide partial information (e.g., partially masked email) | Data display |
| k-anonymity | Ensure each record is indistinguishable from at least k-1 other records | Dataset release |
Before starting research, answer the following questions: