qoder-config/skills/deep-research/references/irb_decision_tree.md

IRB Decision Tree — Human Subjects Research Ethics Review Guide

Purpose

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.

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1. Human Subjects Research Determination Decision Tree

Does your research collect, use, or analyze data from humans?
│
├── 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?
          │
          ├── 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
          │
          └── Yes → Does the research involve direct interaction with subjects?
                    │
                    ├── 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

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2. Three-Level Review System

2.1 Exempt Review

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.

2.2 Expedited Review

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

2.3 Full Board Review

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

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3. Taiwan IRB Process

3.1 Governing Authorities

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

3.2 Regulatory Framework

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

3.3 Application Process

1. Write research proposal
   ↓
2. Determine whether human subjects are involved
   ↓ (Involved)
3. Confirm review level (Exempt / Expedited / Full Board)
   ↓
4. Submit application to institutional IRB
   - Research proposal
   - Informed consent form
   - Questionnaire/interview guide
   - Researcher qualification documentation (CITI or equivalent training)
   ↓
5. IRB review (timeline: Expedited 2-4 weeks, Full Board 4-8 weeks)
   ↓
6. Research may only begin after receiving approval letter
   ↓
7. Periodic progress reports (typically annual)
   ↓
8. Final report

3.4 Online Research Ethics Review Platforms

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

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4. Higher Education Research Quick Reference Table

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

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5. Informed Consent Form Elements

5.1 Required Items

• Research title
• Research institution and principal investigator name
• Research purpose
• Research procedures description (what subjects need to do, how long it takes)
• Potential risks and discomfort
• Potential benefits
• Confidentiality measures (how data is stored, who has access, retention period)
• Voluntary nature of participation (may withdraw at any time, no penalties)
• Researcher contact information
• IRB contact information (complaint channel)
• Subject signature and date field

5.2 Special Situations

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

5.3 Informed Consent Form Template Structure

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: __________

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6. Data De-identification and Privacy Protection

6.1 De-identification Strategies

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

6.2 Common Privacy Risks in Higher Education Research

• Small sample identification: Small departments may allow re-identification through descriptive statistics
• Cross-referencing: Combining multiple de-identified datasets may enable re-identification
• Narrative identification: Qualitative research quotations may reveal interviewee identity
• Institutional identification: Overly specific institutional characteristics may allow institution identification

6.3 Recommended Practices

• Remove direct identifiers (names, student IDs, national ID numbers)
• Assess indirect identifier risks (department + year + gender combinations may identify individuals)
• Check qualitative quotations: remove identifiable details
• Handle institutional names: decide whether to anonymize based on research needs
• Encrypt data storage with access controls
• Establish data retention and destruction timeline

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Quick Reference: Researcher Self-Check

Before starting research, answer the following questions:

1. Does my research collect, use, or analyze human-related data?
2. If yes, is the data completely de-identified and publicly available?
3. If not, which level of IRB review do I need to apply for?
4. Have I completed research ethics training (CITI or equivalent)?
5. Does my informed consent form include all required elements?
6. Do I have an appropriate data protection plan?
7. If vulnerable populations are involved, are there additional protective measures?
8. Has the IRB review timeline been incorporated into the research project timeline?