researcher

Review categories

Principal investigators should apply based on eligibility; the final review category is determined by the NCCU Research Ethics Committee.

Definition

Research that does not involve minors, detainees, Indigenous peoples, pregnant women, individuals with disabilities, psychiatric patients, or those deemed vulnerable to coercion or unable to give free consent, and meets any of the following criteria, after approval by the Committee, it may be exempt from review and receive an exemption certificate from the Research Ethics Committee :

Processing Time

7-10 days
  1. Non-identifiable, non-interactive, and non-invasive research conducted in public settings.
  2. Use of legally and publicly available information, in accordance with its intended purpose.
  3. Public policy evaluation studies conducted by government agencies or authorized institutions.
  4. Educational assessments, testing, or evaluations conducted in standard teaching environments.
  5. Minimal-risk research where participants face no greater risk than in daily life, as determined by the Ethics Review Committee.

Definition

Applicable to research involving minimal risk and excluding vulnerable populations. The likelihood and severity of physical, psychological, or social harm to participants must not exceed those encountered in daily life or routine medical procedures.

Processing Time

20-30 days

Criteria for Expedited Review:

  1. Blood collection from adults (≥50 kg) via finger, heel, ear, or venous sampling, with limits of:
    1. ≤320 mL in 8 weeks
    2. ≤2 times per week
    3. ≤20 mL per draw
  2. Non-invasive sample collection, including:
    1. Hair, nails, or naturally shed skin cells
    2. Extracted permanent teeth (for routine care)
    3. Excretions and secretions (e.g., sweat)
    4. Saliva (non-invasive collection methods only)
    5. Dental plaque and calculus (standard cleaning or less invasive methods)
    6. Oral or skin cell collection via scraping or rinsing
    7. Sputum collected after steam inhalation
    8. Other non-invasive methods excluding puncture, incision, or device insertion
  3. Non-invasive data collection using government-approved medical devices that do not involve ionizing radiation, microwaves, anesthesia, or sedation:
    1. Surface or remote sensors without significant energy input or privacy concerns
    2. Weight measurements and sensory tests
    3. MRI scans
    4. ECG, EEG, body temperature, radiation exposure detection, retinal imaging, ultrasound, infrared diagnostics, Doppler blood flow, and echocardiography
    5. Exercise, muscle strength, identity verification, and flexibility assessments based on participant age, weight, and health
    6. Other non-invasive methods that comply with the provisions of this paragraph
  4. Use of clinical treatment or diagnostic records (excluding HIV-positive cases).
  5. Audio, video, or image data collection for research, excluding personally identifiable or sensitive data that may affect employment, insurance, finances, or social relations.
  6. Behavioral studies on individuals or groups, excluding those that may lead to discrimination.
  7. Previously approved studies under these conditions:
    1. No new participants, all trials completed, but long-term follow-up required
    2. Extended study period due to insufficient recruitment, with no added risks
    3. Continuation of prior-phase data analysis
  8. Research using de-identified or unlinkable biospecimens or data from legal biobanks, excluding cases affecting group interests.
  9. Studies previously approved by another accredited review board.
  10. Follow-up research on closed cases using the same design and methods, with no increased risk to participants.
 

Definition

Research that does 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) falls under Full-Board Review.

Processing Time

40-50 days