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[TMU-JIRB Announcement] Effective November 01, 2026: Exemption from IRB Review No Longer Applies to Research Projects Utilizing "Data Release (Data to
[TMU-JIRB Announcement] Effective November 01, 2026: Exemption from IRB Review No Longer Applies to Research Projects Utilizing "Data Release (Data to
1. Regulatory and Legal Basis:
Articles 5 and 8 of the Human Subjects Research Act.
Department of Health (now Ministry of Health and Welfare) Announcement No. 1010265098 dated July 5, 2012, "Scope of Human Subject Research Eligible for Expedited Review by Research Ethics Committees," Item 4: "Research using medical records derived from routine clinical treatment or diagnosis, including case reports, provided, however, that medical records of patients testing positive for Human Immunodeficiency Virus (HIV) are excluded."
Audit observations from the Ministry of Health and Welfare Research Ethics Committee and Human Subject Protection Program Audit (October 2026).
2. Review Procedures for Data Release Projects:
Under the “Data Release (Data to Go)” model, researchers directly store and manage individual patient-level medical record data. Such studies fall within Item 4 above and shall therefore be subject to Expedited Review. Projects involving medical records of HIV-positive patients shall undergo Full Board Review.
3. Other Data Access Models and Sources:
Research projects utilizing other database access models (e.g., analysis within a secure enclave or data import/ linkage) or other data sources shall temporarily continue to follow current rules and procedures.
4. Handling of Approved Projects and Pending Submissions:
Approved Studies: Exemption certificates issued prior to the effective date (November 1, 2026) shall remain valid.
Pending Submissions: “Data Release” applications submitted prior to the effective date that have not yet received a review determination shall be processed in accordance with this announcement (i.e., routed to Expedited or Full Board Review).
5. Inquires:
For any questions or future information, please contact TMU JIRB Administration Section at tmujirb@gmail.com.
