Resources: For Accreditation - International Addendum

The Taiwan Addendum to the Evaluation Instrument for Accreditation is intended for use by organizations in Taiwan seeking accreditation, by site visitors evaluating organizations in Taiwan, and by accredited organizations in the US that conduct or oversee research in Taiwan. This Addendum includes Standards and Elements where Taiwan laws, regulations, and guidelines require significant additional protections beyond those defined in the Evaluation Instrument, and is intended to be used in conjunction with the Evaluation Instrument.

The Addendum is based on a review of the following laws, policies, and guidance:

• Human Subjects Research Act (Ministry of Health & Welfare, 2019)
• Medical Care Act (Ministry of Health & Welfare, 2020)
• Pharmaceutical Affairs Act (Ministry of Health & Welfare, 2018)
• Pharmaceutical Affairs Act Enforcement Rules (Ministry of Health & Welfare, 2020)
• Regulations for Good Clinical Practice (Ministry of Health & Welfare, 2014)
• Regulations on Human Trials (Ministry of Health & Welfare, 2016)
• Regulations for Organization and Operation of Human Research Ethics Review Board (Ministry of Health & Welfare, 2018)

This Addendum does not include additional requirements that may be required in any of the 22 sub-national divisions or administrative units. This Addendum represents AAHRPP’s current understanding of additional requirements covering organizations conducting or reviewing research in Taiwan. If you have any questions, concerns, and suggestions to improve this document, please email accreditation@aahrpp.org.