Taiwan Addendum to the Evaluation Instrument

Last updated: January 20, 2021

General Comments

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.

Domain I: Organization

Domain II: Institutional Review Board or Ethics Committee

standard ii-1: The structure and composition of the IRB or EC are appropriate to the amount and nature of the research reviewed and in accordance with requirements of applicable laws, regulations, codes, and guidance.

Element II.1.A.

element ii.1.a.: The IRB or EC membership permits appropriate representation at the meeting for the types of research under review, and this is reflected on the IRB or EC roster. The IRB or EC has one or more unaffiliated members; one or more members who represent the general perspective of participants; one or more members who do not have scientific expertise; one or more members who have scientific or scholarly expertise; and, when the IRB or EC regularly reviews research that involves vulnerable participants, one or more members who are knowledgeable about or experienced in working with such participants.

The research institution may set up at least one IRB or EC, which may establish sub-groups for operational purposes. (Regulations for Organization and Operation of Human Research Ethics Review Board, Article 2)

Where an entity does not have an established IRB or EC, the review may be conducted by an IRB or EC of another entity. (Human Research Act, Article 5)

According to IRB or EC rosters:

Each IRB or EC has at least five members with varying backgrounds to promote complete and adequate review of research commonly conducted by the organization.
People of either gender must constitute no less than one third of the IRB or EC.
More than two-fifths shall not be affiliated with the research entity or have immediate family members who are affiliated with the organization.
Each IRB or EC has at least one member whose primary concerns are in scientific areas.
Each IRB or EC has at least one member whose primary concerns are in nonscientific areas, including legal specialists or other impartial members of the community.
No IRB or EC may have members who represent a single profession.
Each IRB or EC must have at least one member who represents the perspective of research participants. (Human Subjects Research Act, Article 7; Regulations on Good Clinical Practice, Chapter I, Article 3.5)
A single member may represent more than one category.
The name list of the joint IRB or EC members shall be disclosed to the public. (Regulations on Human Trials, Article 6)

Element II.1.D.

element ii.1.d.: The IRB or EC has and follows written policies and procedures so that members and consultants do not participate in the review of research protocols or plans in which they have a conflict of interest, except to provide information requested by the IRB or EC.

IRB or EC members are considered to have a conflict of interest and must recuse themselves from review under the following circumstances:

Serving as the trial conductor, assistant trial conductor, or entrustor of the human trial.
Being, currently or in the past, the spouse, blood relative of four degrees or closer, or relative by marriage of three degrees or closer of the trial conductor. • Being in an employment relationship with the entrustor of the human trial.
Having an employment relationship with the commissioning enterprise of the research project under review.
Being in other situations where the recusal of the IRB or EC member is deemed necessary by the IRB or EC.
There are specific facts pointing to potential bias.

(Human Subjects Research Act, Chapter 2, Article 17; Regulations for Organization and Operation of Human Research Ethics Review Board, Article 8; Regulations on Human Trials, Article 8)

standard ii-2:

The IRB or EC evaluates each research protocol or plan to ensure the protection of participants.