並列摘要
The origin of human subject protection in Taiwan begun in 1986 when the Medical Care Act was enacted which requires the informed consent for all medical treatments and researches. The Enforcement Rules of Medical Care Act in 1987 stipulate the mandatory items for research protocols and requirements for Institutional review board (IRB) review. Protocols reviewed by IRB must compliance with Declaration of Helsinki and other international ethics codes. Good clinical practice (GCP) guidelines were originally announced in November 1996 and a proposed revision of the GCP guidelines to harmonize with ICH-GCP was published in September 2002. An official GCP inspection has begun since 2000. IRB Operational Guidelines were announced by DOH in November 2003. The IRB review system in Taiwan provides an important mechanism for human subject protection.