Due to the potential risks of clinical trials, participants should be fully informed and must also understand the purposes, potential benefits and risks of the clinical trial prior to deciding whether to enroll in a clinical trial or not. Clinical trials should be conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the regulatory requirements. In order to establish a safety-oriented clinical trial environment, the following agencies or units will work together not only to ensure the rights and interests of participants, but also to protect their safety:

 

(I) Taiwan Food and Drug Administration (TFDA): Protecting the rights, safety and welfare of human subjects in clinical trials is a critical aspect of TFDA’s mission. TFDA works to ensure clinical trials are designed, conducted, analyzed and reported according to good clinical practice (GCP) regulations.

 

(II) Institutional Review Board/Research Ethics Committee (IRB/REC): The responsibility of IRBs is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the clinical trials.  IRBs review protocols and related materials (e.g., informed consent documents), work with the TFDA to ensure that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the clinical trials.

 

(III) Principal Investigator (PI): The PI is the individual who has the primary responsibility for ensuring the ethical conduct of the clinical trials and assumes full responsibility for the conduct of the clinical trials. They should strictly abide by the detailed protocols of clinical trials, to protect the rights and welfare of the participants.

 

(IV) Human Subject Protection Association in Taiwan (HuSPAT): The association is the non-governmental human subject protection organization in Taiwan. It continuously protects of trial subjects and promotes awareness of human subject protection.

 

     TFDA has endeavored to promote the drug clinical trial training programs  and the subjects’ protection promotion activities to enhance the capacities of implementing clinical trials in compliance with Guideline for Good Clinical Practice as well as the spirit of ICH. Thus, we strongly believe that the legal, scientific and ethical environment for clinical trials can be established under everyone's efforts. More pharmaceutical products can then be developed for the benefit of the people, yielding a win-win situation.