Clinical trials are essential to the advance of medical treatments; however, there are unknown risks to trial subjects.  Therefore, in order to protect the safety and rights of trial subjects, clinical trials have to be conducted in compliance with certain regulations.  Furthermore, the trial protocols have to pass a strict assessment and obtain a prior official approval before it can be started. As the standards of the clinical trials keep improving, more and more regulations have been laid to protect trial subjects. 

Due to the potential risk of clinical trials, subjects have to be fully informed of the purposes and all the potential benefits and risks of a trial so that they can make an informed decision as to whether they want to participate in the trial or not.  The trial should comply with the ethical principles of the Declaration of Helsinki, as well as the GCP Guidelines and other related regulations.  The agencies listed below also play an important role in safeguarding trial subjects’ safety:

1. Taiwan Food and Drug Administration (TFDA): The TFDA strictly assesses the proposal of a clinical trial in the aspects of science, adequacy, potential benefits and risks, etc. in order to conclude a decision on granting an approval. 
2. Hospital Institutional Review Board (IRB):  The IRB is responsible for the evaluation of the trial protocol, the protection of the subjects and the supervision and monitoring of the subjects’ safety and rights during a trial. 
3. Investigator:  Investigators must have a complete background of clinical trials and must put the subjects’ interests in the first place.  Investigators must consider the science and ethics at the same time and ensure the subjects’ safety while conducting the trial.
4. Human Subject Protection Association in Taiwan (HuSPAT):  The Association is a devoted campaigner for the protection of trial subjects.

In order to educate the public about the correct knowledge concerning clinical trials, the TFDA will continue organizing events and training courses.  By doing so, the TFDA hopes to improve the clinical trial standards, train new talents and create a legal, scientific and ethical environment for clinical trials. 

【2021-11-17 / TFDA】