Pharmaceutical News
TFDA revises the informed consent form template for drug clinical trials

The first “informed consent form template for drug clinical trials” was announced by the health authority on May 30, 2007 to protect the rights of subjects participating in drug clinical trials.  The template serves as a reference for applicants of clinical trials.  After 10 years, it is necessary to bring the template up-to-date and into line with the advances in clinical trial designs.  To revise the template, the TFDA has sought suggestions from the Taiwan Association of IRB, medical experts and the industry representatives.  A new version of the informed consent form template was announced on August 22, 2017.

This revised template provides further protection on subjects’ rights, including their acknowledgment of the use and reuse of their specimens (including derivatives) and leftover specimens, as well as their options for reusing the specimens.  It also stipulates that subjects should be informed of possible commercial interests and applications derived from the research, pursuant to Article 14 of the Human Research Act.

Clinical trial is an important stage of drug R&D.  It paves the way to medical applications and advances.  However, clinical trials should be conducted with subjects’ informed consent.  The TFDA made this revision by taking account of comments made by the Taiwan Association of IRB and experts/ academia in related field with a view to strengthening the protection for subjects.

【2017-08-22/ TFDA】