Under the current Act, the Institutional Bioethics Committee reviews research plans of the institutions conducting clinical trials, protects researchers and research subjects through investigation, supervision, etc., of their research processes and results, and may receive regular evaluation and certification of its composition or operating performance from the Minister of Health and Welfare to increase transparency and fairness.

In March, 2018, however, while the Dongnam Institute of Radiological and Technical Sciences was conducting clinical trials on a dendritic cell-based immunotherapy approved by the Institutional Bioethics Committee, an accident occurred which led to the loss of 2 lives out of 7 trial participants and three subjects suffered a relapse.

As a result, since the Institutional Bioethics Committee is not free from the interests of the institutions conducting clinical trials, along with the fact that regular evaluation and certification are not mandatory, clinical trial subjects’ rights and safety are being threatened.

Accordingly, to conduct deliberation, investigation, and supervision of clinical trials, the Amendment aims to obligate the evaluation and certification of the Institutional Bioethics Committees established in the institutions conducting clinical trials, prepare sanctionable provisions to allow revocation of such institutions’ designation and registration as authorized to conduct clinical trials depending on certification results, thereby tightening managerial and supervisory controls on clinical trials (Article 14-1, Article 56-1, subparagraphs 2 and 3 newly inserted).

Require evaluation and certification by the Institutional Bioethics Committee (Article 14)

Allow revocation of an institutions’ registration and suspension of business in case of failure to receive the Institutional Bioethics Committee’s certification or revocation of certification (Article 56)