After being established in 1994, the Severance Hospital Institutional Review Board (IRB) operates as an independent and fair review board. In order to protect the rights, safety, and welfare of the research participants, the IRB reviews and consistently reconfirms the research protocol, modified protocol, methods and information used to obtain written consent from the participants. With this objective in mind, the IRB determines the feasibility of all the research related to human research participants and continuously conducts audits throughout the research process.
Severance hospital IRB has total 8 panels including medical devices-specialized panels.
By reviewing the clinical trials to ensure that the bioethics and safety are in place, the IRB aims to prevent the infringement of human dignity and values and to improve the health and quality of life of the research participants.
The IRB abides by the pharmaceutical affair law, Bioethics and Safety Act, International Conference on Harmonization (ICH) Good Clinical Practice (GCP) E6(R2) Consensus Guideline and other relevant laws and regulations.
division | 2016 | 2017 | 2018 | 2019 | 2020 |
---|---|---|---|---|---|
SIT | 297 | 324 | 306 | 328 | 349 |
IIT | 946 | 1028 | 1025 | 1101 | 1220 |
*Duration: January 1 to December 31, including medical devices