Ethical and Regulatory Problems of Molecular Imaging.
- Author:
Jae Min JEONG
1
Author Information
1. Department of Nuclear Medicine Seoul National University College of Medicine, Seoul Korea. jmjng@snu.ac.kr
- Publication Type:Original Article
- Keywords:
Molecular imaging;
Ethics;
Regnlation
- MeSH:
Animal Care Committees;
Animal Experimentation;
Ethics;
Ethics Committees, Research;
Helsinki Declaration;
Humans;
Korea;
Ligands;
Molecular Imaging*;
Nuclear Medicine;
United States Food and Drug Administration
- From:Korean Journal of Nuclear Medicine
2004;38(2):140-142
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
As a molecular imaging is the most up-to-date technology in Nuclear Medicine, it has complicate ethical and regulatory problems. For animal experiment, we have to follow institutional animal care committee. For clinical experiment, we have to get approval of Institutional Review Board according to Helsinki declaration. In addition, approval from Korea Food and Drug Administration (KFDA) is essential for manufacturing and commercialization. However, too much regulation would suppress development of new technology, which would result in the loss of national competitive power. In addition, most new radioactive ligands for molecular imaging are administered to human at sub-pharmacological and sub-toxicological level. In conclusion, a balanced regulation is essential for the safety of clinical application and development of new technology.
