Korean J Nucl Med.  2004 Apr;38(2):140-142.

Ethical and Regulatory Problems of Molecular Imaging

• Jeong JM

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.

Keyword

Molecular imaging; Ethics; Regnlation

MeSH Terms

Animal Care Committees
Animal Experimentation
Ethics
Ethics Committees, Research
Helsinki Declaration
Humans
Korea
Ligands
Molecular Imaging*
Nuclear Medicine
United States Food and Drug Administration
Ligands