Regulating preimplantation genetic diagnosis--how to control PGD.
OBJECTIVE
To assess the regulations for Preimplantation Genetic Diagnosis (PGD). How to regulate and control PGD. Is any special licensing procedure necessary?


METHODS
A review of the statements of the organization and the Japan Society of Obstetrics and Gynecology (JSOG). Also, we assess the JSOG guidelines for PGD and the statements on diagnosis of genetic diseases of the Japan Society of Human Genetics. We discuss extra licenses and qualifications for laboratories, staff, and directors.


RESULTS
At present, there are no regulations governing PGD for laboratories, scientists, directors, and staff. Regulations are set by committees and organizations of the countries involved. We don't have any worldwide system of controls. In Japan, we are considering regulations in the fields of reproduction and genetics.


CONCLUSIONS
PGD requires high-level techniques in taking samples, and high-level knowledge about genetic diseases. In diagnosis, we have to be as close to 100% accurate as possible. However, samples for PGD are so small that there is always a risk of failure. Also, we are required to have highly specialized knowledge about reproduction and genetics. In Japan, JSOG has a plan to join with the Society for Investigating Infertility and Society for Genetics.
Takeshita
Naoki
N
The 1st Department of Obstetrics and Gynecology, TOHO University School of Medicine, 6-11-1 Ohmori-Nishi, Ohta-Ku, Tokyo 143-8541, Japan. ntakesit@med.toho-u.ac.jp
Kubo
Harumi
H
D005260:Female; D030342:Genetic Diseases, Inborn / Q000175:diagnosis; D005820:Genetic Testing; D006801:Humans; D007564:Japan; D007883:Legislation, Medical; D008007:Licensure, Medical / Q000592:standards; D011247:Pregnancy; D019836:Preimplantation Diagnosis / Q000379:methods / Q000592:standards*; D011786:Quality Control; D012955:Societies, Medical