[The revised Japanese pharmaceutical law and research ethics: risk-benefit assessment of fetal stem cell research].
[The revised Japanese pharmaceutical law and research ethics: risk-benefit assessment of fetal stem cell research].
Where did the research take place?
Possible study sites were matched from the text; these need review.
US · Possible study site · country only
The authors conducted risk-benefit assessment of fetal stem cell research, reviewing the scientific, ethical, legal, and social aspects, including a case study of critical appraisal on a report of the double-blind, sham surgery-controlled trial of implantation of fetal tissues in patients with Parkinson's disease conducted in the USA.Location evidence
Ebisu, JP · Author affiliation
Sato Jitsugyo Ebisu Bldg. 4F, 1-11-2 Ebisu, Shibuya-ku, Tokyo 150-0013, Japan. chieko.kurihara@nifty.ne.jpLocation evidence
Tokyo, JP · Author affiliation
Sato Jitsugyo Ebisu Bldg. 4F, 1-11-2 Ebisu, Shibuya-ku, Tokyo 150-0013, Japan. chieko.kurihara@nifty.ne.jpLocation evidence
A plain-language reading has not been prepared for this paper yet.
Original abstract
The Japanese Pharmaceutical Law was revised at the end of July 2002. The important features of this revision are the postmarketing safety scheme, especially for biological products, and reconstruction of the legislation for effective pharmaceutical development. This is based on the national policy to foster life sciences such as genetic research and regenerative medicine for both healthcare improvement and industrial promotion. Such research requires study participants who donate human tissue including abandoned embryos or aborted fetuses, which may touch the human dignity. In particular, fetal stem cell research appears to have unpredictable risks not only to women who undergo abortions but also to societal epistemology. The authors conducted risk-benefit assessment of fetal stem cell research, reviewing the scientific, ethical, legal, and social aspects, including a case study of critical appraisal on a report of the double-blind, sham surgery-controlled trial of implantation of fetal tissues in patients with Parkinson's disease conducted in the USA. It is concluded that risk-benefit assessment with a wide, profound perspective is necessary for advanced biotechnology. Some types of research should not be assessed based only on such utilitarian viewpoints as risk and benefit. Conscientious reflection is necessary to reach a public consensus on which types of human material can be utilized as research or pharmaceutical resources.