Until recently, many of Japan's medical and bioethical communities had ignored the issue of conflicts of interest. This is no longer the case. Discussion on the economic and ethical problems defined by CIs is now apparent in academic, political, and even industrial spheres. In June 2004, this debate was sparked by a scandal involving AnGes MG, Inc., a bioventure company set up by a faculty member at Osaka University Graduate School of Medicine. AnGes MG developed a gene therapy using the (...) Hepatic Growth Factor for obstructive blood vessel disease. Japanese newspapers reported that “several physicians involved with clinical trials for AnGes obtained unlisted shares of stock. One physician allegedly received 32 million yen after AnGes MG went public on the ‘Mothers’ stock exchange”. (shrink)

In the past few years, a second phase of biomedical ethics in Japan has begun to surface with a succession of governmental guidelines and laws regulating biomedical technology. Although this rush of guidelines exemplifies a heightened awareness concerning ethical standards for healthcare research, it also invites several practical, political, and procedural problems.

Background Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications. Discussion The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel to considerable (...) amendments designed to minimise participant harm in New Zealand. Assessment of minimal risk is a complex and unreliable estimation further compounded by insufficient information on probabilities of particular individuals suffering harm. Estimating potential benefits/ risks ratio and protecting participants' autonomy similarly are not straightforward exercises. Summary Safeguarding moral/humane principles should be balanced with promotion of ethical research which does not impede research posing minimal risk to participants. In ensuring that ethical standards are met and research has scientific merit, ethics committees have obligations to participants (to meet their rights and protect them from harm); to society (to ensure good quality research is conducted); and to researchers (to treat their proposals with just consideration and respect). To facilitate meeting all these obligations, the preferable focus should be promotion of ethical research, rather than the prevention of unethical research, which inevitably results in the impediment of researchers from doing their work. How the ethical principles should be applied and balanced requires further consideration. (shrink)

Until recently, many of Japan's medical and bioethical communities had ignored the issue of conflicts of interest . This is no longer the case. Discussion on the economic and ethical problems defined by CIs is now apparent in academic, political, and even industrial spheres. In June 2004, this debate was sparked by a scandal involving AnGes MG, Inc., a bioventure company set up by a faculty member at Osaka University Graduate School of Medicine. AnGes MG developed a gene therapy using (...) the Hepatic Growth Factor for obstructive blood vessel disease. Japanese newspapers reported that “several physicians involved with clinical trials for AnGes obtained unlisted shares of stock. One physician allegedly received 32 million yen after AnGes MG went public on the ‘Mothers’ stock exchange”. (shrink)

In Japan, modern biomedical ethics emerged in the early 1980s. One of the main triggers was the nationwide debate on organ transplantation and brain death. A lengthy process of academic, religious, and political discussion concerning organ transplantation, lasting well over a few decades, resulted in the enactment of the Organ Transplantation Law in 1997.1 The defining of death and other bioethical issues, including death with dignity and euthanasia, were also stimulating topics throughout the latter end of the twentieth century. For (...) instance, the death-with-dignity movement, which started around the late 1960s, developed into a hospice/palliative-care movement by the end of the 1980s. (shrink)