Easing of international stem cell research regulations

13 May 2009

In the US, the National Institutes of Health (NIH) recently issued for public comment draft guidance on the federal funding of research on human embryonic stem cells, intended to implement President Obama’s recent Executive Order 13505 lifting a previous ban on such funding (see previous news). The new guidelines permit "funding for research using human embryonic stem cells that were derived from embryos created by in vitro fertilization for reproductive purposes and were no longer needed for that purpose”.

In other countries with restrictive regulations on stem cell research, the US developments have further increased pressure from scientists to ease restrictions. South Korea recently reversed a ban on stem cell research using human oocytes (eggs), granting approval to a new research project using oocytes from aborted human fetuses. The ban was originally imposed in 2006 following a scandal surrounding Professor Hwang Woo-suk, a prominent South Korean stem cell researcher who in 2004 published a paper reporting the creation of the first cloned human embryo (see previous news). However, this research not only generated ethical controversy leading to his resignation from Seoul National University (see previous news) but was also subsequently discredited (see previous news) and the paper retracted by Science.

Now a research team from Seoul's Cha General Hospital have received approval from the national presidential committee on bioethics for a new therapeutic cloning project, subject to specific conditions. The researchers will be required to minimise the use of oocytes as far as possible by the use of laboratory animal experiments, to obtain formal written consent from oocyte donors for the researchers, and to establish an internal oversight body to guard against potential ethical abuses. The committee also stipulated that the research project title must not use phrases that could raise unrealistic expectations, such as a previous reference to ‘stem cell research which can cure diseases such as Parkinson's’ (see Yahoo news report). An unnamed health official reportedly commented “"We have never technically banned stem cell research but we have always called for strict guidelines" (see Reuters news report). A similar research application to use human cells from Hwang, who is currently working on animal cloning, was rejected by the committee; he remains on trial for various charges relating to the discredited human cloning research, as well as embezzlement.

Meanwhile, the Japanese Council for Science and Technology Policy is expected to approve amendments to current regulations governing stem cell research, removing the requirement for approval from a ministerial commission such that approval would only be needed from a local institutional review board. Therapeutic human cloning (the creation of human embryos for research into or treatment of serious human disease, as opposed to reproductive cloning) is expected to be permitted from this month for basic research purposes (see Nature news).

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