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Stem cell scientists issue new guidelines to cover embryo editing

16 May 2016
Appeared in BioNews 851

An international body representing stem cell scientists has included human genome editing in its updated guidance on the manipulation of stem cells and their use in therapy.

The International Society for Stem Cell Research (ISSCR) says that research involving the genome editing of gametes and embryos can be supported if performed under 'rigorous review', but that its clinical application is still a long way off and should remain prohibited.

The ISSCR comprises 4100 researchers in the field of stem-cell research from over 60 countries. Its guidelines advocate a model of self-regulation, explains Nature News, which adds that the authors of the guidelines hope they will allay ethical concerns and avoid calls for strict legal regulation that could impede research.

'Self-regulation is the best form of regulation,' said Dr Charles Murry of the University of Washington and a member of the committee that updated the guidelines. 'The biomedical community is best poised to strike the balance between rapid progress and safe, ethical research practice.'

The ISSCR has previously released guidance on research involving embryonic stem cells and on clinical uses of stem cells. Their 2016 guidelines have been updated to deal with ethical issues applicable to all research, such as patient welfare, respect for research subjects and transparency, but also to specifically address particular concerns around the use of human embryos.

One newly included recommendation is that all research involving human embryos, even that not relating to stem cells, should undergo the same review procedure as research that involves the creation of new stem cell lines from human embryos. This would entail the use of oversight committees involving scientists, ethicists, and other ISSCR members.

It also says that iPS (induced pluripotent stem) cells that do not generate human embryos should no longer be subjected to specific stem-cell research oversight, but should fall under existing processes that deal with donor-cell recruitment on screening and informed consent. The ISSCR says this would clarify how iPS cells should be classified for use in research, clearing the way for further use in the future.

Nature News reports that the introduction of oversight committees for embryonic stem-cell research has been a divisive issue in the scientific community. 'No scientist or physician jumps for joy when new regulations are put in place,' said Dr Murry, but he added they are necessary to avoid 'a Wild West environment, where sensitive research is done without proper regard for community standards'.

Another guideline calls for the continuance of the ban on keeping embryos in vitro for more than 14 days, a time limit that some commentators see as an arbitrary barrier to research. The 14-day rule has been in the spotlight recently, following reports that suggest scientists may soon be able to grow embryos beyond this point (see BioNews 850).

As the field of stem-cell research is rapidly advancing, the continuing ethical debate is crucial, said Professor Sean Morrison of the University of Texas Southwestern Medical Center and president of the ISSCR, adding that: 'These guidelines are essential to protect the integrity of the research and to assure that stem-cell treatments are safe and effective.'

The report also addresses how the application and scope of stem cell research has often been exaggerated by the media. It says that while the field does hold the potential to treat many diseases, only therapies that are proven safe and effective should be marketed.

The ISSCR warns against hyperbolic representations of the application of stem cells, with Dr Murry explaining that the guidelines ask 'researchers to "take it down a notch" when they speak about the implications of their work'.

Guidelines for stem cell science and clinical translation
International Society for Stem Cell Research (guidelines) |  12 May 2016
Human-embryo editing now covered by stem-cell guidelines
Nature News |  12 May 2016
New ISSCR guidelines for stem cell research and translation outline best practices
Eurekalert (press release) |  12 May 2016
Policy: Global standards for stem-cell research
Nature (comment) |  12 May 2016
Stop Hyping Stem Cell Science, Say Stem Cell Scientists
Bloomberg |  12 May 2016
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