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Guidelines on Using Cells from Established Human Embryonic Stem Cell Lines for Research Discussion document

 

 

 

The purpose of this discussion document is to seek your views on proposed guidelines for using cells from established human embryonic stem cell lines for research.

 

  Established human embryonic stem cell lines are stable populations of undifferentiated cells, obtained from human embryos, that can self-replicate and remain undifferentiated for long periods of time in culture outside of the body.  Proposed guidelines on the research use of such cells are to be found at the end of this discussion document. 

 

Once finalised, these guidelines will be used by researchers and by ethics committees that consider research using human embryonic stem cells.

 

In New Zealand, research involving human embryos, including the generation of human embryonic stem cell lines, is under the statutory control of committees established under the Human Assisted Reproductive Technology (HART) Act 2004.  Once established, human embryonic stem cells are not embryos, and their use does not require the same level or type of regulation.  However, the generation of embryonic stem cell lines involves the destruction of human embryos, which raises a number of ethical issues.  These issues are discussed in the chapter on ethics (chapter 4).

 

Human embryonic stem cell research is carried out in most jurisdictions in the developed world, under a variety of regulatory systems.  Although legislation and regulations relevant to human embryonic stem cell research already exist in New Zealand, there is no guidance specific to this research, and no such research takes place in this country.  Guidelines are needed to clarify the issues that this research raises, to place appropriate restrictions on such research and to provide certainty for researchers, ethics committees and members of the public.

 

The Ministry of Health (the Ministry) is aware that delays in clarifying the regulation of human embryonic stem cell research have created difficulties for researchers in planning research programmes and that further delays may mean that opportunities to develop capability and capacity in this type of research may be lost.  The Ministry has undertaken to develop final guidelines on research using established embryonic stem cell lines as soon as possible.