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Proposed NIH guidelines on human embryonic stem cell lines elicit concerns for scientists

Jun2

Written by:Stem Cell Standard
6/2/2009 

 

It is accepted that hES lines created by in vitro fertilization solely for reproductive purposes and which would otherwise have been discarded by fertility clinics can be funded. But after this fact, the new guidelines become problematic, with informed consent at the core of the issue. The proposed rules require nine consent elements to be documented in the written consent form for donors of embryos for research purposes. Until now, funding for cell line derivation has been based on the ethical protocols approved by institutional review boards, and the NAS or ISSCR guidelines. While these guidelines do require informed consent at the time of donation, not all nine consent elements have always been included. 
The new guidelines should have expanded the number of existing stem cell lines and government funding, but it appears that the reality may fall short in the guideline details. Hopefully scientists and NIH can coalesce, possibly by grandfathering the existing lines or making the new laws only applicable to future derivations. This may be a case where science progresses faster than regulation, and the next few weeks will require researchers and government to work together to find a mutually acceptable way that fast-growing science can satisfy rigorous regulation.

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