New US guidelines for research on human embryos

US embryonic stem cell researchers now have relief from the patchwork of regulations and funding restrictions they currently face.

In August 2001 the US president limited federally funded researchers to the use of tissue derived from several dozen human embryonic stem cell lines which were created before that time. This policy is still being debated, most recently in May, when the US House of Representatives voted to extend federal funding for stem cell research, despite the threat of a presidential veto.

Meanwhile, state-level agencies, private industry and foundations are supporting research on stem cells derived from sources not approved by the National Institutes of Health. However, “Both the investigators and the institutions have been left with no guidance as to what's appropriate and what's not,” says Richard Hynes, a cancer researcher at the Massachusetts Institute of Technology.

Hynes cochaired a US National Academy of Sciences (NAS) committee that issued guidelines in April on deriving, storing, distributing and using embryonic stem cell lines. Although the guidelines remain strictly voluntary, Hynes says institutions and state governments have responded positively. Harvard University and the State of California are adopting them.

The NAS guidelines call for Embryonic Stem Cell Research Oversight (ESRO) committees to ensure the guidelines are followed.

Among other things, the guidelines require donor consent before a blastocyst is used to generate stem cells. This mirrors the Canadian Institutes of Health Research stem cell guidelines.

The NAS guidelines also address the implications of introducing human cells into animals; the breeding of chimeras and the transfer of human attributes to animals is proscribed. The guidelines also disallow the transplantation of animal cells into human blastocysts.