Final Version of NIH Guidelines for Human Stem Cell Research Released

The National Institutes of Health (NIH) last week published the final version of its guidelines regarding human stem cell research, in part determining which human embryonic stem cells (hESCs) are eligible for research with NIH funding. The final guidelines contain adjustments from the draft version of the guidelines released on April 23 for public comment, from which the NIH received approximately 49,000 statements from advocacy groups, scientists, medical organizations, religious groups, members of Congress, and private citizens.

After condensing and responding to these public comments, the recent NIH publication outlined the final guidelines text include:

• The NIH will create and maintain registry of all approved human embryonic stem cell lines;
• It must be proven the hESCs were derived from human embryos created for vitro fertilization by fertility clinics for reproductive purposes;
• No payments, cash or in-kind, can be offered for donated embryos;
• Any stem cell lines created after July 7, 2009 (the date of the guidelines' release) must come with documented informed consent of the donation by the parents or mother; and,
• Any stem cell lines created before July 7, 2009 - including those created with private funds - can be used in research eligible for NIH funding if a designated advising committee determines previous consent to use the embryos has been provided.

This final bullet is a component amended from the draft version, which originally required stem cell lines created before July 7 also to demonstrate the stricter "documented" level of informed consent. There was concern this previous need for documentation would make some older stem cell lines not eligible for NIH funding. With these new guidelines, the NIH's standards on hESCs are more closely aligned with other countries and recent ethical recommendations put forth by the National Academies.

The most consistent complaint among scientists at the University of Wisconsin-Madison of the newest guidelines is that they exclude cloned embryos that may be ideally suited for future transplantation because of genetic similarities, according to an article by Todd Finkelmeyer with Madison's The Capital Times. The guidelines also prohibit hESCs derived from other sources, including "somatic cell nuclear transfer, parthenogenesis, and/or in-vitro fertilization embryos created for research purposes" to be used in NIH-funded research.

As mentioned in a previous article on President Obama's executive order on stem cell research (see the March 11, 2009 issue of the Digest), the impact to the states of federal changes on stem cell guidelines depends on the existence of any state legislation limiting stem cell research.

The new NIH guidelines, as issued on July 9, 2009, are available at: http://stemcells.nih.gov/policy/2009guidelines.htm