NIH Guidelines for Human Stem Cell Research
On July 6, 2009, the National Institutes of Health (NIH) released new guidelines for research using human stem cells; the rules went into effect on July 7, 2009. President Obama released an executive order, Removing Barriers to Responsible Scientific Involving Human Stem Cells, shortly after taking office calling on the NIH to establish policy and procedures under which NIH will fund research in embryonic stem cells more broadly than outlined by President Bush’s 2001 executive order limiting federal funding to research using 21 preexisting stem cell lines. In response, the NIH released draft guidelines in April, and accepted public comments on that draft through May 26. NIH received close to 49,000 comments from patient-advocacy groups, scientists and scientific societies, academic institutions, medical organizations, religious organizations, private citizens, and members of Congress.
The new Guidelines allow funding for research using human embryonic stem cells derived from surplus embryos created by in vitro fertilization (IVF) for reproductive purposes and no longer needed for that purpose. In order to be eligible for funding, the stem cell lines must meet very specific conditions for informed consent by the embryo donors.
Many of the public comments received by the NIH focused on concern that the 21 stem cell lines approved for use under the Bush administration would not be eligible for federal funding under the new guidelines. Many of these previously approved lines cannot demonstrate the donors’ voluntary consent to allow their human embryonic stem cells to be used for research, as required by the new policy.
In response to this concern, the NIH clarified that none of the lines approved by President Bush would be “grandfathered” in, but that a working group comprised of scientists, ethicists and advocates will review them individually and recommend they be eligible for funding if they conform to the spirit of the guidelines.
For lines derived outside the United States, the NIH will determine if the rules under which the stem cells were obtained are “at least equivalent” to the NIH rules.
NIH approved the first 13 human embryonic stem cell (hESC) lines eligible for federal funding in December 2009. These lines, which included 11 lines from Children’s Hospital in Boston and two from Rockefeller University in New York City, were found to meet the strict letter of the guidelines without need for additional review. "I am happy to say that we now have human embryonic stem cell lines eligible for use by our research community under our new stem cell policy," Dr. Collins said in a press release at the time of the announcement. "In accordance with the guidelines, these stem cell lines were derived from embryos that were donated under ethically sound informed consent processes. More lines are under review now, and we anticipate continuing to expand this list of responsibly derived lines eligible for NIH funding."
As of August 2010, 76 stem cell lines were eligible for funding, including the most widely used line, H9, that was one of the only twenty-one acceptable to federal funding by President Bush. Three others of those 21 are also on the approved list: H7, H13 and H14.
The April 2010 announcement that H7, H9, H13, and H14 were approved for federal funding lifted concerns of some in the research community that the new stem cell policy meant to improve human embryonic stem cell research was actually hindering it. The lines originally approved by President Bush for federal funding had to be vetted to ensure that they met the new ethic requirements, including making sure couples who donated embryos were fully informed of their options.
Of the 76 approved lines, some were approved by the NIH with caveat. For example, in the case of 27 lines, the informed consent documentation of these lines only discusses their use for research involving the development of pancreatic cells. Thus, the Advisory Committee to the Director recommended that this restriction continue to be honored in future use of the 27 lines.
The NIH maintains an up-to-date registry of eligible lines that researchers and institutions can use as a resource. That registry is available at http://grants.nih.gov/stem_cells/registry/current.htm
NIH funding for research using human embryonic stem cells derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is not allowed under the new Guidelines, nor is funding for the derivation of embryonic stem cells. Funding will continue to be allowed for human stem cell research using adult stem cells and induced pluripotent stem cells.
To read the full-text of the guidelines, please visit: http://stemcells.nih.gov/policy/2009guidelines.htm