The U.S. government’s medical research agency has published the final guidelines for human stem cell research in response to President Obama’s executive order earlier this year.
Having been directed by the president to issue the guidelines before July 7, the National Institutes of Health (NIH) released the guidelines on Monday after scanning through the approximately 49,000 comments it received from around the nation as well as comments from members of Congress.
“The guidelines apply to the expenditure of NIH funds for research using human embryonic stem cells (hESCs) and certain uses of induced pluripotent stem cells,” explained Dr. Raynard S Kington, acting director for the government agency.
"These guidelines implement Executive Order 13505, as it pertains to extramural NIH-funded stem cell research, establish policy and procedures under which the NIH will fund such research, and helps ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law," he added.
According to Kington, the guidelines are based on two principles – the first being that responsible research with hESCs has the potential to improve understanding of human health and illness and to discover new ways to prevent and/or treat illness. The second principle is that individuals donating embryos for research purposes should do so freely, with voluntary and informed consent.
Under the new guidelines, stem cells created solely for research in whatever manner, including cloning, still won't qualify for funding.
But hundreds of new embryonic stem cell lines, once ineligible for federal funding under a Bush Administration restriction, will now be eligible for funding so long as proof is provided that they (1) were created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose; and (2) were donated by individuals who sought reproductive treatment and who gave voluntary written consent for the human embryos to be used for research purposes.
Furthermore, scientists using stem cell lines created before Tuesday – the day the new guidelines takes effect – can seek eligibility by submitting materials that demonstrate that the hESCs were derived in the spirit of the new guidelines, though perhaps not by the letter.
"Many of the lines already in existence may have met very rigorous standards of informed consent but may have been implemented in ways not consistent with the present guidelines," Kington said during a news conference Monday. "It's unreasonable to retroactively apply procedures intended for future use."
Though titled "National Institutes of Health Guidelines for Human Stem Cell Research," the new guidelines pertain primarily to the donation of embryos for the derivation of hESCs, which has been at the center of the debate of stem cell research.
Many within the pro-life community equate the processes involved in embryonic stem cell research to abortion as they require the destruction of embryos, unlike research on other types of stem cells, such as adult stem cells (taken from bone marrow and other tissue sources) and neonatal stem cells (from umbilical cord blood and the placenta).
In comments made Tuesday, Tony Perkins, president of the conservative Family Research Council, said the new guidelines “implement a plan that will force taxpayers to foot the bill for research that involves human destruction, not healing.”
"The NIH guidelines create an incentive to create and destroy so-called 'excess' embryos, pasting a veneer of 'ethics' on unethical experiments. They remove limits on taxpayer funding of experiments that require embryo destruction, and open the door to future abuses,” Perkins stated. “NIH clearly believes the President's order allows them to fund other forms of unethical research at any point in the future.”
Perkins accused the NIH of ignoring the some 30,000 comments that were submitted against any federal funding of human embryonic stem cell research and chastised the government agency for not investing more in research that is not only undoubtedly ethical but also more fruitful.
Despite the highly touted potential of embryonic stem cells to develop into any cell of the body, embryonic stem cell research has yielded no cures to date. Adult stem cells and neonatal stem cells, meanwhile, have been used in successfully treating over 100 diseases and have been hailed by some as having many superior qualities to embryonic stem cells.
"Instead of funding more life-destroying experiments, federal funding should go toward life-saving treatments and clinical trials using adult stem cells, which are on the cutting edge of treating patients for diabetes, spinal cord injury, heart disease, multiple sclerosis, and other diseases," concluded Perkins.
According to a poll released last year by the polling company, inc., 69 percent of Americans say they support stem cell research but only 45 percent say they support both adult and embryonic stem cell research when asked more specifically.
Furthermore, only 17 percent of Americans say they are “very familiar” with stem cell research while 41 are either “a little bit familiar” or “not at all familiar.” Roughly 42 percent say they are “somewhat familiar.”
According NIH acting director Kington, the NIH will review and update the stem cell guidelines "periodically, as appropriate,” as directed by Obama's executive order.
Obama had signed the order on March 9, effectively reversing former President Bush's stem cell policy by undoing his 2001 directive that banned federal funding for research into stem lines created after Aug. 9, 2001.