NIH Issues New Guidelines

The New York Times, July 7, 2009

Attempting to establish a new direction for national policy, today the National Institutes of Health released the final copy of its Guidelines on stem cell research.

The Guidelines are in response to President Obama's Executive Order 13505, issued on March 9, 2009. According to NIH, "These Guidelines implement Executive Order 13505, as it pertains to 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. Internal NIH policies and procedures, consistent with Executive Order 13505 and these Guidelines, will govern the conduct of intramural NIH stem cell research."

On April 23 of this year, NIH published a draft of the Guidelines for research involving human embryonic stem cells (hESCs), after which a "comment period" lasted for approximately the next month, until May 26, during which time NIH accepted comments from the general public.

Under the new Guidelines, NIH has established a review process by which scientists will be able to use many of the hESC lines that already exist and which were created by private funding. Newly established hESC lines will qualify for research provided certain criteria are met, such as rules pertaining to "voluntary and informed consent" from the donors. In other words, the donors must be informed in writing of other options for their surplus embryos, as well as of the fact that any embryo donated for scientific research will be destroyed in the process. Financial as well as nonfinancial compensation of any kind is forbidden in return for the donated embryos. Additionally, embryo donors must be allowed to change their minds within a specified time frame, and they must not expect medical nor financial benefits from their donated embryos. Additionally, NIH funding will only apply to hESCs that are obtained from the surplus embryos of IVF clinics and which were created specifically for reproductive purposes, not for scientific research.

Issues relating to informed consent were among the most hotly debated points of the earlier draft version of the Guidelines, which would render most of the already existing hESC lines ineligible for funding. In order to address such concerns, NIH has agreed to establish a review panel to determine if some of the already existing cell lines might still qualify for federal funding.

In the new Guidelines, NIH has still banned the federal funding of any hESC lines that might be created from so-called "therapeutic cloning" methods, more correctly known as somatic cell nuclear transfer (SCNT), which is also the same procedure used in reproductive cloning. Despite the fact that no one has ever actually succeeded in deriving a hESC line from SCNT, nevertheless there are many ESC scientists who had hoped that NIH would allow funding of hESCs that might someday be created by this highly controversial procedure.

By some accounts, as many as 60% of the comments that NIH received in regard to their earlier draft of the Guidelines had come from people who expressed disapproval of the use of taxpayer money for research that will destroy human embryos. According to the Catholic News Service, at least 30,000 of the 48,955 comments which NIH received were from individuals and organizations who voiced opposition to hESC research but who strongly favored adult stem cell research instead. However, NIH dismissed such comments as being "not responsive to the question put forth." In a July 6 telephone briefing to the media, Dr. Raynard S. Kington, acting director of NIH, reacted to this fact by stating, "We did not ask them whether to fund such funding, but how it should be funded."

According to Cardinal Justin Rigali, Chairman of the U.S. Catholic Bishops' Committee on Pro-Life Activities, "The comments of tens of thousands of Americans opposing the destruction of innocent human life for stem cell research were simply ignored in this process. Even comments filed by the Catholic bishops' conference and others against specific abuses in the draft guidelines were not addressed."

According to Cardinal Rigali, NIH failed to address specific abuses of hESCs which might potentially occur after the cell lines have been obtained. Even though Section IV of the Guidelines specifically prohibits the introduction of hESCs into "primates," as well as the "breeding" of human cells with the cells of primates, nevertheless the laboratory creation of other types of "chimeras" and human-nonhuman mixed species is still allowed. As Cardinal Rigali adds, "For example, federally funded researchers will be allowed to insert human embryonic stem cells into the embryos of animal species other than primates. Federal grants will be available even to researchers who themselves destroyed human embryos to obtain the stem cells for their research. Existing federal law against funding research in which human embryos are harmed or destroyed is not given due respect here."

Both conservative and liberal critics of the new NIH Guidelines point out that the final version differs minimally in substance from the earlier draft proposed in April. Those who are in favor of hESC research criticize the new Guidelines for complications that may result from the "voluntary and conformed consent" rules, as well as for not allowing funding of future hESC lines that might be obtained from SCNT. Pro-life supporters, on the other hand, criticize the new Guidelines for having ignored nearly two-thirds of all comments received from people who advocated adult stem cell research over embryonic stem cell research.

Even though the new Guidelines forbid the federal funding of any research conducted on human embryos that are deliberately created only for research purposes, the Legislative Director of the National Right to Life Committee, Douglas Johnson, echoes the concern of many scientists as well as non-scientists when he states that, "This seeming restraint is part of an incremental strategy intended to desensitize the public to the concept of killing human embryos for research purposes. The Obama Administration today slides further down the slippery slope of exploiting non-consenting members of the human species - human embryos."

The full NIH Guidelines may be read in their entirety on the website of NIH, at: http://stemcells.nih.gov/policy/2009guidelines.htm.

(Please see the related news articles on this website, entitled, "NIH Receives Nearly 50,000 Comments", dated June 5, 2009; "Pros and Cons of the New NIH Guidelines", dated June 3, 2009; "Embryonic Stem Cell Advocates Protest NIH Guidelines", dated May 25, 2009; and "NIH Issues Guidelines Restricting Embryonic Stem Cell Research", dated April 17, 2009).