The Obama administration looks like they are playing it more cautious and safe than some may have thought when it comes to embryonic stem cell research. Just this afternoon, NIH released new guidelines for what IS and WHAT isn’t allowed when it comes to embryonic stem cell research. Bottom line: as expected the guidelines go further than the Bush administration when it comes to research on discarded embryos from fertility clinics. BUT the Obama administration (through the NIH guidelines) is not allowing scientists to create embryos just to destroy them for research purposes. Reuters puts it this way:
The guidelines restrict funding of work on cells made using certain more experimental methods, such as creating stem cells from a human egg only, a process called parthenogenesis, and a cloning technique called somatic cell nuclear transfer.
They also would prohibit funding of work on embryos created specifically for research purposes, with the aim of keeping the money going to work using cells taken from embryos that parents donated after they decided not to try to use fertility clinic embryos to create a pregnancy.
They also lay out guidance to make sure parents know and agree to how the embryos would be used, and limit the use of federal tax money to create certain human-animal hybrids.
That won’t particularly thrill everyone in the scientific community but may be a sigh of relief for some in the faith community. In addition, as The Brody File reads through the guidelines there looks to be a long list of ‘informed consent” restrictions which seem even longer than under the Bush administration. It’ll take a little time to go through those.
We knew President Obama wanted to expand embryonic stem cell research and these guidelines do that but it isn't as broad as many expected. This makes sense because President Obama has made a point during his time as President to not be an "in your face" President. His policies may not "jive" totally with conservative Evangelicals and this move may not win any of his political enemies over but Mr. Obama seems to be showing a willingness to understand the sensitive nature of the matter. This has been his "M.O." from day one. NIH may makes the guidelines but history will show that these guidelines took effect under the Obama administration.
By the way, be aware of two points:
Federal law does not allow the use of taxpayer money to create or destroy human embryos. But it is legal to use private money for those purposes. Also, the public will now have one month to comment on the guidelines. The final rules are issued by early July.
Here is the link to the just released guidelines and below are some excerpts from the guidelines:
These draft Guidelines would allow funding for research using human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose. Funding will continue to be allowed for human stem cell research using adult stem cells and induced pluripotent stem cells. Specifically, these Guidelines describe the conditions and informed consent procedures that would have been required during the derivation of human embryonic stem cells for research using these cells to be funded by the NIH. 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 these Guidelines.
NIH funding of the derivation of stem cells from human embryos is prohibited by the annual appropriations ban on funding of human embryo research (Consolidated Appropriations Act, 2009, Pub. L. 110-161, 3/11/09), otherwise known as the Dickey-Wicker Amendment.
According to these Guidelines, there are some uses of human embryonic stem cells and human induced pluripotent stem cells that, although those cells may come from allowable sources, are nevertheless ineligible for NIH funding.
NIH currently funds ongoing research involving human embryonic stem cells as detailed under prior Presidential policy. Under that policy, Federal funds have been used for research on human embryonic stem cells where the derivation process was initiated prior to 9:00 p.m. EDT August 9, 2001, the embryo was created for reproductive purposes, the embryo was no longer needed for these purposes, informed consent was obtained for the donation of the embryo, and no financial inducements were provided for donation of the embryo.
These draft Guidelines would allow funding for research using only those human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose.
Here are the “Informed Consent” guidelines:
Human embryonic stem cells may be used in research using NIH funds, if the cells were derived from human embryos that were created for reproductive purposes, were no longer needed for this purpose, were donated for research purposes, and for which documentation for all of the following can be assured:
All options pertaining to use of embryos no longer needed for reproductive purposes were explained to the potential donor(s).
No inducements were offered for the donation.
A policy was in place at the health care facility where the embryos were donated that neither consenting nor refusing to donate embryos for research would affect the quality of care provided to potential donor(s).
There was a clear separation between the prospective donor(s)'s decision to create human embryos for reproductive purposes and the prospective donor(s)'s decision to donate human embryos for research purposes.
At the time of donation, consent for that donation was obtained from the individual(s) who had sought reproductive services. That is, even if potential donor(s) had given prior indication of their intent to donate to research any embryos that remained after reproductive treatment, consent for the donation should have been given at the time of the donation. Donor(s) were informed that they retained the right to withdraw consent until the embryos were actually used for research.
Decisions related to the creation of human embryos for reproductive purposes were made free from the influence of researchers proposing to derive or utilize human embryonic stem cells in research. Whenever it was practicable, the attending physician responsible for reproductive clinical care and the researcher deriving and/or proposing to utilize human embryonic stem cells should not have been the same person.
Written informed consent was obtained from individual(s) who sought reproductive services and who elected to donate human embryos for research purposes. The following information, which is pertinent to making the decision of whether or not to donate human embryos for research purposes, was in the written consent form for donation and discussed with potential donor(s) in the informed consent process:
A statement that donation of the embryos for research was voluntary;
A statement that donor(s) understood alternative options pertaining to use of the embryos;
A statement that the embryos would be used to derive human embryonic stem cells for research;
Information about what would happen to the embryos in the derivation of human embryonic stem cells for research;
A statement that human embryonic stem cells derived from the embryos might be maintained for many years;
A statement that the donation was made without any restriction or direction regarding the individual(s) who may receive medical benefit from the use of the stem cells;
A statement that the research was not intended to provide direct medical benefit to the donor(s);
A statement as to whether or not information that could identify the donor(s) would be retained prior to the derivation or the use of the human embryonic stem cells (relevant guidance from the DHHS Office for Human Research Protections (OHRP) should be followed, as applicable; see OHRP's Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells, and Stem Cell-Derived Test Articles and Guidance on Research Involving Coded Private Information or Biological Specimens and
A statement that the results of research using the human embryonic stem cells may have commercial potential, and a statement that the donor(s) would not receive financial or any other benefits from any such commercial development.
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