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Already, the Federal Government has given out 31 grants totaling about $21 million for research involving the larger pool of human embryonic stem cells. But the recipients of that money have been waiting to use it since September, when the NIH, charged with establishing and applying the stem-cell vetting criteria, began reviewing potentially eligible cells. In addition to the 13 lines approved on Wednesday, another 96 lines are waiting for the green light, 20 of which may get it by Friday...
...exciting to be able to say that, after what clearly has been a time of frustration on the part of the scientific community over their inability to gain access to federally funded cell lines, that's now changing," Dr. Francis Collins, director of NIH, told reporters during a telephone briefing. "Because the vast majority of basic biomedical research that goes on in the U.S. is supported by NIH, the fact that researchers who are our grantees could not work on the new lines was seen by many people as a significant deterrent to rapid progress in the field...
...approved lines, 11 came from the lab of Dr. George Daley, director of the Stem Cell Transplantation Program at Children's Hospital Boston and a member of the Harvard Stem Cell Institute; the other two came from Dr. Ali Brivanlou, an embryologist at Rockefeller University. Daley's submission for NIH review was 130 pages long, he says, including a 16-page informed-consent document signed by each of the donors of the embryos from which the stem-cell lines were derived, ensuring that the donors were aware of where their embryos were going and what they would be used...
That kind of meticulousness probably helped expedite the NIH's approval of the new lines, a process that involves applying a checklist of criteria spelled out by the agency and providing documentation that the cells meet all of the requirements exactly. This review, says Collins, boils down to NIH staff agreeing that all the necessary criteria for inclusion have been met. Approval of some lines may be less straightforward if certain requirements have not been met to the letter. For instance, since stem-cell lines are drawn from unused embryos donated to research by couples undergoing the IVF procedure, researchers...
...stem-cell lines because of a congressional ban on harming or destroying embryos.) According to some estimates, as many as 780 such lines may exist worldwide, but not all labs may be willing to subject themselves to the scrutiny and administrative hassle of registering their lines with the NIH. Even among the handful of stem-cell lines that were eligible for federally funded study under President Bush, only one has so far been resubmitted for NIH review and inclusion in the government registry. (See the most common hospital mishaps...