BETHESDA, MD—With the goal of increasing the number of human stem cell lines eligible for federal funding, the National Institutes of Health released new draft guidelines for federal funding of stem cell research last month. The proposed guidelines limit research to human stem cell lines derived from embryos created for reproductive purposes and no longer needed for that purpose. They disallow any stem cell line derived from any other method.

In March President Obama announced he was lifting the restriction created in August 2001 by President Bush limiting federal funding to research using stem cell lines derived prior to that date. President Obama charged NIH leaders with creating new guidelines that would allow “scientifically worthy and ethically responsible research.” NIH was given a deadline of July 9 for the creation of the final guidelines.

What is Allowed and What is Not

The draft guidelines are relatively uncomplicated, with much of the text centering on the use of cell lines derived from embryos created by in vitro fertilization for reproductive purposes and then no longer required. Specifically, the guidelines describe the conditions and informed consent policies that would be required for the derivation of those stem cell lines.

Investigators wishing to use the cell lines must provide documentation that certain conditions were met when the embryo was donated that protected the donor from pressure by the researcher or the IVF clinic and that they understood exactly what the embryo was being used for. The guidelines also go into great detail what is needed for researchers to obtain proper consent from the donor.

If the investigator can provide assurances that all the requirements at the IVF clinic were met during the donation and during the obtaining of the consent, then their application for funding can be accepted for consideration.

What is not allowed are stem cell lines derived from any sources other than discarded IVF embryos. These include somatic cell nuclear transfer, parthenogenesis, and IVF embryos created specifically for research purposes.As for induced pluripotent stem cell lines, NIH officials said that research using those lines would be virtually unaffected.

Just “A First Step”

During a teleconference last month, Acting NIH Director Raynard Kington, M.D., Ph.D., explained the reasoning behind the new guidelines and how NIH arrived at them. “Because of President Obama’s executive order, NIH is taking the first step in expanding funding of this important area of research,” he said. “We think this is a significant new step and will lead in a short amount of time to a significant number of increased stem cell lines eligible for federal funding. Until the guidelines are issued and final, no new uses of stem cells can be initiated using NIH funding. Any applications previously submitted to NIH and already reviewed proposed to use stem cells will be held for funding decision until the final guidelines are issued.”

He added, “This is a remarkable development that promises to speed the research that will one day fundamentally change how we research health and disease.”

Asked why NIH chose to limit federal funding to cell lines derived from discarded IVF embryos, Dr. Kington said that the decision was made using a combination of best science and what they see as the broadest public support.

“There is strong broad support for the use of federal funds on stem cell research using lines derived from embryos created for reproductive purposes and no longer needed for those purposes. The best proof of that is that twice legislation that would allow that has passed both the Senate and the [House of Representatives],” he said. “There is not similar broad support for using the other sources.”

He also noted that there are no documented cases of cell lines derived from somatic cell nuclear transfer or of any line created specifically for research. However, he said, President Obama’s order includes the continual reevaluation of the guidelines as science progresses. “NIH will review guidelines periodically in the future as directed in the executive order, but the draft guidelines represent the best guideline in this time,” Dr. Kingston said. “We thought to aim the guidelines, in the beginning, at where there is broad support from the public and the scientific community.”

Asked if NIH based its decision on politics rather than science, Dr. Kington said, “I think you’re equating ethically responsible with politically responsible, and we didn’t do that. We make decisions like this all the time. This is our best judgment now for a reasonable policy at this time.”

NIH estimates that as many as 700 stem cell lines are in existence, though it is currently impossible to tell how many of those would be eligible for funding. However, Dr. Kington is hopeful since many of those lines were derived using guidelines recommended by the National Academy of Sciences, whose own recommendations are very similar to the NIH proposed guidelines.

NIH’s draft guidelines were published in the Federal Register on April 24. There is a 30-day open response period, after which NIH will take those comments into consideration when drafting the final guidelines.

“The whole point of the draft guidelines is to give a public forum for everyone, the public and the scientific community,” Dr. Kington said. “The formal consultation period is about to start.”