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Vol. LXI, No. 7
April 3, 2009

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President Directs NIH to Issue Stem Cell Research Guidelines within 120 Days

On the front page...

On Mar. 9, President Obama issued an executive order removing Bush administration limits on federally supported research on human embryonic stem cells and directing NIH to expand its support for human stem cell research.

“For the past 8 years, the authority of the Department of Health and Human Services, including the National Institutes of Health, to fund and conduct human embryonic stem cell research has been limited by Presidential actions,” read the order, which contained five brief sections. “The purpose of this order is to remove these limitations on scientific inquiry.”


The order, signed at the White House with several NIH officials on hand, allows NIH to “support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.” NIH must develop guidelines on the conduct of such research within 120 days of Mar. 9. Specifically, NIH was ordered to “review existing NIH guidance and other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards, and issue new NIH guidance on such research that is consistent with this order. The [HHS] Secretary, through NIH, shall review and update such guidance periodically, as appropriate.”

During a press teleconference that afternoon, three NIH officials commented on Obama’s order and answered a handful of questions.

“NIH applauds President Obama’s decision today to lift restrictions,” said Dr. Lawrence Tabak, acting NIH deputy director. “This research promises to revolutionize how we conduct research…and will lead to life-saving treatments. We will develop the guidelines as expeditiously as possible.”

Tabak said it would likely take NIH the full 120 days to draft guidelines, open them to scrutiny by the public and by scientists, then proceed to issuance. He confirmed that NIH stimulus funds could be used for stem cell research and noted that “the Executive Order does not address the issue of how human embryonic stem cells [hESCs] are to be derived. NIH will take a careful and deliberative look at that. Our goal is responsible and scientifically worthy stem cell research.”

Dr. Story Landis, director of the National Institute of Neurological Disorders and Stroke, who is current chair of NIH’s long-standing stem cell task force, said, “NIH’s goal is to expand stem cell research. We should consult with other organizations’ guidelines, and make use of previous deliberative processes.”

NIH already has in place guidelines on stem cell research, governing not just the 21 lines of hESCs permitted by the Bush administration but also adult stem cells and other types. But the current guidelines were based on limitations imposed by the previous administration.

In response to reporters’ questions, Tabak noted that “there has never been a ceiling on” the amount of funds committed to stem cell research. “We have no preconceived number in mind. Scientific opportunity and merit will drive the process.” Added Landis, “We’re looking forward to getting a lot of excellent applications.”

Dr. Lana Skirboll, acting director of NIH’s new Division of Program Coordination, Planning, and Strategic Initiatives, noted, “We expect to be spending more on stem cell research in the future.” She said the average stem cell R01 grant is about $375,000 per year for 4-5 years.

Asked what immediate benefits the President’s order will have, Tabak responded, “The most immediate benefit is that it signals the scientific community that this field will be expanded…It has enormous potential and should be especially attractive to young scientists just entering the field.”

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