Wednesday, July 8, 2009

NIH Final Stem Cell Guidelines (discussed in simpler terms)

On Tuesday, the National Institutes of Health released its final Guidelines for Human Stem Cell Research. It's felt like a long time coming.

President Barack Obama signed an Executive Order in March directing the NIH to draft new guidelines to expand federal funding for embryonic stem cell research. In April, the NIH released a draft of the guidelines and solicited comments on the draft guidelines from researchers and the public. The NIH received and reviewed approximately 49,000 comments from scientists, organizations, citizens, and members of Congress. NIH released a summary of the public comments and the NIH responses with the final guidelines. Reviewing the comments alone was a monumental task, and the NIH should be commended for completing the review ahead of schedule.

President Obama signing the stem cell Executive Order

The NIH Guidelines significantly change the research policy environment for the better from the restrictive years of the Bush administration. There is consensus among the scientific community that the final guidelines are a considerable improvement over the draft guidelines released in April. We’ve taken the liberty to summarize the highlights of the final guidelines.

Guidelines allow funding for stem cell lines created before June 30, 2009
A point of contention among the research community with the draft guidelines was the possible exclusion of funding for stem cell lines created before the guidelines were issued. Researchers were worried that years of discoveries would be excluded from further study. Thankfully, the NIH created a system to separate stem cell lines created before and after the effective date of June 30, 2009. A special review committee will review the informed consent procedures and ethical standards of stem cells lines created before the effective date to determine if they meet ethical requirements for funding.

NIH Registry will list approved lines created after June 30, 2009
For stem cell lines created after June 30, 2009, the NIH will establish a registry of approved lines. To be approved, these stem cell lines must (1) be created for reproductive purposes, (2) be donated with voluntary, informed written consent, and (3) provide documentation of other ethical requirements. The registry will take some of the “guess-work” out of using stem cell lines. This, in turn, will allow researchers to spend more time researching, and less time guessing about approval.

Federal funding not allowed for some types of stem cells
To the disappointment of many researchers, the final NIH Guidelines do not allow federal funds to be used for stem cell lines created for research purposes. The NIH determined that the use of stem cells from somatic cell nuclear transfer (also known as therapeutic cloning), for example, “involve complex ethical and scientific issues on which a similar consensus has not emerged” (NIH Guidelines, 5).

It seems logical that the advocacy focus of the stem cell community will shift to building consensus for somatic cell nuclear transfer. According to Research!America polling, the stem cell community is well on their way—nearly 60% of Americans think therapeutic cloning should be allowed (slides 19, 24).

Stay tuned for more reaction from the scientific community. Share your thoughts about the NIH Guidelines in the comments section!

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