July 06, 2009

Final NIH Guidelines for Human Stem Cell Research

On March 9, President Obama issued Executive Order (EO)13505 Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The EO states that the Secretary of Health and Human Services, through the Director of the National Institues of Health, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law.

On July 6, the NIH published final NIH Guidelines for Human Stem Cell Research, along with the public comments on the draft Guidelines. The Guidelines will be effective on July 7, 2009.

From the July 6 NIH Guide Notice:
The Guidelines will ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law. Internal NIH policies and procedures, consistent with the EO and these Guidelines, will govern the conduct of intramural NIH stem cell research.

The Guidelines prescribe the assurances and supporting documentation that must accompany requests for NIH funding for research using hESCs, and describe research that is not eligible for NIH funding. NIH will provide additional guidance concerning the implementation of the Guidelines and the status of pending applications in future Guide Notices.

Ongoing NIH-supported research involving previously approved hESC lines may continue. No new uses of hESC may be initiated in ongoing funded studies unless reviewed and approved by the NIH.

Update: A July 15 NIH Guide Notice, Status of Applications and Awards under the New NIH Guidelines for Human Stem Cell Research, “provides information about new applications proposing to use hESCs, ongoing NIH research using previously approved hESC lines, and the status of applications previously submitted to NIH proposing to use hESCs, including those that received initial peer review prior to April 17, 2009 when NIH announced that applications that had not already been reviewed would be held pending issuance of the final Guidelines. ”

April 23 Research Advocate article: NIH Issues Implementation Notice and Draft Guidelines for Human Stem Cell Research