Category: Biomedical Research

Yesterday, July 6th, the National Institutes of Health issued new guidelines for the use of embryonic stem cells in research. The new guidelines reflect feedback received during a public comment period. Several higher education associations have praised NIH for addressing concerns with the initial draft guidelines.

SUMMARY: The National Institutes of Health (NIH) is hereby publishing final “National Institutes of Health Guidelines for Human Stem Cell Research” (Guidelines).

On March 9, 2009, President Barack H. Obama issued Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The Executive Order states that the Secretary of Health and Human Services, through the Director of NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law.

These Guidelines implement Executive Order 13505, as it pertains to extramural NIH-funded stem cell research, establish policy and procedures under which the NIH will fund such research, and helps 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 Executive Order 13505 and these Guidelines, will govern the conduct of intramural NIH stem cell research.

EFFECTIVE DATE: These Guidelines are effective on July 7, 2009.

SUMMARY OF PUBLIC COMMENTS ON DRAFT GUIDELINES: On April 23, 2009 the NIH published draft Guidelines for research involving hESCs in the Federal Register for public comment, 74 Fed. Reg. 18578 (April 23, 2009). The comment period ended on May 26, 2009.

The NIH received approximately 49,000 comments from patient advocacy groups, scientists and scientific societies, academic institutions, medical organizations, religious organizations, and private citizens. The NIH also received comments from members of Congress. This Notice presents the final Guidelines together with the NIH response to public comments that addressed provisions of the Guidelines.

Full NIH Guidelines on Embryonic Stem Cell Research

The Association of American Universities (AAU) has provided comment on proposed NIH Stem Cell Guidelines (see below).

May 27, 2009

AAU President Robert M. Berdahl yesterday submitted AAU’s comments on proposed guidelines for human embryonic stem cell research funded by the National Institutes of Health (NIH). 

The AAU letter praises President Obama’s March 9, 2009 Executive Order removing Bush Administration constraints on stem cell research, commends NIH for issuing draft guidelines for such research promptly, and expresses support of the proposed guidelines. 

The letter also raises several concerns, including the following:

• It recommends that stem cell lines derived before August 9, 2001, that are currently eligible for NIH funding not be subjected to retroactive consent and approval processes and that they remain eligible for federal funding.
• It recommends that stem cell lines derived under appropriate guidelines after August 9, 2001, and before the effective date of the new regulations also not be subjected to retroactive consent and approval processes and that they be made eligible for federal funding going forward.
• It expresses disappointment that the proposed guidelines unnecessarily limit federal support to research on cell lines derived from surplus in vitro fertilization embryos, making lines derived by other methods—such as somatic cell nuclear transfer—ineligible for federal funding.
• It recommends that NIH rely on institutional assurances and material transfer agreements in regulating the research use and sharing of cell lines, and that review and approval by institutional review boards of such lines or transfers not be required.

AAU Comment of NIH Stem Cell Guidelines