FASEB NEWS JANUARY 28, 2000
FEDERATION OF AMERICAN SOCIETIES FOR EXPERIMENTAL BIOLOGY
Office of Public Affairs
9650 Rockville Pike
Bethesda, Md. 20814-3998
Contact: Paulette W. Campbell
(301) 571-7795
[email protected]
For Immediate Release
Bethesda, Md. -- The leadership of the Federation of American Societies for Experimental Biology (FASEB) has endorsed the National Institutes of Health's draft guidelines for research involving human pluripotent stem cells (http://www.nih.gov/news/stemcell/draftguidelines.htm). In a January 28 letter to the agency's Office of Science Policy, FASEB President David G. Kaufman, M.D., Ph.D., applauded the N.I.H. for its "forward looking" stance in regards to the issue.
"The careful efforts of theWorking Group of the [N.I.H.] Advisory Committee have resulted in guidelines that will facilitate the research necessary to realize the future medical benefits of human pluripotent stem cells, and yet will preserve the dignity of human donors and respect the unique ethical sensitivity of these cells," Dr. Kaufman wrote.
Elements of the guidelines that FASEB supports are: the appropriateness of federal oversight for the generation and use of embryonic stem cells in federally-funded research, and the creation of the Human Pluripotent Stem Cell Review Group (HPSCRG) for this purpose; limiting the use of NIH funds for embryonic stem cell research to those cell lines derived from embryos that were generated for treatment of infertility and were in excess of clinical need; and requiring that human embryo donation be voluntary and not recompensed, and that only frozen embryos be donated.
In addition, FASEB leaders offered two revisions that would improve the effectiveness of N.I.H. support for research on pluripotent human stem cells:
-- Research employing pluripotent human stem cells derived before the publication of the draft guidelines (pre-existing cells) should be considered eligible for NIH support, subject to review of their derivation protocols and consent processes by the HPSCRG.
-- The NIH should establish a certification mechanism for specific pluripotent human stem cell lines, publishing periodically a list of such lines that have been reviewed and found acceptable for federally-supported research.
"Our membership includes many researchers interested in and qualified to conduct such research," Dr. Kaufman wrote. "Together with N.I.H., therefore, we have a mutual interest of achieving, in an appropriate manner, the momentous possibilities of medical research at this frontier of experimental biology. Under these conditions, pluripotent human stem cell research promises to have an enormous impact on the health and longevity of people everywhere."
FASEB is the largest coalition of biomedical research sciences societies in the United States and is comprised of 20 societies with over 67,000 members. The mission of FASEB is to serve the interests of biomedical and life scientists, particularly those related to public policy issues. FASEB facilitates coalition activities among member societies and disseminates information on biological research through scientific conferences and publications. For additional information about FASEB, please visit our Web site at http://www.faseb.org.
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Attached are:
1. FASEB Letter
January 28, 2000
Stem Cell Guidelines
NIH Office of Science Policy
1 Center Drive
Building 1, Room 218
Bethesda, MD 20892
To Whom it May Concern:
I am writing to comment on the Draft NIH Guidelines for Research Involving Human Pluripotent Stem Cells (Guidelines) on behalf of the Federation of American Societies for Experimental Biology (FASEB), representing over 67,000 of the nation's scientists in the area of biomedical research. First, we wish to applaud the NIH for its forward-looking stance in seeking to support exploration of human pluripotent cells. Because pluripotent stem cells are able to form all of the cell types of the body, understanding how to control their differentiation could lead to novel therapies for presently untreatable diseases. Moreover, an understanding of the process of pluripotent cell specialization could yield new insights into both normal and abnormal human development, leading to prevention or treatments for birth defects or cancer. In addition, the specialized cells that could be generated from pluripotent cells may provide novel means for discovering and testing new drugs, thus furthering the treatment of other diseases. The careful efforts of the Working Group of the Advisory Committee have resulted in guidelines that will facilitate the research necessary to realize the future medical benefits of human pluripotent stem cells, and yet will preserve the dignity of human donors and respect the unique ethical sensitivity of these cells.
Specific elements of the Guidelines that FASEB supports are:
- the appropriateness of federal oversight for the generation and use of embryonic stem cells in federally-funded research, and the creation of the Human Pluripotent Stem Cell Review Group (HPSCRG) for this purpose
- limiting the use of NIH funds for embryonic stem cell research to those cell lines derived from embryos that were generated for treatment of infertility and were in excess of clinical need
- requiring that human embryo donation be voluntary and not recompensed, and that only frozen embryos be donated
While FASEB overwhelmingly supports the Guidelines, we did find two specific areas in which we recommend revisions that would improve the effectiveness of NIH support for research on pluripotent human stem cells.
- FASEB recommends that research employing pluripotent human stem cells derived before the publication of the Draft Guidelines (pre-existing cells) be considered eligible for NIH support, subject to review of their derivation protocols and consent processes by the HPSCRG.
The consent and derivation protocols for pre-existing pluripotent human stem cell lines, while not fulfilling all the criteria articulated in the Guidelines will nonetheless protect human donors and respect the unique status of these cells. (For example, the consent process for deriving pre-existing cells would not have specified that cells would be derived and used following the NIH Guidelines, which did not exist at the time of their derivation.) To require the derivation of additional pluripotent human stem cell lines in order to initiate federally-supported research would delay the future benefits of such research.
- FASEB recommends that NIH establish a certification mechanism for specific pluripotent human stem cell lines, publishing periodically a list of such lines that have been reviewed and found acceptable for federally-supported research.
The independent certification of derivation and consent protocols for pluripotent human stem cell lines by each investigator proposing research for federal funding would cause an unnecessary duplication of effort. Moreover, the individual investigator would not (and should not in the interest of patient confidentiality) have access to the detailed information needed to verify that derivation and consent fulfils the criteria specified in the Guidelines. Accordingly, FASEB recommends that NIH review the qualifications of specific cell lines for federal support and establish list of such cell lines that satisfy the guidelines.
Finally, I wish to affirm the continued support of FASEB for research on pluripotent human stem cells under conditions that preserve the dignity of human donors and respect the ethical sensitivity of these cells. Our membership includes many researchers interested in and qualified to conduct such research. Together with NIH, therefore, we have a mutual interest of achieving, in an appropriate manner, the momentous possibilities of medical research at this frontier of experimental biology. Under these conditions, pluripotent human stem cell research promises to have an enormous impact on the health and longevity of people everywhere.
David G. Kaufman, M.D., Ph.D.
President, FASEB
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