WASHINGTON -- The National Academies today released amended guidelines for research involving human embryonic stem cells, revising those that were issued in 2005 and updated in 2007. The Academies originally produced the guidelines to offer a common set of ethical standards for the responsible conduct of research using human stem cells, an area that, due to an absence of comprehensive federal funding, was lacking national standards. Since their initial release, the guidelines have served effectively as the basis for oversight of this research in the United States. In addition, a standing advisory committee -- a joint project between the Academies' National Research Council and Institute of Medicine -- was established to monitor and review scientific advances and determine any need for revisions.
Embryonic stem cells have the potential to produce all of the body's cell types. Researchers are working to harness stem cells' ability both to regenerate themselves and produce specialized cells that may lead to medical treatments that replace certain types of cells damaged or lost to debilitating illness and injury, such as nerve cells.
One reason for the 2008 modifications is to provide guidance on the derivation and use of new human stem cells that were first developed last year. These cells -- called "induced pluripotent cells" -- are made by reprogramming nonembryonic adult cells into a stem-cell-like state, in which they can be manipulated to form a wide array of specialized body cells. Although induced pluripotent stem cells can be derived without using embryos, the ethical and policy concerns related to their potential uses are similar to those pertaining to human embryonic stem cells. For example, issues arising from mixing human and animal cells in a single organism are relevant for stem cells from both embryonic and nonembryonic sources. However, derivation of induced pluripotent stem cells does not require special stem cell expertise and is adequately covered by current Institutional Review Board regulations, the report says.
At this time it is still undetermined which stem cell types will prove the most useful for regenerative medicine, as most likely each will have some utility, noted the committee that wrote the report. Therefore, the need for research with human embryonic stem cells still exists despite the availability of new cell sources.
The amended guidelines also clarify that "direct expenses" for reimbursement to women donating their eggs for use in stem cell research may include costs associated with travel, housing, child care, medical care, health insurance, and actual lost wages. This language extends the 2005 guidelines, which stated that women who undergo hormonal induction to generate eggs specifically for research purposes should be reimbursed only for "direct expenses" incurred as a result of the procedure, although they did not specify which expenses qualified as direct. The committee stressed that reimbursement for lost wages is not a payment for eggs; the intent is to leave all donors neither better off nor worse off financially.
To instill a high level of confidence that institutions and their researchers are conducting stem cell research responsibly, the guidelines recommend that the public be informed about the types of stem cell research under way and how the research conforms to the institution's established procedures. Moreover, the committee strongly suggested as a good management practice that institutions conducting human embryonic stem cell research carry out periodic audits of their embryonic stem cell research oversight (ESCRO) committees to ensure proper performance and make the findings of the audits available to the public. The audits should document decisions regarding the acceptance of research proposals and verify that cell lines in use were acceptably derived.
Additionally, the new guidelines clarify that an institutional ESCRO committee may conduct expedited review for research done exclusively in a laboratory dish or test tube that does not create new lines of stem cells but uses previously derived human embryonic stem cell lines. The original guidelines stated that research is "permissible after currently mandated review and proper notification of the relevant research institution." However the word "notification" led some experts to question if the requirement could be fulfilled by merely informing ESCRO committees that the research would occur. Although allowing for expedited review, the guidelines still require an ESCRO committee to determine if the human embryonic stem cells have been acceptably derived.
Future committee deliberations will consider items for which additional information-gathering and more extensive debate and discussion may be necessary. For example, the National Institutes of Health determined that the human embryonic stem cell lines declared in 2001 by President George W. Bush to be eligible for federally funded research were derived from embryos donated with informed consent and without financial inducement. Based on this determination, the Academies' 2007 guidelines had deemed those lines to have been acceptably derived. However, questions about their derivation were raised when this report was near completion. In addition, a breakthrough in the ability to "reprogram" adult cells from one type to another in a living animal was recently announced. The committee will continue to monitor developments in stem cell research to decide whether any future changes to the guidelines are warranted.
The report was sponsored by the Ellison Medical Foundation, the Greenwall Foundation, and the Howard Hughes Medical Institute. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. They are private, nonprofit institutions that provide science, technology, and health policy advice under a congressional charter. The Research Council is the principal operating agency of the National Academy of Sciences and the National Academy of Engineering. A committee roster follows.
Copies of 2008 AMENDMENTS TO THE NATIONAL ACADEMIES' GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at HTTP://WWW.NAP.EDU. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).
[This news release and report are available at HTTP://NATIONAL-ACADEMIES.ORG ]
NATIONAL RESEARCH COUNCIL
Division on Earth and Life Studies
Board on Life Sciences
INSTITUTE OF MEDICINE
Board on Health Sciences Policy
HUMAN EMBRYONIC STEM CELL RESEARCH ADVISORY COMMITTEE
R. ALTA CHARO, J.D.1 (CO-CHAIR)
Warren P. Knowles Professor of Law and Bioethics
Law School and School of Medicine and Public Health
University of Wisconsin
RICHARD O. HYNES, PH.D.1, 2 (CO-CHAIR)
Howard Hughes Medical Institute; and
Daniel K. Ludwig Professor of Cancer Research
Koch Institute for Integrative Cancer Research and Department of Biology
Massachusetts Institute of Technology
ELI Y. ADASHI, M.D., M.S., FACOG1
Professor of Medical Science,
Former Dean of Medicine and Biological Sciences, and Frank L. Day Professor of Biology
Warren Alpert Medical School
BRIGID L.M. HOGAN, PH.D.1, 2
George Barth Geller Professor and Chair
Department of Cell Biology
Duke University Medical Center
Arthritis Foundation; and
TERRY MAGNUSON, PH.D.
Sarah Graham Kenan Professor and Chair
Department of Genetics; and
Carolina Center for Genome Sciences
University of North Carolina
LINDA B. MILLER, O.T.R., M.S.1
Volunteer Trustees Foundation
JONATHAN D. MORENO, PH.D.1
Center for American Progress; and
David and Lyn Silfen University Professor and Professor of Medical Ethics and of the History and Sociology of Science
Center for Bioethics
University of Pennsylvania
PILAR NICOLE OSSORIO, PH.D., J.D.
Associate Professor of Law and Bioethics
University of Wisconsin
E. ALBERT REECE, M.D., PH.D., M.B.A.1
Vice President for Medical Affairs, and Dean
School of Medicine
University of Maryland
JOSHUA R. SANES, PH.D.2
Department of Molecular and Cellular Biology, and
Paul J. Finnegan Family Director
Center for Brain Science
HAROLD T. SHAPIRO, PH.D.1
President Emeritus, and
Professor of Economics and Public Affairs
Woodrow Wilson School of Public and International Affairs
JOHN E. WAGNER JR., M.D.
Professor of Pediatrics, and
Scientific Director of Clinical Research
Stem Cell Institute
University of Minnesota Medical School
ADAM P. FAGEN, PH.D.
Study Co-Director, Board on Life Sciences
BRUCE M. ALTEVOGT, PH.D.
Study Co-Director, Institute of Medicine
FRANCES E. SHARPLES, PH.D.
Director, Board on Life Sciences
1 Member, Institute of Medicine
2 Member, National Academy of Sciences