Regulation of the field that would eventually include human embryonic stem cell (hESC) research began in the mid-1970s, well before hESCs were first isolated in 1998. Below, we discuss the current U.S. regulations governing federally-funded stem cell research.
Federal regulations and the NIH stem cell registry
In July 2009, under President Barack Obama, the National Institutes of Health issued new policy guidelines for human embryonic stem cell research, replacing those established by the Bush Administration. The guidelines apply to the expenditure of NIH funds for research using hESCs, as well and certain uses of induced pluripotent cell (iPS cells).
In issuing the guidelines, the NIH also established a Human Embryonic Stem Cell Registry listing hESCs it has deemed eligible for use in NIH funded research. On December, 2, 2009, 11 hESC lines developed at Boston Children’s Hospital were among the first 13 to be placed in the registry. As of March 1, 2010, there were a total of 43 lines eligible for NIH research funding, and 115 lines pending review.
The guidelines specify that the hESCs should have been derived from human embryos:
- that were created using in vitro fertilization (IVF) for reproductive purposes and were no longer needed for this purpose
- that were donated by individuals who sought reproductive treatment and who gave voluntary written consent for the human embryos to be used for research purposes
- for which all of the following can be assured and documented:
- All options available for embryos no longer needed for reproductive purposes were explained to the individual(s) who sought reproductive treatment.
- No payments, cash or in kind, were offered for the donated embryos.
- Policies and procedures were in place to ensure that neither consenting nor refusing to donate embryos for research would affect the quality of care provided.
- There was a clear separation between the prospective donor(s)’s decision to create human embryos for reproductive purposes and the prospective donor(s)’s decision to donate human embryos for research purposes.
- During the consent process, the donor(s) were informed of the following:
- that the embryos would be used to derive hESCs for research;
- what would happen to the embryos in the derivation of hESCs for research;
- that hESCs derived from the embryos might be kept for many years;
- that the donation was made without any restriction or direction as to who may receive medical benefit from the use of the hESCs, such as who may be the recipients of cell transplants;
- that the research was not intended to provide direct medical benefit to the donor(s);
- that the results of research using the hESCs may have commercial potential, and that the donor(s) would not receive financial or any other benefits from any such commercial development;
- whether information that could identify the donor(s) would be available to researchers.
Under the guidelines, research using hESCs derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is not eligible for NIH funding.
In addition, the 1996 Dickey Amendment (also known as the Dickey-Wicker amendment) is still in effect. This means that although federal funding can now support research on many of the existing hESC cell lines (once they are reviewed and approved by the NIH), researchers cannot use federal funding to create new hESC lines from embryos.
Other guidelines for embryonic stem cell research
- The International Society for Stem Cell Research issued Guidelines for the Conduct of Human Embryonic Stem Cell Research in 2007, summarized in this press release. The guidelines outline ethical procedures for procuring tissues; obtaining consent from donors; creating, banking, and distributing hESC lines; and oversight of hESC research. The task force that formulated these guidelines was chaired by George Q. Daley, MD, PhD, Director of Stem Cell Transplantation Program at Boston Children’s Hospital, and included experts in science and medicine, ethics, and law from 14 countries. The guidelines also include downloadable sample consent documents and material transfer documents.
- In 2008, the ISSCR released new guidelines for the responsible development of safe and effective stem cell therapies for patients. The Guidelines for the Clinical Translation of Stem Cells were developed to address the problem of unproven, potentially risky stem cell therapies being marketed directly to patients. The guidelines call for standardization of manufacturing techniques for processing cells, with appropriate quality control measures; preclinical testing in animal models; ensuring full informed consent by patients; close patient monitoring and adverse event reporting; full reporting of study results, whether positive or negative, and more.
- The National Academies of Science published Guidelines for Human Embryonic Stem Cell Research in 2005, offering a common set of ethical standards for the field. To keep the Guidelines up to date, the NAS also established the Human Embryonic Stem Cell Research Advisory Committee in 2006. The Committee issued additional amendments to the guidelines in 2007 and 2008.
Articles authored by members of Children’s Stem Cell Program
Taylor PL. Retroactive ethics in rapidly developing scientific fields.
Cell Stem Cell 2009 Jun 5; 4(6):479-82. Epub 2009 May 14.
This article, by Patrick Taylor, JD, deputy general counsel at Boston Children’s Hospital and a lecturer at Harvard Medical School, addresses proposed NIH funding rules. It argues that in fast-developing scientific fields, applying rules retroactively unduly restricts research, and that researchers should be able to work with new or existing hESC lines if the work is approved under then-existing standards. Link to article in PubMed.
Taylor PL. Scientific self-regulation – how can it fail? Sci Eng Ethics 2009 Sep; 15(3):395-406. Epub 2009 Apr 10.
To be a functional alternative to government regulation, self-regulation of science must be credible to both scientists and the public, accountable, ethical, and effective. This article examines why self-regulation sometimes fails, and how to make it succeed. Link to article in PubMed.
Hyun I; et al. New ISSCR guidelines underscore major principles for responsible translational stem cell research. Cell Stem Cell 2008 Dec 4; 3(6):607-9.
The ISSCR task force that developed new Guidelines for the Clinical Translation of Stem Cells discusses the guidelines’ core principles for taking basic stem cell research into clinical applications. Link to article in PubMed.
Taylor PL. Rules of engagement. Nature 2007 Nov 8; 450:163-4.
This article argues that engaging with the public and earning public trust are essential for scientists. Link to article in PubMed.
Daley GQ; et al. Ethics. The ISSCR guidelines for human embryonic stem cell research. Science 2007 Feb 2; 315(5812):603-4.
The ISSCR describes major principles that should guide ethical stem cell research. Link to article in PubMed.
Taylor PL. Research sharing, ethics and public benefit. Nature Biotechnology 2007 Apr; 25(4):398-401.
Calls on other areas of biomedical research to emulate ISSCR’s new standards highlighting the importance of sharing materials, data and research rights, and requiring fair global access to resulting diagnostics and therapies. Link to article in PubMed.
Lensch M. The Ethics of Stem Cell Research: A Personal View.
This essay by M. William Lensch, PhD, in the Daley laboratory, presents the views of a researcher working in the field. Lensch’s research uses hESCs as platforms for understanding genetics, human development, and diseases of the blood-forming system.
Senate testimony about embryonic stem cell research
In 2007 testimony before the U.S. Senate, George Q. Daley, MD, PhD, Director of Stem Transplantation Program, argues for the value of embryonic stem cell research from the point of view of a both a scientist and a hematologist. Here, and in 2005 testimony to a Senate subcommittee, he explains why alternative forms of adult stem cell research cannot substitute for the study of embryonic stem cells.
- Embryonic stem cell research: the facts
- Stem cell policy and ethics: a timeline
- Stem Cell Glossary
- Frequently Asked Questions (FAQs) about stem cell research
- FAQs (NIH website)
- FAQs (ISSCR website)
- FAQs (Harvard Stem Cell Institute)
- Research Ethics and Stem Cells (NIH website)
- Resources on the Ethics of Human Stem Cell Research (ISSCR website)
- Stem Cell Basics: Ethics, Moral Values, and U.S. Law (from the National Academies’ Booklet, Understanding Stem Cells)