This time line provides guideposts on the history of research involving human embryonic stem cells and regulation of that work.
Created by appratt on Jan 15, 2009
Last updated: 03/17/11 at 09:45 PM
Tags: stem cells research stem-cells
By this point, NIH had received over 50,000 responses on the committee's proposed guidelines.
Barack Obama is sworn in as the 44th president of the United States, having promised to change the current restrictions on human embryonic stem cell research.
The International Society for Stem Cell Research releases its new “Guidelines for the Clinical Translation of Stem Cells.” From: “Guidelines for the Clinical Translation of Stem Cells,” available at www.isscr.org/clinical_trans/pdfs/ISSCRGLClinicalTrans.pdf
The National Academies releases the 2008 amendments for its guidelines. From: “2008 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research,” available at http://books.nap.edu/catalog.php?record_id=12260
Robert Streiffer, a bioethicist at the University of Wisconsin-Madison, publishes a paper detailing his investigation into the consent forms for the federally approved human embryonic stem cell lines. Although 21 lines were viable at the time, he discovers that no more than 16 are both viable and ethically derived.
Shinya Yamanaka of Kyoto University and James Thomson of the University of Wisconsin-Madison both publish papers on their separate discoveries of induced pluripotent stem cells. These pluripotent cells were created from skin cells that had four genes inserted into them with viruses. This procedure resulted in the skin cells acquiring properties similar to embryonic stem cells. Researchers were able to coax these so-called iPS cells into becoming beating heart cells and nerve cells.
President Bush issues an executive order calling upon the HHS secretary to support and encourage research on alternative sources of pluripotent stem cells. He also requests that the Human Embryonic Stem Cell Registry be renamed the Human Pluripotent Stem Cell Registry. From: “Executive Order: Expanding Approved Stem Cell Lines in Ethically Responsible Ways,” available at www.whitehouse.gov/news/releases/2007/06/20070620-6.html
The National Academies releases the 2007 amendments for its guidelines. From: “2007 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research,” available at http://books.nap.edu/catalog.php?record_id=11871.
The International Society for Stem Cell Research releases its “Guidelines for the Conduct of Human Embryonic Stem Cell Research.” From: “Guidelines for the Conduct of Human Embryonic Stem Cell Research,” available at www.isscr.org/guidelines/ISSCRhESCguidelines2006.pdf
The President’s Council on Bioethics, now chaired by Edmund Pellegrino, is updated on stem cell research and alternative sources of pluripotent stem cells by Hans Robert Schöler, Ph.D. director of the Cell and Developmental Biology Max Planck Institute for Molecular Biomedicine. From: “Transcripts: Session 1: Stem Cell Research Update,” available at http://bioethics.gov/transcripts/nov06/session1.html and “Transcripts: Session 2: Stem Cell Research Update and Alternative Sources of Pluripotent Stem Cells,” available at http://bioethics.gov/transcripts/nov06/session2.html
The President’s Council on Bioethics releases a white paper titled “Alternative Sources of Pluripotent Stem Cells.” From: “White Paper: Alternative Sources of Pluripotent Stem Cells,” available at http://bioethics.gov/reports/white_paper/index.html
The National Academies releases its “Guidelines for Human Embryonic Stem Cell Research.” In the news release, committee co-chair Richard O. Hynes explains, “A standard set of requirements for deriving, storing, distributing, and using embryonic stem cell lines—one to which the entire U.S. scientific community adheres—is the best way for this research to move forward.” From: “Guidelines for Human Embryonic Stem Cell Research,” available at http://books.nap.edu/catalog.php?record_id=11278#description and “Guidelines Released for Embryonic Stem Cell Research,” available at www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=11278
The President’s Council on Bioethics, chaired by Leon Kass, publishes “Monitoring Stem Cell Research,” a report that contains “no proposed guidelines and regulations, nor indeed any specific recommendations for public policy.” But according to Kass, the overarching goal of the report is “to convey the moral and social importance of the issue at hand and to demonstrate how people of different backgrounds, ethical beliefs, and policy preferences can reason together about it.” From: “Monitoring Stem Cell Research,” available at http://bioethics.gov/reports/stemcell/ index.html and “Monitoring Stem Cell Research,” available at http://bioethics.gov/reports/stemcell/ transmittal.html
President Bush prohibits the federal funding of any research using stem cell lines derived after August 9, 2001, but his policy does not affect research in the private sector or research conducted with state funding.2 The president claims that more than 60 stem cell lines are available for funding. From: “President Discusses Stem Cell Research,” available at www.whitehouse.gov/ news/releases/2001/08/20010809-2.html
NIH is supposed to begin reviewing grant applications for human embryonic stem cell research, but postpones the review in order to give the Bush administration time to review HHS policies. Bush had declared his opposition to the research in his campaign speeches.
NIH Guidelines for Research Using Human Pluripotent Stem Cells are published are the Federal Register over the summer and go into effect on this day. They stipulate that: human embryonic stem cells must be derived with private funds from frozen embryos from fertility clinics; they must have been created for fertility treatment purposes; be in excess of the donor's clinical need; and obtained with the consent of the donor. These guidelines also outlawed the federal funding of stem cells derived from embryos created by SCNT, even if the derivation took place with private funds.
By this point, over 50,000 responses had been received on the committee's proposed guidelines.
Harold Varmus appoints an oversight committee to draft guidelines for federally funding embryonic stem cells. The committee includes scientists, clinicians, ethicists, lawyers, patients, and patient advocates.
NIH Director Harold Varmus receives a legal opinion from DHHS general council Harriet Rabb. Rabb finds that the Dickey-Wicker amendment does not apply to federal funding for research on embryonic stem cells because the cells do not meet the statutory definition of an embryo. The cells, however, would have to be derived with private funding.
The NIH develops guidelines for funding human embryonic stem cell research, but presidential candidate George W. Bush declares his opposition to the research in a campaign speech so NIH remains cautious about entertaining funding proposals until after the presidential election.
University of Wisconsin scientist James Thomson isolates human embryonic stem cells and shows their remarkable potential to rejuvenate and to specialize into tissues. This exciting discovery also initiates the ethical debate on human embryonic stem cell research because his team derives the stem cells through a process that destroys human embryos.
Congress bans the federal funding for research on embryos through the Dickey-Wicker Amendment, named after its sponsors Jay Dickey (R-AR) and Roger Wicker (R-MI). The amendment prohibits the use of federal funds for “the creation of a human embryo or embryos for research purposes; or research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g (b)).” From: “Dickey-Wicker Amendment,” available at www.dnapolicy.org/policy.international. php?action=detail&laws_id=36
A National Institutes of Health human embryo research panel supports the research but thousands of letters urge President Clinton to reverse his earlier decision. He agrees. Federal funding of embryo research is stopped.
HHS Secretary Donna Shalala lifts the moratorium on federal funding of human embryo research in accordance with President Bill Clinton’s executive order.
Congress attempts to override the moratorium through legislation but President George H.W. Bush vetoes the measure.
Human Fetal Tissue Transplantation Research Panel reopens the question and votes 18-3 to approve the federal funding of embryo research. Despite this level of support for the research, the Department of Health and Human Services accepts the testimony of three conservative dissenters who argue that embryo research would lead to an increase in abortions and in response extends the moratorium on this research.
President Ronald Reagan decides not to renew the Ethics Advisory Board’s charter. The EAB had recommended federally funded investigations into the safety of in vitro fertilizations using human embryos developed in vitro for no more than 14 days, but a de facto moratorium halts federal funding of human embryo research due to the EAB’s disbanding.
Commission releases guidelines on federal funding of fetal and fetal tissue research. The guidelines establish an Ethics Advisory Board for fetal and fetal tissue research that originate from abortions.
The 93rd Congress implements a ban on almost all federally funded fetal tissue research until the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research devises guidelines for it.
National Research Act establishes the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research within the Department of Health, Education, and Welfare to define policy for protection of human subjects during medical or scientific experiments.
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