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Background and Legal Issues Related to Stem Cell Research

June 4th, 2015 9:45 am

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Diane T. Duffy, Congressional Research Service Updated June 12, 2002

Summary

With certain restrictions, the President has announced that federal funds may be used to conduct research on human embryonic stem cells. Federal research is limited to 64 1 existing stem cell lines that were derived (1) with the informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors. No federal funds will be used for the derivation or use of stem cell lines derived from newly destroyed embryos; the creation of any human embryos for research purposes; or cloning of human embryos for any purposes. Several lawsuits have been filed relating to stem cell research, and questions have been raised concerning access to existing stem cell lines by federal researchers.

Human Embryonic Stem Cells. Human embryonic stem cells are "master cells" and are able to develop into almost any cell in the human body. Building on earlier stem cell research, in 1998, researchers at the University of Wisconsin isolated cells from the inner cell mass of the early human embryo, called the blastocyst, and developed the first human embryonic stem cell lines. 2 Research has focused on the potential that these cells can offer to treat or mitigate diseases and conditions and to generate replacement tissues for disfunctioning cells or organs. 3 Research efforts have focused on spinal cord injury, multiple sclerosis, Parkinson's disease, Alzheimer's disease, diabetes, and other diseases or conditions. Scientists hope to use specialized cells to replace dysfunctional cells in the brain, spinal cord, pancreas, and other organs. 4 The sources for stem cells include: one week old embryos (blastocysts) created via in vitro fertilization (IVF) to treat infertility; five to nine week old embryos or fetuses obtained through elective abortion; embryos created through IVF for research purposes; embryos created through cloning or somatic cell nuclear transfer (SCNT); and adult tissues (umbilical cord blood, bone marrow). Controversy surrounds the derivation of stem cells from human embryos and fetuses. In order to derive or extract the stem cells found within the embryo, the embryo is destroyed in the removal process. The earliest embryonic stem cells are called totipotent cells, which means they can develop into an entire organism, producing both the embryo and tissues required to support it in the uterus. At a later stage of development, pluripotent embryonic stem cells exist and can develop into almost any type of cell in the body. These stem cells cannot form the supporting tissues, as seen with totipotent cells. 5 Human embryonic stem cells found in the early stage embryo are believed to have a greater ability to become different types of body cells and have more uses than adult stem cells.

Background and Recent Presidential and Congressional Action

Executive Action. When President Bush took office in January, 2001, he announced he would conduct a review of the stem cell research issue and ordered the Department of Health and Human Services (HHS) to review the National Institutes of Health's (NIH) guidelines issued by the former administration. During the review period, NIH suspended its review of applications from researchers seeking federal funds to perform human embryonic stem cell research. On August 9, 2001, President Bush announced that federal funds would be available to support limited human embryonic stem cell research. The new policy provides that federal funds may be used for research on 64 existing stem cell lines that have already been derived or were already in existence as of the date of the announcement. In identifying the 64 stem cell lines as being eligible for federal funding, the President said these embryos, from which the existing stem cell lines were created, had been destroyed previously and could not develop as human beings.

Under the new policy, federal agencies, primarily NIH, will consider applications for funding if certain standards or eligibility criteria are met. The White House fact sheet setting forth the President's policy states: federal funds will only be used for research on existing stem cell lines that were derived (1) with the informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors. 6 The President directed NIH to examine the derivation of all existing stem cell lines and create a registry of those lines. Pursuant to this new policy, no federal funds will be used for: (1) the derivation or use of stem cell lines derived from newly destroyed embryos; (2) the creation of any human embryos for research purposes; or (3) cloning of human embryos for any purposes. The new policy replaces previously issued stem cell guidelines and policies. The policy also requires the creation of the President's Council on Bioethics to study stem cells and embryo research as well as other issues. NIH has listed entities that have developed stem cells lines that meet the President's criteria and are eligible for federal funding (the Human Embryonic Stem Cell Registry). The President also stated that in FY2001, the government will spend $250 million on research involving stem cells from other sources, e. g., umbilical cord, placenta, adult and animal tissues.

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Background and Legal Issues Related to Stem Cell Research

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