BIOETHICS Progressive Stem Cell Policy 101

   Responsible and Ethical Research SOURCE: James Thomson, University of Wisconsin Embryonic stem cell research is good science, and it needs to be part of our federally funded biomedical research enterprise if the United States is to retain its status as a global scientific leader. That’s why it must be conducted responsibly and ethically. Above: induced pluripotent cells from the laboratory of James Thomson at the University of Wisconsin.
    Friday, July 24th, 2009 | What is stem cell research?  Embryonic stem cells can develop into any kind of cell in the body and can replicate themselves indefinitely. Investigating how they work helps life scientists to create new disease therapies, test new drugs, and understand the human development process and how it can go wrong. As therapeutic tools they have the potential to replace, reconstruct, or regenerate failing tissues and organs.    
   James Thompson and a team of colleagues at the University of Wisconsin first isolated human embryonic stem cells in 1998, and since then scientists around the world have cultivated thousands of stem cell lines. Why is it important to the United States?      Embryonic stem cell research is an important new area of science and must be part of our federally funded biomedical research enterprise if the United States is to retain its status as a global scientific leader. But embryonic stem cell research must be conducted responsibly and ethically.      Stem cell research is an important component of the new field of regenerative medicine, the goal of which is to develop new therapies. A small sample of a patient’s own cells are cultivated, reprogrammed, and used to treat the patient without the risk of rejection or severe side effects that often result from introducing for­eign materials. What therapies are stem cell researchers working on, and what are they learning?    
   The potential therapies range from transforming the pancreatic cells of diabetics so they can produce insulin to reconnecting the nerves in severed spinal cords. Indeed, there have already been some modest clinical applications where heart muscles and cartilage have been repaired with stem cells derived from bone marrow.     
    But that is just the tip of the iceberg. The greatest potential for regenerative medicine lies in scientists’ ability to tap into the process of cell differentiation and development. This is only possible by tracing the development of human cells from the very beginning. To do so, scientists need to conduct research on embryonic stem cells so that they can dis­cover how these all-purpose cells can change into any one of the more than 200 different cell types in the human body. Why do some groups oppose human embryonic stem cell research?     
    Opponents of embryonic stem cell research argue that there have been many scientific advances made using stem cells that do not come from embryos, such as bone marrow-derived stem cells, which are a type of adult stem cell. Opponents also point to so-called induced pluripotent stem cells, which are created when adult cells-say, skin cells-are reprogrammed to become all-purpose “pluripotent” cells. These arguments are valid, but only up to a point. The reason: embryonic stem cells are both the original “master cells” capable of turning into any cell in the body as well as the “gold standard” against which all other stem cells must be compared.     
   In September of 2001, President George W. Bush announced that federal funding would be available only for research on the lines of embryonic stem cells that were derived before August 9, 2001, only 21 of which turned out to be viable. But it is likely that the inability of the National Institutes of Health to fund research on a variety of human embryonic stem cell lines from 2001 to 2008 impaired biologists’ understanding of the properties that mark pluripotency. Science and ethics: the new federal embryonic stem cell research agenda     
   President Barack Obama lifted the Bush administration’s arbitrary limit on March 9, 2009 and directed NIH to develop guidelines for scientists who wish to research embryonic stem cells in accordance with rules for ethically derived human embryonic cells. The final guidelines, released July 6 and effective July 7, 2009, make certain that scientists conduct stem cell research with the highest ethical standards. They will also ensure that U.S. public and private biomedical research laboratories live up to the highest scientific standards.     
   Those rules are similar to those proposed in the Center for American Progress/Science Progress report, “A Life Sciences Crucible: Stem Cell Research and Innovation Done Responsibly and Ethically,” published in January. They include: Funding only for cell lines from excess embryos remaining after fertility procedures, including lines from other countriesFull informed consent from the donorsNo financial inducements to donateA demonstrated understanding by the donors that the research will not confer benefits upon them personally
   A strict separation of the privately funded cell-derivation process from the publicly funded cell researchA new working group in the federally chartered Advisory Committee to the NIH Director composed of scientists and ethicists to review the donation process of cell lines derived prior to implementation of the new guidelines for their eligibility for federal fundingA registry of cell lines that have been found eligible for federal funding.     
   The Executive Order also instructs NIH to review and update these guidelines periodically, as appropriate. Acting Director Raynard Kington, explaining the new rules, said that they are “the right policy for where we are scientifically” at this moment in time.      It is important to note that these rules are in accordance with existing federal law, including the so-called Dickey-Wicker amendment, which prohibits federal funding of research that creates, harms, or destroys embryos. The rules likewise support the rapid advances in induced pluripotent cell research, which still relies on access to embryonic stem cells so that scientists can understand the hallmarks of pluripotency. Why did the National Institutes of Health develop these rules?     
   Experts at NIH have deep knowledge with research ethics, biomedical distributive justice, and other fields of social science that focus on the fair integration of pluralistic American values with the intellectual and humanistic imperative to explore science and reduce suffering. NIH received and analyzed more than 49,000 comments submitted during the public review period for the draft guidelines.     
   The president’s Executive Order also charged NIH with reviewing “existing NIH guidance and other widely recognized guidelines.” This refers to the guidelines put out by organizations such as the National Academies of Science and the International Society for Stem Cell Research, which both include ethical safeguards that ensure responsible conduct of embryonic stem cell research. As the president noted, the point is not to assume that science and ethics are opposed, but to view ethics as inherent in the pursuit of scientific knowledge.