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New Stem Cell Policy Founded on Ethics and Expertise

SOURCE: AP Photo/Ron Edmonds

President Barack Obama is applauded by members of Congress, and others, after signing an executive order on stem cells and a Presidential Memorandum on scientific integrity, Monday, March 9, 2009, in the East Room of the White House in Washington.

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President Barack Obama was true to his word when, last week, he told the nation and the world that federally funded scientists wishing to study embryonic stem cells would no longer be hamstrung by Bush-era restrictions based on the former president’s limited view of the phrase “responsible research.”

Predictably, Obama has run into some political pushback. The complaints have arisen primarily over two issues, neither of which is substantial and both of which deserve to be countered.

For one, some opponents of the research have inferred that because the president himself did not announce in his executive order any preordained limits on the research field, there is no aspect of human embryonic stem cell research that he is not willing to endorse. But anyone who paid attention to Obama’s words during the signing ceremony last Monday would know better than that. He spoke repeatedly about the need for such research to be “legal”—a clear reference to the Dickey-Wicker amendment that Congress has renewed annually for 13 years running, which precludes the use of federal funds for any work that could cause harm to a human embryo—and “responsible,” an even more demanding level of ethical care than that of mere legality. Obama also spoke forcefully against the prospect of human cloning in words that could leave no question in any listener’s mind that the president is not going to let this field of science run amok.

Second, some research opponents are upset that the president turned to the National Institutes of Health to create guidelines that will set limits on embryonic stem cell research. In their eyes, these critics saw that approach as one that puts scientists unilaterally in charge of overseeing science—arguably no better than putting theologians in charge.

But that view ignores the expertise within the NIH in areas such as 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. The executive order also charges the 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 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.

Finally, Obama observed that the stem cell policy issue is only one example of the need for policymakers to have access to the best evidence, an important realization after the last eight years. Reasonable people may disagree, but reason cannot flourish without the facts.

Earlier this year, Science Progress and the Center for American Progress released a report, “A Life Sciences Crucible: Stem Cell Research and Innovation Done Responsibly and Ethically,” in which Michael Rugnetta of CAP and Michael Peroski spell out a basic formula that would lead to a new openness in this research field without overstepping ethical lines. We review some of the key recommendations below in the hope that it will help the NIH and assorted experts find a path to bringing this important field to maturity while addressing the concerns of those who have good questions with this new and promising frontier.

Key recommendations from the report

Currently, federal funding is only available for research on the 21 lines of embryonic stem cells that were derived before August 9, 2001. Once this arbitrary limit is lifted, the National Institutes of Health will be able to issue grants to scientists who wish to research embryonic stem cells in accordance with guidelines for ethically derived cells.

CAP believes that the quickest and best way to open up the stem cell field is to focus first on those areas where there is common ground among a wide array of Americans, by allowing funding for research in which:

  • The stem cells come from embryos that were originally created at in vitro fertiliza tion clinics for the purpose of fertility treatment and are now stored at these IVF clinics because more were created than required to fulfill the patient’s clinical need
  • Proper written informed consent is obtained from the donors.
  • As part of the informed consent process, the embryo donors determine along with the physician that the embryos will never be implanted in a womb and would otherwise be destroyed.
  • There are no financial inducements and the donors understand the purpose of the research is not to eventually confer therapeutic benefits upon the donors.

CAP also recommends that embryonic stem cell research requirements along these lines be codified in legislation by the 111th Congress and become law so that future presidents can not obstruct this research.

Over a period of time the NIH must also address the more contentious issue of deploying federal funds for research on stem cells that have been derived with private funds from embryos created for research.

To enforce ethical guidelines and to ensure that all stem cell research (embryonic or otherwise) is conducted cautiously and responsibly so as not to threaten the safety or autonomy of research subjects or the donors of research materials, the following administrative oversight requirements should be included either in the NIH guidelines that respond to the president’s executive order or in legislation that should be passed in the first session of the 111th Congress:

  • The National Institutes of Health should require that all research be conducted under the review of a stem cell research oversight committee that adheres to the standards put forth in the regulations issued by the NIH and the Department of Health and Human Services as informed by the National Academies or the International Society for Stem Cell Research guidelines. Any embryonic stem cells that are not in compliance with these rules, or are derived from embryos that are not in compliance with these rules, will not be eligible for federal funding.
  • The one caveat to this requirement is that the 21 cell lines that were approved by the Bush administration should be grandfathered into the new policy because federal funding has already been provided for research that is now well underway.

These policy guidelines will ensure that human embryonic stem cell research is carried out with the highest ethical standards. It will also ensure that U.S. public and private biomedical research laboratories live up to the highest scientific standards.

Jonathan Moreno is a Senior Fellow at the Center for American Progress. Michael Rugnetta is a Research Assistant with the Progressive Bioethics Initiative at the Center for American Progress.

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