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Final Stem Cell Rules Support Ethics and Innovation

SOURCE: University of Wisconsin-Madison/Su-Chun Zhang After eight years of doing research (in the words of the former NIH director), with one hand tied behind their backs, scientists now have ethical guidelines for embryonic stem cell research that will channel federal support to the science that makes the United States a leader in regenerative medicine. Above: neural cells derived from human embryonic stem cells.

Today the National Institutes of Health released final guidelines for federally funded stem cell research that will help put the United States back at the forefront of scientific research and innovation. The progressive approach of the new rules balances ethical considerations with support for groundbreaking science, a welcome reprieve for scientists, advocates, and patients who saw research opportunities contract under the eight years of the Bush administration’s distorted policy.

In March, President Barack Obama issued an Executive Order that lifted restrictions limiting federal support to 21 Bush-approved lines of human embryonic stem cells, and that directed NIH to develop new guidelines. Since then, new requests for fund involving embryonic stem cell lines have been on “pause.” The path to today’s rules demonstrates respect for scientific integrity and democratic governance by providing for a full period of public comment, during which individuals and groups submitted some 49,000 comments on the draft policy, according to Acting NIH Director Dr. Raynard Kington during a conference call this afternoon. In contrast, President George W. Bush and his advisors developed their rules without such a process and without a formal policy mechanism like an Executive Order. Their approach consisted of a televised address and a “Fact Sheet” distributed to the media.

We’re pleased that the new guidelines 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 countries
• Full informed consent from the donors
• No financial inducements to donate
• A 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 research
• A new working group 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 funding
• A registry of cell lines that have been found eligible for federal funding.

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, the ability of stem cells to grow into any tissue in the body.

Biomedical researchers will now have the opportunity to expand their work at the cutting edge of the life sciences in a framework that respects the values of the American people.

Jonathan D. Moreno, Ph.D., is the David and Lyn Silfen University Professor of Ethics and Professor of Medical Ethics and of the History and Sociology of Science at the University of Pennsylvania, and the Editor-in-Chief of Science Progress.

For more from Science Progress and the Center for American Progress on stem cells:

Report: A Life Sciences Crucible: Stem Cell Research and Innovation Done Responsibly and Ethically (CAP)

Timeline: A Brief History of Stem Cell Research (SP)

Top Eight: Eight Reasons to Applaud Action on Stem Cells (CAP)

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