Back to the Future
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.
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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)
Comments on this article
Now maybe we can be number one in the science of the human body once again.
July 6th, 2009 at 5:42 pmAs someone who has mapped stem cell policy around the world for six years, I am happy to see that the U.S. has now rejoined the world’s scientific mainstream with this balanced approach.
July 6th, 2009 at 11:36 pmDid you see the mouse with an ear on its back?
Do you think that now that we know the drugs made by the body with our own DNA we also know how are each of them used? How are each activated? How are the propser dose determined?
Whatever happened to the idea of drugs designed by the personal DNA? Did I miss their arrival? I have seen nothing about Personal Drugs (PD) designed from the DNA.
Perhaps the most important use of DNA is to identify criminals and something else, I forgot!
So, should we abandon the promises of DNA and the Gnome Project in deciphering the biological Rossetta Stone?
Is the Stem Cell, the “Soup of the Day!”
Are we done with DNA?
Have you thought how will the new Stem Cell drugs tested?
July 25th, 2009 at 8:31 pmWhat if NOTHING happens, but the patient dies exactly 8 years and 2.5 months later. Do you think anybody will notice?
Remember, medical doctors of similar training did Medical Experiments in Nazi Germany and Lobotomies in the USA, before them. Lobotomies are now illegal in all the USA and all the Nations in the world. Not True! Some states and some nations still practice Lobotomies.
The new treatment is “Radio Waves” but, if I told you what it is, you would not believe it and will think I am crazy, don’t worry, if our roles were reversed, I would think the same of you.