Senator Eliot Shapleigh - El Paso, Texas

With Barack Obama in the Oval Office, opportunities for human embryonic stem cell research are expected to increase dramatically. Our new president has promised to back legislation that would allow federal funding of additional stem cells — a move that has been welcomed by scientists across the globe.

But allowing expanded research is only one part of U.S. leadership in this important area of biomedical research. President Obama should also act to develop a broader, comprehensive federal stem cell policy that ensures stem cell research is conducted in a responsible, thoughtful and ethical manner that restores the federal government’s essential role in oversight of this critical subject.

Human embryonic stem cell research focuses on the cells derived from five- to six-day-old fertilized eggs. Unlike adult stem cells, which are specialized to particular tissues or organs, embryonic stem cells have the potential to specialize into any cell in the body and therefore have the capability to be utilized in tissues and organs where stem cells are missing or damaged. Advocates predict that embryonic stem cells could be used to produce tissues or organs to replace damaged ones, to understand and combat diseases such as diabetes and Parkinson’s, and to test and develop new drugs.

The field is relatively new, dating back just over a decade, and the need for strong ethical guidelines and coordination is increasingly apparent. Unfortunately, current regulation of stem cell research in the United States is, at best, haphazard, with scientists who accept state and private funding on cells playing by a different set of rules than researchers using government cells.

In 2001, President George W. Bush restricted federal funding for stem cell research, severely limiting the amount and scope of research. But the restriction applied only to federal funding. So some universities, including Harvard University and the University of Wisconsin–Madison, obtained private funding for their research. Other researchers convinced legislators and governors in states such as California, Illinois and Connecticut to fund projects.

In the absence of federal oversight and coordination, the National Academies stepped in with voluntary guidelines in 2005 — but there was no mechanism to ensure these practices are followed. Additionally, as the federal government has pulled back from stem cell research, the United States’ leadership role in this area has diminished, with research here stagnating compared to the rest of the world.

To rectify this, the Obama administration should create a comprehensive federal stem cell policy with the National Institutes of Health (NIH) taking the lead.

This could be done by creating an Embryonic Stem Cell Research Oversight (ESCRO) board within the NIH to review controversial research and recommend policy for the agency, similar to the committee recommended by the National Academies, the most distinguished society of scientists and engineers in the country.

The ESCRO board would contain representatives with expertise in ethical and legal issues and biology, as well as policy scholars and patient advocates. The role of the board should be to review grant applications and to develop policy options for all aspects of research involving human embryos. Moreover, NIH should work with states that have already implemented human stem cell programs to provide guidance on ethics and research, as well as to help with peer review.

The government must also outlaw any effort to clone a human being, regardless of the source of funding. Human reproductive cloning has been denounced by scientists and policymakers around the world. Fourteen states and more than 40 countries have already banned the practice. This increased federal involvement reflects public sentiment. Public support for stem cell research has increased over the past seven years, with 56 percent of Americans supporting federal funding according to Research!America. And approximately two-thirds of Americans agree that there should be a uniform federal stem cell policy.

There is also a historical precedent for an empowered NIH. In the past, NIH has played a strong leadership role in creating research policy for controversial areas of biomedical research. For example, the Recombinant DNA Advisory Committee (RAC) was created to review proposals involving the use of DNA in research and clinical therapies.

Additionally, President Obama should continue the President’s Council on Bioethics (PCB) and provide it with a mandate, along with the necessary financial support, to guide the president on bioethical questions as well as serve as a means for public outreach on these topics.

These steps are critical if the United States is to resume its leadership role in scientific research and help establish global standards that reflect scientists’ interests while respecting human dignity.

Let’s hope our new president takes this opportunity to promote a federal stem cell policy that expands research in a responsible, thoughtful and ethical manner.

Matthews is a fellow in science and technology policy at the Baker Institute. She is responsible for managing the activities of the Science and Technology Policy Program, including the institute’s International Stem Cell Policy Program. Matthews has a B.A. in biochemistry from The University of Texas at Austin and a Ph.D. in molecular biology from The University of Texas Health Science Center at Houston. Visit the Baker Institute online at www.bakerinstitute.org to learn more.