Recommendations include federal oversight but do not put major restrictions on research.

The Presidential Commission for the Study of Bioethical Issues today released its first review of synthetic biology. Current suggestions neither give ultimate freedom to scientists nor do they put major restrictions on research but instead emphasize discussion, ongoing evaluation, and education of the public and scientists about the risks and harms.

Overall, the report suggests that the very newness of the science, which involves the design and construction of laboratory-made biological parts, gives regulators, ethicists, and others time to identify any problems early on and craft solutions that can harness the technology for the public good.

The panel, comprising 13 scientists, ethicists, and public policy experts, concluded that while the technical challenges of synthetic biology remain daunting, the field is likely to become more decentralized as the relevant tools become increasingly available and affordable. “While the ‘Do-It-Yourself’ community has an important role to play in advancing synthetic biology, we recognize that technical challenges and costs are too high right now for a completely novel organism to be developed in a noninstitutional setting,” says James W. Wagner, Ph.D., Commission vice chair and president of Emory University.

“We strongly support an open dialogue between DIY groups and the government as we go forward so that scientists and government can discuss the research constraints necessary to protect public safety as the field continues to evolve.”

The Commission recommended the following steps to minimize risks and to foster innovation:

• The Executive Office of the President, possibly through the Office of Science and Technology Policy, should coordinate federal agencies that oversee areas related to synthetic biology, including product licensing and funding.

• Risk assessment activities across the government need to be coordinated and field release permitted only after reasonable risk assessment.

• The Executive Office of the President should remain actively engaged with DIY groups to communicate and discuss applicable safety and security issues.

• Recognizing that international coordination is essential for safety and security, the Department of State, in concert with the HHS and the Department of Homeland Security, should collaborate with governments around the world as well as leading international organizations such as the WHO to promote ongoing dialogue about emerging technologies like synthetic biology.

• The NIH, the DOE, and other federal agencies should evaluate research proposals through peer-review to make sure that the most promising scientific research is conducted on the public’s behalf.

• Educational classes on the ethical dilemmas raised by synthetic biology should be a mandatory part of training for young researchers, engineers, and others who work in this field.

• Forums should be established to improve the general public’s understanding of this field, including the creation of a biology equivalent to, in which a private group would track statements about the science and offer an independent view of the truth of such claims.

“We comprehensively reviewed the developing field of synthetic biology to understand both its potential rewards and risks,” notes Amy Gutmann, Ph.D., the Commission chair and president of the University of Pennsylvania. “We considered an array of approaches to regulation—from allowing unfettered freedom with minimal oversight and another to prohibiting experiments until they can be ruled completely safe beyond a reasonable doubt. We chose a middle course to maximize public benefits while also safeguarding against risks.”

Dr. Gutmann notes that the Commission’s approach recognizes the great potential of synthetic biology, including life-saving medicines, and the still distant risks posed by the field. “Prudent vigilance suggests that federal oversight is needed and can be exercised in a way that is consistent with scientific progress.”

President Obama asked the Commission to study the implications of synthetic biology following the May 20 announcement by the J. Craig Venter Institute that it had inserted a laboratory-made genome into a bacterial cell, creating an organism not found in nature. In three public hearings held over the past five months in Washington, D.C., Philadelphia, and Atlanta, the Commission reportedly heard from over 36 ethicists, scientists, and others close to the issue.

Several experts explored potential benefits of synthetic biology, including the development of vaccines and new drugs and the production of biofuels that could someday reduce the need for fossil fuels. Discussions addressed the risks posed by the technology, including the inadvertent release of a laboratory-created organism into nature and the potential adverse effects of such a release on ecosystems.

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