Oversight Federal Activity
Fostering Responsibility and Accountability
Evaluate, and re-evaluate periodically, the effectiveness of current research oversight mechanisms and determine what, if any, additional steps should be taken to foster accountability at the institutional level without unduly limiting intellectual freedom.
Recommendation
The government should support a continued culture of individual and corporate responsibility and self-regulation by the research community, including institutional monitoring, enhanced watchfulness, and application of the National Institutes of Health Guidelines for Recombinant DNA Research. As part of the coordinated approach urged in Recommendation 4, the Executive Office of the President should evaluate, and re-evaluate periodically, the effectiveness of current research oversight mechanisms and determine what, if any, additional steps should be taken to foster accountability at the institutional level without unduly limiting intellectual freedom. Academic and private institutions, the public, the National Institutes of Health, and other federal funders of synthetic biology research should be engaged in this process. An initial assessment should be completed within 18 months and the results made public.
Activities
Federal
- Executive Office of the President
- On Jan. 18, 2011, the Office of the President published Executive Order 13563, Improving Regulation and Regulatory Review, instructing each agency to develop and submit, within 120 days of the date of the order, a preliminary plan to the Office of Information and Regulatory Affairs. Under the plans, each agency will periodically review its existing significant regulations to determine whether any such regulations should be modified, streamlined, expanded, or repealed so as to make the agency’s regulatory program more effective or less burdensome in achieving the regulatory objectives.
- On March 11, 2011, Emerging Technologies Interagency Policy Coordination Committee released a set of broad principles, Principles for Regulation and Oversight of Emerging Technologies, pursuant to Executive Order 13563, to guide the development and implementation of policies for oversight of emerging technologies at agency level.
- National Institutes of Health (NIH)
- National Science Advisory Board for Biosecurity (NSABB)
- NSABB published an April 2010 report, Addressing Biosecurity Concerns Related to Synthetic Biology, which sought to “identify, assess and recommend strategies to address any biosecurity or dual use research concerns that may arise from work being conducted in the nascent field of synthetic biology.” This report evaluated the potential that information and/or technology stemming from legitimate scientific research could be misused to threaten elements of national security. It assessed “biosecurity concerns presented by the ability to synthesize new genes, metabolic pathways, proteins, or chemicals and ultimately to design genetic systems and organisms with specified functions, and analyzes whether all such biosecurity concerns would be adequately addressed by current and proposed oversight frameworks.”
- NSABB published a June 2010 report “Strategies to Educate Amateur Biologists and Scientists in Non-life Science Disciplines About Dual Use Research in the Life Sciences," containing recommendations for dealing with potential dual-use biotechnology, aiming specifically at awareness for “(1) scientists trained in non-life science fields who collaborate in the life sciences on such endeavors as synthetic biology, and (2) amateur biologists who pursue life science research as an avocation and whose activities are becoming increasingly sophisticated.”
- National Science Advisory Board for Biosecurity (NSABB)
Non-Federal
- In June 2011, the Synthetic Biology Project at the Woodrow Wilson Center partnered up with DIYbio.org, an organization dedicated to making biology an accessible pursuit for citizen scientists, amateur biologists and biological engineers who value openness and safety. This partnership aims to ensure safety within the rapidly expanding community of amateur biologists by identifying relevant biosafety guidance, working with members to distill that information into user-friendly guidelines, and developing and disseminating basic codes of conduct in the community.
- Synthetic Genomics: Options for Governance, a 2007 report from the J. Craig Venter Institute, Massachusetts Institute of Technology, and Center for Strategic and International Studies, addressed the safety and security concerns posed by synthetic biology. This report also assessed the current state of the technology, identified potential risks and benefits to society, and formulated a series of policy options for its governance.
