The Newsletter of the National Academy of Sciences' Committee on Science, Technology, and Law
Volume 3, Number 2
We are pleased to present the latest issue of the Committee on Science, Technology, and Law newsletter, a semi-annual report on the activities, projects, and people of the National Academy of Sciences’ Committee on Science, Technology, and Law (CSTL). CSTL was established by the National Academy of Sciences in 1998 to examine the growing number of areas where science, engineering, and law intersect in this era of increasing globalization. It is the only national committee that brings leading figures in science, engineering, and medicine together with members of the legal and policy communities for discussions about critical issues of mutual interest and concern. The committee meets bi-annually in a roundtable setting that provides a unique forum for intellectual inquiry and debate. Through its reports and activities, CSTL brings widespread attention to issues of pressing national and international concern. The committee considers challenging issues at the nexus of science and law from three perspectives: 1) how law influences and constrains the practice of scientific and engineering research (law in the laboratory); 2) how scientists and engineers participate in, and how their work is used by, the legal community (science in the courts); and 3) public policy formation, including looking at the uses and misuses of science in shaping public policy at the confluence of the scientific, engineering, medical, and legal arenas.
October 2012 CSTL Meeting
The next meeting of the Committee on Science, Technology, and Law will be held on October 22-23, 2012 at the National Academies’ J. Erik Jonsson Center in Woods Hole, MA. The meeting will feature panel discussions of the following topics: 1) Cost-Benefit Analysis – Use/Distortion/Potential; 2) Recent Decisions in Patent Law; 3) IP/Ownership/Sharing Arrangements for Synthetic Biology; 4) Eyewitness Identification; 5) The Modern University; and 6) Public Dialogue in the Century of Biological Discovery. For more information about the October and future meetings, please contact Steven Kendall at 202-334-1713 or firstname.lastname@example.org.
Improving the Use of Science in the Administrative Process: A Workshop
On September 10, 2012, at the request of the Administrative Conference of the United States, CSTL hosted a one-day public workshop to consider a draft report entitled Science in the Administrative Process: A Study of Agency Decisionmaking Approaches and discuss the report's recommendations. The workshop was made possible with support from the Alfred P. Sloan Foundation.
Synthetic Biology for the Next Generation
On June 12-13, on behalf of the National Academy of Sciences and with support from the Alfred P. Sloan Foundation, CSTL and the Board on Life Sciences (BLS) organized, in conjunction with the National Academy of Engineering, the British Royal Society and Royal Academy of Engineering, and the Chinese Academy of Sciences and Chinese Academy of Engineering, the third in a series of three international symposia on synthetic biology. The June 12-13 symposium, entitled Synthetic Biology for the Next Generation, was held in Washington, DC at the newly restored National Academy of Sciences Building on the National Mall. The symposium featured the following sessions:
- Meeting Global Challenges
- Overview of Research in Key Application Areas
- Organizational Strategies in Support of Synthetic Biology
- National Strategies for Advancing Synthetic Biology
- Perspectives on Synthetic Biology from within the Political Process
- Rebuilding the Social Contract
- Exploring Fundamental Questions in Biology
- Advancing Fundamental Needs in Engineering
- Enabling the Next Generation of Leadership and Community
- Prudent Practice: Lessons from Real World Case Studies
- Ownership, Sharing, and Innovation
- Critical Issues for Success
View Video of the event at: http://events.tvworldwide.com/Events/IOM/NAS120612.aspx
A summary report of the proceedings of the three symposia will be issued in the winter.
Issues Raised, Lessons Learned, and Paths Forward for Dual-Use Research in the Life Sciences: The H5N1 Research Controversy – A Workshop
On May 1, CSTL, in conjunction with the National Academy of Sciences' Board on Life Sciences and the Institute of Medicine's Forum on Microbial Threats and with support from the Alfred P. Sloan Foundation, hosted a workshop to discuss the implications of the H5N1 avian influenza research controversy and provide a forum wherein the concerns and interests of the broader community of stakeholders, including policy makers, biosafety and biosecurity experts, non-governmental organizations, international organizations, and the general public might be articulated. The workshop featured the following sessions:
- The Ongoing Revolution in the Life Sciences and Associated Technologies
- Two Case Studies from Conceptualization to Dissemination of Findings with Consideration of Plausible Points of Intervention and Decision-Making
- Roundtable Discussion on the Nature of the Social Contract
- Roundtable Discussion on Governance, Oversight, and the Path Forward
View Video of the event at: http://events.tvworldwide.com/Events/IOM/IOM120501.aspx
A summary report of the workshop proceedings will be issued in late 2012.
Harold Varmus and Leroy Hood Speak at Spring CSTL Meeting
At the March 2012 CSTL meeting, Harold Varmus, Director of the National Cancer Institute at the National Institutes of Health and Leroy Hood, President of the Institute for Systems Biology, addressed the committee. Dr. Varmus’ discussed ethical and legal conundrums in modern cancer research practice. He reflected on how the expansion of our understanding of genetics has profoundly transformed the practice of oncology by providing clinicians with the tools to practice precision medicine. Dr. Varmus noted, however, that a better understanding of the human genome has led to ethical and legal debates centered around issues of patient identifiability, privacy, and notions of consent and suggested that the committee consider activities that address questions about the resolution of privacy concerns in research and care and how to create a “medical learning system” that effectively advances research while addressing patient concerns about misuse of personal data. In his remarks to the committee, Dr. Hood shared his thoughts about biology and medicine as information sciences and where medicine might be headed in the future. Hood argued that the digital revolution and associated amalgamation of clinical research data will, in concert with a systems medicine approach to disease, revolutionize medicine by providing tremendous insight into the biology of disease at an almost individual level. The end result, Hood predicts, will be P4 (Predictive, Preventive, Personalized, and Participatory) medicine that transforms medical practice both by tailoring medical care to the individual and driving down the cost of medical care. Hood observed, however, that the compartmentalization of research data represents a significant hurdle to achieving P4 medicine.
CSTL Forensic Science Report Continues to Resonate on Capitol Hill / In the Media
On March 28, the U.S. Senate Committee on Commerce, Science, and Transportation held a hearing on “The Science and Standards of Forensics.” In his opening remarks, Committee Chairman John D. Rockefeller IV observed that “What’s clear at this point is that we need more research and better standards in forensic science. And to be credible, this work needs to be performed by scientific experts outside of the law enforcement culture.” The CSTL forensic science report called for “more and better research” in the forensic sciences disciplines and the removal of “all public forensic laboratories from the administrative control of law enforcement agencies or prosecutors offices.” Dr. Eric Lander, Co-Chair of the President’s Council of Advisors on Science and Technology (PCAST), Dr. Patrick Gallagher, Director of the National Institute of Standards and Technology (NIST), and Dr. Subra Suresh, Director of the National Science Foundation (NSF) provided testimony. Each supports the creation of standards in the forensic sciences that are based on sound scientific principles.
Subsequent to the hearing, on July 12th, Rockefeller introduced the Forensic Science and Standards Act of 2012 “to help prevent wrongful criminal convictions by bringing reliable, science-based standards to forensic evidence.” The bill calls for the creation of a Forensic Science Advisory Committee at NIST to set and work with the U.S. Attorney General to implement new science-based standards for the forensic sciences. The CSTL report supported a role for NIST in the development of “tools for advancing measurement, validation, reliability, information sharing, and proficiency testing in forensic science.” The Rockefeller legislation calls upon NSF to develop a strategy for federal research on forensic science and establish a forensic science grant program. The CSTL report called for the development of “a strategy to improve forensic science research and education programs” and competitively funded peer-reviewed research in areas including studies designed to establish the scientific bases which demonstrate the validity of forensic methods.
On July 18, the Senate Committee on the Judiciary held a hearing entitled “Improving Forensic Science in the Criminal Justice System” to consider “the important issue of how best to ensure the effectiveness and scientific integrity of forensic evidence used in criminal cases.” Committee Chairman Patrick Leahy had, in January 2011, introduced legislation designed to improve the state of the forensic sciences. Referencing the CSTL report, Leahy insisted that “More research and tighter standards will ensure that good evidence is accepted as a matter of course. Strong research, standards, and oversight will also help to ensure that forensic evidence is never misused to convict innocent people.”
In April, the CSTL report was featured in series of Washington Post articles that described problems in the criminal justice system caused by inaccurate forensic evidence and the failure to release the results of re-examinations. The Post identified several convicted defendants who had not been informed when the U.S. Department of Justice found flaws in the FBI forensic evidence used to convict them. According to the Post’s April 16 article, "Hundreds of defendants nationwide remain in prison or on parole for crimes that might merit exoneration, a retrial or a retesting of evidence using DNA because FBI hair and fiber experts may have misidentified them as suspects." The Department of Justice and FBI subsequently launched a review of thousands of criminal cases to determine whether any defendants were wrongly convicted or deserve a new trial because of flawed forensic evidence.
On September 26, the American Chemical Society, as part of its Science & the Congress Project, held a briefing for congressional staff entitled Forensics: Science Policies to Increase Confidence. During the briefing, an expert panel discussed the setting of research priorities for forensic standards, training and certification for forensic analysts, and best approaches to informing and educating “justice system professionals on the proper use and presentation of forensic evidence to ensure consistency and fairness.” CSTL Director Anne-Marie Mazza moderated the discussion. The panel included two members of the committee that authored the CSTL forensic science report; Constantine Gatsonis, Henry Ledyard Goddard University Professor of Biostatistics, Brown University and Randall Murch, Associate Director, Research Program Development, Center for Technology, Security, and Policy, VirginiaTech. The audience at the briefing included 36 congressional and 12 executive branch staff members.
On October 17, a NOVA episode entitled Forensics on Trial premiered on PBS. Referencing the CSTL forensic science report, the episode examined how modern forensics can send innocent men and women to prison. “With few established scientific standards, no central oversight, and poor regulation of examiners,” writers observed, “forensics in the U.S. is in a state of crisis.” The CSTL report makes recommendations designed to address each of these deficiencies.
Reference Manual on Scientific Evidence Goes Global
On June 2, 2011, thousands of National Academies’ reports were made available for download without charge by the National Academies Press (NAP). The following June, only nine months after its September 2011 release, CSTL’s Reference Manual on Scientific Evidence, Third Edition, had become the sixth most downloaded title. Today, the Reference Manual remains on the list of the top twenty most downloaded National Academies’ reports. To date, more than 11,000 copies of the text have either been downloaded or purchased in hardcopy.* Of this number, more than 700 copies have been sent to developing countries - Brazil, China, India, and Mexico are at the top of the list. Copies of the Manual have been downloaded in nations including Fiji, Kazakhstan, and Syria. Foreign translations of the text are forthcoming. Translations have been requested by, among others, the National Judges College of the People’s Republic of China’s Supreme People's Court. A group of Argentine judges are working on a translation of several chapters of the volume. In addition, the Canadian federal judiciary has plans to incorporate certain chapters into a volume that will address issues that are of specific concern in Canadian law.
While case citations may not provide an especially useful measure of the impact of the volume, as it was not intended to be an authoritative expression of settled law or science, the Manual is routinely cited in opinions to support various points. References to the third edition recently appeared, for example, in Apsley v. Boeing Co. (U.S. Court of Appeals for the 10th Circuit), American Petroleum Institute v. E.P.A. (U.S. Court of Appeals for the District of Columbia), and State v. Kofoed (Nebraska Supreme Court).
*This number does not reflect the copies downloaded from the website of the Federal Judicial Center. The Federal Judicial Center produced the first two editions of the Manual and collaborated with CSTL on the third edition.
CSTL MEMBER NEWS
CSTL Member Wallace Loh Appointed Chair of the Homeland Security Academic Advisory Council
On March 1, the U.S. Department of Homeland Security (DHS) announced the formation of the Homeland Security Academic Advisory Council (HSAAC). CSTL Member Wallace Loh, President, University of Maryland, has been appointed as the Council's first Chairman. HSAAC consists of prominent university presidents and academic leaders who advise DHS Secretary Janet Napolitano and other leadership on issues related to engaging the academic community in the Department's mission. The Council is tasked with providing advice and recommendations "on issues related to student and recent graduate recruitment; international students; academic research; campus and community resiliency, security and preparedness; and faculty exchanges."
CSTL Member Margaret Marshall Receives Radcliffe Institute Medal, Honorary Degrees from Haverford College and Yale University
On May 13, CSTL Member Margaret Marshall, retired Chief Justice of the Massachusetts Supreme Judicial Court, was awarded an honorary degree from Haverford College. Marshall was one of three individuals to receive an honorary degree from Haverford. Each year, the college awards “up to four honorary degrees to men and women who have distinguished themselves in letters, the sciences, or the arts.”
On May 21, Marshall was awarded an honorary Doctor of Laws degree from Yale University. When awarding the degree, Yale President Richard C. Levin observed: “You have devoted your life to the pursuit of justice…changed the legal landscape with your courageous decision to recognize the right of same-sex couples to marry…You are a mentor and role model, a respected jurist, and a friend.”
On May 25, Marshall received the 2012 Radcliffe Institute Medal from the Radcliffe Institute for Advanced Study at Harvard University. The medal “honors an individual whose life and work have substantially and positively influenced society.”
CSTL Co-Chair Richard Meserve Receives Inaugural Richard L. Garwin Award, Completes Work for Blue Ribbon Commission on America’s Nuclear Future, Elected President of Harvard Board of Overseers
In February, the Federation of American Scientists (FAS) presented the inaugural Richard L. Garwin Award to CSTL Co-Chair Richard Meserve, President of the Carnegie Institution for Science and Senior Of Counsel, Covington & Burling LLP. The FAS established the Garwin Award to honor the career of physicist Richard. L. Garwin “and to recognize his exceptional contributions in both scientific and technical achievement.” The award recognizes Dr. Meserve’s “distinguished service and significant contributions to nuclear safety and leadership in science policy.” Dr. Meserve served as Chairman of the U.S. Nuclear Regulatory Commission from 1999-2003.
Dr. Meserve also completed his commission as a member of the Blue Ribbon Commission on America’s Nuclear Future. The purpose of the 15-member Commission was “to conduct a comprehensive review of policies for managing the back end of the nuclear fuel cycle and recommend a new plan.” The Commission submitted its final report to U.S. Department of Energy Secretary Steven Chu on January 26, 2012. On February 8th, Dr. Meserve and Lt. General Brent Scowcroft, the Commission’s Co-Chair, discussed the report’s recommendations at a hearing of the House Committee on Space, Science, and Technology.
In April, Dr. Meserve was elected president of Harvard University’s Board of Overseers for 2012-13. The Board’s “chief functions include superintendence of the visitation process, the principal mechanism for periodic external review of the quality and direction of the University’s schools, departments, and selected other programs and activities.” Dr. Meserve has served as a member of the Board of Overseers since 2007.
CSTL Member David Relman Elected to Institute of Medicine
On October 17, 2011, CSTL Member David Relman, Thomas C. and Joan M. Merigan Professor, Departments of Medicine, and of Microbiology and Immunology, Stanford University; Chief, Infectious Disease Section, VA Palo Alto Health Care System, was one of 65 new members elected to the Institute of Medicine. Members of the class of 2011 received their official welcome from Institute of Medicine President Harvey Fineberg at the institute's annual meeting this week. Members are elected for their excellence and professional achievement in a field relevant to the institute's mission and for their willingness to participate actively in its work.
CSTL Co-Chair David Korn Discusses Personalized Medicine
In an interview published in the May 2012 issue of Personalized Medicine, CSTL Co-Chair David Korn, Consultant in Pathology at Massachusetts General Hospital and Professor of Pathology at Harvard Medical School, discussed how a career begun in pathology shifted to career focused on research policy and the structure and function of U.S. research universities. In the interview, Dr. Korn highlighted his work with CSTL, the Committee’s work on the issue of direct-to-consumer genetic testing, and his concerns about genetic testing industry and the field of personalized medicine. Direct-to-consumer genetic testing was the subject of a 2009 cross-academies workshop organized by CSTL in collaboration with the National Academy of Sciences’ Board on Life Sciences and the Institute of Medicine. The workshop proceedings were summarized in the 2010 report Direct-to-Consumer Genetic Testing: Summary of a Workshop.
The Margaret A. Berger Scholarship
The Brooklyn Law School has established a scholarship in memory of Professor Margaret A. Berger. The Margaret A. Berger Scholarship was endowed by her sons, David and Joshua Berger and by family and friends. Professor Berger was a member of the faculty of Brooklyn Law School for more than thirty-five years. She was a pioneer in the field of scientific evidence and a founding member of CSTL. “Beyond the law,” the Law School notes, “she was a passionate reader, operagoer, Mets fan, gourmet cook, loving family member and treasured friend.” The scholarship is to be awarded to a student who demonstrates exceptional achievement in the law of evidence or civil procedure.
ACTIVITIES IN PROGRESS
Six Party Symposia on Synthetic Biology
Under the auspices of the National Academy of Sciences (NAS), CSTL and the Board on Life Sciences organized, in conjunction with the National Academy of Engineering (NAE), Royal Society (RS), Royal Academy of Engineering (RAE), Chinese Academy of Sciences (CAS) and Chinese Academy of Engineering (CAE), three symposia on synthetic biology in 2011-2012. The symposia built on a successful 2009 collaboration between the Royal Society, NAS/NAE, and the Organization for Economic Cooperation and Development (OECD) when these organizations partnered to sponsor an international symposium in Washington, D.C. entitled, Opportunities and Challenges in the Emerging Field of Synthetic Biology. The first symposium, which was held in the U.K. in April 2011, provided an overview of synthetic biology and developments in the past 5 years; an estimate of what might be achieved in the next 5, 10, and 25 year periods; the requirements and resources necessary for realizing value creation from synthetic biology; and the necessary conditions for an enabling environment. The focus of the October 2012 symposium in China was scientific and technical challenges that must be met to enable further development of the field. The June 2012 U.S. symposium focused on next-generation tools, platforms, and infrastructure necessary for continued progress in synthetic biology, and the associated policy implications. For more information on the symposium series, visit http://sites.nationalacademies.org/PGA/stl/synthetic_biology/index.htm. A summary report of the symposia proceedings will be issued in the winter.
The H5N1 Research Controversy
At the suggestion of and with support from the Alfred P. Sloan Foundation, CSTL, the National Research Council’s Board on Life Sciences, and the Institute of Medicine's Forum on Microbial Threats convened an ad hoc committee to organize a workshop to discuss the recent H5N1 Avian influenza virus controversy. The H5N1 Research Controversy arose in response to a December 2011 announcement that two research groups, one in the U.S. and the other in the Netherlands, both supported by funding from the U.S. National Institutes of Health (NIH), had submitted for publication papers describing research whereby variants of H5N1 influenza viruses produced in the laboratory by well-established techniques had become readily transmitted among ferrets. It also was announced that the U.S. National Science Advisory Board for Biosecurity (NSABB), after consideration of the benefits and risks of publishing these papers, had recommended that details of these studies be redacted from the manuscripts prior to publication, and that the U.S. government had endorsed this recommendation. These announcements precipitated a vigorous and far-reaching international discussion about the appropriateness and the risk assessment of this work and of dual use research, in general. As a result, the two research groups and other influenza researchers called for a temporary moratorium on research involving H5N1 influenza viruses that might lead to the creation of highly pathogenic, highly transmissible strains. For more information on the resulting workshop, visit http://sites.nationalacademies.org/PGA/stl/H5N1/index.htm. A summary report of the workshop proceedings will be issued in late 2012.
ACTIVITIES IN DEVELOPMENT
Responsive Oversight of Emerging Technologies: Legal, Ethical, and Regulatory Challenges
CSTL proposes to appoint an ad hoc committee to organize an exploratory workshop to consider the range of legal, ethical and governance issues associated with emerging technologies. The workshop will include presentations on a number on cutting-edge and rapidly advancing scientific and technological fields. Each presentation will be followed by formal discussions of the legal, ethical and governance challenges associated with the field. The committee will issue a letter report to the Alfred P. Sloan Foundation that evaluates the feasibility of undertaking a consensus study that would 1) identify principles to guide researchers and their institutions, policy makers, research funders, and others in developing appropriate administrative, legal, ethical, and regulatory responses to prevent or minimize adverse impacts from emerging technologies; 2) identify appropriate governmental and private sector institutions to provide leadership for addressing limitations and gaps in existing regulatory and oversight regimes; 3) identify policy mechanisms that might be developed for the purposes of responding to emerging technologies; and 4) consider when and how to engage the press and public in discussions regarding regulatory and governance issues associated with emerging sciences and new technologies.
Preparing the Next Generation of Policy Makers for Science-Based Policy Decisions
CSTL proposes to appoint an ad hoc committee to oversee the development of an educational mission statement, modules, and contextual materials that elucidate the role of science in decision-making for professional school students – with a particular emphasis on scientific and statistical methods of inference. The committee will commission a survey of existing courses and materials germane to the role of science in decision-making. Informed by the results of the survey, the committee will then solicit proposals for the development of suitable new material, evaluate submitted proposals, award contracts for winning proposals, and review and approve module submissions. Materials will be designed for use by faculty seeking to improve scientific understanding among legal, policy, and business students, either as parts of courses or as a course itself which individual faculty members will design. They will be structured to explicate core competencies in science and technology through illustrative case studies. After modules have been approved by the committee, the committee will organize a one-day meeting to disseminate information about the project and modules to relevant faculty/stakeholders. Initially, the modules will be posted on the National Academies website.
Understanding International Practice and Mechanisms for Funding, Conducting, and Disseminating Life Sciences Research of Concern
CSTL proposes to appoint an ad hoc committee to conduct a study of practices, policies, and oversight for supporting the responsible funding, conduct, and dissemination of life sciences research of concern. The committee will organize an international workshop to explore these issues and present the experiences of various countries and international organizations to address risks of security and safety that arise from the point of research conceptualization to the final dissemination of the research results. Particular attention will be paid to life sciences research that is, or that may be perceived to be, associated with heightened risks to the environment, public health, or national security. The workshop will be preceded by commissioned papers and structured to allow for focused discussion among smaller subsets of participants. The committee will author a report that summarizes the workshop discussions and identifies gaps and needs.
Synthetic Biology Forum
CSTL proposes to establish a forum for discussions about scientific, technical, ethical, legal, regulatory, security, and other policy issues associated with synthetic biology. Forum membership will include scientists and engineers from academia, industry, government, and NGOs, science and technology policy experts, security experts, ethicists, and lawyers. The Forum will stimulate dialogue about issues of mutual interest to its membership by serving as a venue in which to discuss scientific advances in, challenges and opportunities for, and public policy concerns about synthetic biology. The specific agendas for Forum meetings will be determined by the Forum membership. It is expected, however, that the Forum will begin its consideration of synthetic biology by addressing the near, mid- and far- term technical advances that have potential security and safety aspects and identifying possible strategies to address these aspects during both the development and post-development phases of the emerging technologies. The Forum will meet three times in a period of one year with options for two additional years. It may commission papers to inform its discussions and suggest topics for studies, workshops, or other public meetings to be held in conjunction with Forum meetings.