The patenting and licensing of human genetic material and proteins represents an extension of intellectual property (IP) rights to naturally occurring biological material and scientific information, much of it well upstream of drugs and other disease therapies. This report concludes that IP restrictions rarely impose significant burdens on biomedical research, but there are reasons to be apprehensive about their future impact on scientific advances in this area. The report recommends 13 actions that policy-makers, courts, universities, and health and patent officials should take to prevent the increasingly complex web of IP protections from getting in the way of potential breakthroughs in genomic and proteomic research. It endorses the National Institutes of Health guidelines for technology licensing, data sharing, and research material exchanges and says that oversight of compliance should be strengthened. It recommends enactment of a statutory exception from infringement liability for research on a patented invention and raising the bar somewhat to qualify for a patent on upstream research discoveries in biotechnology. With respect to genetic diagnostic tests to detect patient mutations associated with certain diseases, the report urges patent holders to allow others to perform the tests for purposes of verifying the results. Table of Contents <ul>
<li>Front Matter</li>
<li>Summary</li>
<li>1 Introduction</li>
<li>2 Genomics, Proteomics, and the Changing Research Environment</li>
<li>3 The U.S. Patent System, Biotechnology, and the Courts</li>
<li>4 Trends in the Patenting and Licensing of Genomic and Protein Inventions and Their Impact on Biomedical Research</li>
<li>5 Conclusions and Recommendations</li>
<li>References</li>
<li>Appendix A Biographical Information of Committee and Staff</li>
<li>Appendix B Search Algorithms Used to Identify Patents of Interest</li>
</ul>

Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health

Science & Math

Policy and Global Affairs

Committee on Science, Technology, and Law

Board on Science, Technology, and Economic Policy

National, Research Council

Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation

Biological Sciences

National Academies Press

Based on a series of regional meetings on university campuses with officials from the national security community and academic research institutions, this report identifies specific actions that should be taken to maintain a thriving scientific research environment in an era of heightened security concerns. Actions include maintaining the open exchange of scientific information, fostering a productive environment for international scholars in the U.S., reexamining federal definitions of sensitive but unclassified research, and reviewing policies on deemed export controls. The federal government should establish a standing entity, preferably a Science and Security Commission, that would review policies regarding the exchange of information and the participation of foreign-born scientists and students in research. Table of Contents <ul>
<li>Front Matter</li>
<li>Summary</li>
<li>I. Introduction</li>
<li>II. Policies for Openness and Information Control</li>
<li>III. The Internationalization of U.S. Science and Engineering</li>
<li>IV. Biosecurity and Dual-Use Research in the Life Sciences</li>
<li>V. Research Priorities</li>
<li>VI. Partnerships for Science and Security</li>
<li>Appendix A Letter to Honorable John H. Marburger</li>
<li>Appendix B Previous Reports Regarding Science and Security</li>
<li>Appendix C References</li>
<li>Appendix D Committee on a New Government-University Partnership for Science and Security</li>
<li>Appendix E Meeting Agendas</li>
</ul>

Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities

Engineering & Transportation

Committee on a New Government-University Partnership for Science and Security

Engineering

Strengthening Forensic Science in the United States: A Path Forward

Scores of talented and dedicated people serve the forensic science community, performing vitally important work. However, they are often constrained by lack of adequate resources, sound policies, and national support. It is clear that change and advancements, both systematic and scientific, are needed in a number of forensic science disciplines to ensure the reliability of work, establish enforceable standards, and promote best practices with consistent application. Strengthening Forensic Science in the United States: A Path Forward provides a detailed plan for addressing these needs and suggests the creation of a new government entity, the National Institute of Forensic Science, to establish and enforce standards within the forensic science community. The benefits of improving and regulating the forensic science disciplines are clear: assisting law enforcement officials, enhancing homeland security, and reducing the risk of wrongful conviction and exoneration. Strengthening Forensic Science in the United States gives a full account of what is needed to advance the forensic science disciplines, including upgrading of systems and organizational structures, better training, widespread adoption of uniform and enforceable best practices, and mandatory certification and accreditation programs. While this book provides an essential call-to-action for congress and policy makers, it also serves as a vital tool for law enforcement agencies, criminal prosecutors and attorneys, and forensic science educators. Table of Contents <ul>
<li>Front Matter</li>
<li>Summary</li>
<li>1 Introduction</li>
<li>2 The Forensic Science Community and the Need for Integrated Governance</li>
<li>3 The Admission of Forensic Science Evidence in Litigation</li>
<li>4 The Principles of Science and Interpreting Scientific Data</li>
<li>5 Descriptions of Some Forensic Science Disciplines</li>
<li>6 Improving Methods, Practice, and Performance in Forensic Science</li>
<li>7 Strengthening Oversight of Forensic Science Practice</li>
<li>8 Education and Training in Forensic Science</li>
<li>9 Medical Examiner and Coroner Systems: Current and Future Needs</li>
<li>10 Automated Fingerprint Identification Systems</li>
<li>11 Homeland Security and the Forensic Science Disciplines</li>
<li>Appendix A: Biographical Information of Committee and Staff</li>
<li>Appendix B: Committee Meeting Agendas</li>
<li>Index</li>
</ul>

Health, Fitness & Dieting

Division on Engineering and Physical Sciences

Committee on Applied and Theoretical Statistics

Committee on Identifying the Needs of the Forensic Sciences Community

Psychology & Counseling

Thirty years ago federal policy underwent a major change through the Bayh-Dole Act of 1980, which fostered greater uniformity in the way research agencies treat inventions arising from the work they sponsor. Before the Act, if government agencies funded university research, the funding agency retained ownership of the knowledge and technologies that resulted. However, very little federally funded research was actually commercialized. As a result of the Act's passage, patenting and licensing activity from such research has accelerated. Although the system created by the Act has remained stable, it has generated debate about whether it might impede other forms of knowledge transfer. Concerns have also arisen that universities might prioritize commercialization at the expense of their traditional mission to pursue fundamental knowledge--for example, by steering research away from curiosity-driven topics toward applications that could yield financial returns. To address these concerns, the National Research Council convened a committee of experts from universities, industry, foundations, and similar organizations, as well as scholars of the subject, to review experience and evidence of the technology transfer system's effects and to recommend improvements. The present volume summarizes the committee's principal findings and recommendations. Table of Contents <ul>
<li>Front Matter</li>
<li>Summary</li>
<li>1 The Growth of University Technology Transfer</li>
<li>2 Influence of Technology Transfer on University Research Norms and Practices</li>
<li>3 Effectiveness and Accountability of University Technology Transfer Activities</li>
<li>4 Findings and Recommendations</li>
<li>Appendix A: Conference Agenda</li>
<li>Appendix B: Conference Presenters</li>
<li>Appendix C: Biographical Information of Committee and Staff</li>
</ul>

Managing University Intellectual Property in the Public Interest

Committee on Management of University Intellectual Property: Lessons from a Generation of Experience, Research, and Dialogue

Research

Today, scores of companies, primarily in the United States and Europe, are offering whole genome scanning services directly to the public. The proliferation of these companies and the services they offer demonstrate a public appetite for this information and where the future of genetics may be headed; they also demonstrate the need for serious discussion about the regulatory environment, patient privacy, and other policy implications of direct-to-consumer (DTC) genetic testing.  Rapid advances in genetic research already have begun to transform clinical practice and our understanding of disease progression. Existing research has revealed a genetic basis or component for numerous diseases, including Parkinson's disease, Alzheimer's disease, diabetes, heart disease, and several forms of cancer. The availability of the human genome sequence and the HapMap, plummeting costs of high-throughput screening, and increasingly sophisticated computational analyses have led to an explosion of discoveries of linkages between patterns of genetic variation and disease susceptibility. While this research is by no means a straight path toward better public health, improved knowledge of the genetic linkages has the potential to change fundamentally the way health professionals and public health practitioners approach the prevention and treatment of disease. Realizing this potential will require greater sophistication in the interpretation of genetic tests, new training for physicians and other diagnosticians, and new approaches to communicating findings to the public. As this rapidly growing field matures, all of these questions require attention from a variety of perspectives.  To discuss some of the foregoing issues, several units of the National Academies held a workshop on August 31 and September 1, 2009, to bring together a still-developing community of professionals from a variety of relevant disciplines, to educate the public and policy-makers about this emerging field, and to identify issues for future study. The meeting featured several invited presentations and discussions on the many technical, legal, policy, and ethical questions that such DTC testing raises, including: (1) overview of the current state of knowledge and the future research trajectory; (2) shared genes and emerging issues in privacy; (3) the regulatory framework; and (4) education of the public and the medical community.

Direct-to-Consumer Genetic Testing: Summary of a Workshop

Business & Money

Division on Earth and Life Studies

Board on Health Sciences Policy

Board on Health Care Services

Board on Life Sciences

Forum on Drug Discovery, Development, and Translation

INSTITUTE OF MEDICINE

National Cancer Policy Forum

Roundtable on Translating Genomic-Based Research for Health

Marketing & Sales

Less than a month after the September 11, 2001 attacks, letters containing spores of anthrax bacteria (Bacillus anthracis, or B. anthracis) were sent through the U.S. mail. Between October 4 and November 20, 2001, 22 individuals developed anthrax; 5 of the cases were fatal. During its investigation of the anthrax mailings, the FBI worked with other federal agencies to coordinate and conduct scientific analyses of the anthrax letter spore powders, environmental samples, clinical samples, and samples collected from laboratories that might have been the source of the letter-associated spores. The agency relied on external experts, including some who had developed tests to differentiate among strains of B. anthracis. In 2008, seven years into the investigation, the FBI asked the National Research Council (NRC) of the National Academy of Sciences (NAS) to conduct an independent review of the scientific approaches used during the investigation of the 2001 B. anthracis mailings. Review of the Scientific Approaches Used During the FBI's Investigation of the Anthrax Letters evaluates the scientific foundation for the techniques used by the FBI to determine whether these techniques met appropriate standards for scientific reliability and for use in forensic validation, and whether the FBI reached appropriate scientific conclusions from its use of these techniques. This report reviews and assesses scientific evidence considered in connection with the 2001 Bacillus anthracis mailings. Table of Contents <ul>
<li>Front Matter</li>
<li>Summary</li>
<li>1 Introduction</li>
<li>2 Biology and History of Bacillus anthracis</li>
<li>3 Scientific Investigation in a Law Enforcement Case and Description and Timeline of the FBI Scientific Investigation</li>
<li>4 Physical and Chemical Analyses</li>
<li>5 Microbiological and Genetic Analyses of Material in the Letters</li>
<li>6 Comparison of the Material in the Letters with Samples in the FBI Repository</li>
<li>Bibliography</li>
<li>Index of Documents Provided by the Federal Bureau of Investigation</li>
<li>Appendix A: Radiocarbon Dating</li>
<li>Appendix B: The Forensics Potential of Stable Isotope Analysis</li>
<li>Appendix C: Committee Evaluation of Statistical Analysis Report</li>
<li>Appendix D: Biographical Information of Committee and Staff</li>
<li>Index</li>
</ul>

Review of the Scientific Approaches Used During the FBI's Investigation of the 2001 Anthrax Letters

Politics & Social Sciences

Committee on Review of the Scientific Approaches Used During the FBI's Investigation of the 2001 Bacillus anthracis Mailings

Social Sciences

The Reference Manual on Scientific Evidence, Third Edition, assists judges in managing cases involving complex scientific and technical evidence by describing the basic tenets of key scientific fields from which legal evidence is typically derived and by providing examples of cases in which that evidence has been used. First published in 1994 by the Federal Judicial Center, the Reference Manual on Scientific Evidence has been relied upon in the legal and academic communities and is often cited by various courts and others. Judges faced with disputes over the admissibility of scientific and technical evidence refer to the manual to help them better understand and evaluate the relevance, reliability and usefulness of the evidence being proffered. The manual is not intended to tell judges what is good science and what is not. Instead, it serves to help judges identify issues on which experts are likely to differ and to guide the inquiry of the court in seeking an informed resolution of the conflict. The core of the manual consists of a series of chapters (reference guides) on various scientific topics, each authored by an expert in that field. The topics have been chosen by an oversight committee because of their complexity and frequency in litigation. Each chapter is intended to provide a general overview of the topic in lay terms, identifying issues that will be useful to judges and others in the legal profession. They are written for a non-technical audience and are not intended as exhaustive presentations of the topic. Rather, the chapters seek to provide judges with the basic information in an area of science, to allow them to have an informed conversation with the experts and attorneys. Table of Contents <ul>
<li>Front Matter</li>
<li>Introduction--Stephen Breyer</li>
<li>The Admissibility of Expert Testimony--Margaret A. Berger</li>
<li>How Science Works--David Goodstein</li>
<li>Reference Guide on Forensic Identification Expertise--Paul C. Giannelli, Edward J. Imwinkelried, and Joseph L. Peterson</li>
<li>Reference Guide on DNA Identification Evidence--David H. Kaye and George Sensabaugh</li>
<li>Reference Guide on Statistics--David H. Kaye and David A. Freedman</li>
<li>Reference Guide on Multiple Regression--Daniel L. Rubinfeld</li>
<li>Reference Guide on Survey Research--Shari Seidman Diamond</li>
<li>Reference Guide on Estimation of Economic Damages--Mark A. Allen, Robert E. Hall, and Victoria A. Lazear</li>
<li>Reference Guide on Exposure Science--Joseph V. Rodricks</li>
<li>Reference Guide on Epidemiology--Michael D. Green, D. Michal Freedman, and Leon Gordis</li>
<li>Reference Guide on Toxicology--Bernard D. Goldstein and Mary Sue Henifin</li>
<li>Reference Guide on Medical Testimony--John B. Wong, Lawrence O. Gostin, and Oscar A. Cabrera</li>
<li>Reference Guide on Neuroscience--Henry T. Greely and Anthony D. Wagner</li>
<li>Reference Guide on Mental Health Evidence--Paul S. Appelbaum</li>
<li>Reference Guide on Engineering--Channing R. Robertson, John E. Moalli, and David L. Black</li>
<li>Appendix A: Biographical Information of Committee and Staff</li>
<li>Index</li>
</ul>

Reference Manual on Scientific Evidence: Third Edition

Federal Judicial Center

Committee on the Development of the Third Edition of the Reference Manual on Scientific Evidence

Legal Education

Synthetic biology -- unlike any research discipline that precedes it -- has the potential to bypass the less predictable process of evolution to usher in a new and dynamic way of working with living systems. Ultimately, synthetic biologists hope to design and build engineered biological systems with capabilities that do not exist in natural systems -- capabilities that may ultimately be used for applications in manufacturing, food production, and global health. Importantly, synthetic biology represents an area of science and engineering that raises technical, ethical, regulatory, security, biosafety, intellectual property, and other issues that will be resolved differently in different parts of the world. As a better understanding of the global synthetic biology landscape could lead to tremendous benefits, six academies -- the United Kingdom's Royal Society and Royal Academy of Engineering, the United States' National Academy of Sciences and National Academy of Engineering, and the Chinese Academy of Science and Chinese Academy of Engineering -- organized a series of international symposia on the scientific, technical, and policy issues associated with synthetic biology. Positioning Synthetic Biology to Meet the Challenges of the 21st Century summarizes the symposia proceedings. Table of Contents <ul>
<li>Front Matter</li>
<li>1 Introduction</li>
<li>2 Synthetic Biology: Science and Technology for the New Millennium</li>
<li>3 Strategies for Advancing Synthetic Biology</li>
<li>4 Opportunities and Challenges Emerging via a Networked World</li>
<li>Appendixes</li>
<li>Appendix A: London Symposium Agenda</li>
<li>Appendix B: Shanghai Symposium Agenda</li>
<li>Appendix C: Washington, DC Symposium Agenda</li>
</ul>

Positioning Synthetic Biology to Meet the Challenges of the 21st Century: Summary Report of a Six Academies Symposium Series

National Academy of Engineering

Animals are widely used in neuroscience research to explore biological mechanisms of nervous system function, to identify the genetic basis of disease states, and to provide models of human disorders and diseases for the development of new treatments. To ensure the humane care and use of animals, numerous laws, policies, and regulations are in place governing the use of animals in research, and certain animal regulations have implications specific to neuroscience research. To consider animal research regulations from a global perspective, the IOM Forum on Neuroscience and Nervous System Disorders, in collaboration with the National Research Council and the Institute for Laboratory Animal Research, held a workshop in Buckinghamshire, UK, July 26-27, 2011. The workshop brought together neuroscientists, legal scholars, administrators, and other key stakeholders to discuss current and emerging trends in animal regulations as they apply to the neurosciences.  This document summarizes the workshop.

International Animal Research Regulations: Impact on Neuroscience Research: Workshop Summary

Institute for Laboratory Animal Research

Forum on Neuroscience and Nervous System Disorders

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