submitting them for publication or for incorporation into other databases. Also provides a good overview of intellectual property issues related to data. Data itself is not copyrightable, and there are significant limitations on copywriting databases. The policy context has not changed much since the time of this report, as the United States and other nations have not followed the European Union to create new intellectual property protection for databases.

Finding the Path: Issues of Access to Research Resources (1999)

Committee on Federal Policy for Access to Research, Resources, National Research Council

Synopsis: This conference summary describes issues affecting access to a variety of research resources in the life sciences, including data and databases, materials, software, and so forth. Provides background on data access issues in the life sciences. The recommendations are largely superseded by Sharing Publication-Related Data and Materials (2003).

Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making: Workshop Report (1999)

Jonathan R. Davis, Vivian P. Nolan, Janet Woodcock, and Ronald W. Estabrook, Editors, Institute of Medicine

Synopsis: Describes the process for assuring the integrity of clinical trial data and suggests improvements. Background to the issues of clinical trials data discussed in this study.

Bits of Power: Issues in Global Access to Scientific Data (1997)

Committee on Issues in the Transborder Flow of Scientific Data, National Research Council

Synopsis: Outlines the needs for access to data in the physical, astronomical, geological, and biological sciences. Characterizes the legal, economic, policy, and technical factors and trends that have an influence on access to data by the scientific community. Identifies and analyzes the barriers to international access to scientific data. Recommends approaches that could help overcome those barriers. The two key challenges are the increasing quantities, varieties, dissemination modes, and interdisciplinary relevance of data, and increasing legal and economic restrictions on publicly funded data. States the principle that “full and open access to scientific data should be adopted as the international norm for the exchange of scientific data derived from publicly funded research. The public-good interests in the full and open access to and use of scientific data need to be balanced against legitimate concerns for the protection of national security, individual privacy, and intellectual property.” This study would extend this principle somewhat, to include private-sector-funded data on which published research results are based.

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