proposed in OMB Circular A-21 to determine a defensible set of allocation principles for animal care.

INTELLECTUAL PROPERTY RIGHTS

Advances in science have progressed through the sharing of intellectual, technical, and material resources. Scientific tools have generally been available to all investigators in a nonexclusive manner. During the last several years, there has been a substantial increase in the patenting of animals, animal products and reagents, and research tools and techniques. Some believe the aggressive enforcement of some patents and the broad interpretations of these patents have resulted in severe limitations on the use and distribution of some animals and research tools. Although intellectual property and research success should be protected, a balance is needed between patenting and research access to avoid severe restrictions on the free flow of information and biomedical resources. For example, the use of the oncomouse and the Cre-lox mouse model technologies is severely restricted by broad-based aggressive "reach-through" actions by patent holders. National involvement at all levels, with possible issue of a new national policy, is needed to resolve this issue in a satisfactory and appropriate manner. Two recent workshops sponsored by the National Research Council described the concerns of the scientific community in considerable detail (NRC 1994b; NRC 1996b).

DATABASES AND CONFIDENTIALITY

An emerging issue of critical concern to workshop members was the issue of data-sharing vs. confidentiality (NRC 1997). There is an increasing call from NIH for collaborative sharing of research databases, many of which contain data that explicitly identify individuals who might not have given consent to their wider distribution. This problem is exacerbated by the increasing capability of data-analysis methods to extract individual and confidential information from extensive collections of ostensibly innocuous research data. This issue is beyond the scope of this study on biomedical models, but it is mentioned because failure to resolve it is a potential impediment to future sharing of data related to comparison of biomedical models and human conditions.



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