Ownership of Human Tissues and Cells: New Developments in Biotechnology

Front Cover
In this special report, the Office of Technology Assessment of the United States Congress analyzes the economic, legal and ethical rights of the human sources of tissues and cells and also those of the physicians or researchers who obtain and develop these biological materials. The study describes the potential of these rapidly moving technologies (tissue and cell culture, cell fusion to produce monoclonal antibodies, and recombinant DNA) for manipulating human tissues and cells to yield commercially valuable products. The report includes a range of options for congressional action related to commercialization of human biological materials, regulation of research with human subjects, and disclosure of physicians commercial interest in patient treatment.

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Contents

Chapter Page 1 Summary Policy Issues and Options for Congressional Action
3
Legal Considerations
9
Introduction
23
Tables
30
The Technologies
31
Table No Page
48
The Interested Parties
49
Many Questions Few Definitive Answers 3
68
Figure
114
Economic Considerations
115
Ethical Considerations
129
Appendix A Code of Federal Regulations Part 46 Subpart A
147
B Acknowledgments
155
Glossary
156
Index
161
Box No Page
162

Legal Considerations
69
Informed Consent and Disclosure
93

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