Ownership of Human Tissues and Cells: New Developments in BiotechnologyIn 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 |
161 | |
162 | |
Common terms and phrases
action activities addition antibodies application approved benefits biotechnology blood body called cell culture cell line claim cloned commercial gain common companies concerning consider continue costs courts Department determine developed disclosure donations established ethical example existing factor Federal funded gene genetic growth Health human biological materials human cells human tissues hybridoma important individual industry informed consent institution interest inventions involving isolated issues limited living ment molecule moral nature nonprofit obtained organs original participation particular patient payment person physician possible potential principle probably procedures profits protection protein reason recombinant regarding regulations relationship removed requirements research subjects respect response result risks sample setting sources specific specimens substance tion tissues and cells tort transplantation treatment tumor types University