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Journal of Long-Term Effects of Medical Implants
Abstract of "Researchers Must Review Informed Consent Laws' New Decisions"
Department of Periodontics and Implants Dentistry, Senior Advisor to Office of Clinical Case Review, New York University College of Dentistry, New York, NY 10010
Recent court decisions could make it more difficult for scientists to individually secure usage rights for research involving the study if human biological materials, since patients and clinicians have begun to question exactly what is grantedand to whom it is grantedwhen a patient signs an informed consent agreement. In 1978, John Moore had hairy-cell leukemia and his physician found that his white cells overproduced lymphokines, the proteins that regulate the immune system. Moore's cells were therefore both scientifically and commercially valuable. Later, the Regents of the University of California applied for a patent based on results using the cells with the profits to be shared between the applicants and the inventors. Moore sued using such grounds as conversion, lack of informed consent, and breach of fiduciary duty. He claimed his excised cells were his personal property. These grounds are discussed together with the implications of the result. Moore comes to a conclusion and cases that follow address similar issues using other legal theory including property law. Informed consent is the phrase used in tort law with respect to the requirement that a patient be apprised of the nature and risks of a medical procedure before the physician can validly claim exemption from liability for battery or from responsibility for medical complications. A conversion in the sense of the law consists either in appropriation thing to the party's own and beneficial enjoyment, or in destruction, or in exercising dominion over it, in exclusion or defiance of the plaintiff's right, or in withholding possession from the plaintiff under claim of title inconsistent with his own.
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