Greenberg v. Miami Children's Hospital Research Institute
Legal case on genetic research and informed consent
Greenberg v. Miami Children's Hospital Research Institute was a landmark legal case in the United States that addressed issues of informed consent, intellectual property, and the commercialization of genetic research. The case was decided in the United States District Court for the Southern District of Florida.
Background[edit | edit source]
The case arose from research conducted on Canavan disease, a rare genetic disorder that affects the central nervous system. The plaintiffs, including families affected by Canavan disease and the Greenberg family, had provided tissue samples and other biological materials to researchers at the Miami Children's Hospital Research Institute. The research was led by Dr. Reuben Matalon, who was instrumental in identifying the gene responsible for Canavan disease.
Legal Issues[edit | edit source]
The plaintiffs claimed that they had provided their biological materials with the understanding that the research would be used to develop a test for Canavan disease that would be freely available to the public. However, the researchers patented the gene and the test, and began charging royalties for its use. The plaintiffs argued that this constituted a breach of informed consent and fiduciary duty, as they were not informed that the research could lead to commercial patents.
Court Decision[edit | edit source]
The court ruled in favor of the defendants, stating that the plaintiffs did not have a property interest in the biological materials once they were donated. The court also found that the researchers did not have a fiduciary duty to the plaintiffs. However, the case highlighted the need for clearer guidelines on informed consent and the ethical implications of genetic research.
Impact[edit | edit source]
The case had significant implications for the field of genetic research, particularly in terms of how informed consent is obtained and how genetic materials are used. It raised awareness about the potential for commercialization of genetic discoveries and the need for transparency with research participants.
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