This research focuses on the analysis regarding disclosure of financial conflicts of interest (FCOI) after Gelsinger v. University of Pennsylvania (Penn). The main legal issue was that the participants did not have enough opportunity to make an autonomous decision about participating in the research because he was not informed about the researchers' and the institution's substantial FCOI. The disclosure system was adopted by the Code of Federal Regulations. Under the regulation, researchers and institutions need to report FCOI over $5,000 to the institution, and the internal review boards have to report to the federal authority if needed. In case of human research, the disclosure to Food and Drug Administration is mandatory. FCOI disclosure system would help participants to make an autonomous decision, and increase trust to the research process and researchers. Moreover, the system would let researchers keep fiduciary duty while (possibly) lowering legal liability in case of a lawsuit. There were discussions about the disclosure methodology in the United States. However, there have not been a lot of discussions in Korea even after the "Humidifier Disinfectant" case. Therefore, new legislations need to be considered. First, the system requires disclosure funded by not only government but also private institutions. Second, like California Supreme Court, the subject would be reviewed under the reasonable person standard by participants, including patents, equity, and stock. Third, the disclosure needs to include simple or brief explanation to the FCOI to be better understood by the participants. Fourth, the disclosure should be in the informed consent process. https://doi.org/10. 3346/jkms.2017.32.12.1910 • J Korean Med Sci 2017 32: 1910-1916 Keywords INTRODUCTIONShould research participants be told about the financial conflicts of interest (FCOI) of researchers or institutions? Until 1999, legal issues in the human research disclosure process had been focused on the disclosure of the potential risks and its management (1). However, when Dr. James M. Wilson conducted research without disclosing important FCOI information and resulted in a young human subject's death, critical opinions had emerged regarding whether the FCOI should be disclosed, and if so, how the process needs to be established in detail (2,3). CASE STUDY: WILSON CASE (GELSINGER V. UNIVERSITY OF PENNSYLVANIA [Penn])An 18-year-old participant named Jesse Gelsinger, died in one "human gene transfer study" conducted at the Penn in 1999. His death occurred after 4 days of infusion with a geno-vector.After the Food and Drug Administration (FDA)'s investigation, the government concluded that the subject's death was caused by two improper research procedures (4).First, the risk of Jesse's participation should have been reviewed under strict procedure regulation before the research, and Jesse, because of his rare disease, should not have been involved in the research (5). Jesse had ornithine transcarbamylase deficiency (OTCD), which makes it difficult for ...
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