Legislative Issues in Disclosing Financial Conflicts of Interest to Participants in Biomedical Research: Effectiveness and Methodology.

Legislative Issues in Disclosing Financial Conflicts of Interest to Participants in Biomedical Research: Effectiveness and Methodology. J Korean Med Sci. 2017 Dec;32(12):1910-1916 Authors: Kim JS Abstract 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 syste...
Source: Journal of Korean Medical Science - Category: Biomedical Science Tags: J Korean Med Sci Source Type: research