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Documentation of Human Subjects Research in the Patients Health
Failure to Fully Describe the Research: Research Procedures The protocol had a dose ranging component Jesse was the first participant assigned to the largest dose group Jesse was not informed that he may receive a dose larger than that given to any previous subject Failure to Revise Informed Consent Document Previous subjects in this trial had experienced severe elevated liver enzymes and serious adverse reactions These adverse effects had not been reported to federal regulators The consent form had not been amended to include these reactions Protocol procedures continued with increasing dosages despite warning signs Failure to Disclose Potential Conflicts of Interest The lead investigator and the University are reported to have had financial stakes in the research Financial conflicts of interest for the investigators and/or the institution were not disclosed in the informed consent process Failure to Assess Participants Understanding Statement by PAUL GELSINGER: “Jesse was doing exceptionally well on his medications, and nothing should have prevented him from living a full and happy life. He believed, after discussions with representatives from Penn, that the worst that could happen in the trial would be that he would have flu-like symptoms for a week. He was excited to help.” Was Jesse able to make an informed decision regarding his participation in this trial? Statement by Paul Gelsinger I still support our need for clinical trials, but with this caution: Informed consent is only possible if all facets of the research endeavor are ethical and in the open. Because of the secretive and conflicting influences on clinical research, the average research subject has little hope of understanding and giving truly informed consent. All research subjects really want is to be able to trust the system. If we can somehow get that system to apply Jesses Intent... not for recognition and not for money, but only to help... then research will get all it wants and more; the
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