research subjects to decide if they want to participate. It is important both to consider the safety of the experimental treatment and to understand the risks and benefits to the subjects. In utero gene therapy has the added complexity of posing risks not only to the fetus, but also to the pregnant woman. Further, voluntary consent is imperative. Gene therapy may be the only possible treatment, or the treatment of last resort, for some individuals. In such cases, it becomes questionable whether the patient can truly be said to make a voluntary decision to participate in the trial.
clinical trials tests per- Gene therapy clinical trials came under scrutiny in September 1999, formed on human sub- after the highly publicized death of a gene therapy clinical trial participant several days after he received the experimental treatment. This case raised concerns about the overall protection of human subjects in clinical testing, and specifically about the reliability of the informed consent process. In this case, it was alleged that information about potential risks to the patient was not fully disclosed to the patient and his family. It was further alleged that full information regarding adverse events (serious side effects or deaths) that occurred in animals receiving experimental treatment had not been adequately disclosed. Adverse events should be disclosed in a timely manner not only to the participants in these trials, but also to the regulatory bodies overseeing gene therapy clinical trials. Furthermore, participants had not been told of a conflict of interest posed by a financial relationship between
?the university researchers and the company supporting the research. Obviously, any conflicts of interests could interfere with the objectivity of researchers in evaluating the effectiveness of the clinical trials and should
Ka A1 ncn/i nnnnrf f no inmrmon /»Ancont nrn^occ be disclosed during the informed consent process.
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