informed consent, mentally ill, research, clinical research, schizophrenia


This Note demonstrates that the federal regulations regarding human subject research must provide more specific guidelines that emphasize the process of obtaining informed consent from persons with mental illnesses. Part I discusses schizophrenia as a case example of mental illness that requires more stringent informed consent standards in human subject research. Part II describes the legal foundations of informed consent to human experimentation and the current federal regulations for human subject research. Part III examines the inadequacy of current federal regulations for mentally ill research subjects and proposes revisions to ensure that mentally ill persons provide adequate informed consent to participate in research. This Note concludes that when the potential subject is a person with schizophrenia, the process of obtaining informed consent should require a conversation between the physician-investigator and the potential subject in the presence of a third party patient advocate.



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