This article begins with an in-depth discussion of the UCLA incident followed by the history of protecting human research subjects and a review of the current law intended to protect research participants. Next, it explains the nature of schizophrenia and discusses the topic of schizophrenia and the informed consent process, explaining why persons with schizophrenia warrant more protection than is currently given, especially in the areas of monitoring and informed consent. This article also examines proposed ideas, from various sources, for better protection of the mentally disabled as research subjects. This article concludes with this writer's proposal as to how the DHHS regulations could provide true protection to the mentally disabled, such as those with schizophrenia, who serve as research subjects, by devising a separate subpart to the regulations. A rationale for each proposed section of the subpart is provided.
Note, True Protection for Persons with Severe Mental Disabilities, Such as Schizophrenia, Involved as Subjects in Research - A Look and Consideration of the Protection of Human Subjects, 9 J.L. & Health 349 (1994-1995)