California's new law allowing surrogate consent for clinical research involving subjects with impaired decision-making capacity

Luce, John M.
June 2003
Intensive Care Medicine;Jun2003, Vol. 29 Issue 6, p1024
Academic Journal
journal article
The article discusses on California's new law allowing surrogate consent for clinical research involving subjects with impaired decision-making capacity. In the United States federally funded clinical research is governed by the Code of Federal Regulations for the Protection of Human Subjects, which also is called the Common Rule. Many critically ill patients are incapable of giving informed consent because their decision-making capacity is impaired by their underlying diseases or by the administration of psychoactive drugs. The California Health and Safety Code formerly required that investigators obtain informed consent from the subject him or herself or through a legally authorized representative defined as a court appointed conservator.


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