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January 7, 1974

Informed Consent

Author Affiliations

Clinton, NC

JAMA. 1974;227(1):73. doi:10.1001/jama.1974.03230140043012

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In the current issue of the Archives of General Psychiatry (30:129-135, 1974) Romano writes on the always elusive concept of informed consent in clinical research and again suggests the still unresolved ethical question: how informed is informed consent?

His research project deals with children at risk for schizophrenia and their parents, and while he does not list exactly what the project involves, he makes it clear that it does not include the risks of pharmacological liabilities (either in the administration or withholding of drugs) or surgical invasions, but rather such minimal risk procedures as observations, questions, and suggestions involving perhaps inconvenience and psychic discomfort, and the risks of invaded confidentiality, albeit in an appropriately protected context.

While Romano recognizes the vulnerability of confidential information in a research setting, including it under the notion of risk and seeking appropriate methods of getting informed consent, his main concern seems to be the