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January/February 2024    Volume 5 Issue 1
Health Law Connections

Informed Consent and Its Newest Challenger: The Direct-to-Consumer Testing Industry

This Feature Article is brought to you by AHLA's Physician Organizations Practice Group.
  • January 01, 2024
  • Alexa De la Vega , Serpe Andrews PLLC
At Home Test

The earliest documentation of informed consent reverts to the nineteenth century, when Major Walter Reed asked volunteers to sign for their participation in a clinical experiment on Yellow Fever. Reed and his team wanted to ensure that volunteers understood the potential risks of their involvement in the research. Shortly thereafter, our judicial system gave legal significance to informed consent when the New York Court of Appeals decided Schloendorff v. Society of New York Hospital in 1914. In Schloendorff, the court sided with a patient who underwent and developed severe complications from an unconsented-to medical procedure at New York Hospital. In the court’s opinion, Justice Cardozo famously wrote that “every human being of adult years and sound mind has a right to determine what shall be done with his own body.” His words reappeared in a flurry of case law to follow, seemingly making strides for bodily autonomy in medicine. However, as informed consent gained conceptual recognition around the globe, society continued to witness decades of medical experimentation on nonconsenting subjects. Today, the contemporary doctrine of informed consent represents statutory guidance to protect patients against a history of abuse.


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