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Primer on informed consent

Elizabeth Cameron (Cameron@alma.edu) is a Professor of Management and Business Law at Alma College in Alma, MI. Tom Ealey (ealey@alma.edu) is a Professor of Business Administration at Alma College.

Consent is largely a function of state law, with many common threads weaving through the various statutes. All providers should be well versed in the laws of their state. Medicare regulations also play a role in consent standards.[1]

Protecting the rights of patients is paramount, but compliance with the law also protects providers. There is a significant interest in monitoring compliance with informed consent policies and regulations. Important regulatory and litigation risks exist in the failure of informed consent practices. Compliance efforts must be directed toward ensuring a robust program of informed consent and faithful adherence to organizational standards. How do we discover consent failures? Usually through complaints, regulatory sanctions, and/or litigation. All are best avoided!

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