Quality Assurance:
Informed consent requires more than just a good written form—it also requires preparation for a full discussion with the patient and a check to ensure that the messages have been received.
Informed consent is the process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention [AMA 1998].
Disclosure of facts related to an individual’s health care, including level and location of care, are central to the fulfillment of informed consent. When an individual is unable to provide informed consent because they lack the decision-making capacity to process the information and/or they have been deemed legally incompetent, the health care team should obtain assent from the individual whenever possible.
Questions remain as to how to proceed when assent cannot be gained and the decision involved causes a level of distress for the individual that is difficult to resolve. A focus on maintaining hope and support with a clear transition and follow-up plan are important variables to consider for an ethical, caring response.
Traditionally, the ethical principle of patient confidentiality, including the right to personal privacy has been an important consideration in healthcare. Recent incidents involving identify theft, confidentiality, and patient privacy have led to increasingly restrictive policies on patient health information and access to records and data. Some believe that these restrictions can harm efforts to protect the public’s health. This has prompted discussions on a more appropriate balance between privacy concerns and the protection of public health.
Upon successful completion of this module, the student will be able to satisfy the following outcomes:
• Case:
? Review a legal case on consent and identify the elements of a legal citation.
? Explain the meaning and importance of the doctrine of informed consent.
? Discuss why we have this doctrine and what would happen if we did not.
? Discuss the two elements that must be present for informed consent to exist under the law.
? In a legal case of negligence and liability explain why the basis for negligence may be battery, unconsented touching, or breach of a duty imposed on the doctor to disclose material information.
• SLP
? Discuss the importance of collecting sensitive information.
? Explain methods that might ensure security for patient records and data.
? Explain applicable regulations, statutes, or sources that support the collection of private medical information.
• TD
Discuss whether the courts are correct to hold that a physician may be liable for failure to inform the patient of the availability of a diagnostic procedure.