HLT POL 100 Chapter Notes - Chapter N/A: Drawa, Chemotherapy, Carrier Testing
DepartmentHealth Policy and Management
Course CodeHLT POL 100
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HLT POL week 5 reading 2
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].
Although this process of patient-physician communication involves much more than getting a patient to
sign a written consent form (See Sidebar: “Informed Consent: It’s Not About the Form”), it is the very
formality and finality of that signed document that for practical purposes distinguishes full informed
consent from the routine patient education that occurs in nearly every clinical encounter
And for some very basic procedures—like a whole blood draw—a “basic consent” process involving a
simple description and request for verbal approval may be adequate. On the other end of the extreme,
the informed consent process for patients volunteering for clinical research is much more complex,
involving special Institutional Review Boards and close monitoring.
The case law and rules pertaining to informed consent have changed over the years and all 50 states
now have legislation that requires some level of informed consent. [Pape T 1997] Although the details of
these laws vary from state to state, the bottom line is that failure to obtain informed consent renders
any U.S. physician liable for negligence or battery and constitutes medical malpractice.
• Pennsylvania state law specifically requires that consent be obtained for blood transfusions,
chemotherapy, and methadone use as part of a narcotics treatment program. [PA Law Code]
• Many states have developed specific laws governing breast cancer diagnosis and treatment. [ACS
• The American College of Obstetrics and Gynecology has developed detailed guidelines for informed
consent issues related to sterilization and carrier testing for cystic fibrosis. [ACOG 2004]
But common sense suggests that not every potential risk can be described in detail and that only the
most prevalent and/or serious risks and side effects would be covered. [Wescott 2005] The number and
type of complications also may vary widely depending on the severity of the patient’s underlying
conditions or comorbidities
How often does informed consent work as intended?
• How do your practices match up to the national norms for informed consent?
• How does one even begin to measure the “success” of informed consent?
These are complex questions that have been tackled by clinicians and researchers from different
settings and perspectives. Many studies have focused on one therapeutic area of interest. Others have
analyzed the consent process only in the research setting. And some have evaluated the process in
targeted patient groups such as those with low literacy.
• A large segment of the American population has basic (29%) to below basic (14%) prose literacy skills
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