Introduction: What is informed consent?
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]. For both ethical and legal reasons, patients must be given enough information to be fully informed before deciding to undergo a major treatment, and this informed consent must be documented in writing.
Ten Barriers to Effective Informed Consent
Based on studies such as those reviewed in Appendix A, ten of the main challenges that have been identified in direct relation to informed consent are summarized here. See Appendix B for a full discussion of these barriers, and note that most of these involve the “process” of informed consent rather than written consent form itself.
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Lack of clinician time
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Confusion among clinicians about when informed consent is needed
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Physician concerns about giving too much information
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Perception of patients that the informed consent form is “just a legal release” for the doctor or hospital to proceed
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Patient unawareness that they can refuse the procedure or delay the decision
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Patient language and cultural issues
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Special patient circumstances and human factors (e.g. IQ, stress, timing)
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Poor quality of consent form and related educational materials
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Patient misunderstanding of information on the informed consent form or related educational information about the proposed surgery or procedure
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Clinician inability to detect patient's lack of comprehension
Key “best practices” that we endorse in the next section include:
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Recognize differences in education or literacy levels and provide more help to patients with less education or low literacy.
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Have extended discussions with patients and when possible have other staff (e.g. nurses) provide additional explanation of information presented by the doctor.
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To ensure thoroughness in content and consistency in language, employ a consistent outline or template when starting to create informed consent forms for different procedures.
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Use lower reading levels, better formatting, graphics, shorter lengths, and remove unnecessary material.
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Use consent forms as an outline for discussion with patients (e.g. to ensure that all key information about risks and benefits is presented).
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Give patients information or fact sheets that can be taken home.
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Consider use of multimedia formats (e.g. webcasts, podcasts, DVDs) along with written information to bolster understanding
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Use a “teach back” method in which patients are asked to repeat back the information that has been presented to them.
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Make sure patients are given an opportunity to decline procedures and are aware of their right to do so.
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