While a few clinicians
and patients may mourn the shift from the “good old
days” of patients implicitly trusting their doctors
and nurses to help them make decisions without a bureaucratic
need for signed proof of consent, the fact is that much
in the old patient-physician relationship has changed in
the past century. Certainly, medicine has become more option-filled
and complex. Many patients now expect choices and can easily
find more information at their fingertips. The internet
has created a society, or at least half of a society, of
information-saturated but often knowledge-starved patients.
Society has also become more litigious. Meanwhile, there
are financial pressures on doctors to keep visits short
and there is increasing ethnic, cultural, and linguistic
diversity in the country—changes that only increase
the chances for imperfect communication. The Joint Commission
recently highlighted impacts of this increasing diversity
on health literacy; among the facts cited in that report
[Joint Commission 2007] [2003 National Assessment of Adult
Literacy (NAAL) National Center for Education for Educational
Statistics, U.S. Department of Education]:
A large segment of the American population has basic
(29%) to below basic (14%) prose literacy skills
Even larger segments have basic (33%) or below basic
(22%) simple quantitative skills
Five percent of Americans are non-literate in English
Awareness of these and
other barriers to truly informed consent (as summarized
in Table 3 and more fully explored in Appendix
B) is a good preliminary step toward improving the
whole informed consent process.
[Table 3, See Appendix B] 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.
1] Lack of clinician time
2] Confusion among clinicians about
when informed consent is needed
3] Physician concerns about giving
too much information
4] Perception of patients that the
informed consent form is “just a legal release”
for the doctor or hospital to proceed
5] Patient unawareness that they can
refuse the procedure or delay the decision
6] Patient language and cultural issues
7] Special patient circumstances and
human factors (e.g. IQ, stress, timing)
8] Poor quality of consent form and
related educational materials
9] Patient misunderstanding of information
on the informed consent form or related
educational information about the proposed surgery
or procedure
10] Clinician inability to detect patient's lack
of comprehension
Developed with a grant from the Robert Wood Johnson Foundation
