The SRA Symposium - College of Medicine

Papers
Even if prospective subjects can recall key elements of the clinical trial when asked, such recall
may reflect only rote memory with little influence on subjects’ decision making process. For
people with average memories, let alone those patients whose memories may be affected by psychological
stress, emotions, their illness or drug treatments, remembering every piece of information
in the consent process would be psychologically overwhelming, making a carefully reasoned
decision virtually impossible.
Better understanding via enhanced consent forms? Because of concerns about participants’ ability
to understand the information given to them in the informed consent process/consent form, some
researchers have tried to improve subjects’ level of understanding, usually by trying to modify
and improve the consent form. In their review of these efforts, Flory and Emanuel (2004) found
that enhanced consent forms didn’t significantly improve participants’ understanding—but more
person-to-person contact by a study team member or neutral educator did improve understanding.
As they note, much of the “enhanced” research has emphasized the consent form, although
the informed consent process includes both conversational and written components. While they
noted that this research varied in terms of methodologies and measurement instruments, they did
not explore the psychologically relevant issues of instrument validity and reliability. If measures
of consent form comprehension were not developed with an awareness of validity and reliability
issues, the findings from those studies are scientifically meaningless.
Similar conclusions were reached by Campbell, Goldman, Boccia, et al (2004) who compared informed
consent information recalled via four presentations: 1) original written forms, 2) enhanced
print—simpler language, topic headings, pictures, 3) narrated videotapes, 4) self-paced Power-
Point laptop presentations with bullet points, picture, and narration. They found no overall differences
in the amount of information recalled, but did find recall improvements with the enhanced
print version for subjects with 8th grade or lower reading comprehension scores. But the links
between memory, understanding, and decision making are presumed, not proven.
Over the past 20 years, Paul Appelbaum and his colleagues (Appelbaum, Roth, Lidz, 1982; Appelbaum,
Roth, Lidz, et al 1987) have written extensively about “therapeutic misconception” in
clinical trials—the mistaken belief held by many patients that research projects will directly benefit
them. A recent study (Appelbaum, Lidz, and Grisso, 2004) found about 30% of participants having
inaccurate beliefs about the degree of individualized treatment they would get in a clinical trial;
about 50% had unreasonable beliefs about the benefits of being in a clinical trial. These researchers
have consistently suggested that the informed consent process include specific information to
patients so that they do not believe that a clinical trial is just another form of treatment. One possible
way to address these issues is to have a summary (see Table #1) of how research differs from
treatment that can be discussed with patients during the informed consent process.
108 2005 Symposium Proceedings Book