BETHESDA, Md--Good informed consent improves both recruiting and
compliance in clinical trials involving genetic testing, said Robert
T. Croyle, PhD, associate professor of psychology, University of Utah.
"Consent shouldnt be considered just an afterthought, but
rather as part of a larger educational counseling process," he
said at the 22nd annual meeting of the American Society of Preventive
The psychological goal of a good consent process is to tell
participants not just what theyre being asked to do, but why. A
concept as basic to researchers as randomization--that some receive
treatment and others dont--may be disturbing to the layperson,
Dr. Croyle said. But, he added, it is worth the time and effort to
get subjects to understand, because it increases adherence later on.
This kind of explanation also gives participants more perceived
choice, reducing their uncertainty about entering the trial, he noted.
"We have to create an alliance," Dr. Croyle said. "We
shouldnt be afraid to inspire people with our own enthusiasm
for the research."
The present medical and social environment demands a better informed
consent process, he said, adding that both the public and government
are taking informed consent more seriously today.
Genetic testing, for example, raises issues that are important not
only to the subject but also to parents, siblings, and children,
especially since genetic testing may carry with it potentially
harmful effects--loss of job, loss of insurance, even social harm.
Traditionally, consent focused myopically on the content of the
consent form. Investigators rewrote, pilot tested, and revised forms
endlessly, Dr. Croyle said.
He argues that consent should be seen in the context of an overall
process of recruitment and accrual, with as much emphasis on the
"informed" as on the "consent." Much information
(like randomization) is better conveyed during recruitment, rather
than being postponed, only to surprise participants in the consent
phase, he said.
Changes in terminology from recruitment to consent to intervention
can confuse patients. Imagine how a patient would feel, Dr. Croyle
said, if told at recruitment only that he would be undergoing a
"genetic test." Then later he is told that the test was to
look for an "alteration in a gene," and that he, in fact,
carries a gene "mutation."
Dr. Croyle suggested a number of
methods to bolster the consent process.