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 shouldn’t 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 Oncology (ASPO).
The psychological goal of a good consent process is to tell participants not just what they’re being asked to do, but why. A concept as basic to researchers as randomization--that some receive treatment and others don’t--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 shouldn’t 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.
