Kenneth A. Getz
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For years now, clinical research professionals across a variety of disciplines—from government- and industry-funded research
sponsor professionals to investigative site staff, bio-ethicists, and IRB members—have spoken passionately about the need
for improvements in the informed consent process. Numerous initiatives have been implemented, including those utilizing multimedia
technologies, those simplifying and streamlining consent form language, and those modifying approaches to communicating and
educating study volunteers. Despite all of these well-intentioned initiatives, however, little has been done to fundamentally
and sustainably improve the informed consent process.
Wide reaching problems
"Most initiatives are ineffective and in some cases ignore the spirit if not the letter of federal regulations on the matter,"
explained Mark Hochhauser, a Minnesota based readability consultant, IRB member, and informed consent expert. "Repeated attempts
to shorten consent forms have really accomplished nothing," he said. Factoring in the eight elements mandated by the FDA,
six "when appropriate" elements, and another five to 11 pieces of information required by the Health Insurance Portability
and Accountability Act (HIPAA), the average consent document still averages more than 12 pages, according to Hochhauser.
The informed consent process should begin with general education about clinical trials before participants walk in the door.
Next, during informed consent form review and discussion, the study volunteer has the opportunity to read, talk about, and
question the protocol and the risks and benefits of participation with the investigator and study staff. The informed consent
process continues during the clinical trial with the sharing of any new information investigators learn about the molecule
being studied. The process ends with poststudy communication about how participants' involvement mattered. Conceptually, this process seems not only reasonable but also essential to engaging study volunteers and establishing their
partnership with clinical research professionals. In practice, the informed consent process leaves much to be desired.
Problems abound widely and at every level. Informed consent form review is generally not viewed as an educational experience
but rather as "information overload" for most study volunteers. It may be irrelevant, for instance, to tell would-be participants
about side effects seen solely in animals, although some would argue it is Good Clinical Practice to do so. Lengthy lists
of side effects—some containing hundreds of them—likely leave a number of prospective subjects ruminating more about the many
dangers of a given clinical trial before they properly understand and can weigh the benefits. Decision-making is further hindered
by vague statements about medical benefits rather than what sponsors hope the study might accomplish.
Investigative sites, for their part, may be reticent to share any new information learned about an undesirable side effect
midway through a study. Yet, according to Hochhauser, there is no evidence of subjects dropping out of trials because a site
is forthcoming with such information. "If they have cancer, especially, it may well be a risk they're willing to take," he
said.
Stumbling blocks
There is little to no evidence demonstrating that various initiatives and interventions are actually improving volunteer comprehension.
Based on research in this area, all that appears to help is for study participants to spend more time reviewing and discussing
the protocol and clinical trial expectations with the investigator and study staff. Hochhauser suggests that these studies
are themselves scientifically flawed, in part because there are no baseline or follow-up testing phases. "For all we know,
the consent process makes comprehension scores go down," he added.
Hochhauser is an advocate of federally funded research on the consent process using forms written at the recommended 6th to
8th grade reading level, which no one has ever been able to produce. "If that is to change," he said, "federal regulators
need to provide sponsors with examples of simplified narratives pulled from real consent forms used in real clinical trials."
He would also like to see federal agencies offer plain English examples of a complete HIPAA privacy notice. "Without these
examples, health care organizations and their law firms develop compliant HIPAA notices that are then used by the organizations'
members, even though such notices cannot easily be understood by patients. The goal is compliance, not communication," Hochhauser
said.
