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Informed consent goes beyond a signed form
The process is equally important
At first glance, developing a template for an informed consent form seems like a simple thing. After all, the elements required to be included in a consent form have not changed much since they were first codified 25 years ago.
But ensuring consent forms accomplish those elements has proven tricky for researchers time and again, sometimes at a high price to studies and participants.
Federal regulations require that subjects must be provided certain information — that the study involves research and what the research is for; foreseeable risks and benefits to the participant; alternative procedures that might be more advantageous to the participant; the participant’s rights to confidentiality; and the patient’s right to refuse to participate or to discontinue participation.
"What the statutes provide is a basic guideline for what needs to be in the form," says LaDale George, JD, a Chicago attorney specializing in health care law. "The guideline is set up on the premise that if you have these elements [in the form], then communication will have occurred. That’s not necessarily the case."
A consent form might fully describe the research and its risks and benefits, but be understandable only to a participant who has a college degree in a scientific field, or only to patients who speak English. A form might contain the necessary wording and be understandable to a potential subject, but cultural or custom differences with the person presenting the consent form might prevent him or her from agreeing to participate.
Is form appropriate for special populations?
In addition to language and cultural considerations, the informed consent process must be applicable and appropriate to the study and to the population — consent forms for pediatric studies, those involving people who are mentally disabled, and those that involve prison or institutionalized populations, for example, all require special handling, language, and consideration.
"The three main elements of informed consent are full disclosure, adequate comprehension, and voluntary choice," says Barbara LoDico, CIP, executive director of human subjects protection at University of Medicine & Dentistry of New Jersey/Newark.
"But for subjects to understand the research and knowledgeably and voluntarily decide whether or not to participate is going to depend on whether the consent form is such that the population you’re dealing with can understand it," she adds.
Institutional review boards (IRBs) and health care legal specialists stress that informed consent is not a form, but a process, and while the core elements have not changed, approaches to making the process work better for a wide variety of studies and subjects have changed.
Sarah Hutchinson, with the University of Minnesota’s Research Subjects Protection Program, describes some sections of her IRB’s informed consent template that recently were revised to help investigators design consent forms that are more understandable to potential participants.
"What we tried to do is offer more explanation at the onset [for investigators drawing up consent forms], in hopes that we could bypass problems that would result later," she says.
One area that required some redesign was the Minnesota IRB’s recommendations regarding language dealing with the storage and use of DNA samples.
"Technology in that area has really evolved in recent years, so the presence of that language in consent forms has been ramped up," Hutchinson says. "We feel that investigators need to make people aware of the ramifications of storing their DNA for future use."
Anticipating current and future issues that might arise from clinical trials makes frequent reevaluation of consent forms a good idea, Hutchinson points out.
According to George, there are some elements of a consent form that have historically proven troublesome, and they are ones that bear close scrutiny when a template is designed.
"Risk and benefits, hands down, are where investigators go wrong," he says. "It needs to be clearly stated if there is a therapeutic benefit to the participant."
As examples, he points out studies at Johns Hopkins University and Penn State University that paid large monetary settlements after it was determined that they failed to disclose that study participants would receive no therapeutic benefits.
"You don’t neglect to mention that there are no benefits, and then shortchange on revealing the known and foreseeable risks involved," George states. "That is the standard that investigations must meet in their consent forms."
Costs incurred by patients is another area in which studies sometimes fall short in fully informing their subjects.
"If the patient gets sick from the study or test article and needs hospitalization or therapy, who will pay for that? Some insurance won’t cover treatment for adverse effects, while certain sponsors will tell investigators that they will cover the costs of any follow-up care that is required as a result of the subject’s participation, and that needs to be clearly set forth," George says.
And finally, while the core requirements haven’t changed, the U.S. Department of Health and Human Services (HHS) has issued a draft guideline seeking more disclosure of financial relationships between institutions/investigators and the companies sponsoring research. HHS does not mandate this disclosure, but if IRBs adopt the requirement, investigators are required to put the disclosures in their consent forms.