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Risk managers have been more worried lately about the informed consent forms their institutions use since it has become apparent the forms can backfire. An informed consent form that doesn’t properly inform the patient can be used against you in court later, and writing a good one is more difficult than you can imagine.
Simply writing the informed consent form for a lower reading level may not be enough, experts say. The best solution may be to actually get patients involved in the process. But that’s the case only if you really want patients to understand the consent form, says Mark Hoch-hauser, PhD, a psychologist in Golden Valley, MN, who specializes in readability consulting and works extensively with health care providers. For years, he says, lawyers and risk managers have seen informed consent forms primarily as a way to protect the provider against lawsuits, not necessarily a way to tell patients what they need to know. The two goals don’t have to be incompatible, he says, but over the years, health care providers have let the informed consent document drift decidedly into the former camp.
"Most of these forms are written by lawyers in legalese, then handed to sick people to decipher," he says. "The purpose is not really to get informed consent, it’s just to keep people from suing you. You have to have language in there to protect the institution, but if that’s all there is, you’re not getting informed consent."
Hochhauser says the problem is rampant throughout the health care industry and, in many cases, providers are trying unsuccessfully to do the right thing. He says he recently saw a health care facility that printed a lengthy "Patient Bill of Rights" to help patients, but it was written at a postgraduate reading level. "For your typical hospital patient, that’s incomprehensible," he says. "What’s the point?"
Hochhauser says a recent case involving Tampa (FL) General Hospital illustrates how a consent form can backfire when it is designed only to protect the hospital. The hospital and the University of South Florida (USF) recently agreed to pay a $3.8 million settlement to plaintiffs claiming they consented to medical research studies but did not understand the consent form. The hospital paid $1.1 million and the university paid $2.7 million.1
In effect, the defendants claimed the hospital performed procedures on them without their consent. USF researchers focused on women at high risk of delivering small, premature babies. The women were treated with corticosteroid injections and had to undergo amniocentesis, sometimes repeatedly. The lawsuit alleged that "defendants engaged in a policy or practice of conducting randomized medical research studies on the named plaintiffs and other similarly situated pregnant females without obtaining lawful informed consent from them." The case was litigated for 10 years and, in the consent decree filed in November 2000, the hospital and university still denied the charge but agreed to improve the consent process.
"USF shall implement a policy requiring that USF researchers, when engaged in research studies involving pregnant women at Tampa General Hospital, will apply a standard readability test to research consent forms prior to their submission to the IRB [investigational review board]," the consent decree states. "The purpose of such policy is to provide help and guidance to researchers in the drafting and preparation of research consent forms. At its option, USF may terminate this policy, on a prospective basis only, seven years after the approval date."
The decree also requires that $25,000 of the funds paid by the university be used to help the school’s researchers design improved informed consent documents. Hochhauser studied the consent forms at issue in the case, and says they required a reading level equal to two years of college. The forms provided the necessary information for the patient, he says, but only if the patient could understand them. He is certain that very few could.
"The USF case didn’t get much attention, but it deserves it," Hochhauser says. "The consent form wasn’t different from what is used at institutions across the country, but they eventually had to come to an agreement that those patients didn’t know what they were agreeing to. It cost them a lot of money."
Stephen Moore, JD, partner in charge of the corporate health services section at the law firm of Hinshaw & Culbertson in Rockford, IL, says health care providers risk significant liability if they do not review and improve their consent forms. Though the forms may not provide a basis for a lawsuit by themselves, they may factor into other malpractice claims. "If the form is not readable by an average person, you don’t really have a useful form at all," he says. "A form that is difficult to understand actually could be produced in court and serve to prove the case that the patient was confused and did not understand the risks."
When reviewing a consent form, Moore suggests you consider how it would sound if read aloud to a jury during a malpractice trial. Imagine the form being read aloud by a smarmy plaintiff’s attorney using a good measure of sarcasm. Consider how the jury would react. Would it think a reasonable, average person would understand the consent document? Or would it dismiss the form as gobbledygook that no one but a lawyer could understand? "The document must be easy to understand or it has little value and actually can be harmful to you," he says. "I’ve heard of a number of cases in which the plaintiff alleged that the form was so indecipherable that they didn’t understand what they were consenting to. That can be damaging."
Even so, a poorly written consent form is not likely to spark a lawsuit all by itself, Moore says. Rather, the consent form can create added exposure when the provider is sued for whatever went wrong in the procedure. "Remember that if you don’t have informed consent, you have technical battery once you put your hands on that person," Moore says. "We do see some cases where there was no harm to the patient at all, but patients have filed claims of battery because there was no informed consent. They usually don’t get any substantial payout when that’s the case, but the consent issue can be significant when it’s tacked on to other claims."
While the issue has gained more attention in recent years, Hochhauser says providers still aren’t doing much to improve consent forms. The USF case should provide a financial reason to provide better consent forms, he says. "Things are improving, but improving very slowly," he says. "It will take more high-profile cases to get people’s attention. It’s just not a high-priority issue for most hospitals, and it won’t be unless they see a real compelling reason to do something, preferably with a financial incentive."
Hochhauser says all health care providers should review their consent forms and make an effort to improve them. Writing them at a lower reading level will help, he says, but don’t be lulled into thinking that is the whole problem. Rewriting the consent form for a lower reading level may address only some of the issues that prevent the patient from truly understanding the exchange.
Changing consent forms may prove a difficult task for risk managers, Hochhauser says. Even if the risk manager can overcome the tendency to write in a stuffy, academic manner, there may be many other egos to deal with. It is not uncommon for doctors, lawyers, and administrators to resist any attempts to make the consent form easier to understand, he says. Some resistance comes from people who would rather write in a complex way to show off their language skills, and some comes from simply not understanding the limits of the average person’s reading and comprehension. Lawyers and doctors can be accustomed to communicating with people with high educational levels and forget that the average patient may be quite different.
On a more cynical level, Hochhauser cautions that some hospital leaders, especially legal counsel, don’t want the patient to understand the form better. "Some lawyers argue that if you change the wording, you make it more likely you’ll be sued," he says. "They’re saying that if people really understand what we’re doing here, they’ll sue us. So let’s confuse them so they don’t understand and don’t know to sue us. I don’t think that’s how you want to run your hospital."
1. Diaz, et al. v. Hillsborough General Hospital Authority, et al., Case No. 90-120-CIV-T-25B, United States District Court for the Middle District of Florida, Tampa Division.