Informed consent - not.

A nurse hands a breast cancer patient a seven-page, single-spaced consent form describing the potential risks of an experimental treatment. The patient signs on the line, indicating she understands the possible dangers of unproven cancer therapy But does she really?

Two new studies raise troubling questions about the way researchers and physicians gather informed consent for experimental and routine medical procedures. In the first study, Terry C. Davis of the Louisiana State University Medical Center in Shreveport and her colleagues recruited 183 people, including 53 who had cancer or another medical condition.

The researchers gave the participants an adult literacy test. They discovered that, on average, the recruits were reading at a 7th to 8th grade level. Next, the team gave 69 participants an informed consent form that had been used in a cancer treatment study. The form had been written at a 16th grade level.

The remaining 114 people got a consent form written at a 7th grade level. The researchers gave all the recruits time to read the forms and then interviewed them about the contents.

Most people preferred the simplified form, the researchers found. However, those who read the easier version didn't seem to gain any better understanding of the implications of the experimental treatment, "It really didn't improve comprehension," Davis told Science News.

About 90 million adults in the United States have literacy skills ranking below 7th grade, the authors note. "Our findings raise ethical and legal questions about the ability of informed consent documents to aid all individuals in the decision-making process for study participation," the authors say in the May 6 Journal of th National Cancer Institute.

A second study suggests that forms used by hospitals to obtain consent for routine surgical procedures are needlessly complex.

Kenneth D. Hopper of the Pennsylvania State University College of Medicine in Hershey and his colleagues studied 616 hospital consent forms. They found that 25 percent of the forms assumed that patients have college-level skills and 9 percent required postgraduate education in order to fully understand the risks and benefits of a given procedure.

Even so, the team found that many forms didn't give patients enough information to make an informed decision about a procedure. The study appears in the May issue of Surgery.