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Consent form gobbledygook: Are medical research subjects adequately informed?

Sunday, June 20, 2010 by: S. L. Baker, features writer
Tags: medical research, consent forms, health news

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(NaturalNews) When a person signs up to participate in medical research, he or she is given a form to sign that is supposed to state the goal of the study as well as all the known possible risks of the drug or procedure being tested. But a new report by researchers from the University of Pennsylvania Law School and Columbia University concludes informed consent forms are often too long and complicated -- full of legalese and technical gobbledygook -- for many people to understand.

For anyone who takes a look at the sometimes shameful history of human experimentation in this country, even the slightest concern research subjects are not fully informed is worrisome. One of the most heartbreaking cases of study participants denied informed consent involved the infamous Tuskegee Syphilis Study. Between 1932 and 1972, the U.S. Public Health Service conducted experiments on 399 poor African-American men suffering from syphilis. The men were never told what disease they had or its seriousness. Instead, they were told they were being treated for "bad blood" by doctors who had no intention of curing them of syphilis at all. In fact, the goal was to collect data from the men's bodies after they died from the excruciating effects of untreated syphilis.

In 1966, Henry K Beecher, M.D., published a scholarly article, "Ethics and Clinical Research," that documented 22 unethical research trials published in U.S. medical journals since World War II. The paper revealed horrendously dangerous experiments conducted on unsuspecting research subjects. For example, malignant cells from cancer patients were injected into elderly and debilitated inmates of the Jewish Chronic Disease Hospital -- people who were incapable of giving informed consent.

No one is suggesting that the horrors of the Tuskegee Syphilis Study or the unethical research described by Dr. Beecher are still taking place in the 21st century. However, there are reasons to be concerned that many people participating in medical studies as research subjects are not always given comprehensible or accurate information.

Experimenting on Native American Indians

A case in point: in a high-profile legal case last April, a Native American tribe won a substantial settlement from Arizona State University because blood samples provided by Havasupai tribe members were used for purposes never revealed in the consent forms they signed. A researcher told the Indians, who live in the Grand Canyon, their blood samples would be used to find out why the tribe had high rates of diabetes. The blood was actually used to study rates of schizophrenia and for racial migration research.

For the new review of informed consent forms, which was just published in the journal IRB: Ethics and Human Research Efforts, the authors examined the accuracy and length of research consent forms used for 215 studies by one department in a major academic center over the past 25 years. Their conclusion? There is both good news and bad news. The actual information in consent forms has become far more accurate over time. However, the consent forms have become increasingly lengthier and more complicated -- growing from an average of a paragraph or two to more than four and a half pages.

The study authors cited data showing that these longer, wordier consent forms "are unlikely to be read, perhaps in part because of the time involved." And that raises the obvious question: if informed consent forms are not being read and understood before they are signed, what is the true state of genuinely informed consent among today's medical research subjects?

For more information:
http://www.thehastingscenter.org/Publication...
http://www.rcsed.ac.uk/journal/vol46_2/46200...

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