Hopkins Study: Medical Consent Forms Confusing

Hopkins Study: Medical Consent Forms Confusing

Wed, 19 Feb 2003

A Johns Hopkins study reviewed the template of informed consent forms of 114 campuses– nearly all the country’s accredited medical schools. It applied two widely used readability tests and found the consent forms approved by local institutional review boards (IRB) failed to meet federal requirements of readability.

Consent forms are supposed to lay out rights, risks and potential benefits supposedly in a way that ordinary people can grasp–not above an 8th grade reading level.

“IRBs are supposed to protect folks from the legalese and medicalese,” said the study’s lead author, Dr. Michael Paasche-Orlow of Johns Hopkins University. “Unfortunately, from the implications of the study, it doesn’t seem they’re doing that.” Dr. Paasche-Orlow lays the blame on the IRBs.

ABC News includes an example calibrated for different reading levels. However, the particular example selected–the “Miranda Right” to refuse– is not ever as prominent in a real consent form as the example selected would lead one to assume.

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Study: Medical Consent Forms Confusing Study Suggests Most Americans Could Not Understand Consent Forms for Medical Studies

The Associated Press

BOSTON Feb. 19

The consent forms signed by patients who take part in medical studies are written in such complex language that most Americans could not understand them, a study suggests.

The study looked at the model forms that are drawn up by medical school ethics committees called Institutional Review Boards, or IRBs. The actual forms given to patients often lift long passages word-for-word from these templates, though some of the details differ from experiment to experiment.

The study found that these templates are written at a 10th-grade reading level or higher. The average American is believed to read at an eighth-grade level.

“IRBs are supposed to protect folks from the legalese and medicalese,” said the study’s lead author, Dr. Michael Paasche-Orlow of Johns Hopkins University. “Unfortunately, from the implications of the study, it doesn’t seem they’re doing that.”

Previous research has shown that medical consent forms both for routine and experimental treatment are often hard to understand. This study suggests a possible reason: The medical school committees assigned to protect research participants are writing forms that are too dense.

“More frequently than not, if there is a consequence, it’s going to be someone who agrees to participate but really doesn’t understand fully what’s going to happen,” said John M. Allen, assistant vice president for scientific affairs at Downstate Medical Center in New York City. That campus earned special mention in the study with its form requiring just sixth-grade reading skills.

Federal rules require consent forms. The modern emphasis on formal consent of human subjects grew largely out of the post-World War II Nuremberg military tribunal and its review of Nazi experiments on prisoners. Consent forms lay out rights, risks and potential benefits supposedly in a way that ordinary people can grasp.

Ethicists say clear and explicit consent forms are important because patients are often desperate for relief and have mistaken assumptions when they agree to take part in a study of a new drug or medical procedure.

Consent forms also help protect researchers and their institutions from lawsuits.

The Johns Hopkins study reviewed the template forms of 114 campuses nearly all the country’s accredited medical schools. It applied two widely used readability tests: the Flesch-Kincaid and the Fry. They gauge readability by the frequency of shorter words and sentences.

The computer-run Flesch-Kincaid test showed that the forms require on average a 10th-grade reading level. A smaller but representative sample of 24 forms tested by the Fry method showed they required the reading skills of a first-year college student.

Medical schools ordinarily set the eighth grade as their readability goal. But only 8 percent of the campuses met their own standards.

The study probably understates the challenges of reading consent forms, the researchers said, partly because they ignored the difficulty of medical terms.

However, Dr. Jeremy Sugarman, who runs the Center for the Study of Medical Ethics at Duke University, cautioned that researchers also generally review the risks and benefits with subjects, beyond asking them to read and sign consent forms.

“The consent forms are only the culmination of a process,” he said.

Excerpts From Medical Consent Forms Excerpts From Medical Consent Forms

The Associated Press

Feb. 19 – Excerpts from model consent forms put out by medical schools. A Johns Hopkins University study rated them for readability by grade level. Medical schools typically strive for an eighth-grade level.

4th Grade You don’t have to be in this research study. You can agree to be in the study now and change your mind later. Your decision will not affect your regular care. Your doctor’s attitude toward you will not change.

6th Grade Taking part in this study is your choice. If you decide not to take part, this will not harm your relations with your doctors or with the university.

8th Grade Participation in this study is entirely voluntary. You have the right to leave the study at any time. Leaving the study will not result in any penalty or loss of benefits to which you are entitled.

10th Grade Your participation in this study is voluntary and you are free to withdraw at any time. Participation or withdrawal will not affect any rights to which you are entitled.

12th Grade Your participation in this study is strictly voluntary. You have the right to choose not to participate or to withdraw your participation at any point in this study without prejudice to your future health care or other services to which you are otherwise entitled.

College You voluntarily consent to participate in this research investigation. You may refuse to participate in this investigation or withdraw your consent and discontinue participation in this study without penalty and without affecting your future care or your ability to receive alternative medical treatment at the university.

Copyright 2003 The Associated Press.

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