This article
strongly illustrates the problems caused when scientific writing isn’t
understood
by the ‘typical’ reader. Excellent examples are shown at the end. djs
Boston - 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 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, although some of the
details differ from experiment to experiment.
The study, published in last week’s New
England Journal of Medicine, 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, 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% 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.
Here are 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.
Fourth 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.
Sixth 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.
Eighth 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.