Informed consent
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Both words in the phrase “informed consent” are important, and both can be controversial. Subjects must be informed in advance about the nature of a study and any risk of harm it may bring. In the case of a sample survey, physical harm is not possible. The subjects should be told what kinds of questions the survey will ask and about how much of their time it will take. Experimenters must tell subjects the nature and purpose of the study and outline possible risks. Subjects must then consent, usually in writing.
EXAMPLE 2 Who can consent?
Are there some subjects who can’t give informed consent? It was once common, for example, to test new vaccines on prison inmates who gave their consent in return for good-behavior credit. Now we worry that prisoners are not really free to refuse, and the law forbids medical experiments in prisons.
Children can’t give fully informed consent, so the usual procedure is to ask their parents. A study of new ways to teach reading is about to start at a local elementary school, so the study team sends consent forms home to parents. Many parents don’t return the forms. Can their children take part in the study because the parents did not say No, or should we allow only children whose parents returned the form and said Yes?
What about research into new medical treatments for people with mental disorders? What about studies of new ways to help emergency room patients who may be unconscious or have suffered a stroke? In most cases, there is no time even to get the consent of the family. Does the principle of informed consent bar realistic trials of new treatments for unconscious patients?
These are questions without clear answers. Reasonable people differ strongly on all of them. There is nothing simple about informed consent.
NOW IT’S YOUR TURN
Question 7.2
7.2 Informed consent? A 72-year-old man with multiple sclerosis is hospitalized. His doctor feels he may need to be placed on a feeding tube soon to ensure adequate nourishment. He asks the patient about this in the morning and the patient agrees. However, in the evening (before the tube has been placed), the patient becomes disoriented and seems confused about his decision to have the feeding tube placed. He tells the doctor he doesn’t want it in. The doctor revisits the question in the morning, when the patient is again lucid. Unable to recall his state of mind from the previous evening, the patient again agrees to the procedure. Do you believe the patient has given informed consent to the procedure?
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Statisticians, honest and dishonest
Developed nations rely on government statisticians to produce honest data. We trust the monthly unemployment rate, for example, to guide both public and private decisions. Honesty can’t be taken for granted, however. In 1998, the Russian government arrested the top statisticians in the State Committee for Statistics. They were accused of taking bribes to fudge data to help companies avoid taxes. “It means that we know nothing about the performance of Russian companies,” said one newspaper editor.
The difficulties of informed consent do not vanish even for capable subjects. Some researchers, especially in medical trials, regard consent as a barrier to getting patients to participate in research. They may not explain all possible risks; they may not point out that there are other therapies that might be better than those being studied; they may be too optimistic when talking with patients even when the consent form has all the right details. On the other hand, mentioning every possible risk leads to very long consent forms that really are barriers. “They are like rental car contracts,” one lawyer said. Some subjects don’t read forms that run five or six printed pages. Others are frightened by the large number of possible (but unlikely) disasters that might happen and so refuse to participate. Of course, unlikely disasters sometimes happen. When they do, lawsuits follow, and the consent forms become yet longer and more detailed.