EXAMPLE 3.29 Who Can Give Informed 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 almost all medical research 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”?

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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? In most cases, there is not time 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.²⁹