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Informed consent without words

Investigators must obtain informed consent from human subjects before enrolling them in a clinical trial. This is usually done with a document and a conversation. The information conveyed has to do with risks and benefits, the concept that this is research and not treatment, compensation, and other elements required by regulation. The quality of the informed consent form varies tremendously - readability, reading level, clarity, and so on, and is the object of much review and discussion before the research is approved. My question is inspired by Dr. Tufte's Bose product manual: Would it be possible to convey graphically the information, much of which is abstract, needed by a subject to give informed consent to participate in research? That is, with no or few words?

-- Steven Byers (email)

So that medical experiments can be conducted on the illiterate?

-- Edward Tufte

An interesting scenario I had not thought of ... what is the current protocol for emergency treatment when the patient is unconscious, and ER personnel cannot contact relatives?

Michael Round

-- Michael Round (email)

Interesting idea worth considering. Saving a life takes precedence over over filling out forms, even important ones e.g., informed consent. How can one give informed consent when unconscious (or even intoxicated). In the case where the patient is unable to give consent and no relatives are available, a physician will proceed with emergency treatment in order to save a life, e.g., surgery to repair an aneurysm, perform a tracheostomy (a cut into the airway and insert a breathing tube), or relieve pressure of a tension pneumothorax by inserting a chest tube...

Most institutions also have ethics committees to advise and help resolve questions where the situations are less immediate, but critical, e.g., 3 daughters who decide to have life support stopped for 87 year-old mom with no detectable brain function, but the step-daughter who lives in California is opposed.


-- Steve A. McClain, MD (email)

To answer Mr. Tufte's question above ("So that medical experiments can be conducted on the illiterate?"): yes. For example, a clinical efficacy trial of a candidate HIV vaccine may recruit volunteers considered to be at high risk of HIV infection. Such people may live in "Third World" conditions, for example in certain African countries or certain US cities. In such conditions illiteracy is common: if not the total inability to read, then a grade-school ability that is inadequate to understand the tortured syntax of regulatory documents. There are standards in place to protect illiterate volunteers (such as having the document explained by a case worker, translator, etc.), but it would be nice if the document itself were not part of the problem.

Elements required by US regulations for informed consent are summarized at

I would share Mr. Byers's question: can such information be conveyed graphically?

-- Erik Schwab (email)

For an up-to-date discussion, see Oonagh P. Corrigan and Bryn Williams-Jones, "Consent is not enough--putting incompetent patients first in clinical trials," The Lancet, 361 (June 21, 2003), pp. 2096-2097. This article also provides links to the current worldwide literature. I have seen only the paper version of the article; perhaps it is posted also.

-- Edward Tufte

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