April 1980 I/8
Informed consent is back in the news. A recent issue of the New England Journal of Medicine (1) contains two articles which indicate that this most important ethical and legal norm ensuring patient's rights is not well observed.
The first article (2) demonstrates that patients often do not understand clearly the content of the informed consent form. 'Within one day of signing consent forms for chemotherapy, radiation therapy, or surgery, 200 cancer patients completed a test of their recall of the material in the consent explanation and filled out a questionnaire regarding their opinions of its purpose, content, and implications. Only 60 percent understood the purpose and nature of the procedure, and only 55 percent correctly listed even one major risk or complication.... only 40 percent had read the form carefully.... and only 27 percent could name one alternative treatment."
The second article,(3) using two standard tests, analyzes the readability of consent forms from five representative hospitals. The conclusion is that "the readability of all five were approximately equivalent to that of material intended for upper division undergraduates or graduate students. Four of the five forms were written at the level of a scientific journal, and the fifth at the level of a specialized academic magazine."
In both of the above articles the authors call for a revision of the forms used for informed consent and the process by which the information in the form is communicated to the patient. My intention is not to confirm nor to deny the conclusions in the above mentioned articles. They speak for themselves. But they also offer an opportunity to review some thoughts about informed consent and to discuss why it is necessary in the first place.
Elements of Informed Consent
The ethical and legal requirements for informed consent are (1) information, (2) comprehension, (3) voluntariness.
1. The specific information that should be provided for the patient concerns the purpose of the procedure, the risks and benefits that are anticipated, the alternative procedures and the hoped for results. Information should never be withheld for the purpose of eliciting consent and truthful answers should always be given to direct questions. If a research project is in question, then information may be withheld provided the research subject is informed that some information will not be revealed until the research is completed and that no direct harm results from withholding the information.
2. Comprehension of the conveyed knowledge is a requirement that is more complex than it might seem at first. Because the capability of the subjects to understand varies so greatly, the material must be adapted to the subject's capacities. Health care professionals are responsible for ascertaining that the subject has comprehended the information, especially if the risk is serious. If the patient cannot comprehend, then some third party, usually a family member but sometimes one appointed by the court, should be asked to act in the patient's best interest. Some have maintained that comprehension of difficult medical terms is not possible for the ordinary person. However, research has shown that persons uneducated in medical terms can understand and retain explanations about medical procedures if the explanations are well planned and in plain language.(4)
3. Voluntariness implies that the person understands the situation clearly and that no coercion nor undue influence is exercised by the health care professional. However, it is often difficult to determine where justifiable persuasion ends and undue influence begins. The health care professional who believes that some particular treatment is better for the patient should state her conviction but should also explain clearly the reason for this opinion. Voluntariness does not imply that the patient will be free from all pressure or persuasion that would come from the circumstances in which one finds oneself, For example, a person who has an inflamed appendix is limited insofar as freedom of choice is concerned. But voluntariness does imply that, over and above the limitations arising from the circumstances, no external coercion or moral manipulation is present.
The Reason Why
Some think that informed consent is required only for research protocols or for experimental procedures. Actually, informed consent is required for any action which would affect a person's physiological, psychological or moral integrity. Why is informed consent so important? Does it merely help avoid malpractice or does it fulfill an important human need?
Respect for persons, one of the most basic ethical principles, is carried out in practice through informed consent. The patient's right to informed consent arises from the conviction that human beings are responsible for their own actions and their own destinies. They must be treated as equals and allowed to make the important decisions of life for themselves whenever possible. Only in this way will they be able to reach their full potential as human beings. Though the health care professional offers help to the patient, in return, the health care professional is not given the right to make decisions for the patient nor to manipulate the patient. Health care professionals will dispose for the total and integrative betterment of the human beings whom they serve only if they are careful in observing the requirements of informed consent.
Kevin O'Rourke, OP
1. April 17, 1980, Vol. 302, n.16.
2. "Informed Consent--Why Are Its Goals Imperfectly Realized," B. Cassileth et al, p.896.
3. "On Readability of Surgical Consent Forms," T. Grunder, p.900,
4. "Informed Consent of Volunteers; A Direct Measurement of Comprehension and Retention of Information," Clinical Research, Sept. 1979.
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