The Right Choice?

More than a document: The importance of the informed consent process


In a recent issue of JAMA Surgery, Dr. Jacqueline M. Garonzik-Wang and colleagues presented the results of an important study of missing surgical consent forms at Johns Hopkins Hospital. The authors tallied the absence of a surgical consent form in a patient’s medical record and the resulting delays and other impacts on the surgical services. The authors also surveyed nurses, surgical residents, and surgical faculty regarding their satisfaction with the informed consent process. The results of the study show that cases are often delayed and surgical residents are often pulled away from other activities (e.g., educational conferences) to have new consent forms signed in the preoperative area. In addition, both faculty and residents had concerns about residents obtaining informed consent for major elective procedures.

This is undoubtedly an important study in that it casts light upon an important source of delays and dissatisfaction in the preoperative setting. However, are there additional lessons about informed consent that might be gleaned from this type of analysis?

Moving beyond the study itself, other important issues arise. Consider a patient who comes to the office for evaluation of a symptomatic hernia. Once the surgeon decides that the operation is indicated, the consent process requires a description of the indications (benefits), risks, and alternatives for the patient. Even though the surgeon may be convinced that the benefits of the operation outweigh the risks, the patient still needs to be convinced. Depending on the patient and the procedure being recommended, the time necessary to explain the above to the patient so that he or she is adequately informed and willing to sign the consent form will vary greatly.

In contemporary surgical practice, the determination of when the patient has been adequately informed is made by the patient. At the point that he or she is comfortable enough with the recommendation to proceed to an operation, the informed consent process has reached its conclusion. Only at this point, is the informed consent form even relevant to the discussion. The patient’s signature on the informed consent form is designed to signify the conclusion of the informed consent process.

Although we often mix the signature on the form with the process itself, they are, in fact, markedly different. The informed consent process is an ethical requirement; whereas the signature on the form is a legal requirement. The fact that these two requirements are different can readily be seen from the Mayo Clinic experience. For years, no informed consent forms were even used at the Mayo Clinic! The discussion of the indications, risks, and alternatives was documented in the surgeon’s notes and the fact that the patient showed up for the elective operation could be taken as the evidence of the adequacy of the informed consent process. Although this practice was acceptable to both surgeons and patients for years, the Clinic ultimately changed its practice in response to federal regulations that require the patient’s signature on an informed consent form.

Certainly, there is nothing inherently wrong with the practice of obtaining a signature from a patient on a consent form at the conclusion of the informed consent process. However, the current emphasis on the form itself has had a tendency for the process to be short changed in favor of getting the signature. The fact that both practicing surgeons and surgeons in training often slip into the habit of referring to the process solely by the form can frequently be seen. How often have we or our colleagues talked about "consenting the patient" when we really mean "obtaining informed consent from a patient"?

The Hopkins study serves to remind us that if we really take the process of obtaining informed consent from surgical patients as ethically important, we must be sure to give it the attention it deserves in our practice. If obtaining informed consent is central to the ethical practice of surgery, then why do we so often depend on the least experienced member of the surgical team to carry out this task right before surgery? Perhaps this practice does not reflect our devaluation of the informed consent process as much as a realization that if a patient scheduled for elective surgery has discussed the operation with the surgeon and has chosen to come to the hospital for the procedure, we can assume that the patient has already had a satisfactory consent process. In this context, the problem of the missing consent form is less an ethical issue than a clerical one that might be solved by eliminating the paper form and depending on technology for a solution.

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