Consent Forms: Documentation and Guidance

Abstract

As suggested in Chapter 8, there are multiple reasons that obtaining informed consent is mistakenly considered to be a discrete event occurring at a particular moment in a patient’s medical career, rather than a process that is (or should be) an integral part of the patient’s healthcare experience. Perhaps the most common reason for this mistaken view is that the consent form has become the symbol of informed consent. Some physicians, in fact, equate informed consent with a patient’s signature on the form. “Consenting the patient” has become a too familiar shorthand for seeking the patient’s authorization of treatment; behaviorally, “consenting the patient” often amounts merely to obtaining the patient’s signature, rather than facilitating an informed, voluntary decision. One critic observes that “with informed consent having its roots in the law, it is not surprising that the idea was implemented through legalistic approaches” and that, therefore, the pursuit of patient autonomy has “achieved an ethics in practice that revolves around the signing and filing of pieces of paper” . Informed consent is a process, not a form—without the process, the form is just a piece of paper. In the absence of the elements of informed consent, a signed consent form is largely worthless. If appropriate disclosure was not made, if the form’s signatory was not competent to understand the disclosure and make a decision, if the signatory signed the form but did not make a decision or understand what she signed, or if her signature was unduly pressured—the signed consent form will not serve any purpose. The continued focus on forms rather than the physician-patient interaction led one commentator to suggest that “instead of improving . . . consent forms, we should abolish consent forms—prohibit them by legal fiat as necessary” (2). Other commentators regard them as necessary evils (3). We believe that both of these positions are, at least, exaggerations. Properly designed, appropriately employed consent forms might be more than necessary evils. They could actually modestly enhance the informed consent process and promote its goals.