You are well prepared for your last consultation of the day. Your patient is an introspective philosophy professor who was referred to you by a local prosthodontist. His request is that you upright her mandibular second molars for future replacement of the absent first molars. There is no question that uprighting the second molars will improve her periodontal prognosis by eradicating the vertical osseous defects at their mesial roots. Support of her vertical dimension will also be significantly enhanced. In lay terms, you emphasize the need for devoted control of gingival inflammation to minimize the possibility of further bone loss as uprighting proceeds. You explain that although 1 option is to restore the missing teeth without orthodontic cotherapy, you also review the pros and cons of treatment to confirm that your service is worth her commitment.
The discussion lasts about a half hour, during which time you reiterate the array of treatment risks as delineated in your written consent form. The professor seems to be riveted to your every word and appears to follow your thought process. As the consultation finally concludes, she interjects with a question that almost floors you. “But Doctor,” she asks, “is there any benefit to orthodontic treatment for me?” Your jaw drops. You cannot determine whether you have miscommunicated or whether the professor’s mind was elsewhere during the entire consultation.
Informed consent—a corollary of the principle of autonomy—can be difficult to communicate effectively, even to the most astute listener. There is ample evidence that adults’ understanding and recall of informed consent discussions are often lacking, especially in elective procedures such as dentistry. In a meta-analysis comprising 19 studies, comprehension of orally presented treatment plans and their associated risks ranged between only 27% and 85% of the information provided in dentist-patient dialog. Recollection levels of the presented information was between 20% and 86%. Few patients were able to recall potential complications associated with their planned procedures. In a study of recollection of written informed consent involving extractions, 40% of the information disclosed in the informed consent was not understood.
Obtaining thorough and adequately comprehended consent in research involving human participants is even more challenging. Experts in drafting consent forms for human studies advocate that the document’s language level should be no more complex than that of an eighth grade vocabulary. This might not always be possible, given the complexity of some investigations. Even if this level of clarity is achieved, do potential participants and their parents understand the risks and benefits of the investigational studies in which they will enroll? Do we consistently respect an eager participant’s vulnerability? For example, in studies involving in-vivo debonding procedures, especially with ceramic brackets, do patients understand that even slight changes in enamel integrity are possible, the degree of which might vary with different debonding techniques? Should the patient fully comprehend this and does the informed consent process reflect this possibility?
Whether our interest is in treatment or research, informed consent must be provided with sufficient clarity and veracity for participants to make an educated decision regarding whether they wish to enlist. The participant must have sufficient opportunity to comprehend the procedure, preferably with enough time to contemplate the involvement.
The process of informed consent is just that: a process that will extend throughout the treatment or the study’s duration. Therefore, transparency for the duration of your relationship is paramount.
Your responsibility to the professor includes a another review of the treatment plan and its associated risks until you are convinced that she comprehends both to the level of a reasonable person. When the health of your patient is involved, no degree of obscurity—anytime during your contact with her—is too small.