Professor Scott is Research Professor at the Health Law and Policy Institute, University of Houston Law Center, Tex.
The concept of informed consent arose from the idea of bodily autonomy. A physician has a duty to secure a patient's consent to treatment, the patient has the right to refuse treatment even against medical advice, and the patient has a right to be informed of the risks and benefits of the treatment, including unusual and/or undesirable outcomes and side effects. Initially, the law addressed lack of informed consent by a civil tort action of battery, and the patient only needed to plead and prove an "unconsented to touching."
Under current law, an action for failing to obtain informed consent is now ordinarily treated as a form of negligence. Physicians can be liable for failing to obtain consent altogether or exceeding consent that has been given. The law has struggled with the relevance of a patient's testimony, such as, "If I had known, I would never have consented"?the so-called lay, or materiality, standard. Alternatively, the "professional" standard looks to what information a reasonable physician would have provided a patient under similar circumstances.
Courts have been reluctant to make physicians the final arbiter of a patient's informational needs, yet have also recognized the difficulty in allowing a purely subjective law standard. How is the physician going to satisfy his duty if he does not know the extent of his patient's informational needs? Therefore, even jurisdictions that use the lay standard are likely to consider what information an "average" patient would need rather than looking solely at a particular patient.
The elements of legal informed consent are simple. The physician should disclose the nature of the procedure, the risks and hazards of the procedure, any alternative to the procedure that may be available, and the anticipated benefits of the procedure. Many states have even legislated the form and substance of required consent for common procedures. In Texas, the Medical Disclosure Panel prepares separate lists of those medical treatments and surgical procedures that do and do not require disclosure, and for those treatments and procedures that do require disclosure, the panel establishes the degree of disclosure required and the form in which the disclosure will be made.
Certain procedures require that consent be in writing, signed by the patient, and witnessed, which creates a rebuttable presumption of informed consent, and such an instruction would be given to the jury. A nurse may present the form, but the physician remains liable, and consent is a nondelegateable duty. It might be possible to rebut the presumption if, for example, the patient spoke a different language, was highly medicated, or illiterate. Therefore, although the law creates a substantial safe harbor for a physician who complies with the law, it would still be legally useful for the physician to have further evidence that a patient truly understood the informed consent she signed.
Informed consent is often treated solely as a legal requirement by physicians, yet principles of medical ethics may demand a higher standard. The gold standard ethically would be to fulfill all the patient's informational needs. Given the time constraints of modern medical practice, this may seem a lofty ideal, but technology may offer solutions that allow a physician to realize this high standard in a cost-effective way. At the same time, such technology could be used as a powerful tool to defend legal allegations that the patient was not adequately informed.
Consider, for example, a high-volume laser surgery facility performing hundreds of Lasik eye surgery procedures annually. Such facilities typically require potential patients to watch a detailed informational video recording that carefully explains the risks and benefits associated with the surgery, using sophisticated multimedia techniques. A written consent form simply cannot begin to explain the procedure as well as can be done through photographs, video, drawings, and carefully worded explanations. It is relatively inexpensive to have the video produced in multiple languages in clinics where the patient population warrants such an approach.
The patient's viewing of the video will undoubtedly be documented in her medical file along with a more typical informed consent form. If the patient later sues, claiming she didn't understand the risks of the surgery, the video can be shown to the jury as evidence that proper disclosures were made to the patient. More positively, the video allows the patient to understand enough about the procedure to intelligently discuss any concerns with her physician.
J Med Internet Res.
More sophisticated educational tools are being developed that can assist patients in making tough decisions about their care. One study examined an "interactive multimedia expert system," which is being developed to help patients diagnosed with prostate cancer (see Diefenbach MA, Butz BP. A multimedia interactive education system for prostate cancer patients: development and preliminary evaluation. 2004;6:e3). The system, called PIES (prostate interactive education system), allows the patient to virtually consult with a radiologist and/or a surgeon to seek information about treatment options. The patient can also access videos of other patients' experiences. The system is an "expert" system in that it follows the patient's movements within the system, and suggests that the patient view other areas for information when that patient has not been thorough in considering all medical options.
Systems such as PIES are not being developed as defensive legal medicine. However, there are legal implications arising from the eventual adoption of such systems. First, as in the example of the Lasik video, such systems could provide an effective defense against a charge that a patient was not adequately informed of treatment options or side effects. The flip side of this issue is that once such systems are more widely adopted, a patient could successfully argue that failure to use such a tool resulted in inadequate informed consent. Medical negligence cases have frequently arisen from the failure of a health care provider to utilize available technology.