For clinical audiologists performing cerumen removal, what is the level of informed consent recommended to best comply with ethical standards, statutory regulations, and liability concerns?
In general, informed consent must be obtained in circumstances when the patient does not expressly or impliedly know of the relevant risks and benefits of a particular diagnostic or treatment activity. In these cases, the provider must indicate to the patient, in a manner the patient can understand, what the proposed treatment activity is, the risks and benefits of the treatment, and the risk of doing nothing. This results in a patient's ''informed'' consent because he or she understands what kinds of associated risks and benefits are attendant to the clinical activity. In contrast, simple consent [e.g., ''just get the patient to sign the form''] is NOT informed and thus has no validity in the general law on informed consent. Informed consent also fulfills a provider's ethical obligations to the patient by allowing him or her full autonomy over his or her person by providing the relevant information to the patient so that he or she can determine whether a provider can render the services offered.
As to what the audiologist should discuss with the patient, the general legal rule of informed consent is that all aspects of the diagnostic or treatment activity that are ''material'' should be discussed.
What's material? Alas, this is not well defined, but audiologists and other health care providers should consider ''what information, if it came to fruition, would be seen as material in hindsight?'' This is the general question to consider because if an adverse event does occur, it will be seen and potentially defined by the patient, their lawyer, and perhaps the judge and jury as material.
Consider -- Even if the literature on the topic deems the probability of a negative consequence to be one in a million, the mantra ''It may be one in a million, but when it happens to you, it's 100 percent'' is impressive.
Further, even if you prevail legally, it will require months or perhaps years of very painful and very expensive legal and emotional costs to you and your family.
As to cerumen removal and any other procedure, the best thing to do is to know the facts. You should describe the procedure with regard to what you are going to do and what the patient may feel. Then, tell the patient the range of important clinical side effects that may occur and their incidence as noted in the literature. At this point, ask the patient if he or she has any questions or requires any clarification. If not, then you should indicate what you discussed with the patient on the ''informed consent'' form, and THEN
ask them to sign the form. NOTE: Work slowly and cautiously with your patient while explaining the issues. Patients generally do not sue if they have a good relationship with their provider.
This standard provides the best legal protections, serves to inform the patient in the most direct and honest manner, allows the patient full and complete control over his or her body, and fulfills the audiologist's ethical obligations to the patient regarding the clinical activity. Also, if the process and information are standardized with the most common clinical activities, rather than current practice which seems to be whatever the individual provider thinks is appropriate at that moment, quality of care and efficiency regarding consent for the specific procedure will go up.
Finally, it should be noted that informed consent is a subject typically addressed by state law, that is, the subject is generally outside federal requirements except for research studies. Thus, providers should ask their general counsel or other legal experts what the law is specifically in their state and what particular characteristics are important to consider in addition to the above approach.
However, being honest, up-front, and informed, and applying these characteristics to your patients regarding informed consent issues, will fulfill your ethical and legal obligations while establishing a strong diagnostic and therapeutic relationship with your patients.
Bryan A. Liang, MD, PhD, JD, is Arthur W. Grayson Distinguished Professor of Law & Medicine at Southern Illinois University Schools of Law and Medicine, Carbondale, Illinois. Dr. Liang is also the author of ''Health, Law and Policy: A Survival Guide to MedicoLegal Issues for Practitioners''. Published by Butterworth—Heinemann in Woburn, Massachusetts. Dr. Liang is currently (February, 2001) in Europe assisting in developing health care policies in the areas of managed care, medical liability, alternative dispute resolution, and patient safety.