Medicare Conditions of Participation, which hospitals must meet in order to be reimbursed under the Medicare program, include informed consent requirements. The Joint Commission  accreditation standards also provide directives that require informed consent be obtained and that policies are provided to address informed consent. The law has identified that the physician/patient relationship is a consensual one. If the consent of the patient is not obtained, the physician may be held liable under the “legal theory” of battery. Thus, under Pennsylvania law, a physician is required to obtain full and voluntary informed consent for his/her patient concerning any non-emergency invasive procedure. More importantly than any law or regulatory directive, informed consent is a communication process that underscores the relationship between physician and patient and helps to ensure quality, safe patient care.

Many lawsuits include counts for lack of informed consent despite that the actual informed consent document is signed by the patient. Keep in mind that consent is more than a form and signature, it is a process. The process provides for the “prudent patient” standards which require that a physician disclose all the facts, risks, and alternatives that a reasonable person in this situation would deem significant in making the decision to undergo the recommended treatment. There does not need to be a bad outcome for an allegation of lack of informed consent. 

Informed consent is based on good communication and patient’s right to self-determination. It has not only a legal, but ethical component that can help to manage expectations. The purpose is to provide patients (or authorizing parities) with the necessary information, including risks and benefits to make an informed decision about a given procedure. Consent forms/notes may vary in appearance and the tool (written materials, video, audio) to provide education regarding a given procedure may vary, but the need to obtain consent never varies. There can be an exception when a true emergency exists and the patient is unable to give consent, appropriate parties cannot be reached, and the procedure is life saving.  The physician (not administration) can make a determination to do the procedure, but must make a detailed note in the patient chart.

Informed consent is obtained for numerous procedures. At minimum, Pennsylvania law requires informed consent be obtained for these procedures:

• Performing surgery
• Administering anesthesia
• Administering radiation or chemotherapy
• Administering blood transfusion
• Inserting a surgical device or appliance
• Administering an experimental medication, using an experimental device or using an approved medication/device in an experimental manner.

While nursing may witness the signing of consent form, they cannot obtain consent on behalf of the physician. The process of obtaining informed consent involves a discussion between patient and physician regarding: diagnosis, nature of proposed treatment, likelihood of success of proposed treatment and its risks and benefits, available alternatives (including no treatment) and their risks/benefits. If practitioners, other than the operating practitioner, including residents, will be performing important tasks related to the procedure, it should be acknowledged and their scope/responsibility shared with the patient. Additionally, the process should include an opportunity to ask questions and receive understandable answers and time to make an informed decision to consent or refuse treatment. The best way to test understanding is to ask the patient to summarize for you what you just discussed. This will allow you to revisit, if needed, the critical points the patient may have missed. 

A patient age 18 or older, deemed to have the capacity to consent by the physician, is the responsible party to give consent. When scenarios present when the patient does not have the capacity to provide consent then the appropriate party (Power of Attorney or next of kin) can give consent.