Informed Consent: Whose Responsibility Is It?

Informed Consent: Whose Responsibility Is It?

What is informed consent? Informed consent is an interactive process culminating in an agreement between a patient and a healthcare provider on a course of treatment. A signed consent form validates that the patient and provider have reached an agreement through this process. Lack of informed consent or battery is often alleged in medical malpractice claims. Battery occurs when a patient is treated or even touched without prior consent. In cases of battery, the treatment need not have been negligent or have caused an adverse outcome. The only negligence that need be shown is not having obtained the consent of the patient.

Lack of informed consent occurs when a physician does not provide adequate information to the patient to make an informed decision. The patient must demonstrate that if adequate information had been provided he or she would have made a different decision. The purpose of this article is to take the mystery out of the informed consent process, to explain an ambulatory surgery center (ASC)’s responsibility for validating consent, and to provide suggestions for inclusion in an ASC’s policies and procedures.

Elements of Informed Consent

The laws of informed consent vary from state to state. However, it is generally accepted that it is the physician’s duty to obtain the informed consent from each patient for each procedure. To satisfy this duty, the physician should disclose sufficient information in each of the following areas:

• The patient’s diagnosis 
• The patient’s prognosis 
• The proposed treatment 
• The risks and benefits associated with the proposed treatment 
• Any alternative treatments 
• The risks and benefits of the alternatives 
• The risks of forgoing treatment, should the patient refuse 

Depending on the state, the responsibility for signing the consent form, in other words, validating the consent, may rest with or be delegated to an ASC. ASCs should establish policies for this practice.

Things to keep in mind when doing so include:

• Only licensed professionals — nurses or physicians — should obtain and witness the patient’s signature 
• The conversation should be conducted in a private setting, such as the holding area, rather than in the waiting room, and before the patient has received any sedation 
• The patient should be asked to state the procedure he or she is consenting to and whether all of his or her questions have been satisfactorily answered 
• If a patient expresses unanswered questions or concerns, he or she should not sign the form until the physician has addressed all concerns

Documentation of the Informed Consent Process

In informed consent litigation, it is usually the content of the documentation that is at issue, rather than the location of the documentation (i.e., the medical record or on a form). There is debate regarding the way in which physicians should document what is disclosed and discussed with the patient. One school of thought is that physicians should list all of the information that was disclosed and the risks and benefits that were discussed. Critics of this method suggest that if a patient suffers a complication that is not listed, the physician may be subject to a claim of lack of informed consent. Alternatively, physicians may document informed consent in a more general way, such as stating “risks, benefits and alternatives discussed.” Critics of the latter method believe that it is too general and does not document enough of the consent process.

Although informed consent documentation is evaluated on a case-by-case basis, generally, the amount of documentation provided parallels the amount of protection gained. Therefore, physicians should consider including a list of information that was disclosed and discussed, along with a preliminary statement such as “including but not limited to.” Additionally, any aids, such as brochures, print material, or videos that were shown to the patient, should be documented.

Special Situations

Special situations that also require informed consent and should be disclosed to patients include:

• Students performing or participating in any procedure 
• The presence of equipment manufacturing representatives or other non-employees 
• The taking of photographs, videotaping or the production of slides 
• Procedures for the disposal of tissue or its use in grafts 
• Any procedure that is experimental, including clinical trials or institutional review board consents 
• The possibility of the need for and the administration of blood or blood products 

While it is generally accepted that the responsibility for engaging in the informed consent process with the patient lies with the physician who will be performing the procedure, ASCs may have a responsibility to validate that the process has been conducted to the patient’s satisfaction. ASCs should become familiar with the laws of their state and ensure that their policies are consistent with those laws.

In addition to legal protection, physicians and ASCs should embrace the informed consent process as a way to demonstrate concern for their patients. A well-performed consent process will make patients feel both informed and involved in their care, and may be the best medicine in warding off a medical malpractice claim. 

Darwin Professional Underwriters, Inc. provides specialty liability insurance solutions to the healthcare industry. Its healthcare experts provide tailored insurance programs to niche segments of the industry, like ASCs, that address specific coverage challenges and areas of exposure. It is Darwin’s goal to increase awareness of its specialized talents, products, and services, and to assist buyers in expecting more from their insurance partner. Darwin provides general risk management information as a service to its clients. This information is not meant to be legal advice. Consult your legal counsel or other professional in connection with insurance, claim, risk management, or other legal issues specific to your organization.