Q. What is informed consent? Does informed consent extend beyond the consent form itself?
A. Informed consent is both a discussion and a document. During the discussion of a proposed procedure, an ophthalmologist must disclose the risks, benefits, facts and alternatives to the procedure; verify the capacity of the patient to understand and assent to the procedure; and verify that the patient is there and undergoing the procedure voluntarily. Documentation establishes that this conversation happened, but should not be perceived as the only aspect of the informed consent process.
Q. Why should we implement an informed consent process?
A. Whenever a medical procedure is proposed, both good professional ethics and the law require that patient and physician discuss inherent risks and benefits. Beyond this, initiating practice guidelines for good informed consent processes can minimize patient surprise over adverse outcomes and help establish and maintain good patient-physician communication. This is particularly important, as a 1992 study has shown that two-thirds of all malpractice cases are associated with patient-physician communication breakdown.1
Q. Who is in charge of gathering informed consent from the patient? Do I have to do it, or can my office staff handle this?
A. The surgeon must be involved in the final discussion and documentation of the informed consent process. Staff members can provide patient education and can often provide the surgeon with insight into the patient’s expectations and level of understanding, but the ultimate responsibility for verifying informed consent rests with the surgeon.
Q. How is informed consent obtained and documented?
A. Numerous methods exist to provide and document informed consent. Educational brochures and videos are extremely useful for increasing the patient’s understanding of his condition and the proposed procedure. The patient’s medical record should reflect what materials and videos were provided. Consider asking the patient to sign a document indicating that she received the brochures, as well as having viewed and understood the video information. A signed consent form merely affirms in writing the patient’s understanding of the risks, benefits and alternatives to the proposed procedure.
Note that it is advisable that informed consent forms with multiple pages contain a patient initial on each page and a signature on the last page. This indicates that the patient had the opportunity to review each page and not just the final page of the form.
Q. When is informed consent obtained?
A. Timing depends on a variety of factors. Informed consent must include a discussion between the patient and the surgeon. Do not ask patients to sign a consent form until they have had a detailed discussion with the surgeon and their questions answered. After the discussion and educational information is provided, give the patient a copy of the consent form to take home, read and return, if possible. If the patient signs the consent form without the opportunity to take it home and review it, give the patient a signed copy for his records.
The informed consent discussion and the signing of the consent form require that the patient is alert, aware and able to participate in the process. Therefore, informed consent cannot be conducted after anesthesia induction or when the patient’s eyes are dilated to the point that reading ability is compromised.
Q. What information is required to consider the patient “informed”?
A. Legal requirements and case law have spelled out specific informed consent requirements in all 50 states; consult your local medical board for more information about your specific state laws. In general, the discussion should include patient diagnosis, the nature of and proposed treatment(s) or procedure(s), alternatives, risks and benefits of all the proposed and alternative treatment(s), and the risks and benefits of not pursuing any form of treatment. The process should also address any patient concerns, with room at the end of the form to document these concerns and physician response appropriately.
Procedure-specific consent forms are highly recommended, in order to convey only necessary information to the patient. These forms contain detailed information about the specific procedure and give patients substantive information. Patients sign the physician consent form in the physician’s office and it remains a part of the clinic medical record.
Q. Are patients expected to sign separate consent forms at hospitals and ambulatory surgery centers?
A. Yes. In addition to signing consent forms for the surgeon, patients also sign consent forms at the hospital or ASC. Facility consent forms address issues specific to the facility service, such as patient care preferences in the face of catastrophic injury, and are not specific to the risks and benefits of the proposed ophthalmic procedure. These forms are not a substitute for the physician’s consent form.
Q. Are there specific procedures that require informed consent?
A. All services you provide require consent. The question is how much and how to document it. Since the discussion between patient and provider is the most important aspect of informed consent, explaining what is being done and why remains a crucial aspect of patient care. Physicians typically have patients sign consent forms for major surgical procedures and tests with associated risks (e.g., fluorescein angiography). Minor procedures might not have a signed consent but, at a minimum, document verbal consent in the medical record.
Q. Where can physicians find prototype consent forms?
A. Some physicians write their own consent forms. Any physician writing his own consent forms should ask his malpractice company to review them for completeness and defensibility. Check with your malpractice carrier for consent forms; the malpractice carrier OMIC provides consent forms on its website at omic.com.
Q. What are some best practices to implement regarding the informed consent process?
A. There are several. You should set aside sufficient time for it and, if extensive, document the amount of time spent. Answer questions honestly and provide information in writing. It is also important to educate staff on the importance of the informed consent process. Finally, be sure that your informed consent forms are written in a language that is easily accessible to your patient population. The Centers for Disease Control and Prevention notes that nearly 90 percent of patients lack the necessary health literacy to fully understand everyday health-care information.2 For more information on writing in plain language, see nih.gov/clearcommunication.
Q. Are there things to avoid when providing informed consent?
A.Yes. Do not delegate the responsibility or rely only on the written consent form. Do not downplay procedural risk and never ignore unrealistic expectations. REVIEW
Ms. McCune is vice president of the Corcoran Consulting Group. Contact her at DMcCune@corcoranccg.com.
1. Hickson GB, Clayton PB, Giethen PE, Sloan FA. Factors that prompted families to file medical malpractice claims following perinatal injuries. J Am Med Assoc 1992;267:2359-1363.
2. Kutner M, Greenberg E, Jin Y, Paulsen C. The health literacy of america’s adults: Results from the 2003 national assessment of adult literacy (NCES 2006-483). U.S. Department of Education, National Center for Education Statistics; 2006.