Practice of Medicine
Informed Consent is Not Just a Piece of Paper
The informed consent process is important before any procedure or long-term medication that carries significant risks and benefits. Documenting the details of consent discussions is important to avoid the risk of litigation.
- Guide conversations with patients regarding procedures utilizing informed consent forms that contain medical information specific to the procedure.
- Thoroughly document informed consent discussions with patients.
- Discuss treatment alternatives with the patient, including the risks of not performing the procedure.
Informed consent is a process; the informed consent document (or the term “surgical permit” in some instances) refers to the signed written document that affirms and memorializes the informed consent process. Informed consent should be given on the basis that a patient has a clear appreciation and understanding of the facts, implications and future consequences of an action. In order to give informed consent, the individual concerned must have adequate reasoning faculties and be in possession of all relevant facts at the time consent is given. Competency can also be alleged to be impaired if significant medications were given prior to the consent.
A well-designed informed consent should include:
- A description of the proposed procedure, including site and laterality
- The indications for the proposed procedure
- Material risks/side effects and benefits for the patient related to the procedure, the likelihood of each based on the available clinical evidence in the reasonable judgment of the practitioner
- Treatment alternatives, including not performing the procedure
- Who will conduct the procedure (exact names, not “associates”)
- Whether other practitioners, including but not limited to residents, will be performing important elements of the procedure, often defined as opening and closing, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, implanting devices and placing invasive lines
- Whether, as permitted by state law, qualified medical practitioners who are not physicians will perform important parts of the procedure; if so, the types of tasks that the practitioner will carry out and that such practitioners will be performing tasks within their scope of practice
The Medical Records CoP (42 CFR 482.24 (c) (2) (v)) also requires that the form contain the signature of the patient or their legal representative which should include the date and time of the signature as well as the signature of the practitioner who conducted the informed consent conversation, also with the date and time. There should also be witness signatures, with dates and times of the signatures.
We are now seeing many practitioners move toward procedure specific consent forms, so that the risks, benefits, alternatives, likelihood of success and recuperation information can be pre-populated. Some practitioners like this option and use the procedure specific forms to guide their conversations with patients. Some of these forms may need to be tailored to address state specific laws or regulations, so please make sure that your forms comply with your state’s rules and regulations.
The allegation of lack of informed consent is common in medical liability claims. Typical to these types of claims is a dispute over who said what and whether a particular side effect was discussed. International experts published a study in PLOS Medicine1, an open access journal for research on world health, which found that physicians in Australia routinely underestimate small risks that vex patients.
The research analyzed 481 medical liability claims in an effort to understand disputes in the process of obtaining informed consent. The authors found that almost half were disagreements over whether a particular side effect should have been discussed. The vast majorities of these cases were surgical procedures and revolved around five adverse outcomes: the resultant need for further surgery, poor cosmetic results, impaired vision or hearing, pain and infertility or sexual dysfunction.
The authors suggest that surgeons are often unsure what risks should be discussed prior to a procedure or treatment. Even though the research focused on Australian physicians, there are important points that apply to how we practice medicine here, what we need to know about informed consent and how to perform it properly.
In addition, the research found that doctors reported the most common cause for not going over a particular risk was the perception that the risks were too rare or that a specific risk was covered under the discussion of a more general risk. Approximately 90 percent of the disputes were around who said what and when, otherwise known as “he said, she said” disagreements.
“Documentation of the details of consent discussions in the lead-up to surgical procedures is particularly important, as the vast majority of informed consent disputes involve complications following operations,” stated the article. “Our findings suggest that doctors may underestimate the premium patients place on understanding the risks of them in advance of treatment...Improved understanding of these situations helps to spotlight gaps between what patients want to hear and what doctors perceive patients want (or should want) to hear. It may also be useful information for doctors eager to avoid medico-legal disputes.”
Proper Use of Informed Consent
The informed consent process is important prior to any procedure or long-term medication that carries significant risks and benefits. The informed consent document needs to be completed for specific procedures in many institutions prior to performing a procedure. Many states have very specific consent statutes with specific requirements. MagMutual recommends that the informed consent process is completed before the following:
- All surgical procedures usually requiring general or regional anesthesia
- Any other procedure usually requiring general or regional anesthesia
- Cerebral and coronary angiography
- Endoscopy/flex sigmoidoscopy
- All sterilization procedures
- Diagnostic procedures involving the injection of IV contract material
- Any procedure where the usual risk is substantially increased because of some aspect of the patient’s medical condition
- All plastic surgery procedures
- All surgical procedures upon the eye
- Needle biopsy of internal organs
- Allergy treatments (initial treatment)
- Treadmill tests
- Vaginal birth after C-section
- Long-term steroid therapy
- Long-term anticoagulation
While assistants and delegates can assist in providing educational materials and responding to questions, the essential step of assessing the six elements of informed consent should be completed by the person performing the procedure. This essential step should not be delegated. What should you disclose to the patient? Again, your state's law may have very specific requirements so please be sure to familiarize yourself with the legal requirements in your state. Certainly any common side effects should be mentioned. A substantial risk is one that a physician knows or that a reasonably careful physician should know would be important to the patient to understand in deciding whether to agree to a particular course of treatment. One question you might ask is “what would a reasonable person want to know prior to agreeing to this procedure?” In general, we recommend the following:
- Discuss the clinical issues, illness, injury or condition and the nature of the clinical decision.
- Discuss the nature of the treatment you suggest.
- Discuss the alternative, including doing nothing.
- Discuss the substantial risks, if any, involved in undergoing the treatment and the substantial risks, if any, of alternative treatments and the risks of not proceeding.
- After discussing, assess the patient's understanding.
- Explore the patient's preferences.
- Assess the patient’s understanding of the information you provide in the informed consent process and explore any questions or preferences they may have.
- Consider developing protocols for adding commonly asked questions and concerns mentioned by patients into the informed consent process.
- Document the questions and concerns regarding treatment raised by patients and note the explanations that the patient was provided.
Providers who fail to engage in adequate informed consent with a patient prior to treatment run the risk of negligence or assault and battery charges for unauthorized treatment. Claims brought for failing to provide adequate information regarding the risks and benefits of treatment are continuing to rise and defending against such claims can quickly become expensive.
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The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.