Whether it is an annual wellness visit with a primary care physician, a trip to urgent care for an issue that develops on the weekend, or an emergency room visit for a severe illness or injury, you trust that the medical professionals assisting you have your best interests in mind and are recommending medications, procedures and treatments that will help you, not hurt you. While this may be true, it is still important that you remain in control of the care you receive and one way this happens is through informed patient consent. Sometimes, you may think you gave informed consent but you did not or you may know without a doubt that you did not. In those cases, your healthcare provider may have been negligent. An experienced medical negligence attorney with Erin Marshall Law may be able to review your records and assist you in determining whether you were denied the right to give informed consent and if so, what your legal rights and options are. Call (505) 218-9949 to book your consultation in our Albuquerque office.
What Is Informed Patient Consent?
Informed patient consent, which many people know as informed consent, is a process in which the communication between a patient and their physician results in the patient’s agreement or authorization to undergo a particular medical intervention, according to the American Medical Association’s Code of Medical Ethics. In this process, a healthcare provider informs the patient about a medical procedure or treatment for a condition. The information provided includes the nature and purpose of the procedure, the possible risks, expected benefits, and any alternative options available to the patient. This allows the patient to have the information they need to make informed decisions about their healthcare and to voluntarily accept the treatment suggested. Getting a patient’s informed consent is a legal and ethical obligation for healthcare providers, including doctors, advanced practice nurses, and physician’s assistants. Other healthcare professionals, such as registered nurses, may obtain informed consent, but they are typically doing so on behalf of the physician and the physician will likely be ultimately responsible for any failure to do so. Pharmacists are also required to get a patient’s verbal informed consent when offering patient counseling regarding prescriptions. Failure to get a patient’s informed consent may be a form of medical negligence.
In some cases, when a patient is presented with the information regarding the procedure or treatment, they decide they do not want the treatment. When this happens, it is called informed refusal.
Why Is Informed Consent and Informed Refusal Important?
Informed consent is crucial to patient autonomy. Patients have emotions, values, preferences, plans, and desires that may be impacted by their condition and any treatment or procedure they undergo. While one patient may be willing to undergo any treatment recommended by their doctor for a particular condition, another patient may feel that some treatments are too risky, or that the benefits do not outweigh the risks. They may simply feel that the benefits will not provide enough relief and therefore, the treatment is not something they want. Because of these differences between individuals, ensuring that each patient is given all the information regarding proposed procedures or treatments allows each patient to make a decision in alignment with their preferences and values.
Additionally, informed patient consent protects patients from harm by ensuring their awareness of potential risks before they consent to treatment. If the patient feels that a potential risk is not something they are willing to expose themselves to, they can decline the treatment. At the same time, it ensures that when the patient does accept the potential risk, they do so with full awareness of what they are agreeing to. However, giving consent with an understanding of the potential risks is not giving consent for the provider to be negligent. If the provider is negligent in other ways, the patient’s consent does not prevent them from pursuing legal action, even if the result is one of the risks that was explained to the patient prior to the procedure.
Key Elements of Informed Patient Consent
When a provider is getting informed patient consent, there are four key elements that must be present for the consent to be considered informed: disclosure, understanding, voluntary consent, and competency. If even one of these elements is missing, any consent obtained is not informed. That means the provider may be medically negligent if they accept that consent and move forward with the treatment.
Element #1: Disclosure
For the element of disclosure, the provider must clearly and accurately explain to the patient the purpose and nature of the procedure, any potential risks associated with it, and the benefits they expect the patient to receive from it. The provider must also explain any alternative options the patient may have, and must provide the same information regarding those alternatives. They must also explain the burdens, risks, and benefits of foregoing any treatment and living with the condition as it is.
To be considered a clear and accurate explanation, the provider should avoid complex medical jargon and instead use easy to understand, plain language. Interactive media and graphical tools, such as photo or cartoon narratives that explain the details may also ensure the information is presented clearly and accurately. Patients should also be encouraged to ask questions to ensure they get as much accurate and clear information as possible.
Element #2: Understanding
The second element of informed patient consent is understanding. This element means that once the provider has clearly and accurately disclosed the required information, the patient understands that information. When it comes to understanding, most people immediately think of conditions such as dementia, traumatic brain injuries (TBI), or mental health conditions that may interfere with an individual’s cognitive functioning and therefore, make it difficult for them to understand the information.
However, for informed patient consent, understanding goes beyond chronic conditions such as dementia or a TBI. For the patient to be considered as understanding their options, they also should not be cognitively impaired by medication (for example, informed consent cannot be given after the patient has been given a sedative to help them sleep), external stress such as family members or their healthcare providers, or personal emotional stress. Of course, many patients are emotionally stressed as a result of their condition and the treatment options being presented, which means that the provider must assess the patient and determine whether that stress rises to the level of impairing the patient’s ability to understand what they are agreeing to.
Element #3: Voluntary Consent
Voluntary consent is the third element of informed patient consent. In this context, voluntary means of the patient’s own free will and free mind. This not only means that the patient is not pressured or coerced by a medical professional, but also not pressured, coerced, or otherwise unduly influenced by a family member, caregiver, or other individual. While many patients may turn to loved ones to seek advice or opinions on what they should do, a medical provider should not accept the patient’s consent if they believe that it is the result of someone else forcing or convincing the patient to give that consent.
Element #4: Competency
The fourth element of informed patient consent, competency, means the patient must have the cognitive capacity to make decisions about their own healthcare. Capacity means the individual has the ability to process the information they are receiving and can communicate a meaningful response to that information. Legally, this also means that the patient is an adult (aged 18 or over) and has not been declared incompetent by a court or otherwise legally prohibited from exercising their decision-making capacity. Specifically, decision-making capacity means the patient is capable of understanding the risks, benefits, and alternatives to any proposed treatment and that they can make and communicate a decision regarding their healthcare.
In circumstances where the patient does not have decision-making capacity, healthcare providers should speak to their healthcare surrogate or the individual who makes healthcare decisions on behalf of the patient. If that person is not available, the healthcare provider should not move forward with treatment unless the circumstances fall under one of the exceptions to informed patient consent.
Potential Issues in Obtaining Informed Consent
The National Library of Medicine highlights several areas of concern in obtaining informed patient consent, some of which are particularly prevalent in New Mexico, where there are a variety of cultures living together and a significant healthcare provider shortage that continues to grow. If one of these issues resulted in you or a loved one undergoing a medical procedure without first giving informed consent, an experienced medical negligence attorney with Erin Marshall Law may be able to assist you in determining whether you have a case and what your next steps should be.
Lack of Patient Comprehension
Patient comprehension can be inhibited by complex medical language as well as the patient’s own health literacy level (ability to obtain, understand, and use health information to make informed decisions about their own well-being and health). If the provider does not use plain language that the patient can understand, they will not fully comprehend the information being provided. If the patient does not have a high level of health literacy, simplified language and unique methods of sharing information such as photos may be required to ensure the patient’s comprehension. If these steps are not taken, and the patient agrees to care without fully comprehending the information, the provider may be medically negligent.
Time Pressures
With New Mexico’s shortage of healthcare providers across all practice types, providers are often overbooked and rushing through appointments. This rush can cause them to speak too quickly to be understood, use complex language because it is easier and faster than determining how to rephrase it, or even try to skip over gaining informed patient consent altogether in their rush to move on to the next patient. This can leave the patient feeling uncertain or uninformed but pressured to give consent anyway. Instead, patients should be provided with a period to reflect on the information before making a decision. Patients who are not given this time can ask for a few minutes, or even hours or days, to consider the information before making a decision unless it is an emergency. However, even in an emergency, the patient can often have a few moments to consider the information and speak with a loved one before making their decision.
Cultural Differences
Cultural differences can be a significant barrier to informed patient consent. From immigrants who are hesitant to sign legal documents out of fear to cultures who make decisions as a group or see written consent as mistrustful, there are many cultural differences that can confuse or prevent informed consent. Being sensitive to these cultural differences is critical to gaining true informed consent. If patients are pressured to ignore their cultural concerns or beliefs to give consent, it is unlikely to be truly informed.
Language Barriers
The Migration Policy Institute indicates that as many as 50% of immigrants (both legal and undocumented) living in New Mexico and approximately 4% of United States-born residents do not speak English very well. If a healthcare provider is not proficient in the language their patient speaks, or does not have a translator, informed patient consent is not realistically possible. For consent to be informed, the patient must be able to understand the information provided, and they cannot understand that information if they do not speak the language in which it is provided. Patients who do not speak English very well can improve their chances of giving informed consent by seeking out providers who speak their native language or who provide translators, or by bringing a friend or relative who speaks English and can act as a translator.
Power Dynamics or Perceived Authority
Healthcare providers are often perceived as having authority over the patient, or being “in charge.” Their education, skill, and knowledge can inspire trust, but it can also intimidate some patients. In particular, vulnerable populations such as older or disabled individuals or those facing a scary diagnosis may feel even more dependent upon their provider. While providers must inform the patient of what they believe to be the best treatment option and the benefits and risks associated with it, they must use care to do so in a way that does not undermine the patient’s autonomy and push them to give consent.
Changing Medical Circumstances
Particularly in emergency situations, a patient’s medical circumstances can change quickly. What was appropriate at one moment can be ineffective the next. This means that a patient may give informed consent to one treatment and when their provider sees that there is a change in circumstances that warrants a different treatment, the provider should explain the change in circumstances and treatment to the patient to request informed consent again. However, in some instances, the provider will not do this and will assume or claim that the previously given informed patient consent covered the new circumstances and treatment.
Incomplete Disclosure
Informed patient consent requires the provider involved in the procedure to explain the nature and purpose of the procedure, the known risks and expected benefits, and any alternatives available. What is key about this disclosure is that this information may change from patient to patient depending on the nature of the procedure and other conditions the patient may have. The provider is also only expected to disclose those risks that are reasonably known to occur. This means that for a patient with a history of strokes, disclosing a risk of stroke would be required, but for a patient with no history of strokes and who is otherwise healthy, there may be no stroke risk to disclose. However, if the provider does not clearly disclose all the reasonably known potential risks, or other details that a patient would reasonably need to know in order to be an informed participant in the decision, they may be guilty of incomplete disclosure and potential medical negligence.
Inadequate Documentation
Just as it requires complete disclosure, informed patient consent also requires adequate documentation. While the patient’s signature on a consent form is a critical component of informed consent, adequate documentation should also include the nature of the procedure, risks, benefits, and alternatives written on the consent form. This allows patients to not only verbally hear the information from the provider, but to read it on the form. This can not only increase comprehension for some patients, but also allows the patient to ensure the information listed on the form is the same information they were given verbally.
Child Patients
Children, generally defined as those who are under age 18, cannot give informed patient consent. Instead, their parents must give consent, which is called informed permission. While it is easy to tell the difference between younger children and adults, it can prove more difficult with patients who are in their later teens. Providers should be confirming a patient’s age and in cases where the patient is under 18, getting permission from the parent. However, depending on the child’s age, the provider should be addressing both the parent and the child to allow the child an opportunity to express their concerns and feelings to their parent before a decision is made.
Additionally, while minors under 18 generally cannot give informed patient consent, some can. Legally emancipated minors, including mothers of children, married, serving in the military, or able to prove financial independence to a court, can give their own consent.
Patients With Impaired Decision-Making Capacity
Cognitive impairment, severe illness, and mental health conditions by themselves do not revoke an individual’s right to give informed consent, but they can complicate the situation. To give informed patient consent, the patient must be able to retain and understand information, evaluate their options, and effectively communicate their decision. If a cognitive impairment, severe illness, or mental health condition interferes with the patient’s ability to do any of those things, providers may need to involve legal guardians or healthcare surrogates.
Exceptions to Informed Patient Consent
While the majority of circumstances require informed patient consent, there are some exceptions that allow providers to proceed with treatment without it. These exceptions are deliberately narrow and carefully defined to avoid compromising patient rights and autonomy.
Instances in which the provider does not need to get informed consent include:
- The patient is incapacitated
- Life-threatening emergencies without enough time to obtain consent (if the patient has previously refused a specific treatment, this exception may not apply.)
- The patient voluntarily waives consent
- The patient has an advance care directive such as a living will that outlines their wishes for the care needed
- Therapeutic privilege (when the provider reasonably believes disclosing information about the condition or treatment would cause significant psychological harm and the patient’s health would be further jeopardized. This is extremely rare.)
- Court-ordered treatments or ones that are legally mandated
Proving Informed Consent Was Not Given
When a patient is subjected to a procedure or treatment without giving informed patient consent, the provider may be medically negligent. However, proving this negligence requires first proving that informed consent was not given. While the patient can certainly say that they did not give informed consent, they will need evidence to back up that statement. This can come from medical records, witness testimony, expert testimony, and second opinions.
Patient Testimony
The patient’s testimony regarding the events that occurred, their lack of understanding the information provided or the incomplete or missing disclosure, will be an important part of proving that informed patient consent was not given. They will be able to best explain their own state of mind, what they did or did not understand, whether they were given an opportunity to ask questions, and other details that will help show that they did not give informed consent. An important aspect of this testimony is accuracy, so patients who are concerned about not giving informed consent will want to take some time to write down a detailed account of what occurred while the memory is still fresh. They should include the names of the providers involved, details about the medical condition, the treatments or procedures offered, the questions they asked, and anything else they can recall. This will help ensure they do not forget these important details later.
Witness Testimony
Testimony from others who witnessed what happened can also be helpful. These witnesses can be other healthcare providers such as nurses or assistants, or they can be family or friends who were present with the patient. If the witnesses are healthcare providers or other individuals the patient does not personally know, they should get the names and contact information so they can contact them later. Additionally, like the patient, these witnesses may find it helpful to write down the details of what they saw and heard so they do not forget any important details.
Expert Testimony
Expert testimony may not specifically indicate whether the patient did or did not give informed patient consent. However, expert testimony can be used to provide insights into the standard of care in the circumstances that occurred and whether the provider’s actions were negligent. The standard of care is the level of care that a prudent and reasonable healthcare provider would give under similar circumstances. An expert witness can review the patient’s medical records, including the documentation (or lack of such documentation), and discuss whether the provider was negligent in meeting the standard of care.
Medical Records
The patient’s medical records can also be used to prove whether informed patient consent was given. Medical records should document the information provided to the patient. They should also document the patient’s understanding of that information. The New Mexico Healthcare Authority requires that patient records must include documentation showing properly executed informed patient consent. While missing or incomplete documentation does not necessarily prove the lack of informed patient consent or that the provider was negligent, it is strong evidence that may be used to prove one or both.
Second Opinions
Second opinions can be helpful in much the same way as expert testimony. Second opinions can review the patient’s medical records and any documentation regarding informed consent and evaluate whether the standard of care was met. Additionally, a second opinion may also provide insight into whether the proposed procedure or treatment was appropriate for the condition or whether an alternative may have been more suited to the circumstances.
How a New Mexico Medical Negligence Attorney May Help
Even when it is not an emergency, the world of healthcare can feel intimidating and overwhelming. With diagnoses that can be frightening, treatments and procedures that are invasive and may have significant risks, and often feeling as though decisions must be made immediately with no time to consider the options, many people simply agree to whatever their provider says. However, in most circumstances, you have the right to be informed about your condition, the recommended treatment or procedure, the risks and benefits associated with it, and alternative choices for treatment, including not treating the condition at all. You have the right to take some time to consider the information you have been given and to then make a decision. If you believe your right to give informed patient consent was violated, your healthcare provider may have been medically negligent. An experienced New Mexico medical negligence attorney may be able to assist you in getting your medical records, reviewing the circumstances and determining whether any consent you gave was informed or not, and finding expert witnesses or second opinions to assist in building your claim. Erin Marshall Law is prepared to review your case and determine whether we may be able to assist you. Call (505) 218-9949 and book your consultation to learn more about your legal rights and options.
