Before providing medical treatment, except for routine matters, the health care provider is required to obtain the patient’s informed consent. Although, the specific definition of informed consent may vary from state to state, it essentially means that a health care provider must tell a patient all of the potential risks, benefits, and alternatives involved in any surgical procedure, medical procedure, or other course of treatment, and must obtain the patient’s written consent to proceed. 

The Code of Medical Ethics, Opinion 2.1.1, states that “Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care. Successful communication in the patient-physician relationship fosters trust and supports shared decision making.”

The concept is based on the principle that a physician has a duty to disclose information to the patient so the patient can make a reasonable decision regarding treatment. Informed consent is both an ethical and legal obligation of medical practitioners in the United States and originates from the patient’s right to direct what happens to their body. Implicit in providing informed consent is an assessment of the patient’s understanding, rendering an actual recommendation, and documentation of the process. 

In the doctor-patient relationship, the doctor owes to the patient the duty of care and treatment with that degree of skill, care, and diligence as possessed by or expected of a reasonably competent physician under the same or similar circumstances. The “circumstances” include the area of medicine in which the physician practices, the customary or accepted practices of other physicians in the area, the level of equipment and facilities available at the time and in that locality, and the exigent circumstances, if any, surrounding the treatment or medical service rendered. 

Informed consent became a vital part of patients’ rights in the 1970s, as illustrated in the landmark case of Canterbury v. Spence, 464 F.2d. 772 (D.C. Cir. 1972). The court held in that case that “the patient’s right of self-decision shapes the boundaries of the [physician’s] duty to reveal.” The court found that a patient must be fully informed by the physician or other health care provider so that he or she can make an intelligent choice as to which medical procedure, if any, to undergo. Physicians must communicate to their patients information that is “material” to the decision at hand, including all risks associated with the procedure that might sway the patient’s decision. A risk is “material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy.” In other words, if a physician fails to inform a patient of risks that he or she knows are important or that may have an impact on the patient’s decision about the proposed therapy, then the physician is legally liable for not fully informing the patient.

The elements needed to establish informed consent may vary depending on the state, although the general principles are consistent. For example, the following components should be discussed and included in the written consent form:

In 2016, The Joint Commission Center for Transforming Healthcare identified the elements of informed consent as (1) the nature of the procedure, (2) the risks and benefits and the procedure, (3) reasonable alternatives, (4) risks and benefits of alternatives, and (5) assessment of the patient’s understanding of elements 1 through 4.

Ultimately, informed consent is designed to ensure that the health care provider makes it clear that the patient is participating in the decision-making process in a meaningful way, to avoid making the patient feel forced to agree with the provider, and provide the patient with sufficient information to make a reasonable decision regarding treatment. 

Experience and data show that brain injured victims frequently never know, or are never told, about either the extent of their injury; the statistics about untreated brain injuries; complications that accompany untreated brain injuries over time; nor alternatives to “standard of care.”

Informed Consent is a necessity for patients with a brain injury because it is vitally important that the health care provider inform the patient of the availability of proven, alternative therapies like Hyperbaric Oxygen Therapy (HBOT) to treat brain injuries. In our opinion, if the health care provider does not inform the patient of this option, the healthcare provider has failed to enable a patient to make an informed decision about how to proceed. Consequently, the patient is not being served and the health care provider is opening herself or himself up to a liability.

As we have discussed in previous blog posts, a concussion is a form of traumatic brain injury (TBI), a wound to the brain. The current medical standard of care for such brain injuries relies on a protocol that essentially recommends rest and little other medical intervention. We have known for decades that “the tincture of time: may allow a brain to get better or recover, but such care-management will not heal the brain.   

HBOT, on the other hand, has been proved to enhance several natural processes related to wound healing: it reduces inflammation, inhibits apoptosis (cell death), reduces Intracranial pressure; and promotes neurogenesis and angiogenesis. HBOT also promotes growth of new neuronic tissue and new blood vessels. The combination of oxygen (typically 100% O2) and pressure (varying, depending on the diagnosis) leads to the production of more stem cells available for wound healing as well. All this has been proven by rigorous, scientific studies that have explored the role of oxygen and pressure in the brain healing process. It is well established that HBOT aids tremendously in wound healing, typically 20-40 percent faster healing than the norm.

Because a physical wound to the brain is like a physical wound to soft tissue and any other organ in the body, it is imperative that HBOT be discussed as a potential treatment for a brain injury. This has not been done for many reasons. Although HBOT has already been approved by the FDA for certain types of wound healing (air embolism; arterial insufficiencies; compromised skin grafts and flaps; acute thermal burns; crush injuries; and other acute traumatic injuries that lead to oxygen and blood constriction), HBOT has not yet received FDA approval for brain injuries. Therefore, many believe that whether a doctor must inform a patient with a brain injury of the availability of HBOT is an open question. We disagree. HBOT has been shown to be a safe and effective off-label treatment for brain injuries. In a current Randomized Controlled Trial across more than a dozen hospitals in the US, doctors are investigating the use of HBOT for severe TBI. One of their published premises is that “Preclinical and clinical investigations strongly indicate that hyperbaric oxygen (HBO2) is physiologically active in improving the destructive processes in severe Traumatic Brain Injury (TBI).” The entire study at prestigious universities is to determine the most efficacious protocol for healing, not whether HBOT works. [See https://bit.ly/2SMXaA5 ] Thus, we believe that for the elements of informed consent to be met, a doctor must inform a patient with a brain injury of the availability of HBOT as a preeminent treatment.   

With regard to the use of medications or treatments off-label, generally, a doctor does not have a legal duty to inform a patient of a treatment or drug’s regulatory status and is obligated only to provide a patient with clinical information. However, medicine is a rapidly evolving profession and the trend appears to be to reduce the risk that patients consider themselves under-informed, and to protect against associated liability, doctors should expand their informed consent process to explicitly incorporate any off-label treatments. Nevertheless, you do not want to rely solely on this trend.

Instead, we recommend that you be your own advocate. Go to appointments with research showing that HBOT works. The FDA does not prohibit physicians from off-label prescriptions. Congress has repeatedly taken legal steps to prevent the FDA from interfering with the practice of medicine. Ask questions. Explain that you want to discuss HBOT as a treatment and if the doctor refuses, you are entitled to a second or third opinion.