Informed Consent [Template Included]

The legal definition of “informed consent” is the requirement that, prior to treating a patient, the doctor must provide adequate information concerning the possible risks, benefits, and alternatives to a particular procedure.  In Illinois, informed consent standards have arisen from both statutory (written laws) and common law (court cases).   Additionally, for any recommended “hands-on” procedures, including those on or near sensitive areas, the ICS strongly recommends including a physical description and patient acknowledgement of anticipated treatment.

Informed Consent

The Illinois Medical Patients Right Act (410 ILCS 50/3 establishes the right of each patient “to receive information concerning his or her condition and proposed treatment [and] to refuse any treatment to the extent permitted by law.” Under the healing art malpractice law, health professionals are held to a standard that requires them to inform a patient of consequences of a procedure if a “reasonable health professional” would have done so under the circumstances.

Additionally, courts have long held that doctors must obtain patient consent as a condition of providing medical care and treatment.  Historically, when doctors treated patients without obtaining legally valid consent, patients could bring civil damage lawsuits against the doctors on the theory of wrongful touching, or assault and battery.  This is still the law in Illinois in cases where there is a complete lack of consent to treatment, or where the treatment clearly extends beyond the scope of the patient’s consent. Of course, where the treatment crosses the line into inappropriate or wrongful touching, the doctor also may be criminally prosecuted.

Failure To Disclose Risks Of Treatment

A common basis for alleged malpractice is when   a patient who has consented to treatment makes a claim against a doctor for an injury due to a risk  that the doctor did not disclose prior to treatment.  Courts have allowed patients to sue doctors on a negligence theory in cases where the doctor fails to provide such information as would have been disclosed by the “reasonable medical practitioner of the same school, in the same or similar circumstances.”  (Green v. Hussey, 127 Ill. App.2d 174 (1970)).  

Usually, these cases involve a patient’s claim that he or she would have chosen not to undergo the procedure had the doctor adequately informed him or her of the risks and alternatives.  Illinois holds that the physician’s duty to disclose is dictated by the prevailing professional standard as established by expert testimony.  Thus, if the case goes to trial, the patient must present expert testimony to articulate the standard of disclosure, and the doctor would need to present a qualified expert (one with experience in the procedure at issue) to testify that the doctor met the standard for the procedure at issue.

It is clear that doctors must provide information concerning risks, benefits, and alternatives to treatment,  but what is the scope of the information the doctor must provide?  Illinois subscribes to the “material risk” standard; that is, doctors cannot be held to disclose every conceivable risk, but only those that are “material.”  (Miceikis v. Field, 37 Ill. App.3d 763 (1976)).  Generally, this means that the risk is reasonably foreseeable and could influence a patient to undergo or decline the procedure.  Further, once those material risks are disclosed, courts evaluate cases based on an objective standard, which is what a “reasonably prudent person” would have decided regarding a particular procedure, not necessarily what the actual patient states he or she would have decided if adequately informed by the doctor.  (Guebard v. Jabaay, 117 Ill. App.3d 1 (1983)). 

Cervical Manipulation

The above information regarding the disclosure of risk applies to all procedures that doctors recommend to their patients.  However, cervical manipulation is one particular procedure that warrants special attention, due to media reports of its alleged association with stroke.  Although the available empirical studies indicate the risk is small, the ICS suggests that physicians include in their consent forms as much accurate, specific, up-to-date information as possible on the subject.  The goal is not to dissuade a patient from undergoing a procedure, but simply to provide as much accurate information as is available so the patient may weigh risks and benefits, resulting in an informed decision.  As is the case with any procedure, the consent document protects you from a “failure to warn” malpractice claim that the patient would not have undergone the treatment if he or she had known the risks.

Failure To Follow Medical Advice 

Unlike the above-cited cases in which the patients followed medical advice but later claimed the doctor had not provided sufficient information, other cases may arise where the doctor provides appropriate information, but the patient is non-compliant with the doctor’s advice.  The question raised by our member pertains to the proper steps to take at the time the doctor renders his or her advice to protect both the doctor and patient should the patient subsequently suffer illness or injury due to the non-compliant patient.

Patients have a right to refuse treatment in Illinois (see Medical Patient Rights Act, 410 ILCS 50/3).  However, physicians are not liable for damages that result from a non-compliant patient’s choice not to follow medical advice.  Illinois is a “comparative negligence” state in which the plaintiff is barred from recovering damages from a doctor if the patient is found to be responsible for more than 50% of the cause of the injury (735 ILCS 5/2-1107.1).  

Thus, in the automobile accident case where the doctor recommends an MRI to the patient and the patient refuses, then is later found to have a herniated disk causing severe pain and motion limitation, then sues the doctor for failure to diagnose the herniated disk, the patient would not be able to prevail if the jury were to find that the patient himself contributed more than 50% to his injury by not undergoing the MRI and in so, being non-compliant with the doctor’s recommendation.

Another Category Requiring Special Handling: Innovative Techiques

Because chiropractic medicine is designed to assist patients without the use of drugs and surgery, it lends itself uniquely to innovative diagnostic and therapeutic procedures. Chiropractic physicians and their patients also tend to be more open-minded about considering them. However, if the technique is considered too experimental, the physician could be called to answer charges of dishonorable, unethical or unprofessional conduct. The doctor should always be sure that reliable, recognized empirical evidence exists to support the procedure. When an innovative procedure is used, the informed consent form is of particular importance to advise the patient and protect the physician. 

The written form should include the following: the doctor has explained that the procedure is not considered the primary standard of care for the condition in question; the doctor has explained which procedure is considered the primary standard of care; the doctor has explained the risks and benefits of undergoing this procedure, as well as the risks and benefits of other procedures that may be used under the conventional standard of care for the condition; the doctor may recommend additional testing or treatment; and the doctor may advise the patient to consult with other health care professionals where appropriate.

The form should also provide specific details about the use and indications for the procedures used in the particular case. If applicable, the form should include a statement that the patient has requested the specific innovative procedure. The form should state that the doctor has answered any questions the patient has had and that the patient has chosen to undergo the procedure of his or her own volition with a full understanding of the risks and benefits.

Sensitive Procedures

For sensitive procedures (for example, pelvic floor rehabilitation) or treatments on or near sensitive or private areas of the body (for example, a low spinal adjustment that requires the patient to partially disrobe), it is strongly recommended that the physician provide the patient with a clear description of the procedure, including the body parts involved, the physician action for the treatment, and the medical necessity for the treatment. The physician should include this information on the Informed Consent document, which the patient should sign and return to be maintained in the patient record.

Physicians who plan to perform a sensitive procedure may use the ICS template Informed Consent Form, check the box marked “Customizable,” and add a description of the procedure in the lines provided below the checklist of procedures.  Providing this information will give the patient a clear understanding of what to expect, as well as to alleviate any potential misunderstanding about why the treatment may involve contact with a sensitive area.  Following this guideline encourages patients to collaborate in an informed treatment decision, and serves as a risk management tool in minimizing patient surprise or complaint.

In addition, for sensitive procedures, patients should be offered the option of a chaperone.  Having such a choice supports the argument that the patient consented to the treatment with full information, understanding, and control.

Duty To Inform

What all of these cases have in common is that physicians have a duty to provide sufficient information about risks, benefits, and alternatives to recommended procedures. Prudent practice strongly suggests that physicians also should advise patients of the risks of being non-compliant and not following medical advice.  How, then, can chiropractic physicians best protect their patients and themselves?  Obviously, doctors must properly and clearly communicate with their patients. However, if that exchange is later called into question, documentation of the communication will be the key.  Because the Medical Practice Act does not dictate the specific form or content of such documentation, it is within the doctor’s discretion based on each individual case, but it is apparent that the more complete the documentation, the easier it will be for the doctor to prove in a specific case that he or she met his duty, should it become necessary to do so.

Conclusion

The ICS recommends that chiropractic physicians memorialize their communications in two ways:  all patients should sign a general consent to chiropractic care, in which they acknowledge that they have discussed chiropractic procedures with the doctor; that no results have been guaranteed; and that certain risks are possible.  The patients should acknowledge their understanding of the form by signing it, and the doctor should maintain the form in the patient file.  The doctor may tailor this general form to add specific treatments and procedures for particular patients, including, without limitation, a description of sensitive procedures and what to expect when treatments will be applied to or near sensitive areas.  Where the doctor deems necessary, he or she may add a statement acknowledging that the doctor has disclosed risks of not proceeding with recommended tests or procedures.   

In addition to the consent form, the doctor should note in the patient record all recommendations, including the risks, benefits, and alternatives to treatment.  The doctor should also enter a brief note where the patient indicates that he or she declines to follow medical advice and is non-compliant.  Although these forms of documentation need not be elaborate, they would provide good evidence to contradict a patient’s claim of illness or injury against a doctor for failure to properly treat a condition that arises later.

NOTE:  The ICS has made available to members a template Informed Consent Form, which incorporates a general consent, as well as specific disclosures regarding cervical manipulation and stroke.

Informed Consent Form (Spanish) This document was translated using Microsoft Word Translate and is provided as a courtesy only. The Illinois Chiropractic Society does not guarantee its accuracy and is not responsible for any errors or misinterpretations. By using this form, you agree to hold ICS harmless and indemnify us against any claims related to its use. Always consult a qualified translator or legal advisor before relying on this version.

Is Your Patient A Minor?

Here is a sample “Consent to Treatment of Minor Patient” form.
For more information, see our article on “Treating Minors in Illinois.