Informed Consent: an Overview
We know you’ve heard the term “informed consent” many times before – and chances are you’re familiar with what it means – but we thought it’d be a good idea to give our policyholders a little “refresher” on the term so they’re absolutely sure they’re doing everything they can to be fully protected in the event of a lawsuit.
What is Informed Consent?
Informed consent is the legal doctrine affirming a patient’s right to determine and control his or her own medical treatment. In essence, it is the discussion that takes place between the physician who is rendering care and the patient. Specifically,
- It may not be delegated to any staff member. It is the responsibility of the treating physician to provide information and explanations that will assist patients in their decision-making process.
- In other words, the patient must be afforded the opportunity to evaluate adequate information before making a decision. The treating physician must advise the patient of reasonably foreseeable risks, benefits, and alternatives of the proposed treatment or procedure, including the option of no treatment and, specifically, the most severe and most frequent risks.
- Failure to procure an adequate informed consent from the patient can lead both to malpractice and professional misconduct charges and may also be an indication of inadequate communication. The patient’s consent must be voluntary, competent, and informed. The patient must have “capacity,” i.e. the ability to understand the nature and consequences of the treatment.
- Although a signed consent form is helpful in defense, a patient’s signature is not conclusive evidence of an informed consent discussion. The signed consent document merely confirms that such a discussion took place. If there is a witness to the consent document, he only confirms that the patient has read and understood the document, appeared to be competent for the purpose of consent, and has signed the form. That is why the discussion and documentation of it are so important.
Procedures Requiring Informed Consent
Although it is always good practice and important for a physician to explain to a patient the treatment he is rendering, obtaining an informed consent in New York State is only statutorily necessary if there is non-emergency treatment, procedure, or surgery, or, if a diagnostic procedure involves an invasion or disruption of the integrity of the body. A physician is not required to procure an informed consent for an emergency. If a physician is in doubt as to whether a diagnostic procedure requires informed consent, it is a good idea to err on the side of obtaining an informed consent.
Informed Consent and Minors
Generally, the New York statute states that children under the age of eighteen are minors. And, when the patient is a minor, consent for his medical treatment must be obtained from the parent or legal guardian. There are some exceptions:
- If there is an emergency and the person is in need of medical attention, and an attempt to secure consent would result in delay of treatment which would increase the risk to a person’s life or health, parental consent is not necessary;
- If a person is married or has borne a child, they can give consent for themselves as well as for the child;
- If a person is pregnant or sexually active, or has questions relating to sexual behavior, the person can give their own consent to the care and treatment rendered, e.g., abortion, contraception or treatment of STDs;
- Any person in a parental relationship to the child (as defined by the statute) may give consent for the immunization of a child, unless this person knows the child’s parent objects to the immunization;
- A minor may also consent for treatment or testing in other limited situations, e.g., for HIV testing and treatment, voluntary out-patient mental health assessment and treatment under certain circumstances, and a 17-year old may consent to give blood; and
- Any medical provider who acts in good faith, based on the representation by a person that he is eligible to consent, shall be deemed to have received effective consent.
In addition to having the consent formed signed, physicians should always write a note in the chart after they have had an informed consent discussion with the patient. The note should be dated and should include the following, “The risks, benefits, and alternatives, including no treatment, were discussed with the patient. The risks discussed included, but were not limited to . . .” and list a few of the most severe and a few of the most frequent risks or complications. Finally, note that “the patient understood, had all his/her questions answered, and consented to the treatment or procedure.” This type of documentation will confirm and be evidence that a discussion actually took place with the patient.